105 CMR: DEPARTMENT OF PUBLIC HEALTH

105 CMR 120.000: THE CONTROL OF RADIATION

Section

120.001: GENERAL PROVISIONS

120.002: Purpose and Scope
120.003: Regulatory Authority
120.004: Citation
120.005: Definitions
120.006: Exemptions
120.007: Prohibited Uses
120.008: Impounding
120.009: Records
120.010: Inspections
120.011: Tests
120.012: Additional Requirements
120.013: Communications
120.014: Units of Exposure and Dose
120.015: Units of Activity

ENFORCEMENT
120.016: Enforcement Policy and Procedures
120.017: Severability
120.018: Public Disclosure of Enforcement Actions
120.019: Appendix A -- Severity Categories

120.020: REGISTRATION OF RADIATION MACHINE FACILITIES AND SERVICES

120.021: Purpose and Scope
120.022: Definitions
120.023: Exemptions
120.024: Plan Review
120.025: Application for Registration
120.026: Application for Registration Services
120.027: Certificate of Registration
120.028: Expiration of Notice of Registration
120.029: Renewal of Notice of Registration
120.030: Report of Changes
120.031: Approval Not Implied
120.032: Assembler and/or Transfer Obligation
120.033: Out-of-state Radiation Machines
120.040: Notification to Fire Department

120.050: PHYSICAL PROTECTION OF CATEGORY 1 AND CATEGORY 2 QUANTITIES OF

RADIOACTIVE MATERIAL
120.051: Purpose
120.052: Scope
120.053: Definitions
120.054: Communications
120.055: Specific Exemptions
120.056: Personnel Access Authorization Requirements for Category 1 or Category 2 Quantities of
Radioactive Materials

(MA REG. # 1373, Dated 9-7-18)

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.057: Access Authorization Program Requirements

120.058: Background Investigations
120.059: Requirements for Criminal History Records Checks of Individuals Granted Unescorted
Access to Category 1 or Category 2 Quantities of Radioactive Material
120.060: Relief from Fingerprinting, Identification, and Criminal History Records Checks and Other
Elements of Background Investigations for Designated Categories of Individuals Permitted
Unescorted Access to Certain Radioactive Materials
120.061: Protection of Information
120.062: Access Authorization Program Review
120.063: Security Progam
120.064: General Security Program Requirements
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Section: continued

120.065: LLEA Coordination

120.066: Security Zones
120.067: Monitoring, Detection, and Assessment
120.068: Maintenance and Testing
120.069: Requirements for Mobile Devices
120.070: Security Program Review
120.071: Reporting of Events
120.072: Additional Requirements for Transfer of Category 1 and Category 2 Quantities of
Radioactive Material
120.073: Applicability of Physical Protection of Category 1 and Category 2 Quantities of Radioactive
Material During Transit
120.074: Pre-planning and Coordination of Shipment of Category 1 or Category 2 Quantities of
Radioactive Material
120.075: Advance Notification of Shipment of Category 1 Quantities of Radioactive Material
120.076: Requirements for Physical Protection of Category 1 and Category 2 Quantities of
Radioactive Material During Shipment
120.077: Reporting of Events
120.078: Form of Records
120.079: Record Retention
120.080: Appendix A - Category 1 and Category 2 Radioactive Materials

120.100: LICENSING OF RADIOACTIVE MATERIAL

120.101: Purpose and Scope
120.102: Definitions
120.103: Source Material
120.104: Radioactive Material Other than Source Material
120.120: Types of Licenses
120.121: General Licenses - Source Material
120.122: General Licenses - Radioactive Material Other than Source Material
120.124: Filing Application for Specific Licenses
120.125: General Requirements for the Issuance of Specific Licenses
120.126: Special Requirements for Issuance of Certain Specific Licenses for Radioactive Material
120.127: Special Requirements for Specific Licenses of Broad Scope
120.128: Special Requirements for a Specific License to Manufacture, Assemble, Repair, or Distribute
Commodities, Products, or Devices Which Contain Radioactive Material
120.130: Issuance of Specific Licenses
120.131: Specific Terms and Conditions of Licenses
120.132: Expiration and Termination of Licenses and Decommissioning of Sites and Separate Buildings
or Outdoor Areas
120.133: Renewal of Licenses
120.134: Amendment of Licenses and Registration Certificates at Request of Licensee
120.135: Agency Action on Applications to Renew or Amend
120.136: Persons Possessing a License for Source, Byproduct, or Special Nuclear Material in Quantities
Not Sufficient to Form a Critical Mass on March 21, 1997
120.137: Persons Possessing Naturally Occurring and Accelerator-produced Radioactive Material
(NARM) on March 21, 1997
120.140: Transfer of Material
120.142: Reporting Requirements
120.146: Emergency Plan for Responding to a Release
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.150: Modification and Revocation of Licenses

120.190: Reciprocal Recognition of Licenses
120.195: Appendix A – Exempt Concentrations
120.196: Appendix B – Table 1 Exempt Quantities
Table II – Quantities for Use With 105 CMR 120.125(C)(1)
Table III – Quantities of Radioactive Materials Requiring Consideration of the Need for an
Emergency Plan for Responding to a Release
120.197: Appendix C – Limits for Broad Licenses
120.198: Appendix D – Criteria Relating to Use of Financial Tests and Parent Company Guarantees for
Providing Reasonable Assurance of Funds for Decommissioning
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Section: continued

120.198: Appendix E – Criteria Relating to Use of Financial Tests and Self Guarantees for Providing
Reasonable Assurance of Funds for Decommissioning
120.198: Appendix F – Criteria Relating to Use of Financial Tests and Self Guarantees for Providing
Reasonable Assurance of Funds for Decommissioning by Commercial Companies That Have No
Outstanding Rated Bonds
120.198: Appendix G – Criteria Relating to Use of Financial Tests and Self Guarantee for Providing
Reasonable Assurance of Funds for Decommissioning by Nonprofit Colleges, Universities, and
Hospitals

120.200: STANDARDS FOR PROTECTION AGAINST RADIATION

120.201: Purpose
120.202: Scope
120.203: Definitions
120.204: Implementation
120.210: Radiation Protection Programs
120.211: Occupational Dose Limits for Adults
120.212: Compliance with Requirements for Summation of External and Internal Doses
120.213: Determination of External Dose from Airborne Radioactive Material
120.214: Determination of Internal Exposure
120.216: Planned Special Exposures
120.217: Occupational Dose Limits for Minors
120.218: Dose Equivalent to an Embryo/Fetus

RADIATION DOSE LIMITS

120.221: Dose Limits for Individual Members of the Public

120.222: Compliance with Dose Limits for Individual Members of the Public
120.223: Testing for Leakage or Contamination of Sealed Sources

SURVEYS AND MONITORING

120.225: General
120.226: Conditions Requiring Individual Monitoring of External and Internal Occupational Dose
120.227: Control of Access to High Radiation Areas
120.228: Control of Access to Very High Radiation Areas
120.229: Control of Access to Very High Radiation Areas -- Irradiators
120.231: Use of Process or Other Engineering Controls
120.232: Use of Other Controls
120.233: Use of Individual Respiratory Protection Equipment
120.234: Further Restrictions on the Use of Respiratory Protection Equipment
120.235: Application for Use of Higher Assigned Protection Factors
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Section: continued

120.236: Security and Control of Licensed or Registered Sources of Radiation

120.237: Caution Signs
120.238: Posting Requirements
120.239: Exceptions to Posting Requirements
120.240: Labeling Containers and Radiation Machines
120.241: Exemptions to Labeling Requirements
120.242: Procedures for Receiving and Opening Packages
120.243: Vacating Premises

RADIOLOGICAL CRITERIA FOR LICENSE TERMINATION

120.244: General Provisions and Scope

120.245: Radiological Criteria for Unrestricted Use
120.246: Criteria for License Termination under Restricted Conditions
120.247: Alternate Criteria for License Termination
120.248: Public Notification and Public Participation
120.249: Minimization of Contamination
120.251: General Requirements
120.252: Method for Obtaining Approval of Proposed Disposal Procedures
120.253: Discharge by Release into Sanitary Sewerage
120.254: Treatment or Disposal by Incineration
120.255: Disposal of Specific Wastes
120.256: Transfer for Disposal and Manifests
120.257: Compliance with Environmental and Health Protection Regulations
120.258: Disposal of Certain Byproduct Material

RECORDS
120.261: General Provisions
120.262: Records of Radiation Protection Programs
120.263: Records of Surveys
120.264: Records of Tests for Leakage or Contamination of Sealed Sources
120.265: Determination and Records of Prior Occupational Dose
120.266: Records of Planned Special Exposures
120.267: Records of Individual Monitoring Results
120.268: Records of Dose to Individual Members of the Public
120.269: Records of Waste Transfers
120.270: Records of Testing Entry Control Devices for Very High Radiation Areas
120.271: Form of Records

REPORTS

120.281: Reports of Stolen, Lost, or Missing Licensed or Registered Sources of Radiation

120.282: Notification of Incidents
120.283: Reports of Exposures, Radiation Levels, and Concentrations of Radioactive Material Exceeding
the Constraints or the Limits
120.284: Reports of Planned Special Exposures
120.285: Reports to Individuals of Exceeding Dose Limits
120.286: Reports of Individual Monitoring
120.287: Notifications and Reports to Individuals
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.288: Reports of Leaking or Contaminated Sealed Sources

120.290: Reports of Transactions Involving Nationally Tracked Sources
120.295: Appendix A – Assigned (APF) Protection Factors for Respiratorsa
120.296: Appendix B – Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of
Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release
to Sanitary Sewerage
120.297: Appendix C – Quantities1 of Licensed Material Requiring Labeling
120.298: Appendix D – Nationally Tracked Source Thresholds
120.299: Appendix E – Classification and Characteristics of Low-level Radioactive Waste
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Section: continued

120.300: RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC

OPERATIONS
120.301: Purpose and Scope
120.302: Definitions
120.303: Exemptions
120.305: Licensing and Registration Requirements for Industrial Radiographic Operations
120.310: Records of Receipt, Transfer, and Disposal of Sources of Radiation
120.311: Limits on Levels of Radiation for Radiographic Exposure Devices, Source Changers, and
Transport Containers
120.312: Locking of Sources of Radiation, Storage Containers and Source Changers
120.314: Radiation Survey Instruments
120.315: Performance Requirements for Industrial Radiography Equipment
120.316: Quarterly Inventory
120.317: Utilization Logs
120.318: Inspection and Maintenance of Radiation Machines, Radiographic Exposure Devices, Transport
and Storage Containers, Associated Equipment, Source Changers, and Survey Instruments
120.319: Permanent Radiographic Installations

RADIATION SAFETY REQUIREMENTS

120.320: Training and Testing

120.321: Applications and Examinations
120.322: Revocation or Suspension of an I.D. Card
120.323: Personnel Monitoring
120.325: Operating and Emergency Procedures
120.326: Supervision of Radiographer Trainee
120.328: Conducting Industrial Radiographic Operations
120.331: Surveillance
120.332: Posting
120.333: Radiation Surveys and Survey Records
120.334: Records Required at Temporary Job Sites
120.337: Special Requirements and Exemptions for Enclosed Radiography
120.340: Underwater and Lay-barge Radiography
120.350: Prohibitions

RECORDKEEPING REQUIREMENTS

120.360: Records for Industrial Radiography

120.361: Records of Receipt, Transfer, and Disposal of Sources of Radiation
120.362: Records of Radiation Survey Instruments
120.363: Records of Leak Testing of Sealed Sources and Devices Containing DU
120.364: Records of Quarterly Inventory
120.365 Utilization Logs
120.366: Records of Inspections and Maintenance of Radiation Machines, Radiographic Exposure Devices,
Transport and Storage Containers, associated Equipment, Source Changers, and Survey
Instruments
120.367: Records of Alarm System and Entrance Control Tests at Permanent Radiographic Installations
120.368: Records of Training and Certification
120.369: Copies of Operating and Emergency Procedures
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.370: Records of Personnel Monitoring

120.371: Records of Radiation Surveys
120.372: Form of Records
120.373: Location of Documents and Records
120.380: Radiation Safety Officer
120.385: Notification of Incidents
120.390: Reciprocity

120.400: X-RAYS IN THE HEALING ARTS

120.401: Purpose and Scope
120.402: Definitions
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Section: continued

120.403: General Requirements

120.404: General Requirements for All Diagnostic X-ray Systems
120.405: Fluoroscopic X-ray Systems
120.406: Diagnostic X-ray Systems
120.407: Dental Radiographic Systems
120.408: Veterinary X-ray Systems
120.409: Computed Tomography (CT) X-ray Systems
120.410: Bone Densitometry
120.420: Appendix A -- Radiation Shielding and Safety Requirements
120.421: Appendix B -- Information to be Submitted by Persons Proposing to Conduct Healing Arts
Screening
120.422: Appendix C -- Design Requirements for an Operator's Booth
120.423: Appendix D --Exemptions from Shielding for Certain Fluoroscopic Procedures

120.430: THERAPEUTIC RADIATION MACHINES IN THE HEALING ARTS

120.431: Purpose and Scope
120.432: Definitions
120.433: General Administrative Requirements for Facilities Using Therapeutic Radiation Machines
120.434 General Technical Requirements for Facilities Using Therapeutic Radiation Machines
120.435: Written Directives
120.436: Therapeutic Radiation Machines of Less than 500 kV
120.437: Therapeutic Radiation Machines - Photon Therapy Systems (500 kV and Above) and Electron
Therapy Systems (500 keV and Above)
120.438: Calibration of Survey Instruments
120.439: Shielding and Safety Design Requirements
120.440: Appendix A: Information on Radiation Shielding Required for Plan Reviews

120.500: USE OF RADIONUCLIDES IN THE HEALING ARTS

120.501: Purpose and Scope
120.502: Definitions
120.503: Maintenance of Records
120.504: Provisions for Research Involving Human Subjects
120.505: Implementation
120.506: License Required
120.507: Application for License, Amendments, or Renewal
120.508: License Amendments
120.509: Notifications
120.510: Exemptions Regarding Type A Specific Licenses of Broad Scope
120.511: License Issuance
120.513: Specific Exemptions
120.515: Authority and Responsibilities for the Radiation Protection Program
120.517: Radiation Protection Program Changes
120.518: Duties of Authorized User and Authorized Medical Physicist
120.519: Supervision
120.520: Visiting Authorized User, Visiting Authorized Nuclear Pharmacist or Visiting Medical Physicist
120.521: Written Directives
120.522: Procedures for Administrations Requiring a Written Directive
120.523: Suppliers for Sealed Sources or Devices Containing Sealed Sources for Medical Use
120.524: Training for Radiation Safety Officer
120.525: Training for Authorized Medical Physicist
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.526: Training for an Authorized Nuclear Pharmacist

120.528: Training for Experienced Radiation Safety Officer, Teletherapy or Medical Physicist, Authorized
Medical Physicist, Authorized User, Nuclear Pharmacist, and Authorized Nuclear Pharmacist
120.529: Recentness of Training
120.531: Quality Control of Diagnostic Equipment
120.532: Possession, Use, and Calibration of Instruments used to Measure the Activity of Unsealed
Radioactive Material
120.533: Calibration of Survey Instruments
120.534: Determination of Dosages of Unsealed Radioactive Material for Medical Use
120.535: Authorization for Calibration, Transmission and Reference Sources
120.536: Requirements for Possession of Sealed Sources and Brachytherapy Sources
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Section: continued

120.537: Labeling of Vials and Syringes

120.539: Surveys for Ambient Radiation Dose Rate and Contamination
120.540: Release of Individuals Containing Unsealed Radioactive Material or Implants Containing
Radioactive Material
120.541: Provision of Mobile Medical Service
120.542: Storage of Volatiles and Gases
120.543: Decay-in-storage
120.544: Use of Unsealed Radioactive Material for Uptake, Dilution, or Excretion Studies for which a
Written Directive is not Required
120.545: Possession of Survey Instrument
120.546: Training for Uptake, Dilution, and Excretion Studies
120.547: Use of Unsealed Byproduct Material for Imaging and Localization Studies for which a Written
Directive is not Required
120.548: Radionuclide Contaminants
120.551: Training for Imaging and Localization Studies
120.552: Use of Unsealed Byproduct Material for which a Written Directive is Required
120.553: Safety Instruction
120.554: Safety Precautions
120.556: Training for Use of Unsealed Byproduct Material for which a Written directive is Required
120.557: Training for the Oral Administration of Sodium Iodide I-131 in Quantities Less than or Equal to
1.22 Gigabequerels (33 millicurie) for which a Written Directive is Required
120.558: Training for the Oral Administration of Sodium Iodide I-131 in Quantities Greater than 1.22
Gigabequerels (33 millicurie) for which a Written Directive is Required
120.558A: Training for the Parenteral Administration of Unsealed Byproduct Material Requiring a Written
Directive
120.559: Use of Sealed Sources for Manual Brachytherapy
120.560: Surveys After Source Implant and Removal
120.561: Brachytherapy Sources Accountability
120.562: Safety Instruction
120.563: Safety Precautions for Patients or Human Research Subjects Receiving Brachytherapy
120.564: Calibration Measurement of Brachytherapy Sealed Sources
120.565: Therapy-related Computer Systems
120.566: Training for Use of Manual Brachytherapy Sources
120.567: Training for Ophthalmic Use of Strontium-90
120.568: Sealed Sources for Diagnosis
120.569: Training for Use of Sealed Sources for Diagnosis
120.570: Use of Sealed Sources in a Remote Afterloader Unit, Teletherapy Unit, or Gamma Stereotactic
Radiosurgery Unit
120.571: Surveys of Patients and Human Research Subjects Treated with Remote Afterloader Unit
120.572: Installation, Maintenance, Adjustment, and Repair
120.573: Safety Procedures and Instructions for Remote Afterloader Units, Teletherapy Units, and Gamma
Stereotactic Radiosurgery Units
120.574: Safety Precautions for Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic
Radiosurgery Units
120.575: Dosimetry Equipment
120.576: Full Calibration Measurements on Teletherapy Units
120.577: Full Calibration Measurements on Remote Afterloader Units
120.578: Full Calibration Measurements on Gamma Stereotactic Radiosurgery Units
120.579: Periodic Spot-checks for Teletherapy Units
120.580: Periodic Spot-checks for Remote Afterloader Units
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.581: Periodic Spot-checks for Gamma Stereotactic Radiosurgery Units

120.582: Additional Technical Requirements for Mobile Remote Afterloader Units
120.583: Radiation Surveys
120.584: Five Year Inspection for Teletherapy and Gamma Stereotactic Radiosurgery Units
120.585: Therapy-related Computer Systems
120.587: Training for Use of Remote Afterloader Units, Teletherapy units, and Gamma Stereotactic
Radiosurgery Units
120.589: Other Medical Uses of Radioactive Material or Radiation from Radioactive Material
120.590: Requirements for Record Keeping
120.592: Requirements for Record Keeping Pertaining to the Use of Sealed Sources
120.594: Reports and Notifications
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Section: continued

120.600: RADIATION SAFETY REQUIREMENTS FOR ANALYTICAL X-RAY EQUIPMENT

120.601: Purpose and Scope
120.602: Definitions
120.603: Equipment Requirements
120.604: Area Requirements
120.605: Operating Requirements
120.606: Personnel Requirements

120.620: LICENSING AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS

120.621: Purpose and Scope
120.622: Definitions
120.631: Application for a Specific License
120.633: Specific Licenses for Irradiators
120.635: Commencement of Construction
120.637: Applications for Exemptions
120.639: Request for Written Statements
120.641: Performance Criteria for Sealed Sources
120.643: Access Control
120.645: Shielding
120.647: Fire Protection
120.649: Radiation Monitors
120.651: Control of Source Movement
120.653: Irradiator Pools
120.655: Source Rack Protection
120.657: Power Failures
120.659: Design Requirements
120.661: Construction Monitoring and Acceptance Testing
120.671: Training
120.673: Operating, Safety, and Emergency Procedures
120.675: Personnel Monitoring
120.677: Radiation Surveys
120.679: Detection of Leaking Sources
120.681: Inspection and Maintenance
120.683: Pool Water Purity
120.685: Attendance During Operation
120.687: Entering and Leaving the Radiation Room
120.689: Irradiation of Explosive or Flammable Materials
120.691: Records and Retention Periods
120.693: Reports

120.700: RADIATION SAFETY REQUIREMENTS FOR PARTICLE ACCELERATORS

120.701: Purpose and Scope
120.702: Registration Requirements
120.703: General Requirements for the Issuance of a Registration for Particle Accelerators
120.704: Human Use of Particle Accelerators
120.705: Limitations
120.706: Shielding and Safety Design Requirements
120.707: Particle Accelerator Controls and Interlock Systems
120.708: Warning Devices
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.709: Operating Procedures

120.710: Radiation Monitoring Requirements
120.711: Ventilation Systems

120.750: NOTICES, INSTRUCTIONS, AND REPORTS TO WORKERS; INSPECTIONS

120.751: Purpose and Scope
120.752: Posting of Notices to Workers
120.753: Instructions to Workers
120.754: Notifications and Reports to Individuals
120.755: Presence of Representatives of Licensees or Registrants and Workers During Inspection
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Section: continued

120.756: Consultation with Workers during Inspections

120.757: Requests by Workers for Inspections
120.758: Inspections Not Warranted; Informal Review
120.760: Emergency Plans

120.770: TRANSPORTATION OF RADIOACTIVE MATERIAL

120.771: Purpose and Scope
120.772: Definitions
120.773: Requirement for License
120.774: Transportation of Licensed Material
120.775: Exemptions
120.776: General Licenses for Carriers
120.777: General License: Nuclear Regulatory Commission - Approved Packages
120.779: General License: U.S. Department of Transportation Specification Container
120.780: General License: Use of Foreign Approved Package
120.781: General License: Fissile Material, Limited Quantity per Package
120.782: General License: Plutonium Beryllium Special Form Material
120.783: External Radiation Standards for All Packages
120.784: Assumptions as to Unknown Properties of Fissile Material
120.785: Preliminary Determinations
120.786: Routine Determinations
120.787: Air Transport of Plutonium
120.788: Opening Instructions
120.789: Records
120.790: Advance Notification of Shipment of Nuclear Waste
120.791: Quality Assurance Requirements
120.792: Quality Assurance Organization
120.793: Quality Assurance Program
120.794: Changes to Quality Assurance Program
120.795: Corrective Action
120.796: Quality Assurance Records
120.797: Audits
120.798: Appendix A – Determination of A1 and A2

120.800: LICENSING AND OPERATIONAL REQUIREMENTS FOR LOW-LEVEL RADIOACTIVE

WASTE FACILITIES
120.801: Purpose and Scope
120.802: Regulatory Authority
120.803: Definitions
120.810: General Requirements
120.811: Protection of the General Population from Releases of Radioactivity
120.812: Protection of Individuals from Inadvertent Intrusion
120.813: Protection of Individuals during Operations
120.814: Stability of the Facility after Closure
120.815: Facility Design
120.816: Facility Institutional Control
120.820: License Required
120.821: Licensing Process
120.822: Content of Application
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.823: General Information

120.824: Specific Technical Information
120.825: Technical Analyses
120.826: Institutional Information
120.827: Financial Information
120.828: Preoperational Environmental Monitoring
120.829: Standards for Issuance of a License
120.830: Conditions of Licenses
120.831: Environmental Monitoring
120.832: Facility Design
120.833: Facility Construction
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Section: continued

120.834: Operating Budget Reimbursements

120.840: Facility Opening
120.841: Facility Operation
120.842: Receipt, Handling, and Inspection of Waste
120.843: Facility Boundaries and Markers
120.844: Contingency Plans for Facility Operations
120.845: Facility Maintenance
120.850: Funding for Facility Closure
120.851: Application for Renewal or Closure
120.852: Procedures for Review of Application for Facility Closure and Closure Plan
120.853: Facility Closure
120.860: Post-closure Observation and Maintenance
120.870: Transfer of License
120.871: Institutional Control
120.880: Maintenance of Records, Reports, and Transfers
120.881: Tests on Facilities
120.882: Department Inspection of Facilities
120.885: Waivers

120.890: LOW-LEVEL RADIOACTIVE WASTE MINIMIZATION REGULATIONS GENERAL

PROVISIONS
120.891: Purpose and Scope
120.892: Regulatory Authority
120.893: Definitions
120.895: Objectives
120.896: Statement and Plan Requirements
120.897: Waste Minimization Plan Content

120.900: RADIATION SAFETY REQUIREMENTS FOR WIRELINE SERVICE OPERATIONS

AND SUBSURFACE TRACER STUDIES
120.901: Purpose and Scope
120.902: Definitions
120.903: Licensing and Registration Requirements for Wireline Service Operations
120.904: Agreement with Well Owner or Operator
120.911: Labels, Security, and Transport Requirements
120.914: Radiation Survey Instruments
120.915: Leak Testing of Sealed Sources
120.916: Physical Inventory
120.917: Utilization Records
120.918: Design, Performance, and Certification Criteria for Sealed Sources Used in Downhole
Operations
120.920: Inspection, Maintenance and Opening of a Source or Source Holder
120.922: Handling Tools
120.923: Subsurface Tracer Studies
120.924: Radioactive Markers
120.925: Uranium Sinker Bars
120.926: Use of a Sealed Source in a Well without a Surface Casing
120.927: Energy Compensated Sources
120.928: Tritium Neutron Generator Target Source
120.929: Particle Accelerators
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.931: Training Requirements

120.932: Operating and Emergency Procedures
120.933: Personnel Monitoring
120.941: Radiation Surveys
120.951: Security
120.952: Documents and Records Required at Field Stations
120.953: Documents and Records Required at Temporary Jobsites
120.954: Notification of Incidents, Abandonment, and Lost Sources
120.960: Appendix A – Subjects to Be Included in Training Courses for Logging Supervisors
120.961: Appendix B – Example of Plaque for Identifying Wells Containing Sealed Sources Containing
Radioactive Material Abandoned Downhole
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.001: GENERAL PROVISIONS

120.002: Purpose and Scope

Except as otherwise specifically provided, 105 CMR 120.000 apply to all persons who
receive, possess, use, transfer, own, or acquire any source of radiation; provided, however, that
nothing in 105 CMR 120.000 shall apply to any person to the extent such person is subject to
regulation by the U.S. Nuclear Regulatory Commission (NRC). Regulation by the
Commonwealth of source material, byproduct material, and special nuclear material in quantities
not sufficient to form a critical mass is subject to the provisions of the agreement between the
State and the NRC and to 10 CFR Part 150 of the NRC's regulations.

120.003: Regulatory Authority

The authority for the Department of Public Health to promulgate 105 CMR 120.000 is found
in: M.G.L. c. 111, §§ 3, 5M, 5N, 5O, and 5P.

120.004: Citation

105 CMR 120.000 shall be known and may be cited as the Massachusetts Regulations for
the Control of Radiation (MRCR).

120.005: Definitions

As used in 105 CMR 120.000, these terms have the definitions set forth in 105 CMR
120.005. Additional definitions used only in a certain Section will be found in that Section.

105 CMR 120.000 means all Sections of the Massachusetts Regulations for the Control of
Radiation.

Absorbed Dose means the energy imparted by ionizing radiation per unit mass of irradiated
material. The units of absorbed dose are the gray (Gy) and the rad.

Accelerator means any machine capable of accelerating electrons, protons, deuterons, or other
charged particles in a vacuum and of discharging the resultant particulate or other radiation into
a medium at energies usually in excess of 1 MeV. For purposes of Accelerator, "particle
accelerator" is an equivalent term.

Accelerator-produced Material means any material made radioactive by a particle accelerator.

Activity means the rate of disintegration or transformation or decay of radioactive material. The
units of activity are the becquerel (Bq) and the curie (Ci).

Adult means an individual 18 years of age or older.

Agency means the Radiation Control Program of the Massachusetts Department of Public
Health.

Agreement State means any State with which the U.S. Nuclear Regulatory Commission or the
U.S. Atomic Energy Commission has entered into an effective agreement under § 274b of the
Atomic Energy Act of 1954, as amended (St. 1973, c. 689).
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Airborne Radioactive Material means any radioactive material dispersed in the air in the form
of dusts, fumes, particulates, mists, vapors, or gases.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.005: continued

Airborne Radioactivity Area means a room, enclosure, or area in which airborne radioactive
materials exist in concentrations:
(a) In excess of the derived air concentrations (DACs) specified in 105 CMR
120.200: Appendix B, Table I; or
(b) To such a degree that an individual present in the area without respiratory protective
equipment could exceed, during the hours an individual is present in a week, an intake of
0.6% of the annual limit on intake (ALI) or 12 DAC- hours.

Airline Respirator (see Supplied-air Respirator (SAR)).

Air-purifying Respirator means a respirator with an air-purifying filter, cartridge, or canister that
removes specific air contaminants by passing ambient air through the air-purifying element.

Alert means events may occur, are in progress, or have occurred that could lead to a release of
radioactive material but that the release is not expected to require a response by offsite response
organizations to protect persons offsite.

As Low as is Reasonably Achievable (ALARA) means making every reasonable effort to

maintain exposures to radiation as far below the dose limits in 105 CMR 120.000 as is practical,
consistent with the purpose for which the licensed or registered activity is undertaken, taking into
account the state of technology, the economics of improvements in relation to state of
technology, the economics of improvements in relation to benefits to the public health and safety,
and other societal and socioeconomic considerations, and in relation to utilization of ionizing
radiation and licensed or registered sources of radiation in the public interest.

Assigned Protection Factor (APF) means the expected workplace level of respiratory protection
that would be provided by a properly functioning respirator or a class of respirators to properly
trained and fitted users. Operationally, the inhaled concentration can be estimated by dividing
the ambient airborne concentration by the APF.

Atmosphere-supplying Respirator means a respirator that supplies the respirator user with
breathing air from a source independent of the ambient atmosphere, and includes supplied-air
respirators (SAR’s) and self-contained breathing apparatus (SCBA) units.

Background Radiation means radiation from cosmic sources; non-technologically enhanced

naturally occurring radioactive material, including radon, except as a decay product of source or
special nuclear material, and including global fallout as it exists in the environment from the
testing of nuclear explosive devices or from past nuclear accidents such as Chernobyl that
contribute to background radiation and are not under the control of the licensee or registrant.
"Background radiation" does not include sources of radiation from radioactive materials
regulated by the Agency.

Becquerel (Bq) means the SI unit of activity. One becquerel is equal to one disintegration or
transformation per second (dps or tps).

Bioassay means the determination of kinds, quantities, or concentrations, and, in some cases, the
locations of radioactive material in the human body, whether by direct measurement (in vivo
counting), or by analysis and evaluation of materials excreted or removed from the human body.
For purposes of 105 CMR 120.000, Radiobioassay is an equivalent term.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Brachytherapy means a method of radiation therapy in which sealed sources are utilized to
deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, or
interstitial application.

Byproduct Material means:

(1) Any radioactive material (except special nuclear material) yielded in, or made radio-
active by, exposure to the radiation incident to the process of producing or using special
nuclear material;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.005: continued

(2) (a) Any discrete source of radium-226 that is produced, extracted, or converted after
extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or
research activity; or
(b) Any material that:
1. Has been made radioactive by use of a particle accelerator; and
2. Is produced, extracted, or converted after extraction, before, on, or after
August 8, 2005, for use for a commercial, medical, or research activity; and
(3) Any discrete source of naturally occurring radioactive material, other than source
material, that:
(a) The Commission, in consultation with the Administrator of the Environmental
Protection Agency, the Secretary of Energy, the Secretary of Homeland Security, and the
head of any other appropriate Federal agency, determines would pose a threat similar to
the threat posed by a discrete source of radium-226 to the public health and safety or the
common defense and security; and
(b) Before, on, or after August 8, 2005, is extracted or converted after extraction for use
in a commercial, medical, or research activity.

Calendar Quarter means not less than 12 consecutive weeks nor more than 14 consecutive weeks.
The first calendar quarter of each year shall begin in January and subsequent calendar quarters
shall be so arranged such that no day is included in more than one calendar quarter and no day
in any one year is omitted from inclusion within a calendar quarter. The method observed by the
licensee or registrant for determining calendar quarters shall only be changed at the beginning
of a year.

Calibration means the determination of:

(1) the response or reading of an instrument relative to a series of known radiation values
over the range of the instrument; or
(2) the strength of a source of radiation relative to a standard.

CFR means Code of Federal Regulations.

Chelating Agent means amine polycarboxylic acids, hydroxy-carboxylic acids, gluconic acid, and
polycarboxylic acids.

CMR means Code of Massachusetts Regulations.

Collective Dose means the sum of the individual doses received in a given period of time by a
specified population from exposure to a specified source of radiation.

Commissioner means the Commissioner, Massachusetts Department of Public Health.

Committed Dose Equivalent (HT,50) means the dose equivalent to organs or tissues of reference
(T) that will be received from an intake of radioactive material by an individual during the 50-
year period following the intake.

Committed Effective Dose Equivalent (HE,50) means the sum of the products of the weighting
factors applicable to each of the body organs or tissues that are irradiated and the committed dose
equivalent to each of these organs or tissues (HE,50 = 3 wTHT,50).
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Confirmatory Action Letters means letters, confirming a licensee’s, registrant’s, or vendor’s

agreement to take certain actions to remove significant concerns about health and safety,
safeguards, or the environment.

Consortium means an association of medical use licensees and a PET radionuclide production
facility in the same geographical area that jointly own or share in the operation and maintenance
cost of the PET radionuclide production facility that produces PET radionuclides for use in
producing radioactive drugs within the consortium for noncommercial distributions among its
associated members for medical use. The PET radionuclide production facility within the
consortium must be located at an educational institution or a Federal facility or a medical facility.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.005: continued

Constraint (Dose Constraint) means a value above which specified licensee actions are required.

Critical Group means the group of individuals reasonably expected to receive the greatest
exposure to residual radioactivity for any applicable set of circumstances.

Curie means a unit of quantity of activity. One curie (Ci) is that quantity of radioactive material
which decays at the rate of 3.7 x 1010 "disintegrations or transformations per second (dps or tps).
Commonly used submultiples of the curie are the millicurie and the microcurie. One millicurie
(mCi) = 1 x 10-3 curie = 3.7 x 107 tps. One microcurie (µCi) = 1 x 10-6 curie = 3.7 x 104 tps. One
nanocurie (nCi) = 1 x 10-9 curie = 3.7 x 101 tps. One picocurie (pCi) = 1 x 10-12 curie = 10-2 tps.

Cyclotron means a particle accelerator in which the charged particles travel in an outward spiral
or circular path. A cyclotron accelerates charged particles at energies usually in excess of ten
megaelectron volts and is commonly used for production of short half-life radionuclides for
medical use. (See 105 CMR 120.005: Accelerator).

Decommission means to remove safely from service and reduce residual radioactivity to a level
that permits release of the property for unrestricted use and/or termination of license.

Deep Dose Equivalent (Hd) means the dose equivalent at a tissue depth of one centimeter (1000
mg/cm2) and applies to external whole body exposure.

Demand Respirator means an atmosphere-supplying respirator that admits breathing air to the
face piece only when a negative pressure is created inside the facepiece by inhalation.

Department means the Department of Public Health.

Depleted Uranium means the source material uranium in which the isotope uranium-235 is less
than 0.711 weight percent of the total uranium present. Depleted uranium does not include
special nuclear material.

Discrete Source means a radionuclide that has been processed so that its concentration within
a material has been purposely increased for use for commercial, medical, industrial, or research
activities.

Disposable Respirator means a respirator for which maintenance is not intended and that is
designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical
damage, or end-of-service-life renders it unsuitable for use. Examples of this type of respirator
are a disposable half-mask respirator or a disposable escape-only self-contained breathing
apparatus (SCBA).

Distinguishable from Background means that the detectable concentration of a radionuclide is

statistically different from the background concentration of that radionuclide in the vicinity of
the site or, in the case of structures, in similar materials using adequate measurement technology,
survey, and statistical techniques.

Dose is a generic term that means absorbed dose, dose equivalent, effective dose equivalent,
committed dose equivalent, committed effective dose equivalent, total organ dose equivalent,
or total effective dose equivalent. For purposes of 105 CMR 120.000, Radiation Dose is an
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

equivalent term.

Dose Equivalent (HT) means the product of the absorbed dose in tissue, quality factor, and all
other necessary modifying factors at the location of interest. The units of dose equivalent are the
sievert (Sv) and rem.

Dose Limits means the permissible upper bounds of radiation doses established in accordance
with 105 CMR 120.000. For purposes of 105 CMR 120.000, Limits is an equivalent term.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.005: continued

Effective Dose Equivalent (HE) means the sum of the products of the dose equivalent to each
organ or tissue (HT) and the weighting factor (wT) applicable to each of the body organs or tissues
that are irradiated (HE = 3 wTHT).

Embryo/Fetus means the developing human organism from conception until the time of birth.

Entrance or Access Point means any location through which an individual could gain access to
radiation areas or to licensed or registered radioactive materials. This includes entry or exit
portals of sufficient size to permit human entry, irrespective of their intended use.

Explosive Material means any chemical compound, mixture, or device which produces a
substantial instantaneous release of gas and heat spontaneously or by contact with sparks or
flame.

Exposure means being exposed to ionizing radiation or to radioactive material.

Exposure means the quotient of dQ by dm where "dQ" is the absolute value of the total charge
of the ions of one sign produced in air when all the electrons (negatrons and positrons) liberated
by photons in a volume element of air having mass "dm" are completely stopped in air. The SI
unit of exposure is the coulomb per kilogram (C/kg). See 105 CMR 120.014: Units of Exposure
and Dose for the special unit.

Exposure Rate means the exposure per unit of time, such as roentgen per minute and
milliroentgen per hour.

External Dose means that portion of the dose equivalent received from any source of radiation
outside the body.

Extremity means hand, elbow, arm below the elbow, foot, knee, and leg below the knee.

Filtering Facepiece (Dust Mask) means a negative pressure particulate respirator with a filter as
an integral part of the facepiece or with the entire facepiece composed of the filtering medium,
not equipped with elastomeric sealing surfaces and adjustable straps.

Fit Factor means a quantitative estimate of the fit of a particular respirator to a specific
individual, and typically estimates the ratio of the concentration of a substance in ambient air to
its concentration inside the respirator when worn.

Fit Test means the use of a protocol to qualitatively evaluate the fit of a respirator on an
individual.

Former U.S. Atomic Energy Commission (AEC) or U.S. Nuclear Regulatory Commission
(NRC) Licensed Facilities means nuclear reactors, nuclear fuel reprocessing plants, uranium
enrichment plants, or critical mass experimental facilities where AEC or NRC licenses have been
terminated.

Generally Applicable Environmental Radiation Standards means standards issued by the U.S.
Environmental Protection Agency (EPA) under the authority of the Atomic Energy Act of 1954,
as amended, that impose limits on radiation exposures or levels, or concentrations or quantities
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

of radioactive material, in the general environment outside the boundaries of locations under the
control of persons possessing or using radioactive material.

Gray (Gy) means the SI unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule
per kilogram (100 rad).

Half-value layer (HVL) means the thickness of a specified material which attenuates X-radiation
or gamma radiation to an extent that the air kerma rate, exposure rate, or absorbed dose rate is
reduced to ½ of the value measured without the material at the same point.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.005: continued

Hazardous Waste means those wastes designated as hazardous by U.S. Environmental Protection
Agency regulations in 40 CFR Part 261.

Healing Arts means any discipline which involves the diagnosis or treatment of persons by a
practitioner or animals by a veterinarian, and who is licensed for that purpose by the
Commonwealth of Massachusetts, and which discipline includes the intentional exposure of
persons and animals to sources of radiation for diagnosis or treatment.

Healing Arts Radiologic Screening means the completion of a procedure that irradiates an
individual, with no symptoms or other potential indicators of disease, to ionizing radiation for
the purpose of diagnosing the presence or absence of disease within the individual.

Helmet means a rigid respiratory inlet covering that also provides head protection against impact
and penetration.

High Radiation Area means an area, accessible to individuals, in which radiation levels could
result in an individual receiving a dose equivalent in excess of 1 mSv (0.1 rem) in one hour at
30 centimeters from any source of radiation or from any surface that the radiation penetrates.

Hood means a respiratory inlet covering that completely covers the head and neck and may also
cover portions of the shoulders and torso.

Human Use means the internal or external administration of radiation or radioactive material to
human beings.

Individual means any human being.

Individual Monitoring means the assessment of:

(1) Dose equivalent.
(a) by the use of individual monitoring devices; or
(b) by the use of survey data; or
(2) Committed effective dose equivalent.
(a) by bioassay; or
(b) by determination of the time-weighted air concentrations to which an individual has
been exposed, that is, DAC-hours. (See the definition of DAC-hours in 105 CMR
120.200).

Individual Monitoring Devices means devices designed to be worn by a single individual for the
assessment of dose equivalent. For purposes of 105 CMR 120.000, Personnel Dosimeter and
"dosimeter" are equivalent terms. Examples of individual monitoring devices are film badges,
thermoluminescent dosimeters (TLDs), pocket ionization chambers, optically stimulated
luminescence (OSL) dosimeters, and personal (lapel) air sampling devices.

Inspection means an official examination or observation including but not limited to, tests,
surveys, and monitoring to determine compliance with rules, regulations, orders, requirements,
and conditions of the Agency.

Instrument Traceability means the ability to show that an instrument has been calibrated at
specified time intervals using a national standard or a transfer standard. If a transfer standard is
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

used, the calibration must be at laboratory accredited by a program which requires continuing
participation in measurement quality assurance with the National Institute of Standards and
Technology or other equivalent national or international program.

Interlock means a device arranged or connected such that the occurrence of an event or condition
is required before a second event or condition can occur or continue to occur.

Internal Dose means that portion of the dose equivalent received from radioactive material taken
into the body.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.005: continued

Ionizing Radiation (See Radiation).

Irradiation means the exposure of a living being or matter to ionizing radiation.

Kilovolt (kV) [Kilo Electron Volt (keV)] means the energy equal to that acquired by a particle
with one electron charge in passing through a potential difference of 1,000 volts in a vacuum.
[Note: current convention is to use kV for photons and keV for electrons.]

Lead Equivalent means the thickness of the material in question affording the same attenuation,
under specified conditions, as lead.

Leakage Radiation means radiation emanating from the diagnostic or therapeutic source
assembly except for:
(1) The useful beam; and,
(2) Radiation produced when the exposure switch or timer is not activated.

Lens Dose Equivalent (LDE) means the external exposure to the lens of the eye as the dose
equivalent at a tissue depth of 0.3 centimeter (300 mg/cm2).

License means a license issued by the Agency in accordance with the regulations adopted by the
Agency.

Licensed (or Registered) Material means radioactive material received, possessed, used,
transferred or disposed of under a general or specific license [or registration] issued by the
Agency.

Licensee means any person who is licensed by the Agency in accordance with 105 CMR 120.000
and M.G.L. c. 111, §§ 3, 5M, 5N, 5O and 5P.

Licensing State means any State which has been finally designated as such by the Conference
of Radiation Control Program Directors, Inc., which reviews state regulations to establish
equivalency with the Suggested State Regulations and ascertains whether a State has an effective
program for control of natural occurring or accelerator produced radioactive material (NARM).
The Conference will designate as Licensing States those states with regulations for control of
radiation relating to, and an effective program for, the regulatory control of NARM.

Limits (See Dose limits).

Loose-fitting Facepiece means a respiratory inlet covering that is designed to form a partial seal
with the face.

Lost or Missing Source of Radiation means licensed (or registered) source of radiation whose
location is unknown. This definition includes, but is not limited to, licensed (or registered)
material that has been shipped but has not reached its planned destination and whose location
cannot be readily traced in the transportation system.

Major Processor means a user processing, handling, or manufacturing radioactive material

exceeding Type A quantities as unsealed sources or material, or exceeding four times Type B
quantities as sealed sources, but does not include nuclear medicine programs, universities,
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

industrial radiographers, or small industrial programs. Type A and B quantities are defined in
105 CMR 120.772.

Manifest means a detailed record of the characteristics and quantities of packaged waste as
presented for transportation, treatment, storage, or disposal which usually accompanies waste
transfers for these purposes.

Member of the Public means an individual except when that individual is receiving an
occupational dose.

Minor means an individual less than 18 years of age.

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.005: continued

Monitoring means the measurement of radiation, radioactive material concentrations, surface

area activities or quantities of radioactive material and the use of the results of these
measurements to evaluate potential exposures and doses. For purposes of 105 CMR 120.000,
Radiation Monitoring and Radiation Protection Monitoring are equivalent terms.

NARM means any naturally occurring or accelerator-produced radioactive material. It does not
include byproduct, source, or special nuclear material.

Nationally Tracked Source means a sealed source containing a quantity equal to or greater than
Category 1 or Category 2 levels of any radioactive material listed in 105 CMR 120.298:
Appendix D. In this context a sealed source is defined as radioactive material that is sealed in
a capsule or closely bonded, in a solid form and which is not exempt from regulatory control.
It does not mean material encapsulated solely for disposal, or nuclear material contained in any
fuel assembly, subassembly, fuel rod, or fuel pellet. Category 1 nationally tracked sources are
those containing radioactive material at a quantity equal to or greater than the Category 1
threshold. Category 2 nationally tracked sources are those containing radioactive material at a
quantity equal to or greater than the Category 2 threshold but less than the Category 1 threshold.

Natural Radioactivity means radioactivity of naturally occurring nuclides.

Negative Pressure Respirator (Tight Fitting) means a respirator in which the air pressure inside
the facepiece is negative during inhalation with respect to the ambient air pressure outside the
respirator.

Non-ionizing Radiation (See Radiation).

NORM means any naturally occurring radioactive material. It does not include accelerator
produced, byproduct, source, or special nuclear material.

Nuclear Regulatory Commission (NRC) means the U.S. Nuclear Regulatory Commission or its
duly authorized representatives.

Occupational Dose means the dose received by an individual in the course of employment in
which the individual's assigned duties for the licensee or registrant involve exposure to sources
of radiation, whether or not the sources of radiation are in the possession of the licensee,
registrant, or other person. Occupational dose does not include dose received: from background
radiation, or from any medical administration the individual has received, from exposure to
individuals administered radioactive material and released in accordance with 105 CMR
120.527, or from voluntary participation in medical research program, or as a member of the
public.

Package means the packaging together with its radioactive contents as presented for transport.

Particle Accelerator (See Accelerator).

Patient means an individual subjected to healing arts examination, diagnosis, or treatment

Person means any individual, corporation, partnership, firm, association, trust, estate, public or
private institution, group, agency of the commonwealth other than the Department, any political
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

subdivision of the commonwealth, any other state or political subdivision or agency thereof, and
any legal successor, representative, agent, or agency of the foregoing, but not including federal
government agencies.

Personnel Monitoring Equipment (See Individual Monitoring Devices).

Phantom means a volume of material behaving in a manner similar to tissue with respect to the
attenuation and scattering of radiation. This requires that both the atomic number (Z) and the
density of the material be similar to that of tissue.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.005: continued

Pharmacist means an individual certified as such under M.G.L. c. 112, § 24 to compound and
dispense drugs, prescriptions, and poisons.

Physician means an individual certified as a physician under M.G.L. c. 112, § 2 or corresponding

citation of earlier laws.

Positive Pressure Respirator means a respirator in which the pressure inside the respiratory inlet
covering exceeds the ambient air pressure outside the respirator.

Positron Emission Tomography (PET) radionuclide production facility means a facility

operating a cyclotron or accelerator for the purpose of producing PET radionuclides.

Powered Air-purifying Respirator (PAPR) means an air-purifying respirator that uses a blower
to force the ambient air through air-purifying elements to the inlet covering.

Pressure Demand Respirator means a positive pressure atmosphere-supplying respirator that

admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece
by inhalation.

Principal Activities means activities authorized by the license which are essential to achieving
the purpose(s) for which the license was issued or amended. Storage during which no licensed
material is accessed for use or disposal and activities incidental to decontamination or
decommissioning are not principal activities.

Protective Apron means an apron made of radiation-attenuating materials used to reduce

exposure to radiation.

Protective Barrier means a barrier of radiation absorbing material(s) used to reduce radiation
exposure. The types of protective barriers are as follows:
(1) Primary protective barrier means the material, excluding filters, placed in the useful
beam.
(2) Secondary protective barrier means the material which attenuates stray radiation.

Public Dose means the dose received by a member of the public from exposure to sources of
radiation released by the licensee or registrant, or to any other source of radiation under the
control of the licensee or registrant. Public dose does not include occupational dose, or dose
received from background radiation, from any medical administration the individual has
received, from exposure to individuals administered radioactive material and released in
accordance with 105 CMR 120.540, or from voluntary participation in medical research
programs.

Pyrophoric Material means any liquid that ignites spontaneously in dry or moist air at or below
130°F (54.4°C) or any solid material, other than one classed as an explosive, which under normal
conditions is liable to cause fires through friction, retained heat from manufacturing or
processing, or which can be ignited readily and, when ignited, burns so vigorously and
persistently as to create a serious transportation, handling, or disposal hazard. Included are
spontaneously combustible and water-reactive materials.

Qualified Expert means an individual having the knowledge and training to measure ionizing
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

radiation, to evaluate safety techniques, and to advise regarding radiation protection needs, for
example, individuals certified in the appropriate field by the American Board of Radiology, or
the American Board of Health Physics, or the American Board of Medical Physics, or those
having equivalent qualifications. With reference to the calibration of radiation therapy
equipment, an individual having, in addition to the above qualifications, training and experience
in the clinical applications of radiation physics to radiation therapy, for example, individuals
certified in Therapeutic Radiological Physics or X-ray and Radium Physics by the American
Board of Radiology, or those having equivalent qualifications.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.005: continued

Qualitative Fit Test (QLFT) means a pass/fail fit test to assess the adequacy of respirator fit that
relies on the individual’s response to the test agent.

Quality Factor (Q) means the modifying factor, listed in 105 CMR 120.014: Tables I and II, that
is used to derive dose equivalent from absorbed dose.

Quantitative Fit Test (QNFT) means an assessment of the adequacy of respirator fit by
numerically measuring the amount of leakage into the respirator.

Rad means the special unit of absorbed dose. One rad is equal to an absorbed dose of 100 erg
per gram or 0.01 joule per kilogram (0.01 gray).

Radiation means alpha particles, beta particles, gamma rays, x-rays, neutrons, high-speed
electrons, high-speed protons, and other particles capable of producing ions. For purposes of
105 CMR 120.000, ionizing radiation is an equivalent term. Radiation, as used in 105 CMR
120.000, does not include non-ionizing radiation, such as radiowaves or microwaves, visible,
infrared, or ultraviolet light.

Radiation Area means any area, accessible to individuals, in which radiation levels could result
in an individual receiving a dose equivalent in excess of 0.05 mSv (0.005 rem) in one hour at 30
centimeters from the source of radiation or from any surface that the radiation penetrates.

Radiation Dose (See Dose).

Radiation Detector means a device which, in the presence of radiation, provides by either direct
or indirect means a signal or other indication suitable for use in measuring one or more quantities
of incident radiation.

Radiation Machine means any device capable of producing radiation except, those devices with
radioactive material as the only source of radiation.

Radiation Safety Officer means an individual who has the knowledge and responsibility to apply
appropriate radiation protection regulations and programs and has been assigned such
responsibility by the licensee or registrant.

Radioactive Material means any solid, liquid, or gas which emits radiation spontaneously.

Radioactivity means the transformation of unstable atomic nuclei with the emission of radiation.

Radiobioassay (See Bioassay).

Registrant means any person who is registered with the Agency and is legally obligated to
register with the Agency pursuant to 105 CMR 120.000 and M.G.L. c. 111, §§ 3, 5M, 5N, 5O,
and 5P.

Registration means registration with the Agency in accordance with the regulations adopted by
the Agency.

Regulations of the U.S. Department of Transportation (U.S. DOT) means the regulations in
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

49 CFR Parts 100 through 189.

Rem means the special unit of any of the quantities expressed as dose equivalent. The dose
equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor (one rem
= 0.01 Sv).

Research and Development means:

(1) theoretical analysis, exploration, or experimentation; or
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.005: continued

(2) the extension of investigative findings and theories of a scientific or technical nature
into practical application for experimental and demonstration purposes, including the
experimental production and testing of models, devices, equipment, materials, and processes.
Research and development does not include the internal or external administration of
radiation or radioactive material to human beings.

Residual Radioactivity means radioactivity in structures, materials, soils, groundwater, and other
media at a site resulting from activities under the licensee’s control. This includes radioactivity
from all licensed and unlicensed sources used by the licensee, but excludes background radiation.
It also includes radioactive materials remaining at the site as a result of routine or accidental
releases of radioactive materials at the site and previous burials at the site, even if those burials
were made in accordance with the provisions of 105 CMR 120.200.

Restricted Area means an area, access to which is limited by the licensee or registrant for the
purpose of protecting individuals against undue risks from exposure to sources of radiation.
Restricted area does not include areas used as residential quarters, but separate rooms in a
residential building may be set apart as a restricted area.

Roentgen means the special unit of exposure. One roentgen (R) equals 2.58 x 10-4
coulombs/kilogram of air (see Exposure).

Scattered Primary Radiation means that scattered radiation that has been deviated in direction
only by materials irradiated by the useful beam.

Scattered Radiation means ionizing radiation emitted by the interaction of ionizing radiation with
matter, the interaction being accompanied by a change in direction of the radiation.

Sealed Source means any radioactive material that is used as a source of radiation and is encased
in a capsule designed to prevent leakage or escape of the radioactive material.

Sealed Source and Device Registry means the national registry that contains the registration
certificates, generated by both the Nuclear Regulatory Commission (NRC) and the Agreement
States, that summarize the radiation safety information for sealed sources and devices, and
describe the licensing and use conditions approved for the product.

Self-contained Breathing Apparatus (SCBA) means an atmosphere-supplying respirator for

which the breathing air source is designed to be carried by the user.

Shallow Dose Equivalent (Hs), which applies to the external exposure of the skin or an extremity,
means the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm2).

Shutter means a device attached to the tube housing assembly which can totally intercept the
useful beam and which has a lead equivalency not less than that of the tube housing assembly.

SI means the abbreviation for the International System of Units.

Sievert means the SI unit of any of the quantities expressed as dose equivalent. The dose
equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor (one
Sv = 100 rem).
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Site Area Emergency means events may occur, are in progress, or have occurred that could lead
to a significant release of radioactive material and that could require a response by off-site
response organizations to protect persons offsite.

Site Boundary means that line beyond which the land or property is not owned, leased, or
otherwise controlled by the licensee or registrant.

Source Material means:

(1) uranium or thorium, or any combination thereof, in any physical or chemical form; or
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.005: continued

(2) ores which contain by weight 1/20 of one percent (0.05%) or more of:
(a) uranium;
(b) thorium; or
(c) any combination thereof.
Source material does not include special nuclear material.

Source Material Milling means any activity that results in the production of byproduct material
as defined by 105 CMR 120.005: Byproduct Material(2).

Source of Radiation means any radioactive material or any device or equipment emitting, or
capable of producing, radiation.

Source Traceability means the ability to show that a radioactive source has been calibrated either
by the national standards laboratory of the National Institute of Standards and Technology
(NIST), or by a laboratory which participates in a continuing measurement quality assurance
program with NIST or other equivalent national or international program.

Special Form Radioactive Material means radioactive material which satisfies the following
conditions:
(1) It is either a single solid piece or is contained in a sealed capsule that can be opened only
by destroying the capsule;
(2) The piece or capsule has at least one dimension not less than five millimeters (0.2 inch);
and
(3) It satisfies the requirements of 10 CFR 71.75. A special form encapsulation designed
in accordance with the Nuclear Regulatory Commission requirements of 10 CFR 71.4 in
effect on June 30, 1983 (see 10 CFR part 71, revised as of January 1, 1983), and constructed
prior to July 1, 1985, may continue to be used. A special form encapsulation designed in
accordance with the Nuclear Regulatory Commission requirements of 10 CFR 71.4 in effect
on March 31, 1996 (see 10 CFR part 71, revised as of January 1, 1996), and constructed prior
to April 1, 1998, may continue to be used. Special form material that was successfully tested
before September 10, 2015 in accordance with the Nuclear Regulatory Commission
requirements of 10 CFR 71.75(d) in effect before September 10, 2015 may continue to be
used. Any other special form encapsulation must meet the specifications of Special Form
Radioactive Material.

Special Nuclear Material means:

(1) Plutonium, uranium-233, uranium enriched in the isotope 233 or in the isotope 235, and
any other material that the U.S. Nuclear Regulatory Commission, pursuant to the provisions
of § 51 of the Atomic Energy Act of 1954, as amended, determines to be special nuclear
material, but does not include source material; or
(2) Any material artificially enriched by any of the foregoing but does not include source
material.

Special Nuclear Material in Quantities not Sufficient to Form a Critical Mass means uranium
enriched in the isotope U-235 in quantities not exceeding 350 grams of contained U-235;
uranium- 233 in quantities not exceeding 200 grams; plutonium in quantities not exceeding 200
grams; or any combination of them in accordance with the following formula: For each kind of
special nuclear material, determine the ratio between the quantity of that special nuclear material
and the quantity specified above for the same kind of special nuclear material. The sum of such
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

ratios for all of the kinds of special nuclear material in combination shall not exceed one. For
example, the following quantities in combination would not exceed the limitation and are within
the formula:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.005: continued

175 (grams U-235) + 50 (grams U-233) + 50 (grams Pu) = 1

350 200 200

Supplied Air Respirator (SAR) or Airline Respirator means an atmosphere supplying respirator
for which the source of breathing air is not designed to be carried by the user.

Survey means an evaluation of the radiological conditions and potential hazards incident to the
production, use, transfer, release, disposal, and/or presence of sources of radiation. When
appropriate, such evaluation includes, but is not limited to, tests, physical examinations, and
measurements of levels of radiation or concentrations of radioactive material present.

Test means the process of verifying compliance with an applicable regulation.

Tight-fitting Facepiece means a respiratory inlet covering that forms a complete seal with the
face.

Total Effective Dose Equivalent (TEDE) means the sum of the effective dose equivalent (for
external exposures) and the committed effective dose equivalent (for internal exposures).

Total Organ Dose Equivalent (TODE) means the sum of the deep dose equivalent and the
committed dose equivalent to the organ receiving the highest dose as described in 105 CMR
120.267(A)(6).

Traceable to National Standard (See Instrument Traceability or Source Traceability)

U.S. Department of Energy means the Department of Energy established by Public Law 95-91,
August 4, 1977, 91 Stat. 565, 42 U.S.C. 7101 et seq., to the extent that the Department exercises
functions formerly vested in the U.S. Atomic Energy Commission, its Chairman, members,
officers and components and transferred to the U.S. Energy Research and Development
Administration and to the Administrator thereof pursuant to sections 104(b), (c) and (d) of the
Energy Reorganization Act of 1974 (Public Law 93-438, October 11, 1974, 88 Stat. 1233 at
1237, effective January 19, 1975) and retransferred to the Secretary of Energy pursuant to section
301(a) of the Department of Energy Organization Act (Public Law 95-91, August 4, 1977,
91 Stat. 565 at 577-578, 42 U.S.C. 7151, effective October 1, 1977).

Unrefined and Unprocessed Ore means ore in its natural form prior to any processing, such as
grinding, roasting, beneficiating, or refining. Processing does not include sieving or
encapsulating of ore or preparation of samples for laboratory analysis.

Unrestricted Area (Uncontrolled Area) means area access to which is neither limited nor
controlled by the licensee or registrant. For purposes of 105 CMR 120.000, Uncontrolled Area
is an equivalent term.

User Seal Check (Fit Check) means an action conducted by the respirator user to determine if
the respirator is properly seated to the face. Examples include negative pressure check, positive
pressure check, irritant smoke check, or isoamyl acetate check.

Vendor means a supplier of products or services to be used by a licensee or registrant or a

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

licensed or registered facility or activity.

Very High Radiation Area means an area, accessible to individuals, in which radiation levels
from radiation sources external to the body could result in an individual receiving an absorbed
dose in excess of 5 Gy (500 rad) in one hour at one meter from a source of radiation or one meter
from any surface that the radiation penetrates. [Note: At very high doses rates, units of adsorbed
dose, gray and rad, are appropriate, rather than units of dose equivalent, sievert and rem].
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.005: continued

Waste means those low-level radioactive wastes containing source, special nuclear, or byproduct
material that are acceptable for disposal in a land disposal facility. For the purposes of this
definition, low-level radioactive waste means radioactive waste not classified as high-level
radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in
105 CMR 120.005: Byproduct Material(2) and (3).

Waste Handling Licensees means persons licensed to receive and store radioactive wastes prior
to disposal and/or persons licensed to dispose of radioactive waste.

Week means seven consecutive days starting on Sunday.

Whole Body means, for purposes of external exposure, head, trunk including male gonads, arms
above the elbow, or legs above the knee.

Worker means an individual engaged in work under a license or registration issued by the
Agency and controlled by a licensee or registrant, but does not include the licensee or registrant.

Working Level (WL) means any combination of short-lived radon daughters in one liter of air
that will result in the ultimate emission of 1.3E+5 MeV of potential alpha particle energy. The
short-lived radon daughters are -- for radon-222: polonium-218, lead-214, bismuth-214, and
polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212.

Working Level Month (WLM) means an exposure to one working level for 170 hours - 2,000
working hours per year divided by 12 months per year is approximately equal to 170 hours per
month.

Year means the period of time beginning in January used to determine compliance with the
provisions of 105 CMR 120.000. The licensee or registrant may change the starting date of the
year used to determine compliance by the licensee or registrant provided that the change is made
at the beginning of the year and that no day is omitted or duplicated in consecutive years.

120.006: Exemptions

(A) General Provision. The Agency may, upon application therefore or upon its own initiative,
grant such exemptions or exceptions from the requirements of 105 CMR 120.000 as it
determines are authorized by law and will not result in undue hazard to public health and safety
or property.

(B) U.S. Department of Energy Contractors and U.S. Nuclear Regulatory Commission
Contractors. Any U.S. Department of Energy contractor or subcontractor and any U.S. Nuclear
Regulatory Commission contractor or subcontractor of the following categories operating within
this Commonwealth is exempt from 105 CMR 120.000 to the extent that such contractor or
subcontractor under his contract receives, possesses, uses, transfers or acquires sources of
radiation:
(1) Prime contractors performing work for the U.S. Department of Energy at U.S.
Government-owned or Government-controlled sites, including the transportation of sources
of radiation to or from such sites and the performance of contract services during temporary
interruptions of such transportation;
(2) Prime contractors of the U.S. Department of Energy performing research in, or
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

development, manufacture, storage, testing, or transportation of, atomic weapons or

components thereof;
(3) Prime contractors of the U.S. Department of Energy using or operating nuclear reactors
or other nuclear devices in a United States Government-owned vehicle or vessel; and,
(4) Any other prime contractor or subcontractor of the U.S. Department of Energy or of the
U.S. Nuclear Regulatory Commission when the State and the U.S. Nuclear Regulatory
Commission jointly determine:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.006: continued

(a) That the exemption of the prime contractor or subcontractor is authorized by law;
and
(b) That under the terms of the contract or subcontract, there is adequate assurance that
the work thereunder can be accomplished without undue risk to the public health and
safety.

120.007: Prohibited Uses

(A) A hand-held fluoroscopic screen shall not be used with x-ray equipment unless it has been
listed in the Registry of Sealed Source and Devices or accepted for certification by the U.S. Food
and Drug Administration, Center for Devices and Radiological Health.

(B) A Shoe-fitting fluoroscopic device shall not be used.

120.008: Impounding

Sources of radiation shall be subject to impounding pursuant to M.G.L. c. 111, §§ 5O and

5P.

120.009: Records

(A) Each licensee and registrant shall maintain records showing the receipt, transfer, and
disposal of all sources of radiation. Additional record requirements are specified elsewhere in
105 CMR 120.000.

(B) Prior to license termination, each licensee authorized to possess radioactive material with
a half-life greater than 120 days, in an unsealed form, shall forward the following records to the
Agency:
(1) Records of disposal of licensed material made under 105 CMR 120.252 (including
burials authorized before January 28, 1981), 105 CMR 120.253, 120.254,120.255; and,
(2) Records required by 105 CMR 120.263(B)(4).

(C) If licensed activities are transferred or assigned in accordance with 105 CMR 120.131(B),
each licensee authorized to possess radioactive material, with a half-life greater than 120 days,
in an unsealed form, shall transfer the following records to the new licensee and the new licensee
will be responsible for maintaining these records until the license is terminated:
(1) Records of disposal of licensed material made under 105 CMR 120.252 (including
burials authorized before January 28, 1981), 105 CMR 120.253, 120.254,120.255; and,
(2) Records required by 105 CMR 120.263(B)(4).

(D) Prior to license termination, each licensee shall forward the records required by 105 CMR
120.125(C)(1)(g) to the Agency.

120.010: Inspections

(A) Each licensee and registrant shall afford the Agency at all reasonable times opportunity to
inspect sources of radiation and the premises and facilities wherein such sources of radiation are
used or stored.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(B) Each licensee and registrant shall make available to the Agency for inspection, upon
reasonable notice, records maintained pursuant to 105 CMR 120.000.

120.011: Tests

Each licensee and registrant shall perform upon instructions from the Agency, or shall permit
the Agency to perform, such reasonable tests as the Agency deems appropriate or necessary
including, but not limited to, tests of:

(A) Sources of radiation;

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.011: continued

(B) Facilities wherein sources of radiation are used or stored;

(C) Radiation detection and monitoring instruments; and,

(D) Other equipment and devices used in connection with utilization or storage of licensed or
registered sources of radiation.

120.012: Additional Requirements

(A) The Agency may, by rule, regulation, or order, impose upon any licensee or registrant such
requirements in addition to those established in 105 CMR 120.000 as it deems appropriate or
necessary to minimize danger to public health and safety or property.

(B) Any person who finds or detects any source of radiation that is not under the physical or
administrative control of a licensee or registrant, and that is not excluded, exempted or otherwise
authorized under the provisions of 105 CMR 120.000, shall immediately report such source to
the Radiation Control Program.

120.013: Communications

All correspondence in compliance with 105 CMR 120.000 shall be sent to the Department
of Public Health, Radiation Control Program, at the programs’s current mailing address, as stated
in the website http://mass.gov.dph/rcp.

120.014: Units of Exposure and Dose

(A) As used in 105 CMR 120.000, the unit of Exposure is the coulomb per kilogram (C/kg) of
air. One roentgen is equal to 2.58 x 10-4 coulomb per kilogram of air.

(B) As used in 105 CMR 120.000, the units of dose are:

Rad is the special unit of absorbed dose. One rad is equal to an absorbed dose of 100 ergs
per gram or 0.01 joule per kilogram (0.01 gray).
Gray (Gy) is the SI unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule
per kilogram (100 rads).
Rem is the special unit of any of the quantities expressed as dose equivalent. The dose
equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor (1 rem =
0.01 sievert).
Sievert is the SI unit of any of the quantities expressed as dose equivalent. The dose
equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor
(1 sievert = 100 rems).
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.014: continued

(C) As used in 105 CMR 120.000, the quality factors for converting absorbed dose to dose
equivalent are shown in Table I.
TABLE I
QUALITY FACTORS AND ABSORBED DOSE EQUIVALENCIES

Quality Factor Absorbed Dose

Equal to
TYPE OF RADIATION (Q) a Unit Dose
Equivalent*

X, gamma, or beta radiation and 1 1

high-speed electrons
Alpha particles, multiple-charged
particles, fission fragments and
heavy particles of unknown charge 20 0.05
Neutrons of unknown energy 10 0.1
High-energy protons 10 0.1

(D) If it is more convenient to measure the neutron fluence rate than to determine the neutron
dose equivalent rate in sievert per hour or rem per hour, as provided in 105 CMR 120.014(C),
0.01 Sv (1 rem) of neutron radiation of unknown energies may, for purposes of 105 CMR
120.000, be assumed to result from a total fluence of 25 million neutrons per square centimeter
incident upon the body. If sufficient information exists to estimate the approximate energy
distribution of the neutrons, the licensee or registrant may use the fluence rate per unit dose
equivalent or the appropriate Q value from Table II to convert a measured tissue dose in gray
or rad to dose equivalent in sievert or rem.

*
Absorbed dose in gray equal to 1 Sv or the absorbed dose in rad equal to 1 rem.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.014: continued

TABLE II
MEAN QUALITY FACT0RS, Q, AND FLUENCE PER UNIT DOSE
EQUIVALENT FOR MONOENERGETIC NEUTRONS

Neutron Quality Fluence per Unit Fluence per Unit

Energy Factor* Dose Equivalent** Dose Equivalent**
(MeV) (Q) (neutrons (neutrons
cm-2 rem-1) cm-2 Sv-1)

1.0 x 10-7 2 980 x 106 980 x 108

1.0 x 10-6 2 810 x 106 810 x 108
1.0 x 10-5 2 810 x 106 810 x 108
1.0 x 10-4 2 840 x 106 840 x 108
1.0 x 10-3 2 980 x 106 980 x 108
1.0 x 10-2 2.5 1010 x 106 1010 x 108
1.0 x 10-1 7.5 170 x 106 170 x 108
5.0 x 10-1 11 39 x 106 39 x 108
1 11 27 x 106 27 x 108
2.5 9 29 x 106 29 x 108
5 8 23 x 106 23 x 108
7 7 24 x 106 24 x 108
10 6.5 24 x 106 24 x 108
14 7.5 17 x 106 17 x 108
20 8 16 x 106 16 x 108
40 7 14 x 106 14 x 108
60 5.5 16 x 106 16 x 108
1.0 x 102 4 20 x 106 20 x 108
2.0 x 102 3.5 19 x 106 19 x 108
3.0 x 102 3.5 16 x 106 16 x 108
4.0 x 102 3.5 14 x 106 14 x 108

120.015: Units of Activity

For purposes of 105 CMR 120.000, activity is expressed in the SI unit of becquerel (Bq) or
in the special unit of curie (Ci), or their multiples, or disintegrations or transformations per unit
of time.

(A) One becquerel (Bq) = 1 disintegration or transformation per second (dps or tps).

(B) One curie (Ci) = 3.7 x 1010 disintegrations or transformations per second (dps or tps) = 3.7
x 1010 becquerel (Bq) = 2.22 x 1012 disintegrations or transformations per minute (dpm or tpm).

*
Value of quality factor (Q) at the point where the dose equivalent is maximum in a 30-
centimeter diameter cylinder tissue-equivalent phantom.
**
Monoenergetic neutrons incident normally on a 30-centimeter diameter cylinder tissue-
equivalent phantom.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

ENFORCEMENT

120.016: Enforcement Policy and Procedures

(A) Purpose. The purpose of the enforcement program of the Agency is to promote and protect
the radiological health and safety of the public, including employees' health and safety, and the
environment by:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.016: continued

(1) Ensuring compliance with regulations and conditions of license;

(2) Obtaining prompt correction of violations that may affect safety;
(3) Deterring future violations; and
(4) Encouraging improvement of licensee, registrant and vendor performance, and by
example, that of industry, including the prompt identification and reporting of potential
safety problems.
Consistent with the purpose of this program, prompt and vigorous enforcement action will
be taken when dealing with all persons who do not comply with regulations. In no case will
licensees who do not achieve and maintain adequate levels of protection be permitted to conduct
licensed activities.

(B) Grounds for Immediate Suspension of a License or Certificate of Registration or Issuance

of an Order to Immediately Cease Activity. In accordance with M.G.L. c. 111, § 5O, the
Commissioner may summarily suspend a license or certificate of registration or order immediate
cessation of an activity, without a prior hearing, whenever the Department finds that public
health, safety or the environment would be threatened by delay in issuance of an order. A facility
or person may not operate during the period of a suspension of his/its license or certificate of
registration and may not conduct a prohibited activity after notification of an order requiring the
immediate cessation of an activity. However, upon request by the licensee or registrant, a
hearing shall be provided promptly after the issuance of such suspension or order.

(C) Grounds for Denial, Modification, Limitation, Revocation or Refusal to Renew a License
or Certificate of Registration.
(1) Specific Grounds. The Department may issue an order denying, revoking, modifying,
limiting, or refusing to renew a license or certificate of registration sought or issued under
105 CMR 120.000, or issue an order to cease an activity, for any one of the following
reasons:
(a) The applicant, licensee or registrant has failed to submit the information required for
licensure or registration under 105 CMR 120.000.
(b) The applicant failed to meet the requirements for licensure or registration as
specified in 105 CMR 120.000.
(c) The applicant, licensee or registrant is not suitable and responsible to operate a
facility as required or provide the service as licensed or registered.
(d) The applicant, licensee or registrant has obtained or attempted to obtain or maintain
a certificate of registration or license by fraud, misrepresentation, or by the submission
of incorrect, false or misleading information.
(e) The applicant, licensee or registrant has failed to pay licensure and/or registration
fees.
(f) The applicant, licensee or registrant has failed to pay civil penalties or criminal fines
levied in accordance with of M.G.L. c. 111, § 5O or 5P and/or 105 CMR 120.000.
(g) The applicant, licensee or registrant has:
1. failed to allow duly authorized agents of the Agency to conduct inspections; or
2. attempted to impede the work of duly authorized representatives of the Agency
or the enforcement of any provisions of M.G.L. c. 111 §§ 5N through 5P or
105 CMR 120.000.
(h) The applicant, licensee or registrant has been convicted of, pleaded guilty to, or has,
in a judicial proceeding, admitted facts sufficient for a finding that he/she is guilty of, any
criminal violation relating directly or indirectly to his/her fitness to be licensed or
registered under 105 CMR 120.000.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(i) The applicant, licensee or registrant has been the subject of proceedings which
resulted in the suspension, denial, modification, limitation, or revocation of a similar
license or certificate of registration or refusal of renewal of a similar license.
(j) The applicant, licensee or registrant has violated 105 CMR 120.000 or a license
condition and has a history of non-compliance with the same or similar violation or has
received a warning letter from the Department within the last five years for the same or
similar violation.
(k) The applicant, licensee or registrant has been disciplined in another jurisdiction in
any way by a licensing authority for reasons substantially the same as those set forth in
105 CMR 120.016(C).
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.016: continued

(l) The applicant or licensee operated a facility after the expiration of the license.
(m) The applicant, licensee or registrant has failed to remedy or correct a cited violation
by the date specified in the written notice from the Department under M.G.L. c. 111, §
5O or by the date specified in the plan of correction accepted or modified by the
Department, unless the applicant, licensee or registrant demonstrates to the satisfaction
of the Department that such failure was not due to neglect of duty and occurred despite
his/her good faith attempt to make corrections by the specified time.
(n) The applicant or licensee has engaged in or aided in the falsification of test results
or any other records required to be maintained in accordance with 105 CMR 120.000.
(o) The applicant, licensee or registrant receives, possesses, uses, transfers, owns or
operates or uses radioactive materials or machines which emit ionizing radiation in a
manner which endangers public health, safety, or the environment.
(2) Other Grounds. The Department reserves the right to deny, modify, limit revoke or
refuse to renew a license or certificate of registration for any other sufficient reason not listed
in 105 CMR 120.016(C)(1) if it reasonably considers such action necessary to protect the
public health, safety or the environment. In addition, nothing in 105 CMR 120.000 shall be
deemed to limit the Department's authority to establish or recognize further general or
specific grounds for discipline through rulemaking, adjudication, the issuance of polices or
advisories or other similar means.

(D) Severity of Violations.

(1) Violations of 105 CMR 120.000 are categorized in terms of five levels of severity to
show their relative importance within each of the following five activity areas:
(a) Health Physics;
(b) Transportation;
(c) Materials Operations;
(d) Miscellaneous Matters; and,
(e) Emergency Preparedness.
(2) Within each activity area, Severity Level I has been assigned to violations that are the
most significant and Severity Level V to those that are the least significant. Severity Level
I and II violations are of very significant regulatory concern. In general, violations that are
included in these categories involve actual or high potential impact on the public. Severity
Level III violations are cause for significant concern. Severity Level IV violations are less
serious but are of more than minor concern; i.e. if left uncorrected, they could lead to a more
serious concern. Severity Level V violations are of minor safety or environmental concern.
(3) Comparisons of significance between activity areas are inappropriate. For example, the
immediacy of any hazard to the public associated with Severity Level I violations in Health
Physics is not directly comparable to that associated with Severity Level I violations in
Emergency Preparedness.
(4) While examples are provided in 105 CMR 120.019: Appendix A for determining the
appropriate severity level for violations in each of the five activity areas, the examples are
neither exhaustive nor controlling. These examples do not create new requirements. Each
of the examples is predicated on a violation of an existing regulatory requirement. Each is
designed to illustrate the significance which the Department places on a particular type of
violation of regulatory requirements.
(5) In each case, the severity of a violation will be characterized at the level best suited to
the significance of the particular violation. In some cases, violations may be evaluated in the
aggregate and a single severity level assigned for a group of violations.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.016: continued

(6) The severity level of a violation may be increased if the circumstances surrounding the
matter involve careless disregard of requirements, deception, or other indication of
willfulness. The term "willfulness" includes, but is not limited to, the deliberate violation
of any provision of M.G.L. c. 111, §§ 3, 5M, 5N, 5O, and 5P or careless disregard of the
requirements of M.G.L. c. 111, §§ 3, 5M, 5N, 5O, and 5P. Willfulness does not include acts
which do not rise to the level of careless disregard, e.g. inadvertent clerical errors in a
document submitted to the Agency. In determining the specific severity level of a violation
involving willfulness, consideration will be given to such factors as the position of the person
involved in the violation (e.g., first-line supervisor or senior manager), the significance or
any underlying violation, the intent of the violator (i.e. negligence not amounting to careless
disregard, careless disregard, or deliberateness), and the economic advantage, if any, gained
as a result of the violation. The relative weight given to each of these factors in arriving at
the appropriate severity level will be dependent on the circumstances of the violation.
(7) The Agency expects licensees to provide complete, timely, and accurate information and
reports. Accordingly, unless otherwise categorized in 105 CMR 120.019: Appendix A the
severity level of a violation involving the failure to make a required report to the Agency will
be based upon the significance of and the circumstances surrounding the matter that should
have been reported. A licensee will not normally be cited for a failure to report a condition
or event unless the licensee was actually aware of the condition or event which it failed to
report or should have been aware of the condition or event. However, the severity level of
an untimely report, in contrast to no report, may be reduced depending on the circumstances
surrounding the matter.

(E) Enforcement Conference. Whenever the Agency has learned of the existence of a potential
violation for which a civil penalty or other escalated enforcement action may be warranted, or
recurring nonconformance on the part of a vendor, the Agency may schedule an enforcement
conference with the licensee or vendor prior to taking enforcement action. The Agency may also
elect to hold an enforcement conference for other violations, e.g. Severity Level IV violation
which, if repeated, could lead to escalated enforcement action. The purpose of the enforcement
conference is to:
(a) Discuss the violations or nonconformance, their significance and causes, and the
licensee's or vendor's corrective actions;
(b) Determine whether there are any aggravating or mitigating circumstances;
(c) Obtain other information which will help determine the appropriate enforcement action;
and
(d) Provide an opportunity for the licensee to explain what corrective actions have been
taken or will be taken in response to the Notice of Violation. (See 105 CMR 120.016(F).

(F) Enforcement Procedures.

(1)(a) Notice of Violation. Whenever the Agency finds upon inspection, investigation of
a complaint or through information in its possession that an applicant, licensee or
registrant is not in compliance with provisions of M.G.L. c. 111, §§ 5N through 5P or a
regulation promulgated thereunder, the Agency shall notify the applicant, licensee or
registrant of such violation or deficiency. The notice shall include a statement of the
violations or deficiencies found, the provision of the law relied upon, and a reasonable
period of time for correction. A violation or deficiency may result in denial, suspension,
revocation or refusal to renew a license or certificate of registration; a modification or
limitation of a license or certificate of registration; a cease and desist order; and/or the
imposition of a civil penalty and/or criminal sanctions.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(b) Confirmatory Action Letters. The Agency may issue Confirmatory Action Letters
confirming a licensee’s, registrant’s, or vendor’s agreement to take certain actions to
remove significant concerns about health and safety, safeguards, or the environment.
(2) Plan of Correction.
(a) The applicant, licensee or registrant shall within ten days of receipt of the notice, file
with the Agency a written plan of correction. The plan shall clearly identify the licensee
or registrant, state the date, reference the violation(s) cited, state specific corrective
action(s) and timetable(s) and date(s) for completion for each violation cited, and shall
be signed by either the applicant, licensee or registrant or his/her designee.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.016: continued

(b) The Agency may re-inspect a facility in order to determine whether the corrections
have been made. If upon review of plan of correction and/or reinspection the Agency
finds that the applicant, licensee or registrant is in compliance with 105 CMR 120.000
and that the applicant, licensee or registrant has submitted an acceptable plan of
correction, the Agency shall notify the applicant, licensee or registrant of its findings of
compliance and/or its acceptance or modification of the plan of correction.
(c) If upon review of plan of correction and/or reinspection the Agency finds the plan
of correction is unacceptable, the Agency may request that the applicant, licensee or
registrant amend and resubmit the plan of correction within five days of the date of notice
of the required amendment to the plan of correction or such other time as the Agency
may specify for resubmission.
(d) If upon review of the plan of correction and/or reinspection the Agency determines
that an applicant, licensee or registrant remains non-compliant with applicable laws and
regulations regarding licensure, or the Agency determines that further enforcement action
is necessary to ensure compliance with regulatory requirements and deter future non-
compliance the Department may initiate enforcement procedures as set forth in 105 CMR
120.016.

(3) Notice of Department's Intent to Issue an Order.

(a) Except as specified in 105 CMR 120.016(F)(4)(b), prior to the Department issuing
an order to modify, limit, deny, revoke or refuse to renew a license, and/or to require a
person to cease and desist any activity, and/or to impose civil penalties, the applicant,
licensee or registrant shall be notified in writing of the Agency’s Intent to Issue an Order.
The Notice of Intent to Issue an Order shall include the grounds for the Department's
action, the provision(s) of law relied upon, the amount of any civil penalty or the
requirements of the proposed order, and a right to request an adjudicatory hearing.
(b) If a license or certificate of registration is to be denied, modified, limited, revoked
or refused renewal or if an activity is to be ceased or a civil penalty imposed by the
Department, then the aggrieved applicant, licensee or registrant may request an
adjudicatory hearing within 21 days of receipt of notification of the Department's Intent
to Issue an Order. Said request shall be filed in accordance with 801 CMR
1.00: Standard Adjudicatory Rules of Practice and Procedures.

(4) Administrative Hearings: Procedure.

(a) Immediate Suspension of a License or Certificate of Registration or Issuance of an
Order to Immediately Cease an Activity:
1. The Department shall give the licensee or registrant written notice stating the
reason(s) for the immediate suspension or issuance of an order to immediately cease
an activity and the provisions of law relied upon. The immediate suspension or order
to immediately cease an activity shall take effect immediately upon issuance of the
notice.
2. The Department shall provide for a hearing pursuant to 801 CMR 1.00: Standard
Adjudicatory Rules of Practice and Procedures promptly after the issuance of an
order of immediate suspension or an order to immediately cease an activity.
3. In cases of immediate suspension of a license or certificate of registration or
issuance of an order to immediately cease an activity, the Hearing Officer shall
determine whether the Department has proved by a preponderance of the evidence
that there existed, immediately prior to or at the time of the immediate suspension or
cease and desist order, a threat to public health, safety or the environment.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

4. In the event that the Department determines that the violation of state law or of
105 CMR 120.000 which posed a threat to public health, safety or the environment
is corrected prior to the decision of the Hearing Officer, the Department may lift the
immediate suspension by giving written notice to the licensee or registrant.
(b) Denial, Modification, Limitation, Revocation, or Refusal to Renew a License or
Certificate of Registration Based on Failure to File Reports or Pay Fees or Maintain
Insurance: In accordance with M.G.L. c. 30A, § 13, no Notice of Intent to Issue an Order
shall be required and no hearing shall be offered where denial, modification, limitation,
revocation, suspension or refusal to renew is based solely upon failure of the licensee or
registrant to file timely reports, schedules or applications or to pay lawfully prescribed
fees, or to maintain insurance coverage as required by any law or regulation.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.016: continued

(c) Denial, Modification, Limitation, Revocation or Refusal to Renew a License or

Certificate of Registration; Orders to Cease an Activity; Civil Penalties:
1. All adjudicatory proceedings shall be conducted in accordance with
M.G.L. c. 30A and 801 CMR 1.00: Standard Adjudicatory Rules of Practice and
Procedures.
2. Except for circumstances specified in 105 CMR 120.016(F)(4)(b), if the
Department determines that a license or certificate of registration should be denied,
modified, limited, revoked, or refused renewal, and/or that a facility should cease an
activity, and/or that a civil penalty should be imposed, and if the Department notifies
the applicant, licensee or registrant of its intended action, upon receipt of a Notice of
Claim for an Adjudicatory Proceeding, the Department shall initiate a hearing
pursuant to 801 CMR 1.00: Standard Adjudicatory Rules of Practice and
Procedures.
3. The Hearing Officer shall determine whether the Department has proved by a
preponderance of the evidence that the license or certificate of registration should be
denied, modified, limited, revoked or refused renewal; that an activity should be
ceased; and/or that a civil penalty be imposed based on relevant facts as they existed
at or prior to the time the Department initiated the hearing procedure.
4. If the Hearing Officer finds any single ground for denial, modification, limitation,
revocation, suspension, or refusal to renew a license or certificate of registration; for
a cessation of an activity; and/or for imposition of a civil penalty, then the Hearing
Officer shall render a recommended decision affirming the issuance of the
Department's Order.
(d) Final Agency Decision and Judicial Review:
1. The recommended decision of a Hearing Officer in any adjudicatory proceeding
conducted under 105 CMR 120.000 shall be reviewed by the Commissioner. The
Commissioner’s decision upon this review shall constitute a final agency decision in
an adjudicatory proceeding subject to judicial review pursuant to M.G.L. c. 30A,
§ 14.
2. Any applicant, licensee or registrant that fails to exercise its right to an
adjudicatory proceeding under 105 CMR 120.000 waives its right to an adjudicatory
hearing, its right to administrative review by the Commissioner and its right to
judicial review pursuant to M.G.L. c. 30A, § 14.

(G) Civil Penalties.

(1) If the Department determines, after a notice has been issued and an opportunity for a
hearing has been provided, that a licensee, registrant or vendor has not complied with an
order issued pursuant to M.G.L. c. 111, § 5O or with any provision of M.G.L. c. 111, §§ 5N
through 5P or with any applicable rule, regulation, license or certificate of registration
adopted or issued thereunder, the Department, in lieu of, or in addition to suspending,
denying, modifying, limiting, revoking, or refusing renewal of a license or certificate of
registration, may assess civil penalties in an amount not exceeding $100,000 per violation.
Such civil penalty may be assessed whether or not the violation was willful.
(2) The decision whether to issue a civil penalty and the amount of any civil penalty
depends on the facts of each case. Generally, civil penalties are most likely to be imposed
for Severity Level I violations and if mitigating circumstances are absent, for Severity Level
II violations. Civil penalties are considered for Severity Level III violations, and may be
imposed for Severity Level IV violations that are similar to previous violations that occurred
after the date of the last inspection or within two years, whichever period is greater for which
the licensee did not take effective corrective action.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(3) Civil penalties may be assessed for known and conscious violations of the reporting
requirements of 105 CMR 120.000 and for any willful violation of any Agency requirement
including those at any severity level.
(4) Payment of civil penalties imposed under M.G.L. c. 111, § 5O shall be made by check,
draft, or money order payable to the Commonwealth of Massachusetts, and mailed to the
Radiation Control Program.
(5) Factors in Determining the Amount of Penalty. In determining the amount of the civil
penalty, the Department shall consider the following:
(a) The willfulness of the violation;
(b) The actual and potential danger to the public health or the environment;
(c) The actual or potential costs of such danger to the public health or the environment;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.016: continued

(d) The actual or potential damage or injury to the public health or environment;
(e) The actual and potential cost of such damage or injury;
(f) The actual or potential cost to the Commonwealth of enforcing provisions of
105 CMR 120.000;
(g) Whether the person being assessed the civil penalty did everything reasonable to
prevent failure to, to come into compliance promptly, and to remedy and mitigate
whatever harm might have been done as a result of the failure to comply;
(h) Whether the person being assessed the civil penalty has previously failed to comply
with any order issued pursuant to M.G.L. c. 111, §§ 5N through 5P;
(i) Whether imposition of a civil penalty is likely to deter future non-compliance;
(j) The financial condition of the person being assessed the civil penalty; and
(k) The public interest.

(H) Escalation of Enforcement Sanctions.

(1) The Department considers violations of Severity Levels I, II or III to be of significant
regulatory concern. When Severity Level I, II or III violations occur, the Department will,
where necessary, issue orders in conjunction with civil penalties to achieve immediate
corrective actions and to deter further recurrence of serious violations. The Department
carefully considers the circumstances of each case in selecting and applying the sanction(s)
appropriate to the case in accordance with the criteria described in 105 CMR 120.016(D).
(2) The progression of enforcement actions for similar violations will usually be based on
similar violations at an individual facility and not on similar violations under the same
license. However, under some circumstances, e.g., where there is common control over
some facet of facility operations, similar violations may be charged even though the second
violation occurred at a different facility or under a different license. For example, a health
physics violation at one division of a dual unit hospital that repeats an earlier violation of the
other division might be considered similar.

(I) Criminal Enforcement. The Department may elect to enforce any section of 105 CMR
120.000 or provision of M.G.L. c. 111, § 5P by seeking to have criminal sanctions imposed. Any
person who violates M.G.L. c. 111, § 5N or § 5O or any rule, regulation, license, registration,
or order adopted or issued under said M.G.L. c. 111, § 5N or § 5O shall be fined not less than
$100 nor more than $2,000, or be imprisoned for a period of not more than two years, or both.
Any person who continues to violate the provisions of the aforementioned laws after due notice
by the Department shall be fined not less than $1,000 nor more than $20,000 or be imprisoned
for a period of not more than 20 years, or both. After due notice has been issued by the
Department, each day of such violation shall constitute a separate offense.

(J) Judicial Enforcement. The Department may apply directly to the Supreme Judicial Court
or Superior Court to enforce any provision of M.G.L. c. 111, §§ 5N through 5P and/or any rule
or regulation, license, registration, or order adopted and issued thereunder by the Department.
When a person is engaged in or about to engage in any act or practice which constitutes or will
constitute a violation of such provision, rule, regulation, license, registration, or order, the
Department may seek to restrain such act or practice or the use or occupation of premises or parts
thereof or such other equitable relief as public health and safety requires.

(K) Nonexclusivity of Enforcement Procedures. None of the enforcement procedures contained

in 105 CMR 120.000 are mutually exclusive. Any enforcement procedures may be invoked
simultaneously if the situation so requires.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(L) Deliberate Misconduct.

(1) Any licensee; certificate of registration holder; quality assurance program approval
holder; applicant for a license or certificate of registration or quality assurance program
approval; employee of a licensee, certificate of registration holder, quality assurance program
approval holder or applicant; or any contractor (including a supplier or consultant),
subcontractor, employee of a contractor or subcontractor of any licensee or certificate of
registration holder, quality assurance program approval holder or applicant for a license or
certificate of registration or quality assurance program approval, who knowingly provides
to any licensee, applicant, certificate holder, quality assurance program approval holder,
contractor, or subcontractor, any components, equipment, materials, or other goods or
services that relate to a licensee's, certificate holder's, quality assurance program approval
holder's or applicant's activities in this part, may not:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.016: continued

(a) Engage in deliberate misconduct that causes or would have caused, if not detected,
a licensee, certificate of registration holder, quality assurance program approval holder
or applicant to be in violation of any rule, regulation, or order; or any term, condition, or
limitation of any license or certificate of registration or quality assurance program
approval issued by the Agency; or
(b) Deliberately submit to the Agency, a licensee, certificate of registration holder,
quality assurance program approval holder, an applicant, or a licensee's, certificate
holder's, quality assurance program approval holder's or applicant's contractor or
subcontractor, information that the person submitting the information knows to be
incomplete or inaccurate in some respect material to the Agency.
(2) A person who violates 105 CMR 120.016(L)(1)(a) or (b) may be subject to enforcement
action in accordance with the procedures in 105 CMR 120.016.
(3) For the purposes of 105 CMR 120.016(L)(1)(a), deliberate misconduct by a person
means an intentional act or omission that the person knows:
(a) Would cause a licensee, certificate of registration holder, quality assurance program
approval holder or applicant to be in violation of any rule, regulation, or order; or any
term, condition, or limitation, of any license issued by the Agency; or
(b) Constitutes a violation of a requirement, procedure, instruction, contract, purchase
order, or policy of a licensee, certificate of registration holder, quality assurance program
approval holder, applicant, contractor, or subcontractor.

120.017: Severability

The provisions of 105 CMR 120.000 are severable. If any section, subsection, paragraph or
provision is declared unconstitutional or invalid by a court of competent jurisdiction, the validity
of the remaining provisions shall not be so affected.

120.018: Public Disclosure of Enforcement Actions

In accordance with M.G.L. c. 30A, the Administrative Procedures Act, all enforcement
actions and licensees' responses are publicly available for inspection. In addition, press releases
may be issued for civil penalties related to violations at Severity Level I, II, or III.

120.019: Appendix A – Severity Categories

The following examples of severity levels are neither exhaustive nor controlling. They
reflect only the seriousness of the violation and not the intent of the violator, the history of the
violator, the amount necessary to deter future violations, or efforts to correct the violation.

(A) Severity Level 1 – Most Significant Violations.

(1) Health Physics.
(a) Single exposure of a worker in excess of 25 rems of radiation to the whole body, 150
rems to the skin of the whole body, or 375 rems to the feet, ankles, hands or forearms;
(b) Annual whole body exposure of a member of the public in excess of 2.5 rems of
radiation;
(c) Release of radioactive material to an unrestricted area in excess of ten times the
limits of 105 CMR 120.253;
(d) Disposal of licensed material in quantities or concentrations in excess of ten times
the limits of 105 CMR 120.253;
(e) Exposure of a worker in restricted areas of ten times the limits of 105 CMR 120.212.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(2) Transportation.
(a) Annual whole body radiation exposure of a member of the public in excess of 0.5
rems of radiation; or
(b) Breach of package integrity resulting in surface contamination or external radiation
levels in excess of ten times the Agency limits.
(3) Materials Operations.
(a) Radiation levels, contamination levels, or releases that exceed ten times the limits
specified in the license;
(b) A system designed to prevent or mitigate a serious safety event not being operable
when actually required to perform its design function.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.019: continued

(4) Miscellaneous Matters.

(a) A Material False Statement (MFS)1 in which the statement made was deliberately
false;
(b) Falsification of records which the Agency requires be kept of significant information
in which the records were deliberately falsified by or with the knowledge of
management; or,
(c) A knowing and intentional failure to provide any notice required by 105 CMR
120.000.
(d) Possession of licensable quantities of radioactive material without a license, or loss
of control of a source of radiation.
(e) Refusing authorized Agency personnel access to facilities, records and/or equipment
to conduct inspections or investigations.
(5) Emergency Preparedness. In an emergency, licensee failure to promptly:
(a) correctly identify the event;
(b) make required notifications to responsible Federal, State, and local agencies; or
(c) respond to the event (e.g., assess actual or potential offsite consequences, activate
emergency response facilities, and augment shift staff).

(B) Severity Level II -- Very Significant Violations.

(1) Health Physics.
(a) Single exposure of a worker in excess of 10 rems total effective dose equivalent, 30
rems to the lens of the eye or 100 rems to the skin of the whole body, or to the feet,
ankles, hands or forearms or to any other organ or tissue;
(b) Annual whole body exposure of a member of the public in excess of 0.5 rems of
radiation;
(c) Release of radioactive material to an unrestricted area in excess of five times the
limits of 105 CMR 120.222;
(d) Failure to make an immediate notification as required by 105 CMR 120.282(A), and
(B);
(e) Disposal of license material in quantities or concentrations in excess of five times
the limits of 105 CMR 120.253;
(f) Exposure of a worker in restricted areas in excess of five times the limits of 105
CMR 120.212.
(g) An x-ray system having a malfunction such that inadvertent exposures could occur
e.g., a system such that when the exposure switch is activated, not one but repeated
exposures occur, or the timer fails to terminate exposure, or exposure initiated without
utilizing the exposure switch.
(h) A fluoroscopic x-ray system with a tabletop entrance exposure rate of greater than
or equal to 25 R/min. at the point where the center of the useful beam enters the patient,
except:
a. During recording of fluoroscopic images; or,
b. When an optional high level control is activated.
(i) A fluoroscopic system such that the entire x-ray beam is not intercepted by the
primary protective barrier; or,
(j) Therapy systems which exhibit excessive leakage and/or inoperable door interlocks,
shutters, timers, etc.
(k) Therapy system, with improper operator/patient communication/observation.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

S))))))))))))))))))))))))))))Q
1
In essence, a Material False Statement is a statement that is false by omission or commission
and is relevant to the regulatory process. As can be seen in the examples, in determining the
specific severity level of a violation involving material false statements or falsification of
records, consideration will be given to such factors as the position of the person involved in
the violation (e.g., first line supervisor or senior manager), the significance of the information
involved, and the intent of the violator (i.e., negligence not amounting to careless disregard
or deliberateness). The relative weight given to each of these factors will be dependent on
the circumstances of the violation.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.019: continued

(2) Transportation.
(a) Breach of package integrity resulting in surface contamination or external radiation
levels in excess of Agency requirements;
(b) Surface contamination or external radiation levels in excess of five times Agency
limits that did not result from a breach of package integrity; or,
(c) Failure to make required initial notifications associated with Severity Level I or II
violations.
(3) Material Operations.
(a) Radiation levels, contamination levels, or releases that exceed five times the limits
specified in the license; or,
(b) A system designed to prevent or mitigate a serious safety event being inoperable.
(4) Miscellaneous Matters.
(a) A MFS, or a reporting failure, involving information which, had it been available
to the Agency and accurate at the time the information should have been submitted,
would have resulted in regulatory action or would likely have resulted in the Agency
seeking further information;
(b) A MFS in which the false statement was made with careless disregard.
(c) Deliberate falsification of records which the Agency requires be kept involving
significant information; or,
(d) A failure to provide the notice required.
(e) Failure to register sources of radiation or services as required by 105 CMR 120.000.
(f) Action by management to discriminate against an employee for attempting to
communicate or for actually communicating with the Agency.
(5) Emergency Preparedness. Licensee failure to meet or implement more than one
emergency planning standard involving assessment or notification.

(C) Severity Level III --- Significant Violations.

(1) Health Physics.
(a) A radiation exposure during any year of a worker in excess of 5 rems total effective
dose equivalent, 15 rems to the lens of the eye, or 50 rems to the skin of the whole body
or to the feet, ankles, hands or forearms, or to any other organ or tissue;
(b) A radiation level in an unrestricted area such that an individual could receive greater
than 100 millirem in a one hour period or 500 millirem in a seven consecutive days;
(c) Failure to make a 24-hour notification as required by 105 CMR 120.281 or an
immediate notification required by 105 CMR 120.282;
(d) Substantial potential for an exposure or release in excess of 105 CMR 120.200,
whether or not such exposure or release occurs (e.g., entry into high radiation areas, such
as under reactor vessels or in the vicinity of exposed radiographic sources, without
having performed an adequate survey, operation of a radiation facility with a
nonfunctioning interlock system);
(e) Release of radioactive material to an unrestricted area in excess of the limits of 105
CMR 120.222;
(f) Improper disposal of licensed material not covered in Severity Level I or II;
(g) Exposure of worker in restricted areas in excess of the limits of 105 CMR 120.212;
(h) Release for unrestricted use of contaminated or radioactive material or equipment
which poses a realistic potential for significant exposure to members of the public, or
which reflects a programmatic (rather than isolated) weakness in the radiation control
program;
(i) Cumulative worker exposure above regulatory limits when such cumulative exposure
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

reflects a programmatic, rather than an isolated weakness in radiation protection;

(j) Conduct of licensee activities by a technically unqualified person;
(k) Significant failure to control licensed material;
(l) Failure to use exposure reduction devices properly (e.g., collimators, filtration);
(m) For a fluoroscopic system where the maximum allowable tabletop exposure rate is
5 R/min., test values of greater than or equal to 7 R/min. (uncorrected), but less than 25
R/min. Correspondingly, for a maximum allowable rate of 10 R/min., test values of
greater than or equal to 14 R/min. (uncorrected) but less than 25 R/min. are included.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.019: continued

(n) A radiographic x-ray system having positive beam limitation where the x-ray field
size in the plane of the image receptor, whether automatically or manually adjusted, is
such that either the length or the width of the x-ray field differs from that of the image
receptor by greater than 10% of the SID when the equipment indicates that the beam axis
is perpendicular to the plane of the image receptor.
(o) Intraoral dental systems capable of operations in the above 50 kVp range for which
the field size at the cone tip is greater than or equal to nine centimeters or which exhibit
a minimum SSD less than 16 centimeters.
(p) Dental radiographic systems in which it is possible to produce x-rays with the timer
in the zero or off position.
(q) Mammographic x-ray systems in which the edge of the x-ray field at the chest wall
extends beyond the edges of the image receptor by more than 5% of the source to image
receptor distance.
(r) Therapy systems which fail to maintain proper surveys, calibrations, spot checks or
operating procedures.
(2) Transportation.
(a) Breach of package integrity;
(b) Surface contamination or external radiation levels in excess of, but less than a factor
of five above Agency requirements that did not result from a breach of package integrity;
(c) Any noncompliance with labeling, placarding, shipping paper, packaging loading,
or other requirements that could reasonably result in the following:
a. Improper identification of the type, quantity, or form of material;
b. Failure of the carrier or recipient to exercise adequate controls; or,
c. Substantial potential for personnel exposure or contamination, or improper
transfer of material; or,
(d) Failure to make required initial notification associated with Severity Level III
violations.
(3) Materials Operations.
(a) Failure to control access to licensed materials for radiation purposes as specified by
Agency requirements;
(b) Possession or use of unauthorized equipment or materials in the conduct of licensee
activities which degrades safety;
(c) Use of radioactive material on humans where such use is not authorized;
(d) Conduct of licensed activities by a technically unqualified person;
(e) Radiation levels, contamination levels, or releases that exceed the limits specified
in the license; or,
(f) Medical therapeutic misadministrations.
(g) Failure to obtain appropriate Agency approval before moving to a new use and/or
storage location.
(4) Miscellaneous Matters.
(a) An MFS not amounting to a Severity Level I or II violation; or,
(b) Deliberate falsification, or falsification by or with the knowledge of management of
records which the Agency requires be kept that did not involve signification information.
(5) Emergency Preparedness. Violations of lesser severity than Severity Level II violations.

(D) Severity Level IV -- Violations.

(1) Health Physics.
(a) Exposures in excess of the limits of 105 CMR 120.211 not constituting Severity
Level I, II, or III violations;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(b) A radiation level in an unrestricted area such that an individual could receive greater
than two millirem in a one-hour period or 50 millirem in a year;
(c) Failure to make a 30-day notification required by 105 CMR 120.283;
(d) Failure to make a follow-up written report as required by 105 CMR 120.281,
120.287 and 120.750; or,
(e) Any other matter that has more than minor safety or environmental significance.
(f) A capacitor storage radiographic system such that the standby radiation is greater
than 3.0 mR/hr, but less than 25 mR/hr.
(g) Systems equipped with positive beam limiting devices which do not allow the field
size to be reduced to a size less than that of the image receptor.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.019: continued

(h) Systems equipped with positive beam limiting devices which do not provide for an
automatic return to PBL from a reduced field size.
(i) Mobile radiographic systems for which the minimum source to skin distance is less
than 27.5 centimeters.
(j) Mammographic systems manufactured after October 1977 for which the edges of the
x-ray field on the right or left sides extend beyond the edges of the image receptor. If
manufactured prior to November 1977 and the edges of the x-ray field on either side
extend beyond the edge of the image receptor by more than 5% of the SID.
(2) Transportation.
(a) Package selection of preparation requirements which do not result in a breach of
package integrity or surface contamination or external radiation levels in excess of
Agency requirements; or,
(b) Other violations that have more than minor safety or environmental significance.
(3) Material Operations.
(a) Failure to maintain patients hospitalized who have cobalt-60, cesium-137, or
iridium-192 implants or to conduct required leakage or contamination tests, or to use
properly calibrated equipment;
(b) Other violations that have more than minor safety or environmental significance; or,
(c) Failure to report medical diagnostic misadministrations.
(4) Miscellaneous Matters.
(a) A false statement caused by an inadvertent clerical or similar error involving
information which, had it been available to the Agency and accurate at the time the
information should have been submitted, would probably not have resulted in regulatory
action or the Agency seeking additional information.
(b) Unless specified in a more severe category, changes in procedures or other
conditions of a license or certificate of registration of which the Agency was not
informed (e.g., change of address, expiration of certificate of registration); or,
(5) Emergency Preparedness. Violations of lesser severity than Severity Level III
violations.

120.020: REGISTRATION OF RADIATION MACHINE FACILITIES AND SERVICES

120.021: Purpose and Scope

(A) 105 CMR 120.020 through 120.040 provides for the registration of radiation machine
facilities and for the registration of persons providing radiation machine installation, servicing,
and/or services to Department registrants or registrable facilities. For the purposes of 105 CMR
120.020, particle accelerators, whether used primarily for x-ray production or other purposes,
shall be considered a radiation machine facility.

(B) In addition to the requirements of 105 CMR 120.020 through 120.040, all registrants are
subject to the applicable provisions of other parts of 105 CMR 120.000.

120.022: Definitions

As used in 105 CMR 120.020 through 120.040, "facility" means the location at which one
or more devices or sources are installed and/or located within one building, vehicle, or under one
roof and are under the same administrative control.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.023: Exemptions

(A) Electronic equipment that produces radiation incidental to its operation for other purposes
is exempt from the registration and notification requirements of 105 CMR 120.020 through
120.040, providing dose equivalent rate averaged over an area of ten square centimeters does not
exceed 0.5 millirem (5: Sv) per hour at five centimeters from any accessible surface of such
equipment. The production, testing, or factory servicing of such equipment shall not be exempt.

(B) Radiation machines while in transit or storage incident thereto are exempt from the
requirements of 105 CMR 120.020 through 120.040.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.023: continued

(C) Domestic television receivers are exempt from the requirements of 105 CMR 120.020
through 120.040.

120.024: Plan Review

(A) Prior to construction, the floor plans and equipment arrangements of all new installations,
or modifications of existing installations, utilizing ionizing radiation for diagnostics or
therapeutic purposes shall be submitted to the Agency for review and approval. The installation
shall meet the requirements of 105 CMR 120.420: Appendix A and 105 CMR 120.422:
Appendix C unless specifically exempted. Additional shielding and design requirements are
specified elsewhere in 105 CMR 120.000.

(B) The Agency may require the applicant to utilize the services of a qualified expert to
determine the shielding requirements prior to the plan review and approval.

(C) The approval of such plans shall not preclude the requirement of additional modifications
should a subsequent analysis of operating conditions indicate the possibility of an individual
receiving a dose in excess of the limits prescribed in 105 CMR 120.211, 120.217, 120.218 and
120.221.

120.025: Application for Registration

Each person who owns or possess and administratively controls a facility, unless specifically
exempted in 105 CMR 120.023 shall:

(A) Apply for registration of such facility with the Agency prior to the operation of a radiation
machine facility. Application for registration shall be completed on forms furnished by the
Agency and shall contain all the information required by the form and accompanying
instructions.

(B) Designate on the application form an individual to be responsible for radiation protection.

(C) Each registrant shall prohibit any person from furnishing radiation machine servicing or
services as described in 105 CMR 120.026(D) to his radiation machine facility until such person
provides evidence that he has been registered with the Agency as a provider of services in
accordance with 105 CMR 120.026.

120.026: Application for Registration Services

(A) Each person, prior to engaging in the business of installing or offering to install radiation
machines or engaging in the business of furnishing or offering to furnish radiation machine
servicing or services in this Commonwealth shall apply for and receive registration for such
services with the Agency.

(B) Application for registration shall be completed on forms furnished by the Agency and shall
contain all information required by the Agency as indicated on the forms and accompanying
instructions.

(C) Each person applying for registration under 105 CMR 120.020 through 120.040 shall
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

specify:
(1) That he has read and understands the requirements of 105 CMR 120.020 through
120.040;
(2) The services for which he is applying for registration; and,
(3) The training and experience that qualify him to discharge the services for which he is
applying for registration;

(D) For the purpose of 105 CMR 120.026, services may include but shall not be limited to:
(1) Installation and/or servicing of radiation machines and associated radiation machine
components;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.026: continued

(2) Calibration of radiation machines or radiation measurement instruments or devices;

(3) Radiation protection or health physics consultations or surveys; and,
(4) Personnel dosimetry services.

120.027: Certificate of Registration

(A) No person shall maintain a facility that is required by 105 CMR 120.000 to be registered
unless such a person has obtained a valid certificate of registration for such facility.

(B) A person who applies for registration and whose application meets the requirements of 105
CMR 120.000, shall, upon payment of the required fee, be issued a certificate of registration
effective on the date stated on such certificate.

(C) A current certificate of registration or a legible copy thereof shall be posted conspicuously
at each registered facility.

(D) The Director of the Radiation Control Program may incorporate in the certificate of
registration, at the time of issuance or thereafter, any such additional requirements and conditions
with respect to the registrant's receipt, possession, use, and transfer of radiation machines as said
Director finds appropriate and necessary for the protection of the general public or individuals
against radiation hazards.

120.028: Expiration of Notice of Registration

Each certificate of registration shall expire at the end of the specified day in the month and
year stated therein.

120.029: Renewal of Notice of Registration

(A) Application for renewal of registration shall be filed in accordance with 105 CMR 120.025
or 105 CMR 120.026.

(B) In any case in which a registrant not less than 30 days prior to the expiration of his existing
notice of registration has filed an application in proper form for renewal, such existing notice of
registration shall not expire until the application status has been finally determined by the
Agency.

120.030: Report of Changes

The registrant shall notify the Agency in writing before making any change which would
render the information contained in the application for registration and/or the certificate of
registration no longer accurate. In the case of disposition of an x-ray system, such notification
should specify the recipient of the system. In the case of modification involving a structural
change, or the addition or relocation of an x-ray system, the Director of the Radiation Control
Program may require the registrant to submit the information contained in 105 CMR 120.420:
Appendix A and/or 105 CMR 120.421: Appendix C.

120.031: Approval Not Implied

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

No person, in any advertisement, shall refer to the fact that he or his facility is registered with
the Agency pursuant to the provisions of 105 CMR 120.025 or 120.026, and no person shall state
or imply that any activity under such registration has been approved by the Agency.

120.032: Assembler and/or Transfer Obligation

(A) Any person who sells, leases, transfers, lends, disposes, assembles, or installs radiation
machines in this Commonwealth shall notify the Agency within 15 days of:
(1) The name and address of persons who have received these machines;
(2) The manufacturer, model, and serial number of each radiation machine transferred; and,
(3) The date of transfer of each radiation machine.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.032: continued

(4) In the case of diagnostic x-ray system which contain certified components, a copy of the
assembler's report prepared in compliance with requirements of the Federal Diagnostic
X-Ray Standard (21 CFR 1020.30 (d)) shall be submitted to the Agency within 15 days
following completion of the assembly. Such report shall suffice in lieu of any other by the
assembler.

(B) No person shall make, sell, lease, transfer, lend, assemble, or install radiation machines or
the supplies used in connection with such machines unless such supplies and equipment when
properly placed in operation and use shall meet the requirements of 105 CMR 120.000.

120.033: Out-of-state Radiation Machines

(A) Whenever any radiation machine is to be brought into the Commonwealth, for any
temporary use, the person proposing to bring such machine into the Commonwealth shall give
written notice to the Agency at least ten working days before such machine is to be used in the
Commonwealth. The notice shall include:
(1) The type of radiation machine;
(2) The nature, duration, and scope of use;
(3) The exact location(s) where the radiation machine is to be used; and,
(4) States in which this machine is registered.

(B) The person referred to in 105 CMR 120.033 shall:

(1) Comply with all applicable regulations of the Agency;
(2) Register the radiation machine(s) with the Agency; and,
(3) Submit payment of the required fee for registration.

(C) A pre-operational inspection may be required at the discretion of the Director of the
Radiation Control Program.

(D) If, for a specific case, the ten working day period is not practical, notification to the Agency
by telephone and hardcopy, permission to proceed sooner may be granted.

120.040: Notification to Fire Department

The user shall notify the local fire department of the presence on his premises of any
radioactive material that may present special fire-fighting problems or require special
precautionary measures in case of fire or other natural catastrophe, and he shall establish
effective liaison with the fire department in regards to this matter.

120.050: PHYSICAL PROTECTION OF CATEGORY 1 AND CATEGORY 2 QUANTITIES OF

RADIOACTIVE MATERIAL

GENERAL PROVISIONS

120.051: Purpose

105 CMR 120.050 through 120.080 has been established to provide the requirements for the
physical protection program for any licensee that possesses an aggregated category 1 or category
2 quantity of radioactive material listed in 105 CMR 120.080: Appendix A: Table 1. 105 CMR
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.050 through 120.080 provide reasonable assurance of the security of category 1 or category
2 quantities of radioactive material by protecting these materials from theft or diversion.
Specific requirements for access to material, use of material, transfer of material, and transport
of material are included. No provision of 105 CMR 120.050 through 120.080 authorizes
possession of licensed material.

120.052: Scope

(A) 105 CMR 120.056 through 120.071 applies to any person who, under the regulations in
105 CMR 120.000, possesses or uses at any site, an aggregated category 1 or category 2 quantity
of radioactive material.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.052: continued

(B) 105 CMR 120.072 through 120.077 applies to any person who, under 105 CMR 120.000:
(1) Transports or delivers to a carrier for transport in a single shipment, a category 1 or
category 2 quantity of radioactive material; or
(2) Imports or exports a category 1 or category 2 quantity of radioactive material; the
provisions only apply to the domestic portion of the transport.

120.053: Definitions

As used in 105 CMR 120.050 through 120.080, the following definitions apply:

Access Control means a system for allowing only approved individuals to have unescorted
access to the security zone and for ensuring that all other individuals are subject to escorted
access.

Aggregated means accessible by the breach of a single physical barrier that would allow access
to radioactive material in any form, including any devices that contain the radioactive material,
when the total activity equals or exceeds a category 2 quantity of radioactive material.

Approved Individual means an individual whom the licensee has determined to be trustworthy
and reliable for unescorted access in accordance with 105 CMR 120.056 through 120.062 and
who has completed the training required by 105 CMR 120.064(C).

Background Investigation means the investigation conducted by a licensee or applicant to

support the determination of trustworthiness and reliability.

Carrier means a person engaged in the transportation of passengers or property by land or water
as a common, contract, or private carrier, or by civil aircraft.

Category 1 Quantity of Radioactive Material means a quantity of radioactive material meeting

or exceeding the category 1 threshold in 105 CMR 120.080: Appendix A: Table 1. This is
determined by calculating the ratio of the total activity of each radionuclide to the category 1
threshold for that radionuclide and adding the ratios together. If the sum is equal to or exceeds
1, the quantity would be considered a category 1 quantity. Category 1 quantities of radioactive
material do not include the radioactive material contained in any fuel assembly, subassembly,
fuel rod, or fuel pellet.

Category 2 Quantity of Radioactive Material means a quantity of radioactive material meeting

or exceeding the category 2 threshold but less than the category 1 threshold in 105 CMR
120.080: Appendix A: Table 1. This is determined by calculating the ratio of the total activity
of each radionuclide to the category 2 threshold for that radionuclide and adding the ratios
together. If the sum is equal to or exceeds one, the quantity would be considered a category 2
quantity. Category 2 quantities of radioactive material do not include the radioactive material
contained in any fuel assembly, subassembly, fuel rod, or fuel pellet.

Diversion means the unauthorized movement of radioactive material subject to 105 CMR
120.050 through 120.080 to a location different from the material's authorized destination inside
or outside of the site at which the material is used or stored.

Escorted Access means accompaniment while in a security zone by an approved individual who
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

maintains continuous direct visual surveillance at all times over an individual who is not
approved for unescorted access.

Fingerprint Orders means the orders issued by the U.S. Nuclear Regulatory Commission or the
legally binding requirements issued by Agreement States that require fingerprints and criminal
history records checks for individuals with unescorted access to category 1 and category 2
quantities of radioactive material or safeguards information-modified handling.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.053: continued

Government Agency means any executive department, commission, independent establishment,

corporation, wholly or partly owned by the United States of America which is an instrumentality
of the United States, or any board, bureau, division, service, office, officer, authority,
administration, or other establishment in the executive branch of the Government.

Local Law Enforcement Agency (LLEA) means a public or private organization that has been
approved by a federal, state, or local government to carry firearms and make arrests, and is
authorized and has the capability to provide an armed response in the jurisdiction where the
licensed category 1 or category 2 quantity of radioactive material is used, stored, or transported.

Mobile Device means a piece of equipment containing licensed radioactive material that is
either mounted on wheels or casters, or otherwise equipped for moving without a need for
disassembly or dismounting; or designed to be hand carried. Mobile devices do not include
stationary equipment installed in a fixed location.

Movement Control Center means an operations center that is remote from transport activity and
that maintains position information on the movement of radioactive material, receives reports
of attempted attacks or thefts, provides a means for reporting these and other problems to
appropriate agencies and can request and coordinate appropriate aid.

No-later-than Arrival Time means the date and time that the shipping licensee and receiving
licensee have established as the time at which an investigation will be initiated if the shipment
has not arrived at the receiving facility. The no-later-than arrival time may not be more than six
hours after the estimated arrival time for shipments of category 2 quantities of radioactive
material.

Reviewing Official means the individual who shall make the trustworthiness and reliability
determination of an individual to determine whether the individual may have, or continue to
have, unescorted access to the category 1 or category 2 quantities of radioactive materials that
are possessed by the licensee.

Sabotage means deliberate damage, with malevolent intent, to a category 1 or category 2

quantity of radioactive material, a device that contains a category 1 or category 2 quantity of
radioactive material, or the components of the security system.

Safe Haven means a readily recognizable and readily accessible site at which security is present
or from which, in the event of an emergency, the transport crew can notify and wait for the local
law enforcement authorities.

Security Zone means any temporary or permanent area determined and established by the
licensee for the physical protection of category 1 or category 2 quantities of radioactive material.

State means a State or Commonwealth of the United States, the District of Columbia, the
Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, and the
Commonwealth of the Northern Mariana Islands.

Telemetric Position Monitoring System means a data transfer system that captures information
by instrumentation and/or measuring devices about the location and status of a transport vehicle
or package between the departure and destination locations.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Trustworthiness and Reliability are characteristics of an individual considered dependable in

judgment, character, and performance, such that unescorted access to category 1 or category 2
quantities of radioactive material by that individual does not constitute an unreasonable risk to
the public health and safety or security. A determination of trustworthiness and reliability for
this purpose is based upon the results from a background investigation.

Unescorted Access means solitary access to an aggregated category 1 or category 2 quantity of

radioactive material or the devices that contain the material.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.054: Communications

Except where otherwise specified or covered, all communications and reports concerning
105 CMR 120.050 through 120.080 may be sent as stated in 105 CMR 120.013.

120.055: Specific Exemptions

(A) The Agency may, upon application of any interested person or upon its own initiative, grant
such exemptions from the requirements of 105 CMR 120.050 through 120.080 as it determines
are authorized by law and will not endanger life or property or the physical protection of
agreement material, and are otherwise in the public interest.

(B) A licensee that possesses radioactive waste that contains category 1 or category 2 quantities
of radioactive material is exempt from the requirements of 105 CMR 120.056 through 120.077.
Except that any radioactive waste that contains discrete sources, ion-exchange resins, or activated
material that weighs less than 2,000 kg (4,409 lbs) is not exempt from the requirements of
105 CMR 120.050 through 120.080. The licensee shall implement the following requirements
to secure the radioactive waste:
(1) Use continuous physical barriers that allow access to the radioactive waste only through
established access control points;
(2) Use a locked door or gate with monitored alarm at the access control point;
(3) Assess and respond to each actual or attempted unauthorized access to determine
whether an actual or attempted theft, sabotage, or diversion occurred; and
(4) Immediately notify the LLEA and request an armed response from the LLEA upon
determination that there was an actual or attempted theft, sabotage, or diversion of the
radioactive waste that contains category 1 or category 2 quantities of radioactive material.

BACKGROUND INVESTIGATIONS AND ACCESS AUTHORIZATION PROGRAM

120.056: Personnel Access Authorization Requirements for Category 1 or Category 2 Quantities of

Radioactive Materials

(A) General.
(1) Each licensee that possesses an aggregated quantity of radioactive material at or above
the category 2 threshold shall establish, implement, and maintain its access authorization
program in accordance with the requirements of 105 CMR 120.056 through 120.062.
(2) An applicant for a new license and each licensee that would become newly subject to
the requirements of 105 CMR 120.056 through 120.062 upon application for modification
of its license shall implement the requirements of 105 CMR 120.056 through 120.062, as
appropriate, before taking possession of an aggregated category 1 or category 2 quantity of
radioactive material.
(3) Any licensee that has not previously implemented the Security Orders or been subject
to the provisions of 105 CMR 120.056 through 120.062 shall implement the provisions of
105 CMR 120.056 through 120.062 before aggregating radioactive material to a quantity that
equals or exceeds the category 2 threshold.

(B) General Performance Objective. The licensee's access authorization program must ensure
that the individuals specified in 105 CMR 120.056(C)(1) are trustworthy and reliable.

(C) Applicability.
(1) Licensees shall subject the following individuals to an access authorization program:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(a) Any individual whose assigned duties require unescorted access to category 1 or
category 2 quantities of radioactive material or to any device that contains the radioactive
material; and
(b) Reviewing officials.
(2) Licensees need not subject the categories of individuals listed in 105 CMR
120.060(A)(1) through (13) to the investigation elements of the access authorization
program.
(3) Licensees shall approve for unescorted access to category 1 or category 2 quantities of
radioactive material only those individuals with job duties that require unescorted access to
category 1 or category 2 quantities of radioactive material.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.056: continued

(4) Licensees may include individuals needing access to safeguards information-modified

handling under 10 CFR Part 73 in the access authorization program under 105 CMR 120.056
through 120.062.

120.057: Access Authorization Program Requirements

(A) Granting Unescorted Access Authorization.

(1) Licensees shall implement the requirements of 105 CMR 120.056 through 120.062 for
granting initial or reinstated unescorted access authorization.
(2) Individuals who have been determined to be trustworthy and reliable shall also complete
the security training required by 105 CMR 120.064(C) before being allowed unescorted
access to category 1 or category 2 quantities of radioactive material.

(B) Reviewing Officials.

(1) Reviewing officials are the only individuals who may make trustworthiness and
reliability determinations that allow individuals to have unescorted access to category 1 or
category 2 quantities of radioactive materials possessed by the licensee.
(2) Each licensee shall name one or more individuals to be reviewing officials. After
completing the background investigation on the reviewing official, the licensee shall provide
under oath or affirmation, a certification that the reviewing official is deemed trustworthy
and reliable by the licensee. The fingerprints of the named reviewing official must be taken
by a law enforcement agency, Federal or State agencies that provide fingerprinting services
to the public, or commercial fingerprinting services authorized by a State to take fingerprints.
The licensee shall recertify that the reviewing official is deemed trustworthy and reliable
every ten years in accordance with 105 CMR 120.058(C).
(3) Reviewing officials must be permitted to have unescorted access to category 1 or
category 2 quantities of radioactive materials or access to safeguards information or
safeguards information-modified handling, if the licensee possesses safeguards information
or safeguards information-modified handling.
(4) Reviewing officials cannot approve other individuals to act as reviewing officials.
(5) A reviewing official does not need to undergo a new background investigation before
being named by the licensee as the reviewing official if:
(a) The individual has undergone a background investigation that included
fingerprinting and an FBI criminal history records check and has been determined to be
trustworthy and reliable by the licensee; or
(b) The individual is subject to a category listed in 105 CMR 120.060(A).

(C) Informed Consent.

(1) Licensees may not initiate a background investigation without the informed and signed
consent of the subject individual. This consent must include authorization to share personal
information with other individuals or organizations as necessary to complete the background
investigation. Before a final adverse determination, the licensee shall provide the individual
with an opportunity to correct any inaccurate or incomplete information that is developed
during the background investigation. Licensees do not need to obtain signed consent from
those individuals that meet the requirements of 105 CMR 120.058(B). A signed consent
must be obtained prior to any reinvestigation.
(2) The subject individual may withdraw his or her consent at any time. Licensees shall
inform the individual that:
(a) If an individual withdraws his or her consent, the licensee may not initiate any
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

elements of the background investigation that were not in progress at the time the
individual withdrew his or her consent; and
(b) The withdrawal of consent for the background investigation is sufficient cause for
denial or termination of unescorted access authorization.

(D) Personal History Disclosure. Any individual who is applying for unescorted access
authorization shall disclose the personal history information that is required by the licensee's
access authorization program for the reviewing official to make a determination of the
individual's trustworthiness and reliability. Refusal to provide, or the falsification of, any
personal history information required by 105 CMR 120.056 through 120.062 is sufficient cause
for denial or termination of unescorted access.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.057: continued

(E) Determination Basis.

(1) The reviewing official shall determine whether to permit, deny, unfavorably terminate,
maintain, or administratively withdraw an individual's unescorted access authorization based
on an evaluation of all of the information collected to meet the requirements of 105 CMR
120.056 through 120.062.
(2) The reviewing official may not permit any individual to have unescorted access until the
reviewing official has evaluated all of the information collected to meet the requirements of
105 CMR 120.056 through 120.062 and determined that the individual is trustworthy and
reliable. The reviewing official may deny unescorted access to any individual based on
information obtained at any time during the background investigation.
(3) The licensee shall document the basis for concluding whether or not there is reasonable
assurance that an individual is trustworthy and reliable.
(4) The reviewing official may terminate or administratively withdraw an individual's
unescorted access authorization based on information obtained after the background
investigation has been completed and the individual granted unescorted access authorization.
(5) Licensees shall maintain a list of persons currently approved for unescorted access
authorization. When a licensee determines that a person no longer requires unescorted access
or meets the access authorization requirement, the licensee shall remove the person from the
approved list as soon as possible, but no later than seven working days, and take prompt
measures to ensure that the individual is unable to have unescorted access to the material.

(F) Procedures. Licensees shall develop, implement, and maintain written procedures for
implementing the access authorization program. The procedures must include provisions for the
notification of individuals who are denied unescorted access. The procedures must include
provisions for the review, at the request of the affected individual, of a denial or termination of
unescorted access authorization. The procedures must contain a provision to ensure that the
individual is informed of the grounds for the denial or termination of unescorted access
authorization and allow the individual an opportunity to provide additional relevant information.

(G) Right to Correct and Complete Information.

(1) Prior to any final adverse determination, licensees shall provide each individual subject
to the requirements of 105 CMR 120.056 through 120.062 with the right to complete,
correct, and explain information obtained as a result of the licensee's background
investigation. Confirmation of receipt by the individual of this notification must be
maintained by the licensee for a period of one year from the date of the notification.
(2) If, after reviewing his or her criminal history record, an individual believes that it is
incorrect or incomplete in any respect and wishes to change, correct, update, or explain
anything in the record, the individual may initiate challenge procedures. These procedures
include direct application by the individual challenging the record to the law enforcement
agency that contributed the questioned information or a direct challenge as to the accuracy
or completeness of any entry on the criminal history record to the Federal Bureau of
Investigation, Criminal Justice Information Services (CJIS) Division, ATTN: SCU, Mod.
D-2, 1000 Custer Hollow Road, Clarksburg, WV 26306 as set forth in 28 CFR 16.30 through
16.34. In the latter case, the Federal Bureau of Investigation (FBI) will forward the challenge
to the agency that submitted the data, and will request that the agency verify or correct the
challenged entry. Upon receipt of an official communication directly from the agency that
contributed the original information, the FBI Identification Division makes any changes
necessary in accordance with the information supplied by that agency. Licensees must
provide at least ten days for an individual to initiate action to challenge the results of an FBI
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

criminal history records check after the record being made available for his or her review.
The licensee may make a final adverse determination based upon the criminal history records
only after receipt of the FBI's confirmation or correction of the record.

(H) Records.
(1) The licensee shall retain documentation regarding the trustworthiness and reliability of
individual employees for three years from the date the individual no longer requires
unescorted access to category 1 or category 2 quantities of radioactive material.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.057: continued

(2) The licensee shall retain a copy of the current access authorization program procedures
as a record for three years after the procedure is no longer needed. If any portion of the
procedure is superseded, the licensee shall retain the superseded material for three years after
the record is superseded.
(3) The licensee shall retain the list of persons approved for unescorted access authorization
for three years after the list is superseded or replaced.

120.058: Background Investigations

(A) Initial Investigation. Before allowing an individual unescorted access to category 1 or

category 2 quantities of radioactive material or to the devices that contain the material, licensees
shall complete a background investigation of the individual seeking unescorted access
authorization. The scope of the investigation must encompass at least the seven years preceding
the date of the background investigation or since the individual's 18th birthday, whichever is
shorter. The background investigation must include at a minimum:
(1) Fingerprinting and an FBI identification and criminal history records check in
accordance with 105 CMR 120.059;
(2) Verification of True Identity. Licensees shall verify the true identity of the individual
who is applying for unescorted access authorization to ensure that the applicant is who he or
she claims to be. A licensee shall review official identification documents (e.g., driver's
license; passport; government identification; certificate of birth issued by the state, province,
or country of birth) and compare the documents to personal information data provided by the
individual to identify any discrepancy in the information. Licensees shall document the type,
expiration, and identification number of the identification document, or maintain a photocopy
of identifying documents on file in accordance with 105 CMR 120.061. Licensees shall
certify in writing that the identification was properly reviewed, and shall maintain the
certification and all related documents for review upon inspection;
(3) Employment History Verification. Licensees shall complete an employment history
verification, including military history. Licensees shall verify the individual's employment
with each previous employer for the most recent seven years before the date of application;
(4) Verification of Education. Licensees shall verify that the individual participated in the
education process during the claimed period;
(5) Character and Reputation Determination. Licensees shall complete reference checks to
determine the character and reputation of the individual who has applied for unescorted
access authorization. Unless other references are not available, reference checks may not be
conducted with any person who is known to be a close member of the individual's family,
including but not limited to the individual's spouse, parents, siblings, or children, or any
individual who resides in the individual's permanent household. Reference checks under
105 CMR 120.056 through 120.062 must be limited to whether the individual has been and
continues to be trustworthy and reliable;
(6) The licensee shall also, to the extent possible, obtain independent information to
corroborate that provided by the individual (e.g., seek references not supplied by the
individual); and
(7) If a previous employer, educational institution, or any other entity with which the
individual claims to have been engaged fails to provide information or indicates an inability
or unwillingness to provide information within a time frame deemed appropriate by the
licensee but at least after ten business days of the request or if the licensee is unable to reach
the entity, the licensee shall document the refusal, unwillingness, or inability in the record
of investigation; and attempt to obtain the information from an alternate source.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(B) Grandfathering.
(1) Individuals who have been determined to be trustworthy and reliable for unescorted
access to category 1 or category 2 quantities of radioactive material under the Fingerprint
Orders may continue to have unescorted access to category 1 and category 2 quantities of
radioactive material without further investigation. These individuals shall be subject to the
reinvestigation requirement.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.058: continued

(2) Individuals who have been determined to be trustworthy and reliable under the
provisions of 10 CFR Part 73 or the security orders for access to safeguards information,
safeguards information-modified handling, or risk-significant material may have unescorted
access to category 1 and category 2 quantities of radioactive material without further
investigation. The licensee shall document that the individual was determined to be
trustworthy and reliable under the provisions of 10 CFR Part 73 or a security order. Security
order, in this context, refers to any order that was issued by the NRC that required
fingerprints and an FBI criminal history records check for access to safeguards information,
safeguards information-modified handling, or risk significant material such as special nuclear
material or large quantities of uranium hexafluoride. These individuals shall be subject to
the reinvestigation requirement.

(C) Reinvestigations. Licensees shall conduct a reinvestigation every ten years for any
individual with unescorted access to category 1 or category 2 quantities of radioactive material.
The reinvestigation shall consist of fingerprinting and an FBI identification and criminal history
records check in accordance with 105 CMR 120.059. The reinvestigations must be completed
within ten years of the date on which these elements were last completed.

120.059: Requirements for Criminal History Records Checks of Individuals Granted Unescorted Access to
Category 1 or Category 2 Quantities of Radioactive Material

(A) General Performance Objective and Requirements.

(1) Except for those individuals listed in 105 CMR 120.060 and those individuals
grandfathered under 105 CMR 120.058(B), each licensee subject to the provisions of
105 CMR 120.056 through 120.062 shall fingerprint each individual who is to be permitted
unescorted access to category 1 or category 2 quantities of radioactive material. Licensees
shall transmit all collected fingerprints to the U.S. Nuclear Regulatory Commission for
transmission to the FBI. The licensee shall use the information received from the FBI as part
of the required background investigation to determine whether to grant or deny further
unescorted access to category 1 or category 2 quantities of radioactive materials for that
individual.
(2) The licensee shall notify each affected individual that his or her fingerprints will be used
to secure a review of his or her criminal history record, and shall inform him or her of the
procedures for revising the record or adding explanations to the record.
(3) Fingerprinting is not required if a licensee is reinstating an individual's unescorted
access authorization to category 1 or category 2 quantities of radioactive materials if:
(a) The individual returns to the same facility that granted unescorted access
authorization within 365 days of the termination of his or her unescorted access
authorization; and
(b) The previous access was terminated under favorable conditions.
(4) Fingerprints do not need to be taken if an individual who is an employee of a licensee,
contractor, manufacturer, or supplier has been granted unescorted access to category 1 or
category 2 quantities of radioactive material, access to safeguards information, or safeguards
information-modified handling by another licensee, based upon a background investigation
conducted under 105 CMR 120.056 through 120.062, the Fingerprint Orders, or 10 CFR
Part 73. An existing criminal history records check file may be transferred to the licensee
asked to grant unescorted access in accordance with the provisions of 105 CMR 120.061(C).
(5) Licensees shall use the information obtained as part of a criminal history records check
solely for the purpose of determining an individual's suitability for unescorted access
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

authorization to category 1 or category 2 quantities of radioactive materials, access to

safeguards information, or safeguards information-modified handling.

(B) Prohibitions.
(1) Licensees may not base a final determination to deny an individual unescorted access
authorization to category 1 or category 2 quantities of radioactive material solely on the basis
of information received from the FBI involving:
(a) An arrest more than one year old for which there is no information of the disposition
of the case; or
(b) An arrest that resulted in dismissal of the charge or an acquittal.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.059: continued

(2) Licensees may not use information received from a criminal history records check
obtained under 105 CMR 120.056 through 120.062 in a manner that would infringe upon the
rights of any individual under the First Amendment to the Constitution of the United States,
nor shall licensees use the information in any way that would discriminate among individuals
on the basis of race, religion, national origin, gender, or age.

(C) Procedures for Processing of Fingerprint Checks.

(1) For the purpose of complying with 105 CMR 120.056 through 120.062, licensees shall
submit to the U.S. Nuclear Regulatory Commission, Director, Division of Facilities and
Security, 11545 Rockville Pike, Rockville, Maryland 20852-2738, ATTN: Criminal History
Program, Mail Stop T-03B46M, one completed, legible standard fingerprint card (Form
FD-258, ORIMDNRCOOOZ), electronic fingerprint scan or, where practicable, other
fingerprint record for each individual requiring unescorted access to category 1 or category 2
quantities of radioactive material. Copies of these forms may be obtained by writing the
Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington,
DC 20555-0001, by calling 1-630-829-9565, or by email to FORMS.Resource@nrc.gov.
Guidance on submitting electronic fingerprints can be found at
http://www.nrc.gov/site-help/e-submittals.html.
(2) Fees for the processing of fingerprint checks are due upon application. Licensees shall
submit payment with the application for the processing of fingerprints through corporate
check, certified check, cashier's check, money order, or electronic payment, made payable
to ''U.S. NRC.'' (For guidance on making electronic payments, contact the Security Branch,
Division of Facilities and Security at 301-415-7513.) Combined payment for multiple
applications is acceptable. The U.S. Nuclear Regulatory Commission publishes the amount
of the fingerprint check application fee on the NRC's public Web site. (To find the current
fee amount, go to the Electronic Submittals page at
http://www.nrc.gov/site-help/e-submittals.html and see the link for the Criminal History
Program under Electronic Submission Systems.)
(3) The U.S. Nuclear Regulatory Commission will forward to the submitting licensee all
data received from the FBI as a result of the licensee's application(s) for criminal history
records checks.

120.060: Relief from Fingerprinting, Identification, and Criminal History Records Checks and Other
Elements of Background Investigations for Designated Categories of Individuals Permitted
Unescorted Access to Certain Radioactive Materials

(A) Fingerprinting, and the identification and criminal history records checks required by
section 149 of the Atomic Energy Act of 1954, as amended, and other elements of the
background investigation are not required for the following individuals prior to granting
unescorted access to category 1 or category 2 quantities of radioactive materials:
(1) An employee of the U.S. Nuclear Regulatory Commission or of the Executive Branch
of the U.S. Government who has undergone fingerprinting for a prior U.S. Government
criminal history records check;
(2) A Member of Congress;
(3) An employee of a member of Congress or Congressional committee who has undergone
fingerprinting for a prior U.S. Government criminal history records check;
(4) The Governor of a State or his or her designated State employee representative;
(5) Federal, State, or local law enforcement personnel;
(6) State Radiation Control Program Directors and State Homeland Security Advisors or
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

their designated State employee representatives;

(7) Agreement State employees conducting security inspections on behalf of the NRC under
an agreement executed under section 274.i. of the Atomic Energy Act;
(8) Representatives of the International Atomic Energy Agency (IAEA) engaged in
activities associated with the U.S./IAEA Safeguards Agreement who have been certified by
the NRC;
(9) Emergency response personnel who are responding to an emergency;
(10) Commercial vehicle drivers for road shipments of category 1 and category 2 quantities
of radioactive material;
(11) Package handlers at transportation facilities such as freight terminals and railroad
yards;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.060: continued

(12) Any individual who has an active Federal security clearance, provided that he or she
makes available the appropriate documentation. Written confirmation from the agency/
employer that granted the Federal security clearance or reviewed the criminal history records
check must be provided to the licensee. The licensee shall retain this documentation for a
period of three years from the date the individual no longer requires unescorted access to
category 1 or category 2 quantities of radioactive material; and
(13) Any individual employed by a service provider licensee for which the service provider
licensee has conducted the background investigation for the individual and approved the
individual for unescorted access to category 1 or category 2 quantities of radioactive material.
Written verification from the service provider must be provided to the licensee. The licensee
shall retain the documentation for a period of three years from the date the individual no
longer requires unescorted access to category 1 or category 2 quantities of radioactive
material.

(B) Fingerprinting, and the identification and criminal history records checks required by
section 149 of the Atomic Energy Act of 1954, as amended, are not required for an individual
who has had a favorably adjudicated U.S. Government criminal history records check within the
last five years, under a comparable U.S. Government program involving fingerprinting and an
FBI identification and criminal history records check provided that he or she makes available the
appropriate documentation. Written confirmation from the agency/employer that reviewed the
criminal history records check must be provided to the licensee. The licensee shall retain this
documentation for a period of three years from the date the individual no longer requires
unescorted access to category 1 or category 2 quantities of radioactive material. These programs
include, but are not limited to:
(1) National Agency Check;
(2) Transportation Worker Identification Credentials (TWIC) under 49 CFR part 1572;
(3) Bureau of Alcohol, Tobacco, Firearms, and Explosives background check and
clearances under 27 CFR part 555;
(4) Health and Human Services security risk assessments for possession and use of select
agents and toxins under 42 CFR part 73;
(5) Hazardous Material security threat assessment for hazardous material endorsement to
commercial driver's license under 49 CFR part 1572; and
(6) Customs and Border Protection's Free and Secure Trade (FAST) Program.

120.061: Protection of Information

(A) Each licensee who obtains background information on an individual under 105 CMR
120.056 through 120.062 shall establish and maintain a system of files and written procedures
for protection of the record and the personal information from unauthorized disclosure.

(B) The licensee may not disclose the record or personal information collected and maintained
to persons other than the subject individual, his or her representative, or to those who have a need
to have access to the information in performing assigned duties in the process of granting or
denying unescorted access to category 1 or category 2 quantities of radioactive material,
safeguards information, or safeguards information-modified handling. No individual authorized
to have access to the information may disseminate the information to any other individual who
does not have a need to know.

(C) The personal information obtained on an individual from a background investigation may
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

be provided to another licensee:

(1) Upon the individual's written request to the licensee holding the data to disseminate the
information contained in his or her file; and
(2) The recipient licensee verifies information such as name, date of birth, social security
number, gender, and other applicable physical characteristics.

(D) The licensee shall make background investigation records obtained under 105 CMR
120.056 through 120.062 available for examination by an authorized representative of the
Agency to determine compliance with the regulations and laws.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.061: continued

(E) The licensee shall retain all fingerprint and criminal history records (including data
indicating no record) received from the FBI, or a copy of these records if the individual's file has
been transferred, on an individual for three years from the date the individual no longer requires
unescorted access to category 1 or category 2 quantities of radioactive material.

120.062: Access Authorization Program Review

(A) Each licensee shall be responsible for the continuing effectiveness of the access
authorization program. Each licensee shall ensure that access authorization programs are
reviewed to confirm compliance with the requirements of 105 CMR 120.056 through 120.062
and that comprehensive actions are taken to correct any noncompliance that is identified. The
review program shall evaluate all program performance objectives and requirements. Each
licensee shall periodically (at least annually) review the access program content and
implementation.

(B) The results of the reviews, along with any recommendations, must be documented. Each
review report must identify conditions that are adverse to the proper performance of the access
authorization program, the cause of the condition(s), and, when appropriate, recommend
corrective actions, and corrective actions taken. The licensee shall review the findings and take
any additional corrective actions necessary to preclude repetition of the condition, including
reassessment of the deficient areas where indicated.

(C) Review records must be maintained for three years.

PHYSICAL PROTECTION REQUIREMENTS DURING USE

120.063: Security Program

(A) Applicability.
(1) Each licensee that possesses an aggregated category 1 or category 2 quantity of
radioactive material shall establish, implement, and maintain a security program in
accordance with the requirements of 105 CMR 120.063 through 120.071.
(2) An applicant for a new license and each licensee that would become newly subject to
the requirements of 105 CMR 120.063 through 120.071 upon application for modification
of its license shall implement the requirements of 105 CMR 120.063 through 120.071, as
appropriate, before taking possession of an aggregated category 1 or category 2 quantity of
radioactive material.
(3) Any licensee that has not previously implemented the Security Orders or been subject
to 105 CMR 120.063 through 120.071 shall provide written notification to the Agency as
specified in 105 CMR 120.054 at least 90 days before aggregating radioactive material to a
quantity that equals or exceeds the category 2 threshold.

(B) General Performance Objective. Each licensee shall establish, implement, and maintain a
security program that is designed to monitor and, without delay, detect, assess, and respond to
an actual or attempted unauthorized access to category 1 or category 2 quantities of radioactive
material.

(C) Program Features. Each licensee's security program must include the program features,
as appropriate, described in 105 CMR 120.064 through 120.070.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.064: General Security Program Requirements

(A) Security Plan.

(1) Each licensee identified in 105 CMR 120.063(A) shall develop a written security plan
specific to its facilities and operations. The purpose of the security plan is to establish the
licensee's overall security strategy to ensure the integrated and effective functioning of the
security program required by 105 CMR 120.063 through 120.071. The security plan must,
at a minimum:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.064: continued

(a) Describe the measures and strategies used to implement the requirements of
105 CMR 120.063 through 120.071; and
(b) Identify the security resources, equipment, and technology used to satisfy the
requirements of 105 CMR 120.063 through 120.071.
(2) The security plan must be reviewed and approved by the individual with overall
responsibility for the security program.
(3) A licensee shall revise its security plan as necessary to ensure the effective
implementation of Agency requirements. The licensee shall ensure that:
(a) The revision has been reviewed and approved by the individual with overall
responsibility for the security program; and
(b) The affected individuals are instructed on the revised plan before the changes are
implemented.
(4) The licensee shall retain a copy of the current security plan as a record for three years
after the security plan is no longer required. If any portion of the plan is superseded, the
licensee shall retain the superseded material for three years after the record is superseded.

(B) Implementing Procedures.

(1) The licensee shall develop and maintain written procedures that document how the
requirements of 105 CMR 120.063 through 120.071 and the security plan will be met.
(2) The implementing procedures and revisions to these procedures must be approved in
writing by the individual with overall responsibility for the security program.
(3) The licensee shall retain a copy of the current procedure as a record for three years after
the procedure is no longer needed. Superseded portions of the procedure must be retained
for three years after the record is superseded.

(C) Training.
(1) Each licensee shall conduct training to ensure that those individuals implementing the
security program possess and maintain the knowledge, skills, and abilities to carry out their
assigned duties and responsibilities effectively. The training must include instruction in:
(a) The licensee's security program and procedures to secure category 1 or category 2
quantities of radioactive material, and in the purposes and functions of the security
measures employed;
(b) The responsibility to report promptly to the licensee any condition that causes or
may cause a violation of Agency requirements;
(c) The responsibility of the licensee to report promptly to the local law enforcement
agency and licensee any actual or attempted theft, sabotage, or diversion of category 1
or category 2 quantities of radioactive material; and
(d) The appropriate response to security alarms.
(2) In determining those individuals who shall be trained on the security program, the
licensee shall consider each individual's assigned activities during authorized use and
response to potential situations involving actual or attempted theft, diversion, or sabotage of
category 1 or category 2 quantities of radioactive material. The extent of the training must
be commensurate with the individual's potential involvement in the security of category 1 or
category 2 quantities of radioactive material.
(3) Refresher training must be provided at a frequency not to exceed 12 months and when
significant changes have been made to the security program. This training must include:
(a) Review of the training requirements of 105 CMR 120.064(C) and any changes made
to the security program since the last training;
(b) Reports on any relevant security issues, problems, and lessons learned;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(c) Relevant results of Agency inspections; and

(d) Relevant results of the licensee's program review and testing and maintenance.
(4) The licensee shall maintain records of the initial and refresher training for three years
from the date of the training. The training records must include dates of the training, topics
covered, a list of licensee personnel in attendance, and related information.

(D) Protection of Information.

(1) Licensees authorized to possess category 1 or category 2 quantities of radioactive
material shall limit access to and unauthorized disclosure of their security plan, implementing
procedures, and the list of individuals that have been approved for unescorted access.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.064: continued

(2) Efforts to limit access shall include the development, implementation, and maintenance
of written policies and procedures for controlling access to, and for proper handling and
protection against unauthorized disclosure of, the security plan and implementing procedures.
(3) Before granting an individual access to the security plan or implementing procedures,
licensees shall:
(a) Evaluate an individual's need to know the security plan or implementing procedures;
and
(b) If the individual has not been authorized for unescorted access to category 1 or
category 2 quantities of radioactive material, safeguards information, or safeguards
information-modified handling, the licensee must complete a background investigation
to determine the individual's trustworthiness and reliability. A trustworthiness and
reliability determination shall be conducted by the reviewing official and shall include
the background investigation elements contained in 105 CMR 120.058(A)(2) through (7).
(4) Licensees need not subject the following individuals to the background investigation
elements for protection of information:
(a) The categories of individuals listed in 105 CMR 120.060(A)(1) through (13); or
(b) Security service provider employees, provided written verification that the employee
has been determined to be trustworthy and reliable, by the required background
investigation in 105 CMR 120.058(A)(2) through (7), has been provided by the security
service provider.
(5) The licensee shall document the basis for concluding that an individual is trustworthy
and reliable and should be granted access to the security plan or implementing procedures.
(6) Licensees shall maintain a list of persons currently approved for access to the security
plan or implementing procedures. When a licensee determines that a person no longer needs
access to the security plan or implementing procedures or no longer meets the access
authorization requirements for access to the information, the licensee shall remove the person
from the approved list as soon as possible, but no later than seven working days, and take
prompt measures to ensure that the individual is unable to obtain the security plan or
implementing procedures.
(7) When not in use, the licensee shall store its security plan and implementing procedures
in a manner to prevent unauthorized access. Information stored in nonremovable electronic
form must be password protected.
(8) The licensee shall retain as a record for three years after the document is no longer
needed:
(a) A copy of the information protection procedures; and
(b) The list of individuals approved for access to the security plan or implementing
procedures.

120.065: LLEA Coordination

(A) A licensee subject to 105 CMR 120.063 through 120.071 shall coordinate, to the extent
practicable, with an LLEA for responding to threats to the licensee's facility, including any
necessary armed response. The information provided to the LLEA must include:
(1) A description of the facilities and the category 1 and category 2 quantities of radioactive
materials along with a description of the licensee's security measures that have been
implemented to comply with 105 CMR 120.063 through 120.071; and
(2) A notification that the licensee will request a timely armed response by the LLEA to any
actual or attempted theft, sabotage, or diversion of category 1 or category 2 quantities of
material.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(B) The licensee shall notify the Agency within three business days if:
(1) The LLEA has not responded to the request for coordination within 60 days of the
coordination request; or
(2) The LLEA notifies the licensee that the LLEA does not plan to participate in
coordination activities.

(C) The licensee shall document its efforts to coordinate with the LLEA. The documentation
must be kept for three years.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.065: continued

(D) The licensee shall coordinate with the LLEA at least every 12 months, or when changes to
the facility design or operation adversely affect the potential vulnerability of the licensee's
material to theft, sabotage, or diversion.

120.066: Security Zones

(A) Licensees shall ensure that all aggregated category 1 and category 2 quantities of
radioactive material are used or stored within licensee-established security zones. Security zones
may be permanent or temporary.

(B) Temporary security zones must be established as necessary to meet the licensee's transitory
or intermittent business activities, such as periods of maintenance, source delivery, and source
replacement.

(C) Security zones must, at a minimum, allow unescorted access only to approved individuals
through:
(1) Isolation of category 1 and category 2 quantities of radioactive materials by the use of
continuous physical barriers that allow access to the security zone only through established
access control points. A physical barrier is a natural or man-made structure or formation
sufficient for the isolation of the category 1 or category 2 quantities of radioactive material
within a security zone; or
(2) Direct control of the security zone by approved individuals at all times; or
(3) A combination of continuous physical barriers and direct control.

(D) For category 1 quantities of radioactive material during periods of maintenance, source
receipt, preparation for shipment, installation, or source removal or exchange, the licensee shall,
at a minimum, provide sufficient individuals approved for unescorted access to maintain
continuous surveillance of sources in temporary security zones and in any security zone in which
physical barriers or intrusion detection systems have been disabled to allow such activities.

(E) Individuals not approved for unescorted access to category 1 or category 2 quantities of
radioactive material must be escorted by an approved individual when in a security zone.

120.067: Monitoring, Detection, and Assessment

(A) Monitoring and Detection.

(1) Licensees shall establish and maintain the capability to continuously monitor and detect
without delay all unauthorized entries into its security zones. Licensees shall provide the
means to maintain continuous monitoring and detection capability in the event of a loss of
the primary power source, or provide for an alarm and response in the event of a loss of this
capability to continuously monitor and detect unauthorized entries.
(2) Monitoring and detection must be performed by:
(a) A monitored intrusion detection system that is linked to an onsite or offsite central
monitoring facility; or
(b) Electronic devices for intrusion detection alarms that will alert nearby facility
personnel; or
(c) A monitored video surveillance system; or
(d) Direct visual surveillance by approved individuals located within the security zone;
or
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(e) Direct visual surveillance by a licensee designated individual located outside the
security zone.
(3) A licensee subject to 105 CMR 120.063 through 120.071 shall also have a means to
detect unauthorized removal of the radioactive material from the security zone. This
detection capability must provide:
(a) For category 1 quantities of radioactive material, immediate detection of any
attempted unauthorized removal of the radioactive material from the security zone. Such
immediate detection capability must be provided by:
1. Electronic sensors linked to an alarm; or
2. Continuous monitored video surveillance; or
3. Direct visual surveillance.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.067: continued

(b) For category 2 quantities of radioactive material, weekly verification through

physical checks, tamper indicating devices, use, or other means to ensure that the
radioactive material is present.

(B) Assessment. Licensees shall immediately assess each actual or attempted unauthorized
entry into the security zone to determine whether the unauthorized access was an actual or
attempted theft, sabotage, or diversion.

(C) Personnel Communications and Data Transmission. For personnel and automated or
electronic systems supporting the licensee's monitoring, detection, and assessment systems,
licensees shall:
(1) Maintain continuous capability for personnel communication and electronic data
transmission and processing among site security systems; and
(2) Provide an alternative communication capability for personnel, and an alternative data
transmission and processing capability, in the event of a loss of the primary means of
communication or data transmission and processing. Alternative communications and data
transmission systems may not be subject to the same failure modes as the primary systems.

(D) Response. Licensees shall immediately respond to any actual or attempted unauthorized
access to the security zones, or actual or attempted theft, sabotage, or diversion of category 1 or
category 2 quantities of radioactive material at licensee facilities or temporary job sites. For any
unauthorized access involving an actual or attempted theft, sabotage, or diversion of category
1 or category 2 quantities of radioactive material, the licensee's response shall include requesting,
without delay, an armed response from the LLEA.

120.068: Maintenance and Testing

(A) Each licensee subject to 105 CMR 120.063 through 120.071 shall implement a maintenance
and testing program to ensure that intrusion alarms, associated communication systems, and
other physical components of the systems used to secure or detect unauthorized access to
radioactive material are maintained in operable condition and are capable of performing their
intended function when needed. The equipment relied on to meet the security requirements of
105 CMR 120.050 through 120.080 must be inspected and tested for operability and performance
at the manufacturer's suggested frequency. If there is no suggested manufacturer's suggested
frequency, the testing must be performed at least annually, not to exceed 12 months.

(B) The licensee shall maintain records on the maintenance and testing activities for three years.

120.069: Requirements for Mobile Devices

Each licensee that possesses mobile devices containing category 1 or category 2 quantities
of radioactive material must:

(A) Have two independent physical controls that form tangible barriers to secure the material
from unauthorized removal when the device is not under direct control and constant surveillance
by the licensee; and

(B) For devices in or on a vehicle or trailer, unless the health and safety requirements for a site
prohibit the disabling of the vehicle, the licensee shall utilize a method to disable the vehicle or
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

trailer when not under direct control and constant surveillance by the licensee. Licensees shall
not rely on the removal of an ignition key to meet this requirement.

120.070: Security Program Review

(A) Each licensee shall be responsible for the continuing effectiveness of the security program.
Each licensee shall ensure that the security program is reviewed to confirm compliance with the
requirements of 105 CMR 120.063 through 120.071 and that comprehensive actions are taken
to correct any noncompliance that is identified. The review must include the radioactive material
security program content and implementation. Each licensee shall periodically (at least annually)
review the security program content and implementation.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.070: continued

(B) The results of the review, along with any recommendations, must be documented. Each
review report must identify conditions that are adverse to the proper performance of the security
program, the cause of the condition(s), and, when appropriate, recommend corrective actions,
and corrective actions taken. The licensee shall review the findings and take any additional
corrective actions necessary to preclude repetition of the condition, including reassessment of
the deficient areas where indicated.

(C) The licensee shall maintain the review documentation for three years.

120.071: Reporting of Events

(A) The licensee shall immediately notify the LLEA after determining that an unauthorized
entry resulted in an actual or attempted theft, sabotage, or diversion of a category 1 or category
2 quantity of radioactive material. As soon as possible after initiating a response, but not at the
expense of causing delay or interfering with the LLEA response to the event, the licensee shall
notify the Agency by telephone. In no case shall the notification to the Agency be later than four
hours after the discovery of any attempted or actual theft, sabotage, or diversion.

(B) The licensee shall assess any suspicious activity related to possible theft, sabotage, or
diversion of category 1 or category 2 quantities of radioactive material and notify the LLEA as
appropriate. As soon as possible but not later than four hours after notifying the LLEA, the
licensee shall notify the Agency by telephone.

(C) The initial telephonic notification required by 105 CMR 120.071(A) must be followed
within a period of 30 days by a written report submitted to the Agency by an appropriate method
listed in 105 CMR 120.054. The report must include sufficient information for Agency analysis
and evaluation, including identification of any necessary corrective actions to prevent future
instances.

PHYSICAL PROTECTION IN TRANSIT

120.072: Additional Requirements for Transfer of Category 1 and Category 2 Quantities of Radioactive
Material

A licensee transferring a category 1 or category 2 quantity of radioactive material to a

licensee of the Agency, U.S. Nuclear Regulatory Commission, or an Agreement State shall meet
the license verification provisions of 105 CMR 120.072(A) through (D) instead of those listed
in 105 CMR 120.140(D):

(A) Any licensee transferring category 1 quantities of radioactive material to a licensee of the
Agency, U.S. Nuclear Regulatory Commission, or an Agreement State, prior to conducting such
transfer, shall verify with the NRC's license verification system or the license issuing authority
that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive
material to be transferred and that the licensee is authorized to receive radioactive material at the
location requested for delivery. If the verification is conducted by contacting the license issuing
authority, the transferor shall document the verification. For transfers within the same
organization, the licensee does not need to verify the transfer.

(B) Any licensee transferring category 2 quantities of radioactive material to a licensee of the
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Agency, U.S. Nuclear Regulatory Commission, or an Agreement State, prior to conducting such
transfer, shall verify with the NRC's license verification system or the license issuing authority
that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive
material to be transferred. If the verification is conducted by contacting the license issuing
authority, the transferor shall document the verification. For transfers within the same
organization, the licensee does not need to verify the transfer.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.072: continued

(C) In an emergency where the licensee cannot reach the license issuing authority and the
license verification system is nonfunctional, the licensee may accept a written certification by
the transferee that it is authorized by license to receive the type, form, and quantity of radioactive
material to be transferred. The certification must include the license number, current revision
number, issuing agency, expiration date, and for a category 1 shipment the authorized address.
The licensee shall keep a copy of the certification. The certification must be confirmed by use
of the NRC's license verification system or by contacting the license issuing authority by the end
of the next business day.

(D) The transferor shall keep a copy of the verification documentation as a record for three
years.

120.073: Applicability of Physical Protection of Category 1 and Category 2 Quantities of Radioactive

Material During Transit

(A) For shipments of category 1 quantities of radioactive material, each shipping licensee shall
comply with the requirements for physical protection contained in 105 CMR 120.074(A) and (E);
120.075; 120.076(A)(1), (B)(1) and (C); and 120.077(A), (C), (E), (G), and (H).

(B) For shipments of category 2 quantities of radioactive material, each shipping licensee shall
comply with the requirements for physical protection contained in 105 CMR 120.074(B) through
(E); 120.076(A)(2) and (3) and (B)(2), and (C); and 120.077(B), (D), (F), (G), and (H). For those
shipments of category 2 quantities of radioactive material that meet the criteria of 105 CMR
120.790(B), the shipping licensee shall also comply with the advance notification provisions of
105 CMR 120.790.

(C) The shipping licensee shall be responsible for meeting the requirements of 105 CMR
120.072 through 120.077 unless the receiving licensee has agreed in writing to arrange for the
in-transit physical protection required under 105 CMR 120.072 through 120.077.

(D) Each licensee that imports or exports category 1 quantities of radioactive material shall
comply with the requirements for physical protection during transit contained in 105 CMR
120.074(A)(2) and (E); 120.075; 120.076(A)(1), (B)(1), and (C); and 120.077(A), (C), (E), (G),
and (H) for the domestic portion of the shipment.

(E) Each licensee that imports or exports category 2 quantities of radioactive material shall
comply with the requirements for physical protection during transit contained in 105 CMR
120.076(A)(2) and (3), and (B)(2); and 120.077(B), (D), (F), (G), and (H) for the domestic
portion of the shipment.

120.074: Pre-planning and Coordination of Shipment of Category 1 or Category 2 Quantities of

Radioactive Material

(A) Each licensee that plans to transport, or deliver to a carrier for transport, licensed material
that is a category 1 quantity of radioactive material outside the confines of the licensee's facility
or other place of use or storage shall:
(1) Pre-plan and coordinate shipment arrival and departure times with the receiving
licensee;
(2) Pre-plan and coordinate shipment information with the governor or the governor's
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

designee of any State through which the shipment will pass to:
(a) Discuss the State's intention to provide law enforcement escorts; and
(b) Identify safe havens; and
(3) Document the pre-planning and coordination activities.

(B) Each licensee that plans to transport, or deliver to a carrier for transport, licensed material
that is a category 2 quantity of radioactive material outside the confines of the licensee's facility
or other place of use or storage shall coordinate the shipment no-later-than arrival time and the
expected shipment arrival with the receiving licensee. The licensee shall document the
coordination activities.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.074: continued

(C) Each licensee who receives a shipment of a category 2 quantity of radioactive material shall
confirm receipt of the shipment with the originator. If the shipment has not arrived by the
no-later-than arrival time, the receiving licensee shall notify the originator.

(D) Each licensee, who transports or plans to transport a shipment of a category 2 quantity of
radioactive material, and determines that the shipment will arrive after the no-later-than arrival
time provided pursuant to 105 CMR 120.074(B), shall promptly notify the receiving licensee of
the new no-later-than arrival time.

(E) The licensee shall retain a copy of the documentation for pre-planning and coordination and
any revision thereof, as a record for three years.

120.075: Advance Notification of Shipment of Category 1 Quantities of Radioactive Material

As specified in 105 CMR 120.075(A) and (B), each licensee shall provide advanced
notification to the Agency and to the governor of a State, or the governor's designee, of the
shipment of licensed material in a category 1 quantity, through or across the boundary of the
State, before the transport, or delivery to a carrier for transport of the licensed material outside
the confines of the licensee's facility or other place of use or storage.

(A) Procedures for Submitting Advance Notification.

(1) The notification must be made to the Agency and to the office of each appropriate
governor or governor's designee. The contact information, including telephone and mailing
addresses, of governors and governors' designees, is available on the U.S. Nuclear Regulatory
Commission website at https://scp.nrc.gov/special/designee.pdf. A list of the contact
information is also available upon request from the Director, Division of Material Safety,
State, Tribal and Rulemaking programs, Office of Nuclear Material Safety and Safeguards,
U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Notifications to the
Agency must be made in accordance with 105 CMR 120.054.
(2) A notification delivered by mail must be postmarked at least seven days before transport
of the shipment commences at the shipping facility.
(3) A notification delivered by any means other than mail must reach the Agency at least
four days before the transport of the shipment commences and must reach the office of the
governor or the governor's designee at least four days before transport of a shipment within
or through the State.

(B) Information to be Furnished in Advance Notification of Shipment. Each advance

notification of shipment of category 1 quantities of radioactive material must contain the
following information, if available at the time of notification:
(1) The name, address, and telephone number of the shipper, carrier, and receiver of the
category 1 radioactive material;
(2) The license numbers of the shipper and receiver;
(3) A description of the radioactive material contained in the shipment, including the
radionuclides and quantity;
(4) The point of origin of the shipment and the estimated time and date that shipment will
commence;
(5) The estimated time and date that the shipment is expected to enter each State along the
route;
(6) The estimated time and date of arrival of the shipment at the destination; and
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(7) A point of contact, with a telephone number, for current shipment information.

(C) Revision Notice.

(1) The licensee shall provide any information not previously available at the time of the
initial notification, as soon as the information becomes available but not later than
commencement of the shipment, to the governor of the State or the governor's designee and
to the Agency by an appropriate method listed in 105 CMR 120.054.
(2) A licensee shall promptly notify the governor of the State or the governor's designee of
any changes to the information provided in accordance with paragraphs 105 CMR
120.075(B) and (C)(1). The licensee shall also immediately notify the Agency of any such
changes.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.075: continued

(D) Cancellation Notice. Each licensee who cancels a shipment for which advance notification
has been sent shall send a cancellation notice to the governor of each State or to the governor's
designee previously notified and to the Agency. The licensee shall send the cancellation notice
before the shipment would have commenced or as soon thereafter as possible. The licensee shall
state in the notice that it is a cancellation and identify the advance notification that is being
cancelled.

(E) Records. The licensee shall retain a copy of the advance notification and any revision and
cancellation notices as a record for three years.

(F) Protection of Information. State officials, State employees, and other individuals, whether
or not licensees of the Agency, who receive schedule information of the kind specified in
105 CMR 120.075(B) shall protect that information against unauthorized disclosure as specified
in 105 CMR 120.064(D).

120.076: Requirements for Physical Protection of Category 1 and Category 2 Quantities of Radioactive
Material During Shipment

(A) Shipments by Road.

(1) Each licensee who transports, or delivers to a carrier for transport, in a single shipment,
a category 1 quantity of radioactive material shall:
(a) Ensure that movement control centers are established that maintain position
information from a remote location. These control centers must monitor shipments 24
hours a day, seven days a week, and have the ability to communicate immediately, in an
emergency, with the appropriate law enforcement agencies.
(b) Ensure that redundant communications are established that allow the transport to
contact the escort vehicle (when used) and movement control center at all times.
Redundant communications may not be subject to the same interference factors as the
primary communication.
(c) Ensure that shipments are continuously and actively monitored by a telemetric
position monitoring system or an alternative tracking system reporting to a movement
control center. A movement control center must provide positive confirmation of the
location, status, and control over the shipment. The movement control center must be
prepared to promptly implement pre-planned procedures in response to deviations from
the authorized route or a notification of actual, attempted, or suspicious activities related
to the theft, loss, or diversion of a shipment. These procedures will include, but not be
limited to, the identification of and contact information for the appropriate LLEA along
the shipment route.
(d) Provide an individual to accompany the driver for those highway shipments with a
driving time period greater than the maximum number of allowable hours of service in
a 24-hour duty day as established by the Department of Transportation Federal Motor
Carrier Safety Administration. The accompanying individual may be another driver.
(e) Develop written normal and contingency procedures to address:
1. Notifications to the communication center and law enforcement agencies;
2. Communication Protocols. Communication protocols must include a strategy for
the use of authentication codes and duress codes and provisions for refueling or other
stops, detours, and locations where communication is expected to be temporarily lost;
3. Loss of communications; and
4. Responses to an actual or attempted theft or diversion of a shipment.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(f) Each licensee who makes arrangements for the shipment of category 1 quantities of
radioactive material shall ensure that drivers, accompanying personnel, and movement
control center personnel have access to the normal and contingency procedures.
(2) Each licensee that transports category 2 quantities of radioactive material shall maintain
constant control and/or surveillance during transit and have the capability for immediate
communication to summon appropriate response or assistance.
(3) Each licensee who delivers to a carrier for transport, in a single shipment, a category 2
quantity of radioactive material shall:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.076: continued

(a) Use carriers that have established package tracking systems. An established package
tracking system is a documented, proven, and reliable system routinely used to transport
objects of value. In order for a package tracking system to maintain constant control
and/or surveillance, the package tracking system must allow the shipper or transporter
to identify when and where the package was last and when it should arrive at the next
point of control.
(b) Use carriers that maintain constant control and/or surveillance during transit and
have the capability for immediate communication to summon appropriate response or
assistance; and
(c) Use carriers that have established tracking systems that require an authorized
signature prior to releasing the package for delivery or return.

(B) Shipments by Rail.

(1) Each licensee who transports, or delivers to a carrier for transport, in a single shipment,
a category 1 quantity of radioactive material shall:
(a) Ensure that rail shipments are monitored by a telemetric position monitoring system
or an alternative tracking system reporting to the licensee, third-party, or railroad
communications center. The communications center shall provide positive confirmation
of the location of the shipment and its status. The communications center shall
implement pre-planned procedures in response to deviations from the authorized route
or to a notification of actual, attempted, or suspicious activities related to the theft or
diversion of a shipment. These procedures will include, but not be limited to, the
identification of and contact information for the appropriate LLEA along the shipment
route.
(b) Ensure that periodic reports to the communications center are made at preset
intervals.
(2) Each licensee who transports, or delivers to a carrier for transport, in a single shipment,
a category 2 quantity of radioactive material shall:
(a) Use carriers that have established package tracking systems. An established package
tracking system is a documented, proven, and reliable system routinely used to transport
objects of value. In order for a package tracking system to maintain constant control
and/or surveillance, the package tracking system must allow the shipper or transporter
to identify when and where the package was last and when it should arrive at the next
point of control.
(b) Use carriers that maintain constant control and/or surveillance during transit and
have the capability for immediate communication to summon appropriate response or
assistance; and
(c) Use carriers that have established tracking systems that require an authorized
signature prior to releasing the package for delivery or return.

(C) Investigations. Each licensee who makes arrangements for the shipment of category 1
quantities of radioactive material shall immediately conduct an investigation upon the discovery
that a category 1 shipment is lost or missing. Each licensee who makes arrangements for the
shipment of category 2 quantities of radioactive material shall immediately conduct an
investigation, in coordination with the receiving licensee, of any shipment that has not arrived
by the designated no-later-than arrival time.

120.077: Reporting of Events

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(A) The shipping licensee shall notify the appropriate LLEA and the Agency by telephone
within one hour of its determination that a shipment of category 1 quantities of radioactive
material is lost or missing. The appropriate LLEA would be the law enforcement agency in the
area of the shipment's last confirmed location. During the investigation required by 105 CMR
120.076(C), the shipping licensee will provide agreed upon updates to the Agency on the status
of the investigation.

(B) The shipping licensee shall notify the Agency by telephone within four hours of its
determination that a shipment of category 2 quantities of radioactive material is lost or missing.
If, after 24 hours of its determination that the shipment is lost or missing, the radioactive material
has not been located and secured, the licensee shall immediately notify the Agency.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.077: continued

(C) The shipping licensee shall notify the designated LLEA along the shipment route as soon
as possible upon discovery of any actual or attempted theft or diversion of a shipment or
suspicious activities related to the theft or diversion of a shipment of a category 1 quantity of
radioactive material. As soon as possible after notifying the LLEA, the licensee shall notify the
Agency by telephone upon discovery of any actual or attempted theft or diversion of a shipment,
or any suspicious activity related to the shipment of category 1 radioactive material.

(D) The shipping licensee shall notify the Agency by telephone as soon as possible upon
discovery of any actual or attempted theft or diversion of a shipment, or any suspicious activity
related to the shipment, of a category 2 quantity of radioactive material.

(E) The shipping licensee shall notify the Agency by telephone and the LLEA as soon as
possible upon recovery of any lost or missing category 1 quantities of radioactive material.

(F) The shipping licensee shall notify the Agency by telephone as soon as possible upon
recovery of any lost or missing category 2 quantities of radioactive material.

(G) The initial telephonic notification required by 105 CMR 120.077(A) through (D) must be
followed within a period of 30 days by a written report submitted to the Agency by an
appropriate method listed in 105 CMR 120.054. A written report is not required for notifications
on suspicious activities required by 105 CMR 120.077(C) and (D). The report must set forth the
following information:
(1) A description of the licensed material involved, including kind, quantity, and chemical
and physical form;
(2) A description of the circumstances under which the loss or theft occurred;
(3) A statement of disposition, or probable disposition, of the licensed material involved;
(4) Actions that have been taken, or will be taken, to recover the material; and
(5) Procedures or measures that have been, or will be, adopted to ensure against a
recurrence of the loss or theft of licensed material.

(H) Subsequent to filing the written report, the licensee shall also report, by an appropriate
method listed in 105 CMR 120.054, any additional substantive information on the loss or theft
within 30 days after the licensee learns of such information.

RECORDS

120.078: Form of Records

Each record required by 105 CMR 120.050 through 120.080 must be legible throughout the
retention period specified by each Agency regulation. The record may be the original or a
reproduced copy or a microform, provided that the copy or microform is authenticated by
authorized personnel and that the microform is capable of producing a clear copy throughout the
required retention period. The record may also be stored in electronic media with the capability
for producing legible, accurate, and complete records during the required retention period.
Records such as letters, drawings, and specifications, must include all pertinent information such
as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against
tampering with and loss of records.

120.079: Record Retention

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Licensees shall maintain the records that are required by the regulations in 105 CMR 120.050
through 120.080 for the period specified by the appropriate regulation. If a retention period is
not otherwise specified, these records must be retained until the Agency terminates the facility's
license. All records related to 105 CMR 120.050 through 120.080 may be destroyed upon
Agency termination of the facility license.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.080: Apendix A - Category 1 and Category 2 Radioactive Materials

Table 1 - Category 1 and Category 2 Threshold

The terabecquerel (TBq) values are the regulatory standard. The curie (Ci) values specified
are obtained by converting from the TBq value. The curie values are provided for practical
usefulness only.

Category 1 Category 1 Category 2 Category 2

Radioactive material (TBq) (Ci) (TBq) (Ci)
Americium-241............................................. 60 1,620 0.6 16.2
Americium-241/Be........................................ 60 1,620 0.6 16.2
Californium-252............................................ 20 540 0.2 5.40
Cobalt-60....................................................... 30 810 0.3 8.10
Curium-244................................................... 50 1,350 0.5 13.5
Cesium-137................................................... 100 2,700 1 27.0
Gadolinium-153............................................. 1,000 27,000 10 270
Iridium-192.................................................... 80 2,160 0.8 21.6
Plutonium-238............................................... 60 1,620 0.6 16.2
Plutonium-239/Be......................................... 60 1,620 0.6 16.2
Promethium-147............................................ 40,000 1,080,000 400 10,800
Radium-226................................................... 40 1,080 0.4 10.8
Selenium-75................................................... 200 5,400 2 54.0
Strontium-90.................................................. 1,000 27,000 10 270
Thulium-170.................................................. 20,000 540,000 200 5,400
Ytterbium-169............................................... 300 8,100 3 81.0

Note: Calculations Concerning Multiple Sources or Multiple Radionuclides

The ''sum of fractions'' methodology for evaluating combinations of multiple sources or multiple radionuclides
is to be used in determining whether a location meets or exceeds the threshold and is thus subject to the
requirements of 105 CMR 120.050 through 120.080.

I. If multiple sources of the same radionuclide and/or multiple radionuclides are aggregated at a location,
the sum of the ratios of the total activity of each of the radionuclides must be determined to verify whether
the activity at the location is less than the category 1 or category 2 thresholds of Table 1, as appropriate. If
the calculated sum of the ratios, using the equation below, is greater than or equal to 1.0, then the applicable
requirements of 105 CMR 120.050 through 120.080 apply.

II. First determine the total activity for each radionuclide from Table 1. This is done by adding the activity
of each individual source, material in any device, and any loose or bulk material that contains the
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

radionuclide. Then use the equation below to calculate the sum of the ratios by inserting the total activity of
the applicable radionuclides from Table 1 in the numerator of the equation and the corresponding threshold
activity from Table 1 in the denominator of the equation. Calculations must be performed in metric values
(i.e., TBq) and the numerator and denominator values must be in the same units.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.080: continued

R1 = total activity for radionuclide 1

R2 = total activity for radionuclide 2
Rn = total activity for radionuclide n
AR1 = activity threshold for radionuclide 1
AR2 = activity threshold for radionuclide 2
ARn = activity threshold for radionuclide n

120.100: LICENSING OF RADIOACTIVE MATERIAL

120.101: Purpose and Scope

(A) 105 CMR 120.100, 120.500 and 120.770, provide for the licensing of radioactive material.
No person shall manufacture, produce, receive, possess, use, transfer, own, or acquire radioactive
material except as authorized pursuant to 105 CMR 120.100, 120.500 or 120.770, or as
otherwise provided in 105 CMR 120.000.

(B) In addition to the requirements of 105 CMR 120.100, all licensees are subject to the
requirements of 105 CMR 120.000, 120.200, 120.750, and 120.770. Furthermore, licensees
engaged in industrial radiographic operations are subject to the requirements of 105 CMR
120.300; licensees using radionuclides in the healing arts are subject to the requirements of
105 CMR 120.500, licensees engaged in land disposal of radioactive material are subject to the
requirements of 105 CMR 120.801 through 120.885, and licensees engaged in wireline and
subsurface tracer studies are subject to the requirements of 105 CMR 120.900.

120.102: Definitions

As used in 105 CMR 120.100, the following definitions apply:

Alert means events may occur, are in progress, or have occurred that could lead to a release of
radioactive material but that the release is not expected to require a response by offsite response
organizations to protect persons offsite.

Commencement of Construction means taking any action defined as “construction" or any other
activity at the site of a facility subject to 105 CMR 120.100 through 120.198 that has a
reasonable nexus to radiological health and safety. Commencement of construction as defined
in 105 CMR 120.102 may include non-construction activities if the activity has a reasonable
nexus to radiological safety or security.

Construction means the installation of foundations, or in-place assembly, erection, fabrication,

or testing for any structure, system, or component of a facility or activity subject to 105 CMR
120.100 through 120.198 that are related to radiological safety or security. The term
"construction" does not include:
(1) Changes for temporary use of the land for public recreational purposes;
(2) Site exploration, including necessary borings to determine foundation conditions or
other preconstruction monitoring to establish background information related to the
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

suitability of the site, the environmental impacts of construction or operation, or the

protection of environmental values;
(3) Preparation of the site for construction of the facility, including clearing of the site,
grading, installation of drainage, erosion and other environmental mitigation measures, and
construction of temporary roads and borrow areas;
(4) Erection of fences and other access control measures that are not related to the safe use
of, or security of, radiological materials subject to 105 CMR 120.100 through 120.198;
(5) Excavation;
(6) Erection of support buildings (e.g., construction equipment storage sheds, warehouse
and shop facilities, utilities, concrete mixing plants, docking and unloading facilities, and
office buildings) for use in connection with the construction of the facility;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.102: continued

(7) Building of service facilities (e.g., paved roads, parking lots, railroad spurs, exterior
utility and lighting systems, potable water systems, sanitary sewerage treatment facilities, and
transmission lines);
(8) Procurement or fabrication of components or portions of the proposed facility occurring
at other than the final, in-place location at the facility; or
(9) Taking any other action that has no reasonable nexus to radiological health and safety.

Decommissioning Funding Plan means a written document that contains a cost estimate for
decommissioning and a description of the method for assuring for decommissioning, including
means of adjusting cost estimates and associated funding levels periodically over the life of the
facility.

Facility means the location within one building, vehicle, or under one roof and under the same
administrative control:
(1) at which the possession, use, processing or storage of radioactive material is or was
authorized; or
(2) at which one or more radioactivity-inducing machines are installed or located.
Facility may also mean multiple such locations at a site or part of a site.

Financial Surety means the method of assuring that sufficient funds will be available at the time
of license termination and decommissioning of the facility to cover all costs associated with the
decommissioning.

Site means the area contained within the boundary of a location under the control of persons
generating or storing radioactive materials.

Site Area Emergency means events may occur, are in progress, or have occurred that could lead
to a significant release of radioactive material and that could require a response by offsite
response organizations to protect persons offsite.

120.103: Source Material

(A) Any person is exempt from 105 CMR 120.100 to the extent that such person receives,
possesses, uses, owns, or transfers source material in any chemical mixture, compound, solution,
or alloy in which the source material is by weight less than 1/20 of 1% (0.05%) of the mixture,
compound, solution, or alloy.

(B) Any person is exempt from 105 CMR 120.100 to the extent that such person receives,
possesses, uses, or transfers unrefined and unprocessed ore containing source material; provided
that, except as authorized in a specific license, such person shall not refine or process such ore.

(C) Any person is exempt from 105 CMR 120.100, 120.200 and 120.750 to the extent that such
person receives, possesses, uses, or transfers:
(1) any quantities of thorium contained in:
(a) incandescent gas mantles;
(b) vacuum tubes;
(c) welding rods;
(d) electric lamps for illuminating purposes provided that each lamp does not contain
more than 50 milligrams of thorium;
(e) germicidal lamps, sunlamps, and lamps for outdoor or industrial lighting provided
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

that each lamp does not contain more than two grams of thorium;
(f) rare earth metals and compounds, mixtures, and products containing not more than
0.25% by weight thorium, uranium, or any combination of these; or
(g) personnel neutron dosimeters, provided that each dosimeter does not contain more
than 50 milligrams of thorium;
(2) source material contained in the following products:
(a) glazed ceramic tableware manufactured before August 27, 2013, provided that the
glaze contains not more than 20% by weight source material;
(b) glassware containing not more than 2% by weight source material or, for glassware
manufactured before August 27, 2013, 10% by weight source material; but not including
commercially manufactured glass brick, pane glass, ceramic tile, or other glass or
ceramic used in construction;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.103: continued

(c) glass enamel or glass enamel frit containing not more than 10% by weight source
material imported or ordered for importation into the United States, or initially
distributed by manufacturers in the United States, before July 25, 1983; or
(d) piezoelectric ceramic containing not more than 2% by weight source material.
(3) photographic film, negatives, and prints containing uranium or thorium;
(4) any finished product or part fabricated of, or containing, tungsten-thorium or
magnesium-thorium alloys, provided that the thorium content of the alloy does not exceed
4% by weight and that this exemption shall not be deemed to authorize the chemical,
physical, or metallurgical treatment or processing of any such product or part;
(5) uranium contained in counterweights installed in aircraft, rockets, projectiles, and
missiles, or stored or handled in connection with installation or removal of such
counterweights, provided that:
(a) each counterweight has been impressed with the following legend clearly legible
through any plating or other covering: “DEPLETED URANIUM”1;
(b) each counterweight is durably and legibly labeled or marked with the identification
of the manufacturer and the statement: “UNAUTHORIZED ALTERATIONS
PROHIBITED”1; and
(c) this exemption shall not be deemed to authorize the chemical, physical, or
metallurgical treatment or processing of any such counterweights other than repair or
restoration of any plating or other covering.
(6) natural or depleted uranium metal used as shielding constituting part of any shipping
container, provided that:
(a) the shipping container is conspicuously and legibly impressed with the legend
"CAUTION - RADIOACTIVE SHIELDING - URANIUM"; and
(b) the uranium metal is encased in mild steel or equally fire resistant metal of minimum
wall thickness of c inch (3.2 mm);
(7) thorium or uranium contained in or on finished optical lenses and mirrors, provided that
each lens or mirror does not contain more than 10% by weight of thorium or uranium or, for
lenses manufactured before August 27, 2013, 30% by weight of thorium; and that this
exemption shall not be deemed to authorize either:
(a) the shaping, grinding, or polishing of such lens or mirror or manufacturing processes
other than the assembly of such lens or mirror into optical systems and devices without
any alteration of the lens or mirror; or
(b) the receipt, possession, use, or transfer of thorium or uranium contained in contact
lenses, or in spectacles, or in eyepieces in binoculars or other optical instruments.
(8) thorium contained in any finished aircraft engine part containing nickel-thoria alloy,
provided that:
(a) the thorium is dispersed in the nickel-thoria alloy in the form of finely divided thoria
(thorium dioxide); and
(b) the thorium content in the nickel-thoria alloy does not exceed 4% by weight.

(D) The exemptions in 105 CMR 120.103(C) do not authorize the manufacture of any of the
products described.

(E) No person may initially transfer for sale or distribution a product containing source material
to persons exempt under 105 CMR 120.103(C), or equivalent regulations of the NRC or an
Agreement State, unless authorized by a license issued by the NRC under 10 CFR 40.52 to
initially transfer such products for sale or distribution. Persons authorized to manufacture,
process, or produce these materials or products containing source material under a specific
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

license issued by the Agency, and persons who import finished products or parts, for sale or
distribution must be authorized by a license issued by NRC under 10 CFR 40.52 for distribution
only and are exempt from the requirements of 10 CFR 19, 20 and 40.32(b) and (c).

S)))))))))))))))))))))))))Q
1
The requirements specified in 105 CMR 120.103(C)(5)(a) and (b) need not be met by
counterweights manufactured prior to December 31, 1969; provided that such counterweights
were manufactured under a specific license issued by the Atomic Energy Commission and
are impressed with the legend, "CAUTION - RADIOACTIVE MATERIAL - URANIUM",
as previously required by 105 CMR 120.000.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.104: Radioactive Material Other than Source Material

(A) Exempt Concentrations.

(1) Except as provided in 105 CMR 120.104(A)(3), and (4), any person is exempt from
105 CMR 120.100 to the extent that such person receives, possesses, uses, transfers, owns
or acquires products containing byproduct material introduced in concentrations not in excess
of those listed in 105 CMR 120.195: Appendix A.
(2) 105 CMR 120.104(A) shall not be deemed to authorize the import of byproduct material
or products containing byproduct material.
(3) A manufacturer, processor, or producer of a product or material is exempt from the
requirements for a license set forth in 105 CMR 120.100 to the extent that this person
transfers byproduct material contained in a product or material in concentrations not in
excess of those specified in 105 CMR 120.195: Appendix A and introduced into the product
or material by a licensee holding a specific license issued by NRC expressly authorizing such
introduction. This exemption does not apply to the transfer of byproduct material contained
in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion
or inhalation by, or application to, a human being.
(4) No person may introduce byproduct material into a product or material knowing or
having reason to believe that it will be transferred to persons exempt under 105 CMR
120.104(A) or equivalent regulations of the NRC, or an Agreement State except in
accordance with a specific license issued pursuant to 10 CFR 32.11.

(B) Exempt Quantities.

(1) Except as provided in 105 CMR 120.104(B)(2), (3), and (5), any person is exempt from
105 CMR 120.100 to the extent that such person receives, possesses, uses, transfers, owns,
or acquires byproduct material in individual quantities each of which does not exceed the
applicable quantity set forth in 105 CMR 120.196: Appendix B Table I provided they have
been distributed pursuant to a license as described in 105 CMR 120.104(B)(3).
(2) 105 CMR 120.104(B) does not authorize the production, packaging or repackaging of
byproduct material for purposes of commercial distribution, or the incorporation of
byproduct material into products intended for commercial distribution.
(3) No person may, for purposes of commercial distribution, transfer byproduct material in
the individual quantities set forth in 105 CMR 120.196: Appendix B, Table 1, knowing or
having reason to believe that such quantities of byproduct material will be transferred to
persons exempt under 105 CMR 120.104(B) or equivalent regulations of the NRC, an
Agreement State except in accordance with a specific license issued by the NRC pursuant
to 10 CFR Part 32, § 32.18 which license states that the byproduct material may be
transferred by the licensee to persons exempt under 105 CMR 120.104(B) or the equivalent
regulations of the NRC, an Agreement State.2
(4) Any person who possesses byproduct material received or acquired prior to
September 25, 1971 under the general license then provided in 10 CFR 31.4 or similar
general license of a State, is exempt from the requirements for a license set forth in 105 CMR
120.100 if such person possesses, uses, transfers, or owns such byproduct material.
(5) No person may, for purposes of producing an increased radiation level, combine
quantities of byproduct material covered by the exemption in 105 CMR 120.104(B) so that
the aggregate quantity exceeds the limits set forth in 105 CMR 120.196: Appendix B
Table I , except for byproduct material combined within a device placed in use before May
3, 1999, or as otherwise permitted by 105 CMR 120.100.

(C) Exempt Items.

(1) Certain Items Containing Byproduct Material. Except for persons who apply radioactive
material to, or persons who incorporate radioactive material into, the following products, or
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

persons who initially transfer for sale or distribution the following products containing
byproduct materials, any person is exempt from 105 CMR 120.100 to the extent that he
receives, possesses, uses, transfers, owns, or acquires the following products:

S)))))))))))))))))))))))))Q
2
Authority to transfer possession or control by the manufacturer, processor, or producer of any
equipment, device, commodity, or other product containing byproduct material whose
subsequent possession, use, transfer, and disposal by all other persons are exempted from
regulatory requirements may be obtained only from the Nuclear Regulatory Commission
(NRC), Washington, D.C.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.104: continued

(a) Timepieces or hands or dials containing not more than the following specified
quantities of radioactive material and not exceeding the following specified radiation
dose rate:
1. 25 millicuries (925 MBq) of tritium per timepiece.
2. five millicuries (185 MBq) of tritium per hand.
3. 15 millicuries (555 MBq) of tritium per dial (bezels when used shall be
considered as part of the dial).
4. 100 microcuries (3.7 MBq) of promethium-147 per watch or 200 microcuries (7.4
MBq) of promethium-147 per any other timepiece.
5. 20 microcuries (0.74 MBq) of promethium-147 per watch hand or 40 microcuries
(1.48 MBq) of promethium-147 per other timepiece hand.
6. 60 microcuries (2.22 MBq) of promethium-147 per watch dial or 120 microcuries
(4.44 MBq) of promethium-147 per other timepiece dial (bezels when used shall be
considered as part of the dial).
7. The radiation dose rate from hands and dials containing promethium-147 will not
exceed, when measured through 50 milligrams per square centimeter of absorber:
a. For wrist watches, 0.1 millirad (1 :Gy) per hour at ten centimeters from any
surface.
b. For pocket watches, 0.1 millirad (1 :Gy) per hour at one centimeter from any
surface.
c. For any other timepiece, 0.2 millirad (2 :Gy) per hour at ten centimeters from
any surface.
8. One microcurie (37 kBq) of radium-226 per timepiece in intact timepieces
manufactured prior to November 30, 2007.
(b) Precision balances containing not more than one millicurie (37 MBq) of tritium per
balance or not more than 0.5 millicurie (18.5 MBq) of tritium per balance part
manufactured before December 17, 2007.
(c) Marine compasses containing not more than 750 millicuries (27.8 GBq) of tritium
gas and other marine navigational instruments containing not more than 250 millicuries
(9.25 GBq) of tritium gas manufactured before December 17, 2007.
(d) Ionization chamber smoke detectors containing not more than 1 microcurie (:Ci)
of americium-241 per detector in the form of a foil and designed to protect life and
property from fires.
(e) Electron tubes; provided, that each tube does not contain more than one of the
following specified quantities of byproduct material:
1. 150 millicuries (5.55 GBq) of tritium per microwave receiver protector tube or
10 millicuries (370 MBq) of tritium per any other electron tube.
2. 1 microcurie (37 kBq) of cobalt-60.
3. 5 microcuries (185 kBq) of nickel-63.
4. 30 microcuries (1.11 MBq) of krypton-85.
5. 5 microcuries (185 kBq) of cesium-137.
6. 30 microcuries (1.11 MBq) of promethium-147.
And provided further, that the radiation dose rate from each electron tube containing
byproduct material will not exceed one millirad (ten :Gy) per hour at one centimeter
from any surface when measured through seven milligrams per square centimeter of
absorber. For purposes of 105 CMR 120.104(C)(1)(e), "electron tubes" include spark gap
tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes,
indicator tubes, pick-up tubes, radiation detection tubes, and any other completely sealed
tube that is designed to conduct or control electrical currents.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(f) Ionizing radiation measuring instruments containing, for purposes of internal

calibration or standardization, one or more sources of radioactive material, provided that:
1. Each source contains no more than one exempt quantity set forth in 105 CMR
120.196: Appendix B, Table 1; and
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.104: continued

2. Each instrument contains no more than ten exempt quantities. For purposes of
this requirement, an instrument's source(s) may contain either one or different types
of radionuclides and an individual exempt quantity may be composed of fractional
parts of one or more of the exempt quantities in 105 CMR 120.196: Appendix B,
Table 1, provided that the sum of such fractions shall not exceed unity.
3. For americium-241, 0.05 microcurie (1.85 kBq) is considered an exempt quantity
under 105 CMR 120.104(C)(1)(f).
(g) 1. Static elimination devices which contain, as a sealed source or sources, byproduct
material consisting of a total of not more than 18.5 MBq (500 µCi) of polonium-210
per device.
2. Ion generating tubes designed for ionization of air that contain, as a sealed source
or sources, byproduct material consisting of a total of not more than 18.5 MBq (500
µCi) of polonium-210 per device or of a total of not more than 1.85 GBq (50 mCi)
of hydrogen-3 (tritium) per device.
3. Such devices authorized before October 23, 2012 for use under the general
license then provided in 105 CMR 120.122(A) and equivalent regulations of the U.S.
Nuclear Regulatory Commission and Agreement States and manufactured, tested,
and labeled by the manufacturer in accordance with the specifications contained in
a specific license issued by the U.S. Nuclear Regulatory Commission.
(h) Any person who desires to apply byproduct material to, or to incorporate byproduct
material into, the products exempted in 105 CMR 120.104(C)(1), or who desires to
initially transfer for sale or distribution such products containing byproduct material,
should apply to the Nuclear Regulatory Commission for a specific license pursuant to
10 CFR 32.14, which license states that the product may be distributed by the licensee
to persons exempt from the regulations pursuant to 105 CMR 120.104(C)(1) or
equivalent regulations of the Nuclear Regulatory Commission, 10 CFR 30.15(a).
(2) Self-luminous Products Containing Radioactive Material.
(a) Tritium, Krypton-85, or Promethium-147. Except for persons who manufacture,
process, produce, or initially transfer for sale or distribution self-luminous products
containing tritium, krypton-85, or promethium-147, any person is exempt from 105 CMR
120.100 to the extent that such person receives, possesses, uses, transfers, owns, or
acquires tritium, krypton-85 or promethium-147 in self-luminous products manufactured,
processed, produced, or initially transferred in accordance with a specific license issued
by the NRC pursuant to 10 CFR Part 32, § 32.22 which license authorizes the transfer
of the product to persons who are exempt from regulatory requirements.
Any person who desires to manufacture, process, or produce, or initially transfer for
sale or distribution self-luminous products containing tritium, krypton-85, or
promethium-147 for use under 105 CMR 120.104(C)(2), should apply to the NRC for
a license under 10 CFR 32.22 and for a certificate of registration in accordance with
105 CMR 120.128(N). The exemption in 105 CMR 120.104(C)(2) does not apply to
tritium, krypton-85, or promethium-147 used in products primarily for frivolous purposes
or in toys or adornments.
(b) Radium-226. Any person is exempt from 105 CMR 120.100 to the extent that such
person receives, possesses, uses, transfers, or owns articles containing less than 0.1
microcurie (3.7 kBq) of radium-226 which were acquired prior to March 11, 1994.
(3) Gas and Aerosol Detectors Containing Radioactive Material.
(a) Except for persons who manufacture, process, produce, or initially transfer for sale
or distribution gas and aerosol detectors containing byproduct material, any person is
exempt from the requirement of a license set forth in 105 CMR 120.100 to the extent that
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

such person receives, possesses, uses, transfers, owns, or acquires byproduct material in
gas and aerosol detectors designed to protect health, safety, or property provided that
detectors containing byproduct material shall have been manufactured, processed,
produced, or initially transferred in accordance with a specific license issued by the U.S.
Nuclear Regulatory Commission pursuant to 10 CFR Part 32, § 32.26, which license
authorizes the initial transfer of the product for use under 105 CMR 120.104(C)(3).
105 CMR 120.104(C)(3) also covers gas and aerosol detectors manufactured or
distributed before November 30, 2007 in accordance with a specific license issued by a
State under comparable provisions to 10 CFR 32.26 authorizing distribution to persons
exempt from regulatory requirements.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.104: continued

(b) Any person who desires to manufacture, process, or produce gas and aerosol
detectors containing byproduct material, or to initially transfer such products for use
pursuant 105 CMR 120.104(C)(3)(a), should apply to the NRC for a license pursuant to
10 CFR 32.26 and for a certificate of registration in accordance with 105 CMR
120.128(N).
(4) Radioactive Drug: Capsules Containing Carbon-14 Urea for In Vivo Diagnostic Use for
Humans.
(a) Except as provided in 105 CMR 120.104(C)(4)(b) and (c), any person is exempt
from the requirements for a license set forth in M.G.L. c. 111, § 5P and from 105 CMR
120.100 and 120.500 provided that such person receives, possesses, uses, transfers, owns,
or acquires capsules containing 37 kBq (1: Ci) carbon-14 urea (allowing for nominal
variation that may occur during the manufacturing process) each, for in vivo diagnostic
use for humans.
(b) Any persons who desires to use the capsules for research involving human subjects
shall apply for and receive a specific license pursuant to 105 CMR 120.500.
(c) Any person who desires to manufacture, prepare, process, produce, package, or
transfer for commercial distribution such capsules shall apply, to NRC, for and receive
a specific license pursuant to 10 CFR 32.21.
(d) Nothing in 105 CMR 120.104(C)(4) relieves persons from complying with
applicable FDA, other Federal, and State requirements governing receipt, administration,
and use of drugs.
(5) Certain Industrial Devices.
(a) Except for persons who manufacture, process, produce, or initially transfer for sale
or distribution industrial devices containing byproduct material designed and
manufactured for the purpose of detecting, measuring, gauging or controlling thickness,
density, level, interface location, radiation leakage, or qualitative or quantitative chemical
composition, or for producing an ionized atmosphere, any person is exempt from the
requirement of a license set forth in 105 CMR 120.100 to the extent that such person
receives, possesses, uses, transfers, owns, or acquires byproduct material, in these certain
detecting, measuring, gauging, or controlling devices and certain devices for producing
an ionized atmosphere, and manufactured, processed, produced, or initially transferred
in accordance with a specific license issued by the NRC under 10 CFR 32.30, which
license authorizes the initial transfer of the device for use under 105 CMR 120.104(C)(5).
This exemption does not cover sources not incorporated into a device, such as calibration
and reference sources.
(b) Any person who desires to manufacture, process, or produce, or initially transfer for
sale or distribution industrial devices containing byproduct material for use pursuant
105 CMR 120.104(C)(5), should apply to the NRC for a license under 10 CFR 32.30 and
for a certificate of registration in accordance with 105 CMR 120.128(N).

120.120: Types of Licenses

Licenses for radioactive materials are of two types: general and specific.

(A) The Agency issues a specific license to a named person who has filed an application for the
license under the provisions of 105 CMR 120.124.

(B) A general license is provided by regulation, grants authority to a person for certain activities
involving radioactive material, and is effective without the filing of an application with the
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Agency or the issuance of a licensing document to a particular person. However, registration

with the Agency may be required by the particular general license.

120.121: General Licenses - Source Material

(A) A general license is hereby issued authorizing commercial and industrial firms; research,
educational, and medical institutions; and state and local government agencies to receive,
possess, use, and transfer uranium and thorium, in their natural isotopic concentrations and in
the form of depleted uranium, for research, development, educational, commercial, or operational
purposes in the following forms and quantities:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.121: continued

(1) No more than 1.5 kg (3.3 lb) of uranium and thorium in dispersible forms (e.g., gaseous,
liquid, powder, etc.) at any one time. Any material processed by the general licensee that
alters the chemical or physical form of the material containing source material must be
accounted for as a dispersible form. A person authorized to possess, use, and transfer source
material under 105 CMR 120.121(A)(1) may not receive more than a total of 7 kg (15.4 lb)
of uranium and thorium in any one calendar year; and
(2) No more than a total of 7 kg (15.4 lb) of uranium and thorium at any one time. A person
authorized to possess, use, and transfer source material under 105 CMR 120.121(A)(2) may
not receive more than a total of 70 kg (154 lb) of uranium and thorium in any one calendar
year. A person may not alter the chemical or physical form of the source material possessed
under 105 CMR 120.121(A)(2) unless it is accounted for under the limits of 105 CMR
120.121(A)(1); or
(3) No more than 7 kg (15.4 lb) of uranium, removed during the treatment of drinking
water, at any one time. A person may not remove more than 70 kg (154 lb) of uranium from
drinking water during a calendar year under 105 CMR 120.121(A)(3); or
(4) No more than 7 kg (15.4 lb) of uranium and thorium at laboratories for the purpose of
determining the concentration of uranium and thorium contained within the material being
analyzed at any one time. A person authorized to possess, use, and transfer source material
under 105 CMR 120.121(A)(4) may not receive more than a total of 70 kg (154 lb) of source
material in any one calendar year.

(B) Any person who receives, possesses, uses, or transfers source material pursuant to the
general license issued in 105 CMR 120.121(A):
(1) Is prohibited from administering source material, or the radiation therefrom, either
externally or internally, to human beings except as may be authorized by the Agency in a
specific license.
(2) Shall not abandon such source material. Source material may be disposed of as follows:
(a) A cumulative total of 0.5 kg (1.1 lb) of source material in a solid, non-dispersible
form may be transferred each calendar year, by a person authorized to receive, possess,
use, and transfer source material under this general license to persons receiving the
material for permanent disposal. The recipient of source material transferred under the
provisions of 105 CMR 120.121(B)(2)(a) is exempt from the requirements to obtain a
license under 105 CMR 120.100 to the extent the source material is permanently
disposed. 105 CMR 120.121(B)(2)(a) does not apply to any person who is in possession
of source material under a specific license issued under 105 CMR 120.100; or
(b) In accordance with 105 CMR 120.251.
(3) Is subject to the provisions in 105 CMR 120.001 through 120.019, 120.101(A),
120.131(A) through (C), 120.140, 120.142, and 120.150.
(4) Shall respond to written requests from the Agency to provide information relating to the
general license within 30 calendar days of the date of the request, or other time specified in
the request. If the person cannot provide the requested information within the allotted time,
the person shall, within that same time period, request a longer period to supply the
information by providing the Agency, using an appropriate method listed in 105 CMR
120.013, a written justification for the request;
(5) Shall not export such source material except in accordance with 10 CFR Part 110.

(C) Any person who receives, possesses, uses, or transfers source material in accordance with
105 CMR 120.121(A) shall conduct activities so as to minimize contamination of the facility and
the environment. When activities involving such source material are permanently ceased at any
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

site, if evidence of significant contamination is identified, the general licensee shall notify the
Agency by an appropriate method listed in 105 CMR 120.013 about such contamination and may
consult with the Agency as to the appropriateness of sampling and restoration activities to ensure
that any contamination or residual source material remaining at the site where source material
was used under this general license is not likely to result in exposures that exceed the limits in
105 CMR 120.245.

(D) A general license is hereby issued authorizing the receipt of title to source material without
regard to quantity. This general license does not authorize any person to receive, possess, use,
or transfer source material.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.121: continued

(E) Depleted Uranium in Industrial Products and Devices.

(1) A general license is hereby issued to receive, acquire, possess, use, or transfer, in
accordance with the provisions of 105 CMR 120.121(E)(2) through (5), depleted uranium
contained in industrial products or devices for the purpose of providing a concentrated mass
in a small volume of the product or device.
(2) The general license in 105 CMR 120.121(E)(1) applies only to industrial products or
devices which have been manufactured either in accordance with a specific license issued
to the manufacturer of the products or devices pursuant to 105 CMR 120.128(M) or in
accordance with a specific license issued to the manufacturer by the U.S. Nuclear Regulatory
Commission or an Agreement State which authorizes manufacture of the products or devices
for distribution to persons generally licensed by the U.S. Nuclear Regulatory Commission
or an Agreement State.
(3) (a) Persons who receive, acquire, possess, or use depleted uranium pursuant to the
general license established by 105 CMR 120.121(E)(1) shall file form MRCP 120.100-1
"Certificate - Use of Depleted Uranium Under General License", with the Agency. The
form shall be submitted within 30 days after the first receipt or acquisition of such
depleted uranium. The general licensee shall furnish on form MRCP 120.100-1 the
following information and such other information as may be required by that form:
1. name and address of the general licensee;
2. a statement that the general licensee has developed and will maintain procedures
designed to establish physical control over the depleted uranium described in
105 CMR 120.121(E)(1) and designed to prevent transfer of such depleted uranium
in any form, including metal scrap, to persons not authorized to receive the depleted
uranium; and
3. name and title, address, and telephone number of the individual duly authorized
to act for and on behalf of the general licensee in supervising the procedures
identified in 105 CMR 120.121(E)(3)(a)2.
(b) The general licensee possessing or using depleted uranium under the general license
established by 105 CMR 120.121(E)(1) shall report in writing to the Agency any changes
in information furnished by him in form MRCP 120.100-1 "Certificate - Use of Depleted
Uranium Under General License". The report shall be submitted within 30 days after the
effective date of such change.
(4) A person who receives, acquires, possesses, or uses depleted uranium pursuant to the
general license established by 105 CMR 120.121(E)(1):
(a) shall not introduce such depleted uranium, in any form, into a chemical, physical,
or metallurgical treatment or process, except a treatment or process for repair or
restoration of any plating or other covering of the depleted uranium;
(b) shall not abandon such depleted uranium;
(c) shall transfer or dispose of such depleted uranium only by transfer in accordance
with the provisions of 105 CMR 120.140. In the case where the transferee receives the
depleted uranium pursuant to the general license established by 105 CMR 120.121(E)(1),
the transferor shall furnish the transferee a copy of 105 CMR 120.100 and a copy of form
MRCP 120.100-1. In the case where the transferee receives the depleted uranium
pursuant to a general license contained in the U.S. Nuclear Regulatory Commission's or
Agreement State's regulation equivalent to 105 CMR 120.121(E)(1), the transferor shall
furnish the transferee a copy of 105 CMR 120.100 and a copy of form MRCP 120.100-1
accompanied by a note explaining that use of the product or device is regulated by the
U.S. Nuclear Regulatory Commission or Agreement State under requirements
substantially the same as those in 105 CMR 120.100;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.121: continued

(d) within 30 days of any transfer, shall report in writing to the Agency the name and
address of the person receiving the depleted uranium pursuant to such transfer; and
(e) shall not export such depleted uranium except in accordance with a license issued
by the U.S. Nuclear Regulatory Commission pursuant to 10 CFR Part 110.
(5) Any person receiving, acquiring, possessing, using, or transferring depleted uranium
pursuant to the general license established by 105 CMR 120.121(E)(1) is exempt from the
requirements of 105 CMR 120.200 and 120.750 with respect to the depleted uranium covered
by that general license.

(F) Any person who receives, possesses, uses, or transfers source material in accordance with
the general license granted in 105 CMR 120.121(A) is exempt from the provisions of 105 CMR
120.200 and 120.750 to the extent that such receipt, possession, use, and transfer are within the
terms of this general license, except that such person shall comply with the provisions of
105 CMR 120.245 and 120.251 to the extent necessary to meet the provisions of 105 CMR
120.121(B)(2) and 120.121(C). However, this exemption does not apply to any person who also
holds a specific license issued under 105 CMR 120.100.

(G) No person may initially transfer or distribute source material to persons generally licensed
under 105 CMR 120.121(A)(1) or (2), or equivalent regulations of the NRC or an Agreement
State, unless authorized by a specific license issued in accordance with 105 CMR 120.128(B)
or equivalent provisions of the NRC or an Agreement State. This prohibition does not apply to
analytical laboratories returning processed samples to the client who initially provided the
sample.

120.122: General Licenses - Radioactive Material Other than Source Material

(A) Requirements for Other General Licenses (Reserved).

(B) Luminous Safety Devices for Aircraft.

(1) A general license is hereby issued to own, receive, acquire, possess, and use tritium or
promethium-147 contained in luminous safety devices for use in aircraft, provided:
(a) each device contains not more than 10 curies (370 GBq) of tritium or 300 millicuries
(11.1 GBq) of promethium-147; and
(b) each device has been manufactured, assembled or imported in accordance with a
specific license issued by the U.S. Nuclear Regulatory Commission, or each device has
been manufactured or assembled in accordance with the specifications contained in a
specific license issued by the Agency or any Agreement State to the manufacturer or
assembler of such device pursuant to licensing requirements equivalent to those in
10 CFR Part 32, § 32.53.
(2) Persons who own, receive, acquire, possess, or use luminous safety devices pursuant to
the general license in 105 CMR 120.122(B)(1) are exempt from the requirements of
105 CMR 120.200 through 120.299 and 120.750 through 120.760 except that they shall
comply with the provisions of 105 CMR 120.281 and 120.282.
(3) This general license does not authorize the manufacture, assembly, or repair of luminous
safety devices containing tritium or promethium-147.
(4) This general license does not authorize the ownership, receipt, acquisition, possession
or use of promethium-147 contained in instrument dials.
(5) This general license is subject to the provisions of 105 CMR 120.005 through 120.016,
120.131, 120.140, 120.150, and 120.770 through 120.798.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(C) Requirements for Other General Licenses (Reserved).

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.122: continued

(D) Certain Detecting, Measuring, Gauging, or Controlling Devices and Certain Devices for
Producing Light or an Ionized Atmosphere.
(1) A general license is hereby issued to commercial and industrial firms and research,
educational and medical institutions, individuals in the conduct of their business, and State
or local government agencies to acquire, receive, possess, use or transfer in accordance with
the provisions of 105 CMR 120.122(D)(2) through (4), radioactive material, excluding
special nuclear material, contained in devices designed and manufactured for the purpose of
detecting, measuring, gauging or controlling thickness, density, level, interface location,
radiation, leakage, or qualitative or quantitative chemical composition, or for producing light
or an ionized atmosphere.
(2)(a) The general license in 105 CMR 120.122(D)(1) applies only to radioactive material
contained in devices which have been manufactured or initially transferred and labeled
in accordance with the specifications contained in:
1. a specific license issued by the Agency pursuant to 105 CMR 120.128(D); or
2. an equivalent specific license issued by the U.S. Nuclear Regulatory
Commission, an Agreement State, or an equivalent specific license issued by a State
with provisions comparable to 105 CMR 120.128(D).
(b) The devices must have been received from one of the specific licensees described
in 105 CMR 120.122(D)(2)(a) or through a transfer made under 105 CMR
120.122(D)(3)(i).
(3) Any person who owns, receives, acquires, possesses, uses, or transfers radioactive
material in a device pursuant to the general license in 105 CMR 120.122(D)(1):
(a) shall assure that all labels affixed to the device at the time of receipt, and bearing a
statement that removal of the label is prohibited, are maintained thereon and shall comply
with all instructions and precautions provided by such labels;
(b) shall assure that the device is tested for leakage of radioactive material and proper
operation of the "on-off" mechanism and indicator, if any, at no longer than six-month
intervals or at such other intervals as are specified in the label, however,
1. devices containing only krypton need not be tested for leakage of radioactive
material; and
2. devices containing only tritium or not more than 100 microcuries (3.7 MBq) of
other beta and/or gamma-emitting material or ten microcuries (0.37 MBq) of
alpha-emitting material and devices held in storage in the original shipping container
prior to initial installation need not be tested for any purpose;
(c) shall assure that the tests required under 105 CMR 120.122(D)(3)(b) and other
testing, installation, servicing, and removal from installation involving the radioactive
material, its shielding or containment, are performed:
1. in accordance with the instructions provided by the labels; or
2. by a person holding an applicable specific license from the Agency, the U.S.
Nuclear Regulatory Commission, or an Agreement State to perform such activities;
(d) shall maintain records showing compliance with the requirements of 105 CMR
120.122(D)(3)(b) and (c). The records shall show the results of tests. The records also
shall show the dates of performance of, and the names of persons performing, testing,
installation, servicing, and removal from installation concerning the radioactive material,
its shielding or containment. The licensee shall retain these records as follows:
1. each record of a test for leakage of radioactive material required by 105 CMR
120.122(D)(3)(b) shall be retained for three years after the next required leak test is
performed or until the sealed source is transferred or disposed of;
2. each record of a test of the "on-off" mechanism and indicator required by 105
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

CMR 120.122(D)(3)(b) shall be retained for three years after the next required test
of the "on-off" mechanism and indicator is performed or until the sealed source is
transferred or disposed of; and
3. each record that is required by 105 CMR 120.122(D)(3)(c) shall be maintained
for a period of three years from the date of the recorded event or until the device is
transferred or disposed of;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.122: continued

(e) shall immediately suspend operation of the device if there is a failure of or damage
to, or any indication of a possible failure of or damage to, the shielding of the radioactive
material or the “on-off” mechanism or indicator, or upon the detection of 185 Bq (0.005
microcurie) or more removable radioactive material. The device shall not be operated
until it has been repaired by the manufacturer or other person holding an applicable
specific license from the Agency, the U.S. Nuclear Regulatory Commission, or an
Agreement State to repair such devices. The device and any radioactive material from
the device shall only be disposed of by transfer to a person authorized by an applicable
specific license to receive the radioactive material contained in the device or as otherwise
approved by the Agency. A report containing a brief description of the event and the
remedial action taken; and, in the case of detection of 0.005 microcurie or more
removable radioactive material or failure of or damage to a source likely to result in
contamination of the premises or the environs, a plan for ensuring that the premises and
environs are acceptable for unrestricted use, must be furnished to the Agency within 30
days. Under these circumstances, the criteria set out in 105 CMR 120.243: Vacating
Premises, may be applicable, as determined by the Agency on a case-by-case basis;
(f) shall not abandon the device containing radioactive material;
(g) shall not export the device containing radioactive material except in accordance with
10 CFR110;
(h) 1. shall transfer or dispose of the device containing radioactive material only by
export as provided in105 CMR 120.122(D)(3)(g), by transfer to another general
licensee as authorized in 105 CMR 120.122(D)(3)(i), or to a person authorized to
receive the device by a specific license issued by the Agency, the U.S. Nuclear
Regulatory Commission, or an Agreement State that authorizes waste collection or
as otherwise approved under 105 CMR 120.122(D)(3)(h)3.
2. shall furnish a report to the Agency within 30 days after the transfer of a device
to a specific licensee or export. The report shall contain:
a. the identification of the device by manufacturer's (or initial transferor's) name,
model number, and serial number;
b. the name, address, and license number of the person receiving the device
(license number not applicable if exported); and
c. the date of the transfer.
3. shall obtain written Agency approval before transferring the device to any other
specific licensee not specifically identified in 105 CMR 120.122(D)(3)(h)1.;
however, a holder of a specific license may transfer a device for possession and use
under its own specific license without prior approval, if, the holder:
a. Verifies that the specific license authorizes the possession and use, or applies
for and obtains an amendment to the license authorizing the possession and use;
b. Removes, alters, covers, or clearly and unambiguously augments the existing
label (otherwise required by 105 CMR 120.122(D)(3)(a)) so that the device is
labeled in compliance with 105 CMR 120.240; however the manufacturer, model
number, and serial number must be retained;
c. Obtains the manufacturer's or initial transferor's information concerning
maintenance that would be applicable under the specific license (such as leak
testing procedures); and
d. Reports the transfer under 105 CMR 120.122(D)(3)(h)2.
(i) shall transfer the device to another general licensee only if:
1. the device remains in use at a particular location. In this case, the transferor shall
give the transferee a copy of 105 CMR 120.122(D), a copy of 120.122, 120.009,
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.281, and 120.282, and any safety documents identified in the label of the device.
Within 30 days of the transfer, the transferor shall report to the Agency:
a. the manufacturer's (or initial transferor's) name;
b. the model number and the serial number of the device transferred;
c. the transferee's name and mailing address for the location of use; and
d. the name, title, and phone number of the responsible individual identified by
the transferee in accordance with 105 CMR 120.122(D)(3)(l) to have knowledge
of and authority to take actions to ensure compliance with the appropriate
regulations and requirements; or
2. the device is held in storage by an intermediate person in the original shipping
container at its intended location of use prior to initial use by a general licensee;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.122: continued

(j) shall comply with the provisions of 105 CMR 120.281 and 120.282 for reporting
radiation incidents, theft, or loss of licensed material, but shall be exempt from the other
requirements of 105 CMR 120.200 and 120.750;
(k) shall respond to written requests from the Agency to provide information relating
to the general license within 30 calendar days of the date of the request, or other time
specified in the request. If the general licensee cannot provide the requested information
within the allotted time, it shall, within that same time period, request a longer period to
supply the information by submitting a letter to the Director, Radiation Control Program,
Massachusetts Department of Public Health, and provide written justification as to why
it cannot comply;
(l) shall appoint an individual responsible for having knowledge of the appropriate
regulations and requirements and the authority for taking required actions to comply with
appropriate regulations and requirements. The general licensee, through this individual,
shall ensure the day-to-day compliance with appropriate regulations and requirements.
This appointment does not relieve the general licensee of any of its responsibility in this
regard;
(m)1. shall register, in accordance with 105 CMR 120.122(D)(3)(m)2. and 3., devices
containing at least 370 MBq (10 mCi) of cesium-137, 3.7 MBq (0.1 mCi) of
strontium-90, 37 MBq (1 mCi) of cobalt-60, 3.7 MBq (0.1 mCi) radium-226, or
37 MBq (1 mCi) of americium-241 or any other transuranic (i.e., element with atomic
number greater than uranium (92)), based on the activity indicated on the label. Each
address for a location of use, as described under 105 CMR 120.122(D)(3)(m)3.d.
represents a separate general licensee and requires a separate registration and fee;
2. if in possession of a device meeting the criteria of 105 CMR 120.122(D)(3)(m)1.,
shall register these devices annually with the Agency and shall pay any prescribed
fee. Registration must be done by verifying, correcting, and/or adding to the
information provided in a request for registration received from the Agency. The
registration information must be submitted to the Agency within 30 days of the date
of the request for registration or as otherwise indicated in the request. In addition,
a general licensee holding devices meeting the criteria of 105 CMR
120.122(D)(3)(m)1. is subject to the bankruptcy notification requirement in
105 CMR 120.131(E);
3. in registering devices, the general licensee shall furnish the following information
and any other information specifically requested by the Agency:
a. name and mailing address of the general licensee;
b. information about each device: the manufacturer (or initial transferor), model
number, serial number, the radioisotope and activity (as indicated on the label);
c. name, title, and telephone number of the responsible person designated as a
representative of the general licensee under 105 CMR 120.122(D)(3)(l);
d. address or location at which the device(s) are used and/or stored. For portable
devices, the address of the primary place of storage;
e. certification by the responsible representative of the general licensee that the
information concerning the device(s) has been verified through a physical
inventory and checking of label information;
f. certification by the responsible representative of the general licensee that they
are aware of the requirements of the general license.
4. persons generally licensed by an Agreement State, or NRC with respect to
devices meeting the criteria in 105 CMR 120.122(D)(3)(m)1. are not subject to
registration requirements if the devices are used in areas subject to Agency
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

jurisdiction for a period less than 180 days in any calendar year. The Agency will not
request registration information from such licensees.
(n) shall report changes to the mailing address for the location of use (including change
in name of general licensee) to the Director, Radiation Control Program, Massachusetts
Department of Public Health, within 30 days of the effective date of the change. For a
portable device, a report of address change is only required for a change in the device's
primary place of storage;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.122: continued

(o) may not hold devices that are not in use for longer than two years. If devices with
shutters are not being used, the shutter must be locked in the closed position. The testing
required by 105 CMR 120.122(D)(3)(b) need not be performed during the period of
storage only. However, when devices are put back into service or transferred to another
person, and have not been tested within the required test interval, they must be tested for
leakage before use or transfer and the shutter tested before use. Devices kept in standby
for future use are excluded from the two-year time limit if the general licensee performs
quarterly physical inventories of these devices while they are in standby.
(4) The general license in 105 CMR 120.122(D)(1) does not authorize the manufacture or
import of devices containing radioactive material.

[Note: Persons possessing radioactive material in devices under a general license in 10 CFR 31.5
before January 15, 1975, may continue to possess, use, or transfer that material in accordance
with the labeling requirements of 10 CFR 31.5 in effect on January 14, 1975.]

(E) General License for Certain Items and Self-luminous Products Containing Radium-226.
(1) A general license is hereby issued to any person to acquire, receive, possess, use, or
transfer, in accordance with the provisions of 105 CMR 120.122(E)(2), (3), and (4),
radium-226 contained in the following products manufactured prior to November 30, 2007.
(a) Antiquities originally intended for use by the general public. For the purposes of
105 CMR 120.122(E)(1)(a), antiquities mean products originally intended for use by the
general public and distributed in the late 19th and early 20th centuries, such as radium
emanator jars, revigators, radium water jars, radon generators, refrigerator cards, radium
bath salts, and healing pads.
(b) Intact timepieces containing greater than 0.037 megabecquerel (one microcurie),
nonintact timepieces, and timepiece hands and dials no longer installed in timepieces.
(c) Luminous items installed in air, marine, or land vehicles.
(d) All other luminous products, provided that no more than 100 items are used or
stored at the same location at any one time.
(e) Small radium sources containing no more than 0.037 megabecquerel (one
microcurie) of radium-226. For the purposes of 105 CMR 120.122(E)(1)(e), "small
radium sources" means discrete survey instrument check sources, sources contained in
radiation measuring instruments, sources used in educational demonstrations (such as
cloud chambers and spinthariscopes), electron tubes, lightning rods, ionization sources,
static eliminators, or as designated by the NRC.
(2) Persons who acquire, receive, possess, use, or transfer byproduct material under the
general license issued in 105 CMR 120 122(E)(1) are exempt from the provisions of
105 CMR 120.750, 120.200, and120.142 and 120.009, to the extent that the receipt,
possession, use, or transfer of byproduct material is within the terms of the general license;
provided, however, that this exemption shall not be deemed to apply to any such person
specifically licensed under 105 CMR 120.100.
(3) Any person who acquires, receives, possesses, uses, or transfers byproduct material in
accordance with the general license in 105 CMR 120.122(E)(1):
(a) Shall notify the Agency should there be any indication of possible damage to the
product so that it appears it could result in a loss of the radioactive material. A report
containing a brief description of the event, and the remedial action taken, must be
furnished to the Director of the Agency within 30 days.
(b) Shall not abandon products containing radium-226. The product, and any radioactive
material from the product, may only be disposed of according to 105 CMR120.256 or by
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

transfer to a person authorized by a specific license to receive the radium-226 in the

product or as otherwise approved by the Agency
(c) Shall not export products containing radium-226 except in accordance with 10 CFR
110.
(d) Shall dispose of products containing radium-226 at a disposal facility authorized to
dispose of radioactive material in accordance with any Federal or State solid or hazardous
waste law, including the Solid Waste Disposal Act, as authorized under the Energy
Policy Act of 2005, by transfer to a person authorized to receive radium-226 by a specific
license issued by the Agency, Nuclear Regulatory Commission, or an Agreement State,
or as otherwise approved by the Agency.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.122: continued

(e) Shall respond to written requests from the Agency to provide information relating
to the general license within 30 calendar days of the date of the request, or other time
specified in the request. If the general licensee cannot provide the requested information
within the allotted time, it shall, within that same time period, request a longer period to
supply the information by providing the Director of the Agency, a written justification
for the request.
(4) The general license in 105 CMR 120.122(E)(1) does not authorize the manufacture,
assembly, disassembly, repair, or import of products containing radium-226, except that
timepieces may be disassembled and repaired.

(F) Ownership of Radioactive Material. A general license is hereby issued to own radioactive
material without regard to quantity. Notwithstanding any other provisions of 105 CMR 120.122,
this general license does not authorize the manufacture, production, transfer, receipt, possession
or use of radioactive material.

(G) Calibration and Reference Sources.

(1) A general license is hereby issued to those persons listed below to own, receive, acquire,
possess, use, and transfer, in accordance with the provisions of 105 CMR 120.122(G)(4) and
(5), americium-241 in the form of calibration or reference sources:
(a) any person who holds a specific license issued by the Agency which authorizes him
to receive, possess, use, and transfer radioactive material; and
(b) any person who holds a specific license issued by the U.S. Nuclear Regulatory
Commission which authorizes him to receive, possess, use, and transfer special nuclear
material.
(2) A general license is hereby issued to own, receive, possess, use, and transfer plutonium
in the form of calibration or reference sources in accordance with the provisions of 105 CMR
120.122(G)(4) and (5) to any person who holds a specific license issued by the Agency which
authorizes him to receive, possess, use, and transfer radioactive material.
(3) A general license is hereby issued to own, receive, possess, use, and transfer radium-226
in the form of calibration or reference sources in accordance with the provisions of 105 CMR
120.122(G)(4) and (5) to any person who holds a specific license issued by the Agency which
authorizes him to receive, possess, use, and transfer radioactive material.
(4) The general licenses in 105 CMR 120.122(G)(1) through (3) apply only to calibration
or reference sources which have been manufactured in accordance with the specifications
contained in a specific license issued to the manufacturer or importer of the sources by the
U.S. Nuclear Regulatory Commission pursuant to 10 CFR Part 32, § 32.57 or 10 CFR Part
70, § 70.39 or which have been manufactured in accordance with the specifications contained
in a specific license issued to the manufacturer by the Agency, any Agreement State or
Licensing State pursuant to licensing requirements equivalent to those contained in 10 CFR
Part 32, § 32.57 or 10 CFR Part 70, § 70.39.
(5) The general licenses provided in 105 CMR 120.122(G)(1) through (3) are subject to the
provisions of 105 CMR 120.005 through 120.016, 120.131, 120.140, 120.150, and 120.770.
In addition, persons who own, receive, acquire, possess, use, or transfer one or more
calibration or reference sources pursuant to these general licenses:
(a) shall not possess at any one time, at any one location of storage or use, more than
five microcuries (185 kBq) of americium-241, five microcuries (185 kBq) of plutonium,
or five microcuries (185 kBq) of radium-226 in such sources;
(b) shall not receive, possess, use, or transfer such source unless the source, or the
storage container, bears a label which includes one of the following statements, as appro-
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

priate, or a substantially similar statement which contains the information called for in
one of the following statements, as appropriate:
1. The receipt, possession, use and transfer of this source, Model , Serial No.
, are subject to a general license and the regulations of the U.S. Nuclear
Regulatory Commission or of a State with which the U.S. Nuclear Regulatory
Commission has entered into an agreement for the exercise of regulatory authority.
Do not remove this label.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.122: continued

CAUTION - RADIOACTIVE MATERIAL

THIS SOURCE CONTAINS (AMERICIUM-241) (PLUTONIUM)3.
DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

))))))))))))))))))))))))))))))))))))Q
Name of Manufacturer or Importer

2. The receipt, possession, use and transfer of this source, Model , Serial No.
, are subject to a general license and the regulations of a Licensing State. Do not
remove this label.

CAUTION - RADIOACTIVE MATERIAL

THIS SOURCE CONTAINS RADIUM-226.
DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.
S))))))))))))))))))))))))))))))))))))Q
Name of Manufacturer or Importer

(c) shall not transfer, abandon, or dispose of such source except by transfer to a person
authorized by a license from the Agency, the U.S. Nuclear Regulatory Commission, an
Agreement State or a Licensing State to receive the source;
(d) shall store such source, except when the source is being used, in a closed container
adequately designed and constructed to contain americium-241, plutonium, or
radium-226 which might otherwise escape during storage; and,
(e) shall not use such source for any purpose other than the calibration of radiation
detectors or the standardization of other sources.
(6) These general licenses do not authorize the manufacture of calibration or reference
sources containing americium-241, plutonium, or radium-226.

(H) Requirements for Other General Licenses (Reserved).

(I) General License for Use of Radioactive Material for Certain In Vitro Clinical or Laboratory
Testing.4
(1) A general license is hereby issued to any physician, veterinarian, clinical laboratory or
hospital to receive, acquire, possess, transfer or use, for any of the following stated tests, in
accordance with the provisions of 105 CMR 120.122(I)(2) through (6), the following
radioactive materials in prepackaged units for use in in vitro clinical or laboratory tests not
involving internal or external administration of radioactive material, or the radiation
therefrom, to human beings or animals:
(a) Carbon-14, in units not exceeding ten microcuries (370 kBq) each.
(b) Cobalt-57, in units not exceeding ten microcuries (370 kBq) each.
(c) Hydrogen-3 (tritium), in units not exceeding 50 microcuries (1.85 MBq) each.
(d) Iodine-125, in units not exceeding ten microcuries (370 kBq) each.
(e) Mock Iodine-125 reference or calibration sources, in units not exceeding 0.05
microcurie (1.85 kBq) of iodine-129 and 0.005 microcurie (185 Bq) of americium-241
each.
(f) Iodine-131, in units not exceeding ten microcuries (370 kBq) each.
(g) Iron-59, in units not exceeding 20 microcuries (740 kBq) each.
(h) Selenium-75, in units not exceeding ten microcuries (370 kBq) each.
(2) No person shall receive, acquire, possess, use or transfer radioactive material pursuant
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

to the general license established by 105 CMR 120.122(I)(1) until he has filed form MRCP
120.100-2, "Certificate - In Vitro Testing with Radioactive Material Under General License",
with the Agency and received from the Agency a validated copy of form MRCP 120.100-2
with certification number assigned, or, has a license that authorizes the medical use of
radioactive material that was issued under 105 CMR 120.500. The physician, veterinarian,
clinical laboratory or hospital shall furnish on form MRCP 120.100-2 the following
information and such other information as may be required by that form:
S))))))))))))))))))))))))))))))Q
3
Showing only the name of the appropriate material.
4
The New Drug provisions of the Federal Food, Drug, and Cosmetic Act also govern the
availability and use of any specific diagnostic drugs in interstate commerce.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.122: continued

(a) Name and address of the physician, veterinarian, clinical laboratory or hospital;
(b) The location of use; and,
(c) A statement that the physician, veterinarian, clinical laboratory or hospital has
appropriate radiation measuring instruments to carry out in vitro clinical or laboratory
tests with radioactive material as authorized under the general license in 105 CMR
120.122(I)(1) and that such tests will be performed only by personnel competent in the
use of such instruments and in the handling of the radioactive material.
(3) A person who receives, acquires, possesses or uses radioactive material pursuant to the
general license established by 105 CMR 120.122(I)(1) shall comply with the following:
(a) The general licensee shall not possess at any one time, pursuant to the general
license in 105 CMR 120.122(I)(1), at any one location of storage or use, a total amount
of iodine-125, iodine-131, selenium-75, iron-59, and/or cobalt-57 in excess of 200
microcuries (7.4 MBq).
(b) The general licensee shall store the radioactive material, until used, in the original
shipping container or in a container providing equivalent radiation protection.
(c) The general licensee shall use the radioactive material only for the uses authorized
by 105 CMR 120.122(I)(1)
(d) The general licensee shall not transfer the radioactive material to a person who is not
authorized to receive it pursuant to a license issued by the Agency, the U.S. Nuclear
Regulatory Commission, any Agreement State or Licensing State, nor transfer the
radioactive material in any manner other than in the unopened, labeled shipping container
as received from the supplier.
(e) The general licensee shall dispose of the Mock Iodine-125 reference or calibration
sources described in 105 CMR 120.122(I)(1)(e) as required by 105 CMR 120.251.
(4) The general licensee shall not receive, acquire, possess, or use radioactive material
pursuant to 105 CMR 120.122(I)(1):
(a) Except as prepackaged units which are labeled in accordance with the provisions of
an applicable specific license issued pursuant to 105 CMR 120.128(H) or in accordance
with the provisions of a specific license issued by the U.S. Nuclear Regulatory
Commission, any Agreement State or Licensing State which authorizes the manufacture
and distribution of iodine-125, iodine-131, carbon-14, hydrogen-3 (tritium), iron-59,
selenium-75, cobalt-57, or Mock Iodine-125 to persons generally licensed under
105 CMR 120.122(I) or its equivalent; and
(b) unless one of the following statements, as appropriate, or a substantially similar
statement which contains the information called for in one of the following statements,
appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure
which accompanies the package:
1. This radioactive material shall be received, acquired, possessed, and used only
by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro
clinical or laboratory tests not involving internal or external administration of the
material, or the radiation therefrom, to human beings or animals. Its receipt,
acquisition, possession, use, and transfer are subject to the regulations and a general
license of the U.S. Nuclear Regulatory Commission or of a State with which the
Commission has entered into an agreement for the exercise of regulatory authority.

Name of Manufacturer

2. This radioactive material shall be received, acquired, possessed, and used only by
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical
or laboratory tests not involving internal or external administration of the material, or the
radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use
and transfer are subject to the regulations and a general license of a Licensing State.

Name of Manufacturer
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.122: continued

(5) The physician, veterinarian, clinical laboratory or hospital possessing or using

radioactive material under the general license of 105 CMR 120.122(I)(1) shall report in
writing to the Agency, any changes in the information furnished by him in the "Certificate
- In Vitro Testing with Radioactive Material Under General License", form MRCP 120.100-
2. The report shall be furnished within 30 days after the effective date of such change.
(6) Any person using radioactive material pursuant to the general license of 105 CMR
120.122(I)(1) is exempt from the requirements of 105 CMR 120.200 and 120.750 with
respect to radioactive material covered by that general license, except that such persons using
the Mock Iodine-125 described in 105 CMR 120.122(I)(1)(e) shall comply with the
provisions of 105 CMR 120.251, 120.281 and 120.282.

(J) Ice Detection Devices.

(1) A general license is hereby issued to own, receive, acquire, possess, use, and transfer
strontium-90 contained in ice detection devices, provided each device contains not more than
50 microcuries (1.85 MBq) of strontium-90 and each device has been manufactured or
imported in accordance with a specific license issued by the U.S. Nuclear Regulatory
Commission or each device has been manufactured in accordance with the specifications
contained in a specific license issued by the Agency or an Agreement State to the
manufacturer of such device pursuant to licensing requirements equivalent to those in
10 CFR Part 32, § 32.61.
(2) Persons who own, receive, acquire, possess, use, or transfer strontium-90 contained in
ice detection devices pursuant to the general license in 105 CMR 120.122(J)(1),
(a) shall, upon occurrence of visually observable damage, such as a bend or crack or
discoloration from overheating to the device, discontinue use of the device until it has
been inspected, tested for leakage and repaired by a person holding a specific license
from the U.S. Nuclear Regulatory Commission or an Agreement State to manufacture or
service such devices; or shall dispose of the device pursuant to the provisions of
105 CMR 120.251;
(b) shall assure that all labels affixed to the device at the time of receipt, and which bear
a statement which prohibits removal of the labels, are maintained thereon; and,
(c) are exempt from the requirements of 105 CMR 120.200 and 120.750 except that
such persons shall comply with the provisions of 105 CMR 120.251, 120.281 and
120.282.
(3) This general license does not authorize the manufacture, assembly, disassembly or repair
of strontium-90 in ice detection devices.
(4) This general license is subject to the provisions of 105 CMR 120.001 through 120.019,
120.131, 120.140, 120.150, and 120.770.

120.124: Filing Application for Specific Licenses

(A) Applications for specific licenses shall be filed in duplicate on form MRCP 120.100-4 as
prescribed by the Agency.

(B) The Agency may at any time after the filing of the original application, and before the
expiration of the license, require further statements in order to enable the Agency to determine
whether the application should be granted or denied or whether a license should be modified or
revoked.

(C) Each application shall be signed by the applicant or licensee or a person duly authorized to
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

act for and on his or her behalf.

(D) An application for a license may include a request for a license authorizing one or more
activities. The Agency will not grant the request if the proposed activities are not under the
control of the same facility, administrator and radiation safety officer. In addition, when
evaluating the request, the Agency will consider complexity, similarity and proximity of the
proposed activities.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.124: continued

(E) In the application, the applicant may incorporate by reference information contained in
previous applications, statements, or reports filed with the Agency provided such references are
clear and specific.

(F) Applications and documents submitted to the Agency may be made available for public
inspection except that the Agency may withhold any document or part thereof from public
inspection if disclosure of its content is not required in the public interest and would adversely
affect the interest of a person concerned.

(G)(1) Except as provided in 105 CMR 120.124(G)(2), (3), and (4), an application for a
specific license to authorize receipt, possession or use of radioactive material in the form of
a sealed source or in a device that contains a sealed source shall either:
(a) identify the sealed source or device that contains a sealed source by manufacturer
and model number as registered with the Agency under 105 CMR 120.128(N), with the
NRC or an Agreement State, or for a source or a device containing radium-226 or
accelerator-produced radioactive material with a State under provisions comparable to
105 CMR 120.128(N); or
(b) contain the information identified in 105 CMR 120.128(N)(3).
(2) for sources or devices manufactured prior to October 23, 2012 that are not registered
with the Agency under 105 CMR 120.128(N) or with the NRC or an Agreement State, and
for which the applicant is unable to provide all categories of information specified in
105 CMR 120.128(N)(3), the applicant must provide:
(a) All available information identified in 105 CMR 120.128(N)(3) concerning the
source, and, if applicable, the device; and
(b) Sufficient additional information to demonstrate that there is reasonable assurance
that the radiation safety properties of the source or device are adequate to protect health
and minimize danger to life and property. Such information must include a description
of the source or device, a description of radiation safety features, the intended use and
associated operating experience, and the results of a recent leak test.
(3) For sealed sources and devices allowed to be distributed without registration of safety
information in accordance with 105 CMR 120.128(N)(7)(a), the applicant may supply only
the manufacturer, model number, and radionuclide and quantity.
(4) If it is not feasible to identify each sealed source and device individually, the applicant
may propose constraints on the number and type of sealed sources and devices to be used and
the conditions under which they will be used, in lieu of identifying each sealed source and
device.

120.125: General Requirements for the Issuance of Specific Licenses

(A) A license application will be approved only if the Agency determines that:
(1) the applicant is qualified by reason of training and experience to use the material in
question for the purpose requested in accordance with 105 CMR 120.000 in such a manner
as to minimize danger to public health and safety or property;
(2) the applicant's proposed equipment, facilities, and procedures are adequate to minimize
danger to public health and safety or property;
(3) the issuance of the license will not be inimical to the health and safety of the public; and,
(4) the applicant satisfies any applicable special requirements in 105 CMR 120.050 through
120.080, 120.126, 120.127, 120.128, 120.300, 120.500, 120.620 120.800, 120.890 and
120.900.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(B) Environmental Report, Commencement of Construction.

(1) In the case of an application for a license to receive and possess radioactive material for
commercial waste disposal, or for the conduct of any other activity which the Agency
determines will significantly affect the quality of the environment, a license application shall
be reviewed and approved by the Agency before commencement of construction of the plant
or facility in which the activity will be conducted. Issuance of the license shall be based
upon a consideration by the Agency of the environmental, economic, technical and other
benefits in comparison with the environmental costs and available alternatives and a
determination that the action called for is the issuance of the proposed license, with any
appropriate conditions to protect environmental values;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.125: continued

(2) Commencement of construction prior to such conclusion shall be grounds for denial of
a license to receive and possess radioactive material in such plant or facility.

(C) Financial Surety Arrangements and Recordkeeping for Decommissioning.

(1) Unless exempted by 105 CMR 120.125(C)(3), issuance, renewal or amendment of a
license shall be dependent upon satisfactory financial surety arrangements to ensure the
protection of the public health and safety in the event of abandonment, default or other
inability of the licensee to meet the requirements of M.G.L. c. 111H, § 9 and 105 CMR
120.000.
(2) Each applicant for a specific license authorizing the possession and use of unsealed
radioactive material with a half-life greater than 120 days and in quantities exceeding 105
times the applicable quantities set forth in 105 CMR 120.196: Appendix B, Table II shall
submit a decommissioning funding plan as described in 105 CMR 120.125(C)(6). The
decommissioning funding plan must also be submitted when a combination of isotopes is
involved if R divided by 105 is greater than 1 (unity rule), where R is defined as the sum of
the ratios of the quantity of each isotope to the applicable value in 105 CMR 120.196:
Appendix B, Table II.
(3) Each applicant for a specific license authorizing possession and use of radioactive
material of half-life greater than 120 days and in quantities specified in 105 CMR
120.125(C)(5) shall either:
(a) submit a decommissioning funding plan as described in 105 CMR 120.125(C)(6);
or
(b) submit a certification that financial assurance for decommissioning has been
provided in the amount prescribed by 105 CMR 120.125(C)(5) using one of the methods
described in 105 120.125(C)(7). For an applicant, this certification may state that the
appropriate assurance will be obtained after the application has been approved and the
license issued, but prior to the receipt of licensed material. As part of the certification,
a copy of the financial instrument obtained to satisfy the requirements of 105 CMR
120.125(C)(7) is to be submitted to the Agency.
(4) (a) Each holder of a specific license issued on or after March 11, 1994, which is of a
type described in 105 CMR 120.125(C)(2) or (3), shall provide financial assurance for
decommissioning in accordance with the criteria set forth in 105 CMR 120.125(C)(1)
through (8).
(b) Each holder of a specific license issued before March 11, 1994, and of a type
described in 105 CMR 120.125(C)(2) shall submit, on or before March 11, 1995, a
decommissioning funding plan or a certification of financial assurance for
decommissioning in an amount at least equal to $1,125,000, in accordance with the
criteria set forth in this part. If the licensee submits the certification of financial
assurance rather than a decommissioning funding plan at this time, the licensee shall
include a decommissioning funding plan in any application for license renewal.
(c) Each holder of a specific license issued before March 11, 1994, and of a type
described in 105 CMR 120.125(C)(3) shall submit, on or before March 11, 1995, a
certification of financial assurance for decommissioning or a decommissioning funding
plan in accordance with the criteria set forth in 105 CMR 120.125(C)(1) through (8).
(d) Waste collectors and waste processors, as defined in 10 CFR part 20, Appendix G
must establish an Agency-approved decommissioning funding plan to assure the
availability of funds for decommissioning activities conducted over the life of the
licensed facility. The decommissioning funding plan must include the cost of disposal
of the maximum radioactivity (curies) of radioactive material permitted by the license,
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

and the cost of disposal of the maximum quantity, by volume, of radioactive material that
could be present at the licensee’s facility at any time, in addition to the cost to remediate
the licensee’s site to meet the license termination criteria of 105 CMR 120.200. The
decommissioning funding plan must be submitted by April 6, 2007.
(e) If, in surveys made under 105 CMR 120.225(A), residual radioactivity in the facility
and environment, including the subsurface, is detected at levels that would, if left
uncorrected, prevent the site from meeting the 105 CMR 120.245 criteria for unrestricted
use, the licensee must submit a decommissioning funding plan within one year of when
the survey is completed.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.125: continued

(5) Table of Required Amounts of Financial Assurance for Decommissioning by Quantity

of Material:
-1 Greater than 104 but less than or equal to 105 times the $1,125,000
applicable quantities in 105 CMR 120.196: Appendix B,
Table II in unsealed form. (For a combination of isotopes, if
R, as defined in 105 CMR 120.125(C)(2), divided by 104 is
greater than 1 but R divided by 105 is less than or equal to 1.)
-2a Greater than 103 but less than or equal to 104 times the $225,000
applicable quantities in 105 CMR 120.196: Appendix B,
Table II in unsealed form. (For a combination of isotopes, if
R, as defined in 105 CMR 120.125(C)(2), divided by 103 is
greater than 1 but R divided by 104 is less than or equal to 1.)
-2b Greater than 10 mCi but less than 100 mCi of source $225,000
material
-3 Greater than 1010 times the applicable quantities in 105 CMR $113,000
120.196: Appendix B, Table II in sealed sources or plated
foils. (For a combination of isotopes, if R, as defined in
105 CMR 120.125(C)(2), divided by 1010 is greater than 1.)

(a) Licensees required to submit the $1,125,000 amount must do so by October 6, 2006.
(b) Licensees required to submit the $113,000 or $225,000 amount must do so by
April 6, 2007.
(6) (a) Each decommissioning funding plan must be submitted for review and approval and
must contain:
1. A detailed cost estimate for decommissioning, in an amount reflecting:
a. The cost of an independent contractor to perform all decommissioning
activities;
b. The cost of meeting the 105 CMR 120.245 criteria for unrestricted use,
provided that, if the applicant or licensee can demonstrate its ability to meet the
provisions of 105 CMR 120.246, the cost estimate may be based on meeting the
105 CMR 120.246 criteria;
c. The volume of onsite subsurface material containing residual radioactivity
that will require remediation to meet the criteria for license termination; and
d. An adequate contingency factor.
2. Identification of and justification for using the key assumptions contained in the
cost estimate for decommissioning;
3. A description of the method of assuring funds for decommissioning from
105 CMR 120.125(C)(7), including means for adjusting cost estimates and associated
funding levels periodically over the life of the facility;
4. A certification by the licensee that financial assurance for decommissioning has
been provided in the amount of the cost estimate for decommissioning; and
5. A signed original of the financial instrument obtained to satisfy the requirements
of 105 CMR 120.125(C)(7) (unless a previously submitted and accepted financial
instrument continues to cover the cost estimate for decommissioning).
(b) At the time of license renewal and at intervals not to exceed three years, the
decommissioning funding plan must be resubmitted with adjustments as necessary to
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

account for changes in costs and the extent of contamination. If the amount of financial
assurance will be adjusted downward, this cannot be done until the updated
decommissioning funding plan is approved. The decommissioning funding plan must
update the information submitted with the original or prior approved plan, and must
specifically consider the effect of the following events on decommissioning costs:
1. Spills of radioactive material producing additional residual radioactivity in on-site
subsurface material;
2. Waste inventory increasing above the amount previously estimated;
3. Waste disposal costs increasing above the amount previously estimated;
4. Facility modifications;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.125: continued

5. Changes in authorized possession limits;

6. Actual remediation costs that exceed the previous cost estimate;
7. On-site disposal; and
8. Use of a settling pond.
(7) The financial instrument must include the licensee's name, license number, and docket
number, and the name, address, and other contact information of the issuer, and, if a trust is
used, the trustee. When any of the foregoing information changes, the licensee must, within
30 days, submit financial instruments reflecting such changes. The financial instrument
submitted must be a signed original or signed original duplicate, except where a copy of the
signed original is specifically permitted. Financial assurance for decommissioning must be
provided by one or more of the following methods:
(a) Prepayment. Prepayment is the deposit prior to the start of operation into an account
segregated from licensee assets and outside the licensee's administrative control of cash
or liquid assets such that the amount of funds would be sufficient to pay
decommissioning costs. Prepayment must be made into a trust account, and the trust
must be acceptable to the Agency.
(b) A Surety Method, Insurance or Other Guarantee Method. These methods guarantee
that decommissioning costs will be paid should the licensee default.
1. A surety method may be in the form of a surety bond, issued by a corporate surety
company authorized to transact business in the Commonwealth; or an irrevocable
letter of credit.
2. A parent company guarantee of funds for decommissioning costs may be used if
the guarantee and test are as contained in 105 CMR 120.198: Appendix D. A parent
company guarantee may not be used in combination with other financial methods to
satisfy the requirements of 105 CMR 120.125(C).
3. For commercial corporations that issue bonds, a guarantee of funds by the
applicant or licensee for decommissioning costs based on a financial test may be used
if the guarantee and test are as contained in 105 CMR 120.198: Appendix E.
4. For commercial companies that do not issue bonds, a guarantee of funds by the
applicant or licensee for decommissioning costs may be used if the guarantee and test
are as contained in 105 CMR 120.198: Appendix F.
5. For nonprofit entities, such as colleges, universities, and nonprofit hospitals, a
guarantee of funds by the applicant or licensee may be used if the guarantee and test
are as contained in 105 CMR 120.198: Appendix G.
6. Any surety method or insurance used to provide financial assurance for
decommissioning must contain the following conditions:
a. The surety method or insurance must be open-ended or, if written for a
specified term, such as five years, must be renewed automatically unless 90 days
or more prior to the renewal date, the issuer notifies the Agency, the beneficiary,
and the licensee of its intention not to renew. The surety method or insurance
must also provide that the full face amount be paid to the beneficiary
automatically prior to the expiration without proof of forfeiture if the licensee
fails to provide a replacement acceptable to the Agency within 30 days after
receipt of notification of cancellation.
b. The surety method or insurance must be payable to a trust established for
decommissioning costs. The trustee and trust must be acceptable to the Agency.
An acceptable trustee includes an appropriate state or federal government agency
or an entity that has the authority to act as a trustee and whose trust operations are
regulated and examined by a federal or state agency.
c. The surety method or insurance must remain in effect until the Agency has
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

terminated the license.

(c) An External Sinking Fund. An external sinking fund in which deposits are made at
least annually, coupled with a surety method or insurance, the value of which may
decrease by the amount being accumulated in the sinking fund. An external sinking fund
is a fund established and maintained by setting aside funds periodically in an account
segregated from licensee assets and outside the licensee's administrative control in which
the total amount of funds would be sufficient to pay decommissioning costs at the time
termination of operation is expected. An external sinking fund must be in the form of
a trust. If the other guarantee method is used, no surety or insurance may be combined
with the external sinking fund. The surety or insurance provisions must be as stated in
105 CMR 120.125(C)(7)(b).
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.125: continued

(d) Statement of Intent. In the case of federal, state, or local government licensees, a
statement of intent containing a cost estimate for decommissioning or an amount
pursuant to 105 CMR 120.125(C)(5), and indicating that funds for decommissioning will
be obtained when necessary.
(8) Each person licensed under 105 CMR 120.100 shall keep records of information
important to the safe and effective decommissioning of the facility in an identified location
until the license is terminated by the Agency. If records of relevant information are kept for
other purposes, reference to these records and their locations may be used. Information the
Agency considers important to decommissioning consists of:
(a) Records of spills or other unusual occurrences involving the spread of contamination
in and around the facility, equipment, or site. These records may be limited to instances
when contamination remains after any cleanup procedures or when there is reasonable
likelihood that contaminants may have spread to inaccessible areas, as in the case of
possible seepage into porous materials such as concrete. These records must include any
known information on identification of involved nuclides, quantities, forms, and
concentrations.
(b) As-built drawings and modifications of structures and equipment in restricted areas
where radioactive materials are used and/or stored, and of locations of possible
inaccessible contamination such as buried pipes that may be subject to contamination.
If required drawings are referenced, each relevant document need not be indexed
individually. If drawings are not available, the licensee shall substitute appropriate
records of available information concerning these areas and locations.
(c) Except for areas containing only sealed sources (provided the sources have not
leaked or no contamination remains after any leak) or radioactive materials having only
half-lives of less than 65 days, a list contained in a single document and updated every
two years, of the following:
1. all areas designated and formerly designated restricted areas as defined in
105 CMR 120.005;
2. all areas outside of restricted areas that require documentation under 105 CMR
120.125(C)(8)(a);
3. all areas outside of restricted areas where current and previous wastes have been
buried as documented under 105 CMR 120.269; and
4. all areas outside of restricted areas which contain material such that, if the license
expired, the licensee would be required to either decontaminate the area to
unrestricted release levels or apply for approval for disposal under 105 CMR
120.252.
(d) Records of the cost estimate performed for the decommissioning funding plan or of
the amount certified for decommissioning, and records of the funding method used for
assuring funds if either a funding plan or certification is used.
(9) The following specific licensees are required to make financial surety arrangements:
(a) major processors;
(b) waste handling licensees;
(c) former U.S. Atomic Energy Commission or NRC licensed facilities; and
(d) all others except persons exempt pursuant to 105 CMR 120.125(C)(10).
(10) The following persons are exempt from the requirements of 105 CMR 120.125(C)(1):
(a) persons authorized to possess no more than 1,000 times the quantity specified in
105 CMR 120.196: Appendix B, Table 1 or combination of radioactive material listed
therein as given in 105 CMR 120.196: Appendix B, Table 1, Note 1;
(b) persons authorized to possess radioactive noble gases in sealed sources with no
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

radioactive daughter product with half-life greater than 30 days.

120.126: Special Requirements for Issuance of Certain Specific Licenses for Radioactive Material

Uses of Sealed Sources in Industrial Radiography. In addition to the requirements set forth
in 105 CMR 120.125, a specific license for use of sealed sources in industrial radiography will
be issued if:
(1) the applicant will have an adequate program for training radiographic personnel and
submits to the Agency a schedule or description of such program which specifies the:
(a) initial training;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.126: continued

(b) periodic training;

(c) on-the-job training; and
(d) means to be used by the licensee to determine the radiographic personnel's
knowledge and understanding of and ability to comply with Agency regulations and
licensing requirements, and the operating and emergency procedures of the applicant.
(2) the applicant has established and submits to the Agency satisfactory written operating
and emergency procedures described in 105 CMR 120.325;
(3) the applicant will have an internal inspection system adequate to assure that 105 CMR
120.001, 120.020, 120.200, 120.300, 120.750, 120.770, license provisions, and the
applicant's operating and emergency procedures are followed by radiographic personnel; the
inspection system shall include the performance of internal inspections at intervals not to
exceed three months and the retention of records of such inspections for five years;
(4) the applicant submits to the Agency a description of the overall organizational structure
pertaining to the industrial radiography program, including specified delegations of authority
and responsibility for operation of the program;
(5) the applicant who desires to conduct his own leak tests has established adequate
procedures to be followed in testing sealed sources for possible leakage and contamination
and submits to the Agency a description of such procedures including:
(a) instrumentation to be used;
(b) method of performing tests; and
(c) pertinent experience of the individual who will perform the test.
(6) the licensee shall conduct a program for inspection and maintenance of radiographic
exposure devices and storage containers to assure proper functioning of components
important to safety.

120.127: Special Requirements for Specific Licenses of Broad Scope

105 CMR 120.127 prescribes requirements for the issuance of specific licenses of broad
scope for radioactive material and certain regulations governing holders of such licenses.

(A) The different types of broad scope licenses are set forth in 105 CMR 120.127(A):
(1) A "Type A specific license of broad scope" is a specific license authorizing receipt,
acquisition, ownership, possession, use and transfer of any chemical or physical form of the
radioactive material specified in the license, but not exceeding quantities specified in the
license, for any authorized purpose. The quantities specified are usually in the multicurie
range.
(2) A "Type B specific license of broad scope" is a specific license authorizing receipt,
acquisition, ownership, possession, use and transfer of any chemical or physical form of
radioactive material specified in 105 CMR 120.197: Appendix C, for any authorized
purpose. The possession limit for a Type B license of broad scope, if only one radionuclide
is possessed thereunder, is the quantity specified for that radionuclide in 105 CMR 120.197:
Appendix C, Column I. If two or more radionuclides are possessed thereunder, the
possession limit for each is determined as follows: For each radionuclide, determine the ratio
of the quantity possessed to the applicable quantity specified in 105 CMR 120.197:
Appendix C, Column I, for that radionuclide. The sum of the ratios for all radionuclides
possessed under the license shall not exceed unity.
(3) A "Type C specific license of broad scope" is a specific license authorizing receipt,
acquisition, ownership, possession, use, and transfer of any chemical or physical form of
radioactive material specified in 105 CMR 120.197: Appendix C, for any authorized
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

purpose. The possession limit for a Type C license of broad scope, if only one radionuclide
is possessed thereunder, is the quantity specified for that radionuclide in 105 CMR 120.197:
Appendix C, Column II. If two or more radionuclides are possessed thereunder, the
possession limit is determined for each as follows: For each radionuclide, determine the ratio
of the quantity possessed to the applicable quantity specified in 105 CMR 120.197:
Appendix C, Column II, for that radionuclide. The sum of the ratios for all radionuclides
possessed under the license shall not exceed unity.

(B) An application for a Type A specific license of broad scope will be approved if:
(1) the applicant satisfies the general requirements specified in 105 CMR 120.125;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.127: continued

(2) the applicant has engaged in a reasonable number of activities involving the use of
radioactive material; and
(3) the applicant has established administrative controls and provisions relating to
organization and management, procedures, record keeping, material control and accounting,
and management review that are necessary to assure safe operations, including:
(a) the establishment of a radiation safety committee composed of such persons as a
radiation safety officer, a representative of management, and persons trained and
experienced in the safe use of radioactive material;
(b) the appointment of a radiation safety officer who is qualified by training and
experience in radiation protection, and who is available for advice and assistance on
radiation safety matters; and
(c) the establishment of appropriate administrative procedures to assure:
1. control of procurement and use of radioactive material;
2. completion of safety evaluations of proposed uses of radioactive material which
take into consideration such matters as the adequacy of facilities and equipment,
training and experience of the user, and the operating or handling procedures; and
3. review, approval, and recording by the radiation safety committee of safety
evaluations of proposed uses prepared in accordance with 105 CMR
120.127(B)(3)(c)2. prior to use of the radioactive material.

(C) An application for a Type B specific license of broad scope will be approved if:
(1) the applicant satisfies the general requirements specified in 105 CMR 120.125; and,
(2) the applicant has established administrative controls and provisions relating to
organization and management, procedures, record keeping, material control and accounting,
and management review that are necessary to assure safe operations, including:
(a) the appointment of a radiation safety officer who is qualified by training and
experience in radiation protection, and who is available for advice and assistance on
radiation safety matters; and
(b) the establishment of appropriate administrative procedures to assure;
1. control of procurement and use of radioactive material;
2. completion of safety evaluations of proposed uses of radioactive material which
take into consideration such matters as the adequacy of facilities and equipment,
training and experience of the user, and the operating or handling procedures; and,
3. review, approval, and recording by the radiation safety officer of safety
evaluations of proposed uses prepared in accordance with 105 CMR
120.127(C)(2)(b)2. prior to use of the radioactive material.

(D) An application for a Type C specific license of broad scope will be approved if:
(1) the applicant satisfies the general requirements specified in 105 CMR 120.125;
(2) the applicant submits a statement that radioactive material will be used only by, or under
the direct supervision of, individuals who have received:
(a) a college degree at the bachelor level, or equivalent training and experience, in the
physical or biological sciences or in engineering; and
(b) at least 40 hours of training and experience in the safe handling of radioactive
material, and in the characteristics of ionizing radiation, units of radiation dose and
quantities, radiation detection instrumentation, and biological hazards of exposure to
radiation appropriate to the type and forms of radioactive material to be used; and
(3) the applicant has established administrative controls and provisions relating to
procurement of radioactive material, procedures, record keeping, material control and
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

accounting, and management review necessary to assure safe operations.

(E) Specific licenses of broad scope are subject to the following conditions:
(1) Unless specifically authorized, persons licensed pursuant to 105 CMR 120.127 shall not:
(a) conduct tracer studies in the environment involving direct release of radioactive
material;
(b) receive, acquire, own, possess, use, or transfer devices containing 100,000 curies
(3.7 PBq) or more of radioactive material in sealed sources used for irradiation of
materials;
(c) conduct activities for which a specific license issued by the Agency under 105 CMR
120.126, 120.128 or 120.500, and 120.800 is required; or
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.127: continued

(d) add or cause the addition of radioactive material to any food, beverage, cosmetic,
drug, or other product designed for ingestion or inhalation by, or application to, a human
being.
(2) Each Type A specific license of broad scope issued under 105 CMR 120.127 shall be
subject to the condition that radioactive material possessed under the license may only be
used by, or under the direct supervision of, individuals approved by the licensee's radiation
safety committee.
(3) Each Type B specific license of broad scope issued under 105 CMR 120.127 shall be
subject to the condition that radioactive material possessed under the license may only be
used by, or under the direct supervision of, individuals approved by the licensee's radiation
safety officer.
(4) Each Type C specific license of broad scope issued under 105 CMR 120.127 shall be
subject to the condition that radioactive material possessed under the license may only be
used by, or under the direct supervision of, individuals who satisfy the requirements of
105 CMR 120.127(D).

120.128: Special Requirements for a Specific License to Manufacture, Assemble, Repair, or Distribute
Commodities, Products, or Devices Which Contain Radioactive Material

(A) Licensing Requirements to Produce for Noncommercial Transfer Positron Emission

Tomography (PET) Radioactive Drugs. An application from a medical facility, educational
institution, or Federal facility to produce Positron Emission Tomography (PET) radioactive drugs
for noncommercial transfer to licensees in its consortium authorized for medical use under
105 CMR 120.500, or equivalent Nuclear Regulatory Commission, or Agreement State
requirements shall include:
(1) A request for authorization for the production of PET radionuclides or evidence of an
existing license issued under 105 CMR 120.100 or equivalent Nuclear Regulatory
Commission, or Agreement State requirements for a PET radionuclide production facility
within its consortium from which it receives PET radionuclides.
(2) Evidence that the applicant is qualified to produce radioactive drugs for medical use by
meeting one of the criteria in 105 CMR 120.128(J)(1)(b).
(3) Identification of individual(s) authorized to prepare the PET radioactive drugs if the
applicant is a pharmacy, and documentation that each individual meets the requirements of
an authorized nuclear pharmacist as specified in 105 CMR 120.128(J)(2)(b).
(4) Information identified in 105 CMR 120.128(J)(1)(c) on the PET drugs to be
noncommercially transferred to members of its consortium.

(B) Licensing Requirements to Initially Transfer Source Material to Persons Generally Licensed
under 105 CMR 120.121(A).
(1) An application for a specific license to initially transfer source material for use under
105 CMR 120.121(A), or equivalent regulations of the NRC or an Agreement State, will be
approved if:
(a) The applicant satisfies the general requirements specified in 105 CMR 120.125; and
(b) The applicant submits adequate information on, and the Agency approves the
methods to be used for quality control, labeling, and providing safety instructions to
recipients.
(2) Each person licensed under 105 CMR 120.128(B) shall label the immediate container
of each quantity of source material with the type of source material and quantity of material
and the words, “‘radioactive material”.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(3) Each person licensed under 105 CMR 120.128(B) shall ensure that the quantities and
concentrations of source material are as labeled and indicated in any transfer records.
(4) Each person licensed under 105 CMR 120.128(B) shall provide the information
specified in 105 CMR 120.128(B)(4) to each person to whom source material is transferred
for use under 105 CMR 120.121(A) or equivalent provisions in the NRC or Agreement State
regulations. This information must be transferred before the source material is transferred
for the first time in each calendar year to the particular recipient. The required information
includes:
(a) A copy of 105 CMR 120.121(A) through (C), (F), and (G) and 105 CMR 120.140,
or relevant equivalent regulations of the NRC or Agreement State.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.128: continued

(b) Appropriate radiation safety precautions and instructions relating to handling, use,
storage, and disposal of the material.
(5) Each person licensed under 105 CMR 120.128(B) shall report transfers as follows:
(a) File a report with the Agency by an appropriate method listed in 105 CMR 120.013.
The report shall include the following information:
1. The name, address, and license number of the person who transferred the source
material;
2. For each general licensee under 105 CMR 120.121(A) or equivalent NRC or
Agreement State provisions to whom greater than 50 grams (0.11 lb) of source
material has been transferred in a single calendar quarter, the name and address of the
general licensee to whom source material is distributed; a responsible agent, by name
and/or position and phone number, of the general licensee to whom the material was
sent; and the type, physical form, and quantity of source material transferred; and
3. The total quantity of each type and physical form of source material transferred
in the reporting period to all such generally licensed recipients.
(b) File a report with each responsible NRC or Agreement State agency that identifies
all persons, operating under provisions equivalent to 105 CMR 120.121(A), to whom
greater than 50 grams (0.11 lb) of source material has been transferred within a single
calendar quarter. The report shall include the following information specific to those
transfers made to the NRC or Agreement State being reported to:
1. The name, address, and license number of the person who transferred the source
material; and
2. The name and address of the general licensee to whom source material was
distributed; a responsible agent, by name and/or position and phone number, of the
general licensee to whom the material was sent; and the type, physical form, and
quantity of source material transferred.
3. The total quantity of each type and physical form of source material transferred
in the reporting period to all such generally licensed recipients within the NRC's
jurisdiction or the Agreement State.
(c) Submit each report by January 31st of each year covering all transfers for the
previous calendar year. If no transfers were made to persons generally licensed under
105 CMR 120.121(A) or equivalent NRC or Agreement State provisions during the
current period, a report shall be submitted to the Agency indicating so. If no transfers
have been made to general licensees within a particular Agreement State during the
reporting period, this information shall be reported to the responsible Agreement State
agency upon request of that agency. If no transfers have been made to NRC general
licensees during the reporting period, this information shall be reported to the NRC.
(6) Each person licensed under 105 CMR 120.128(B) shall maintain all information that
supports the reports required by this section concerning each transfer to a general licensee
for a period of one year after the event is included in a report to the NRC or to an Agreement
State agency.

(C) Requirements for Other Specific Licenses (Reserved).

(D) Licensing Requirements to Manufacture or Initially Transfer Devices Containing

Radioactive Material to Persons Generally Licensed under 105 CMR 120.122(D).
(1) An application for a specific license to manufacture or distribute devices containing
radioactive material, excluding special nuclear material, to persons generally licensed under
105 CMR 120.122(D) or equivalent regulations of the U.S. Nuclear Regulatory Commission,
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

an Agreement State, or a Licensing State will be approved if:

(a) the applicant satisfies the general requirements of 105 CMR 120.125;
(b) the applicant submits sufficient information relating to the design, manufacture,
prototype testing, quality control, labels, proposed uses, installation, servicing, leak
testing, operating and safety instructions, and potential hazards of the device to provide
reasonable assurance that:
1. the device can be safely operated by persons not having training in radiological
protection;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.128: continued

2. under ordinary conditions of handling, storage, and use of the device, the
radioactive material contained in the device will not be released or inadvertently
removed from the device, and it is unlikely that any person will receive in one year
a dose in excess of 10% of the annual limits specified in 105 CMR 120.211(A), and
3. under accident conditions such as fire and explosion associated with handling,
storage, and use of the device, it is unlikely that any person would receive an external
radiation dose or dose commitment in excess of the following organ doses:
a. Whole body; head and trunk; active blood-forming organs; gonads; or lens of
eye . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 rems (150 mSv)
b. Hands and forearms; feet and ankles; localized areas of skin averaged over
areas no larger than one square centimeter . . . . . . . . . . . . . . . 200 rems (2 Sv)
c. Other organs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 rems (500 mSv); and
(c) each device bears a durable, legible, clearly visible label or labels approved by the
Agency, which contain in a clearly identified and separate statement:
1. instructions and precautions necessary to assure safe installation, operation, and
servicing of the device; documents such as operating and service manuals may be
identified in the label and used to provide this information;
2. the requirement, or lack of requirement, for leak testing, or for testing any
"on-off" mechanism and indicator, including the maximum time interval for such
testing, and the identification of radioactive material by isotope, quantity of
radioactivity, and date of determination of the quantity; and
3. the information called for in one of the following statements, as appropriate, in
the same or substantially similar form:
The receipt, possession, use, and transfer of this device, Model , Serial
No. , are subject to a general license or the equivalent and the regulations of
the U.S. Nuclear Regulatory Commission or a State with which the U.S. Nuclear
Regulatory Commission has entered into an agreement for the exercise of regulatory
authority. This label shall be maintained on the device in a legible condition.
Removal of this label is prohibited. [The model, serial number, and name of the
manufacturer or distributor may be omitted from the label provided the information
is elsewhere specified in labeling affixed to the device.]

CAUTION - RADIOACTIVE MATERIAL

Name of Manufacturer or Distributor

[Note: Devices licensed under 10 CFR 32.53 prior to January 19, 1975 may bear labels
authorized by the regulations in effect on January 1, 1975.]

(d) each device having a separable source housing that provides the primary shielding
for the source also bears, on the source housing, a durable label containing the device
model number and serial number, the isotope and quantity, the words,
“Caution-Radioactive Material”, the radiation symbol described in 105 CMR 120.237,
and the name of the manufacturer or initial distributor.
(e) each device meeting the criteria of 105 CMR 120 122(D)(3)(m)1., bears a permanent
(e.g., embossed, etched, stamped, or engraved) label affixed to the source housing if
separable, or the device if the source housing is not separable, that includes the words,
“Caution-Radioactive Material”, and, if practicable, the radiation symbol described in
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

105 CMR 120.237.

(f) the device has been registered in the Sealed Source and Device Registry.
(2) In the event the applicant desires that the device be required to be tested at intervals
longer than six months, either for proper operation of the "on-off" mechanism and indicator,
if any, or for leakage of radioactive material or for both, the applicant shall include in the
application sufficient information to demonstrate that such longer interval is justified by
performance characteristics of the device or similar devices and by design features which
have a significant bearing on the probability or consequences of leakage of radioactive
material from the device or failure of the "on-off" mechanism and indicator. In determining
the acceptable interval for the test for leakage of radioactive material, the Agency will
consider information which includes, but is not limited to:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.128: continued

(a) primary containment or source capsule;

(b) protection of primary containment;
(c) method of sealing containment;
(d) containment construction materials;
(e) form of contained radioactive material;
(f) maximum temperature withstood during prototype tests;
(g) maximum pressure withstood during prototype tests;
(h) maximum quantity of contained radioactive material;
(i) radiotoxicity of contained radioactive material; and
(j) operating experience with identical devices or similarly designed and constructed
devices.
(3) In the event the applicant desires that the general licensee under 105 CMR 120.122(D),
or under equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement
State, or a Licensing State be authorized to install the device, collect the sample to be
analyzed by a specific licensee for leakage of radioactive material, service the device, test the
"on-off" mechanism and indicator, or remove the device from installation, the applicant shall
include in the application written instructions to be followed by the general licensee,
estimated calendar quarter doses associated with such activity or activities, and basis for such
estimates. The submitted information shall demonstrate that performance of such activity
or activities by an individual untrained in radiological protection, in addition to other
handling, storage, and use of devices under the general license, is unlikely to cause that
individual to receive a dose in excess of 10% of the annual limits specified in 105 CMR
120.211(A).
(4) Each person licensed under 105 CMR 120.128(D) to initially transfer devices to
generally licensed persons shall:
(a) if a device containing radioactive material is to be transferred for use under the
general license contained in 105 CMR 120.122(D), each person that is licensed under
105 CMR 120.128(D) shall provide the information specified in 120.128(D)(4) to each
person to whom a device is to be transferred. This information must be provided before
the device may be transferred. In the case of a transfer through an intermediate person,
the information must also be provided to the intended user prior to initial transfer to the
intermediate person. The required information includes:
1. a copy of the general license contained in 105 CMR 120.122(D); if 105 CMR
120.122(D)(3)(b) through (d) do not apply to the particular device, those paragraphs
may be omitted;
2. a copy of 105 CMR 120.122, 120.009(A), 120.281, and 120.282;
3. a list of the services that can only be performed by a specific licensee; and,
4. information on acceptable disposal options including estimated costs of disposal;
(b) if radioactive material is to be transferred in a device for use under an equivalent
general license of the U.S. Nuclear Regulatory Commission, an Agreement State, or a
Licensing State each person that is licensed under 105 CMR 120.128(D) shall provide
the information specified in 105 CMR 120.128(D)(4)(b) to each person to whom a device
is to be transferred. This information must be provided before the device may be
transferred. In the case of a transfer through an intermediate person, the information must
also be provided to the intended user prior to initial transfer to the intermediate person.
The required information includes:
1. a copy of NRC or Agreement State regulations equivalent to 105 CMR
120.122(D), 120.009(A), 120.281, and 120.282. If a copy of the 105 CMR 120.000
is provided to a prospective general licensee in lieu of the U.S. Nuclear Regulatory
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Commission*s, Agreement State*s, or Licensing State*s regulations, it shall be

accompanied by a note explaining that use of the device is regulated by the U.S.
Nuclear Regulatory Commission, the Agreement State; or Licensing State; if certain
paragraphs of the regulations do not apply to the particular device, those paragraphs
may be omitted;
2. a list of the services that can only be performed by a specific licensee;
3. information on acceptable disposal options including estimated costs of disposal;
and,
4 the name or title, address, and phone number of the contact at the U.S. Nuclear
Regulatory Commission, the Agreement State, or Licensing State from which
additional information may be obtained;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.128: continued

(c) an alternative approach to informing customers may be proposed by the licensee for
approval by the Agency;
(d) each device that is transferred after February 19, 2002 must meet the labeling
requirements in 105 CMR 120.128(D)(1)(c) through (e);
(e) if a notification of bankruptcy has been made under 105 CMR 120.131(E) or the
license is to be terminated, each person licensed under 105 CMR 120.128(D) shall
provide, upon request, to the Agency and to any appropriate Agreement State or NRC,
records of final disposition required under 105 CMR 120.128(D)(5)(c).
(5) Each person licensed under 105 CMR 120.128(D) to initially transfer devices to
generally licensed persons shall comply with the requirements of 105 CMR 120.128(D)(5).
(a) The person shall report to the Agency all transfers of devices to persons for use
under the general license in 105 CMR 120.122(D) and all receipts of devices from
persons licensed under 105 CMR 120.122(D). The report must be submitted on a
quarterly basis on NRC Form 653 - “Transfers of Industrial Devices Report” or in a clear
and legible report containing all of the data required by the form.
1. The required information for transfers to general licensees includes:
a. the identity of each general licensee by name and mailing address for the
location of use; if there is no mailing address for the location of use, an alternate
address for the general licensee shall be submitted along with information on the
actual location of use;
b. the name, title, and phone number of the person identified by the general
licensee as having knowledge of and authority to take required actions to ensure
compliance with the appropriate regulations and requirements;
c. the date of transfer;
d. the type, model number, and serial number of the device transferred; and
e. the quantity and type of byproduct material contained in the device.
2. If one or more intermediate persons will temporarily possess the device at the
intended place of use before its possession by the user, the report must include the
same information for both the intended user and each intermediate person, and
clearly designate the intermediate person(s).
3. For devices received from a 105 CMR 120.122(D) general licensee, the report
must include the identity of the general licensee by name and address, the type, model
number, and serial number of the device received, the date of receipt, and, in the case
of devices not initially transferred by the reporting licensee, the name of the
manufacturer or initial transferor.
4. If the licensee makes changes to a device possessed by a 105 CMR 120.122(D)
general licensee, such that the label must be changed to update required information,
the report must identify the general licensee, the device, and the changes to informa-
tion on the device label.
5. The report must cover each calendar quarter, must be filed within 30 days of the
end of the calendar quarter, and must clearly indicate the period covered by the
report.
6. The report must clearly identify the specific licensee submitting the report and
include the license number of the specific licensee.
7. If no transfers have been made to U.S. Nuclear Regulatory Commission
Licensees during the reporting period, this information shall be reported to the U.S.
Nuclear Regulatory Commission.
8. If no transfers have been made to general licensees within a particular State
during the reporting period, this information shall be reported to the responsible State
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

agency upon request of that agency.

(b) The person shall report all transfers of devices to persons for use under a general
license in the U.S. Nuclear Regulatory Commission*s, an Agreement State*s, or a
Licensing State*s regulations that are equivalent to 105 CMR 120.122(D) and all receipts
of devices from general licensees in the U.S. Nuclear Regulatory Commission’s, an
Agreement State*s, or a Licensing State*s jurisdiction to the responsible agency. The
report must be submitted on Form 653 - “Transfers of Industrial Devices Report” or in
a clear and legible report containing all of the data required by the form.
1. The required information for transfers to general licensees includes:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.128: continued

a. the identity of each general licensee by name and mailing address for the
location of use; if there is no mailing address for the location of use, an alternate
address for the general licensee shall be submitted along with information on the
actual location of use;
b. the name, title, and phone number of the person identified by the general
licensee as having knowledge of and authority to take required actions to ensure
compliance with the appropriate regulations and requirements;
c. the date of transfer;
d. the type, model number, and serial number of the device transferred; and
e. the quantity and type of byproduct material contained in the device.
2. If one or more intermediate persons will temporarily possess the device at the
intended place of use before its possession by the user, the report must include the
same information for both the intended user and each intermediate person, and
clearly designate the intermediate person(s).
3. For devices received from a general licensee, the report must include the identity
of the general licensee by name and address, the type, model number, and serial
number of the device received, the date of receipt, and, in the case of devices not
initially transferred by the reporting licensee, the name of the manufacturer or initial
transferor.
4. If the licensee makes changes to a device possessed by a general licensee, such
that the label must be changed to update required information, the report must
identify the general licensee, the device, and the changes to information on the device
label.
5. The report must cover each calendar quarter, must be filed within 30 days of the
end of the calendar quarter, and must clearly indicate the period covered by the
report.
6. The report must clearly identify the specific licensee submitting the report and
must include the license number of the specific licensee.
7. If no transfers have been made to U.S. Nuclear Regulatory Commission
Licensees during the reporting period, this information shall be reported to the U.S.
Nuclear Regulatory Commission.
8. If no transfers have been made to general licensees within a particular State
during the reporting period, this information shall be reported to the responsible State
agency upon request of that agency.
(c) The person shall maintain all information concerning transfers and receipts of
devices that supports the reports required by 105 CMR 120.128(D)(5). Records required
by 105 CMR 120.128(D)(5)(c) must be maintained for a period of three years following
the date of the recorded event.

(E) Special Requirements for the Manufacture, Assembly, or Repair of Luminous Safety
Devices for Use in Aircraft. An application for a specific license to manufacture, assemble, or
repair luminous safety devices containing tritium or promethium-147 for use in aircraft, for
distribution to persons generally licensed under 105 CMR 120.122(B) will be approved if:
(1) the applicant satisfies the general requirements specified in 105 CMR 120.125; and
(2) the applicant satisfies the requirements of 10 CFR Part 32 §§ 32.53 through 32.56.

(F) Special Requirements for License to Manufacture or Initially Transfer Calibration or

Reference Sources Containing Americium-241, or Radium-226 for Distribution to Persons
Generally Licensed under 105 CMR 120.122(G). An application for a specific license to
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

manufacture or initially transfer calibration or reference sources containing americium-241, or

radium-226, for distribution to persons generally licensed under 105 CMR 120.122(G), will be
approved if:
(1) the applicant satisfies the general requirement of 105 CMR 120.125; and
(2) The applicant submits sufficient information regarding each type of calibration or
reference source pertinent to evaluation of the potential radiation exposure, including:
(a) Chemical and physical form and maximum quantity of americium-241 or
radium-226 in the source;
(b) Details of construction and design;
(c) Details of the method of incorporation and binding of the americium-241 or
radium-226 in the source;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.128: continued

(d) Procedures for and results of prototype testing of sources, which are designed to
contain more than 0.005 microcurie of americium-241 or radium-226, to demonstrate that
the americium-241 or radium-226 contained in each source will not be released or be
removed from the source under normal conditions of use;
(e) Details of quality control procedures to be followed in manufacture of the source;
(f) Description of labeling to be affixed to the source or the storage container for the
source;
(g) Any additional information, including experimental studies and tests, required by
the Commission to facilitate a determination of the safety of the source.
(3) Each source will contain no more than 5 microcuries of americium-241 or radium-226.
(4) The Agency determines, with respect to any type of source containing more than 0.005
microcurie of americium-241 or radium-226, that:
(a) The method of incorporation and binding of the americium-241 or radium-226 in the
source is such that the americium-241 will not be released or be removed from the source
under normal conditions of use and handling of the source; and
(b) The source has been subjected to and has satisfactorily passed the prototype tests
prescribed by 10 CFR 32.57(e).
(5) Each person licensed under 105 CMR 120.128(F) shall affix to each source, or storage
container for the source, a label which shall contain sufficient information relative to safe use
and storage of the source and shall include the following statement or a substantially similar
statement which contains the information called for in the following statement:
The receipt, possession, use, and transfer of this source, Model ______, Serial No.
_______, are subject to a general license or the equivalent and the regulations of the U.S.
Nuclear Regulatory Commission or a State with which the U.S. Nuclear Regulatory
Commission has entered into an agreement for the exercise of regulatory authority. Do not
remove this label.

CAUTION - RADIOACTIVE MATERIAL-THIS SOURCE CONTAINS AMERICIUM-241

(OR RADIUM-226). DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

___________________________________
Name of manufacturer or initial transferor

(6) Each person licensed under 105 CMR 120.128(F) shall perform a dry wipe test upon
each source containing more than 3.7 kilobecquerels (0.1 microcurie) of americium-241 or
radium-226 before transferring the source to a general licensee under 105 CMR 120.122(G)
or under equivalent regulations of NRC or an Agreement State. This test shall be performed
by wiping the entire radioactive surface of the source with a filter paper with the application
of moderate finger pressure. The radioactivity on the filter paper shall be measured using
methods capable of detecting 0.185 kilobecquerel (0.005 microcurie) of americium-241 or
radium-226. If a source has been shown to be leaking or losing more than 0.185
kilobecquerel (0.005 microcurie) of americium-241 or radium-226 by the methods described
in 105 CMR 120.128(F)(6), the source shall be rejected and shall not be transferred to a
general licensee under 105 CMR 120.122(G) or equivalent regulations of NRC or an
Agreement State.

(G) Requirements for Other Specific Licenses (Reserved).

(H) Manufacture and Distribution of Radioactive Material for Certain In Vitro Clinical or
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Laboratory Testing Under General License. An application for a specific license to manufacture
or distribute radioactive material for use under the general license of 105 CMR 120.122(I) will
be approved if:
(1) the applicant satisfies the general requirements specified in 105 CMR 120.125.
(2) the radioactive material is to be prepared for distribution in prepackaged units of:
(a) carbon-14 in units not exceeding ten microcuries (370 kBq) each.
(b) cobalt-57 in units not exceeding ten microcuries (370 kBq) each.
(c) hydrogen-3 (tritium) in units not exceeding 50 microcuries (1.85 MBq) each.
(d) iodine-125 in units not exceeding ten microcuries (370 kBq) each.
(e) Mock Iodine-125 in units not exceeding 0.05 microcurie (1.85 kBq) of iodine-129
and 0.005 microcurie (185 Bq) of americium-241 each.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.128: continued

(f) iodine-131 in units not exceeding ten microcuries (370 kBq) each.
(g) iron-59 in units not exceeding 20 microcuries (740 kBq) each.
(h) selenium-75 in units not exceeding ten microcuries (370 kBq) each.
(3) each prepackaged unit bears a durable, clearly visible label:
(a) identifying the radioactive contents as to chemical form and radionuclide, and
indicating that the amount of radioactivity does not exceed ten microcuries (370 kBq) of
iodine-125, iodine-131, carbon-14, cobalt-57, or selenium-75; 50 microcuries (1.85
MBq) of hydrogen-3 (tritium); 20 microcuries (740 kBq) of iron-59; or Mock Iodine-125
in units not exceeding 0.05 microcurie (1.85 kBq) of iodine-129 and 0.005 microcurie
(185 Bq) of americium-241 each; or cobalt-57 in units not exceeding 0.37 megabecquerel
(10 microcuries); and
(b) displaying the radiation caution symbol described in 105 CMR 120.237(A) and the
words, “CAUTION, RADIOACTIVE MATERIAL”, and “Not for Internal or External
Use in Humans or Animals”.
(4) the following statement or a substantially similar statement which contains the
information called for in the following statement, appears on a label affixed to each
prepackaged unit or appears in a leaflet or brochure which accompanies the package:
This radioactive material may be received, acquired, possessed, and used only by
physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or
laboratory tests not involving internal or external administration of the material, or the
radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and
transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory
Commission or of a State with which the U.S. Nuclear Regulatory Commission has entered
into an agreement for the exercise of regulatory authority.

Name of Manufacturer

(5) the label affixed to the unit, or the leaflet or brochure which accompanies the package,
contains adequate information as to the precautions to be observed in handling and storing
such radioactive material. In the case of the Mock Iodine-125 reference or calibration source,
the information accompanying the source must also contain directions to the licensee
regarding the waste disposal requirements set out in 105 CMR 120.251.

(I) Licensing the Manufacture and Distribution of Ice Detection Devices. An application for
a specific license to manufacture and distribute ice detection devices to persons generally
licensed under 105 CMR 120.122(J) will be approved if:
(1) the applicant satisfies the general requirements of 105 CMR 120.125; and
(2) the criteria of 10 CFR Part 32, §§ 32.61 and 32.62 are met.

(J) Manufacture, Preparation, or Transfer for Commercial Distribution of Drugs Containing

Radioactive Material for Medical Use under 105 CMR 120.500.
(1) An application for a specific license to manufacture, prepare, or transfer for commercial
distribution radioactive drugs containing radioactive material for use by persons authorized
pursuant to 105 CMR 120.500 will be approved if:
(a) the applicant satisfies the general requirements specified in 105 CMR 120.125;
(b) the applicant submits evidence that the applicant is at least one of the following:
1. registered or licensed with the U.S. Food and Drug Administration (FDA) as the
owner or operator of a drug establishment that engages in the manufacture,
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

preparation, propagation, compounding, or processing of a drug under 21 CFR

207.20(a);
2. registered or licensed with a State agency as a drug manufacturer;
3. licensed as a pharmacy by a State Board of Pharmacy;
4. operating as a nuclear pharmacy pursuant to 247 CMR 13.00: Registration
Requirements and Minimal Professional Standards for Nuclear Pharmacies;
5. operating as a nuclear pharmacy within a Federal medical institution; or
6. a Positron Emission Tomography (PET) drug production facility registered with
a State agency.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.128: continued

(c) the applicant submits information on the radionuclide; the chemical and physical
form; the maximum activity per vial, syringe, generator, or other container of the
radioactive drug; and the shielding provided by the packaging to show it is appropriate
for safe handling and storage of the radioactive drugs by medical use licensees; and
(d) the applicant satisfies the following labeling requirements:
1. a label is affixed to each transport radiation shield, whether it is constructed of
lead, glass, plastic, or other material of a radioactive drug to be transferred for
commercial distribution. The label must include the radiation symbol and the words
“CAUTION, RADIOACTIVE MATERIAL”, the name of the radioactive drug or its
abbreviation, and the quantity of radioactivity at a specified date and time. For
radioactive drugs with a half life greater than 100 days the time may be omitted.
2. a label is affixed to each syringe, vial, or other container used to hold a
radioactive drug to be transferred for commercial distribution. The label must
include the radiation symbol and the words “CAUTION, RADIOACTIVE
MATERIAL” or “ DANGER, RADIOACTIVE MATERIAL” and an identifier that
ensures that the syringe, vial, or other container can be correlated with the
information on the transport radiation shield label.
(2) A licensee pursuant to 105 CMR 120.128(J)(1)(b)3. or (b)4. or (b)5.:
(a) may prepare radioactive drugs for medical use, as defined in 105 CMR 120.502,
provided that the radioactive drug is prepared by either an authorized nuclear pharmacist,
as specified in 105 CMR 120.128(J)(2)(b) and (d), or an individual under the supervision
of an authorized nuclear pharmacist as specified in 105 CMR 120.519.
(b) may allow a pharmacist to work as an authorized nuclear pharmacist if:
1. this individual qualifies as an authorized nuclear pharmacist as defined in
105 CMR 120.502; or
2. this individual meets the requirements specified in 105 CMR 120.526(B) and
120.529 and the licensee has received an approved license amendment identifying
this individual as an authorized nuclear pharmacist; or
3. this individual is designated as an authorized nuclear pharmacist in accordance
with 105 CMR 120.128(J)(2)(d).
(c) the actions authorized in 105 CMR 120.128(J)(2)(a) and (b) are permitted in spite
of more restrictive language in license conditions.
(d) may designate a pharmacist, as defined in 105 CMR 120.005, as an authorized
nuclear pharmacist if:
1. The individual was a nuclear pharmacist preparing only radioactive drugs
containing accelerator-produced radioactive material; and
2. The individual practiced at a pharmacy at a Government agency or Federally
recognized Indian Tribe before November 30, 2007 or at all other pharmacies before
August 8, 2009, or an earlier date as noticed by the NRC.
(e) shall provide to the Agency:
1. A copy of each individual's certification by a specialty board whose certification
process has been recognized by the Commission or an Agreement State as specified
in 105 CMR 120.526(A) with the written attestation signed by a preceptor as required
by 105 CMR 120.526(B);
2. Agreement State or Nuclear Regulatory Commission license;
3. Nuclear Regulatory Commission master materials licensee permit;
4. The permit issued by a licensee or Nuclear Regulatory Commission master
materials permittee of broad scope or the authorization from a commercial nuclear
pharmacy authorized to list its own authorized nuclear pharmacist;
5. Documentation that only accelerator-produced radioactive materials were used
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

in the practice of nuclear pharmacy at a Government agency or Federally recognized

Indian Tribe before November 30, 2007 or at all other locations of use before
August 8, 2009, or an earlier date as noticed by the NRC; and
6. A copy of the State pharmacy licensure or registration, no later than 30 days
after the date that the licensee allows, under 105 CMR 120.128(J)(2)(b)1. and 3. of
105 CMR 120.128(J), the individual to work as an authorized nuclear pharmacist.
(3) A licensee shall possess and use instrumentation to measure the radioactivity of
radioactive drugs. The licensee shall have procedures for use of the instrumentation. The
licensee shall measure, by direct measurement or by combination of measurements and
calculations, the amount of radioactivity in dosages of alpha-, beta-, or photon-emitting
radioactive drugs prior to transfer for commercial distribution. In addition, the licensee shall:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.128: continued

(a) perform tests before initial use, periodically, and following repair, on each
instrument for accuracy, linearity, and geometry dependence, as appropriate for the use
of the instrument; and make adjustments when necessary; and
(b) check each instrument for constancy and proper operation at the beginning of each
day of use.
(4) Nothing in 105 CMR 120.128(J) relieves the licensee from complying with applicable
FDA, other Federal, and State requirements governing radioactive drugs.

(K) Manufacture and Distribution of Generators or Reagent Kits for Preparation of

Radiopharmaceuticals Containing Radioactive Material5. An application for a specific license
to manufacture and distribute generators or reagent kits containing radioactive material for
preparation of radiopharmaceuticals by persons licensed pursuant to 105 CMR 120.100 for the
uses listed in 105 CMR 120.547 will be approved if:
(1) the applicant satisfies the general requirements specified in 105 CMR 120.125;
(2) the applicant submits evidence that:
(a) the generator or reagent kit is to be manufactured, labeled and packaged in
accordance with the Federal Food, Drug and Cosmetic Act or the Public Health Service
Act, such as a new drug application (NDA) approved by the Food and Drug
Administration (FDA), or a "Notice of Claimed Investigational Exemption for a New
Drug" (IND) that has been accepted by the FDA; or
(b) the manufacture and distribution of the generator or reagent kit are not subject to the
Federal Food, Drug and Cosmetic Act and the Public Health Service Act.
(3) the applicant submits information on the radionuclide, chemical and physical form,
packaging including maximum activity per package, and shielding provided by the packaging
of the radioactive material contained in the generator or reagent kit;
(4) the label affixed to the generator or reagent kit contains information on the radionuclide,
quantity, and date of assay; and
(5) the label affixed to the generator or reagent kit, or the leaflet or brochure which
accompanies the generator or reagent kit, contains:
(a) adequate information, from a radiation safety standpoint, on the procedures to be
followed and the equipment and shielding to be used in eluting the generator or
processing radioactive material with the reagent kit; and
(b) a statement that this generator or reagent kit, as appropriate, is approved for use by
persons licensed by the Agency pursuant to 105 CMR 120.547 or under equivalent
licenses of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing
State. The labels, leaflets, or brochures required by 105 CMR 120.128(K) are in addition
to the labeling required by the Food and Drug Administration (FDA) and they may be
separate from or, with the approval of FDA, may be combined with the labeling required
by FDA.

(L) Manufacture and Distribution of Sources or Devices Containing Radioactive Material for
Medical Use. An application for a specific license to manufacture and distribute sources and
devices containing radioactive material to persons licensed pursuant to 105 CMR 120.500 for
use as a calibration, transmission, or reference source or for the uses listed in 105 CMR 120.559,
120.568, 120.570 and 120.589 will be approved if:
(1) the applicant satisfies the general requirements in 105 CMR 120.125;
(2) the applicant submits sufficient information regarding each type of source or device
pertinent to an evaluation of its radiation safety, including:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

S))))))))))))))))))))))))))))Q
5
Although the Agency does not regulate the manufacture and distribution of reagent kits that
do not contain radioacitve material, it does regulate the use of such reagent kits for the
preparation of radiopharmaceuticals containing radioactive material as part of its licensing
and regulation of the users of radioactive material. Any manufacturer of reagent kits that do
not contain radioactive material who desires to have his reagent kits approved by the Agency
for use by persons licensed pursuant to 105 CMR 120.547 may submit the pertinent
information specified in 105 CMR 120.128(K).
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.128: continued

(a) the radioactive material contained, its chemical and physical form, and amount;
(b) details of design and construction of the source or device;
(c) procedures for, and results of, prototype tests to demonstrate that the source or
device will maintain its integrity under stresses likely to be encountered in normal use
and accidents;
(d) for devices containing radioactive material, the radiation profile of a prototype
device;
(e) details of quality control procedures to assure that production sources and devices
meet the standards of the design and prototype tests;
(f) procedures and standards for calibrating sources and devices;
(g) legend and methods for labeling sources and devices as to their radioactive content;
and
(h) instructions for handling and storing the source or device from the radiation safety
standpoint; these instructions are to be included on a durable label attached to the source
or device or attached to a permanent storage container for the source or device; provided,
that instructions which are too lengthy for such label may be summarized on the label and
printed in detail on a brochure which is referenced on the label.
(3) the label affixed to the source or device, or to the permanent storage container for the
source or device, contains information on the radionuclide, quantity, and date of assay, and
a statement that the Agency has approved the distribution of the (name of source or device)
to persons licensed to use radioactive material identified in 105 CMR 120.535, 120.559,
120.568, and 120.570 or under equivalent licenses of the U.S. Nuclear Regulatory
Commission or an Agreement State;
(4) the source or device has been registered in the Sealed Source and Device Registry;
(5) in the event the applicant desires that the source or device be required to be tested for
leakage of radioactive material at intervals longer than six months, he or she shall include
in his or her application sufficient information to demonstrate that such longer interval is
justified by performance characteristics of the source or device or similar sources or devices
and by design features that have a significant bearing on the probability or consequences of
leakage of radioactive material from the source; and
(6) in determining the acceptable interval for test of leakage of radioactive material, the
Agency will consider information that includes, but is not limited to:
(a) primary containment or source capsule;
(b) protection of primary containment;
(c) method of sealing containment;
(d) containment construction materials;
(e) form of contained radioactive material;
(f) maximum temperature withstood during prototype tests;
(g) maximum pressure withstood during prototype tests;
(h) maximum quantity of contained radioactive material;
(i) radiotoxicity of contained radioactive material; and
(j) operating experience with identical sources or devices or similarly designed and
constructed sources or devices.

(M) Requirements for License to Manufacture and Distribute Industrial Products Containing
Depleted Uranium for Mass-volume Applications.
(1) An application for a specific license to manufacture industrial products and devices
containing depleted uranium for use pursuant to 105 CMR 120.121(E) or equivalent
regulations of the U.S. Nuclear Regulatory Commission or an Agreement State will be
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

approved if:
(a) the applicant satisfies the general requirements specified in 105 CMR 120.125;
(b) the applicant submits sufficient information relating to the design, manufacture,
prototype testing, quality control procedures, labeling or marking, proposed uses, and
potential hazards of the industrial product or device to provide reasonable assurance that
possession, use, or transfer of the depleted uranium in the product or device is not likely
to cause any individual to receive a radiation dose in excess of 10% of the annual limits
specified in 105 CMR 120.211(A); and
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.128: continued

(c) the applicant submits sufficient information regarding the industrial product or
device and the presence of depleted uranium for a mass-volume application in the
product or device to provide reasonable assurance that unique benefits will accrue to the
public because of the usefulness of the product or device.
(2) In the case of an industrial product or device whose unique benefits are questionable,
the Agency will approve an application for a specific license under 105 CMR 120.128(M)
only if the product or device is found to combine a high degree of utility and low probability
of uncontrolled disposal and dispersal of significant quantities of depleted uranium into the
environment.
(3) The Agency may deny any application for a specific license under 105 CMR
120.128(M) if the end use(s) of the industrial product or device cannot be reasonably
foreseen.
(4) Each person licensed pursuant to 105 CMR 120.128(M)(1) shall:
(a) maintain the level of quality control required by the license in the manufacture of the
industrial product or device, and in the installation of the depleted uranium into the
product or device;
(b) label or mark each unit to:
1. identify the manufacturer of the product or device and the number of the license
under which the product or device was manufactured, the fact that the product or
device contains depleted uranium, and the quantity of depleted uranium in each
product or device; and
2. state that the receipt, possession, use, and transfer of the product or device are
subject to a general license or the equivalent and the regulations of the U.S. Nuclear
Regulatory Commission or an Agreement State.
(c) assure that the depleted uranium before being installed in each product or device has
been impressed with the following legend clearly legible through any plating or other
covering: "Depleted Uranium";
(d) 1. furnish a copy of the general license contained in 105 CMR 120.121(E) and a
copy of form MRCP 120.100-1 to each person to whom he or she transfers depleted
uranium in a product or device for use pursuant to the general license contained in
105 CMR 120.121(E); or
2. furnish a copy of the general license contained in the U.S. Nuclear Regulatory
Commission's or Agreement State's regulation equivalent to 105 CMR 120.121(E)
and a copy of the U.S. Nuclear Regulatory Commission's or Agreement State's
certificate, or alternatively, furnish a copy of the general license contained in
105 CMR 120.121(E) and a copy of form MRCP 120.100-1 to each person to whom
he or she transfers depleted uranium in a product or device for use pursuant to the
general license of the U.S. Nuclear Regulatory Commission or an Agreement State,
with a note explaining that use of the product or device is regulated by the U.S.
Nuclear Regulatory Commission or an Agreement State under requirements
substantially the same as those in 105 CMR 120.121(E).
(e) report to the Agency all transfers of industrial products or devices to persons for use
under the general license in 105 CMR 120.121(E). Such report shall identify each
general licensee by name and address, an individual by name and/or position who may
constitute a point of contact between the Agency and the general licensee, the type and
model number of device transferred, and the quantity of depleted uranium contained in
the product or device. The report shall be submitted within 30 days after the end of each
calendar quarter in which such a product or device is transferred to the generally licensed
person. If no transfers have been made to persons generally licensed under 105 CMR
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.121(E) during the reporting period, the report shall so indicate;

(f) 1. report to the U.S. Nuclear Regulatory Commission all transfers of industrial
products or devices to persons for use under the U.S. Nuclear Regulatory
Commission general license in 10 CFR Part 40, § 40.25;
2. report to the responsible State agency all transfers of devices manufactured and
distributed pursuant to 105 CMR 120.128(M) for use under a general license in that
State's regulations equivalent to 105 CMR 120.121(E);
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.128: continued

3. such report shall identify each general licensee by name and address, an
individual by name and/or position who may constitute a point of contact between
the Agency and the general licensee, the type and model number of the device
transferred, and the quantity of depleted uranium contained in the product or device.
The report shall be submitted within 30 days after the end of each calendar quarter
in which such product or device is transferred to the generally licensed person;
4. if no transfers have been made to U.S. Nuclear Regulatory Commission licensees
during the reporting period, this information shall be reported to the U.S. Nuclear
Regulatory Commission; and
5. if no transfers have been made to general licensees within a particular Agreement
State during the reporting period, this information shall be reported to the responsible
Agreement State agency upon the request of that agency.
(g) keep records showing the name, address, and point of contact for each general
licensee to whom he or she transfers depleted uranium in industrial products or devices
for use pursuant to the general license provided in 105 CMR 120.121(E) or equivalent
regulations of the U.S. Nuclear Regulatory Commission or an Agreement State. The
records shall be maintained for a period of two years and shall show the date of each
transfer, the quantity of depleted uranium in each product or device transferred, and
compliance with the report requirements of 105 CMR 120.100.

(N) Sealed Source and Device Registration - Registration of Product Information and
Inactivation of Certificates of Registration of Sealed Sources and Devices.
(1) Any manufacturer or initial distributor of a sealed source or device containing a sealed
source may submit a request to the Agency for evaluation of radiation safety information
about its product and for its registration.
(2) The request for review must be sent to the Agency in duplicate by an appropriate method
listed in 105 CMR 120.013.
(3) The request for review of a sealed source or a device must include sufficient information
about the design, manufacture, prototype testing, quality control program, labeling, proposed
uses and leak testing and, for a device, the request must also include sufficient information
about installation, service and maintenance, operating and safety instructions, and its
potential hazards, to provide reasonable assurance that the radiation safety properties of the
source or device are adequate to protect health and minimize danger to life and property.
(4) The Agency normally evaluates a sealed source or a device using radiation safety criteria
in accepted industry standards. If these standards and criteria do not readily apply to a
particular case, the Agency formulates reasonable standards and criteria with the help of the
manufacturer or distributor. The Agency shall use criteria and standards sufficient to ensure
that the radiation safety properties of the device or sealed source are adequate to protect
health and minimize danger to life and property.
(5) After completing the evaluation and determining that requirements for registration have
been met, the Agency shall issue a certificate of registration to the person making the request.
The certificate of registration acknowledges the availability of the submitted information for
inclusion in an application for a specific license proposing use of the product, or concerning
use under an exemption from licensing or general license as applicable for the category of
certificate.
(6) The person submitting the request for evaluation and registration of safety information
about the product shall manufacture and distribute the product in accordance with:
(a) The statements and representations, including quality control program, contained in
the request; and
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(b) The provisions of the registration certificate.

(7) Authority to manufacture or initially distribute a sealed source or device to specific
licensees may be provided in the license without the issuance of a certificate of registration
in the following cases:
(a) Calibration and reference sources containing no more than:
1. 37 MBq (1 mCi), for beta and/or gamma emitting radionuclides; or
2. 0.37 MBq (10 :Ci), for alpha emitting radionuclides; or
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.128: continued

(b) The intended recipients are qualified by training and experience and have sufficient
facilities and equipment to safely use and handle the requested quantity of radioactive
material in any form in the case of unregistered sources or, for registered sealed sources
contained in unregistered devices, are qualified by training and experience and have
sufficient facilities and equipment to safely use and handle the requested quantity of
radioactive material in unshielded form, as specified in their licenses; and
1. The intended recipients are licensed under 105 CMR 120.127 or comparable
provisions of NRC or an Agreement State;
2. The recipients are authorized for research and development; or
3. The sources and devices are to be built to the unique specifications of the
particular recipient and contain no more than 740 GBq (20 Ci) of tritium or 7.4 GBq
(200 mCi) of any other radionuclide.
(8) After the certificate is issued, the Agency may conduct an additional review as it
determines is necessary to ensure compliance with current regulatory standards. In
conducting its review, the Agency will complete its evaluation in accordance with criteria
specified in 105 CMR 120.128(N). The Agency may request such additional information as
it considers necessary to conduct its review and the certificate holder shall provide the
information as requested.
(9) A certificate holder who no longer manufactures or initially transfers any of the sealed
source(s) or device(s) covered by a particular certificate issued by the Agency shall request
inactivation of the registration certificate. Such a request must be made to the Agency by an
appropriate method listed in 105 CMR 120.013 and must normally be made no later than two
years after initial distribution of all of the source(s) or device(s) covered by the certificate has
ceased. However, if the certificate holder determines that an initial transfer was in fact the
last initial transfer more than two years after that transfer, the certificate holder shall request
inactivation of the certificate within 90 days of this determination and briefly describe the
circumstances of the delay.
(10) If a distribution license is to be terminated in accordance with 105 CMR 120.132, the
licensee shall request inactivation of its registration certificates associated with that
distribution license before the Agency will terminate the license. Such a request for
inactivation of certificate(s) must indicate that the license is being terminated and include the
associated specific license number.
(11) A specific license to manufacture or initially transfer a source or device covered only
by an inactivated certificate no longer authorizes the licensee to initially transfer such sources
or devices for use. Servicing of devices must be in accordance with any conditions in the
certificate, including in the case of an inactive certificate.

120.130: Issuance of Specific Licenses

(A)(1) Upon a determination that an application meets the requirements of M.G.L. c. 111, §§ 3,
5M through 5P and 105 CMR 120.000 and upon payment of the required fee as specified in
105 CMR 120.130(A)(2), the Agency will issue a specific license authorizing the proposed
activity in such form and containing such conditions and limitations as it deems appropriate
or necessary.
(2) Each initial application for a license or a certificate of registration for which a fee is
established in 801 CMR 4.00: Rates shall be accompanied by a nonrefundable fee, payable
to the Commonwealth of Massachusetts, in the amount specified for the corresponding
annual fee. Thereafter, the Radiation Control Program will issue an annual fee invoice based
on the applicable annual fee specified in 801 CMR 4.00. Fees are payable within 30 days
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

after receipt of a fee invoice.

(B) The Agency may incorporate in any license at the time of issuance, or thereafter by
appropriate rule, regulation, or order, such additional requirements and conditions with respect
to the licensee's receipt, possession, use, and transfer of radioactive material subject to 105 CMR
120.100 as it deems appropriate or necessary in order to:
(1) minimize danger to public health and safety or property;
(2) require such reports and the keeping of such records, and to provide for such inspections
of activities under the license as may be appropriate or necessary; and
(3) prevent loss or theft of material subject to 105 CMR 120.100.

120.131: Specific Terms and Conditions of Licenses

(A) Each license issued pursuant to 105 CMR 120.000 shall be subject to all the provisions of
M.G.L. c. 111, §§ 3, 5M through 5P, and to all rules, regulations, orders of the Agency and
license conditions as provided for in 105 CMR 120.130(B).

(B) (1) No license issued or granted under 105 CMR 120.000 and no right to possess or utilize
radioactive material granted by any license issued pursuant to 105 CMR 120.131 shall be
transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily,
directly or indirectly, through transfer of control of any license to any person unless the
Agency shall, after securing full information find that the transfer is in accordance with the
provisions of M.G.L. c. 111, §§ 3, 5M through 5P, and to all valid rules, regulations, and
orders of the Agency, and shall give its consent in writing.
(2) An application for transfer of license must include:
1. The identity, technical and financial qualifications of the proposed transferee; and
2. Financial assurance for decommissioning information required by 105 CMR
120.125(C), as applicable.

(C) Each person licensed by the Agency pursuant to 105 CMR 120.100 shall confine use and
possession of the material licensed to the locations and purposes authorized in the license.
Preparation for shipment and transport of byproduct material shall be in accordance with the
provisions of 10 CFR Part 71 and 105 CMR 120.770.

(D) Each licensee shall notify the Agency in writing when the licensee decides to permanently
discontinue all activities involving materials authorized under the license.

(E) Each licensee shall notify the Agency in writing immediately following the filing of a
voluntary or involuntary petition for bankruptcy under any Chapter of Title 11 (Bankruptcy) of
the United States Code by or against:
(1) the licensee;
(2) an entity (as that term is defined in 11 U.S.C. 101(15)) controlling the licensee or listing
the license or licensee as property of the estate; or
(3) an affiliate (as that term is defined in 11 U.S.C. 101(2)) of the licensee.

(F) The notification specified in 105 CMR 120.131(E) shall indicate the bankruptcy court in
which the petition for bankruptcy was filed and the date of the filing of the petition.

(G) Each portable gauge licensee shall use a minimum of two independent physical controls
that form tangible barriers to secure portable gauges from unauthorized removal, whenever
portable gauges are not under the control and constant surveillance of the licensee.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(H) Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-

99/technetium-99m generators or rubidium-82 from strontium-82/rubidium-82 generators shall
test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85
contamination, respectively, in accordance with 105 CMR 120.548. The licensee shall record
the results of each test and retain each record for three years after the record is made.

(I) (1) Authorization under 105 CMR 120.128(A) to produce Positron Emission Tomography
(PET) radioactive drugs for noncommercial transfer to medical use licensees in its
consortium does not relieve the licensee from complying with applicable FDA, other Federal,
and State requirements governing radioactive drugs.
(2) Each licensee authorized under 105 CMR 120.128(A) to produce PET radioactive drugs
for noncommercial transfer to medical use licensees in its consortium shall:
1. Satisfy the labeling requirements in 105 CMR 120.128(J)(1)(d) for each PET
radioactive drug transport radiation shield and each syringe, vial, or other container used
to hold a PET radioactive drug intended for noncommercial distribution to members of
its consortium.
2. Possess and use instrumentation to measure the radioactivity of the PET radioactive
drugs intended for noncommercial distribution to members of its consortium and meet
the procedural, radioactivity measurement, instrument test, instrument check, and
instrument adjustment requirements in 105 CMR 120.128(J)(3).
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.131: continued

(3) A licensee that is a pharmacy authorized under 105 CMR 120.128(A) to produce PET
radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall
require that any individual that prepares PET radioactive drugs shall be:
1. an authorized nuclear pharmacist that meets the requirements in 105 CMR
120.128(J)(2)(b); or
2. an individual under the supervision of an authorized nuclear pharmacist as specified
in 105 CMR 120.519.
(4) A pharmacy, authorized under 105 CMR 120.128(A) to produce PET radioactive drugs
for noncommercial transfer to medical use licensees in its consortium that allows an
individual to work as an authorized nuclear pharmacist, shall meet the requirements of
105 CMR 120.128(J)(2)(e).
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.132: Expiration and Termination of Licenses and Decommissioning of Sites and Separate Buildings or
Outdoor Areas

(A) Each specific license expires at the end of the day on the expiration date stated in the
license unless the licensee has filed an application for renewal under 105 CMR 120.133 not less
than 30 days before the expiration date stated in the existing license. If an application for
renewal has been filed at least 30 days prior to the expiration date stated in the existing license,
the existing license expires at the end of the day on which the Agency makes a final
determination to deny the renewal application or, if the determination states an expiration date,
the expiration date stated in the determination.

(B) Each specific license revoked by the Agency expires at the end of the day on the date of the
Agency's final determination to revoke the license, or on the expiration date stated in the
determination, or as otherwise provided by Agency Order.

(C) Each specific license continues in effect, beyond the expiration date if necessary, with
respect to possession of radioactive material until the Agency notifies the licensee in writing that
the license is terminated. During this time, the licensee shall:
(1) Limit actions involving radioactive material to those related to decommissioning; and,
(2) Continue to control entry to restricted areas until they are suitable for release in
accordance with Agency requirements.

(D) Within 60 days of the occurrence of any of the following, consistent with the administrative
directions in 105 CMR 120.013, each licensee shall provide notification to the Agency in writing
of such occurrence, and either begin decommissioning its site, or any separate building or
outdoor area that contains residual radioactivity so that the building or outdoor area is suitable
for release in accordance with Agency requirements, or submit within 12 months of notification
a decommissioning plan, if required by 105 CMR 120.132(G)(1) and begin decommissioning
upon approval of that plan if:
(1) The license has expired pursuant to 105 CMR 120.132(A) or (B); or
(2) The licensee has decided to permanently cease principal activities, as defined in 105
CMR 120.005, at the entire site or in any separate building or outdoor area that contains
residual radioactivity such that the building or outdoor area is unsuitable for release in
accordance with Agency requirements; or
(3) No principal activities under the license have been conducted for a period of 24 months;
or
(4) No principal activities have been conducted for a period of 24 months in any separate
building or outdoor area that contains residual radioactivity such that the building or outdoor
area is unsuitable for release in accordance with Agency requirements.

(E) Coincident with the notification required by 105 CMR 120.132(D), the licensee shall
maintain in effect all decommissioning financial assurances established by the licensee pursuant
to 105 CMR 120.125(C) in conjunction with a license issuance or renewal or as required by 105
CMR 120.132. The amount of the financial assurance must be increased, or may be decreased,
as appropriate, to cover the detailed cost estimate for decommissioning established pursuant to
105 CMR 120.132(G)(4)(e).
(1) Any licensee who has not provided financial assurance to cover the detailed cost
estimate submitted with the decommissioning plan shall do so.
(2) Following approval of the decommissioning plan, a licensee may reduce the amount
of the financial assurance as decommissioning proceeds and radiological contamination is
reduced at the site with the approval of the Agency.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(F) The Agency may grant a request to extend the time periods established in 105 CMR
120.132(D) if the Agency determines that this relief is not detrimental to the public health and
safety and is otherwise in the public interest. The request must be submitted no later than 30
days before notification pursuant to 105 CMR 120.132(D). The schedule for decommissioning
set forth in 105 CMR 120.132(D) may not commence until the Agency has made a determination
on the request.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.132: continued

(G) (1) A decommissioning plan must be submitted if required by license condition or if the
procedures and activities necessary to carry out decommissioning of the site or separate
building or outdoor have not been previously approved by the Agency and these procedures
could increase potential health and Safety impacts to workers or to the public, such as in any
of the following cases:
(a) procedures would involve techniques not applied routinely during cleanup or
maintenance operations;
(b) workers would be entering areas not normally occupied where surface contamination
and radiation levels are significantly higher than routinely encountered during operation;
(c) procedures could result in significantly greater airborne concentrations of radioactive
materials than are present during operation; or,
(d) procedures could result in significantly greater releases of radioactive material to the
environment than those associated with operation.
(2) The Agency may approve an alternate schedule for submittal of a decommissioning plan
required pursuant to 105 CMR 120.132(D) if the Agency determines that the alternative
schedule is necessary to the effective conduct of decommissioning operations and presents
no undue risk from radiation to the public health and safety and is otherwise in the public
interest.
(3) Procedures such as those listed in 105 CMR 120.132(G)(1) with potential health and
safety impacts may not be carried out prior to approval of the decommissioning plan.
(4) The proposed decommissioning plan for the site or separate building or outdoor area
must include:
(a) a description of the conditions of the site or separate building or outdoor area
sufficient to evaluate the acceptability of the plan;
(b) a description of planned decommissioning activities;
(c) a description of methods used to ensure protection of workers and the environment
against radiation hazards during decommissioning;
(d) a description of the planned final radiation survey; and,
(e) an updated detailed cost estimate for decommissioning, comparison of that estimate
with present funds set aside for decommissioning, and a plan for assuring the availability
of adequate funds for completion of decommissioning.
(f) For decommissioning plans calling for completion of decommissioning later than 24
months after plan approval, the plan shall include a justification for the delay based on
the criteria in 105 CMR 120.132(H).
(5) The proposed decommissioning plan will be approved by the Agency if the information
therein demonstrates that the decommissioning will be completed as soon as practicable and
that the health and safety of workers and the public will be adequately protected.

(H) (1) Except as provided in 105 CMR 120.132(I), licensees shall complete decommissioning
of the site or separate building or outdoor area as soon as practicable but no later than 24
months following the initiation of decommissioning.
(2) Except as provided in 105 CMR 120.132(I), when decommissioning involves the entire
site, the licensee shall request license termination as soon as practicable but no later than 24
months following the initiation of decommissioning.

(I) The Agency may approve a request for an alternative schedule for completion of
decommissioning of the site or separate building or outdoor area, and license termination if
appropriate, if the Agency determines that the alternative is warranted by consideration of the
following:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(1) whether it is technically feasible to complete decommissioning within the allotted

24-month period;
(2) whether sufficient waste disposal capacity is available to allow completion of
decommissioning within the allotted 24-month period:
(3) whether a significant volume reduction in wastes requiring disposal will be achieved by
allowing short-lived radionuclides to decay;
(4) whether a significant reduction in radiation exposure to workers can be achieved by
allowing short-lived radionuclides to decay; and,
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.132: continued

(5) other site-specific factors which the Agency may consider appropriate on a case-by-case
basis, such as the regulatory requirements of other government agencies, lawsuits, ground-
water treatment activities, monitored natural ground-water restoration, actions that could
result in more environmental harm than deferred cleanup, and other factors beyond the
control of the licensee.

(J) As the final step in decommissioning, the licensee shall:

(1) Certify the disposition of all licensed material including accumulated wastes, by
submitting a completed Agency Form MRCP 120.100-3 or equivalent information; and,
(2) Conduct a radiation survey of the premises where the licensed activities were carried out
and submit a report of the results of this survey unless the licensee demonstrates that the
premises are suitable for release in some other manner. The licensee shall, as appropriate:
(a) Report levels of gamma radiation in units of millisieverts (microroentgen) per hour
at one meter from surfaces, and report levels of radioactivity, including alpha and beta,
in units of megabecquerels (disintegrations per minute or microcuries) per 100 square
centimeters - removable and fixed - for surfaces, megabecquerels (microcuries) per
milliliter for water, and becquerels (picocuries) per gram for solids such as soils or
concrete; and
(b) Specify the survey instrument(s) used and certify that each instrument is properly
calibrated and tested.

(K) Specific licenses, including expired licenses, will be terminated by written notice to the
licensee when the Agency determines that:
(1) radioactive material has been properly disposed;
(2) reasonable effort has been made to eliminate residual radioactive contamination, if
present; and
(3) (a) a radiation survey has been performed which demonstrates that the premises are
suitable for release in accordance with Agency requirements; or
(b) other information submitted by the licensee is sufficient to demonstrate that the
premises are suitable for release in accordance with Agency requirements.

120.133: Renewal of Licenses

(A) Applications for renewal of specific licenses shall be filed in accordance with 105 CMR
120.124.

(B) In any case in which a licensee, not less than 30 days prior to expiration of his existing
license, has filed an application in proper form for renewal or for a new license authorizing the
same activities, such existing license shall not expire until final action by the Agency.

120.134: Amendment of Licenses and Registration Certificates at Request of Licensee

(A) Applications for amendment of a license shall be filed in accordance with 105 CMR
120.124 and shall specify the respects in which the licensee desires the license to be amended
and the grounds for such amendment. Applications for amendment of sealed source and device
registration certificates must be filed in accordance with 105 CMR 120.128(N) and any other
applicable provisions and must specify the respects in which the certificate holder desires its
certificate to be amended and the grounds for the amendment.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(B) An invoice for an amendment fee will be issued on receipt of a request to amend a license.
The amendment will not be issued until after the invoiced amount has been paid.

120.135: Agency Action on Applications to Renew or Amend

In considering an application by a licensee to renew or amend the license or to amend a

sealed source or device registration certificate, the Agency will apply the criteria set forth in
105 CMR 120.125, 120.126, 120.127, and 120.128 and in 120.300, 120.500, 120.800 or
120.900, as applicable.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.136: Persons Possessing a License for Source, Byproduct, or Special Nuclear Material in Quantities Not
Sufficient to Form a Critical Mass on March 21, 1997

Any person who, on March 21, 1997, date of the Agreement between the Commonwealth and
the NRC pursuant to section 274b of the Atomic Energy Act of 1954, as amended (42 USC
2021), possesses a general or specific license for source, byproduct, or special nuclear material
in quantities not sufficient to form a critical mass, issued by the U.S. Nuclear Regulatory
Commission, shall be deemed to possess a like license issued under 105 CMR 120.136 and
M.G.L. c. 111, §§ 3, 5M, 5N, 5O and 5P, such license to expire either 90 days after receipt from
the Agency of a notice of expiration of such license, or on the date or expiration specified in the
U.S. Nuclear Regulatory Commission license, whichever is earlier.

120.137: Persons Possessing Naturally Occurring and Accelerator-produced Radioactive Material

(NARM) on March 21, 1997

Any person who, on October 6, 2006, possesses NARM for which a specific license is
required by M.G.L. c. 111, §§ 3, 5M, 5N, 5O and 5P or 105 CMR 120.137 shall be deemed to
possess such a license issued under M.G.L. c. 111, §§ 3, 5M, 5N, 5O and 5P and 105 CMR
120.137. Such license shall expire on January 6, 2007; provided, however, that if within the 90
days the person possessing such material files an application in proper form for a license, such
existing license shall not expire until the application has been finally determined by the Agency.

120.140: Transfer of Material

(A) No licensee shall transfer radioactive material except as authorized pursuant to 105 CMR
120.140.

(B) Except as otherwise provided in his license and subject to the provisions of 105 CMR
120.140(C) and (D), any licensee may transfer radioactive material:
(1) to the Agency (Only after receiving prior approval from the Agency.);
(2) to the U.S. Department of Energy;
(3) to any person exempt from 105 CMR 120.000 to the extent permitted under such
exemption;
(4) to any person authorized to receive such material under terms of a general license or its
equivalent, or a specific license or equivalent licensing document, issued by the Agency, the
U.S. Nuclear Regulatory Commission, any Agreement State or any Licensing State, or to any
person otherwise authorized to receive such material by the Federal Government or any
agency thereof, the Agency, an Agreement State, or a Licensing State; or,
(5) as otherwise authorized by the Agency in writing.

(C) Before transferring radioactive material to a specific licensee of the Agency, the U.S.
Nuclear Regulatory Commission, an Agreement State or a Licensing State, or to a general
licensee who is required to register with the Agency, the U.S. Nuclear Regulatory Commission,
an Agreement State or a Licensing State prior to receipt of the radioactive material, the licensee
transferring the material shall verify that the transferee's license authorizes the receipt of the type,
form, and quantity of radioactive material to be transferred.

(D) Any of the following methods for the verification required by 105 CMR 120.140(C) is
acceptable:
(1) The transferor may possess and read a current copy of the transferee's specific license
or registration certificate.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(2) The transferor may possess a written certification by the transferee that the transferee
is authorized by license or registration certificate to receive the type, form, and quantity of
radioactive material to be transferred, specifying the license or registration certificate
number, issuing agency, and expiration date.
(3) For emergency shipments, the transferor may accept oral certification by the transferee
that the transferee is authorized by license or registration certificate to receive the type, form,
and quantity of radioactive material to be transferred, specifying the license or registration
certificate number, issuing agency, and expiration date; provided, that the oral certification
is confirmed in writing within ten days.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.140: continued

(4) The transferor may obtain other information compiled by a reporting service from
official records of the Agency, the U.S. Nuclear Regulatory Commission, an Agreement
State, or a Licensing State regarding the identity of licensees and the scope and expiration
dates of licenses and registration.
(5) When none of the methods of verification described in 105 CMR 120.140(D)(1) through
(4) are readily available or when a transferor desires to verify that information received by
one of such methods is correct or up-to-date, the transferor may obtain and record
confirmation from the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement
State, or a Licensing State that the transferee is licensed to receive the radioactive material.

(E) Shipment and transport of radioactive material shall be in accordance with the provisions
of 105 CMR 120.770.

120.142: Reporting Requirements

(A) Immediate Report. Each licensee shall notify the Agency as soon as possible but not later
than four hours after the discovery of an event that prevents immediate protective actions
necessary to avoid exposures to radiation or radioactive materials that could exceed regulatory
limits or releases of licensed material that could exceed regulatory limits (events may include
fires, explosions, toxic gas releases, etc.).

(B) 24 Hour Report. Each licensee shall notify the Agency within 24 hours after the discovery
of any of the following events involving licensed material:
(1) An unplanned contamination event that:
(a) Requires access to the contaminated area, by workers or the public, to be restricted
for more than 24 hours by imposing additional radiological controls or by prohibiting
entry into the area;
(b) Involves a quantity of material greater than five times the lowest annual limit on
intake specified in 105 CMR 120.296: Appendix B for the material; and,
(c) Has access to the area restricted for a reason other than to allow isotopes with a
half-life of less than 24 hours to decay prior to decontamination.
(2) An event in which equipment is disabled or fails to function as designed when:
(a) The equipment is required by regulation or license condition to prevent releases
exceeding regulatory limits, to prevent exposures to radiation and radioactive materials
exceeding regulatory limits, or to mitigate the consequences of an accident;
(b) The equipment is required to be available and operable when it is disabled or fails
to function; and,
(c) No redundant equipment is available and operable to perform the required safety
function.
(3) An event that requires unplanned medical treatment at a medical facility of an individual
with spreadable radioactive contamination on the individual's clothing or body.
(4) An unplanned fire or explosion damaging any licensed material or any device, container,
or equipment containing licensed material when:
(a) The quantity of material involved is greater than five times the lowest annual limit
on intake specified in 105 CMR 120 296: Appendix B for the material; and,
(b) The damage affects the integrity of the licensed material or its container.

(C) Preparation and Submission of Reports. Reports made by licensees in response to the
requirements of 105 CMR 120.142 must be made as follows:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(1) Licensees shall make reports required by 105 CMR 120.142(A) and (B) by telephone
to the Agency during normal working hours or the Nuclear Incident Advisory Team (NIAT)
at all other times. To the extent that the information is available at the time of notification,
the information provided in these reports must include:
(a) The caller's name and call back telephone number;
(b) A description of the event, including date and time;
(c) The exact location of the event;
(d) The isotopes, quantities, and chemical and physical form of the licensed material
involved; and,
(e) Any personnel radiation exposure data available.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.142: continued

(2) Written Report. Each licensee who makes a report required by 105 CMR 120.142(A)
or (B) shall submit a written follow-up report within 30 days of the initial report. Written
reports prepared pursuant to other regulations may be submitted to fulfill this requirement
if the reports contain all of the necessary information and the appropriate distribution is
made. These written reports must be sent to the Massachusetts Department of Public Health,
Radiation Control Program. The report must include the following:
(a) A description of the event, including the probable cause and the manufacturer and
model number (if applicable) of any equipment that failed or malfunctioned;
(b) The exact location of the event;
(c) The isotopes, quantities, and chemical and physical form of the licensed material
involved;
(d) Date and time of the event;
(e) Corrective actions taken or planned and the results of any evaluations or
assessments; and,
(f) The extent of exposure of individuals to radiation or to radioactive materials without
identification of individuals by name.

120.146: Emergency Plan for Responding to a Release

(A) Each application to possess radioactive materials in unsealed form, on foils or plated
sources, or sealed in glass in excess of the quantities in 105 CMR 120.196: Appendix B, Table
III must contain either:
(1) An evaluation showing that the maximum dose to a person offsite due to a release of
radioactive materials would not exceed 1 rem effective dose equivalent or 5 rems to the
thyroid; or
(2) An emergency plan for responding to a release of radioactive material.

(B) One or more of the following factors may be used to support an evaluation submitted
pursuant to 105 CMR 120.146 and 120.760:
(1) The radioactive material is physically separated so that only a portion could be involved
in an accident;
(2) All or part of the radioactive material is not subject to release during an accident because
of the way it is stored or packaged;
(3) The release fraction in the respirable size range would be lower than the release fraction
shown in 105 CMR 120.196: Appendix B, Table III due to the chemical or physical form of
the material;
(4) The solubility of the radioactive material would reduce the dose received;
(5) Facility design or engineered safety features in the facility would cause the release
fraction to be lower than shown in 105 CMR 120.196: Appendix B, Table III;
(6) Operating restrictions or procedures would prevent a release fraction as large as that
shown in 105 CMR 120.196: Appendix B, Table III; or
(7) Other factors appropriate for the specific facility.

(C) An emergency plan for responding to a release of radioactive material submitted pursuant
to 105 CMR 120.146 and 120.760 must include the following information:
(1) Facility Description. A brief description of the licensee's facility and area near the site.
(2) Types of Accidents. An identification of each type of radioactive materials accident for
which protective actions may be needed.
(3) Classification of Accidents. A classification system for classifying accidents as alerts
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

or site area emergencies.

(4) Detection of Accidents. Identification of the means of detecting each type of accident
in a timely manner.
(5) Mitigation of Consequences. A brief description of the means and equipment for
mitigating the consequences of each type of accident, including those provided to protect
workers onsite, and a description of the program for maintaining the equipment.
(6) Assessment of Releases. A brief description of the methods and equipment to assess
releases of radioactive materials.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.146: continued

(7) Responsibilities. A brief description of the responsibilities of licensee personnel should

an accident occur, including identification of personnel responsible for promptly notifying
offsite response organizations and the Agency; also, responsibilities for developing,
maintaining, and updating the plan.
(8) Notification and Coordination. A commitment to and a brief description of the means
to promptly notify offsite response organizations and request offsite assistance, including
medical assistance for the treatment of contaminated injured onsite workers when
appropriate. A control point must be established. The notification and coordination must
be planned so that unavailability of some personnel, parts of the facility, and some equipment
will not prevent the notification and coordination. The licensee shall also commit to notify
the Agency immediately after notification of the appropriate offsite response organizations
and not later than one hour after the licensee declares an emergency.***
(9) Information to Be Communicated. A brief description of the types of information on
facility status, radioactive releases, and recommended protective actions, if necessary, to be
given to offsite response organizations and to the Agency.
(10) Training. A brief description of the frequency, performance objectives, and plans for
the training that the licensee will provide workers on how to respond to an emergency,
including any special instructions and orientation tours the licensee would offer to fire,
police, medical, and other emergency personnel. The training shall familiarize personnel
with site-specific emergency procedures. Also, the training shall thoroughly prepare site
personnel for their responsibilities in the event of accident scenarios postulated as most
probable for the specific site, including the use of team training for such scenarios.
(11) Safe Shutdown. A brief description of the means of restoring the facility to a safe
condition after an accident.
(12) Exercises. Provisions for conducting quarterly communications checks with offsite
response organizations and biennial onsite exercises to test response to simulated
emergencies. Quarterly communications checks with offsite response organizations must
include the check and update of all necessary telephone numbers. The licensee shall invite
offsite response organizations to participate in the biennial exercises. Participation of offsite
response organizations in biennial exercises, although recommended, is not required.
Exercises must use accident scenarios postulated as most probable for the specific site and
the scenarios shall not be known to most exercise participants. The licensee shall critique
each exercise using individuals not having direct implementation responsibility for the plan.
Critiques of exercises must evaluate the appropriateness of the plan, emergency procedures,
facilities, equipment, training of personnel, and overall effectiveness of the response.
Deficiencies found by the critiques must be corrected.
(13) Hazardous Chemicals. A certification that the applicant has met its responsibilities
under the Emergency Planning and Community Right-to-Know Act of 1986, Title III, Pub.
L. 99-499, if applicable to the applicant's activities at the proposed place of use of the
radioactive material.

(D) The license shall allow the offsite response organizations expected to respond in case of
an accident 60 days to comment on the licensee's emergency plan before submitting it to the
Agency. The licensee shall provide any comments received within the 60 days to the Agency

***
These reporting requirements do not supersede or release licensees of complying with the
requirements under the Emergency Planning and Community Right-to-Know Act of 1986,
Title III, Pub. L. 99-499 or other state or federal reporting requirements.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

with the emergency plan.

120.150: Modification and Revocation of Licenses

(A) The terms and conditions of all licenses shall be subject to amendment, revision, or
modification or the license may be suspended or revoked by reason of amendments to M.G.L.
c. 111, §§ 3, 5M, 5N, 5O and 5P, or by reason of rules, regulations, and orders issued by the
Agency.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.150: continued

(B) Any license may be revoked, suspended, or modified, in whole or in part, for any material
false statement in the application or any statement of fact required under provisions of M.G.L.
c. 111, §§ 3, 5M, 5N, 5O and 5P, or because of conditions revealed by such application or
statement of fact or any report, record, or inspection or other means which would warrant the
Agency to refuse to grant a license on an original application, or for violation of, or failure to
observe any of the terms and conditions of M.G.L. c. 111, §§ 3, 5M, 5N, 5O and 5P, or of the
license, or of any rule, regulation, or order of the Agency.

(C) Except in cases of willfulness or those in which the public health, interest or safety requires
otherwise, no license shall be modified, suspended, or revoked unless, prior to the institution of
proceedings therefor, facts or conduct which may warrant such action shall have been called to
the attention of the licensee in writing and the licensee shall have been accorded an opportunity
to demonstrate or achieve compliance with all lawful requirements.

120.190: Reciprocal Recognition of Licenses

(A) Licenses of Byproduct, Source, and Special Nuclear Material in Quantities Not Sufficient
to Form a Critical Mass.
(1) Subject to 105 CMR 120.000, any person who holds a specific license from the U.S.
Nuclear Regulatory Commission or an Agreement State, and issued by the Agency having
jurisdiction where the licensee maintains an office for directing the licensed activity and at
which radiation safety records are normally maintained, is hereby granted a general license
to conduct the activities authorized in such licensing document within this State for a period
not in excess of 180 days in any calendar year provided that:
(a) the licensing document does not limit the activity authorized by such document to
specified installations or locations;
(b) the out-of-state licensee notifies the Agency in writing at least three days prior to
engaging in such activity. Such notification shall indicate the location, period, and type
of proposed possession and use within the State, and shall be accompanied by a copy of
the pertinent licensing document. If, for a specific case, the three day period would
impose an undue hardship on the out-of-state licensee, the licensee may, upon application
to the Agency, obtain permission to proceed sooner. The Agency may waive the
requirement for filing additional written notifications during the remainder of the
calendar year following the receipt of the initial notification from a person engaging in
activities under the general license provided in 105 CMR 120.190(A)(1);
(c) the out-of-state licensee complies with all applicable regulations of the Agency and
with all the terms and conditions of the licensing document, except any such terms and
conditions which may be inconsistent with applicable regulations of the Agency;
(d) the out-of-state licensee supplies such other information as the Agency may request;
and
(e) the out-of-state licensee shall not transfer or dispose of radioactive material
possessed or used under the general license provided in 105 CMR 120.190(A)(1) except
by transfer to a person:
1. specifically licensed by the Agency or by the U.S. Nuclear Regulatory
Commission to receive such material; or,
2. exempt from the requirements for a license for such material under 105 CMR
120.104(A).
(2) Notwithstanding the provisions of 105 CMR 120.190(A)(1), any person who holds a
specific license issued by the U.S. Nuclear Regulatory Commission or an Agreement State
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

authorizing the holder to manufacture, transfer, install, or service a device described in 105
CMR 120.122(D)(1) within areas subject to the jurisdiction of the licensing body is hereby
granted a general license to install, transfer, demonstrate, or service such a device in this
State provided that:
(a) Filing a report with the Agency (Reserved);
(b) the device has been manufactured, labeled, installed, and serviced in accordance
with applicable provisions of the specific license issued to such person by the U.S.
Nuclear Regulatory Commission or an Agreement State;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.190: continued

(c) such person shall assure that any labels required to be affixed to the device under
regulations of the authority which licensed manufacture of the device bear a statement
that "Removal of this label is prohibited"; and,
(d) the holder of the specific license shall furnish to each general licensee to whom he
transfers such device or on whose premises he installs such device a copy of the general
license contained in 105 CMR 120.122(D) or in equivalent regulations of the Agency
having jurisdiction over the manufacture and distribution of the device.
(3) The Agency may withdraw, limit, or qualify its acceptance of any specific license or
equivalent licensing document issued by the U.S. Nuclear Regulatory Commission or an
Agreement State, or any product distributed pursuant to such licensing document, upon
determining that such action is necessary in order to prevent undue hazard to public health
and safety or property.

(B) Exceptions to the General License.

(1) The general license granted in 105 CMR 120.190(A) to conduct activities in the State
does not include activities in areas of exclusive Federal jurisdiction within the State or
offshore waters.
(2) Authorization for use of radioactive materials in areas of exclusive Federal jurisdiction
within the State or offshore waters may be obtained from the U.S. Nuclear Regulatory
Commission as provided for in 10 CFR 150.20.
(3) Before radioactive material can be used at a temporary job site in another State,
authorization shall be obtained from the State if it is an Agreement State, or from the NRC
for any non-Agreement State, either by filing for reciprocity or applying for a specific
license.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.195: Appendix A -- Exempt Concentrations

Element (Atomic Isotope Column I Gas Column II Liquid

Number) Concentration and solid
:Ci/ml 1/ concentration
:Ci/ml 2/
Antimony (51) Sb-122 3X10-4
Sb-124 2X10-4
Sb-125 1X10-3
Argon (18) Ar-37 1X10-3
Ar-41 4X10-7
Arsenic (33) As-73 5X10-3
As-74 5X10-4
As-76 2X10-4
As-77 8X10-4
Barium (56) Ba-131 2X10-3
Ba-140 3X10-4
Beryllium (4) Be-7 2X10-2
Bismuth (83) Bi-206 4X10-4
Bromine (35) Br-82 4X10-7 3X10-3
Cadmium (48) Cd-109 2X10-3
Cd-115m 3X10-4
Cd-115 3X10-4
Calcium (20) Ca-45 9X10-5
Ca-47 5X10-4
Carbon (6) C-14 1X10-6 8X10-3
Cerium (58) Ce-141 9X10-4
Ce-143 4X10-4
Ce-144 1X10-4
Cesium (55) Cs-131 2X10-2
Cs-134m 6X10-2
Cs-134 9X10-5
Chlorine (17) Cl-38 9X10-7 4X10-3
Chromium (24) Cr-51 2X10-2
Cobalt (27) Co-57 5X10-3
Co-58 1X10-3
Co-60 5X10-4
Copper (29) Cu-64 3X10-3
Dysprosium (66) Dy-165 4X10-3
Dy-166 4X10-4
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.195: continued

Element (Atomic Isotope Column I Gas Column II Liquid

Number) Concentration and solid
:Ci/ml 1/ concentration
:Ci/ml 2/
Erbium (68) Er-169 9X10-4
Er-171 1X10-3
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.195: continued

Element (Atomic Isotope Column I Gas Column II Liquid

Number) Concentration and solid
:Ci/ml 1/ concentration
:Ci/ml 2/
Europium (63) Eu-152/ 6X10-4
(9.2h)
Eu-155 2X10-3
Fluorine (9) F-18 2X10-6 8X10-3
Gadolinium (64) Gd-153 2X10-3
Gd-159 8X10-4
Gallium (31) Ga-72 4X10-4
Germanium (32) Ge-71 2X10-2
Gold (79) Au-196 2X10-3
Au-198 5X10-4
Au-199 2X10-3
Hafnium (72) Hf-181 7X10-4
Hydrogen (1) H-3 5X10-6 3X10-2
Indium (49) In-113m 1X10-2
In-114m 2X10-4
Iodine (53) I-126 3X10-9 2X10-5
I-131 3X10-9 2X10-5
I-132 8X10-8 6X10-4
I-133 1X10-8 7X10-5
I-134 2X10-7 1X10-3
Iridium (77) Ir-190 2X10-3
Ir-192 4X10-4
Ir-194 3X10-4
Iron (26) Fe-55 8X10-3
Fe-59 6X10-4
Krypton (36) Kr-85m 1X10-6
Kr-85 3X10-6
Lanthanum (57) La-140 2X10-4
Lead (82) Pb-203 4X10-3
Lutetium (71) Lu-177 1X10-3
Manganese (25) Mn-52 3X10-4
Mn-54 1X10-3
Mn-56 1X10-3
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.195: continued

Element (Atomic Isotope Column I Gas Column II Liquid

Number) Concentration and solid
:Ci/ml 1/ concentration
:Ci/ml 2/
Mercury (80) Hg-197m 2X10-3
Hg-197 3X10-3
Hg-203 2X10-4
Molybdenum (42) Mo-99 2X10-3
Neodymium (60) Nd-147 6X10-4
Nd-149 3X10-3
Nickel (28) Ni-65 1X10-3
Niobium Nb-95 1X10-3
(Columbium) (41) Nb-97 9X10-3
Osmium (76) Os-185 7X10-4
Os-191m 3X10-2
Os-191 2X10-3
Os-193 6X10-4
Palladium (46) Pd-103 3X10-3
Pd-109 9X10-4
Phosphorus (15) P-32 2X10-4
P-33 1X10-3
Platinum (78) Pt-191 1X10-3
Pt-193m 1X10-2
Pt-197m 1X10-2
Pt-197 1X10-3
Potassium (19) K-42 3X10-3
Praseodymium (59) Pr-142 3X10-4
Pr-143 5X10-4
Promethium (61) Pm-147 2X10-3
Pm-149 4X10-4
Rhenium (75) Re-183 6X10-3
Re-186 9X10-4
Re-188 6X10-4
Rhodium (45) Rh-103m 1X10-1
Rh-105 1X10-3
Rubidium (37) Rb-86 7X10-4
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.195: continued

Element (Atomic Isotope Column I Gas Column II Liquid

Number) Concentration and solid
:Ci/ml 1/ concentration
:Ci/ml 2/
Ruthenium (44) Ru-97 4X10-3
Ru-103 8X10-4
Ru-105 1X10-3
Ru-106 1X10-4
Samarium (62) Sm-153 8X10-4
Scandium (21) Sc-46 4X10-4
Sc-47 9X10-4
Sc-48 3X10-4
Selenium (34) Se-75 3X10-3
Silicon (14) Si-31 9X10-3
Silver (47) Ag-105 1X10-3
Ag-110m 3X10-4
Ag-111 4X10-4
Sodium (11) Na-24 2X10-3
Strontium (38) Sr-85 1X10-3
Sr-89 1X10-4
Sr-91 7X10-4
Sr-92 7X10-4
Sulfur (16) S-35 9X10-8 6X10-4
Tantalum (73) Ta-182 4X10-4
Technetium (43) Tc-96m 1X10-1
Tc-96 1X10-3
Tellurium (52) Te-125m 2X10-3
Te-127m 6X10-4
Te-127 3X10-3
Te-129m 3X10-4
Te-131m 6X10-4
Te-132 3X10-4
Terbium (65) Tb-160 4X10-4
Thallium (81) Tl-200 4X10-3
Tl-201 3X10-3
Tl-202 1X10-3
Tl-204 1X10-3
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.195: continued

Element (Atomic Isotope Column I Gas Column II Liquid

Number) Concentration and solid
:Ci/ml 1/ concentration
:Ci/ml 2/
Thulium (69) Tm-170 5X10-4
Tm-171 5X10-3
Tin (50) Sn-113 9X10-4
Sn-125 2X10-4
Tungsten (Wolfram) W-181 4X10-3
(74) W-187 7X10-4
Vanadium (23) V-48 3X10-4
Xenon (54) Xe-131m 4X10-6
Xe-133 3X10-6
Xe-135 1X10-6
Ytterbium (70) Yb-175 1X10-3
Yttrium (39) Y-90 2X10-4
Y-91m 3X10-2
Y-91 3X10-4
Y-92 6X10-4
Y-93 3X10-4
Zinc (30) Zn-65 1X10-3
Zn-69m 7X10-4
Zn-69 2X10-2
Zirconium (40) Zr-95 6X10-4
Zr-97 2X10-4
Beta and/or gamma 1X10-10 1X10-6
emitting radioactive
material not listed
above with half-life of
less than three years.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.195: continued

Note 1: Many radioisotopes transform into isotopes which are also radioactive. In expressing
the concentrations in 105 CMR 120.195: Appendix A, the activity stated is that of the
parent isotope and takes into account the daughters.

Note 2: For purposes of 105 CMR 120.104(A) where there is involved a combination of
isotopes, the limit for the combination should be derived as follows: Determine for
each isotope in the product the ratio between the radioactivity concentration present
in the product and the exempt radioactivity concentration established in
120.195: Appendix A for the specific isotope when not in combination. The sum of
such ratios may not exceed "1".

Example: Concentration of Isotope A in Product +

Exempt concentration of Isotope A

Concentration of Isotope B in Product _< 1

Exempt concentration of Isotope B

Note 3: To convert µCi/ml to SI units of megabecquerels per liter multiply the above values
by 37.

Example: Zirconium (40) Zr-97 (2x10-4 µCi/ml multiplied by 37 is equivalent to 74 x 10-4

MBq/l)
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.196: Appendix B -- Table I Exempt Quantities

Radioactive Micro-
Material curies

Antimony-122 (Sb 122) 100

Antimony-124 (Sb 124) 10
Antimony-125 (Sb 125) 10
Arsenic-73 (As 73) 100
Arsenic-74 (As 74) 10
Arsenic-76 (As 76) 10
Arsenic-77 (As 77) 100
Barium-131 (Ba 131) 10
Barium-133 (Ba 133) 10
Barium-140 (Ba 140) 10
Bismuth-210 (Bi 210) 1
Bromine-82 (Br 82) 10
Cadmium-109 (Cd 109) 10
Cadmium-115m (Cd 115m) 10
Cadmium-115 (Cd 115) 100
Calcium-45 (Ca 45) 10
Calcium-47 (Ca 47) 10
Carbon-14 (C 14) 100
Cerium-141 (Ce 141) 100
Cerium-143 (Ce 143) 100
Cerium-144 (Ce 144) 1
Cesium-129 (Cs 129) 100
Cesium-131 (Cs 131) 1,000
Cesium-134m (Cs 134m) 100
Cesium-134 (Cs 134) 1
Cesium-135 (Cs 135) 10
Cesium-136 (Cs 136) 10
Cesium-137 (Cs 137) 10
Chlorine-36 (Cl 36) 10
Chlorine-38 (Cl 38) 10
Chromium-51 (Cr 51) 1,000
Cobalt-57 (Co 57) 100
Cobalt-58m (Co 58m) 10
Cobalt-58 (Co 58) 10
Cobalt-60 (Co 60) 1
Copper-64 (Cu 64) 100
Dysprosium-165 (Dy 165) 10
Dysprosium-166 (Dy 166) 100
Erbium-169 (Er 169) 100
Erbium-171 (Er 171) 100
Europium-152 (Eu 152)9.2h 100
Europium-152 (Eu 152)13 yr 1
Europium-154 (Eu 154) 1
Europium-155 (Eu 155) 10
Fluorine-18 (F 18) 1,000
Gadolinium-153 (Gd 153) 10
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Gadolinium-159 (Gd 159) 100

Gallium-67 (Ga 67) 100
Gallium-72 (Ga 72) 10
Germanium-68 (Ge 68) 10
Germanium-71 (Ge 71) 100
Gold-195 (Au 195) 10
Gold-198 (Au 198) 100
Gold-199 (Au 199) 100
Hafnium-181 (Hf 181) 10
Holmium-166 (Ho 166) 100
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.196 Table 1: continued

Radioactive Micro-
Material curies

Hydrogen-3 (H 3) 1,000
Indium-111 (In 111) 100
Indium-113m (In 113m) 100
Indium-114m (In 114m) 10
Indium-115m (In 115m) 100
Indium-115 (In 115) 10
Iodine-123 (I 123) 100
Iodine-125 (I 125) 1
Iodine-126 (I 126) 1
Iodine-129 (I 129) 0.1
Iodine-131 (I 131) 1
Iodine-132 (I 132) 10
Iodine-133 (I 133) 1
Iodine-134 (I 134) 10
Iodine-135 (I 135) 10
Iridium-192 (Ir 192) 10
Iridium-194 (Ir 194) 100
Iron-52 (Fe 52) 10
Iron-55 (Fe 55) 100
Iron-59 (Fe 59) 10
Krypton-85 (Kr 85) 100
Krypton-87 (Kr 87) 10
Lanthanum-140 (La 140) 10
Lutetium-177 (Lu 177) 100
Manganese-52 (Mn 52) 10
Manganese-54 (Mn 54) 10
Manganese-56 (Mn 56) 10
Mercury-197m (Hg 197m) 100
Mercury-197 (Hg 197) 100
Mercury-203 (Hg 203) 10
Molybdenum-99 (Mo 99) 100
Neodymium-147 (Nd 147) 100
Neodymium-149 (Nd 149) 100
Nickel-59 (Ni 59) 100
Nickel-63 (Ni 63) 10
Nickel-65 (Ni 65) 100
Niobium-93m (Nb 93m) 10
Niobium-95 (Nb 95) 10
Niobium-97 (Nb 97) 10
Osmium-185 (Os 185) 10
Osmium-191m (Os 191m) 100
Osmium-191 (Os 191) 100
Osmium-193 (Os 193) 100
Palladium-103 (Pd 103) 100
Palladium-109 (Pd 109) 100
Phosphorus-32 (P 32) 10
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Phosphorus-33 (P 33) 100

Platinum-191 (Pt 191) 100
Platinum-193m (Pt 193m) 100
Platinum-193 (Pt 193) 100
Platinum-197m (Pt 197m) 100
Platinum-197 (Pt 197) 100
Polonium-210 (Po 210) 0.1
Potassium-42 (K 42) 10
Potassium-43 (K 43) 10
Praseodymium-142 (Pr 142) 100
Praseodymium-143 (Pr 143) 100
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.196 Table 1: continued

Radioactive Micro-
Material curies

Promethium-147 (Pm 147) 10

Promethium-149 (Pm 149) 10
Rhenium-186 (Re 186) 100
Rhenium-188 (Re 188) 100
Rhodium-103m (Rh 103m) 100
Rhodium-105 (Rh 105) 100
Rubidium-81 (Rb 81) 10
Rubidium-86 (Rb 86) 10
Rubidium-87 (Rb 87) 10
Ruthenium-97 (Ru 97) 100
Ruthenium-103 (Ru 103) 10
Ruthenium-105 (Ru 105) 10
Ruthenium-106 (Ru 106) 1
Samarium-151 (Sm 151) 10
Samarium-153 (Sm 153) 100
Scandium-46 (Sc 46) 10
Scandium-47 (Sc 47) 100
Scandium-48 (Sc 48) 10
Selenium-75 (Se 75) 10
Silicon-31 (Si 31) 100
Silver-105 (Ag 105) 10
Silver-110m (Ag 110m) 1
Silver-111 (Ag 111) 100
Sodium-22 (Na 22) 10
Sodium-24 (Na 24) 10
Strontium-85 (Sr 85) 10
Strontium-89 (Sr 89) 1
Strontium-90 (Sr 90) 0.1
Strontium-91 (Sr 91) 10
Strontium-92 (Sr 92) 10
Sulphur-35 (S 35) 100
Tantalum-182 (Ta 182) 10
Technetium-96 (Tc 96) 10
Technetium-97m (Tc 97m) 100
Technetium-97 (Tc 97) 100
Technetium-99m (Tc 99m) 100
Technetium-99 (Tc 99) 10
Tellurium-125m (Te 125m) 10
Tellurium-127m (Te 127m) 10
Tellurium-127 (Te 127) 100
Tellurium-129m (Te 129m) 10
Tellurium-129 (Te 129) 100
Tellurium-131m (Te 131m) 10
Tellurium-132 (Te 132) 10
Terbium-160 (Tb 160) 10
Thallium-200 (Tl 200) 100
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Thallium-201 (Tl 201) 100

Thallium-202 (Tl 202) 100
Thallium-204 (Tl 204) 10
Thulium-170 (Tm 170) 10
Thulium-171 (Tm 171) 10
Tin-113 (Sn 113) 10
Tin-125 (Sn 125) 10
Tungsten-181 (W 181) 10
Tungsten-185 (W 185) 10
Tungsten-187 (W 187) 100
Vanadium-48 (V 48) 10
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.196 Table 1: continued

Radioactive Micro-
Material curies

Xenon-131m (Xe 131m) 1,000

Xenon-133 (Xe 133) 100
Xenon-135 (Xe 135) 100
Ytterbium-175 (Yb 175) 100
Yttrium-87 (Y 87) 10
Yttrium-88 (Y 88) 10
Yttrium-90 (Y 90) 10
Yttrium-91 (Y 91) 10
Yttrium-92 (Y 92) 100
Yttrium-93 (Y 93) 100
Zinc-65 (Zn 65) 10
Zinc-69m (Zn 69m) 100
Zinc-69 (Zn 69) 1,000
Zirconium-93 (Zr 93) 10
Zirconium-95 (Zr 95) 10
Zirconium-97 (Zr 97) 10

Any radioactive material

not listed above other than
alpha-emitting radioactive
material 0.1

Note 1: For purposes of 105 CMR 100.125(C)(3) where there is involved a combination of
isotopes, the limit for the combination should be derived as follows:

Determine the amount of each isotope possessed and 1,000 times the amount in 105
CMR 120.196: Appendix B, Table 1 for each of those isotopes when not in combination.
The sum of the ratios of those quantities may not exceed 1.

Example:

for Isotope A for Isotope B

Note 2: To convert microcuries (:Ci) to SI units of kilobecquerels (kBq), multiply the above
values by 37.

Example: Zirconium-97 (10 :Ci multiplied by 37 is equivalent to 370 kBq).

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.196: Table II -- Quantities For Use With 105 CMR 120.125(C)(1)

Material Microcuries
Americium-241 0.01
Antimony-122 100.00
Antimony-124 10.00
Antimony-125 10.00
Arsenic-73 100.00
Arsenic-74 10.00
Arsenic-76 10.00
Arsenic-77 100.00
Barium-131 10.00
Barium-133 10.00
Barium-140 10.00
Bismuth-210 1.00
Bromine-82 10.00
Cadmium-109 10.00
Cadmium-115m 10.00
Cadmium-115 100.00
Calcium-45 10.00
Calcium-47 10.00
Carbon-14 100.00
Cerium-141 100.00
Cerium-143 100.00
Cerium-144 1.00
Cesium-131 1,000.00
Cesium-134m 100.00
Cesium-134 1.0
Cesium-135 10.00
Cesium-136 10.00
Cesium-137 10.00
Chlorine-36 10.00
Chlorine-38 10.00
Cobalt-57 10.00
Chromium-51 1,000.00
Cobalt-58m 10.00
Cobalt-58 10.00
Cobalt-60 1.00
Copper-64 100.00
Dysprosium-165 10.00
Dysprosium-166 100.00
Erbium-169 100.00
Erbium-171 100.00
Europium-152 (9.2 h) 100.00
Europium-152 (13 yr) 1.00
Europium-154 1.00
Europium-155 10.00
Fluorine-18 1,000.00
Gadolinium-153 10.00
Gadolinium-159 100.00
Gallium-72 10.00
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Germanium-71 100.00
Gold-198 100.00
Gold-199 100.00
Hafnium-181 10.00
Holmium-166 100.00
Hydrogen-3 1,000.00
Indium-113m 100.00
Indium-114m 10.00
Indium-115m 100.00
Indium-115 10.00
Iodine-125 1.00
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.196 Table II: continued

Material Microcuries

Iodine-126 1.00
Iodine-129 0.1
Iodine-131 1.0
Iodine-132 10.00
Iodine-133 1.00
Iodine-134 10.00
Iodine-135 10.00
Iridium-192 10.00
Iridium-194 100.00
Iron-55 100.00
Iron-59 10.00
Krypton-85 100.00
Krypton-87 10.00
Lanthanum-140 10.00
Lutetium-177 100.00
Manganese-52 10.00
Manganese-54 10.00
Manganese-56 10.00
Mercury-197m 100.00
Mercury-197 100.00
Mercury-203 10.00
Molybdenum-99 100.00
Neodymium-147 100.00
Neodymium-149 100.00
Nickel-59 100.00
Nickel-63 10.00
Nickel-65 100.00
Niobium-93m 10.00
Niobium-95 10.00
Niobium-97 10.00
Osmium-185 10.00
Osmium-191m 100.00
Osmium-191 100.00
Osmium-193 100.00
Palladium-103 100.00
Palladium-109 100.00
Phosphorus-32 10.00
Phosphorus-33 100.00
Platinum-191 100.00
Platinum-193m 100.00
Platinum-193 100.00
Platinum-197m 100.00
Platinum-197 100.00
Plutonium-239 0.01
Polonium-210 0.1
Potassium-42 10.00
Praseodymium-142 100.00
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Praseodymium-143 100.00
Promethium-147 10.00
Promethium-149 10.00
Radium-226 0.01
Rhenium-186 100.00
Rhenium-188 100.00
Rhodium-103m 100.00
Rhodium-105 100.00
Rubidium-86 10.00
Rubidium-87 10.00
Ruthenium-97 100.00
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.196 Table II: continued

Material Microcuries

Ruthenium-103 10.00
Ruthenium-105 10.00
Ruthenium-106 1.00
Samarium-151 10.00
Samarium-153 100.00
Scandium-46 10.00
Scandium-47 100.00
Scandium-48 10.00
Selenium-75 10.00
Silicon-31 100.00
Silver-105 10.00
Silver-110m 1.00
Silver-111 100.00
Sodium-22 1.0
Sodium-24 10.00
Strontium-85 10.00
Strontium-89 1.00
Strontium-90 0.1
Strontium-91 10.00
Strontium-92 10.00
Sulphur-35 100.00
Tantalum-182 10.00
Technetium-96 10.00
Technetium-97m 100.00
Technetium-97 100.00
Technetium-99m 100.00
Technetium-99 10.00
Tellurium-125m 10.00
Tellurium-127m 10.00
Tellurium-127 100.00
Tellurium-129m 10.00
Tellurium-129 100.00
Tellurium-131m 10.00
Tellurium-132 10.00
Terbium-160 10.00
Thallium-200 100.00
Thallium-201 100.00
Thallium-202 100.00
Thallium-204 10.00
Thorium (natural) 100.00
Thulium-170 10.00
Thulium-171 10.00
Tin-113 10.00
Tin-125 10.00
Tungsten-181 10.00
Tungsten-185 10.00
Tungsten-187 100.00
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Uranium (natural) 100.00

Uranium-233 0.01
Uranium-234/235 0.01
Vanadium-48 10.00
Xenon-131m 1,000.00
Xenon-133 100.00
Xenon-135 100.00
Ytterbium-175 100.00
Yttrium-90 10.00
Yttrium-91 10.00
Yttrium-92 100.00
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.196 Table II: continued

Material Microcuries

Yttrium-93 100.00
Zinc-65 10.00
Zinc-69m 100.00
Zinc-69 1,000.00
Zirconium-93 10.00
Zirconium-95 10.00
Zirconium-97 10.00

Any alpha-emitting
radionuclide not listed
above or mixtures of
alpha emitters of
unknown composition 0.01

Any radionuclide other

than alpha-emittingradionuclides, not
listed above or mixtures
of beta emitters of
unknown composition 0.1

Note: For purposes of 105 CMR 120.125(C)(1), where there is involved a combination of
radionuclides in known amounts, the limit for the combination should be derived as
follows: Determine, for each radionuclide in the combination, the ratio between the
quantity present in the combination and the limit otherwise established for the specific
radionuclide when not in combination. The sum of such ratios for all the radionuclides
in the combination is R.

Note: To convert microcuries (:Ci) to SI units of kilobecquerels (kBq), multiply the above
values by 37.

Example: Zirconium-97 (10 :Ci) (37) = 370 kBq.

(10 :Ci multiplied by 37 is equivalent to 370 kBq)
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.196: Table III Quantities of Radioactive Materials Requiring Consideration of the Need for an
Emergency Plan for Responding to a Release

Radioactive Material 1 Release fraction Quantity(Ci)

Actinium-228 0.001 4,000

Americium-241 0.001 2
Americium-242 0.001 2
Americium-243 0.001 2
Antimony-124 0.01 4,000
Antimony-126 0.01 6,000
Barium-133 0.01 10,000
Barium-140 0.01 30,000
Bismuth-207 0.01 5,000
Bismuth-210 0.01 600
Cadmium-109 0.01 1,000
Cadmium-113 0.01 80
Calcium-45 0.01 20,000
Californium-252 0.001 9 (20mg)
Carbon-14 0.01 50,000
Non CO
Cerium-141 0.01 10,000
Cerium-144 0.01 300
Cesium-134 0.01 2,000
Cesium-137 0.01 3,000
Chlorine-36 0.5 100
Chromium-51 0.01 300,000
Cobalt-60 0.001 5,000
Copper-64 0.01 200,000
Curium-242 0.001 60
Curium-243 0.001 3
Curium-244 0.001 4
Curium-245 0.001 2
Europium-152 0.01 500
Europium-154 0.01 400
Europium-155 0.01 3,000
Germanium-68 0.01 2,000
Gadolinium-153 0.01 5,000
Gold-198 0.01 30,000
Hafnium-172 0.01 400
Hafnium-181 0.01 7,000
Holmium-166m 0.01 100
Hydrogen-3 0.5 20,000
Indium-114m 0.01 1,000
Iodine-125 0.5 10
Iodine-131 0.5 10
Iridium-192 0.001 40,000
Iron-55 0.01 40,000
Iron-59 0.01 7,000
Krypton-85 1.0 6000000
Lead-210 0.01 8
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Manganese-56 0.01 60,000

Mercury-203 0.01 10,000
Molybdenum-99 0.01 30,000
Neptunium-237 0.001 2
Nickel-63 0.01 20,000
Niobium-94 0.01 300
Phosphorus-32 0.5 100
____________________
1
For combinations of radioactive materials, consideration of the need for an emergency plan is
required if the sum of the ratios of the quantity of each radioactive material authorized to the quantity
listed for that material in Table III exceeds one.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.196 Table III: continued

Radioactive Material 1 Release fraction Quantity(Ci)

Phosphorus-33 0.5 1,000

Polonium-210 0.01 10
Potassium-42 0.01 9,000
Promethium-145 0.01 4,000
Promethium-147 0.01 4,000
Radium-226 0.001 100
Ruthenium-106 0.01 200
Samarium-151 0.01 4,000
Scandium-46 0.01 3,000
Selenium-75 0.01 10,000
Silver-110m 0.01 1,000
Sodium-22 0.01 9,000
Sodium-24 0.01 10,000
Strontium-89 0.01 3,000
Strontium-90 0.01 90
Sulphur-35 0.5 900
Technetium-99 0.01 10,000
Technetium-99m 0.01 400,000
Tellurium-127m 0.01 5,000
Tellurium-129m 0.01 5,000
Terbium-160 0.01 4,000
Thulium-170 0.01 4,000
Tin-113 0.01 10,000
Tin-123 0.01 3,000
Tin-126 0.01 1,000
Titanium-44 0.01 100
Vanadium-48 0.01 7,000
Xenon-133 1.0 900,000
Yttrium-91 0.01 2,000
Zinc-65 0.01 5,000
Zirconium-93 0.01 400
Zirconium-95 0.01 5,000
Any other beta-gamma emitter 0.01 10,000
Mixed fission products 0.01 1,000
Mixed corrosion products 0.01 10,000
Contaminated equipment $-( 0.001 10,000
Irradiated material, any form
other than solid noncombustible 0.01 1,000
Irradiated material, solid
noncombustible 0.001 10,000
Mixed radioactive waste, $-( 0.01 1,000
Packaged mixed waste 3 0.001 10,000
Contaminated equipment, alpha 0.0001 20
Any other alph emitter 0.001 2
Packaged waste alpha 2 0.0001 20
Combinations of radioactive
materials listed1 ------ ----
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

____________________
1
For combinations of radioactive materials, consideration of the need for an emergency plan
is required if the sum of the ratios of the quantity of each radioactive material authorized to
the quantity listed for that material in Table III exceeds one.
2
For combinations of radioactive materials, consideration of the need for an emergency plan
is required if the sum of the ratios of the quantity of each radioactive material authorized to
the quantity listed for the material in Table III exceeds one.
3
Waste packaged in Type B containers does not require an emergency plan.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.197: Appendix C -- Limits for Broad Licenses

RADIOACTIVE MATERIAL COLUMN I COLUMN II

CURIES CURIES
Antimony-122 1.0 0.01
Antimony-124 1.0 0.01
Antimony-125 1.0 0.01
Arsenic-73 10.0 0.1
Arsenic-74 1.0 0.01
Arsenic-76 1.0 0.01
Arsenic-77 10.0 0.1
Barium-131 10.0 0.1
Barium-140 1.0 0.01
Beryllium-7 10.0 0.1
Bismuth-210 0.1 0.001
Bromine-82 10.0 0.1
Cadmium-109 1.0 0.01
Cadmium-115m 1.0 0.01
Cadmium-115 10.0 0.1
Calcium-45 1.0 0.01
Calcium-47 10.0 0.1
Carbon-14 100.0 1.0
Cerium-141 10.0 0.1
Cerium-143 10.0 0.1
Cerium-144 0.1 0.001
Cesium-131 100.0 1.0
Cesium-134m 100.0 1.0
Cesium-134 0.1 0.001
Cesium-135 1.0 0.01
Cesium-136 10.0 0.1
Cesium-137 0.1 0.001
Chlorine-36 1.0 0.01
Chlorine-38 100.0 1.0
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.197: continued

RADIOACTIVE MATERIAL COLUMN I COLUMN II

CURIES CURIES
Chromium-51 100.0 1.0
Cobalt-57 10.0 0.1
Cobalt-58m 100.0 1.0
Cobalt-58 1.0 0.01
Cobalt-60 0.1 0.001
Copper-64 10.0 0.1
Dysprosium-165 100.0 1.0
Dysprosium-166 10.0 0.1
Erbium-169 10.0 0.1
Erbium-171 10.0 0.1
Europium-152 10.0 0.1
(9.2 h)
Europium-152 (13 y) 0.1 0.001
Europium-154 0.1 0.001
Europium-155 1.0 0.01
Fluorine-18 100.0 1.0
Gadolinium-153 1.0 0.01
Gadolinium-159 10.0 0.1
Gallium-72 10.0 0.1
Germanium-71 100.0 1.0
Gold-198 10.0 0.1
Gold-199 10.0 0.1
Hafnium-181 1.0 0.01
Holmium-166 10.0 0.1
Hydrogen-3 100.0 1.0
Indium-113m 100.0 1.0
Indium-114m 1.0 0.01
Indium-115m 100.0 1.0
Indium-115 1.0 0.01
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.197: continued

RADIOACTIVE MATERIAL COLUMN I COLUMN II

CURIES CURIES
Iodine-125 0.1 0.001
Iodine-126 0.1 0.001
Iodine-129 0.1 0.001
Iodine-131 0.1 0.001
Iodine-132 10.0 0.1
Iodine-133 1.0 0.01
Iodine-134 10.0 0.1
Iodine-135 1.0 0.01
Iridium-192 1.0 0.01
Iridium-194 10.0 0.1
Iron-55 10.0 0.1
Iron-59 1.0 0.01
Krypton-85 100.0 1.0
Krypton-87 10.0 0.1
Lanthanum-140 1.0 0.01
Lutetium-177 10.0 0.1
Manganese-52 1.0 0.01
Manganese-54 1.0 0.01
Manganese-56 10.0 0.1
Mercury-197m 10.0 0.1
Mercury-197 10.0 0.1
Mercury-203 1.0 0.01
Molybdenum-99 10.0 0.1
Neodymium-147 10.0 0.1
Neodymium-149 10.0 0.1
Nickel-59 10.0 0.1
Nickel-63 1.0 0.01
Nickel-65 10.0 0.1
Niobium-93m 1.0 0.01
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.197: continued

RADIOACTIVE MATERIAL COLUMN I COLUMN II

CURIES CURIES
Niobium-95 1.0 0.01
Niobium-97 100.0 1.0
Osmium-185 1.0 0.01
Osmium-191m 100.0 1.0
Osmium-191 10.0 0.1
Osmium-193 10.0 0.1
Palladium-103 10.0 0.1
Palladium-109 10.0 0.1
Phosphorus-32 1.0 0.01
Phosphorus-33 10.0 0.1
Platinum-191 10.0 0.1
Platinum-193m 100.0 1.0
Platinum-193 10.0 0.1
Platinum-197m 100.0 1.0
Platinum-197 10.0 0.1
Polonium-210 0.01 0.0001
Potassium-42 1.0 0.01
Praseodymium-142 10.0 0.1
Praseodymium-143 10.0 0.1
Promethium-147 1.0 0.01
Promethium-149 10.0 0.1
Radium-226 0.01 0.0001
Rhenium-186 10.0 0.1
Rhenium-188 10.0 0.1
Rhodium-103m 1,000.0 10.0
Rhodium-105 10.0 0.1
Rubidium-86 1.0 0.01
Rubidium-87 1.0 0.01
Ruthenium-97 100.0 1.0
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.197: continued

RADIOACTIVE MATERIAL COLUMN I COLUMN II

CURIES CURIES
Ruthenium-103 1.0 0.01
Ruthenium-105 10.0 0.1
Ruthenium-106 0.1 0.001
Samarium-151 1.0 0.01
Samarium-153 10.0 0.1
Scandium-46 1.0 0.01
Scandium-47 10.0 0.1
Scandium-48 1.0 0.01
Selenium-75 1.0 0.01
Silicon-31 10.0 0.1
Silver-105 1.0 0.01
Silver-110m 0.1 0.001
Silver-111 10.0 0.1
Sodium-22 0.1 0.001
Sodium-24 1.0 0.01
Strontium-85m 1,000.0 10.0
Strontium-85 1.0 0.01
Strontium-89 1.0 0.01
Strontium-90 0.01 0.0001
Strontium-91 10.0 0.1
Strontium-92 10.0 0.1
Sulphur-35 10.0 0.1
Tantalum-182 1.0 0.01
Technetium-96 10.0 0.1
Technetium-97m 10.0 0.1
Technetium-97 10.0 0.1
Technetium-99m 100.0 1.0
Technetium-99 1.0 0.01
Tellurium-125m 1.0 0.01
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.197: continued

RADIOACTIVE MATERIAL COLUMN I COLUMN II

CURIES CURIES
Tellurium-127m 1.0 0.01
Tellurium-127 10.0 0.1
Tellurium-129m 1.0 0.01
Tellurium-129 100.0 1.0
Tellurium-131m 10.0 0.1
Tellurium-132 1.0 0.01
Terbium-160 1.0 0.01
Thallium-200 10.0 0.1
Thallium-201 10.0 0.1
Thallium-202 10.0 0.1
Thallium-204 1.0 0.01
Thulium-170 1.0 0.01
Thulium-171 1.0 0.01
Tin-113 1.0 0.01
Tin-125 1.0 0.01
Tungsten-181 1.0 0.01
Tungsten-185 1.0 0.01
Tungsten-187 10.0 0.1
Vanadium-48 1.0 0.01
Xenon-131m 1,000.0 10.0
Xenon-133 100.0 1.0
Xenon-135 100.0 1.0
Ytterbium-175 10.0 0.1
Yttrium-90 1.0 0.01
Yttrium-91 1.0 0.01
Yttrium-92 10.0 0.1
Yttrium-93 1.0 0.01
Zinc-65 1.0 0.01
Zinc-69m 10.0 0.1
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.197: continued

RADIOACTIVE MATERIAL COLUMN I COLUMN II

CURIES CURIES
Zinc-69 100.0 1.0
Zirconium-93 1.0 0.01
Zirconium-95 1.0 0.01
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.197: continued

RADIOACTIVE MATERIAL COLUMN I COLUMN II

CURIES CURIES
Zirconium-97 1.0 0.01
Any Radioactive material 0.1 0.001
other than source material,
special nuclear material, or
alpha emitting radioactive
material not listed above.

Note 1:To convert curies (Ci) to SI units of gigabecquerels (GBq), multiply the above values by
37.

Example: Zirconium-97 (Col. II) (0.01 Ci multiplied by 37 is equivalent to 0.37 GBq)

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.198: Appendix D: Criteria Relating to Use of Financial Tests and Parent Company Guarantees for
Providing Reasonable Assurance of Funds for Decommissioning

I. Introduction. An applicant or licensee may provide reasonable assurance of the availability

of funds for decommissioning based on obtaining a parent company guarantee that funds will be
available for decommissioning costs and on a demonstration that the parent company passes a
financial test. 105 CMR 120.198: Appendix D establishes criteria for passing the financial test
and for obtaining the parent company guarantee.

II. Financial Test.

(A) To pass the financial test, the parent company must meet the criteria of either II.A.1 or
II.A.2:

(1) The parent company must have:

(a) Two of the following three ratios: A ratio of total liabilities to net worth less than
2.0; a ratio of the sum of net income plus depreciation, depletion, and amortization to
total liabilities greater than 0.1; and a ratio of current assets to current liabilities greater
than 1.5;

(b) Net working capital and tangible net worth each at least six times the current
decommissioning cost estimates (or prescribed amount if a certification is used);

(c) Tangible net worth of at least $21 million; and

(d) Assets located in the United States amounting to at least 90% of total assets or at
least six times the current decommissioning cost estimates (or prescribed amount if a
certification is used).

(2) The parent company must have:

(a) A current rating for its most recent uninsured, uncollateralized, and unencumbered
bond issuance of AAA, AA, A, or BBB (including adjustments of + and - ) as issued by
Standard and Poor's or Aaa, Aa, A, or Baa (including adjustments of 1, 2, or 3) as issued
by Moody's;

(b) Tangible net worth at least six times the current decommissioning cost estimate (or
prescribed amount if a certification is used);

(c) Tangible net worth of at least $21 million; and

(d) Assets located in the United States amounting to at least 90% of total assets or at
least six times the current decommissioning cost estimates (or prescribed amount if
certification is used).

(B) The parent company's independent certified public accountant must have compared the data
used by the parent company in the financial test, which is derived from the independently
audited, year-end financial statement. In connection with that procedure, the licensee shall
inform the Agency within 90 days of any matters coming to the auditor's attention that cause the
auditor to believe that the data specified in the financial test should be adjusted and that the
company no longer passes the test.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(C) (1) After the initial financial test, the parent company must repeat the passage of the test
within 90 days after the close of each succeeding fiscal year.

(2) If the parent company no longer meets the requirements of II.A, the licensee must send
notice to the Agency of intent to establish alternate financial assurance as specified in the
Agency's regulations. The notice must be sent by certified mail within 90 days after the end
of the fiscal year for which the year end financial data show that the parent company no
longer meets the financial test requirements. The licensee must provide alternate financial
assurance within 120 days after the end of such fiscal year.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.198: continued

III. Parent Company Guarantee. The terms of a parent company guarantee that an applicant or
licensee obtains must provide that:

(A) The parent company guarantee will remain in force unless the guarantor sends notice of
cancellation by certified mail to the licensee and the Agency. Cancellation may not occur,
however, during the 120 days beginning on the date of receipt of the notice of cancellation by
both the licensee and the Agency, as evidenced by the return receipts.

(B) If the licensee fails to provide alternate financial assurance as specified in the Agency's
regulations within 90 days after receipt by the licensee and the Agency of a notice of cancellation
of the parent company guarantee from the guarantor, the guarantor will provide such alternative
financial assurance in the name of the licensee.

(C) The parent company guarantee and financial test provisions must remain in effect until the
Agency has terminated the license.

(D) If a trust is established for decommissioning costs, the trustee and trust must be acceptable
to the Agency. An acceptable trustee includes an appropriate state or federal government agency
or an entity that has the authority to act as a trustee and whose trust operations are regulated and
examined by a federal or state agency.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.198: Appendix E: Criteria Relating to Use of Financial Tests and Self Guarantees for Providing
Reasonable Assurance of Funds for Decommissioning

I. Introduction. An applicant or licensee may provide reasonable assurance of the availability

of funds for decommissioning based on furnishing its own guarantee that funds will be available
for decommissioning costs and on a demonstration that the company passes the financial test of
105 CMR 120.198: Appendix E, Section II. The terms of the self-guarantee are in 105 CMR
120.198: Appendix E, Section III. 105 CMR 120.198: Appendix E establishes criteria for
passing the financial test for the self-guarantee and establishes the terms for a self-guarantee.

II. Financial Test.

(A) To pass the financial test, a company must meet all of the following criteria:

(1) Tangible net worth of at least $21 million, and at least ten times the total current
decommissioning cost estimate (or the current amount required if certification is used) for
all decommissioning activities for which the company is responsible as self-guaranteeing
licensee and as parent-guarantor.

(2) Assets located in the United States amounting to at least 90% of total assets or at least
ten times the total current decommissioning cost estimate (or the current amount required if
certification is used) for all decommissioning activities for which the company is responsible
as self-guaranteeing licensee and as parent-guarantor.

(3) A current rating for its most recent uninsured, uncollateralized, and unencumbered bond
issuance of AAA, AA, or A (including adjustments of + and - ) as issued by Standard and
Poors (S&P), Aaa, Aa, or A (including adjustments of 1, 2, or 3) as issued by Moody's.

(B) To pass the financial test, a company must meet all of the following additional
requirements:

(1) The company must have at least one class of equity securities registered under the
Securities Exchange Act of 1934.

(2) The company's independent certified public accountant must have compared the data
used by the company in the financial test which is derived from the independently audited,
year-end financial statements for the latest fiscal year, with the amounts in such financial
statement. In connection with that procedure, the licensee shall inform the Agency within
90 days of any matters coming to the attention of the auditor that cause the auditor to believe
that the data specified in the financial test should be adjusted and that the company no longer
passes the test.

(3) After the initial financial test, the company must repeat passage of the test within 90
days after the close of each succeeding fiscal year.

(C) If the licensee no longer meets the requirements of 105 CMR 120.198: Appendix E, Section
II.(A), the licensee must send immediate notice to the Agency of its intent to establish alternate
financial assurance as specified in the Agency's regulations within 120 days of such notice.

III. Company Self-Guarantee. The terms of a self-guarantee which an applicant or licensee

furnishes must provide that:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(A) The guarantee will remain in force unless the licensee sends notice of cancellation by
certified mail to the Agency. Cancellation may not occur, however, during the 120 days
beginning on the date of receipt of the notice of cancellation by the Agency, as evidenced by the
return receipts.

(B) The licensee shall provide alternative financial assurance as specified in the Agency's
regulations within 90 days following receipt by the Agency of a notice of cancellation of the
guarantee.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.198: continued

(C) The guarantee and financial test provisions must remain in effect until the Agency has
terminated the license or until another financial assurance method acceptable to the Agency has
been put in effect by the licensee.

(D) The licensee will promptly forward to the Agency and the licensee's independent auditor
all reports covering the latest fiscal year filed by the licensee with the Securities and Exchange
Commission pursuant to the requirements of section 13 of the Securities and Exchange Act of
1934.

(E) If, at any time, the licensee's most recent bond issuance ceases to be rated in any category
of "A" or above by either Standard and Poors or Moodys, the licensee will provide notice in
writing of such fact to the Agency within 20 days after publication of the change by the rating
service. If the licensee's most recent bond issuance ceases to be rated in any category of A or
above by both Standard and Poors and Moodys, the licensee no longer meets the requirements
of 105 CMR 120 198: Appendix E, Section II.(A).

(F) The applicant or licensee must provide to the Agency a written guarantee (a written
commitment by a corporate officer) which states that the licensee will fund and carry out the
required decommissioning activities or, upon issuance of an order by the Agency, the licensee
will set up and fund a trust in the amount of the current cost estimates for decommissioning.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.198: Appendix F: Criteria Relating to Use of Financial Tests and Self Guarantees for Providing
Reasonable Assurance of Funds for Decommissioning by Commercial Companies That Have No
Outstanding Rated Bonds

I. Introduction. An applicant or licensee may provide reasonable assurance of the availability

of funds for decommissioning based on furnishing its own guarantee that funds will be available
for decommissioning costs and on a demonstration that the company passes the financial test of
105 CMR 120.198: Appendix F, Section II. The terms of the self-guarantee are in 105 CMR
120.198: Appendix F, Section III. 105 CMR 120.198: Appendix F establishes criteria for
passing the financial test for the self-guarantee and establishes the terms for a self-guarantee.

II. Financial Test.

(A) To pass the financial test, a company must meet all of the following criteria:

(1) Tangible net worth greater than $21 million, or at least ten times the total current
decommissioning cost estimate (or the current amount required if certification is used)
whichever is greater, for all decommissioning activities for which the company is responsible
as self-guaranteeing licensee and as parent-guarantor.

(2) Assets located in the United States amounting to at least 90% of total assets or at least
ten times the total current decommissioning cost estimate (or the current amount required if
certification is used) for all decommissioning activities for which the company is responsible
as self-guaranteeing licensee and as parent-guarantor.

(3) A ratio of cash flow divided by total liabilities greater than 0.15 and a ratio of total
liabilities divided by net worth less than 1.5.

(B) In addition, to pass the financial test, a company must meet all of the following additional
requirements:

(1) The company's independent certified public accountant must have compared the data
used by the company in the financial test, which is required to be derived from the
independently audited year end financial statement based on United States generally accepted
accounting practices for the latest fiscal year, with the amounts in such financial statement.
In connection with that procedure, the licensee shall inform the Agency within 90 days of any
matters that may cause the auditor to believe that the data specified in the financial test
should be adjusted and that the company no longer passes the test.

(2) After the initial financial test, the company must repeat passage of the test within 90
days after the close of each succeeding fiscal year.

(3) If the licensee no longer meets the requirements of 105 CMR 120.198: Appendix F,
Section II.(A), the licensee must send immediate notice to the Agency of its intent to
establish alternate financial assurance as specified in 105 CMR 120.125(C). The notice must
be sent by certified mail, return receipt requested, within 90 days after the end of the fiscal
year for which the year end financial data show that the licensee no longer meets the financial
test requirements. The licensee must provide alternative financial assurance within 120 days
after the end of such fiscal year.

III. Company Self-guarantee. The terms of a self-guarantee which an applicant or licensee

furnishes must provide that:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(A) The guarantee shall remain in force unless the licensee sends notice of cancellation by
certified mail, return receipt requested, to the Agency. Cancellation may not occur until an
alternative financial assurance mechanism is in place.

(B) The licensee shall provide alternative financial assurance as specified in the Agency's
regulations within 90 days following receipt by the Agency of a notice of cancellation of the
guarantee.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.198: continued

(C) The guarantee and financial test provisions must remain in effect until the Agency has
terminated the license or until another financial assurance method acceptable to the Agency has
been put in effect by the licensee.

(D) The applicant or licensee must provide to the Agency a written guarantee (a written
commitment by a corporate officer) which states that the licensee will fund and carry out the
required decommissioning activities or, upon issuance of an order by the Agency, the licensee
will set up and fund a trust in the amount of the current cost estimates for decommissioning.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.198: Appendix G: Criteria Relating to Use of Financial Tests and Self Guarantee for Providing
Reasonable Assurance of Funds for Decommissioning by Nonprofit Colleges, Universities, and
Hospitals

I. Introduction. An applicant or licensee may provide reasonable assurance of the availability

of funds for decommissioning based on furnishing its own guarantee that funds will be available
for decommissioning costs and on a demonstration that the applicant or licensee passes the
financial test of 105 CMR 120.198: Appendix G, Section II. The terms of the self-guarantee are
in 105 CMR 120.198: Appendix G, Section III. 105 CMR 120.198: Appendix G establishes
criteria for passing the financial test for the self-guarantee and establishes the terms for a
self-guarantee.

II. Financial Test.

(A) For colleges and universities, to pass the financial test a college or university must meet
either the criteria in 105 CMR 120.198: Appendix G, Section II.(A)(1) or the criteria in 105 CMR
120.198: Appendix G, Section II.(A)(2).

(1) For applicants or licensees that issue bonds, a current rating for its most recent
uninsured, uncollateralized, and unencumbered bond issuance of AAA, AA, or A (including
adjustments of + or - ) as issued by Standard and Poor's (S&P) or Aaa, Aa, or A (including
adjustments of 1, 2, or 3) as issued by Moody's.

(2) For applicants or licensees that do not issue bonds, unrestricted endowment consisting
of assets located in the United States of at least $50 million, or at least 30 times the total
current decommissioning cost estimate (or the current amount required if certification is
used), whichever is greater, for all decommissioning activities for which the college or
university is responsible as a self-guaranteeing licensee.

(B) For hospitals, to pass the financial test a hospital must meet either the criteria in 105 CMR
120.198: Appendix G, Section II.(B)(1) or the criteria in 105 CMR 120.198: Appendix G, Section
II.(B)(2):

(1) For applicants or licensees that issue bonds, a current rating for its most recent
uninsured, uncollateralized, and unencumbered bond issuance of AAA, AA, or A (including
adjustments of + or - ) as issued by Standard and Poor's (S&P) or Aaa, Aa, or A (including
adjustments of 1, 2, or 3) as issued by Moody's.

(2) For applicants or licensees that do not issue bonds, all the following tests must be met:

(a) (Total Revenues less total expenditures) divided by total revenues must be equal to
or greater than 0.04.

(b) Long term debt divided by net fixed assets must be less than or equal to 0.67.

(c) (Current assets and depreciation fund) divided by current liabilities must be greater
than or equal to 2.55.

(d) Operating revenues must be at least 100 times the total current decommissioning
cost estimate (or the current amount required if certification is used) for all
decommissioning activities for which the hospital is responsible as a self-guaranteeing
license.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(C) In addition, to pass the financial test, a licensee must meet the following requirements: (for
institutions using 105 CMR 120.198: Appendix G: Section II, (A)(2) method of qualifying; for
a self-guarantee 105 CMR 120.198: Appendix G: Sections II(C)(1) and II(C)(2) will apply.
(1) The licensee's independent certified public accountant must have compared the data
used by the licensee in the financial test, which is required to be derived from the
independently audited year end financial statements, based on United States generally
accepted accounting practices, for the latest fiscal year, with the amounts in such financial
statement. In connection with that procedure, the licensee shall inform the Agency within
90 days of any matters coming to the attention of the auditor that cause the auditor to believe
that the data specified in the financial test should be adjusted and that the licensee no longer
passes the test.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.198: continued

(2) After the initial financial test, the licensee must repeat passage of the test within 90 days
after the close of each succeeding fiscal year.

(3) If the licensee no longer meets the requirements of 105 CMR 120.198: Appendix G:
Section I, the licensee must send notice to the Agency of its intent to establish alternative
financial assurance as specified in Agency regulations. The notice must be sent by certified
mail, return receipt requested, within 90 days after the end of the fiscal year for which the
year end financial data show that the licensee no longer meets the financial test requirements.
The licensee must provide alternate financial assurance within 120 days after the end of such
fiscal year.

III. Self-guarantee. The terms of a self-guarantee which an applicant or licensee furnishes must
provide that:

(A) The guarantee shall remain in force unless the licensee sends notice of cancellation by
certified mail, and/or return receipt requested, to the Agency. Cancellation may not occur unless
an alternative financial assurance mechanism is in place.

(B) The licensee shall provide alternative financial assurance as specified in 105 CMR
120.125(C) within 90 days following receipt by the Agency of a notice of cancellation of the
guarantee.

(C) The guarantee and financial test provisions must remain in effect until the Agency has
terminated the license or until another financial assurance method acceptable to the Agency has
been put in effect by the licensee.

(D) The applicant or licensee must provide to the Agency a written guarantee (a written
commitment by a corporate officer or officer of the institution) which states that the licensee will
fund and carry out the required decommissioning activities or, upon issuance of an order by the
Agency, the licensee will set up and fund a trust in the amount of the current cost estimates for
decommissioning.

(E) If, at any time, the licensee's most recent bond issuance ceases to be rated in any category
of "A" or above by either Standard and Poor’s or Moody’s, the licensee shall provide notice in
writing of such fact to the Agency within 20 days after publication of the change by the rating
service.

(F) If, at any time, the licensee's most recent bond issuance ceases to be rated in any category
of "A" or above by either Standard and Poor’s or Moody’s, the licensee will provide notice in
writing of such fact to the Agency within 20 days after publication of the change by the rating
service. If the licensee's most recent bond issuance ceases to be rated in any category of A or
above by both Standard and Poor’s and Moody’s, the licensee no longer meets the requirements
of 105 CMR 120 199: Appendix E, Section II.(A).
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.200: STANDARDS FOR PROTECTION AGAINST RADIATION

120.201: Purpose

(A) 105 CMR 120.200 establishes standards for protection against ionizing radiation resulting
from activities conducted pursuant to licenses or registrations issued by the Agency. The
requirements of 105 CMR 120.200 are designed to control the receipt, possession, use, transfer,
and disposal of sources of radiation by any licensee or registrant so the total dose to an
individual, including doses resulting from all sources of radiation other than background
radiation, does not exceed the standards for protection against radiation prescribed in 105 CMR
120.200. However, nothing in 105 CMR 120.200 shall be construed as limiting actions that may
be necessary to protect health and safety.

(B) 105 CMR 120.200 is issued pursuant to M.G.L. c. 111, §§ 3, 5M, 5N, 5O, 5P.

120.202: Scope

Except as otherwise specifically provided in other Parts of 105 CMR 120.000, 105 CMR
120.200 applies to persons licensed or registered by the Department to receive, possess, use,
transfer, or dispose of sources of radiation. The limits in 105 CMR 120.200 do not apply to
doses due to background radiation, to exposure of patients to radiation for the purpose of medical
diagnosis or therapy, to exposure from individuals administered radioactive material and released
in accordance with 105 CMR 120.540 or to voluntary participation in medical research
programs.

120.203: Definitions

As used in 105 CMR 120.200, the following definitions apply:

Annual Limit on Intake (ALI) means the derived limit for the amount of radioactive material
taken into the body of an adult worker by inhalation or ingestion in one year. ALI is the smaller
value of intake of a given radionuclide in one year by Reference Man that would result in a
committed effective dose equivalent of 0.05 sievert (5 rem) or a committed dose equivalent of
0.5 sievert (50 rems) to any individual organ or tissue. ALI values for intake by ingestion and
by inhalation of selected radionuclides are given in 105 CMR 120.296: Appendix B, Table I,
Columns 1 and 2.

Class means a classification scheme for inhaled material according to its rate of clearance from
the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a
range of clearance half-times: for Class D, Days, of less than ten days, for Class W, Weeks, from
ten to 100 days, and for Class Y, Years, of greater than 100 days. For purposes of 105 CMR
120.000, "lung class" and "inhalation class" are equivalent terms.

Declared Pregnant Woman means a woman who has voluntarily informed the licensee or
registrant, in writing, of her pregnancy and the estimated date of conception. The declaration
remains in effect until the declared pregnant woman withdraws the declaration in writing or is
no longer pregnant.

Derived Air Concentration (DAC) means the concentration of a given radionuclide in air which,
if breathed by Reference Man for a working year of 2,000 hours under conditions of light work,
results in an intake of one ALI. For purposes of 105 CMR 120.000, the condition of light work
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

is an inhalation rate of 1.2 cubic meters of air per hour for 2,000 hours in a year. DAC values
are given in 105 CMR 120.296: Appendix B, Table I, Column 3.

Derived Air Concentration-hour (DAC-hour) means the product of the concentration of

radioactive material in air, expressed as a fraction or multiple of the derived air concentration
for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee may
take 2,000 DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent
of 0.05 sievert (5 rems).
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.203: continued

Dosimetry Processor means an individual or an organization that processes and evaluates

individual monitoring equipment in order to determine the radiation dose delivered to the
monitoring equipment.

Inhalation Class see Class.

Lung Class see Class.

Nationally Tracked Source means a sealed source containing a quantity equal to or greater than
Category 1 or Category 2 levels of any radioactive material listed in 105 CMR
120.298: Appendix D. In this context a sealed source is defined as radioactive material that is
sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory
control. It does not mean material encapsulated solely for disposal, or nuclear material contained
in any fuel assembly, subassembly, fuel rod, or fuel pellet. Category 1 nationally tracked sources
are those containing radioactive material at a quantity equal to or greater than the Category 1
threshold. Category 2 nationally tracked sources are those containing radioactive material at a
quantity equal to or greater than the Category 2 threshold but less than the Category 1 threshold.

Nonstochastic Effect means a health effect, the severity of which varies with the dose and for
which a threshold is believed to exist. Radiation-induced cataract formation is an example of a
nonstochastic effect. For purposes of 105 CMR 120.000: Deterministic Effect is an equivalent
term.

Planned Special Exposure means an infrequent exposure to radiation, separate from and in
addition to the annual occupational dose limits.

Quarter means a period of time equal to ¼ of the year observed by the licensee or registrant,
approximately 13 consecutive weeks, providing that the beginning of the first quarter in a year
coincides with the starting date of the year and that no day is omitted or duplicated in consecutive
quarters.

Reference Man means a hypothetical aggregation of human physical and physiological

characteristics determined by international consensus. These characteristics may be used by
researchers and public health employees to standardize results of experiments and to relate
biological insult to a common base. A description of Reference Man is contained in the
International Commission on Radiological Protection report, ICRP Publication 23, Report of the
Task Group on Reference Man.

Respiratory Protective Device means an apparatus, such as a respirator, used to reduce an

individual's intake of airborne radioactive materials.

Sanitary Sewerage means a system of public sewers for carrying off waste water and refuse, but
excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the
licensee or registrant.

Stochastic Effect means a health effect that occurs randomly and for which the probability of the
effect occurring, rather than its severity, is assumed to be a linear function of dose without
threshold. Hereditary effects and cancer incidence are examples of stochastic effects. For
purposes of 105 CMR 120.000: Probabilistic Effect is an equivalent term.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Very High Radiation Area means an area, accessible to individuals, in which radiation levels
from radiation sources external to the body could result in an individual receiving an absorbed
dose in excess of 500 rads (five grays) in one hour at one meter from a source of radiation or
from any surface that the radiation penetrates. (At very high doses received at high dose rates,
units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, sievert
and rem.)

Weighting Factor WT for an Organ or Tissue (T) means the proportion of the risk of stochastic
effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when
the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values
of WT are:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.203: continued

ORGAN DOSE WEIGHTING FACTORS

Organ or
wT
Tissue
Gonads 0.25
Breast 0.15
Red bone marrow 0.12
Lung 0.12
Thyroid 0.03
Bone surfaces 0.03
Remainder 0.30*

Whole Body 1.00**

*
0.30 results from 0.06 for each of 5 "remainder" organs, excluding the skin and the lens of the
eye, that receive the highest doses.
**
For the purpose of weighting the external whole body dose, for adding it to the internal dose, a
single weighting factor, wT = 1.0, has been specified. The use of other weighting factors for
external exposure will be approved on a case-by-case basis until such time as specific guidance
is issued.

120.204 Implementation

(A) Any existing license or certificate of registration condition that is more restrictive than
105 CMR 120.200 remains in force until there is an amendment or renewal of the license or
registration.

(B) If a license or certificate of registration condition exempts a licensee or registrant from a

provision of 105 CMR 120.200 in effect on or before July 9, 1999, it also exempts the licensee
or registrant from the corresponding provision of 105 CMR 120.200.

(C) If a license or registration condition cites provisions of 105 CMR 120.200 in effect prior
to July 9, 1999, which do not correspond to any provisions of the revised 105 CMR 120.200, the
license or registration condition remains in force until there is an amendment or renewal of the
license or registration that modifies or removes this condition.

120.210: Radiation Protection Programs

(A) Each licensee or registrant shall develop, document, and implement a radiation protection
program sufficient to ensure compliance with the provisions of 105 CMR 120.200. See
105 CMR 120.262 for recordkeeping requirements relating to these programs.

(B) The licensee or registrant shall use, to the extent practical, procedures and engineering
controls based upon sound radiation protection principles to achieve occupational doses and
doses to members of the public that are as low as is reasonably achievable (ALARA).

(C) The licensee or registrant shall, at intervals not to exceed 12 months, review the radiation
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

protection program content and implementation.

(D) To implement the ALARA requirements of 105 CMR 120.210(B), and notwithstanding
the requirements in 105 CMR 120.221, a constraint on air emissions of radioactive material to
the environment, excluding Radon-222 and its daughters, shall be established by licensees, such
that the individual member of the public likely to receive the highest dose will not be expected
to receive a total effective dose equivalent in excess of 0.1 mSv (ten mrem) per year from these
emissions. If a licensee subject to this requirement exceeds this dose constraint, the licensee
shall report the exceedance as provided in 105 CMR 120.283 and promptly take appropriate
corrective action to ensure against recurrence.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.211: Occupational Dose Limits for Adults

(A) The licensee or registrant shall control the occupational dose to individual adults, except
for planned special exposures pursuant to 105 CMR 120.216, to the following dose limits:
(1) An annual limit, which is the more limiting of:
(a) the total effective dose equivalent being equal to .05 sievert (five rems); or
(b) the sum of the deep dose equivalent and the committed dose equivalent to any
individual organ or tissue other than the lens of the eye being equal to 0.5 sievert (50
rems).
(2) The annual limits to the lens of the eye, to the skin, and to the extremities which are:
(a) a lens dose equivalent of 0.15 sievert (15 rems); and
(b) a shallow dose equivalent of 0.5 sievert (50 rems) to the skin of the whole body or
to the skin of any extremity.

(B) Doses received in excess of the annual limits, including doses received during accidents,
emergencies, and planned special exposures, shall be subtracted from the limits for planned
special exposures that the individual may receive during the current year and during the
individual's lifetime. See 105 CMR 120.216(E)(1) and (2).

(C) (1) When the external exposure is determined by measurement with an external personal
monitoring device, the deep-dose equivalent must be used in place of the effective dose
equivalent, unless the effective dose equivalent is determined by a dosimetry method
approved by the Agency. The assigned deep-dose equivalent must be for the part of the body
receiving the highest exposure. The assigned shallow-dose equivalent must be the dose
averaged over the contiguous ten square centimeters of skin receiving the highest exposure.
The deep-dose equivalent, lens-dose equivalent, and shallow-dose equivalent may be
assessed from surveys or other radiation measurements for the purpose of demonstrating
compliance with the occupational dose limits, if the individual monitoring device was not
in the region of highest potential exposure, or the results of individual monitoring are
unavailable;
(2) When a protective apron is worn while working medical fluoroscopic equipment and
monitoring is conducted as specified in 105 CMR 120.226(A)(5), the effective dose
equivalent for external radiation shall be determined as follows:
(a) When only one individual monitoring device is used and it is located at the neck
(collar) outside the protective apron, the reported deep dose equivalent shall be the
effective dose equivalent for external radiation; or
(b) When only one individual monitoring device is used and it is located at the neck
(collar) outside the protective apron, and the reported dose exceeds 25% of the limit
specified in 105 CMR 120.211(A), the reported deep dose equivalent value multiplied
by 0.3 shall be the effective dose equivalent for external radiation; or
(c) When individual monitoring devices are worn, both under the protective apron at the
waist and outside the protective apron at the neck, the effective dose equivalent for
external radiation shall be assigned the value of the sum of the deep dose equivalent
reported for the individual monitoring device located at the waist under the protective
apron multiplied by 1.5 and the deep dose equivalent reported for the individual
monitoring device located at the neck outside the protective apron multiplied by 0.04.

(D) Derived air concentration (DAC) and annual limit on intake (ALI) values are specified in
105 CMR 120.296: Appendix B, Table I and may be used to determine the individual's dose and
to demonstrate compliance with the occupational dose limits. See 105 CMR 120.267.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(E) In addition to the annual dose limits, the licensee shall limit the soluble uranium intake by
an individual to ten milligrams in a week in consideration of chemical toxicity. See footnote 3
of 105 CMR 120.296: Appendix B.

(F) The licensee or registrant shall reduce the dose that an individual may be allowed to receive
in the current year by the amount of occupational dose received while employed by any other
person during the current year. See 105 CMR 120.265(E).
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.212: Compliance with Requirements for Summation of External and Internal Doses

(A) If the licensee is required to monitor pursuant to both 105 CMR 120.226(A) and (B), the
licensee shall demonstrate compliance with the dose limits by summing external and internal
doses. If the licensee or registrant is required to monitor only pursuant to 105 CMR 120.226(A)
or only pursuant to 105 CMR 120.226(B), then summation is not required to demonstrate
compliance with the dose limits. The licensee may demonstrate compliance with the
requirements for summation of external and internal doses pursuant to 105 CMR 120.212(B),
(C) and (D). The dose equivalents for the lens of the eye, the skin, and the extremities are not
included in the summation, but are subject to separate limits.

(B) Intake by Inhalation. If the only intake of radionuclides is by inhalation, the total effective
dose equivalent limit is not exceeded if the sum of the deep dose equivalent divided by the total
effective dose equivalent limit, and one of the following, does not exceed unity:
(1) the sum of the fractions of the inhalation ALI for each radionuclide;
(2) the total number of derived air concentration-hours (DAC-hours) for all radionuclides
divided by 2,000; or
(3) the sum of the calculated committed effective dose equivalents to all significantly
irradiated organs or tissues (T) calculated from bioassay data using appropriate biological
models and expressed as a fraction of the annual limit. For purposes of this requirement, an
organ or tissue is deemed to be significantly irradiated if, for that organ or tissue, the product
of the weighting factors, wT, and the committed dose equivalent, HT,50, per unit intake is
greater than 10% of the maximum weighted value of HT,50, that is, wTHT,50, per unit intake for
any organ or tissue.

(C) Intake by Oral Ingestion. If the occupationally exposed individual receives an intake of
radionuclides by oral ingestion greater than 10% of the applicable oral ALI, the licensee shall
account for this intake and include it in demonstrating compliance with the limits.

(D) Intake through Wounds or Absorption through Skin. The licensee shall evaluate and, to the
extent practical, account for intakes through wounds or skin absorption. The intake through
intact skin has been included in the calculation of DAC for hydrogen-3 and does not need to be
evaluated.

120.213: Determination of External Dose from Airborne Radioactive Material

(A) Licensees shall, when determining the dose from airborne radioactive material, include the
contribution to the deep dose equivalent, lens dose equivalent, and shallow dose equivalent from
external exposure to the radioactive cloud. See 105 CMR 120.296: Appendix B, footnotes 1 and
2.

(B) Airborne radioactivity measurements and DAC values shall not be used as the primary
means to assess the deep dose equivalent when the airborne radioactive material includes
radionuclides other than noble gases or if the cloud of airborne radioactive material is not
relatively uniform. The determination of the deep dose equivalent to an individual shall be based
upon measurements using instruments or individual monitoring devices.

120.214: Determination of Internal Exposure

(A) For purposes of assessing dose used to determine compliance with occupational dose
equivalent limits, the licensee shall, when required pursuant to 105 CMR 120.226, take suitable
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

and timely measurements of:

(1) concentrations of radioactive materials in air in work areas; or
(2) quantities of radionuclides in the body; or
(3) quantities of radionuclides excreted from the body; or
(4) combinations of these measurements.

(B) Unless respiratory protective equipment is used, as provided in 105 CMR 120.233, or the
assessment of intake is based on bioassays, the licensee shall assume that an individual inhales
radioactive material at the airborne concentration in which the individual is present.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.214: continued

(C) When specific information on the physical and biochemical properties of the radionuclides
taken into the body or the behavior of the material in an individual is known, the licensee may:
(1) use that information to calculate the committed effective dose equivalent, and, if used,
the licensee shall document that information in the individual's record;
(2) upon prior approval of the Agency, adjust the DAC or ALI values to reflect the actual
physical and chemical characteristics of airborne radioactive material, for example, aerosol
size distribution or density; and,
(3) separately assess the contribution of fractional intakes of Class D, W, or Y compounds
of a given radionuclide to the committed effective dose equivalent. See 105 CMR
120.296: Appendix B.

(D) If the licensee chooses to assess intakes of Class Y material using the measurements given
in 105 CMR 120.214(A)(2) or (3), the licensee may delay the recording and reporting of the
assessments for periods up to seven months, unless otherwise required by 105 CMR 120.282 or
105 CMR 120.283. This delay permits the licensee to make additional measurements basic to
the assessments.

(E) If the identity and concentration of each radionuclide in a mixture are known, the fraction
of the DAC applicable to the mixture for use in calculating DAC-hours shall be either:
(1) the sum of the ratios of the concentration to the appropriate DAC value, that is, D, W,
or Y, from 105 CMR 120.296: Appendix B for each radionuclide in the mixture; or,
(2) the ratio of the total concentration for all radionuclides in the mixture to the most
restrictive DAC value for any radionuclide in the mixture.

(F) If the identity of each radionuclide in a mixture is known, but the concentration of one or
more of the radionuclides in the mixture is not known, the DAC for the mixture shall be the most
restrictive DAC of any radionuclide in the mixture.

(G) When a mixture of radionuclides in air exists, a licensee may disregard certain
radionuclides in the mixture if:
(1) the licensee uses the total activity of the mixture in demonstrating compliance with the
dose limits in 105 CMR 120.211 and in complying with the monitoring requirements in 105
CMR 120.226(B);
(2) the concentration of any radionuclide disregarded is less than 10% of its DAC; and,
(3) the sum of these percentages for all of the radionuclides disregarded in the mixture does
not exceed 30%.

(H) When determining the committed effective dose equivalent, the following information may
be considered:
(1) In order to calculate the committed effective dose equivalent, the licensee may assume
that the inhalation of one ALI, or an exposure of 2,000 DAC-hours, results in a committed
effective dose equivalent of 0.05 sievert (5 rems) for radionuclides that have their ALIs or
DACs based on the committed effective dose equivalent.
(2) For an ALI and the associated DAC determined by the nonstochastic organ dose limit
of 0.5 sievert (50 rems), the intake of radionuclides that would result in a committed effective
dose equivalent of 0.05 sievert (5 rems), that is, the stochastic ALI, is listed in parentheses
in 105 CMR 120.296: Appendix B, Table I. The licensee may, as a simplifying assumption,
use the stochastic ALI to determine committed effective dose equivalent. However, if the
licensee uses the stochastic ALI, the licensee shall also demonstrate that the limit in 105
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

CMR 120.211(A)(1)(b) is met.

120.216: Planned Special Exposures

A licensee or registrant may authorize an adult worker to receive doses in addition to and
accounted for separately from the doses received under the limits specified in 105 CMR 120.211
provided that each of the following conditions is satisfied:

(A) The licensee or registrant authorizes a planned special exposure only in an exceptional
situation when alternatives that might avoid the dose estimated to result from the planned special
exposure are unavailable or impractical.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.216: continued

(B) The licensee or registrant, and employer if the employer is not the licensee or registrant,
specifically authorizes the planned special exposure, in writing, before the exposure occurs.

(C) Before a planned special exposure, the licensee or registrant ensures that each individual
involved is:
(1) informed of the purpose of the planned operation;
(2) informed of the estimated doses and associated potential risks and specific radiation
levels or other conditions that might be involved in performing the task; and
(3) instructed in the measures to be taken to keep the dose ALARA considering other risks
that may be present.

(D) Prior to permitting an individual to participate in a planned special exposure, the licensee
or registrant ascertains prior doses as required by 105 CMR 120.265(B) during the lifetime of
the individual for each individual involved.

(E) Subject to 105 CMR 120.211(B), the licensee or registrant shall not authorize a planned
special exposure that would cause an individual to receive a dose from all planned special
exposures and all doses in excess of the limits to exceed:
(1) the numerical values of any of the dose limits in 105 CMR 120.211(A) in any year; and
(2) five times the annual dose limits in 105 CMR 120.211(A) during the individual's
lifetime.

(F) The licensee or registrant maintains records of the conduct of a planned special exposure
in accordance with 105 CMR 120.266 and submits a written report to the Agency in accordance
with 105 CMR 120.284.

(G) The licensee or registrant records the best estimate of the dose resulting from the planned
special exposure in the individual's record and informs the individual, in writing, of the dose
within 30 days from the date of the planned special exposure. The dose from planned special
exposures shall not be considered in controlling future occupational dose of the individual
pursuant to 105 CMR 120.211(A) but shall be included in evaluations required by 105 CMR
120.216(D) and (E).

120.217: Occupational Dose Limits for Minors

The annual occupational dose limits for minors are 10% of the annual occupational dose
limits specified for adult workers in 105 CMR 120.211.

120.218: Dose Equivalent to an Embryo/Fetus

(A) The licensee or registrant shall ensure that the dose equivalent to an embryo/fetus during
the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not
exceed five millisieverts (0.5 rems). See 105 CMR 120.267 for recordkeeping requirements.

(B) The licensee or registrant shall make efforts to avoid substantial variation above a uniform
monthly exposure rate to a declared pregnant woman so as to satisfy the limit in 105 CMR
120.218(A).

(C) The dose equivalent to the embryo/fetus is the sum of:

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(1) the deep dose equivalent to the declared pregnant woman; and
(2) the dose equivalent resulting from radionuclides in the embryo/fetus and radionuclides
in the declared pregnant woman.

(D) If the dose equivalent to the embryo/fetus is found to have exceeded 5.0 mSv (0.5 rem), or
is within 0.5 mSv (0.05 rem) of this dose, by the time the woman declares the pregnancy to the
licensee or registrant, the licensee or registrant shall be deemed to be in compliance with
105 CMR 120.218(A), if the additional dose to the embryo/fetus does not exceed 0.5 millisievert
(0.05 rem) during the remainder of the pregnancy.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

RADIATION DOSE LIMITS

120.221: Dose Limits for Individual Members of the Public

(A) Each licensee or registrant shall conduct operations so that:

(1) the total effective dose equivalent to individual members of the public from the licensed
or registered operation does not exceed one millisievert (0.1 rem) in a year, exclusive of the
dose contribution from background radiation, from any medical administration the individual
has received, from exposure to individuals administered radioactive material and released
in accordance with 105 CMR 120.540, from voluntary participation in medical research
programs, and from the licensee's disposal of radioactive material into sanitary sewerage in
accordance with 105 CMR 120.253; and
(2) the dose in any unrestricted area from external sources exclusive of the dose
contributions from patients administered radioactive material and released in accordance with
105 CMR 120.540, does not exceed 0.02 millisievert (0.002 rem) in any one hour; and
(3) the total effective dose equivalent to individual members of the public from infrequent
exposure to radiation from radiation machines does not exceed 5mSv (0.5 rem).

(B) If the licensee or registrant permits members of the public to have access to restricted areas,
the limits for members of the public continue to apply to those individuals.

(C) A licensee, registrant, or an applicant for a license or registration may apply for prior
Agency authorization to operate up to an annual dose limit for an individual member of the
public of five millisieverts (0.5 rem). This application shall include the following information:
(1) demonstration of the need for and the expected duration of operations in excess of the
limit in 105 CMR 120.221(A);
(2) the licensee's or registrant's program to assess and control dose within the five
millisieverts (0.5 rem) annual limit; and
(3) the procedures to be followed to maintain the dose ALARA.

(D) In addition to the requirements of 105 CMR 120.200, a licensee subject to the provisions
of the U.S. Environmental Protection Agency's generally applicable environmental radiation
standards in 40 CFR 190 shall comply with those requirements.

(E) The Agency may impose additional restrictions on radiation levels in unrestricted areas and
on the total quantity of radionuclides that a licensee may release in effluents in order to restrict
the collective dose.

120.222: Compliance with Dose Limits for Individual Members of the Public

(A) The licensee or registrant shall make or cause to be made surveys of radiation levels in
unrestricted areas and radioactive materials in effluents released to unrestricted areas to demon-
strate compliance with the dose limits for individual members of the public in 105 CMR
120.221.

(B) A licensee or registrant shall show compliance with the annual dose limit in 105 CMR
120.221 by:
(1) demonstrating by measurement or calculation that the total effective dose equivalent to
the individual likely to receive the highest dose from the licensed or registered operation does
not exceed the annual dose limit; or,
(2) demonstrating that:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(a) the annual average concentrations of radioactive material released in gaseous and
liquid effluents at the boundary of the unrestricted area do not exceed the values specified
in 105 CMR 120.296: Appendix B, Table II; and,
(b) if an individual were continuously present in an unrestricted area, the dose from
external sources would not exceed 0.002 rem (0.02 millisievert) in an hour and 0.05 rem
(0.5 millisievert) in a year.

(C) Upon approval from the Agency, the licensee may adjust the effluent concentration values
in 105 CMR 120.296: Appendix B, Table II, for members of the public, to take into account the
actual physical and chemical characteristics of the effluents, such as, aerosol size distribution,
solubility, density, radioactive decay equilibrium, and chemical form.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.223: Testing for Leakage or Contamination of Sealed Sources

(A) The licensee or registrant in possession of any sealed source shall assure that:
(1) Each sealed source, except as specified in 105 CMR 120.223(B), is tested for leakage
or contamination and the test results are received before the sealed source is put into use
unless the licensee or registrant has a certificate from the transferor indicating that the sealed
source was tested within six months before transfer to the licensee or registrant.
(2) Each sealed source that is not designed to emit alpha particles is tested for leakage or
contamination at intervals not to exceed six months or at alternative intervals approved by
the Agency, after evaluation of information specified by 105 CMR 120.128(N), an
Agreement State, a Licensing State, or the U.S. Nuclear Regulatory Commission.
(3) Each sealed source that is designed to emit alpha particles is tested for leakage or
contamination at intervals not to exceed three months or at alternative intervals approved by
the Agency, after evaluation of information specified by 105 CMR 120.128(N), an
Agreement State, a Licensing State, or the Nuclear Regulatory Commission.
(4) For each sealed source that is required to be tested for leakage or contamination, at any
other time there is reason to suspect that the sealed source might have been damaged or
might be leaking, the licensee or registrant shall assure that the sealed source is tested for
leakage or contamination before further use.

(5) Tests for leakage for all sealed sources, except brachytherapy sources manufactured to
contain radium, shall be capable of detecting the presence of 185 Bq (0.005 :Ci) of
radioactive material on a test sample. Test samples shall be taken from the sealed source or
from the surfaces of the container in which the sealed source is stored or mounted on which
one might expect contamination to accumulate. For a sealed source contained in a device,
test samples are obtained when the source is in the "off" position.

(6) The test for leakage for brachytherapy sources manufactured to contain radium shall be
capable of detecting an absolute leakage rate of 37 Bq (0.001 :Ci) of radon-222 in a 24 hour
period when the collection efficiency for radon-222 and its daughters has been determined
with respect to collection method, volume and time.

(7) Tests for contamination from radium daughters shall be taken on the interior surface of
brachytherapy source storage containers and shall be capable of detecting the presence of 185
Bq (0.005 :Ci) of a radium daughter which has a half-life greater than four days.

(B) A licensee or registrant need not perform test for leakage or contamination on the following
sealed sources:
(1) Sealed sources containing only radioactive material with a half-life of less than 30 days;
(2) Sealed sources containing only radioactive material as a gas;
(3) Sealed sources containing 3.7 MBq (100 :Ci) or less of beta or photon-emitting material
or 370 kBq (10 :Ci) or less of alpha-emitting material;
(4) Sealed sources containing only hydrogen-3;
(5) Seeds of iridium-192 encased in nylon ribbon; and
(6) Sealed sources, except teletherapy and brachytherapy sources, which are stored, not
being used and identified as in storage. The licensee or registrant shall, however, test each
such sealed source for leakage or contamination and receive the test results before any use
or transfer unless it has been tested for leakage or contamination within 6 months before the
date of use or transfer.

(C) Tests for leakage or contamination from sealed sources shall be performed by persons
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

specifically authorized by the Agency, an Agreement State, a Licensing State, or the U.S.
Nuclear Regulatory Commission to perform such services.

(D) Test results shall be kept in units of becquerel or microcurie and maintained for inspection
by the Agency.

(E) The following shall be considered evidence that a sealed source is leaking:
(1) The presence of 185 Bq (0.005 :Ci) or more of removable contamination on any test
sample.
(2) Leakage of 37 Bq (0.001 :Ci) of radon-222 per 24 hours for brachytherapy sources
manufactured to contain radium.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.223: continued

(3) The presence of removable contamination resulting from the decay of 185 Bq (0.005
:Ci) or more of radium.

(F) The licensee or registrant shall immediately withdraw a leaking sealed source from use and
shall take action to prevent the spread of contamination. The leaking sealed source shall be
repaired or disposed of in accordance with this 105 CMR 120.200.

(G) Reports of test results for leaking or contaminated sealed sources shall be made pursuant
to 105 CMR 120.288.

SURVEYS AND MONITORING

120.225: General

(A) Each licensee or registrant shall make, or cause to be made, surveys of areas, including the
subsurface, that:
(1) are necessary for the licensee or registrant to comply with 105 CMR 120.200; and
(2) are necessary under the circumstances to evaluate:
(a) the magnitude and extent of radiation levels;
(b) concentrations or quantities of radioactive material residual radioactivity; and
(c) the potential radiological hazards of the radiation levels and residual radioactivity
detected.

(B) Notwithstanding the provisions in 105 CMR 120.263(A), records from surveys describing
the location and amount of subsurface residual radioactivity identified at the site must be kept
with records important for decommissioning, and such records must be retained in accordance
with 105 CMR 120.125(C)(8), as applicable.

(C) The licensee or registrant shall ensure that instruments and equipment used for quantitative
radiation measurements, for example, dose rate and effluent monitoring, are calibrated at
intervals not to exceed 12 months for the radiation measured except when a more frequent
interval is specified in another applicable section of 105 CMR 120.000 or license condition.

(D) All personnel dosimeters, except for direct and indirect reading pocket ionization chambers
and those dosimeters used to measure the dose to any extremity, that require processing to
determine the radiation dose and that are used by licensees and registrants to comply with
105 CMR 120.211, with other applicable provisions of 105 CMR 120.000, or with conditions
specified in a license or certificate of registration, shall be processed and evaluated by a
dosimetry processor:
(1) holding current personnel dosimetry accreditation from the National Voluntary
Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and
Technology; and
(2) approved in this accreditation process for the type of radiation or radiations included in
the NVLAP program that most closely approximates the type of radiation or radiations for
which the individual wearing the dosimeter is monitored.

(E) The licensee or registrant shall ensure that adequate precautions are taken to prevent a
deceptive exposure of an individual monitoring device.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.226: Conditions Requiring Individual Monitoring of External and Internal Occupational Dose

Each licensee or registrant shall monitor exposures from sources of radiation at levels
sufficient to demonstrate compliance with the occupational dose limits of 105 CMR 120.200.
As a minimum:

(A) Each licensee or registrant shall monitor occupational exposure to radiation from licensed
and unlicensed radiation sources under its control and shall supply and require the use of
individual monitoring devices by:
(1) adults likely to receive, in one year from sources external to the body, a dose in excess
of 10% of the limits in 105 CMR 120.211(A);
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.226: continued

(2) minors likely to receive, in one year from sources external to the body, a deep dose
equivalent in excess of one millisievert (0.1 rem) a lens dose equivalent in excess of 1.5
millisievert (0.15 rem), or a shallow dose equivalent to the skin or to the extremities in
excess of five millisieverts (0.5 rem);
(3) Declared pregnant women likely to receive during the entire pregnancy, from radiation
sources external to the body, a deep dose equivalent in excess of one millisievert (0.1 rem).
[Note: All of the occupational doses in 105 CMR 120.211 continue to be applicable to the
declared pregnant worker as long as the embryo/fetus dose limit is not exceeded];
(4) individuals entering a high or very high radiation area;
(5) individuals working medical fluoroscopic equipment.
(a) An individual monitoring device used for the dose to an embryo/fetus of a declared
pregnant woman, pursuant to 105 CMR 120.218(A), shall be located under the protective
apron at the waist.
(b) An individual monitoring device used for lens dose equivalent shall be located at the
neck (collar), or an unshielded location closer to the eye, outside the protective apron.
(c) When only one individual monitoring device is used to determine the effective dose
equivalent for external radiation pursuant to 105 CMR 120.211(C)(2), it shall be located
at the neck (collar) outside the protective apron. When a second individual monitoring
device is used, for the same purpose, it shall be located under the protective apron at the
waist. The second individual monitoring device is required for a declared pregnant
woman.

(B) Each licensee shall monitor, to determine compliance with 105 CMR 120.214, the
occupational intake of radioactive material by and assess the committed effective dose equivalent
to:
(1) adults likely to receive, in one year, an intake in excess of 10% of the applicable ALI
in 105 CMR 120.296: Appendix B, Table I, Columns 1 and 2; and
(2) minors likely to receive, in one year, a committed effective dose equivalent in excess
of 0.1 millisievert (0.01 rem).
(3) declared pregnant women likely to receive, during the entire pregnancy, a committed
effective dose equivalent in excess of 1m Sv (0.1 rem).

(C) Each licensee or registrant shall ensure that individuals who are required to monitor
occupational doses in accordance with 105 CMR 120.226(A) wear individual monitoring devices
as follows:
(1) An individual monitoring device used for monitoring the dose to whole body shall be
worn at the unshielded location of the whole body likely to receive the highest exposure.
When a protective apron is worn, the location of the individual monitoring device is typically
at the neck (collar).
(2) An individual monitoring device used for monitoring the dose to an embryo/fetus of a
declared pregnant woman, pursuant to 105 CMR 120.218(A), shall be located at the waist
under any protective apron being worn by the woman.
(3) An individual monitoring device used for monitoring lens dose equivalent, to
demonstrate compliance with 105 CMR 120.211(A)(2)(a), shall be located at the neck
(collar), outside any protective apron being worn by the monitored individual, or at an
unshielded location closer to the eye.
(4) An individual monitoring device used for monitoring the dose to the extremities, to
demonstrate compliance with 105 CMR 120.211(A)(2)(b), shall be worn on the extremity
most likely to receive the highest exposure. Each individual monitoring device shall be
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

oriented to measure the highest dose to the extremity being monitored.

120.227: Control of Access to High Radiation Areas

(A) The licensee or registrant shall ensure that each entrance or access point to a high radiation
area has one or more of the following features:
(1) a control device that, upon entry into the area, causes the level of radiation to be reduced
below that level at which an individual might receive a deep dose equivalent of 0.1 rem (one
millisievert) in one hour at 30 centimeters from the source of radiation or from any surface
that the radiation penetrates;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.227: continued

(2) a control device that energizes a conspicuous visible or audible alarm signal so that the
individual entering the high radiation area and the supervisor of the activity are made aware
of the entry; or,
(3) entryways that are locked, except during periods when access to the areas is required,
with positive control over each individual entry.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.227: continued

(B) In place of the controls required by 105 CMR 120.227(A) for a high radiation area, the
licensee or registrant may substitute continuous direct or electronic surveillance that is capable
of preventing unauthorized entry.

(C) The licensee or registrant may apply to the Agency for approval of alternative methods for
controlling access to high radiation areas.

(D) The licensee or registrant shall establish the controls required by 105 CMR 120.227(A) and
120.227(C) in a way that does not prevent individuals from leaving a high radiation area.

(E) The licensee is not required to control each entrance or access point to a room or other area
that is a high radiation area solely because of the presence of radioactive materials prepared for
transport and packaged and labeled in accordance with the regulations of the U.S. Department
of Transportation provided that:
(1) the packages do not remain in the area longer than three days; and,
(2) the dose rate at one meter from the external surface of any package does not exceed 0.1
millisievert (0.01 rem) per hour.

(F) The licensee is not required to control entrance or access to rooms or other areas in hospitals
solely because of the presence of patients containing radioactive material, provided that there are
personnel in attendance who are taking the necessary precautions to prevent the exposure of
individuals to radiation or radioactive material in excess of the established limits in this part and
to operate within the ALARA provisions of the licensee's radiation protection program.

(G) The registrant is not required to control entrance or access to rooms or other areas
containing sources of radiation capable of producing a high radiation area as described in 105
CMR 120.227 if the registrant has met all the specific requirements for access and control
specified in other applicable parts of 105 CMR 120.000, such as, 105 CMR 120.300 for
industrial radiography, 105 CMR 120.430 for x-rays in the healing arts, and 105 CMR 120.700
for particle accelerators.

120.228: Control of Access to Very High Radiation Areas

(A) In addition to the requirements in 105 CMR 120.227, the licensee or registrant shall
institute measures to ensure that an individual is not able to gain unauthorized or inadvertent
access to areas in which radiation levels could be encountered at five grays (500 rads) or more
in one hour at one meter from a source of radiation or any surface through which the radiation
penetrates at this level. This requirement does not apply to rooms or areas in which diagnostic
x-ray systems are the only source of radiation.

(B) The registrant is not required to control entrance or access to rooms or other areas
containing sources of radiation capable of producing a very high radiation area as described in
105 CMR 120.228(A) if the registrant has met all the specific requirements for access and
control specified in other applicable parts of 105 CMR 120.000, such as, 105 CMR 120.300 for
industrial radiography, 105 CMR 120.430 for x-rays in the healing arts, and 105 CMR 120.700
for particle accelerators.

120.229: Control of Access to Very High Radiation Areas -- Irradiators

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(A) 105 CMR 120.229 applies to licensees with sources of radiation in non-self-shielded
irradiators. 105 CMR 120.229 does not apply to sources of radiation that are used in teletherapy,
in industrial radiography, or in completely self-shielded irradiators in which the source of
radiation is both stored and operated within the same shielding radiation barrier and, in the
designed configuration of the irradiator, is always physically inaccessible to any individual and
cannot create high levels of radiation in an area that is accessible to any individual.

(B) Each area in which there may exist radiation levels in excess of five grays (500 rads) in one
hour at one meter from a source of radiation that is used to irradiate materials shall meet the
following requirements:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.229: continued

(1) Each entrance or access point shall be equipped with entry control devices which:
(a) function automatically to prevent any individual from inadvertently entering a very
high radiation area;
(b) permit deliberate entry into the area only after a control device is actuated that
causes the radiation level within the area, from the source of radiation, to be reduced
below that at which it would be possible for an individual to receive a deep dose
equivalent in excess of one millisievert (0.1 rem) in one hour; and,
(c) prevent operation of the source of radiation if it would produce radiation levels in
the area that could result in a deep dose equivalent to an individual in excess of one
millisievert (0.1 rem) in one hour.
(2) Additional control devices shall be provided so that, upon failure of the entry control
devices to function as required by 105 CMR 120.229(B)(1):
(a) the radiation level within the area, from the source of radiation, is reduced below
that at which it would be possible for an individual to receive a deep dose equivalent in
excess of one millisievert (0.1 rem) in one hour; and,
(b) conspicuous visible and audible alarm signals are generated to make an individual
attempting to enter the area aware of the hazard and at least one other authorized
individual, who is physically present, familiar with the activity, and prepared to render
or summon assistance, aware of the failure of the entry control devices.
(3) The licensee shall provide control devices so that, upon failure or removal of physical
radiation barriers other than the sealed source's shielded storage container:
(a) the radiation level from the source of radiation is reduced below that at which it
would be possible for an individual to receive a deep dose equivalent in excess of one
millisievert (0.1 rem) in one hour; and,
(b) conspicuous visible and audible alarm signals are generated to make potentially
affected individuals aware of the hazard and the licensee or at least one other individual,
who is familiar with the activity and prepared to render or summon assistance, aware of
the failure or removal of the physical barrier.
(4) When the shield for stored sealed sources is a liquid, the licensee shall provide means
to monitor the integrity of the shield and to signal, automatically, loss of adequate shielding.
(5) Physical radiation barriers that comprise permanent structural components, such as
walls, that have no credible probability of failure or removal in ordinary circumstances, need
not meet the requirements of 105 CMR 120.229(B)(3) and 120.229(B)(4).
(6) Each area shall be equipped with devices that will automatically generate conspicuous
visible and audible alarm signals to alert personnel in the area before the source of radiation
can be put into operation and in time for any individual in the area to operate a clearly
identified control device, which must be installed in the area and which can prevent the
source of radiation from being put into operation.
(7) Each area shall be controlled by use of such administrative procedures and such devices
as are necessary to ensure that the area is cleared of personnel prior to each use of the source
of radiation.
(8) Each area shall be checked by a radiation measurement to ensure that, prior to the first
individual's entry into the area after any use of the source of radiation, the radiation level
from the source of radiation in the area is below that at which it would be possible for an
individual to receive a deep dose equivalent in excess of one millisievert (0.1 rem) in one
hour.
(9) The entry control devices required in 105 CMR 120.229(B)(1) shall be tested for proper
functioning. See 105 CMR 120.270 for recordkeeping requirements.
(a) Testing shall be conducted prior to initial operation with the source of radiation on
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

any day, unless operations were continued uninterrupted from the previous day.
(b) Testing shall be conducted prior to resumption of operation of the source of
radiation after any unintentional interruption.
(c) The licensee shall submit and adhere to a schedule for periodic tests of the entry
control and warning systems.
(10) The licensee shall not conduct operations, other than those necessary to place the
source of radiation in safe condition or to effect repairs on controls, unless control devices
are functioning properly.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.229: continued

(11) Entry and exit portals that are used in transporting materials to and from the irradiation
area, and that are not intended for use by individuals, shall be controlled by such devices and
administrative procedures as are necessary to physically protect and warn against inadvertent
entry by any individual through these portals. Exit portals for irradiated materials shall be
equipped to detect and signal the presence of any loose radioactive material that is carried
toward such an exit and automatically to prevent loose radioactive material from being
carried out of the area.

(C) Licensees or applicants for licenses for sources of radiation within the purview of 105 CMR
120.229(B) which will be used in a variety of positions or in locations, such as open fields or
forests, that make it impracticable to comply with certain requirements of 105 CMR 120.229(B),
such as those for the automatic control of radiation levels, may apply to the Agency for approval
of alternative safety measures. Alternative safety measures shall provide personnel protection
at least equivalent to those specified in 105 CMR 120.229(B). At least one of the alternative
measures shall include an entry-preventing interlock control based on a measurement of the
radiation that ensures the absence of high radiation levels before an individual can gain access
to the area where such sources of radiation are used.

(D) The entry control devices required by 105 CMR 120.229(B) and (C) shall be established
in such a way that no individual will be prevented from leaving the area.

120.231: Use of Process or Other Engineering Controls

The licensee shall use, to the extent practical, process or other engineering controls, such as,
containment, decontamination or ventilation, to control the concentrations of radioactive material
in air.

120.232: Use of Other Controls

(A) When it is not practicable to apply process or other engineering controls to control the
concentrations of radioactive material in air to values below those that define an airborne
radioactivity area, the licensee shall, consistent with maintaining the total effective dose
equivalent ALARA, increase monitoring and limit intakes by one or more of the following
means:
(1) control of access;
(2) limitation of exposure times;
(3) use of respiratory protection equipment; and,
(4) other controls.

(B) If the licensee performs an ALARA analysis to determine whether or not respirators should
be used, the licensee may also consider the impact of respirator use on workers’ industrial health
and safety.

120.233: Use of Individual Respiratory Protection Equipment

If the licensee or registrant uses respiratory protection equipment to limit intakes pursuant
to 105 CMR 120.232:

(A) Except as provided in 105 CMR 120.233(A)(2), the licensee or registrant shall use only
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

respiratory protection equipment that is tested and certified by the National Institute for
Occupational Safety and Health.

(B) If the licensee or registrant wishes to use equipment that has not been tested or certified by
the National Institute for Occupational Safety, or for which there is no schedule for testing or
certification, the licensee shall submit an application to the Agency for authorization to use this
equipment, except as otherwise noted in 105 CMR 120.200. The application must include
evidence that the material and performance characteristics of the equipment are capable of
providing the proposed degree of protection under anticipated conditions of use. This must be
demonstrated either by the licensee’s or registrant’s testing or on the basis of reliable test
information;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.233: continued

(C) The licensee or registrant shall implement and maintain a respiratory protection program
that includes:
(1) air sampling sufficient to identify the potential hazard, permit proper equipment
selection, and estimate doses;
(2) surveys and bioassays, as necessary, to evaluate actual intakes;
(3) testing of respirators for operability user seal check for face sealing devices and
functional check for others immediately prior to each use;
(4) written procedures regarding:
(a) Monitoring, including air sampling and bioassays;
(b) Supervision and training or respirator users;
(c) Fit testing;
(d) Respirator selection;
(e) Breathing air quality;
(f) Inventory and control;
(g) Storage, issuance, maintenance, repair, testing, and quality assurance of respiratory
protection equipment;
(h) Recordkeeping; and,
(i) Limitations on periods of respirator use and relief from respirator use.
(5) determination by a physician that the individual user is medically fit to use the
respiratory protection equipment before:
(a) The initial fitting of a face sealing respirator;
(b) Before the first field use of non-face sealing respirators, and
(c) Either every 12 months thereafter, or periodically at a frequency determined by a
physician.
(6) Fit testing, with a fit factor $ 10 times the APF for negative pressure devices, and a fit
factor $ 500 for any positive pressure, continuous flow, and pressure-demand devices, before
the first field use of tight fitting, face sealing respirators and periodically thereafter at a
frequency not to exceed one year. Fit testing must be performed with the facepiece operating
in the negative pressure mode.

(D) The licensee or registrant shall advise each respirator user that the user may leave the area
at any time for relief from respirator use in the event of equipment malfunction, physical or
psychological distress, procedural or communication failure, significant deterioration of
operating conditions, or any other conditions that might require such relief.

(E) The licensee or registrant shall also consider limitations appropriate to the type and mode
of use. When selecting respiratory devices the licensee or registrant shall provide for vision
correction, adequate communication, low temperature work environments and the concurrent use
of other safety or radiological protection equipment. The licensee or registrant shall use
equipment in such a way as not to interfere with the proper operation of the respirator.

(F) Standby rescue persons are required whenever one-piece atmosphere-supplying suits, or any
combination of supplied air respiratory protection device and personnel protective equipment are
used from which an unaided individual would have difficulty extricating himself or herself. The
standby persons must be equipped with respiratory protection devices or other apparatus
appropriate for the potential hazards. The standby rescue persons shall observe or otherwise
maintain continuous communication with the workers (visual, voice, signal line, telephone,
radio, or other suitable means), and be immediately available to assist them in case of a failure
of the air supply or for any other reason that requires relief from distress. A sufficient number
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

of standby rescue persons must be immediately available to assist all users of this type of
equipment and to provide effective emergency rescue if needed.

(G) Atmosphere-supplying respirators must be supplied with respirable air of grade D quality
or better as defined by the Compressed Gas Association in publication G-7.1, "Commodity
Specification for Air," 1997 and included in the regulations of the Occupational Safety and
Health Administration (29 CFR 1910.134(i)(1)(ii)(A) through (E). Grade D quality air criteria
include:
(1) Oxygen content (v/v) of 19.5-23.5%;
(2) Hydrocarbon (condensed) content of 5 milligrams per cubic meter of air or less;
(3) Carbon Monoxide (CO) content of 10 ppm or less;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.233: continued

(4) Carbon Dioxide content of 1,000 ppm or less; and,

(5) Lack of noticeable odor

(H) The licensee shall ensure that no objects, materials or substances, such as facial hair, or any
conditions that interfere with the face-facepiece seal or valve function, and that are under the
control of the wearer, are present between the skin of the wearer’s face and the sealing surface
of a tight-fitting respirator facepiece.

(I) In estimating the dose to individuals from intake of airborne radioactive materials, the
concentration of radioactive material in the air that is inhaled when respirators are worn is
initially assumed to be the ambient concentration in air without the respiratory protection,
divided by the assigned protection factor. If the dose is later found to be greater than the
estimated dose, the corrected value must be used. If the dose is later found to be less than the
estimated dose, the corrected value may be used.

120.234: Further Restrictions on the Use of Respiratory Protection Equipment

The Agency may impose restrictions in addition to the provisions of 105 CMR 120.232 and
120.233, and 120.295: Appendix A, in order to:

(A) Ensure that the respiratory protection program of the licensee is adequate to limit doses to
individuals from intakes of radioactive materials consistent with maintaining total effective dose
equivalent ALARA; and,

(B) Limit the extent to which a licensee may use respiratory protection equipment instead of
process or other engineering controls.

120.235: Application for Use of Higher Assigned Protection Factors

The licensee or registrant shall obtain authorization from the Agency before using assigned
respiratory protection factors in excess of those specified in 105 CMR 120.295: Appendix A.
The Agency may authorize a licensee or registrant to use higher protection factors on receipt of
an application that:

(A) Describes the situation for which a need exists for higher protection factors; and,

(B) Demonstrates that the respiratory protection equipment provides these higher protection
factors under the proposed conditions of use.

120.236: Security and Control of Licensed or Registered Sources of Radiation

(A) The licensee shall secure licensed radioactive material from unauthorized removal or
access.

(B) The licensee shall maintain constant surveillance, and use devices or administrative
procedures to prevent unauthorized use of licensed radioactive material that is in an unrestricted
area and that is not in storage.

(C) The registrant shall secure registered radiation machines from unauthorized removal.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(D) The registrant shall use devices or administrative procedures to prevent unauthorized use
of registered radiation machines.

120.237: Caution Signs

(A) Standard Radiation Symbol. Unless otherwise authorized by the Agency, the symbol
prescribed by 105 CMR 120.237 shall use the colors magenta, or purple, or black on yellow
background. The symbol prescribed is the three-bladed design as follows:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.237: continued

RADIATION SYMBOL

1. Cross-hatched area is to be magenta, or purple, or black, and

2. The background is to be yellow.

(B) Exception to Color Requirements for Standard Radiation Symbol. Notwithstanding the
requirements of 105 CMR 120.237(A), licensees or registrants are authorized to label sources,
source holders, or device components containing sources of radiation that are subjected to high
temperatures, with conspicuously etched or stamped radiation caution symbols and without a
color requirement.

(C) Additional Information on Signs and Labels. In addition to the contents of signs and labels
prescribed in this part, the licensee or registrant shall provide, on or near the required signs and
labels, additional information, as appropriate, to make individuals aware of potential radiation
exposures and to minimize the exposures.

120.238: Posting Requirements

(A) Posting of Radiation Areas. The licensee or registrant shall post each radiation area with
a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION,
RADIATION AREA."

(B) Posting of High Radiation Areas. The licensee or registrant shall post each high radiation
area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION,
HIGH RADIATION AREA" or "DANGER, HIGH RADIATION AREA."

(C) Posting of Very High Radiation Areas. The licensee or registrant shall post each very high
radiation area with a conspicuous sign or signs bearing the radiation symbol and words "GRAVE
DANGER [not required to use the word GRAVE, this may be omitted], VERY HIGH
RADIATION AREA."

(D) Posting of Airborne Radioactivity Areas. The licensee shall post each airborne
radioactivity area with a conspicuous sign or signs bearing the radiation symbol and the words
"CAUTION, AIRBORNE RADIOACTIVITY AREA" or "DANGER, AIRBORNE
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

RADIOACTIVITY AREA."

(E) Posting of Areas or Rooms in Which Licensed Material is Used or Stored. The licensee
shall post each area or room in which there is used or stored an amount of licensed material
exceeding ten times the quantity of such material specified in 105 CMR 120.297: Appendix C
with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION,
RADIOACTIVE MATERIAL(S)" or "DANGER, RADIOACTIVE MATERIAL(S)."
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.239: Exceptions to Posting Requirements

(A) A licensee or registrant is not required to post caution signs in areas or rooms containing
radioactive materials for periods of less than eight hours, if each of the following conditions is
met:
(1) the radioactive materials are constantly attended during these periods by an individual
who takes the precautions necessary to prevent the exposure of individuals to radioactive
materials in excess of the limits established in 105 CMR 120.200; and,
(2) the area or room is subject to the licensee's or registrant's control.

(B) Rooms or other areas in hospitals that are occupied by patients are not required to be posted
with caution signs pursuant to 105 CMR 120.242 provided that patient could be released from
confinement pursuant to 105 CMR 120.540.

(C) Rooms or other areas in hospitals that are occupied by patients are not required to be posted
with caution signs, provided that:
(1) A patient being treated with a permanent implant could be released from confinement
pursuant 105 CMR 120.540; or
(2) A patient being treated with a therapeutic radiopharmaceutical could be released from
confinement pursuant 105 CMR 120.540.

(D) A room or area is not required to be posted with a caution sign because of the presence of
a sealed source provided the radiation level at 30 centimeters from the surface of the sealed
source container or housing does not exceed 0.05 mSv (0.005 rem) per hour.

(E) A room or area is not required to be posted with a caution sign because of the presence of
radiation machines used solely for diagnosis in the healing arts.

(F) Rooms in hospitals or clinics that are used for teletherapy are exempt from the requirement
to post caution signs under 105 CMR 120.238 if:
(1) Access to the room is controlled pursuant to 105 CMR 120.573; and,
(2) Personnel in attendance take necessary precautions to prevent the inadvertent exposure
of workers, other patients, and members of the public to radiation in excess of the limits
established in 105 CMR 120.200.

120.240: Labeling Containers and Radiation Machines

(A) The licensee shall ensure that each container of licensed material bears a durable, clearly
visible label bearing the radiation symbol and the words "CAUTION, RADIOACTIVE
MATERIAL" or "DANGER, RADIOACTIVE MATERIAL." The label shall also provide
information, such as the radionuclides present, an estimate of the quantity of radioactivity, the
date for which the activity is estimated, radiation levels, kinds of materials, and mass enrichment,
to permit individuals handling or using the containers, or working in the vicinity of the
containers, to take precautions to avoid or minimize exposures.

(B) Each licensee shall, prior to removal or disposal of empty uncontaminated containers to
unrestricted areas, remove or deface the radioactive material label or otherwise clearly indicate
that the container no longer contains radioactive materials.

(C) Each registrant shall ensure that each radiation machine is labeled in a conspicuous manner
which cautions individuals that radiation is produced when it is energized.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.241: Exemptions to Labeling Requirements

A licensee is not required to label:

(A) containers holding licensed material in quantities less than the quantities listed in 105 CMR
120.297: Appendix C; or

(B) containers holding licensed material in concentrations less than those specified in 105 CMR
120.296: Appendix B, Table III; or
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.241: continued

(C) containers attended by an individual who takes the precautions necessary to prevent the
exposure of individuals in excess of the limits established by 105 CMR 120.200;

(D) containers when they are in transport and packaged and labeled in accordance with the
regulations of the U.S. Department of Transportation1;

(E) containers that are accessible only to individuals authorized to handle or use them, or to
work in the vicinity of the containers, if the contents are identified to these individuals by a
readily available written record. Examples of containers of this type are containers in locations
such as water-filled canals, storage vaults, or hot cells. The record shall be retained as long as
the containers are in use for the purpose indicated on the record; or

(F) installed manufacturing or process equipment, such as piping and tanks.

120.242: Procedures for Receiving and Opening Packages

(A) Each licensee or registrant who expects to receive a package containing quantities of
radioactive material in excess of a Type A quantity, as defined in 105 CMR 120.772 and
105 CMR 120.798: Appendix A, shall make arrangements to receive:
(1) the package when the carrier offers it for delivery; or
(2) the notification of the arrival of the package at the carrier's terminal and to take
possession of the package expeditiously.

(B) Each licensee or registrant shall:

(1) monitor the external surfaces of a labeled package for radioactive contamination unless
the package contains only radioactive material in the form of gas or in special form as
defined in 105 CMR 120.005;
(2) monitor the external surfaces of a labeled2 package for radiation levels unless the
package contains quantities of radioactive material that are less than or equal to the Type A
quantity, as defined in 105 CMR 120.772 and 105 CMR 120.798: Appendix A; and
(3) monitor all packages known to contain radioactive material for radioactive
contamination and radiation levels if there is evidence of degradation of package integrity,
such as packages that are crushed, wet, or damaged.

(C) The licensee or registrant shall perform the monitoring required by 105 CMR 120.242 as
soon as practicable after receipt of the package, but not later than three hours after the package
is received at the licensee's facility if it is received during the licensee's normal working hours,
or if there is evidence of degradation of package integrity, such as a package that is crushed, wet,
or damaged. If a package is received after working hours, and has no evidence of degradation
of package integrity, the package shall be monitored no later than three hours from the beginning
of the next working day.

(D) The licensee or registrant shall immediately notify the final delivery carrier and, by
telephone and telegram, mailgram, or facsimile, the Agency when:
(1) removable radioactive surface contamination exceeds the limits of 105 CMR 120.786(I);
or
(2) External radiation levels exceed the limit of 105 CMR 120.783.

(E) Each licensee or registrant shall:

(1) establish, maintain, and retain written procedures for safely opening packages in which
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

radioactive material is received; and

(2) ensure that the procedures are followed and that due consideration is given to special
instructions for the type of package being opened.

S))))))))))))))))))))))Q
1
Labeling of packages containing radioactive materials is required by the U.S. Department of
Transportation if the amount and type of radioactive material exceeds the limits for an
excepted quantity or article as defined and limited by U.S. Department of Transportation
regulations 49 CFR 173.403(m) and (w) and 173.424.
2
Labeled with a Radioactive White I, Yellow II, or Yellow III label as specified in U.S.
Department of Transportation regulations 49 CFR 172.403 and 172.436 through 172.440.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.242: continued

(F) Licensees or registrants transferring special form sources in vehicles owned or operated by
the licensee to and from a work site are exempt from the contamination monitoring requirements
of 105 CMR 120.246(B), but are not exempt from the monitoring requirement in 105 CMR
120.246(B) for measuring radiation levels that ensures that the source is still properly lodged in
its shield.

120.243: Vacating Premises

Each licensee, registrant, or person possessing non-exempt sources of radiation shall, no less
than 30 days before vacating or relinquishing possession or control of premises which may have
been contaminated with radioactive material as a result of his activity, notify the Agency, in
writing, of the intent to vacate. When deemed necessary by the Agency, the licensee, registrant,
or person possessing non-exempt sources of radiation shall decontaminate the premises in such
a manner as the Agency may specify.

RADIOLOGICAL CRITERIA FOR LICENSE TERMINATION

120.244: General Provisions and Scope

The criteria in 105 CMR 120.244 apply to the decommissioning of facilities licensed under
105 CMR 120.100,120.300, 120.500, 120.800 and 120.900.

(A) The criteria in 105 CMR 120.244 does not apply to sites, which have been decommissioned
prior to October 6, 2006.

(B) After a site has been decommissioned and the license terminated in accordance with the
criteria in 105 CMR 120.244, the Agency will require additional cleanup only if, based on new
information, it determines that the criteria of 105 CMR 120.244 were not met and residual
radioactivity remaining at the site could result in significant threat to public health and safety.

(C) When calculating TEDE to the average member of the critical group the licensee shall
determine the peak annual TEDE dose expected within the first 1000 years after
decommissioning.

(D) Specific time limits for completion of the decommissioning process are as specified in 105
CMR 120.132(G).
(1) Licensees shall complete decommissioning of the site or separate building or outdoor
area as soon as practicable but not later than 24 months following the initiation of
decommissioning.
(2) When decommissioning involves the entire site, the licensee shall request license
termination as soon as practicable but not later than 24 months following the initiation of
decommissioning.

(E) The Agency may approve a request for an alternative schedule for completion of the
decommissioning of the site or separate building or outdoor area, and license termination is
appropriate, if the Agency determines that the alternative is warranted.

120.245: Radiological Criteria for Unrestricted Use

A site will be considered acceptable for unrestricted use if the residual radioactivity that is
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

distinguishable from background radiation results in a TEDE to an average member of the

critical group that shall not exceed 0.10 mSv (10 mrem) per year, including that from
groundwater sources of drinking water and the residual radioactivity has been reduced to levels
that are as low as reasonably achievable (ALARA). Determination of the levels, which are
ALARA, must take into account consideration of any detriments, such as deaths from
transportation accidents, expected to potentially result from decontamination and waste disposal.

120.246: Criteria for License Termination Under Restricted Conditions

A site will be considered acceptable for license termination under restricted conditions if:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.246: continued

(A) The licensee can demonstrate that further reductions in residual radioactivity necessary to
comply with the provisions of 105 CMR 120.245 would result in net public or environmental
harm or were not being made because the residual levels associated with restricted conditions
are ALARA. Determination of the levels, which are ALARA must take into account
consideration of any detriments, such as deaths from transportation accidents, expected to
potentially result from decontamination and waste disposal;

(B) The licensee has made provisions for legally enforceable institutional controls that provide
reasonable assurance that TEDE from residual radioactivity distinguishable from background to
the average member of the critical group will not exceed 0.10 mSv (10 mrem) per year;

(C) The licensee has provided sufficient financial assurance to enable an independent third
party, including a governmental custodian of a site, to assume and carry out responsibilities for
any necessary control and maintenance of the site. Acceptable financial assurance mechanisms
are:
(1) Funds placed into a trust segregated from the licensee’s assets and outside the licensee’s
administrative control, and in which the adequacy of the trust funds is to be assessed based
on an assumed annual 1% real rate of return on investment;
(2) A statement of intent in the case of State, or local Government licensees, as described
in 105 CMR 120.125(C)(7)(d); or
(3) When a governmental entity is assuming custody and ownership of a site, an
arrangement that is deemed acceptable by such governmental entity.

(D) The licensee has submitted a decommissioning plan or License Termination Plan (LTP) to
the Agency indicating the licensee’s intent to decommission in accordance with 105 CMR
120.132(D), and specifying that the licensee intends to decommission by restricting use of the
site. The licensee shall document in the LTP or decommissioning plan how the advice of
individuals and institutions in the community who may be affected by the decommissioning has
been sought and incorporated, as appropriate, following analysis of that advice.
(1) Licensees proposing to decommission by restricting use of the site shall seek advice
from such affected parties regarding the following matters concerning the proposed
decommissioning:
(a) Whether provisions for institutional controls proposed by the licensee:
1. Will provide reasonable assurance that the TEDE from residual radioactivity
distinguishable from background to the average member of the critical group will not
exceed 0.10 mSv (10 mrem) TEDE per year;
2. Will be enforceable; and
3. Will not impose undue burdens on the local community or other affected parties.
(b) Whether the licensee has provided sufficient financial assurance to enable a third
party, including a governmental custodian of a site, to assume and carry out
responsibilities for any necessary control and maintenance of the site;
(2) In seeking advice on the issues identified in 105 CMR 120.246D(1), the licensee shall
provide for:
(a) Participation by representatives of a broad cross section of community interests who
may be affected by the decommissioning;
(b) An opportunity for a comprehensive, collective discussion on the issues by the
participants represented; and
(c) A publicly available summary of the results of all such discussions, including a
description of the individual viewpoints of the participants on the issues and the extent
of agreement and disagreement among the participants on the issues.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(E) Residual radioactivity at the site has been reduced so that if the institutional controls were
no longer in effect, there is reasonable assurance that the TEDE from residual radioactivity
distinguishable from background to the average member of the critical group is as low as
reasonably achievable and would not exceed either:
(1) 1mSv (100 mrem) per year; or
(2) 5mSv (500 mrem) per year provided the licensee:
(a) Demonstrates that further reductions in residual radioactivity necessary to comply
with the one mSv/yr (100 mrem/yr) value of 105 CMR 120.246(E)(1) are not technically
achievable, would be prohibitively expensive, or would result in net public or
environmental harm;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.246: continued

(b) Makes provisions for durable institutional controls;

(c) Provides sufficient financial assurance to enable a responsible government entity or
independent third party, including a governmental custodian of a site, both to carry out
periodic rechecks of the site no less frequently than every three years to assure that the
institutional controls remain in place as necessary to meet the criteria of 105 CMR
120.246(B) and to assume and carry out responsibilities for any necessary control and
maintenance of those controls. Acceptable financial assurance mechanisms are those in
105 CMR 120.246(C).

120.247: Alternate Criteria for License Termination

(A) The Agency may terminate a license using alternate criteria greater than the dose criterion
of 105 CMR 120.245, 120.246(B), and 120.246(D)(1)(a)1., if the licensee:
(1) Provides assurance that public health and safety would continue to be protected, and that
it is unlikely that the dose from all man-made sources combined, other than medical, would
be more than the one mSv/yr (100 mrem/yr) limit, by submitting an analysis of possible
sources of exposure;
(2) Has employed to the extent practical restrictions on the site use according to the
provisions of 105 CMR 120.246 in minimizing exposures at the site; and
(3) Reduces doses to ALARA levels, taking into consideration any detriments such as
traffic accidents expected to potentially result from decontamination and waste disposal.
(4) Has submitted a decommissioning plan or License Termination Plan (LTP) to the
Agency indicating the licensee’s intent to decommission in accordance with 105 CMR
120.132(D), and specifying that the licensee proposes to decommission by use of alternate
criteria. The licensee shall document in the decommissioning plan or LTP how the advice
of individuals and institutions in the community who may be affected by the
decommissioning has been sought and addressed, as appropriate, following analysis of that
advice. In seeking such advice, the license shall provide for:
(a) Participation by representatives of a broad cross section of community interests who
may be affected by the decommissioning;
(b) An opportunity for a comprehensive, collective discussion on the issues by the
participants represented; and
(c) A publicly available summary of the results of all such discussions, including a
description of the individual viewpoints of the participants on the issues and the extent
of agreement and disagreement among the participants on the issues.
(5) Has provided sufficient financial assurance in the form of a trust fund to enable an
independent third party, including a governmental custodian of a site, to assume and carry
out responsibilities for any necessary control and maintenance of the site.

(B) The use of alternate criteria to terminate a license requires the approval of the Agency after
consideration of the Agency’s staff’s recommendations that will address any comments by other
appropriate agencies and any public comments submitted pursuant to 105 CMR 120.248.

120.248: Public Notification and Public Participation

Upon the receipt of an LTP or decommissioning plan from the licensee, or a proposal by the
licensee for release of a site pursuant to 105 CMR 120.246 and 120.247, or whenever the Agency
deems such notice to be in the public interest, the Agency shall:

(A) Notify and solicit comments from:

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(1) Local governments in the vicinity of the site and any Indian Nation or other indigenous
people that have treaty or statutory rights that could be affected by the decommissioning; and
(2) Other appropriate agencies for cases where the licensee proposes to release a site
pursuant to 105 CMR 120.247.

(B) Publish a notice in a forum, such as local newspapers, letters to State or local organizations,
or other appropriate forum, that is readily accessible to individuals in the vicinity of the site, and
solicit comments from affected parties.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.249: Minimization of Contamination

(A) Applicants for licenses, after July 1, 1999, shall describe in the application how facility
design and procedures for operation will minimize, to the extent practicable, contamination of
the facility and the environment, facilitate eventual decommissioning, and minimize, to the
extent practicable, the generation of radioactive waste.

(B) Licensees shall, to the extent practical, conduct operations to minimize the introduction of
residual radioactivity into the site, including the subsurface, in accordance with the existing
radiation protection requirements in 105 CMR 120.210 and radiological criteria for license
termination in 105 CMR 120.244 through 120.249.

120.251: General Requirements

(A) Unless otherwise exempted, a licensee shall transfer waste containing licensed material for
disposal, discharge or decay only:
(1) by transfer to an authorized recipient as provided in 105 CMR 120.256 or in 105 CMR
120.100, or 105 CMR 120.800, or to the U.S. Department of Energy;
(2) by decay in storage;
(3) by release in effluents within the limits in 105 CMR 120.221; or
(4) as authorized pursuant to 105 CMR 120.253 or 120.254.

(B) A person shall be specifically licensed to receive waste containing licensed material from
other persons for:
(1) treatment prior to disposal;
(2) treatment by incineration;
(3) decay in storage;
(4) disposal at a land disposal facility licensed pursuant to 105 CMR 120.800; or
(5) storage until transferred to a storage or disposal facility authorized to receive the waste.

120.252: Method for Obtaining Approval of Proposed Disposal Procedures

A licensee or registrant or applicant for a license or registration may apply to the Agency for
approval of proposed procedures, not otherwise authorized in 105 CMR 120.000, to dispose of
licensed or registered material generated in the licensee's or registrant's operations. Each
application shall include:

(A) A description of the waste containing licensed or registered material to be disposed of,
including the physical and chemical properties that have an impact on risk evaluation, and the
proposed manner and conditions of waste disposal;

(B) An analysis and evaluation of pertinent information on the nature of the environment;

(C) The nature and location of other potentially affected facilities; and

(D) Analyses and procedures to ensure that doses are maintained ALARA and within the dose
limits in 105 CMR 120.200.

120.253: Discharge by Release into Sanitary Sewerage

(A) A licensee may discharge licensed material into sanitary sewerage if each of the following
conditions is satisfied:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(1) the material is readily soluble, or is readily dispersible biological material, in water;
(2) the quantity of licensed radioactive material that the licensee releases into the sewer in
one month divided by the average monthly volume of water released into the sewer by the
licensee does not exceed the concentration listed in 105 CMR 120.296: Appendix B, Table
III; and
(3) if more than one radionuclide is released, the following conditions must also be
satisfied:
(a) the licensee shall determine the fraction of the limit in 105 CMR 120.296:
Appendix B, Table III represented by discharges into sanitary sewerage by dividing the
actual monthly average concentration of each radionuclide released by the licensee into
the sewer by the concentration of that radionuclide listed in 105 CMR 120.296:
Appendix B, Table III; and
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.253: continued

(b) the sum of the fractions for each radionuclide required by 105 CMR
120.253(A)(3)(a) does not exceed unity; and
(4) the total quantity of licensed or other radioactive material that the licensee releases into
the sanitary sewerage in a year does not exceed five curies (185 gigabecquerels) of hydrogen-
3, one curie (37 gigabecquerels) of carbon-14, and one curie (37 gigabecquerels) of all other
radioactive materials combined.

(B) Excreta from individuals undergoing medical diagnosis or therapy with radioactive material
are not subject to the limitations contained in 105 CMR 120.253(A).

120.254: Treatment or Disposal by Incineration

A licensee may treat licensed material by incineration only in the form and concentration
specified in 105 CMR 120.255 or as specifically approved by the Agency pursuant to 105 CMR
120.252.

120.255: Disposal of Specific Wastes

(A) A licensee or registrant may dispose of the following licensed or registered material as if
it were not radioactive:
(1) 1.85 kBq (0.05 µCi), or less, of hydrogen-3 or carbon-14 per gram of medium used for
liquid scintillation counting; and
(2) 1.85 kBq (0.05 µCi), or less, of hydrogen-3 or carbon-14 per gram of animal tissue,
averaged over the weight of the entire animal.

(B) A licensee or registrant shall not dispose of tissue pursuant to 105 CMR 120.255(A)(2) in
a manner that would permit its use either as food for humans or as animal feed.

(C) The licensee or registrant shall maintain records in accordance with 105 CMR 120.269.

120.256: Transfer for Disposal and Manifests

(A) The requirements of 105 CMR 120.256 and 10 CFR 20: Appendix G, herein incorporated
into 105 CMR120.256 by reference are designed to:
(1) Control transfers of low-level waste by any waste generator, waste collector, or waste
processor licensee, as defined in 10 CFR 20: Appendix G, who ships low-level waste either
directly, or indirectly through a waste collector or waste processor, to a licensed low-level
waste land disposal facility as defined in 105 CMR 120.803;
(2) Establish a manifest tracking system; and
(3) Supplement existing requirements concerning transfers and recordkeeping for those
wastes.

(B) (1) Any licensee shipping radioactive waste intended for ultimate disposal at a licensed
land disposal facility must document the information required on the U.S. Nuclear
Regulatory Commission’s Uniform Low-level Radioactive Waste Manifest and transfer this
recorded information to the intended consignee in accordance with 10 CFR 20: Appendix
G.
(2) Any licensee shipping by-product material as defined in 105 CMR 120.005: By-product
Material(2) and (3) intended for ultimate disposal at a land disposal facility licensed under
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

105 CMR 120.800 or equivalent NRC or Agreement State regulations must document the
information required on the NRC's Uniform Low-level Radioactive Waste Manifest and
transfer this recorded manifest information to the intended consignee in accordance with
10 CFR Part 20: Appendix G.

(C) Each shipment manifest shall include a certification by the waste generator as specified in
10 CFR 20: Appendix G.

(D) Each person involved in the transfer of waste for disposal or in the disposal of waste,
including the waste generator, waste collector, and waste processor, shall comply with the
requirements specified in 105 CMR 120.256 and 10 CFR 20: Appendix G.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.256: continued

(E) Reports and notifications required to be made to the nearest NRC regional administrator by
10 CFR 20: Appendix G shall, instead, be made to the Agency.

120.257: Compliance with Environmental and Health Protection Regulations

Nothing in 105 CMR 120.251, 120.253, 20.254, or 120.256 relieves the licensee from
complying with other applicable federal, state and local regulations governing any other toxic
or hazardous properties of materials that may be disposed of in accordance with 105 CMR
120.251, 120.253, 120.254, or 120.256.

120.258: Disposal of Certain Byproduct Material

(A) Licensed material as defined in 105 CMR 120.005: By-product Material(2) and (3) may
be disposed of in accordance with 105 CMR 120.800, even though it is not defined as low-level
radioactive waste. Therefore, any licensed by-product material being disposed of at a facility, or
transferred for ultimate disposal at a facility licensed under 105 CMR 120.800 or equivalent
Nuclear Regulatory Commission or Agreement State requirements, must meet the requirements
of 105 CMR 120.256.

(B) A licensee may dispose of byproduct material, as defined in 105 CMR 120.005: By-
product Material(2) and (3), at a disposal facility authorized to dispose of such material in
accordance with any Federal or State solid or hazardous waste law, including the Solid Waste
Disposal Act, as authorized under the Energy Policy Act of 2005.

RECORDS

120.261: General Provisions

(A) Each licensee or registrant shall use the SI units becquerel, gray, sievert and coulomb per
kilogram, or the special units curie, rad, rem and roentgen, including multiples and subdivisions,
and shall clearly indicate the units of all quantities on records required by 105 CMR 120.261.

(B) Not withstanding the requirements of 105 CMR 120.261(A), when recording information
on shipment manifests, as required in 105 CMR 120.256, information must be recorded in SI
units or in SI units and special units as specified in 105 CMR 120.261(A).

(C) The licensee or registrant shall make a clear distinction among the quantities entered on the
records required by 105 CMR 120.200, such as, total effective dose equivalent, total organ dose
equivalent, shallow dose equivalent, lens dose equivalent, deep dose equivalent, or committed
effective dose equivalent.

120.262: Records of Radiation Protection Programs

(A) Each licensee or registrant shall maintain records of the radiation protection program,
including:
(1) the provisions of the program; and
(2) audits and other reviews of program content and implementation.

(B) The licensee or registrant shall retain the records required by 105 CMR 120.262(A)(1) until
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

the Agency terminates each pertinent license or registration requiring the record. The licensee
or registrant shall retain the records required by 105 CMR 120.262(A)(2) for three years after the
record is made.

120.263: Records of Surveys

(A) Each licensee or registrant shall maintain records showing the results of surveys and
calibrations required by 105 CMR 120.225 and 120.242(B). The licensee or registrant shall
retain these records for three years after the record is made.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.263: continued

(B) The licensee or registrant shall retain each of the following records until the Agency
terminates each pertinent license or registration requiring the record:
(1) records of the results of surveys to determine the dose from external sources of radiation
used, in the absence of or in combination with individual monitoring data, in the assessment
of individual dose equivalents;
(2) records of the results of measurements and calculations used to determine individual
intakes of radioactive material and used in the assessment of internal dose;
(3) records showing the results of air sampling, surveys, and bioassays required pursuant
to 105 CMR 120.233(A)(3)(a) and (b); and
(4) records of the results of measurements and calculations used to evaluate the release of
radioactive effluents to the environment.

120.264: Records of Tests for Leakage or Contamination of Sealed Sources

Records of tests for leakage or contamination of sealed sources required by 105 CMR
120.223 shall be kept in units of becquerel or microcurie and maintained for inspection by the
Agency for five years after the records are made.

120.265: Determination and Records of Prior Occupational Dose

(A) For each individual who is likely to receive, in a year, an occupational dose requiring
monitoring pursuant to 105 CMR 120.226, the licensee or registrant shall:
(1) Determine the occupational radiation dose received during the current year; and
(2) Attempt to obtain the records of cumulative occupational radiation dose.

(B) Prior to permitting an individual to participate in a planned special exposure, the licensee
or registrant shall determine:
(1) The internal and external doses from all previous planned special exposures;
(2) All doses in excess of the limits, including doses received during accidents; and
emergencies, received during the lifetime of the individual.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.265: continued

(C) In complying with the requirements of 105 CMR 120.265(A), a licensee or registrant may:
(1) Accept, as a record of the occupational dose that the individual received during the
current year, a written signed statement from the individual, or from the individual’s most
recent employer for work involving radiation exposure, that discloses the nature and the
amount of any occupational dose that the individual received during the current year;
(2) Accept, as the record of cumulative radiation dose, an up-to-date Agency Form MRCP
120.200-2 or equivalent, signed by the individual and countersigned by an appropriate
official of the most recent employer for work involving radiation exposure, or the individual's
current employer, if the individual is not employed by the licensee or registrant; and
(3) Obtain reports of the individual’s dose equivalent(s) from the most recent employer for
work involving radiation exposure, or the individual’s current employer, if the individual is
not employed by the licensee or registrant, by telephone, telegram, facsimile, other electronic
media or letter. The licensee or registrant shall request a written verification of the dose data
if the authenticity of the transmitted report cannot be established.

(D) The licensee or registrant shall record the exposure history, as required by 105 CMR
120.265(A), on Agency Form MRCP 120.200-2, or other clear and legible record, of all the
information required on that form.
(1) The form or record shall show each period in which the individual received occupational
exposure to radiation or radioactive material and shall be signed by the individual who
received the exposure. For each period for which the licensee or registrant obtains reports,
the licensee or registrant shall use the dose shown in the report in preparing Agency Form
MRCP 120.200-2 or equivalent. For any period in which the licensee or registrant does not
obtain a report, the licensee or registrant shall place a notation on Agency Form Y or
equivalent indicating the periods of time for which data are not available.
(2) For the purposes of complying with this requirement, licensees or registrants are not
required to partition historical dose between external dose equivalent(s) and internal
committed dose equivalent(s). Further, occupational exposure histories obtained and
recorded on Agency Form MRCP 120.200-2 or equivalent before October 6, 2006, would
not have included effective dose equivalent, but may be used in the absence of specific
information on the intake of radionuclides by the individual.

(E) If the licensee or registrant is unable to obtain a complete record of an individual’s current
and previously accumulated occupational dose, the licensee or registrant shall assume:
(1) In establishing administrative controls pursuant to 105 CMR 120.211(F) for the current
year, that the allowable dose limit for the individual is reduced by 12.5 millisievert (1.25
rem) for each quarter for which records were unavailable and the individual was engaged in
activities that could have resulted in occupational radiation exposure; and
(2) That the individual is not available for planned special exposures.

(F) The licensee or registrant shall retain the records on Agency Form MRCP 120.200-2 or
equivalent until the Agency terminates each pertinent license or registration requiring this record.
The licensee or registrant shall retain records used in preparing Agency Form MRCP 120.200-2
or equivalent for three years after the record is made.

(G) Upon termination of the license or registration, the licensee or registrant shall permanently
store records on Agency Form MRCP 120.200-2 or equivalent, or shall make provision with the
Agency for transfer to the Agency.

120.266: Records of Planned Special Exposures

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(A) For each use of the provisions of 105 CMR 120.216 for planned special exposures, the
licensee or registrant shall maintain records that describe:
(1) the exceptional circumstances requiring the use of a planned special exposure;
(2) the name of the management official who authorized the planned special exposure and
a copy of the signed authorization;
(3) what actions were necessary;
(4) why the actions were necessary;
(5) what precautions were taken to assure that doses were maintained ALARA;
(6) what individual and collective doses were expected to result; and,
(7) the doses actually received in the planned special exposure.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.266: continued

(B) The licensee or registrant shall retain the records until the Agency terminates each pertinent
license or registration requiring these records.

120.267: Records of Individual Monitoring Results

(A) Recordkeeping Requirement. Each licensee or registrant shall maintain records of doses
received by all individuals for whom monitoring was required pursuant to 105 CMR 120.226,
and records of doses received during planned special exposures, accidents, and emergency
conditions. Assessments of dose equivalent and records made using units in effect before
January 1, 1994 need not be changed. These records shall include, when applicable:
(1) the deep dose equivalent to the whole body, lens dose equivalent, shallow dose
equivalent to the skin, and shallow dose equivalent to the extremities;
(2) the estimated intake of radionuclides, see 105 CMR 120.212;
(3) the committed effective dose equivalent assigned to the intake of radionuclides;
(4) the specific information used to calculate the committed effective dose equivalent
pursuant to 105 CMR 120.214(A) and 120.214(C) and when required 105 CMR 120.226;
(5) the total effective dose equivalent when required by 105 CMR 120.212; and
(6) the total of the deep dose equivalent and the committed dose to the organ receiving the
highest total dose.

(B) Recordkeeping Frequency. The licensee or registrant shall make entries of the records
specified in 105 CMR 120.267(A) at least annually.

(C) Recordkeeping Format. The licensee or registrant shall maintain the records specified in
105 CMR 120.267(A) on Form MRCP 120.200-3, in accordance with the instructions for Form
MRCP 120.200-3, or in clear and legible records containing all the information required by Form
MRCP 120.200-3.

(D) The licensee or registrant shall maintain the records of dose to an embryo/fetus with the
records of dose to the declared pregnant woman. The declaration of pregnancy, including the
estimated date of conception, shall also be kept on file, but may be maintained separately from
the dose records.

(E) The licensee or registrant shall retain each required form or record until the Agency
terminates each pertinent license or registration requiring the record.

(F) Upon termination of the license or registration, the records of doses received by individuals
shall be transferred to the Agency.

120.268: Records of Dose to Individual Members of the Public

(A) Each licensee or registrant shall maintain records sufficient to demonstrate compliance with
the dose limit for individual members of the public. See 105 CMR 120.221.

(B) The licensee or registrant shall retain the records required by 105 CMR 120.268(A) until
the Agency terminates each pertinent license or registration requiring the record.

120.269: Records of Waste Transfers

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(A) Each licensee shall maintain records of the disposal of licensed materials made pursuant
to 105 CMR 120.252, 105 CMR 120.253, 105 CMR 120.254, 105 CMR 120.255, and 105 CMR
120.800.

(B) The licensee shall retain the records required by 105 CMR 120.269(A) until the Agency
terminates each pertinent license requiring the record.

(C) If any burials of licensed material were made under the provisions of 10 CFR 20.304 prior
to its repeal in 1981 the records of such burials shall be maintained by the licensee.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.270: Records of Testing Entry Control Devices for Very High Radiation Areas

(A) Each licensee or registrant shall maintain records of tests made pursuant to 105 CMR
120.229(B)(9) on entry control devices for very high radiation areas. These records must include
the date, time, and results of each such test of function.

(B) The licensee or registrant shall retain the records required by 105 CMR 120.270(A) for
three years after the record is made.

120.271: Form of Records

Each record required by 105 CMR 120.200 shall be legible throughout the specified retention
period. The record shall be the original or a reproduced copy or a microform, provided that the
copy or microform is authenticated by authorized personnel and that the microform is capable
of producing a clear copy throughout the required retention period or the record may also be
stored in electronic media with the capability for producing legible, accurate, and complete
records during the required retention period. Records, such as letters, drawings, and
specifications, shall include all pertinent information, such as stamps, initials, and signatures.
The licensee or registrant shall maintain adequate safeguards against tampering with and loss of
records.

REPORTS

120.281: Reports of Stolen, Lost, or Missing Licensed or Registered Sources of Radiation

(A) Telephone Reports. Each licensee or registrant shall report to the Agency by telephone as
follows:
(1) immediately after its occurrence becomes known to the licensee, stolen, lost, or missing
licensed radioactive material in an aggregate quantity equal to or greater than 1,000 times the
quantity specified in 105 CMR 120.297: Appendix C, under such circumstances that it
appears to the licensee that an exposure could result to individuals in unrestricted areas;
(2) within 30 days after its occurrence becomes known to the licensee, lost, stolen, or
missing licensed radioactive material in an aggregate quantity greater than ten times the
quantity specified in 105 CMR 120.297: Appendix C that is still missing;
(3) immediately after its occurrence becomes known to the registrant, a stolen, lost, or
missing radiation machine.

(B) Written Reports. Each licensee or registrant required to make a report pursuant to
105 CMR 120.281(A) shall, within 30 days after making the telephone report, make a written
report to the Agency setting forth the following information:
(1) a description of the licensed or registered source of radiation involved, including, for
radioactive material, the kind, quantity, and chemical and physical form; and, for radiation
machines, the manufacturer, model and serial number, type and maximum energy of
radiation emitted;
(2) a description of the circumstances under which the loss or theft occurred;
(3) a statement of disposition, or probable disposition, of the licensed or registered source
of radiation involved;
(4) exposures of individuals to radiation, circumstances under which the exposures
occurred, and the possible total effective dose equivalent to persons in unrestricted areas;
(5) actions that have been taken, or will be taken, to recover the source of radiation; and
(6) procedures or measures that have been, or will be, adopted to ensure against a recurrence
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

of the loss or theft of licensed or registered sources of radiation.

(C) Subsequent to filing the written report, the licensee or registrant shall also report additional
substantive information on the loss or theft within 30 days after the licensee or registrant learns
of such information.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.281: continued

(D) The licensee or registrant shall prepare any report filed with the Agency pursuant to
105 CMR 120.281 so that names of individuals who may have received exposure to radiation
are stated in a separate and detachable portion of the report.

120.282: Notification of Incidents

(A) Immediate Notification. Notwithstanding any other requirements for notification, each
licensee or registrant shall immediately report each event involving a source of radiation
possessed by the licensee or registrant that may have caused or threatens to cause any of the
following conditions:
(1) An individual to receive:
(a) a total effective dose equivalent of 0.25 sievert (25 rems) or more;
(b) a lens dose equivalent of 0.75 sievert (75 rems) or more;
(c) a shallow dose equivalent to the skin or extremities or a total organ dose equivalent
of 2.5 grays (250 rads) or more; or
(2) The release of radioactive material, inside or outside of a restricted area, so that, had an
individual been present for 24 hours, the individual could have received an intake five times
the occupational ALI. This provision does not apply to locations where personnel are not
normally stationed during routine operations, such as hot-cells or process enclosures.

(B) 24 Hour Notification. Each licensee or registrant shall, within 24 hours of discovery of the
event, report to the Agency each event involving loss of control of a licensed or registered source
of radiation possessed by the licensee or registrant that may have caused, or threatens to cause,
any of the following conditions:
(1) An individual to receive, in a period of 24 hours:
(a) a total effective dose equivalent exceeding 0.05 sievert (five rems);
(b) a lens dose equivalent exceeding 0.15 sievert (15 rems);
(c) a shallow dose equivalent to the skin or extremities or a total organ dose equivalent
exceeding 0.5 sievert (50 rems); or
(2) The release of radioactive material, inside or outside of a restricted area, so that, had an
individual been present for 24 hours, the individual could have received an intake in excess
of one occupational ALI. This provision does not apply to locations where personnel are not
normally stationed during routine operations, such as hot-cells or process enclosures.

(C) Licensees or registrants shall make the reports required by 105 CMR 120.282(A) and (B)
by initial contact by telephone to the Agency and shall confirm the initial contact by telegram,
mailgram, or facsimile to the Agency.

(D) The licensee or registrant shall prepare each report filed with the Agency pursuant to
105 CMR 120.282 so that names of individuals who have received exposure to sources of
radiation are stated in a separate and detachable portion of the report.

(E) The provisions of 105 CMR 120.282 do not apply to doses that result from planned special
exposures, provided such doses are within the limits for planned special exposures and are
reported pursuant to 105 CMR 120.284.

120.283: Reports of Exposures, Radiation Levels, and Concentrations of Radioactive Material Exceeding
the Constraints or the Limits
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(A) Reportable Events. In addition to the notification required by 105 CMR 120.282, each
licensee or registrant shall submit a written report within 30 days after learning of any of the
following occurrences:
(1) incidents for which notification is required by 105 CMR 120.282; or
(2) doses in excess of any of the following:
(a) the occupational dose limits for adults in 105 CMR 120.211;
(b) the occupational dose limits for a minor in 105 CMR 120.217;
(c) the limits for an embryo/fetus of a declared pregnant woman in 105 CMR 120.218;
(d) the limits for an individual member of the public in 105 CMR 120.221;
(e) any applicable limit in the license or registration;
(f) the ALARA constraints for air emissions established under 105 CMR 120.210(D);
or
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.283: continued

(3) levels of radiation or concentrations of radioactive material in:

(a) a restricted area in excess of applicable limits in the license or registration;
(b) an unrestricted area in excess of ten times the applicable limit set forth in this part
or in the license or registration, whether or not involving exposure of any individual in
excess of the limits in 105 CMR 120.221; or,
(4) for licensees subject to the provisions of U.S. Environmental Protection Agency's
generally applicable environmental radiation standards in 40 CFR 190, levels of radiation or
releases of radioactive material in excess of those standards, or of license conditions related
to those standards.

(B) Contents of Reports.

(1) Each report required by 105 CMR 120.283(A) shall describe the extent of exposure of
individuals to radiation and radioactive material, including, as appropriate:
(a) estimates of each individual's dose;
(b) the levels of radiation and concentrations of radioactive material involved;
(c) the cause of the elevated exposures, dose rates, or concentrations; and,
(d) corrective steps taken or planned to ensure against a recurrence, including the
schedule for achieving conformance with applicable limits, ALARA constraints generally
applicable environmental standards, and associated license or registration conditions.
(2) Each report filed pursuant to 105 CMR 120.283(A) shall include for each occupationally
exposed individual: the name, social security number, and date of birth. With respect to the
limit for the embryo/fetus in 105 CMR 120.218: Dose Equivalent to an Embryo/Fetus, the
identifiers should be those of the declared pregnant woman. The report shall be prepared so
that this information is stated in a separate and detachable portion of the report.

(C) All licensees or registrants who make reports pursuant to 105 CMR 120.283(A) shall
submit the report in writing to the Agency.

120.284: Reports of Planned Special Exposures

The licensee or registrant shall submit a written report to the Agency within 30 days
following any planned special exposure conducted in accordance with 105 CMR 120.216,
informing the Agency that a planned special exposure was conducted and indicating the date the
planned special exposure occurred and the information required by 105 CMR 120.266.

120.285: Reports to Individuals of Exceeding Dose Limits

When a licensee or registrant is required, pursuant to 105 CMR 120.283 or 120.284 to report
to the Agency any exposure of an identified occupationally exposed individual, or an identified
member of the public, to radiation or radioactive material, the licensee shall also provide a copy
of the report submitted to the Agency to the individual. This report must be transmitted at a time
no later than the transmittal to the Agency.

120.286: Reports of Individual Monitoring

(A) The requirements of 105 CMR 120.286 apply to each person licensed or registered by the
Agency:
(1) Possess or use sources of radiation for purposes of industrial radiography pursuant to
105 CMR 120.100 and 120.300; or
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(2) Possess or use at any time, for processing or manufacturing for distribution pursuant to
105 CMR 120.100 or 120.500, radioactive material in quantities exceeding any one of the
following quantities:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.286: continued

Radionuclide, Activity
Radionuclide Activity
Ci GBq
Cesium-137 1 37
Cobalt-60 1 37
Gold-198 100 3700
Iodine-131 1 37
Iridium-192 10 370
Krypton-85 1000 37000
Promethium-147 10 370
Technetium-99m 1000 37000

[Note: The Agency may require as a license condition, or by rule, regulation, or order pursuant
to 105 CMR 120.012, reports from licensees or registrants who are licensed or registered to use
radionuclides not on this list, in quantities sufficient to cause comparable radiation levels.]

(B) Each licensee or registrant in a category listed in 105 CMR 120.286(A) shall submit an
annual report of the results of individual monitoring carried out by the licensee or registrant for
each individual for whom monitoring was required by 105 CMR 120.226 during that year. The
licensee or registrant may include additional data for individuals for whom monitoring was
provided but not required. The licensee or registrant shall use Agency Form MRCP 120.200-2
or equivalent or electronic media containing all the information required by Agency Form MRCP
120.200-2.

(C) The licensee or registrant shall file the report required by 105 CMR 120.286(A), covering
the preceding year, on or before April 30th each year. The licensee or registrant shall submit the
report to the Agency.

120.287: Notifications and Reports to Individuals

(A) Requirements for notification and reports to individuals of exposure to radiation or

radioactive material are specified in 105 CMR 120.750.

(B) When a licensee or registrant is required pursuant to 105 CMR 120.283 to report to the
Agency any exposure of an individual to radiation or radioactive material, the licensee or
registrant shall also notify the individual. Such notice shall be transmitted at a time not later than
the transmittal to the Agency, and shall comply with the provisions of 105 CMR 120.754(A).

120.288: Reports of Leaking or Contaminated Sealed Sources

The licensee shall immediately notify the Agency if the test for leakage or contamination
required pursuant to 105 CMR 120.223 indicates a sealed source is leaking or contaminated. A
written report of a leaking or contaminated source shall be submitted to the Agency within five
days. The report shall include the equipment involved, the test results and the corrective action
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

taken.

120.290: Reports of Transactions Involving Nationally Tracked Sources

Each licensee who manufactures, transfers, receives, disassembles, or disposes of a nationally

tracked source shall complete and submit a National Source Tracking Transaction Report as
specified in 105 CMR 120.290(A) through (E) for each type of transaction.

(A) Each licensee who manufactures a nationally tracked source shall complete and submit a
National Source TrackingTransaction Report. The report must include the following information:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.290: continued

(1) The name, address, and license number of the reporting licensee;
(2) The name of the individual preparing the report;
(3) The manufacturer, model, and serial number of the source;
(4) The radioactive material in the source;
(5) The initial source strength in becquerels (curies) at the time of manufacture; and,
(6) The manufacture date of the source.

(B) Each licensee that transfers a nationally tracked source to another person shall complete and
submit a National Source Tracking Transaction Report. The report must include the following
information:
(1) The name, address, and license number of the reporting licensee;
(2) The name of the individual preparing the report;
(3) The name and license number of the recipient facility and the shipping address;
(4) The manufacturer, model, and serial number of the source or, if not available, other
information to uniquely identify the source;
(5) The radioactive material in the source;
(6) The initial or current source strength in becquerels (curies);
(7) The date for which the source strength is reported;
(8) The shipping date;
(9) The estimated arrival date; and
(10) For nationally tracked sources transferred as waste under a Uniform Low-level
Radioactive Waste Manifest, the waste manifest number and the container identification of
the container with the nationally tracked source.

(C) Each licensee that receives a nationally tracked source shall complete and submit a National
Source TrackingTransaction Report. The report must include the following information:
(1) The name, address, and license number of the reporting licensee;
(2) The name of the individual preparing the report;
(3) The name, address, and license number of the person that provided the source;
(4) The manufacturer, model, and serial number of the source or, if not available, other
information to uniquely identify the source;
(5) The radioactive material in the source;
(6) The initial or current source strength in becquerels (curies);
(7) The date for which the source strength is reported;
(8) The date of receipt; and
(9) For material received under a Uniform Low-level Radioactive Waste Manifest, the
waste manifest number and the container identification with the nationally tracked source.

(D) Each licensee that disassembles a nationally tracked source shall complete and submit a
National Source TrackingTransaction Report. The report must include the following
information:
(1) The name, address, and license number of the reporting licensee;
(2) The name of the individual preparing the report;
(3) The manufacturer, model, and serial number of the source or, if not available, other
information to uniquely identify the source;
(4) The radioactive material in the source;
(5) The initial or current source strength in becquerels (curies);
(6) The date for which the source strength is reported;
(7) The disassemble date of the source.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(E) Each licensee who disposes of a nationally tracked source shall complete and submit a
National Source Tracking Transaction Report. The report must include the following
information:
(1) The name, address, and license number of the reporting licensee;
(2) The name of the individual preparing the report;
(3) The waste manifest number;
(4) The container identification with the nationally tracked source.
(5) The date of disposal; and
(6) The method of disposal.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.290: continued

(F) The reports discussed in 105 CMR 120.290(A) through (E) must be submitted by the close
of the next business day after the transaction. A single report may be submitted for multiple
sources and transactions. The reports must be submitted to the National Source Tracking System
by using:
(1) The on-line National Source Tracking System;
(2) Electronically using a computerreadable format;
(3) By facsimile;
(4) By mail to the address on the National Source Tracking Transaction Report Form (NRC
Form 748); or
(5) By telephone with followup by facsimile or mail.

(G) Each licensee shall correct any error in previously filed reports or file a new report for any
missed transaction within five business days of the discovery of the error or missed transaction.
Such errors may be detected by a variety of methods such as administrative reviews or by
physical inventories required by regulation. In addition, each licensee shall reconcile the
inventory of nationally tracked sources possessed by the licensee against that licensee's data in
the National Source Tracking System. The reconciliation must be conducted during the month
of January in each year. The reconciliation process must include resolving any discrepancies
between the National Source Tracking System and the actual inventory by filing the reports
identified by 105 CMR 120.290(A) through (E). By January 31st of each year, each licensee must
submit to the National Source Tracking System confirmation that the data in the National Source
Tracking System is correct.

(H) Each licensee that possesses Category 1 nationally tracked sources shall report its initial
inventory of Category 1 nationally tracked sources to the National Source Tracking System by
January 31, 2009. Each licensee that possesses Category 2 nationally tracked sources shall report
its initial inventory of Category 2 nationally tracked sources to the National Source Tracking
System by January 31, 2009. The information may be submitted by using any of the methods
identified by 105 CMR 120.290(F)(1) through (4). The initial inventory report must include the
following information:
(1) The name, address, and license number of the reporting licensee;
(2) The name of the individual preparing the report;
(3) The manufacturer, model, and serial number of each nationally tracked source or, if not
available, other information to uniquely identify the source;
(4) The radioactive material in the sealed source;
(5) The initial or current source strength in becquerels (curies); and
(6) The date for which the source strength is reported.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.295: Appendix A – Assigned (APF) Protection Factors for Respiratorsa

Operating Mode Assigned Protection

Factors
I. Air purifying respirators (Particulateb only)c
Filtering faceplate disposabled . . . . . . . . . . Negative Pressure . . . . . . . . . . . . . (d)
Facepiece, halfe . . . . . . . . . . . . . . . . . . . . . . Negative Pressure . . . . . . . . . . . . . 10
Facepiece, full . . . . . . . . . . . . . . . . . . . . . . . Negative Pressure . . . . . . . . . . . . . 100
Facepiece, . . . . . . . . . . . . . . . . . . . . . . . . . . Powered air-purifying respirators 50
Facepiece, full . . . . . . . . . . . . . . . . . . . . . . . Powered air-purifying respirators 1000
Helmet/hood . . . . . . . . . . . . . . . . . . . . . . . . Powered air-purifying respirators 1000
Facepiece, loosefitting . . . . . . . . . . . . . . . . Powered air-purifying respirators 25

II. Atmosphere suppling respirators

(Particulate, gases, and vaporsf)
1: Air-line Respirator:
Facepiece, half . . . . . . . . . . . . . . . . . . . . . . Demand . . . . . . . . . . . . . . . . . . . . 10
Facepiece, half . . . . . . . . . . . . . . . . . . . . . . Continuous Flow . . . . . . . . . . . . . 50
Facepiece, half . . . . . . . . . . . . . . . . . . . . . . Pressure Demand . . . . . . . . . . . . . 50
Facepiece, full . . . . . . . . . . . . . . . . . . . . . . Demand . . . . . . . . . . . . . . . . . . . . 100
Facepiece, full . . . . . . . . . . . . . . . . . . . . . . Continuous Flow . . . . . . . . . . . . . 1000
Facepiece, full . . . . . . . . . . . . . . . . . . . . . . Pressure Demand . . . . . . . . . . . . . 1000
Helmet/hood . . . . . . . . . . . . . . . . . . . . . . . . Continuous Flow . . . . . . . . . . . . . 1000
Facepiece, loose-fitting . . . . . . . . . . . . . . . Continuous Flow . . . . . . . . . . . . . 25
Suit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Continuous Flow . . . . . . . . . . . . . (g)

2: Self-contained breathing apparatus

h
(SCBA): Demand . . . . . . . . . . . . . . . . . . . . 100
i
Facepiece, full . . . . . . . . . . . . . . . . . . . . . Pressure Demand . . . . . . . . . . . . . 10,000
h
Facepiece, full . . . . . . . . . . . . . . . . . . . . . Demand, Recirculating . . . . . . . . . 100
i
Facepiece, full . . . . . . . . . . . . . . . . . . . . . Positive Pressure Recirculating . . 10,000
Facepiece, full . . . . . . . . . . . . . . . . . . . . .
III. Combination Respirators:
Any combination of air-purifying and Assigned protection factor for
atmosphere-supplying respirators type and mode of operations as
listed above

FOOTNOTES

a. These assigned protection factors apply only in respiratory protection program that meets the
requirements of 105 CMR 120.293: Appendix A. They are applicable only to airborne
radiological hazards and may not be appropriate to circumstances when chemical or other
respiratory hazards exist instead of, or in addition to, radioactive hazards. Selection and use of
respirators for such circumstances must also comply with Department of Labor regulations.
Radioactive contaminants for which the concentration values in 105 CMR 120.296: Appendix B,
Table 1, column 3 are based on internal dose due to inhalation may, in addition, present external
exposure hazards at higher concentrations. Under these circumstances, limitations on occupancy
may have to be governed by external dose limits.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

b. Air purifying respirators with APF <100 must be equipped with particulate filters that are at
least 95% efficient. Air purifying respirators with APF = 100 must be equipped with particulate
filters that are at least 99% efficient. Air purifying respirators with APF >100 must be equipped
with particulate filters that area t least 99.97% efficient.

c. The licensee may apply to the Agency for the use of an APF greater than one for sorbent
cartridges as protection against airborne radioactive gases and vapors (e.g., radioiodine).
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.295: Appendix A: continued

FOOTNOTES - continued

d. Licensees may permit individuals to use this type of respirator who have not been medically
screened or fit tested on the device provided that no credit be taken for their use in estimating
intake or dose. It is also recognized that it is difficult to perform an effective positive or negative
pressure pre-use user seal check on this type of device. All other respiratory protection program
requirements listed in 105 CMR 120.233 apply. An assigned protection factor has not been
assigned for these devices. However, an APF equal to ten may be used if the licensee can
demonstrate a fit factor of at least 100 by use of a validated or evaluated, qualitative or
quantitative fit test.

e. Under-chin type only. No distinction is made in 105 CMR 120.296: Appendix A between
elastomeric half-masks with replaceable cartridges and those designed with the filter medium
as an integral part of the facepiece (e.g., disposable or reusable disposable). Both types are
acceptable so long as the seal area of the latter contains some substantial type of seal enhancing
material such as rubber or plastic, the two or more suspension straps are adjustable, the filter
medium is at least 95% efficient and all other requirements of 105 CMR 120.298: Appendix A
are met.

f. The assigned protection factors for gases and vapors are not applicable to radioactive
contaminants that present an absorption or submersion hazard. For tritium oxide vapor,
approximately a of the intake occurs by absorption through the skin so that an overall protection
factor of three is appropriate when atmosphere-supplying respirators are used to protect against
tritium oxide. Exposure to radioactive noble gases is not considered a significant respiratory
hazard, and protective actions for these contaminants should be based on external (submersion)
dose considerations.

g. No NIOSH approval schedule is currently available for atmospheric supplying units. This
equipment may be used in an acceptable respiratory protection program as long as all the other
minimum program requirements, with the exception of fit testing, are met (i.e., 105 CMR
120.233).

h. The licensee should implement institutional controls to assure that these devices are not used
in areas immediately dangerous to life or health (IDLH).

i. This type of respirator may be used as an emergency device in unknown concentrations for
protection against inhalation hazards. External radiation hazards and other limitations to
permitted exposure such as skin absorption shall be taken into account in these circumstances.
This device may not be used by any individual who experiences perceptible outward leakage of
breathing gas while wearing the device.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: Appendix B -- Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of
Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release
to Sanitary Sewerage

Introduction. For each radionuclide, Table I indicates the chemical form which is to be used
for selecting the appropriate ALI or DAC value. The ALIs and DACs for inhalation are given
for an aerosol with an activity median aerodynamic diameter (AMAD) of 1 :m, micron, and for
three classes (D,W,Y) of radioactive material, which refer to their retention (approximately days,
weeks or years) in the pulmonary region of the lung. This classification applies to a range of
clearance half-times for D if less than 10 days, for W from 10 to 100 days, and for Y greater than
100 days. The class (D, W, or Y) given in the column headed "Class" applies only to the
inhalation ALIs and DACs given in Table I, column 2 and 3. Table II provides concentration
limits for airborne and liquid effluents released to the general environment. Table III provides
concentration limits for discharges to sanitary sewerage.

Note: The values in Tables I, II, and III are presented in the computer "E" notation. In this
notation a value of 6E-02 represents a value of 6 x 10-2 or 0.06, 6E+2 represents 6 x 1O2 or 600,
and 6E+0 represents 6 x 100 or 6.

Table I "Occupational Values"

Note that the columns in 105 CMR 120.296: Appendix B, Table I captioned "Oral Ingestion
ALI," "Inhalation ALI," and "DAC," are applicable to occupational exposure to radioactive
material.
The ALIs in 105 CMR 120.296: Appendix B are the annual intakes of given radionuclide by
"Reference Man" which would result in either (1) a committed effective dose equivalent of 5
rems (0.05 sievert), stochastic ALI, or (2) a committed dose equivalent of 50 rems (0.5 sievert)
to an organ or tissue, non-stochastic ALI. The stochastic ALIs were derived to result in a risk,
due to irradiation of organs and tissues, comparable to the risk associated with deep dose
equivalent to the whole body of five rems (0.05 sievert). The derivation includes multiplying
the committed dose equivalent to an organ or tissue by a weighting factor, wT. This weighting
factor is the proportion of the risk of stochastic effects resulting from irradiation of the organ or
tissue, T, to the total risk of stochastic effects when the whole body is irradiated uniformly. The
values of wT are listed under the definition of "weighting factor" in 105 CMR 120.203. The
non-stochastic ALIs were derived to avoid non-stochastic effects, such as prompt damage to
tissue or reduction in organ function.
A value of wT = 0.06 is applicable to each of the five organs or tissues in the "remainder"
category receiving the highest dose equivalents, and the dose equivalents of all other remaining
tissues may be disregarded. The following portions of the GI tract -- stomach, small intestine,
upper large intestine, and lower large intestine -- are to be treated as four separate organs.
Note that the dose equivalents for an extremity, skin and lens of the eye are not considered
in computing the committed effective dose equivalent, but are subject to limits that must be met
separately.
When an ALI is defined by the stochastic dose limit, this value alone is given. When an ALI
is determined by the non-stochastic dose limit to an organ, the organ or tissue to which the limit
applies is shown, and the ALI for the stochastic limit is shown in parentheses. Abbreviated
organ or tissue designations are used:

LLI wall = lower large intestine wall;

St wall = stomach wall;
Blad wall = bladder wall; and,
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Bone surf = bone surface.

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

The use of the ALIs listed first, the more limiting of the stochastic and non-stochastic ALIs,
will ensure that non-stochastic effects are avoided and that the risk of stochastic effects is limited
to an acceptably low value. If, in a particular situation involving a radionuclide for which the
non-stochastic ALI is limiting, use of that non-stochastic ALI is considered unduly conservative,
the licensee may use the stochastic ALI to determine the committed effective dose equivalent.
However, the licensee shall also ensure that the 50 rems (0.5 sievert) dose equivalent limit for
any organ or tissue is not exceeded by the sum of the external deep dose equivalent plus the
internal committed dose equivalent to that organ, not the effective dose. For the case where there
is no external dose contribution, this would be demonstrated if the sum of the fractions of the
nonstochastic ALIs (ALIns) that contribute to the committed dose equivalent to the organ
receiving the highest dose does not exceed unity, that is, 3 (intake (in :Ci) of each
radionuclide/ALIns) # 1.0. If there is an external deep dose equivalent contribution of Hd, then
this sum must be less than 1 - (Hd/50), instead of # 1.0.
Note that the dose equivalents for an extremity, skin, and lens of the eye are not considered
in computing the committed effective dose equivalent, but are subject to limits that must be met
separately.
The derived air concentration (DAC) values are derived limits intended to control chronic
occupational exposures. The relationship between the DAC and the ALI is given by:
DAC = ALI(in :Ci)/(2000 hours per working year x 60 minutes/hour x 2 x 104 ml per
minute) = [ALI/2.4 x 109] :Ci/ml,
where 2 x 104 ml is the volume of air breathed per minute at work by Reference Man under
working conditions of light work.
The DAC values relate to one of two modes of exposure: either external submersion or the
internal committed dose equivalents resulting from inhalation of radioactive materials. DACs
based upon submersion are for immersion in a semi-infinite cloud of uniform concentration and
apply to each radionuclide separately.
The ALI and DAC values include contributions to exposure by the single radionuclide named
and any in-growth of daughter radionuclides produced in the body by decay of the parent.
However, intakes that include both the parent and daughter radionuclides should be treated by
the general method appropriate for mixtures.
The values of ALI and DAC do not apply directly when the individual both ingests and
inhales a radionuclide, when the individual is exposed to a mixture of radionuclides by either
inhalation or ingestion or both, or when the individual is exposed to both internal and external
irradiation. See 105 CMR 120.212. When an individual is exposed to radioactive materials
which fall under several of the translocation classifications of the same radionuclide, such as,
Class D, Class W, or Class Y, the exposure may be evaluated as if it were a mixture of different
radionuclides.
It should be noted that the classification of a compound as Class D, W, or Y is based on the
chemical form of the compound and does not take into account the radiological half-life of
different radionuclides. For this reason, values are given for Class D, W, and Y compounds,
even for very short-lived radionuclides.

Table II "Effluent Concentrations". The columns in 105 CMR 120.296: Appendix B, Table
II captioned "Effluents," "Air" and "Water" are applicable to the assessment and control of dose
to the public, particularly in the implementation of the provisions of 105 CMR 120.222. The
concentration values given in 105 CMR 120.296: Appendix B, Table II, Columns 1 and 2 are
equivalent to the radionuclide concentrations which, if inhaled or ingested continuously over the
course of a year, would produce a total effective dose equivalent of 0.05 rem (0.5 millisievert).
Consideration of non-stochastic limits has not been included in deriving the air and water
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

effluent concentration limits because non-stochastic effects are presumed not to occur at or
below the dose levels established for individual members of the public. For radionuclides, where
the non-stochastic limit was governing in deriving the occupational DAC, the stochastic ALI was
used in deriving the corresponding airborne effluent limit in Table II. For this reason, the DAC
and airborne effluent limits are not always proportional as was the case in the previous Appendix
105 CMR 120.295: Appendix A.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

The air concentration values listed in Table II, Column 1 were derived by one of two
methods. For those radionuclides for which the stochastic limit is governing, the occupational
stochastic inhalation ALI was divided by 2.4 x 109 ml, relating the inhalation ALI to the DAC,
as explained above, and then divided by a factor of 300. The factor of 300 includes the following
components: a factor of 50 to relate the 5 rems (0.05 sievert) annual occupational dose limit to
the one mSv (0.1 rem) limit for members of the public, a factor of three to adjust for the
difference in exposure time and the inhalation rate for a worker and that for members of the
public; and a factor of two to adjust the occupational values, derived for adults, so that they are
applicable to other age groups.
For those radionuclides for which submersion, that is external dose, is limiting, the
occupational DAC in 105 CMR 120.296: Appendix B, Table I, Column 3 was divided by 219.
The factor of 219 is composed of a factor of 50, as described above, and a factor of 4.38 relating
occupational exposure for 2,000 hours per year to full-time exposure (8,760 hours per year).
Note that an additional factor of 2 for age considerations is not warranted in the submersion case.
The water concentrations were derived by taking the most restrictive occupational stochastic
oral ingestion ALI and dividing by 7.3 x 107. The factor of 7.3 x 107 (ml) includes the following
components: the factors of 50 and 2 described above and a factor of 7.3 x 105 (ml) which is the
annual water intake of "Reference Man".
Note 2 of 105 CMR 120.296: Appendix B provides groupings of radionuclides which are
applicable to unknown mixtures of radionuclides. These groupings, including occupational
inhalation ALIs and DACs, air and water effluent concentrations and releases to sewer, require
demonstrating that the most limiting radionuclides in successive classes are absent. The limit
for the unknown mixture is defined when the presence of one of the listed radionuclides cannot
be definitely excluded as being present either from knowledge of the radionuclide composition
of the source or from actual measurements.

Table III "Releases to Sewers". The monthly average concentrations for release to sanitary
sewerage are applicable to the provisions in 105 CMR 120.253. The concentration values were
derived by taking the most restrictive occupational stochastic oral ingestion ALI and dividing by
7.3 x 106 (ml). The factor of 7.3 x 106 (ml) is composed of a factor of 7.3 x 105 (ml), the annual
water intake by "Reference Man", and a factor of ten, such that the concentrations, if the sewage
released by the licensee were the only source of water ingested by a "Reference Man" during a
year, would result in a committed effective dose equivalent of five mSv (0.5 rem).
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

List of Elements

Name Atomic Name Atomic

Symbol No. Symbol No.

Actinium Ac 89 Lead Pb 82
Aluminium Al 13 Lutetium Lu 71
Americium Am 95 Magnesium Mg 12
Antimony Sb 51 Manganese Mn 25
Argon Ar 18 Mendelevium Md 101
Arsenic As 33 Mercury Hg 80
Astatine At 85 Molybdenum Mo 42
Barium Ba 56 Neodymium Nd 60
Berkelium Bk 97 Neptunium Np 93
Beryllium Be 4 Nickel Ni 28
Bismuth Bi 83 Niobium Nb 41
Bromine Br 35 Nitrogen N 7
Cadmium Cd 48 Osmium Os 76
Calcium Ca 20 Oxygen O 8
Californium Cf 98 Palladium Pd 46
Carbon C 6 Phosphorus P 15
Cerium Ce 58 Platinum Pt 78
Cesium Cs 55 Plutonium Pu 94
Chlorine Cl 17 Polonium Po 84
Chromium Cr 24 Potassium K 19
Cobalt Co 27 Praseodymium Pr 59
Copper Cu 29 Promethium Pm 61
Curium Cm 96 Protactinium Pa 91
Dysprosium Dy 66 Radium Ra 88
Einsteinium Es 99 Radon Rn 86
Erbium Er 68 Rhenium Re 75
Europium Eu 63 Rhodium Rh 45
Femium Fm 100 Rubidium Rb 37
Fluorine F 9 Ruthenium Ru 44
Francium Fr 87 Samarium Sm 62
Gadolinium Gd 64 Scandium Sc 21
Gallium Ga 31 Selenium Se 34
Germanium Ge 32 Silicon Si 14
Gold Au 79 Silver Ag 47
Hafnium Hf 72 Sodium Na 11
Holmium Ho 67 Strontium Sr 38
Hydrogen H 1 Sulfur S 16
Indium In 49 Tantalum Ta 73
Iodine I 53 Technetium Tc 43
Iridium Ir 77 Tellurium Te 52
Iron Fe 26 Terbium Tb 65
Krypton Kr 36 Thallium Tl 81
Lanthanum La 57 Thorium Th 90
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Thulium Tm 69 Xenon Xe 54
Tin Sn 50 Ytterbium Yb 70
Titanium Ti 22 Yttrium Y 39
Tungsten W 74 Zinc Zn 30
Uranium U 92 Zirconium Zr 40
Vanadium V 23
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued
Table II Table III
Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

1 Hydrogen-3 Water, DAC includes skin absorption 8E+4 8E+4 2E-5 1E-7 1E-3 1E-2

Gas (HT or T2 ) Submersion1 : Use above values as HT and T2 oxidize in air and in the body to HTO.

4 Beryllium-7 W, all compounds except those given for Y 4E+4 2E+4 9E-6 3E-8 6E-4 6E-3

Y, oxides, halides, and nitrates = 2E+4 8E-6 3E-8 = =

4 Beryllium-10 W, see 7 Be 1E+3 2E+2 6E-8 2E-10 = =

LLI wall
(1E+3) = = = 2E-5 2E-4

Y, see 7 Be = 1E+1 6E-9 2E-11 = =

6 Carbon-112 Monoxide = 1E+6 5E-4 2E-6 = =

Dioxide = 6E+5 3E-4 9E-7 = =

Compounds 4E+5 4E+5 2E-4 6E-7 6E-3 6E-2

6 Carbon-14 Monoxide = 2E+6 7E-4 2E-6 = =

Dioxide = 2E+5 9E-5 3E-7

Compounds 2E+3 2E+3 1E-6 3E-9 3E-5 3E-4

7 Nitrogen-132 Submersion1 = = 4E-6 2E-8

8 Oxygen-152 Submersion1 = = 4E-6 2E-8

9 Fluorine-182 D, fluorides of H, Li, Na, K, Rb, Cs, and Fr 5E+4 7E+4 3E-5 1E-7 = =

St wall
(5E+4) = = = 7E-4 7E-3

W, fluorides of Be, Mg, Ca, Sr, Ba, Ra, Al, = 9E+4 4E-5 1E-7 = =
Ga, In, Tl, As, Sb, Bi, Fe, Ru, Os, Co, Ni,
Pd, Pt, Cu, Ag, Au, Zn, Cd, Hg, Sc, Y, Ti,
Zr, V, Nb, Ta, Mn, Tc, and Re

Y, lanthanum fluoride = 8E+4 3E-5 1E-7 = =

11 Sodium-22 D, all compounds 4E+2 6E+2 3E-7 9E-10 6E-6 6E-5

11 Sodium-24 D, all compounds 4E+3 5E+3 2E-6 7E-9 5E-5 5E-4

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

12 Magnesium-28 D, all compounds except those given for 7E+2 2E+3 7E-7 2E-9 9E-6 9E-5
W

W, oxides, hydroxides, carbides, halides, = 1E+3 5E-7 2E-9 = =

and nitrates

13 Aluminum-26 D, all compounds except those given for 4E+2 6E+1 3E-8 9E-11 6E-6 6E-5
W

W, oxides, hydroxides, carbides, halides, = 9E+1 4E-8 1E-10 = =

and nitrates

14 Silicon-31 D, all compounds except those given for 9E+3 3E+4 1E-5 4E-8 1E-4 1E-3
W and Y

W, oxides, hydroxides, carbides, and - 3E+4 1E-5 5E-8 - -

nitrates

Y, aluminosilicate glass - 3E+4 1 E-5 4 E-8 - -

14 Silicon-32 D, see 31Si 2E+3 2E+2 1 E-7 3E-10 - -

LLI wall
(3E+3) - - - 4 E-5 4 E-4

W, see 31Si - 1E+2 5 E-8 2E-10 - -

Y, see 31Si - 5E+0 2E-9 7E-12 - -

15 Phosphorus-32 D, all compounds except phosphates given 6E+2 9E+2 4 E-7 1E-9 9 E-6 9 E-5
for W

W, phosphates of Zn2+, S3+, Mg2+, Fe3+, - 4E+2 2 E-7 5E-10 - -

Bi3+, and lanthanides

15 Phosphorus-33 D, see 32P 6E+3 8E+3 1 E-8 1 E-8 8 E-5 8 E-4

W, see 32P - 3E+3 1 E-68 4 E-9 - -

16 Sulfur-35 Vapor 1E+4 6 E-6 2 E-8 - -

D, sulfides and sulfates except those given 1E+4 2E+4 7 E-6 2 E-8 - -
for W
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

LLI wall
(8E+3) - - - 1 E-4 1 E-3

W, elemental sulfur, 6E+3

sulfides of Sr, Ba, Ge, Sn, Pb, As, Sb, - 2E+3 9 E-7 3 E-9 - -
Bi, Cu, Ag, Au, Zn, Cd, Hg, W, and Mo.
Sulfates of Ca, Sr, Ba, Ra, As, Sb, and Bi

17 Chlorine-36 D, chlorides of H, Li, Na, K, Rb, Cs, and Fr 2E+3 2E+3 1 E-6 3 E-9 2 E-+ 2 E-4

W, chlorides of lantha- nides, Be, Mg, Ca, - 2E+2 1 E-7 3 E-10 - --

Sr, Ba, Ra, Al, Ga, In, Tl, Ge, Sn, Pb, As,
Sb, Bi, Fe, Ru, Os, Co, Rh, Ir, Ni, Pd, Pt,
Cu, Ag, Au, Zn, Cd, Hg, Sc, Y, Ti, Zr, Hf,
V, Nb, Ta, Cr, Mo, W, Mn, Tc, and Re

17 Chlorine-382 D, see 36Cl 2E+4 4E+4 2 E-5 6 E-8 -

St wall
(3E+4) - - -

W, see 36Cl - 5E+4 2 E-5 6 E-8 - -

17 Chlorine-392 D, see 36 Cl 2E+4 5E+4 2 E-5 7 E-8 - -

St wall
(4E+4) - - - 5 E-4 5 E-3
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

W, see 36Cl - 6E+4 2E-5 8E-8 - -

18 Argon-37 Submersion1 - - 1E+0 6E-3 - -

18 Argon-39 Submersion1 - - 2E-4 8E-7 - -

18 Argon-41 Submersion1 - - 3E-6 1E-8 - -

19 Potassium-40 D, all compounds 3E+2 4E+2 2E-7 6E-10 4E-6 4E-5

19 Potassium-42 D, all compounds 5E+3 5E+3 2E-6 7E-9 6E-5 6E-4

19 Potassium-43 D, all compounds 6E+3 9E+3 4E-6 1E-8 9E-5 9E-4

19 Potassium-442 D, all compounds 3E+4 7E+4 3E-5 9E+-8 - -

St wall
(4E+4) - - - 5E-4 5E-3

19 Potassium-452 D, all compounds 3E+4 7E+4 5E-5 2E-7 - -

St wall
(5E+4) - - - 7E-4 7E-3

20 Calcium-41 W, all compounds 3E+4 1E+5 2E-6 - - -

Bone surf Bone surf

(4E+3) (4E+3) - 5E-9 6E-5 6-4E

20 Calcium-45 W, all compounds E+3 4E+3 4E-7 1E-9 2E-5 2E-4

20 Calcium-47 W, all compounds 8E+2 9E+2 4E-7 1E-9 1E-5 1E-4

21 Scandium-43 Y, all compounds 7E+3 2E+4 9E-6 3E-8 1E-4 1E-3

21 Scandium-44m Y, all compounds 5E+2 7E+2 3E-7 1E-9 7E-6 7E-5

21 Scandium-44 Y, all compounds 4E+3 1E+4 5E-6 2E-8 5E-5 5E-4

21 Scandium-46 Y, all compounds 9E+2 2E+2 1E-7 3E-10 1E-5 1E-4

21 Scandium-47 Y, all compounds 2E+3 3E+3 1E-6 4E-9 - -

LLI wall
(3E+3) - - - 4E-5 4E-4

21 Scandium-48 Y, all compounds 8E+2 1E+3 6E-7 2E-9 E-5 1E-4

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

21 Scandium-492 Y, all compounds 2E+4 5E+4 2E-5 8E-8 3E-4 3E-3

22 Titanium-44 D, all compounds except those given for 3E+2 1E+1 5E-9 2E-11 4E-6 4E-5
W and Y

W, oxides, hydroxides, carbides, halides, - 3E+1 1E-8 4E-11 - -

and nitrates

Y, SrTi0 - 6E+0 2E-9 8E-12 - -

22 Titanium-45 D, see 44Ti 9E+3 3E+4 1E-5 3E-8 1E-4 1E-3

W, see 44Ti - 4E+4 1E-5 5E-8 - -

Y, see 44Ti - 3E+4 1E-5 4E-8 - -

23 Vanadium-472 D, all compounds except those given for 3E+4 8E+4 3E-5 1E-7 - -
W

St wall
(3E+4) - - -

W, oxides, hydroxides, carbides, and - 1E+5 4E-5 1E-7 - -

halides

23 Vanadium-48 D, see 47V 6E+2 1E+3 5E-7 2E-9 9E-6 9E-5

W, see 47V - 6E+2 3E-7 9E-10 - -

23 Vanadium-49 D, see 47V 7E+4 3E+4 1E-5 - - -

LLI wall Bone surf

(9E+4) (3E+4) - 5E-8 1E-3 1E-2

W, see 47V - 3E+4 8E-6 2E-8 - -

24 Chromium-48 D, all compounds except those given for 6E+3 1E+4 5E-6 2E-8 8E-5 8E-4
W and Y

W, halides and nitrates - 7E+3 3E-6 1E-8 - -

Y, oxides and hydroxides - 7E+3 3E-6 1E-8 - -

24 Chromium-492 D, see 48 Cr 3E+4 8E+4 4E-5 1E-7 4E-4 4E-3

W, see 48Cr - 1E+5 4E-5 1E-7 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

Y, see 48Cr - 9E+4 4E-5 1E-7 - -

24 Chromium-51 D, see 48Cr 4E+4 5E+4 2E-5 6E-8 5E-4 5E-3

W, see 48Cr - 2E+4 1E-5 3E-8 - -

Y, see 48Cr - 2E+4 8E-6 3E-8 - -

25 Manganese-512 D, all compounds except those given for 2E+4 5E+4 2E-5 7E-8 3E-4 3E-3
W

W, oxides, hydroxides, halides, and - 6E+4 3E-5 8E-8 - -

nitrates

25 Manganese-52m2 D, see 51 Mn 3E+4 9E+4 4E-5 1E-7 - -

St wall
(4E+4) - - - 5E-4 5E-3

W, see 51Mn - 1E+5 4E-5 1E-7 - -

25 Manganese-52 D, see 51Mn 7E+2 1E+3 5E-7 2E-9 1E-5 1E-4

W, see 51Mn - 9E+2 4E-7 1E-9 - -

25 Manganese-53 D, see 51Mn 5E+4 1E+4 5E-6 - 7E-4 7E-5

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

Bone surf
- (2E+4) - 3E-8 - -

W, see 51Mn - 1E+4 5E-6 2E-8 - -

25 Manganese-54 D, see 51Mn 2E+3 9E+2 4E-7 1E-9 3E-5 3E-4

W, see 51Mn - 8E+2 3E-7 1E-9 - -

25 Manganese-56 D, see 51Mn 5E+3 2E+4 6E-6 2E-8 7E-5 7E-4

W, see 51Mn - 2E+4 9E-6 3E-8 - -

26 Iron-52 D, all compounds except those given for 9E+2 3E+3 1E-6 4E-9 1E-5 1E-4
W

W, oxides, hydroxides, and halides - 1E+2 1E-6 3E-9 - -

26 Iron-55 D, see 52Fe 9E+3 2E+3 8E-7 3E-9 1E-4 1E-3

W, see 52Fe - 4E+3 2E-6 6E-9 - -

26 Iron-59 D, see 52Fe 8E+2 3E+2 1E-7 5E-10 1E-5 1E-4

W, see 52Fe - 4E+1 2E-7 7E-10- -

26 Iron-60 D, see 52Fe 3E+1 6E+0 3E-9 9E-12 4E-7 4E-6

W, see 52Fe - 2E+1 8E-9 3E-11 - -

27 Cobalt-55 W, all compounds except those given for 1E+3 3E+3 1E-6 4E-9 2E-5 2E-4
Y

Y, oxides, hydroxides, halides, and nitrates - 3E+3 1E-6 4E-9 - -

27 Cobalt-56 W, see 55Co 5E+2 3E+2 1E-7 4E-10 6E-6 6E-5

Y, see 55Co 4E+2 2E+2 8E-8 3E-10 - -

27 Cobalt-57 W, see 55Co 8E+3 3E+3 1E-6 4E-9 6E-5 6E-4

Y, see 55Co 4E+3 7E+2 3E-7 9E-10 - -

27 Cobalt-58m W, see 55Co 6E+4 9E+4 4E-5 1E-7 8E-4 8E-3

Y, see 55Co - 6E+4 3E-5 9E-8 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

27 Cobalt-58 W, see 55Co 1E+3 1E+3 5E-7 2E-9 2E-5 2E-4

Y, see 55Co 1E+3 7E+2 3E-7 1E-9 - -

27 Cobalt-60m2 W, see 55 Co 1E+6 4E+6 2E-3 6E-6 - -

St wall
(1E+6) - - - 2E-2 2E-1

Y, see 55Co - 3E+6 1E-3 4E-6 - -

27 Cobalt-60 W, see 55Co 5E+2 2E+2 7E-8 2E-10 3E-6 3E-5

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

Y, see 55Co 2 E+2 3 E+1 1 E-8 5 E-11 - -

27 Cobalt-612 W, see 55 Co 2 E+4 6 E+4 3 E-5 9 E-8 3 E-4 3 E-3

Y, see 55Co 2 E+4 6 E+4 2 E-5 8 E-8 - -

27 Cobalt-62m2 W, see 55 Co 4 E+4 2 E+5 7 E-5 2 E-7 - -

St wall
(5E+4) - - - 7 E-1 7 E-3

Y, see 55Co - 2 E+5 6 E-5 2 E-7 - -

28 Nickel-56 D, all compounds except those given for W 1 E+3 2 E+3 8 E-7 3 E-9 2 E-5 2 E-4

W, oxides, hydroxides, and carbides - 1 E+3 5 E-7 2 E-9 - -

Vapor - 1 E+3 5 E-7 2 E-9 - -

28 Nickel-57 D, see 56Ni 2 E+3 5 E+3 2 E-6 7 E-9 2 E-5 2 E-4

W, see 56Ni - 3 E+3 1 E-6 4 E-9 - -

Vapor - 6 E+3 3 E-6 9 E-9 - -

28 Nickel-59 D, see 56Ni 2 E+4 4 E+3 2 E-6 5 E-9 3 E-4 3 E-3

W, see 56Ni - 7 E+3 3 E-6 1 E-8 - -

Vapor - 2 E+3 8 E-7 3 E-9 - -

28 Nickel-63 D, see 56Ni 9 E+3 2 E+3 7 E-7 2 E-9 1 E-4 1 E-3

W, see 56Ni - 3 E+3 1 E-6 4 E-9 - -

Vapor - 8 E+2 3 E-7 1 E-9 - -

28 Nickel-65 D, see 56Ni 8 E+3 2 E+4 1 E-5 3 E-8 1 E-4 1 E-3

W, see 56Ni - 3 E+4 1 E-5 4 E-8 - -

Vapor - 2 E+4 7 E-6 2 E-8 - -

28 Nickel-66 D, see 56Ni 4 E+2 2 E+3 7 E-7 2 E-9 - -

LLI wall
(5E+2) - - - 6 E-6 6 E-5
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

W, see 56Ni - 6 E+2 3 E-7 9 E-10 - -

Vapor - 3 E+3 1 E-6 4 E-9 - -

29 Copper-602 D, all compounds except those given for 3 E+4 9 E+4 465 1 E-7 - -
W and Y

St wall
(3E+4) - - - 4 E-4 4 E-5

W, sulfides, halides, and nitrates - 1 E+5 5 E-5 2 E-7 - -

Y, oxides and hydroxides - 1 E+5 4 E-6 1 E-7 - -

29 Copper-61 D, see 60Cu 1E+4 3E+4 1E-5 4E-8 2E-4 2E-3

W, see 60Cu - 4E+4 2E-5 6E-8 - -

Y, see 60Cu - 4E+4 1E-5 5E-8 - -

29 Copper-64 D, see 60Cu 1E+4 3E+4 1E-5 4E-8 2E-4 2E-3

W, see 60Cu - 2E+4 1E-5 3E-8 - -

Y, see 60Cu - 2E+4 9E-6 3E-8 - -

29 Copper-67 D, see 60Cu 5E+3 8E+3 3E-6 1E-8 6E-5 6E-4

W, see 60Cu - 5E+3 2E-6 7E-9 - -

Y, see 60Cu - 5E+3 2E-6 6E-9 - -

30 Zinc-62 Y, all compounds 1E+3 3E+3 1E-6 4E-9 2E-5 2E-4

30 Zinc-632 Y, all compounds 2E+4 7E+4 3E-5 9E-8 - -

St wall
(3E+4) - - - 3E-4 3E-3

30 Zinc-65 Y, all compounds 4E+2 3E+2 1E-7 4E-10 5E-6 5E-5

30 Zinc-69m Y, all compounds 4E+3 7E+3 3E-6 1E-8 6E-5 6E-4

30 Zinc-692 Y, all compounds 6E+4 1E+5 6E-5 2E-7 8E-4 8E-3

30 Zinc-71m Y, all compounds 6E+3 2E+4 7E-6 2E-8 8E-5 8E-4

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

30 Zinc-72 Y, all compounds 1E+3 1E+3 5E-7 2E-9 1E-5 1E-4

31 Gallium-652 D, all compounds except those given for 5E+4 2E+5 7E-5 2E-7 - -
W

St wall
(6E+4) - - - 9E-4 9E-3

W, oxides, hydroxides, carbides, halides, - 2E+5 8E-5 3E-7 - -

and nitrates

31 Gallium-66 D, see 65Ga 1E+3 4E+3 1E-6 5E-9 1E-5 1E-4

W, see 65Ga - 3E+3 1E-6 4E-9 - -

31 Gallium-67 D, see 65Ga 7E+3 1E+4 6E-6 2E-8 1E-4 1E-3

W, see 65Ga - 1E+4 4E-6 1E-8 - -

31 Gallium-682 D, see 65 Ga 2E+4 4E+4 2E-5 6E-8 2E-4 2E-3

W, see 65Ga - 5E+4 2E-5 7E-8 - -

31 Gallium-702 D, see 65 Ga 5E+4 2E+5 7E-5 2E-7 - -

St wall
(7E+4) - - - 1E-3 1E-2

W, see 65Ga - 2E+5 8E+5 3E-7 - -

31 Gallium-72 D, see 65Ga 1E+3 4E+2 1E-6 5E-9 2E-5 2E-4

W, see 65Ga - 3E+3 1E-6 4E-9 - -

31 Gallium-73 D, see 65Ga 5E+3 2E+4 6E-6 2E-8 7E-5 7E-4

W, see 65Ga - 2E+4 6E-6 2E-8 - -

32 Germanium-66 D, all compounds except those given for W 2E+4 3E+4 1E-5 4E-8 3E-4 3E-3

W, oxides, sulfides, and halides - 2E+4 8E-6 3E-8 - -

32 Germanium-672 D, see 66 Ge 3E+4 9E+4 4E-5 1E-7 - -

St wall
(4E+4) - - - 6E-4 6E-3
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

W, see 66Ge - 1E+5 4E-5 1E-7 - -

32 Germanium-68 D, see 66Ge 5E+3 4E+3 2E-6 5E-9 6E-5 6E-4

W, see 66Ge - 1E+2 4E-8 1E-10 - -

32 Germanium-69 D, see 66Ge 1E+4 2E+4 6E-6 2E-8 2E-4 2E-3

W, see 66Ge - 8E+3 3E-6 1E-8 - -

32 Germanium-71 D, see 66Ge 5E+5 4E+5 2E-4 6E-7 7E-3 7E-2

W, see 66Ge - 4E+4 2E-5 6E-8 - -

32 Germanium-752 D, see 66 Ge 4E+4 8E+4 3E-5 1E-7 - -

St wall
(7E+4) - - - 9E-4 9E-3

W, see 66Ge - 8E+4 4E-5 1E-7 - -

32 Germanium-77 D, see 66Ge 8E+3 1E+4 4E-6 1E-8 1E-4 1E-3

W, see 66Ge - 6E+3 2E-6 8E-9 - -

32 Germanium-782 D, see 66 Ge 2E+4 2E+4 9E-6 3E-8 - -

St wall
(2E+4) - - - 3E-4 3E-3

W, see 66Ge - 2E+4 9E-6 3E-8 - -

33 Arsenic-692 W, all compounds 3E+4 1E+5 5E-5 2E-7 - -

St wall
(4E+4) - - - 6E-4 6E-3

33 Arsenic-702 W, all compounds 1E+4 5E+4 2E-5 7E-8 2E-4 2E-3

33 Arsenic-71 W, all compounds 4E+3 5E+3 2E-6 6E-9 5E-5 5E-4

33 Arsenic-72 W, all compounds 9E+2 1E+3 6E-7 2E-9 1E-5 1E-4

33 Arsenic-73 W, all compounds 8E+3 2E+3 7E-7 2E-9 1E-4 1E-3

33 Arsenic-74 W, all compounds 1E+3 8E+2 3E-7 1E-9 2E-5 2E-4

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

33 Arsenic-76 W, all compounds 1E+3 1E+3 6E-7 2E-9 1E-5 1E-4

33 Arsenic-77 W, all compounds 4E+3 5E+5 2E-6 7E-9 - -

LLI wall
(5E+3) - - - 6E-5 6E-4

33 Arsenic-782 W, all compounds 8E+6 2E+4 9E-6 3E-8 1E-4 1E-3

34 Selenium-702 D, all compounds except those given for 2E+4 4E+8 2E-5 5E-8 1E-4 1E-3
W

W, oxides, hydroxides, carbides, and 1E+4 4E+4 2E-5 6E-8 - -

elemental Se

34 Selenium-73m2 D, see 70 Se 6E+4 2E+5 6E-5 2E-7 4E-4 4E-3

W, see 70Se 3E+4 1E+5 6E-5 2E-7 - -

34 Selenium-73 D, see 70Se 3E+3 1E+4 5E-6 2E-8 4E-5 4E-4

W, see 70Se - 2E+4 7E-6 2E-8 - -

34 Selenium-75 D, see 70Se 5E+2 7E+2 3E-7 1E-9 7E-6 7E-5

W, see 70Se - 6E+2 3E-7 8E-10 - -

34 Selenium-79 D, see 70Se 6E+2 8E+2 3E-7 1E-9 8E-6 8E-5

W, see 70Se - 6E+2 2E-7 8E-10 - -

34 Selenium-81m2 D, see 70 Se 4E+4 7E+4 3E-5 9E-8 3E-4 3E-3

W, see 70Se 2E+4 7E+4 3E-5 1E-7 - -

34 Selenium-812 D, see 70 Se 6E+4 2E+5 9E-5 3E-7 - -

St wall
(8E+4) - - - 1E-3 1E-2

W, see 70Se - 2E+5 1E-4 3E-7 - -

34 Selenium-832 D, see 70 Se 4E+4 1E+5 5E-5 2E-7 4E-4 4E-3

W, see 70Se 3E+4 1E+5 5E-5 2E-7 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

35 Bromine-74m2 D, bromides of H, Li, Na, K, Rb, Cs, and 1E+4 5E+5 2E-5 5E-8 - -
Fr

St wall
(2E+4) - - - 3E-4 3E-3

W, bromides of lantha- nides, Be, Mg, Ca, - 4E+4 2E-5 6E-8 - -

Sr, Ba, Ra, Al, Ga, In, Tl, Ge, Sn, Pb, As,
Sb, Bi, Fe, Ru, Os, Co, Rh, Ir, Ni, Pd, Pt,
Cu, Ag, Au, Zn, Cd, Hg, Sc, Y, Ti, Zr, Hf,
V, Nb, Ta, Mn, Tc, and Re
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

35 Bromine-742 D, see 74mBr 2E+4 7E+4 3E-5 1E-7 - -

St wall
(4E+4) - - - 5E-4 53E-3

W, see 74mBr - 8E+4 4E-5 1E-7 - -

35 Bromine-752 D, see 74mBr 3E+4 5E+4 2E-5 7E-8 - -

St wall
(4E+4) - - - 5E-4 5E-3

W, see 74mBr - 5E+4 2E-5 7E-8 - -

35 Bromine-76 D, see 74mBr 4E+3 5E+3 2E-6 7E-8 5E-5 5E-4

W, see 74m Br - 4E+3 2E-6 6E-9 - -

35 Bromine-77 D, see 74mBr 2E+4 2E+4 1E-5 3E-8 2E-4 2E-3

W, see 74m Br - 2E+4 8E-6 3E-8 - -

35 Bromine-80m D, see 74mBr 2E+4 2E+4 7E-6 2E-5 3E-4 3E-3

W, see 74m Br - 1E+4 6E-6 2E-8 - -

35 Bromine-802 D, see 74mBr 5E+4 2E+5 8E-5 3E-7 - -

St wall
(9E+4) - - - 1E-3 1E-2

W, see 74mBr - 2E+5 9E-5 3E-7 - -

35 Bromine-82 D, see 74mBr 3E+3 4E+3 2E-5 5E-9 4E-5 4E-4

W, see 74m Br - 4E+3 2E-6 5E-9 - -

35 Bromine-83 D, see 74mBr 5E+4 6E+4 3E-5 9E-8 - -

St wall
(7E+4) - - - 9E-4 9E-3

W, see 74mBr - 6E+4 3E-5 9E-8 - -

35 Bromine-842 D, see 74mBr 2E+4 6E+4 2E-5 8E-8 - -

St wall
(3E+4) - - - 4E-4 4E-3
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

W, see 74mBr - 6E+4 3E-5 9E-8 - -

36 Krypton-742 Submersion1 - - 3E-6 1E-8 - -

36 Krypton-76 Submersion1 - - 9E-6 4E-8 - -

36 Krypton-772 Submersion1 - - 4E-6 2E-8 - -

36 Krypton-79 Submersion1 - - 2E-5 7E-8 - -

36 Krypton-81 Submersion1 - - 7E-4 3E-6 - -

36 Krypton-83m2 Submersion1 - - 1E-2 5E-5 - -

36 Krypton-85m Submersion1 - - 2E-5 1E-7 - -

36 Krypton-85 Submersion1 - - 1E-4 7E-7 - -

36 Krypton-872 Submersion1 - - 5E-6 2E-8 - -

36 Krypton-88 Submersion1 - - 2E-6 9E-9 - -

37 Rubidium-792 D, all compounds 4E+4 1E+5 5E-5 2E-7 - -

St wall
(6E+4) - - - 8E-4 8E-3

37 Rubidium-81m2 D, all compounds 2E+5 3E+5 1E-4 5E-7 - -

St wall
(3E+5) - - - 4E-3 4E-2

37 Rubidium-81 D, all compounds 4E+4 5E+4 2E-5 7E-8 5E-4 5E-3

37 Rubidium-82m D, all compounds 1E+4 2E+4 7E-6 2E-8 2E-4 2E-3

37 Rubidium-83 D, all compounds 6E+2 1E+3 4E-8 1E-9 9E-6 9E-5

37 Rubidium-84 D, all compounds 5E+2 8E+2 3E-7 1E-9 7E-6 7E-5

37 Rubidium-86 D, all compounds 5E+2 8E+2 3E-7 1E-9 7E-6 7E-5

37 Rubidium-87 D, all compounds 1E+3 2E+3 6E-7 2E-9 1E-5 1E-4

37 Rubidium-882 D, all compounds 2E+4 6E+4 3E-5 9E-8 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

St wall
(3E+4) - - - 4E-4 4E-3

37 Rubidium-892 D, all compounds 4E+4 1E+5 6E-5 2E-7 - -

St wall
(6E+4) - - - 9E-4 9E-3

38 Strontium-802 D, all soluble compounds except SrTiO3 4E+3 1E+4 5E-6 2E-8 6E-5 6E-4

Y, all insoluble compounds and SrTi03 - 1E+4 5E-6 2E-8 - -

38 Strontium-812 D, see 80 Sr 3E+4 8E+4 3E-5 1E-7 3E-4 3E-3

Y, see 80Sr 2E+4 8E+4 3E-5 1E-7 - -

38 Strontium-82 D, see 80Sr 3E+2 4E+2 2E-7 6E-10 - -

LLI wall
(2E+2) - - - 3E-6 3E-5

Y, see 80Sr 2E+2 9E+1 4E-8 1E-10 - -

38 Strontium-83 D, see 80Sr 3E+3 7E+3 3E-6 1E-8 3E-5 3E-4

Y, see 80Sr 2E+3 4E+3 1E-6 5E-9 - -

38 Strontium-85m2 D, see 80 Sr 2E+5 6E+5 3E-4 9E-7 3E-3 3E-2

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

Y, see 80Sr - 8E+5 4E-4 1E-6 - -

38 Strontium-85 D, see 80Sr 3E+3 3E+3 1E-6 4E-9 4E-5 4E-4

Y, see 80Sr - 2E+3 6E-7 2E-9 - -

38 Strontium-87m D, see 80Sr 5E+4 1E+5 5E-5 2E-7 6E-4 6E-3

Y, see 80Sr 4E+4 2E+5 6E-5 3E-7 - -

38 Strontium-89 D, see 80Sr 6E+2 8E+2 4E-7 1E-9 - -

LLI wall
(6E+2) - - - 8E-6 8E-5

Y, see 80Sr 5E+2 1E+2 6E-8 2E-10 - -

38 Strontium-90 D, see 80Sr 3E+1 2E+1 8E-9 - - -

Bone surf Bone surf

(4E+1) (2E+1) - 3E-11 5E-7 5E-6

Y, see 80Sr - 4E+0 2E-9 6E-12 - -

38 Strontium-91 D, see 80Sr 2E+3 6E+3 2E-6 8E-9 2E-5 2E-4

Y, see 80Sr - 4E+3 1E-6 5E-9 - -

38 Strontium-92 D, see 80Sr 3E+3 9E+3 4E-6 1E-8 4E-5 4E-4

Y, see 80Sr - 7E+3 3E-6 9E-9 - -

39 Yttrium-86m2 W, all compounds except those given for 2E+4 6E+4 2E-5 E- 88 3E-4 3E-3
Y

Y, oxides and hydroxides - 5E+4 2E-5 8E-8 - -

39 Yttrium-86 W, see 86mY 1E+3 3E+3 1E-6 5E-9 2E-5 2E-4

Y, see 86mY - 3E+3 1E-6 5E-9 - -

39 Yttrium-87 W, see 86mY 2E+3 3E+3 1E-6 5E-9 3E-5 3E-4

Y, see 86m Y - 3E+3 1E-6 5E-9 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

39 Yttrium-88 W, see 86mY 1E+3 3E+2 1E-7 3E-10 1E-5 1E-4

Y, see 86m Y - 2E+2 1E-7 3E-10 - -

39 Yttrium-90m W, see 86mY 8E+3 1E+4 5E-6 2E-8 1E-4 1E-3

Y, see 86m Y - 1E+4 5E-6 2E-8 - -

39 Yttrium-90 W, see 86mY 4E+2 7E+2 3E-7 9E-10 - -

LLI wall
(5E+2) - - - 7E-6 7E-5

Y, see 86mY - 6E+2 3E-7 9E-10 - -

39 Yttrium-91m2 W, see 86m Y 1E+5 2E+5 1E-4 3E-7 2E-3 2E-2

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

Y, see 86m Y - 2E+5 7E-5 2E-7 - -

39 Yttrium-91 W, see 86mY 5E+2 2E+2 7E-8 2E-10 - -

LLI wall
(6E+2) - - - 8E-6 8E-5

Y, see 86mY - 1E+2 5E-8 2E-10 - -

39 Yttrium-92 W, see 86mY 3E+3 9E+3 4E-6 1E-8 4E-5 4E-4

Y, see 86m Y - 8E+3 3E-6 1E-8 - -

39 Yttrium-93 W, see 86mY 1E+3 3E+3 1E-6 4E-9 2E-5 2E-4

Y, see 86m Y - 2E+3 1E-6 3E-9 - -

39 Yttrium-942 W, see 86mY 2E+4 8E+4 3E-5 1E-7 - -

St wall
(3E+4) - - - 4E-4 4E-3

Y, see 86m Y - 8E+4 3E-5 1E-7 - -

39 Yttrium-952 W, see 86mY 4E+4 2E+5 6E-5 2E-7 - -

St wall
(5E+4) - - - 7E-4 7E-3

Y, see 86m Y - 1E+5 6E-5 2E-7 - -

40 Zirconium-86 D, all compounds except those given for 1E+3 4E+3 2E-5 6E-9 2E-5 2E-4
W and Y

W, oxides, hydroxides, halides, and - 3E+3 1E-6 4E-9 - -

nitrates

Y, carbide - 2E+3 1E-6 3E-9 - -

40 Zirconium-88 D, see 86Zr 4E+3 2E+2 9 E-8 3E-10 5E-5 5E-4

W, see 86Zr - 5E+2 2E-7 7E-10 - -

Y, see 86Zr - 3E+2 1E-7 4E-10 - -

40 Zirconium-89 D, see 86Zr 2E+3 4E+3 1E-6 5E-9 2E-5 2E-4

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

W, see 86Zr - 2E+3 1E-6 3E-9 - -

Y, see 86Zr - 2E+3 1E-6 3E-9 - -

40 Zirconium-93 D, see 86Zr 1E+3 6E+0 3E-9 - - -

Bone surf Bone surf

(3E+3) (2E+1) - 2E-11 4E-5 4E-4

W, see 86Zr - 2E+1 E- 18 - - -

Bone surf
- (6E+1) - 9E-11 - -

Y, see 86Zr - 6E+1 2E-8 - - -

Bone surf
- (7E+1) - 9E-11 - -

40 Zirconium-95 D, see 86Zr 1E+3 1E+2 5E-8 2E-5 2E-4

Bone surf
- (3E+2) - 4E-10 - -

W, see 86Zr - 4E+2 2E-7 5E-10 - -

Y, see 86Zr - 3E+2 1E-7 4E-10 - -

40 Zirconium-97 D, see 86Zr 6E+2 2E+3 8E-7 3E-9 9E-6 9E-5

W, see 86Zr - 1E+3 6E-7 2E-9 - -

Y, see 86Zr - 1E+3 5E-8 2E-9 - -

41 Niobium-882 W, all compounds except those given for 5E+4 2E+5 9E-5 3E-7 - -
Y

St wall
(7E+4) - - - 1E-3 1E-2

Y, oxides and hydroxides - 2E+5 9E-5 3E-7 - -

41 Niobium-892 (66 W, see 88Nb 1E+4 4E+4 2E-5 6E-8 1E-4 1E-3
min)

Y, see 88Nb - 4E+4 2E-5 5E-8 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

41 Niobium-89 (122 W, see 88Nb 5E+3 2E+4 8E-6 3E-8 7E-4 7E-4
min)

Y, see 88Nb - 2E+4 6E-6 2E-8 - -

41 Niobium-90 W, see 88Nb 1E+3 3E+3 1E-6 4E-9 1E-5 1E-4

Y, see 88Nb - 2E+3 1E-6 3E-9 - -

41 Niobium-93m W, see 88Nb 9E+3 2E+3 8E-7 3E-9 - -

LLI wall
(1E+4) - - - 2E-4 2E-3

Y, see 88Nb - 2E+2 7E-8 2E-10 - -

41 Niobium-94 W, see 88Nb 9E+2 2E+2 8E-8 3E-10 1E-6 1E-4

Y, see 88Nb - 2E+1 6E-9 2E-11 - -

41 Niobium-95m W, see 88Nb 2E+3 3E+3 1E-4 4E-9 - -

LLI wall
(2E+3) - - - 3E-5 3E-4

Y, see 88Nb - 2E+3 9E-7 3E-9 - -

41 Niobium-95 W, see 88Nb 2E+3 1E+3 5E-7 2E-9 3E-5 3E-4

Y, see 88Nb - 1E+3 5E-7 2E-9 - -

41 Niobium-96 W, see 88Nb 1E+3 3E+3 1E-6 4E-9 2E-5 2E-4

Y, see 88Nb - 2E+3 1E-6 3E-9 - -

41 Niobium-972 W, see 88 Nb 2E+4 8E+4 3E-5 1E-7 3E-4 3E-3

Y, see 88Nb - 7E+4 3E-5 1E-7 - -

41 Niobium-982 W, see 88 Nb 1E+4 5E+4 2E-5 8E-8 2E-4 2E-3

Y, see 88Nb - 5E+4 2E-5 7E-8 - -

42 Molybdenum-90 D, all compounds except those given for Y 4E+3 7E+3 3E-6 1E-8 3E-5 3E-4

Y, oxides, hydroxides, and MoS2 2E+3 5E+2 2E-6 6E-9 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

42 Molybdenum-93m D, see 90Mo 9E+3 2E+4 7E-6 2E-8 6E-5 6E-4

Y, see 90Mo 4E+3 1E+4 6E-6 2E-8 - -

42 Molybdenum-93 D, see 90Mo 4E+3 5E+3 2E-6 8E-9 5E-5 5E-4

Y, see 90Mo 2E+4 2E+2 8E-8 2E-10 - -

42 Molybdenum-99 D, see 90Mo 2E+3 3E+3 1E-6 4E-9 - -

LLI wall
(1E+3) - - - 2E-5 2E-4

Y, see 90Mo 1E+3 1E+3 6E-7 2E-9 - -

42 Molybdenum-1012 D, see 90 Mo 4E+4 1E+5 6E-5 2E-7 - -

St wall
(5E+4) - - - 7E-4 7E-3

Y, see 90Mo - 1E+5 6E-5 2E-7 - -

43 Technetium-93m2 D, all compounds except those given for W 7E+4 2E+5 6E-5 2E-7 1E-3 1E-2

W, oxides, hydroxides, halides, and nitrates - 6E+5 1E-4 4E-7 - -

43 Technetium-93 D, see 93m Tc 3E+4 7E+4 3E-5 1E-7 4E-4 4E-3

W, see 93m Tc - 1E+5 4E-5 1E-7 - -

43 Technetium-94m2 D, see 93mTc 2E+4 4E+4 2E-5 6E-8 3E-4 3E-3

W, see 93m Tc - 6E+4 2E-5 8E-8 - -

43 Technetium-94 D, see 93mTc 9E+3 2E+4 8E-6 3E-8 1E-4 1E-3

W, see 93m Tc - 2E+4 1E-5 3E-8 - -

43 Technetium-95m D, see 93m Tc 4E+3 5E+3 2E-6 8E-9 5E-5 5E-4

W, see 93m Tc - 2E+3 8E-7 3E-9 - -

43 Technetium-95 D, see 93mTc 1E+4 2E+4 9E-6 3E-8 1E-4 1E-3

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

W, see 93m Tc - 2E+4 8E-6 3E-8 - -

43 Technetium-96m2 D, see 93mTc 2E+5 3E+5 1E-4 4E-7 2E-3 2E-2

W, see 93m Tc - 2E+5 1E-4 3E-7 - -

43 Technetium-96 D, see 93mTc 2E+3 3E+3 1E-6 5E-9 3E-5 3E-4

W, see 93m Tc - 2E+3 9E-7 3E-9 - -

43 Technetium-97m D, see 93mTc 5E+3 7E+1 3E-6 - 6E-5 6E-4

St wall
- (7E+3) - 1E-8 - -

W, see 93m Tc - 1E+3 5E-7 2E-9 - -

43 Technetium-97 D, see 93mTc 4E+4 5E+4 2E-5 7E-8 5E-4 5E-3

W, see 93m Tc - 6E+3 2E-6 8E-9 - -

43 Technetium-98 D, see 93mTc 1E+3 2E+3 7E-7 2E-9 1E-5 1E-4

W, see 93m Tc - 3E+2 1E-7 4E-10 - -

43 Technetium-99m D, see 93mTc 8E+4 2E+5 6E-5 2E-7 1E-3 1E-2

W, see 93m Tc - 2E+5 1E-4 3E-7 - -

43 Technetium-99 D, see 93mTc 4E+3 5E+3 2E-6 - 6E-5 6E-4

St wall
- (6E+3) - 8E-9 - -

W, see 93m Tc - 7E+2 3E-7 9E-10 - -

43 Technetium-1012 D, see 93mTc 9E+4 3E+5 1E-4 5E-7 - -

St wall
(1E+5) - - - 2E-3 2E-2

W, see 93m Tc - 4E+5 2E-4 5E-7 - -

43 Technetium-1042 D, see 93mTc 2E+4 7E+4 3E-5 1E-7 - -

St wall
(3E+4) - - - 4E-4 4E-3
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

W, see 93m Tc - 9E+4 4E-5 1E-7 - -

44 Ruthenium-942 D, all compounds except those given for 2E+4 4E+4 2E-5 6E-8 2E-4 2E-3
W and Y

W, halides - 6E+4 3E-5 9E-8 - -

Y, oxides and hydroxides - 6E+4 2E-5 8E-8 - -

44 Ruthenium-97 D, see 94Ru 8E+3 2E+4 8E-6 3E-8 1E-4 1E-3

W, see 94Ru - 1E+4 5E-6 2E-8 - -

Y, see 94Ru - 1E+4 5E-6 2E-8 - -

44 Ruthenium-103 D, see 94Ru 2E+3 2E+3 7E-7 2E-9 3E-5 3E-4

W, see 94Ru - 1E+3 4E-7 1E-9 - -

Y, see 94Ru - 6E+2 3E-7 9E-10 - -

44 Ruthenium-105 D, see 94Ru 5E+3 1E+4 6E-6 2E-8 7E-5 7E-4

W, see 94Ru - 1E+4 6E-6 2E-8 - -

Y, see 94Ru - 1E+4 5E-6 2E-8 - -

44 Ruthenium-106 D, see 94Ru 2E+2 9E+1 4E-7 1E-10 - -

LLI wall
(2E+2) - - - 3E-6 3E-5

W, see 94Ru - 5E+1 2E-8 8E-11 - -

Y, see 94Ru - 1E+1 5E-9 2E-11 - -

45 Rhodium-99m D, all compounds except those given for 2E+4 6E+4 2E-5 8E-8 2E-4 2E-3
W and Y

W, halides - 8E+4 3E-5 1E-7 - -

Y, oxides and hydroxides - 7E+4 3E-5 9E-8 - -

45 Rhodium-99 D, see 99m Rh 2E+3 3E+3 1E-6 4E-9 3E-5 3E-4

W, see 99m Rh - 2E+3 9E-7 3E-9 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

Y, see 99m Rh - 2E+3 8E-7 3E-9 - -

45 Rhodium-100 D, see 99mRh 2E+3 5E+3 2E-6 7E-9 2E-5 2E-4

W, see 99m Rh - 4E+3 2E-6 6E-9 - -

Y, see 99mRh - 4E+3 2E-6 5E-9 - -

45 Rhodium-101m D, see 99mRh 6E+3 1E+4 5E-6 2E-8 8E-5 8E-4

W, see 99m Rh - 8E+3 4E-6 1E-8 - -

Y, see 99mRh - 8E+3 3E-6 1E-8 - -

45 Rhodium-101 D, see 99mRh 2E+3 5E+2 2E-7 7E-10 E- 35 3E-4

W, see 99mRh - 8E+2 3E-7 1E-9 - -

Y, see 99mRh - 2E+2 6E-8 2E-10 - -

45 Rhodium-102m D, see 99mRh 1E+5 5E+2 2E-7 7E-10 - -

LLI wall
(1E+3) - - - 2E-5 2E-4

W, see 99mRh - 4E+2 2E-7 5E-10 - -

Y, see 99mRh - 1E+2 5E-8 2E-10 - -

45 Rhodium-102 D, see 99mRh 6E+2 9E+1 4E-8 1E-10 8E-6 8E-5

W, see 99m Rh - 2E+2 7E-8 2E-10 - -

Y, see 99mRh - 6E+1 2E-8 8E-11 - -

45 Rhodium-103m2 D, see 99mRh 4E+5 1E+6 5E-4 2E-6 6E-3 6E-2

W, see 99m Rh - 1E+6 5E-4 2E-6 - -

Y, see 99mRh - 1E+6 5E-4 2E-6 - -

45 Rhodium-105 D, see 99mRh 4E+3 1E+4 5E-6 2E-8 - -

LLI wall
(4E+3) - - - 5E-5 5E-4

W, see 99mRh - 6E+3 3E-6 9E-9 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

Y, see 99m Rh - 6E+3 2E-6 8E-9 - -

45 Rhodium-106m D, see 99mRh 8E+3 3E+4 1E-5 4E-8 1E-4 1E-3

W, see 99m Rh - 4E+4 2E-5 5E-8 - -

Y, see 99mRh - 4E+4 1E-5 5E-8 - -

45 Rhodium-1072 D, see 99mRh 7E+4 2E+5 1E-4 3E-4 - -

St wall
(9E+4) - - - 1E-3 12 E-

W, see 99m Rh - 3E+5 1E-4 4E-7 - -

Y, see 99mRh - 3E+5 1E-4 3E-7 - -

46 Palladium-100 D, all compounds except those given for 1E+3 1E+3 6E-8 2E-9 2E-5 2E-4
W and Y

W, nitrates - 1E+3 5E-7 2E-9 - -

Y, oxides and hydroxides - 1E+3 6E-7 2E-9 - -

46 Palladium-101 D, see 100Pd 1E+4 3E+4 1E-5 5E-8 2E-4 2E-3

W, see 100Pd - 3E+4 1E-5 5E-8 - -

Y, see 100Pd - 3E+4 1E-5 4E-8 - -

46 Palladium-103 D, see 100Pd 6E+3 6E+3 3E-6 9E-9 - -

LLI wall
(7E+3) - - - 1E-4 1E-3

W, see 100Pd - 4E+3 2E-6 6E-9 - -

Y, see 100Pd - 4E+3 1E-6 5E-9 - -

46 Palladium-107 D, see 100Pd 3E+4 2E+4 9E-6 - - -

LLI wall Kidneys

(4E+4) (2E+4) - 3E-8 5E-4 5E-3

W, see 100Pd - 7E+3 3E-6 1E-8 - -

Y, see 100Pd - 4E+2 2E-7 6E-10 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

46 Palladium-109 D, see 100Pd 2E+3 6E+3 3E-6 9E-9 3E-5 3E-4

W, see 100Pd - 5E+3 2E-6 8E-9 - -

Y, see 100Pd - 5E+3 2E-6 6E-9 - -

47 Silver-1022 D, all compounds except those given for 5E+4 2E+5 8E-5 2E-7 - -
W and Y
St wall
(6E+4) - - - 9E-4 9E-3

W, nitrates and sulfides - 2E+5 9E-5 3E-7 - -

Y, oxides and hydroxides - 2E+5 8E-5 3E-7 - -

47 Silver-1032 D, see 102Ag 4E+4 1E+5 4E-5 1E-7 5E-4 5E-3

W, see 102Ag - 1E+5 5E-5 2E-7 - -

Y, see 102Ag - 1E+5 5E-5 2E-7 - -

47 Silver-104m2 D, see 102Ag 3E+4 9E+4 4E-5 1E-7 4E-4 4E-3

W, see 102Ag - 1E+5 5E-5 2E-7 - -

Y, see 102Ag - 1E+5 5E-5 2E-7 - -

47 Silver-1042 D, see 102Ag 2E+4 7E+4 3E-5 1E-7 3E-5 3E-3

W, see 102Ag - 1E+5 6E-5 2E-7 - -

Y, see 102Ag - 1E+5 6E-5 2E-7 - -

47 Silver-105 D, see 102Ag 3E+3 1E+3 4E-7 1E-9 4E-5 4E-4

W, see 102Ag - 2E+3 7E-7 2E-9 - -

Y, see 102Ag - 2E+3 7E-7 2E-9 - -

47 Silver-106m D, see 102Ag 8E+2 7E+2 3E-7 1E-9 1E-5 1E-4

W, see 102Ag - 9E+2 4E-7 1E-9 - -

Y, see 102Ag - 9E+2 4E-7 1E-9 - -

47 Silver-1062 D, see 102Ag 6E+4 2E+5 8E-5 3E-7 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)
St. wall
(6E+4) - - - 9E-4 9E-3

W, see 102Ag - 2E+5 9E-5 3E-7 - -

Y, see 102Ag - 2E+5 8E-5 3E-7 - -

47 Silver-108m D, see 102Ag 6E+2 2E+2 8E-8 3E-10 9E-6 9E-5

W, see 102Ag - 3E+2 1E-7 4E-10 - -

Y, see 102Ag - 2E+1 1E-8 3E-11 - -

47 Silver-110m D, see 102Ag 5E+2 1E+2 5E-8 2E-10 6E-6 6E-5

W, see 102Ag - 2E+2 8E-8 3E-10 - -

Y, see 102Ag - 9E+1 4E-8 1E-10 - -

47 Silver-111 D, see 102Ag E+ 92 2E+3 6E-7 - - -

LLI wall Liver

(1E+3) (2E+3) - 2E-9 2E-5 2E-4

W, see 102Ag - 9E+2 4E-7 1E-9 - -

Y, see 102Ag - 9E+2 4E-7 1E-9 - -

47 Silver-112 D, see 102Ag 3E+3 8E+3 3E-6 1E-8 4E-5 4E-4

W, see 102Ag - 1E+4 4E-6 1E-8 - -

Y, see 102Ag - 9E+3 4E-6 1E-8 - -

47 Silver-1152 D, see 102Ag 3E+4 9E+4 4E-5 1E-7 - -

St wall
(3E+4) - - - 4E-4 4E-3

W, see 102Ag - 9E+4 4E-5 1E-7 - -

Y, see 102Ag - 8E+4 3E-5 1E-7 - -

48 Cadmium-1042 D, all compounds except those given for 2E+4 7E+4 3E-5 9E-8 34 E- 3E-3
W and Y

W, sulfides, halides, and nitrates - 1E+5 5E-5 2E-7 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

Y, oxides and hydroxides - 1E+5 5E-5 2E-7 - -

48 Cadmium-107 D, see 104Cd 2E+4 5E+4 2E-5 8E-8 3E-4 3E-3

W, see 104Cd - 6E+4 2E-5 8E-8 - -

Y, see 104Cd - 5E+4 2E-5 7E-8 - -

48 Cadmium-109 D, see 104Cd 3E+2 4E+1 1E-8 - - -

Kidneys Kidneys
(4E+2) (5E+1) - 7E-11 6E-6 6E-5

W, see 104Cd - 1E+2 5E-8 - - -

Kidneys
- (1E+2) - 2E-10 - -

Y, see 104Cd - 1E+2 5E-8 2E-10 - -

48 Cadmium-113m D, see 104Cd 2E+1 2E+0 1E-9 - - -

Kidneys Kidneys
(4E+1) (4E+0) - 5E-12 5E-7 5E-6

W, see 104Cd - 8E+0 4E-9 - - -

Kidneys
- (1E+1) - 2E-11 - -

Y, see 104Cd - 1E+1 5E-9 2E-11 - -

48 Cadmium-113 D, see 104Cd 2E+1 2E+0 9E-10 - - -

Kidneys Kidneys
(3E+1) (3E+0) - 5E-12 4E-7 4E-6

W, see 104Cd - 8E+0 3E-9 - - -

Kidneys
- (1E+1) - 2E-11 - -

Y, see 104Cd - 1E+1 6E-9 2E-11 - -

48 Cadmium-115m D, see 104Cd 3E+2 5E+1 2E-8 - 4E-6 4E-5

Kidneys
- (8E+1) - 1E-10 - -
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

W, see 104Cd - 1E+2 5E-8 2E-10 - -

Y, see 104Cd - 1E+2 6E-8 2E-10 - -

48 Cadmium-115 D, see 104Cd 9E+2 13 E+ 6E-7 2E-9 - -

LLI wall
(1E+3) - - - 1E-5 1E-4

W, see 104Cd - 1E+3 5E-7 2E-9 - -

Y, see 104Cd - 1E+3 6E-7 2E-9 - -

48 Cadmium-117m D, see 104Cd 5E+3 1E+4 5E-6 2E-8 6E-5 6E-4

W, see 104Cd - 2E+4 7E-6 2E-8 - -

Y, see 104Cd - E+ 14 6E-6 2E-8 - -

48 Cadmium-117 D, see 104Cd 5E+3 1E+4 5E-6 2E-8 6E-5 6E-4

W, see 104Cd - 2E+4 7E-6 2E-8 - -

Y, see 104Cd - 1E+4 6E-6 2E-8 - -

49 Indium-109 D, all compounds except those given for W 2E+4 4E+4 2E-5 6E-8 3E-4 3E-3

W, oxides, hydroxides, halides, and nitrates - 6E+4 3E-5 9E-8 - -

49 Indium-1102 D, see 109In 2E+4 4E+4 2E-5 6E-8 2E-4 2E-3

(69.1 min) W, see 109In - 6E+4 2E-5 8E-8 - -

49 Indium-110 D, see 109In 5E+3 2E+4 7E-6 2E-8 7E-5 7E-4

(4.9 h) W, see 109In - 2E+4 8E-6 3E-8 - -

49 Indium-111 D, see 109In 4E+3 6E+3 3E-6 9E-9 6E-5 6E-4

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

W, see 109In - 6E+3 3E-6 9E-9 - -

49 Indium-1122 D, see 109In 2E+5 6E+5 3E-4 9E-7 2E-3 2E-2

W, see 109In - 7E+6 3E-4 1E-6 - -

49 Indium-113m2 D, see 109In 5E+4 1E+4 6E-5 2E-7 7E-4 7E-3

W, see 109In - 2E+5 8E-5 3E-7 - -

49 Indium-114m D, see 109In 3E+2 6E+1 3E-8 9E-11 - -

LLI wall
(4E+2) - - - 5E-6 5E-5

W, see 109In - 1E+2 4E-8 1E-10 - -

49 Indium-115m D, see 109In 1E+4 4E+4 2E-5 6E-8 2E-4 2E-3

W, see 109In - 5E+4 2E-5 7E-8 - -

49 Indium-115 D, see 109In 4E+1 1E+0 6E-10 2E-12 5E-7 5E-6

W, see 109In - 5E+0 2E-9 8E-12 - -

49 Indium-116m2 D, see 109In 2E+4 8E+4 3E-5 1E-7 3E-5 3E-3

W, see 109In - 1E+5 5E-5 2E-7 - -

49 Indium-117m2 D, see 109In 1E+4 3E+4 1E-5 5E-8 2E-4 2E-3

W, see 109In - 4E+4 2E-5 6E-8 - -

49 Indium-1172 D, see 109In 6E+4 2E+5 7E-5 2E-7 8E-4 8E-3

W, see 109In - 2E+5 9E-5 3E-7 - -

49 Indium-119m2 D, see 109In 4E+4 1E+5 5E-5 2E-7 - -

St wall
(5E+4) - - - 7E-4 7E-3

W, see 109In - 1E+5 6E-5 2E-7 - -

50 Tin-110 D, all compounds except those given for W 4E+3 1E+4 5E-6 2E-8 5E-5 5E-4
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

W, sulfides, oxides, hydroxides, halides, - 1E+4 5E-6 2E-8 - -

nitrates, and stannic phosphate

50 Tin-1112 D, see 110Sn 7E+4 2E+5 9E-5 3E-7 1E-3 1E-2

W, see 110Sn - 3E+5 1E-4 4E-7 - -

50 Tin-113 D, see 110Sn 2E+3 1E+3 5E-7 2E-9 - -

LLI wall
(2E+3) - - - 3E-5 3E-4

W, see 110Sn - 5E+2 2E-7 8E-10 - -

50 Tin-117m D, see 110Sn 2E+3 1E+3 5E-7 - - -

LLI wall Bone surf

(2E+3) (2E+3) - 3E-9 3E-5 3E-4

W, see 110Sn - 1E+3 6E-7 2E-9 - -

50 Tin-119m D, see 110Sn 3E+3 2E+3 1E-6 3E-9 - -

LLI wall
(4E+3) - - - 6E-5 6E-4

W, see 110Sn - 1E+3 4E-7 1E-9 - -

50 Tin-121m D, see 110Sn 3E+3 9E+2 4E-7 1E-9 - -

LLI wall
(4E+3) - - - 5E-5 5E-4

W, see 110Sn - 5E+2 2E-7 8E-10 - -

50 Tin-121 D, see 110Sn 6E+3 2E+4 6E-6 2E-8 - -

LLI wall
(6E+3) - - - 8E-6 8E-4

W, see 110Sn - 1E+4 5E-6 2E-8 - -

50 Tin-123m2 D, see 110Sn 5E+4 1E+5 5E-5 2E-7 7E-4 7E-3

W, see 110Sn - 1E+5 6E-5 2E-7 - -

50 Tin-123 D, see 110Sn 5E+2 6E+2 3E-7 9E-10 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

LLI wall
(6E+2) - - - 9E-6 9E-5

W, see 110Sn - 2E+2 7E-8 2E-10 - -

50 Tin-125 D, see 110Sn 4E+2 9E+2 4E-7 1E-9 - -

LLI wall
(5E+2) - - - 6E-6 6E-5

W, see 110Sn - 4E+2 1E-7 5E-10 - -

50 Tin-126 D, see 110Sn 3E+2 6E+1 2E-8 8E-11 4E-6 4E-5

W, see 110Sn - 7E+1 38 9E-11 - -

50 Tin-127 D, see 110Sn 7E+3 2E+4 8E-6 3E-8 9E-5 9E-4

W, see 110Sn - 2E+4 8E-6 3E-8 - -

50 Tin-1282 D, see 110Sn 9E+3 3E+4 1E-5 4E-8 1E-4 1E-3

W, see 110Sn - 4E+4 1E-5 5E-8 - -

51 Antimony-1152 D, all compounds except those given for W 8E+4 2E+5 1E-4 3E-7 1E-3 1E-2
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

W, oxides, hydroxides, halides, sulfides, - 3E+5 1E-4 4E-7 - -

sulfates, and nitrates

51 Antimony-116m2 D, see 115Sb 2E+4 7E+4 3E-5 1E-7 3E-4 3E-3

W, see 115Sb - 1E+5 6E-5 2E-7 - -

51 Antimony-1162 D, see 115Sb 7E+4 3E+5 1E-4 4E-7 - -

St wall
(9E+4) - - - 1E-3 1E-2

W, see 115Sb - 3E+5 1E-4 5E-7 - -

51 Antimony-117 D, see 115Sb 7E+4 2E+5 9E-5 3E-7 9E-4 9E-3

W, see 115Sb - 3E+5 1E-4 4E-7 - -

51 Antimony-118m D, see 115Sb 6E+3 2E+4 8E-6 3E-8 7E-5 7E-4

W, see 115Sb 5E+3 2E+4 9E-6 3E-8 - -

51 Antimony-119 D, see 115Sb 2E+4 5E+4 2E-5 6E-8 2E-4 2E-3

W, see 115Sb 2E+4 3E+4 1E-5 4E-8 - -

51 Antimony-1202 D, see 115Sb 1E+5 4E+5 2E-4 6E-7 - -

(16 min) St wall

(2E+5) - - - 2E-3 2E-2

W, see 115Sb - 5E+5 2E-4 7E-7 - -

51 Antimony-120 D, see 115Sb 1E+3 2E+3 9E-7 3E-9 1E-5 1E-4

(5.76 d) W, see 115Sb 9E+2 1E+3 5E-7 2E-9 - -

51 Antimony-122 D, see 115Sb 8E+2 2E+3 1E-6 3E-9 - -

LLI wall
(8E+2) - - - 1E-5 1E-4

W, see 115Sb 7E+2 1E+3 4E-7 2E-9 - -

51 Antimony-124m2 D, see 115Sb 3E+5 8E+5 4E-4 1E-6 3E-3 3E-2

W, see 115Sb 2E+5 6E+5 2E-4 8E-7 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

51 Antimony-124 D, see 115Sb 6E+2 9E+2 4E-7 1E-9 7E-6 7E-5

W, see 115Sb 5E+2 2E+2 1E-7 3E-10 - -

51 Antimony-125 D, see 115Sb 2E+3 2E+3 1E-6 39 3E-5 3E-4

W, see 115Sb - 5E+2 2E-7 7E-10 - -

51 Antimony-126m2 D, see 115Sb 5E+4 2E+5 8E-5 3E-7 - -

St wall
(7E+4) - - - 9E-4 9E-3

W, see 115Sb - 2E+5 8E-5 3E-7 - -

51 Antimony-126 D, see 115Sb 6E+2 1E+3 5E-7 2E-9 7E-6 7E-5

W, see 115Sb 5E+2 5E+2 2E-7 7E-10 - -

51 Antimony-127 D, see 115Sb 8E+2 2E+3 9E-7 3E-9 - -

LLI wall
(8E+2) - - - 1E-5 1E-4

W, see 115Sb 7E+2 9E+2 4E-7 1E-9 - -

51 Antimony-1282 D, see 115Sb 8E+4 4E+5 2E-4 5E-7 - -

(10.4 min) St wall

(1E+5) - - - 1E-3 1E-2

W, see 115Sb - 4E+5 2E-4 6E-7 - -

51 Antimony-128 D, see 115Sb 1E+3 4E+3 2E-6 6E-9 2E-5 2E-4

(9.01 h) W, see 115Sb - 3E+3 1E-6 5E-9 - -

51 Antimony-129 D, see 115Sb 3E+3 9E+6 4E-6 1E-8 4E-5 4E-4

W, see 115Sb - 9E+3 4E-6 1E-8 - -

51 Antimony-1302 D, see 115Sb 2E+4 6E+4 3E-5 9E-8 3E-4 3E-3

W, see 115Sb - 8E+4 3E-5 1E-7 - -

51 Antimony-1312 D, see 115Sb 1E+4 2E+4 1E-5 - - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

Thyroid Thyroid
(2E+4) (4E+4) - 6E-8 2E-4 2E-3

W, see 115Sb - 2E-4 1E-5 - -

Thyroid
- (4E+4) - 6E-8 - -

52 Tellurium-116 D, all compounds except those given for W 8E+3 2E+4 9E-6 3E-8 1E-4 1E-3

W, oxides, hydroxides, and nitrates - 3E+4 1E-5 4E-8 - -

52 Tellurium-121m D, see 116Te 5E+2 2E+2 8E-8 - - -

Bone surf Bone surf

(7E+2) (4E+2) - 5E-10 1E-5 1E-4

W, see 116Te - 4E+2 2E-7 6E-10 - -

52 Tellurium-121 D, see 116Te 3E+3 4E+3 2E-6 6E-9 4E-5 4E-4

W, see 116Te - 3E+3 1E-6 E- 49 - -

52 Tellurium-123m D, see 116Te 6E+2 3E+3 9E-8 - - -

Bone surf Bone surf

(1E+3) (5E+2) - 8E-10 1E-5 1E-4

W, see 116Te - 5E+2 2E-7 8E-10 - -

52 Tellurium-123 D, see 116Te 5E+2 2E+2 8E-8 - -

Bone surf Bone surf

(1E+3) (5E+2) - 7E-10 2E-5 2E-4

W, see 116Te - 4E+2 2E-7 - - -

Bone surf
- (1E+3) - 2E-9 - -

52 Tellurium-125m D, see 116Te 1E+3 4E+2 2E-7 - - -

Bone surf Bone surf

(1E+3) (1E+3) - 1E-9 2E-5 2E-4

W, see 116Te - 7E+2 3E-7 1E-9 - -

52 Tellurium-127m D, see 116Te 6E+2 3E+2 1E-7 - 9E-6 9E-6

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

Bone surf
- (4E+2) - 6E-10 - -

W, see 116Te - 3E+2 1E-7 1E-0 - -

52 Tellurium-127 D, see 116Te 7E+3 2E+4 9E-6 3E-8 1E-4 1E-3

W, see 116Te - 2E+4 7E-6 2E-8 - -

52 Tellurium-129m D, see 116Te 5E+2 6E+2 3E-7 9E-10 7E-6 7E-5

W, see 116Te - 2E+2 1E-7 3E-10 - -

52 Tellurium-1292 D, see 116Te 3E+4 6E+4 3E-5 9E-8 4E-4 4E-3

W, see 116Te - 7E+4 3E-5 1E-7 - -

52 Tellurium-131m D, see 116Te 3E+2 4E+2 2E-7 - - -

Thyroid Thyroid
(6E+2) (1E+3) - 2E-9 8E-3 8E-5

W, see 116Te - 4E+2 2E-7 - - -

Thyroid
- (9E+2) - 1E-9 - -

52 Tellurium-1312 D, see 116Te 3E+3 5E+3 2E-6 - - -

Thyroid Thyroid
(6E+3) (1E+4) - 2E-8 8E-5 8E-4

W, see 116Te - 8E+3 E- 26 - - -

Thyroid
- (1E+4) - 2E-8 - -

52 Tellurium-132 D, see 116Te 2E+2 2E+2 9E-8 - - -

Thyroid Thyroid
(7E+2) (8E+2) - 1E-9 8E-6 9E-5

W, see 116Te - 2E+2 9E-8 - - -

Thyroid
- (6E+2) - 9E-10 - -

52 Tellurium-133m2 D, see 116Te 3E+3 5E+3 2E-6 - - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

Thyroid Thyroid
(6E+3) (1E+4) - 2E-8 9E-5 9E-4

W, see 116Te - 5E+3 2E-6 - - -

Thyroid
- (1E+4) - 2E-8 - -

52 Tellurium-1332 D, see 116Te 1E+4 2E+4 9E-6 - - -

Thyroid Thyroid
(3E+4) (6E+4) - 8E-8 4E-4 4E-3

W, see 116Te - 2E+4 9E-6 - - -

Thyroid
- (6E+4) - 8E-8 - -

52 Tellurium-1342 D, see 116Te 2E+4 2E+4 1E-5 - - -

Thyroid Thyroid
(2E+4) (5E+4) - 7E-8 3E-4 3E-3

W, see 116Te - 2E+4 1E-5 - - -

- Thyroid - 7E-8 -
(5E+4)

53 Iodine-120m2 D, all compounds 1E+4 2E+4 9E-5 3E-8 - -

Thyroid
(1E+4) - - - 2E-4 2E-3

53 Iodine-1202 D, all compounds 4E+3 8E+3 4E-6 - - -

Thyroid Thyroid
(8E+3) (1E+4) - 2E-8 1E-4 1E-3

53 Iodine-121 D, all compounds 1E+4 2E+4 8E-6 - - -

Thyroid Thyroid
(3E+4) (5E+4) - 7E-8 4E-4 4E-3

53 Iodine-123 D, all compounds 3E+3 6E+3 3E-6 - - -

Thyroid Thyroid
(1E+4) (2E+4) - 2E-8 1E-4 1E-3

53 Iodine-124 D, all compounds 5E+1 8E+1 3E-8 - - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

Thyroid Thyroid
(2E+2) (3E+2) - 4E-10 2E-6 2E-5

53 Iodine-125 D, all compounds 4E+1 6E+1 3E-8 - - -

Thyroid Thyroid
(1E+2) (2E+2) - 3E-10 2E-6 2E-5

53 Iodine-126 D, all compounds 2E+1 4E+1 1E-8 - - -

Thyroid Thyroid
(7E+1) (1E+2) - 2E-10 1E-6 1E-5

53 Iodine-1282 D, all compounds 4E+4 1E+5 5E-5 2E-7 - -

St wall
(6E+4) - - - 8E-4 8E-3

53 Iodine-129 D, all compounds 5E+0 9E+0 4E-9 - - -

Thyroid Thyroid
(2E+1) (3E+1) - 4E-11 2E-7 2E-6

53 Iodine-130 D, all compounds 4E+2 7E+2 3E-7 - - -

Thyroid Thyroid
(1E+3) (2E+3) - 3E-9 2E-5 2E-4

53 Iodine-131 D, all compounds 3E+1 5E+1 2E-8 - - -

Thyroid Thyroid
(9E+1) (2E+2) - 2E-10 1E-6 1E-5

53 Iodine-132m2 D, all compounds 4E+3 8E+3 4E-6 - - -

Thyroid Thyroid
(1E+4) (2E+4) - 3E-8 1E-4 1E-3

53 Iodine-132 D, all compounds 4E+3 8E+3 3E-6 - - -

Thyroid Thyroid
(9E+3) (1E+4) - 2E-8 1E-4 1E-3

53 Iodine-133 D, all compounds 1E+2 3E+2 1E-7 - - -

Thyroid Thyroid
(5E+2) (9E+2) - 1E-9 7E-6 7E-5

53 Iodine-1342 D, all compounds 2E+4 5E+4 2E-5 6E-8 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

Thyroid
(3E+4) - - - 4E-4 4E-3

53 Iodine-135 D, all compounds 8E+2 2E+3 7E-7 - - -

Thyroid Thyroid
(3E+3) (4E+3) - 6E-9 3E-5 3E-4

54 Xenon-1202 Submersion1 - - 1E-5 4E-8 - -

54 Xenon-1212 Submersion1 - - 2E-6 1E-8 - -

54 Xenon-122 Submersion1 - - 7E-5 3E-7 - -

54 Xenon-123 Submersion1 - - 66 3E-8 - -

54 Xenon-125 Submersion1 - - 25 7E-8 - -

54 Xenon-127 Submersion1 - - 15 6E-8 - -

54 Xenon-129m Submersion1 - - 24 9E-7 - -

54 Xenon-131m Submersion1 - - 44 2E-6 - -

54 Xenon-133m Submersion1 - - 1E-4 6E-7 - -

54 Xenon-133 Submersion1 - - 1E-4 5E-7 - -

54 Xenon-135m2 Submersion1 - - 9E-6 4E-8 - -

54 Xenon-135 Submersion1 - - 1E-5 7E-8 - -

54 Xenon-1382 Submersion1 - - 4E-6 2E-8 - -

55 Cesium-1252 D, all compounds 5E+4 1E+5 6E-5 2E-7 - -

St wall
(9E+4) - - - 1E-3 1E-2

55 Cesium-127 D, all compounds 6E+4 9E+4 4E-5 1E-7 9E-4 9E-3

55 Cesium-129 D, all compounds 2E+4 3E+4 1E-5 5E-8 3E-4 3E-3

55 Cesium-1302 D, all compounds 6E+4 2E+5 8E-5 3E-7 - -

St wall
(1E+5) - - - 1E-3 1E-2
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

55 Cesium-131 D, all compounds 2E+4 3E+4 1E-5 4E-8 3E-4 3E-3

55 Cesium-132 D, all compounds 3E+3 4E+3 2E-5 5E-9 4E-5 4E-4

55 Cesium-134m D, all compounds 1E+5 1E+5 6E-5 2E-7 - -

St wall
(1E+5) - - - 2E-3 22 E-

55 Cesium-134 D, all compounds 7E+1 1E+2 4E-8 2E-10 9E-7 9E-6

55 Cesium-135m2 D, all compounds 1E+5 2E+5 8E-5 3E-7 1E-3 1E-2

55 Cesium-135 D, all compounds 7E+2 1E+3 5E-7 2E-9 1E-5 1E-4

55 Cesium-136 D, all compounds 4E+2 7E+2 3E-7 9E-10 6E-6 6E-5

55 Cesium-137 D, all compounds 1E+2 2E+2 6E-8 2E-10 1E-6 1E-5

55 Cesium-1382 D, all compounds 2E+4 6E+4 2E-5 8E-8 - -

St wall
(3E+4) - - - 4E-4 43 E-

56 Barium-1262 D, all compounds 6E+3 2E+4 6E-6 2E-8 8E-5 8E-4

56 Barium-128 D, all compounds 5E+2 2E+3 7E-7 2E-9 7E-6 7E-5

56 Barium-131m2 D, all compounds 4E+5 1E+6 6E-4 2E-6 - -

St wall
(5E+5) - - - 7E-3 72 E-

56 Barium-131 D, all compounds 3E+3 8E+3 3E-6 1E-8 4E-5 4E-4

56 Barium-133m D, all compounds 2E+3 9E+3 4E-6 1E-8 - -

LLI wall
(3E+3) - - - 4E-5 4E-4

56 Barium-133 D, all compounds 2E+3 7E+2 3E-7 9E-10 2E-5 2E-4

56 Barium-135m D, all compounds 3E+3 1E+4 5E-6 2E-8 4E-5 4E-4

56 Barium-1392 D, all compounds 1E+4 3E+4 1E-5 4E-8 2E-4 2E-3

56 Barium-140 D, all compounds 5E+2 1E+3 6E-7 2E-9 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

LLI wall
(6E+2) - - - 86 8E-5

56 Barium-1412 D, all compounds 2E+4 7E+4 3E-5 1E-7 3E-4 3E-3

56 Barium-1422 D, all compounds 5E+4 1E+5 6E-5 2E-7 7E-4 7E-3

57 Lanthanum-1312 D, all compounds except those given for W 5E+4 1E+5 5E-5 2E-7 6E-4 6E-3

W, oxides and hydroxides - 2E+5 7E-5 2E-7 - -

57 Lanthanum-132 D, see 131La 3E+3 1E+4 4E-6 1E-8 4E-5 4E-4

W, see 131La - 1E+4 5E-6 2E-8 - -

57 Lanthanum-135 D, see 131La 4E+4 1E+5 4E-5 1E-7 5E-4 5E-3

W, see 131La - 94 4E-5 1E-7 - -

57 Lanthanum-137 D, see 131La 1E+4 6E+1 3E-8 2E-4 2E-3

Liver
- (7E+1) - 1E-10 - -

W, see 131La - 3E+2 1E-7 - - -

Liver
- (3E+2) - 4E-10 - -

57 Lanthanum-138 D, see 131La 9E+2 4E+0 1E-9 5E-12 1E-5 1E-4

W, see 131La - 1E+1 6E-9 2E-11 - -

57 Lanthanum-140 D, see 131La 6E+2 1E+3 6E-7 2E-9 9E-6 9E-5

W, see 131La - 1E+3 5E-7 2E-9 - -

57 Lanthanum-141 D, see 131La 4E+3 9E+3 4E-6 1E-8 5E-5 5E-4

W, see 131La - 1E+4 5E-6 2E-8 - -

57 Lanthanum-1422 D, see 131La 8E+3 2E+4 9E-6 3E-8 1E-4 1E-3

W, see 131La - 3E+4 1E-5 5E-8 - -

57 Lanthanum-1432 D, see 131La 4E+4 1E+5 4E-5 1E-7 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

St wall
(4E+4) - - - 5E-4 5E-3

W, see 131La - 9E+4 4E-5 1E-7 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

58 Cerium-134 W, all compounds except those given for Y 5E+2 7E+2 3E-7 1E-9 - -

LLI wall
(6E+2) - - - 8E-6 8E-5

Y, oxides, hydroxides, and fluorides - 7E+2 3E-7 9E-10 - -

58 Cerium-135 W, see 134Ce 2E+3 4E+3 2E-6 5E-9 2E-5 2E-4

Y, see 134Ce - 4E+3 1E-6 5E-9 - -

58 Cerium-137m W, see 134Ce 2E+3 4E+3 2E-6 6E-9 - -

LLI wall
(2E+3) - - - 3E-5 3E-4

Y, see 134Ce - 4E+3 2E-6 5E-9 - -

58 Cerium-137 W, see 134Ce 5E+4 1E+5 6E-5 2E-7 7E-4 7E-3

Y, see 134Ce - 1E+5 5E-5 2E-7 - -

58 Cerium-139 W, see 134Ce 5E+3 8E+2 3E-7 1E-9 7E-5 7E-4

Y, see 134Ce - 7E+2 3E-7 9E-10 - -

58 Cerium-141 W, see 134Ce 2E+3 7E+2 3E-7 1E-9 - -

LLI wall
(2E+3) - - - 3E-5 3E-4

Y, see 134Ce - 6E+2 2E-7 8E-10 - -

58 Cerium-143 W, see 134Ce 1E+3 2E+3 8E-7 3E-9 - -

LLI wall
(1E+3) - - - 2E-5 2E-4

Y, see 134Ce - 2E+3 7E-7 2E-9 - -

58 Cerium-144 W, see 134Ce 2E+2 3E+1 1E-8 4E-11 - -

LLI wall
(3E+2) - - - 3E-6 3E-5

Y, see 134Ce - 1E+1 6E-9 2E-11 - -

59 Praseodymium-1362 W, all compounds except those given for Y 5E+4 2E+5 1E-4 3E-7 - -
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

St wall
(7E+4) - - - 1E-3 1E-2

Y, oxides, hydroxides, carbides, and - 2E+5 9E-5 3E-7 - -

fluorides

59 Praseodymium-1372 W, see 136Pr 4E+4 2E+5 6E-5 2E-7 5E-4 5E-3

Y, see 136Pr - 1E+5 65 27 - -

59 Praseodymium-138m W, see 136Pr 1E+4 5E+4 25 88 14 13

Y, see 136Pr - 4E+4 2E-5 6E-8 - -

59 Praseodymium-139 W, see 136Pr 4E+4 1E+5 5E-5 2E-7 6E-3

Y, see 136Pr - 1E+5 5E-5 2E-7 - -

59 Praseodymium- W, see 136Pr 8E+4 2E+5 7E-5 2E-7 1E-3 1E-2

2
142m

Y, see 136Pr - 1E+5 6E-5 2E-7 - -

59 Praseodymium-142 W, see 136Pr 1E+3 2E+3 9E-7 3E-9 1E-5 1E-4

Y, see 136Pr - 2E+3 8E-7 3E-9 - -

59 Praseodymium-143 W, see 136Pr 9E+2 8E+2 3E-7 1E-9 - -

LLI wall
(1E+3) - - - 2E-5 2E-4

Y, see 136Pr - 7E+2 3E-7 9E-10 - -

59 Praseodymium-1442 W, see 136Pr 3E+4 1E+5 5E-5 2E-7 - -

St wall
(4E+4) - - - 6E-4 6E-3

Y, see 136Pr - 1E+5 5E-5 2E-7 - -

59 Praseodymium-145 W, see 136Pr 3E+3 9E+3 4E-6 1E-8 4E-5 4E-4

Y, see 136Pr - 8E+3 3E-6 1E-8 - -

59 Praseodymium-1472 W, see 136Pr 5E+4 2E+5 8E-5 3E-7 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)
St wall
(8E+4) - - - 1E-3 1E-2

Y, see 136Pr - 2E+5 8E-5 3E-7 - -

60 Neodymium-1362 W, all compounds except those given for Y 1E+4 6E+4 2E-5 8E-8 2E-4 2E-3

Y, oxides, hydroxides, carbides, and - 5E+4 2E-5 8E-8 - -

fluorides

60 Neodymium-138 W, see 136Nd 2E+3 6E+3 3E-6 9E-9 3E-5 3E-4

Y, see 136Nd - 5E+3 2E-6 7E-9 - -

60 Neodymium-139m W, see 136Nd 5E+3 2E+4 7E-6 2E-8 7E-5 7E-4

Y, see 136Nd - 14 6E-6 2E-8 - -

60 Neodymium-1392 W, see 136Nd 9E+4 3E+5 1E-4 5E-7 1E-3 1E-2

Y, see 136Nd - 3E+5 1E-4 4E-7 - -

60 Neodymium-141 W, see 136Nd 25 7E+5 3E-4 1E-6 2E-3 2E-2

Y, see 136Nd - 6E+5 3E-4 9E-7 - -

60 Neodymium-147 W, see 136Nd 1E+3 9E+2 4E-7 1E-9 - -

LLI wall
(1E+3) - - - 2E-5 2E-4

Y, see 136Nd - 8E+2 4E-7 1E-9 - -

60 Neodymium-1492 W, see 136Nd 1E+4 3E+4 1E-5 4E-8 1E-4 1E-3

Y, see 136Nd - 2E+4 1E-5 3E-8 - -

60 Neodymium-1512 W, see 136Nd 7E+4 2E+5 8E-5 3E-7 9E-4 9E-3

Y, see 136Nd - 2E+5 8E-5 3E-7 - -

61 Promethium-1412 W, all compounds except those given for Y 5E+4 2E+5 8E-5 3E-7 - -
St wall
(6E+4) - - - 8E-4 8E-3

Y, oxides, hydroxides, carbides, and - 2E+5 7E-5 2E-7 - -

fluorides
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

61 Promethium-143 W, see 141Pm 5E+3 6E+2 2E-7 8E-10 7E-5 7E-4

Y, see 141Pm - 7E+2 3E-7 1E-9 - -

61 Promethium-144 W, see 141Pm 1E+3 1E+2 5E-8 2E-10 2E-5 2E-4

Y, see 141Pm - 1E+2 5E-8 2E-10 - -

61 Promethium-145 W, see 141Pm 1E+4 2E+2 7E-8 - 1E-4 1E-3

Bone surf
- (2E+2) - 3E-10 - -

Y, see 141Pm - 2E+2 8E-8 3E-10 - -

61 Promethium-146 W, see 141Pm 2E+3 5E+1 2E-8 7E-11 2E-5 2E-4

Y, see 141Pm - 4E+1 2E-8 6E-11 - -

61 Promethium-147 W, see 141Pm 4E+3 1E+2 5E-8 - - -

LLI wall Bone surf
(5E+3) (2E+2) - 3E-10 7E-5 7E-4

Y, see 141Pm - 1E+2 68 2E-10 - -

61 Promethium-148m W, see 141Pm 7E+2 3E+2 1E-7 4E-10 1E-5 1E-4

Y, see 141Pm - 3E+2 1E-7 5E-10 - -

61 Promethium-148 W, see 141Pm 4E+2 5E+2 2E-7 8E-10 - -

LLI wall
(5E+2) - - - 7E-6 7E-5

Y, see 141Pm - 5E+2 2E-7 7E-10 - -

61 Promethium-149 W, see 141Pm 1E+3 2E+3 8E-7 3E-9 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)
LLI wall
(1E+3) - - - 2E-5 2E-4

Y, see 141Pm - 2E+3 8E-7 2E-9 - -

61 Promethium-150 W, see 141Pm 5E+3 2E+4 8E-6 3E-8 7E-5 7E-4

Y, see 141Pm - 2E+4 7E-6 2E-8 - -

61 Promethium-151 W, see 141Pm 2E+3 4E+3 1E-6 5E-9 2E-5 2E-4

Y, see 141Pm - 33 1E-6 4E-9 - -

62 Samarium-141m2 W, all compounds 3E+4 1E+5 4E-5 1E-7 4E-4 4E-3

62 Samarium-1412 W, all compounds 5E+4 2E+5 8E-5 2E-7 - -

St wall
(6E+4) - - - 8E-4 8E-3

62 Samarium-1422 W, all compounds 8E+3 3E+4 1E-5 4E-8 1E-4 1E-3

62 Samarium-145 W, all compounds 5E+3 5E+2 2E-7 7E-10 8E-5 8E-4

62 Samarium-146 W, all compounds 1E+1 4E+2 1E-1 - - -

Bone surf Bone surf
(3E+1) (6E-2) - 9E-14 3E-7 3E-6

62 Samarium-147 W, all compounds 2E+1 4E+2 2E-11 - - -

Bone surf Bone surf
(3E+1) (7E-2) - 1E-13 4E-7 4E-6

62 Samarium-151 W, all compounds 1E+4 1E+2 4E-8 - - -

LLI wall Bone surf
(1E+4) (2E+2) - 3E-10 2E-4 2E-3

62 Samarium-153 W, all compounds 2E+3 3E+3 1E-6 4E-9 - -

LLI wall
(2E+3) - - - 3E-5 3E-4

62 Samarium-1552 W, all compounds 6E+4 2E+5 9E-5 3E-7 - -

St wall
(8E+4) - - - 1E-3 1E-2
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

62 Samarium-156 W, all compounds 5E+3 9E+3 4E-6 1E-8 7E-5 7E-4

63 Europium-145 W, all compounds 2E+3 8E+7 3E-9 2E-5 2E-4

63 Europium-146 W, all compounds 1E+3 1E+3 5E-7 2E-9 1E-4 1E-4

63 Europium-147 W, all compounds 3E+3 2E+3 7E-7 2E-9 4E-6 4E-4

63 Europium-148 W, all compounds 1E+3 4E+2 1E-7 5E-10 1E-5 1E-4

63 Europium-149 W, all compounds 1E+4 3E+3 1E-6 4E-9 2E-4 2E-3

63 Europium-150 W, all compounds 3E+3 8E+3 4E-6 1E-8 4E-5 4E-4

(12.62 h)

63 Europium-150 W, all compounds 8E+2 2E+1 8E-9 3E-11 1E-5 1E-4

(34.2 y)

63 Europium-152m W, all compounds 3E+3 6E+3 3E-6 9E-9 4E-5 4E-4

63 Europium-152 W, all compounds 8E+2 2E+1 1E-8 3E-11 1E-5 1E-4

63 Europium-154 W, all compounds 5E+2 2E+1 8E-9 3E-11 7E-6 7E-5

63 Europium-155 W, all compounds 4E+3 9E+1 4E-8 - 5E-5 5E-4

Bone surf
- (1E+2) - 2E-10 - -

63 Europium-156 W, all compounds 6E+2 5E+2 2E-7 6E-10 8E-6 8E-5

63 Europium-157 W, all compounds 2E+3 5E+3 2E-6 7E-9 3E-5 3E-4

63 Europium-1582 W, all compounds 2E+4 6E+4 2E-5 8E-8 3E-4 3E-3

64 Gadolinium-1452 D, all compounds except those given for W 5E+4 2E+5 6E-5 2E-7 - -
St wall
(5E+4) - - - 6E-4 6E-3

W, oxides, hydroxides, and fluorides - 2E+5 7E-5 2E-7 - -

64 Gadolinium-146 D, see 145Gd 1E+3 1E+2 5E-8 2E-10 2E-5 2E-4

W, see 145Gd - 3E+2 1E-7 4E-10 - -

64 Gadolinium-147 D, see 145Gd 2E+3 4E+3 2E-6 6E-9 3E-5 3E-4

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

W, see 145Gd - 4E+3 1E-6 5E-9 - -

64 Gadolinium-148 D, see 145Gd 1E+1 8E+3 3E-12 - - -

Bone surf Bone surf
(2E+1) (2E-2) - 3E-4 3E-7 3E-6

W, see 145Gd - 32 1E-11 - - -

Bone surf
- (6E-2) - 8E-14 - -

64 Gadolinium-149 D, see 145Gd 3E+3 2E+3 9E-7 3E-9 4E-5 4E-4

W, see 145Gd - 2E+3 1E-6 3E-9 - -

64 Gadolinium-151 D, see 145Gd 6E+3 4E+2 2E-7 - 9E-5 9E-4

Bone surf
- (6E+2) - 9E-10 - -

W, see 145Gd - 1E+3 5E-7 2E-9 - -

64 Gadolinium-152 D, see 145Gd 2E+1 1E+2 4E-12 - - -

Bone surf Bone surf
(3E+1) (2E-2) - 3E-14 4E-7 4E-6
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

W, see 145Gd - 4E+2 2E-11 - - -

Bone surf
- (8E-2) - 1E-13 - -

64 Gadolinium-153 D, see 145Gd 5E+3 1E+2 6E-8 6E-5 6E-4

Bone surf
- (2E+2) - 3E-10 - -

W, see 145Gd - 6E+2 2E-7 8E-10 - -

64 Gadolinium-159 D, see 145Gd 3E+3 8E+3 3E-6 1E-8 4E-6 4E-4

W, see 145Gd - 6E+3 2E-6 8E-9 - -

65 Terbium-1472 W, all compounds 9E+3 3E+4 1E-5 5E-8 1E-4 1E-3

65 Terbium-149 W, all compounds 5E+3 7E+2 3E-7 1E-9 7E-5 7E-4

65 Terbium-150 W, all compounds 5E+3 2E+4 9E-6 3E-8 7E-5 7E-4

65 Terbium-151 W, all compounds 4E+3 9E+3 4E-6 1E-8 5E-5 5E-4

65 Terbium-153 W, all compounds 5E+3 7E+3 3E-6 1E-8 7E-5 7E-4

65 Terbium-154 W, all compounds 2E+3 4E+3 2E-6 6E-9 2E-5 2E-4

65 Terbium-155 W, all compounds 4E+3 8E+3 3E-6 1E-8 8E-5 8E-4

65 Terbium-156m W, all compounds 2E+4 3E+4 1E-5 4E-8 2E-4 2E-3

(5.0 h)

65 Terbium-156m W, all compounds 7E+3 8E+3 3E-6 1E-8 1E-4 1E-3

(24.4 h)

65 Terbium-156 W, all compounds 1E+3 1E+3 6E-7 2E-9 1E-5 1E-4

65 Terbium-157 W, all compounds 5E+4 3E+2 1E-7 - - -

LLI wall Bone surf
(5E+4) (6E+2) - 8E-10 7E-4 7E-3

65 Terbium-158 W, all compounds 1E+3 2E+1 8E-9 3E-11 2E-5 2E-4

65 Terbium-160 W, all compounds 8E+2 2E+2 9E-8 3E-10 1E-5 1E-4

65 Terbium-161 W, all compounds 2E+3 2E+3 7E-7 2E-9 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)
LLI wall
(2E+3) - - - 3E-5 3E-4

66 Dysprosium-155 W, all compounds 9E+3 3E+4 1E-5 4E-8 1E-4 1E-3

66 Dysprosium-157 W, all compounds 2E+4 6E+4 3E-5 9E-8 3E-4 3E-3

66 Dysprosium-159 W, all compounds 1E+4 2E+3 1E-6 3E-9 2E-4 2E-3

66 Dysprosium-165 W, all compounds 1E+4 5E+4 2E-5 6E-8 2E-4 2E-3

66 Dysprosium-166 W, all compounds 6E+2 7E+2 3E-7 1E-9 - -

LLI wall
(8E+2) - - - 1E-5 1E-4

67 Holmium-1552 W, all compounds 4E+4 2E+5 6E-5 2E-7 6E-4 6E-3

67 Holmium-1572 W, all compounds 3E+5 1E+6 6E-4 2E-6 4E-3 4E-2

67 Holmium-1592 W, all compounds 1E+5 1E+6 4E-4 1E-6 3E-3 3E-2

67 Holmium-161 W, all compounds 1E+5 4E+5 2E-4 6E-7 1E-3 1E-2

67 Holmium-162m2 W, all compounds 5E+4 3E+5 1E-4 4E-7 7E-4 7E-3

67 Holmium-1622 W, all compounds 5E+5 2E+6 1E-3 3E-6 - -

St wall
(8E+5) - - - 1E-2 1E-1

67 Holmium-164m2 W, all compounds 1E+5 3E+5 1E-4 4E-7 1E-3 1E-2

67 Holmium-1642 W, all compounds 2E+5 6E+5 3E-4 9E-7 - -

St wall
(2E+5) - - - 3E-3 3E-2

67 Holmium-166m W, all compounds 6E+2 7E+0 3E-9 9E-12 9E-6 9E-5

67 Holmium-166 W, all compounds 9E+2 2E+3 7E-7 2E-9 - -

LLI wall
(9E+2) - - - 1E-5 1E-4

67 Holmium-167 W, all compounds 2E+4 6E+4 2E-5 8E-8 2E-4 2E-3

68 Erbium-161 W, all compounds 2E+4 6E+4 3E-5 9E-8 2E-4 2E-3

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

68 Erbium-165 W, all compounds 6E+4 2E+5 8E-5 3E-7 9E-4 9E-3

68 Erbium-169 W, all compounds 3E+3 3E+3 1E-6 4E-9 - -

LLI wall
(4E+3) - - - 5E-5 5E-4

68 Erbium-171 W, all compounds 4E+3 1E+4 4E-6 1E-8 5E-5 5E-4

68 Erbium-172 W, all compounds 1E+3 1E+3 6E-7 2E-9 - -

LLI wall
(1E+3) - - - 2E-5 2E-4

69 Thulium-1622 W, all compounds 7E+4 3E+5 1E-4 4E-7 - -

St wall
(7E+4) - - - 1E-3 1E-2

69 Thulium-166 W, all compounds 4E+3 1E+4 6E-6 2E-8 6E-5 6E-4

69 Thulium-167 W, all compounds 2E+3 2E+3 8E-7 3E-9 - -

LLI wall
(2E+3) - - - 3E-5 3E-4

69 Thulium-170 W, all compounds 8E+2 2E+2 9E-8 31E-0 - -

LLI wall
(1E+3) - - - 1E-5 1E-4

69 Thulium-171 W, all compounds 1E+4 3E+2 1E-7 - - -

LLI wall Bone surf
(1E+4) (6E+2) - 8E-10 2E-4 2E-3

69 Thulium-172 W, all compounds 7E+2 1E+3 5E-7 2E-9 - -

LLI wall
(8E+2) - - - 1E-5 1E-4

69 Thulium-173 W, all compounds 4E+3 1E+4 5E-6 2E-8 6E-5 6E-4

69 Thulium-1752 W, all compounds 7E+4 3E+5 1E-4 4E-7 - -

St wall
(9E+4) - - - 1E-3 1E-2

70 Ytterbium-1622 W, all compounds except those given for Y 7E+4 3E+5 1E-4 4E-7 1E-3 1E-2
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

Y, oxides, hydroxides, and fluorides - 3E+5 1E-4 4E-7 - -

70 Ytterbium-166 W, see 162Yb 1E+3 2E+3 8E-7 3E-9 2E-5 2E-4

Y, see 162Yb - 2E+3 8E-7 3E-9 - -

70 Ytterbium-1672 W, see 162Yb 3E+5 8E+5 3E-4 1E-6 4E-3 4E-2

Y, see 162Yb - 7E+5 3E-4 1E-6 - -

70 Ytterbium-169 W, see 162Yb 2E+3 8E+2 4E-7 1E-9 2E-5 2E-4

Y, see 162Yb - 7E+2 3E-7 1E-9 - -

70 Ytterbium-175 W, see 162Yb 3E+3 4E+3 1E-6 5E-9 - -

3E+3 - - - 4E-5 4E-4

Y, see 162Yb - 3E+3 1E-6 5E-9 - -

70 Ytterbium-1772 W, see 162Yb 2E+4 5E+4 2E-5 7E-8 2E-4 2E-3

Y, see 162Yb - 5E+4 2E-5 6E-8 - -

70 Ytterbium-1782 W, see 162Yb 1E+4 4E+4 2E-5 6E-8 2E-4 2E-3

Y, see 162Yb - 4E+4 2E-5 5E-8 - -

71 Lutetium-169 W, all compounds except those given for Y 3E+3 4E+3 2E-6 6E-9 3E-5 3E-4

Y, oxides, hydroxides, and fluorides - 4E+3 2E-6 6E-9 - -

71 Lutetium-170 W, see 169Lu 1E+3 2E-3 9E-7 3E-9 2E-5

24 Y, see 169Lu - 2E+3 8E-7 39 E- - -

71 Lutetium-171 W, see 169Lu 2E+3 2E+3 8E-7 3E-9 3E-5 3E-4

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

Y, see 169Lu - 2E+3 8E-7 3E-9 - -

71 Lutetium-172 W, see 169Lu 1E+3 1E+3 5E-7 2E-9 1E-5 1E-4

Y, see 169Lu - 1E+3 5E-7 29 - -

71 Lutetium-173 W, see 169Lu 5E+3 3E+2 1E-7 - 7E-5 7E-4

Bone surf
- (5E+2) - 6E-10 - -

Y, see 169Lu - 3E+2 1E-7 4E-10 - -

71 Lutetium-174m W, see 169Lu 2E+3 2E+2 1E-7 - - -

LLI wall Bone surf
(3E+3) (3E+2) - 5E-10 4E-5 4E-4

Y, see 169Lu - 2E+2 9E-8 3E-10 - -

71 Lutetium-174 W, see 169Lu 5E+3 1E+2 5E-8 - 7E-5 7E-4

Bone surf
- (2E+2) - 3E-10 - -

Y, see 169Lu - 2E+2 6E-8 2E-10 - -

71 Lutetium-176m W, see 169Lu 8E+3 3E+4 1E-5 3E-8 1E-4 1E-3

Y, see 169Lu - 2E+4 9E-6 38 - -

71 Lutetium-176 W, see 169Lu 7E+2 5E+0 2E-9 - 1E-5 1E-4

Bone surf
- (1E+1) - 2E-11 - -

Y, see 169Lu - 8E+0 3E-9 1E-11 - -

71 Lutetium-177m W, see 169Lu 7E+2 1E+2 5E-8 - 1E-5 1E-4

Bone surf
- (1E+2) - 2E-10 - -

Y, see 169Lu - 8E+1 3E-8 1E-0 - -

71 Lutetium-177 W, see 169Lu 2E+3 2E+3 9E-7 3E-9 - -

LLI wall
(3E+3) - - - 4E-5 4E-4
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

Y, see 169Lu - 2E+3 9E-7 3E-9 - -

71 Lutetium-178m2 W, see 169 Lu 5E+4 2E+5 8E-5 3E-7 - -

St. wall
(6E+4) - - - 8E-4 8E-3

Y, see 169Lu - 2E+5 7E-5 2E-7 - -

71 Lutetium-1782 W, see 169Lu 4E+4 1E+5 5E-5 27 - -

St wall
(4E+4) - - - 6E-4 6E-3

Y, see 169Lu - 1E+5 5E-5 2E-7 - -

71 Lutetium-179 W, see 169Lu 6E+3 2E+4 8E-6 3E-8 9E-5 9E-4

Y, see 169Lu - 2E+4 6E-6 3E-8 - -

72 Hafnium-170 D, all compounds except those given for W 3E+3 6E+3 2E-6 89 E- 4E-5 4E-4

W, oxides, hydroxides, carbides, and - 5E+3 2E-6 6E-9 - -

nitrates

72 Hafnium-172 D, see 170Hf 1E+3 9E+0 4E-9 - 2E-5 2E-4

Bone surf
- (2E+1) - 3E-11 - -

W, see 170Hf - 41 E+ 2E-8 - - -

Bone surf
- (6E+1) - 8E-11 - -

72 Hafnium-173 D, see 170Hf 5E+3 1E+4 5E-6 2E-8 7E-5 7E-4

W, see 170Hf - 1E+4 5E-6 2E-8 - -

72 Hafnium-175 D, see 170Hf 3E+5 9E+2 4E-7 - 4E-5 4E-4

Bone surf
- (1E+3) - 1E-9 - -

W, see 170Hf - 1E+3 5E-7 2E-9 - -

72 Hafnium-177m2 D, see 170Hf 2E+4 6E+4 2E-5 8E-8 3E-4 3E-3

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

W, see 170Hf - 9E+4 4E-5 1E-7 - -

72 Hafnium-178m D, see 170Hf 3E+2 1E+0 5E-10 - 3E-6 3E-5

Bone surf
- (2E+0) - 3E-12 - -

W, see 170Hf - 5E+10 2E-9 - - -

Bone surf
- (9E+0) - 1E-11 - -

72 Hafnium-179m D, see 170Hf 1E+3 3E+2 1E-7 - 1E-5 1E-4

Bone surf
- (6E+2) - 8E-10 - -

W, see 170Hf - 6E+2 3E-7 8E-10 - -

72 Hafnium-180m D, see 170Hf 7E+3 2E+4 9E-6 3E-8 1E-4 1E-3

W, see 170Hf - 3E+4 1E-4 4E-8 - -

72 Hafnium-181 D, see 170Hf 13 E+ 2E+2 7E-8 - 2E-5 2E-4

Bone surf
- (4E+2) - 6E-10 - -
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

W, see 170Hf - 4E+2 2E-7 6E-10 - -

72 Hafnium-182m2 D, see 170Hf 4E+4 9E+4 4E-5 1E-7 5E-4 5E-3

W, see 170Hf - 1E+5 6E-5 2E-7 - -

72 Hafnium-182 D, see 170Hf 2E+2 8E+1 3E-10 - - -

Bone surf Bone surf
(4E+2) (2E+0) - 2E-12 5E-6 5E-5

W, see 170Hf - 3E+0 1E-9 - - -

Bone surf
- (7E+0) - 1E-11 - -

72 Hafnium-1832 D, see 170Hf 2E+4 5E+4 2E-5 6E-8 3E-4 33

W, see 170Hf - 6E+4 2E-5 8E-8 - -

72 Hafnium-184 D, see 170 Hf E+ 23 8E+3 36 1E-8 3E-5 3E-4

W, see 170Hf - 6E+3 3E-6 9E-9 - -

73 Tantalum-1722 W, all compounds except those given for Y 4E+4 1E+5 5E-5 2E-7 5E-4 5E-3

Y, elemental Ta, oxides, hydroxides, - 1E+5 4E-5 1E-7 - -

halides, carbides, nitrates, and nitrides

73 Tantalum-173 W, see 172Ta 7E+3 2E+4 8E-6 3E-8 9E-6 9E-4

Y, see 172Ta - 2E+4 7E-6 2E-8 - -

73 Tantalum-1742 W, see 172Ta 3E+4 1E+5 4E-5 1E-7 4E-4 4E-3

Y, see 172Ta - 9E+4 4E-5 1E-7 - -

73 Tantalum-175 W, see 172Ta 6E+3 2E+4 7E-6 2E-8 8E-4 8E-4

Y, see 172Ta - 1E+4 6E-6 3E-8 - -

73 Tantalum-176 W, see 172Ta 4E+3 1E+4 5E-6 2E-8 5E-5 5E-4

Y, see 172Ta - 1E+4 5E-6 2E-8 - -

73 Tantalum-177 W, see 172Ta 1E+4 2E+4 8E-6 3E-8 2E-4 2E-3

Y, see 172Ta - 2E+4 7E-6 2E-8 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

73 Tantalum-178 W, see 172Ta 2E+4 9E+4 4E-5 1E-7 2E-4 2E-3

Y, see 172Ta - 7E+4 3E-5 1E-4 - -

73 Tantalum-179 W, see 172Ta 2E+4 5E+3 2E-6 8E-9 3E-4 3E-3

Y, see 172Ta - 9E+2 4E-7 1E-9 - -

73 Tantalum-180m W, see 172Ta 2E+4 7E+4 3E-5 9E-8 3E-4 3E-3

Y, see 172Ta - 6E+4 2E-5 8E-8 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

73 Tantalum-180 W, see 172Ta 1E+3 4E+2 2E-7 6E-10 2E-5 2E-4

Y, see 172Ta - 2E+1 1E-8 3E-11 - -

73 Tantalum-182m2 W, see 172Ta 2E+5 5E+5 2E-4 8E-7 - -

St wall
(2E+5) - - - 3E-3 3E-2

Y, see 172Ta - 4E+5 2E-4 6E-7 - -

73 Tantalum-182 W, see 172Ta 8E+2 3E+2 1E-7 5E-10 1E-5 1E-4

Y, see 172Ta - 1E+2 6E-8 2E-10 - -

73 Tantalum-183 W, see 172Ta 9E+2 1E+3 5E-7 2E-9 - -

LLI wall
(1E+3) - - - 2E-5 2E-4

Y, see 172Ta - 1E+3 4E-7 1E-9 - -

73 Tantalum-184 W, see 172Ta 2E+3 5E+3 2E-6 8E-9 3E-5 3E-4

Y, see 172Ta - 5E+3 2E-6 7E-8 - -

73 Tantalum-1852 W, see 172Ta 3E+4 7E+4 3E-5 1E-7 4E-4 4E-3

Y, see 172Ta - 6E+4 3E-5 9E-8 - -

73 Tantalum-1862 W, see 172Ta 5E+4 2E+6 1E-4 3E-7 - -

St wall
(7E+4) - - - 1E-3 1E-2

Y, see 172Ta - 2E+5 9E-5 3E-7 - -

74 Tungsten-176 D, all compounds 1E+4 5E+4 2E-5 7E-8 1E-4 1E-3

74 Tungsten-177 D, all compounds 2E+4 9E+4 4E-5 1E-7 3E-4 3E-3

74 Tungsten-178 D, all compounds 5E+3 2E+4 8E-6 3E-8 7E-4 7E-4

74 Tungsten-1792 D, all compounds 5E+5 2E+6 7E-4 2E-6 7E-3 7E-2

74 Tungsten-181 D, all compounds 2E+4 3E+4 1E-5 5E-8 2E-4 2E-3

74 Tungsten-185 D, all compounds 2E+3 7E+6 3E-6 9E-9 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)
- - - 4E-5 4E-4

74 Tungsten-187 D, all compounds 2E+3 9E+3 4E-6 1E-8 3E-5 3E-4

74 Tungsten-188 D, all compounds 4E+3 1E+3 5E-7 2E-9 - -

LLI wall
(5E+2) - - - 7E-6 7E-5

75 Rhenium-1772 D, all compounds except those given for W 9E+4 3E+5 1E-4 4E-7 - -
St wall
(1E+5) - - - 2E-3 2E-2

W, oxides, hydroxides, and nitrates - 4E+5 1E-4 5E-7 - -

75 Rhenium-1782 D, see 177Re 7E+4 3E+5 1E-4 4E-7 - -

St wall
(1E+5) - - - 1E-3 1E-2

W, see 177Re - 3E+5 1E-4 4E-7 - -

75 Rhenium-181 D, see 177Re 5E+3 9E+3 4E-6 1E-8 7E-5 7E-4

W, see 177Re - 9E+3 4E-6 1E-8 - -

75 Rhenium-182 D, see 177Re 7E+6 1E+4 5E-6 2E-8 9E-5 9E-4

(12.7 h) W, see 177Re - 2E+4 6E-6 2E-8 - -

75 Rhenium-182 D, see 177Re 1E+3 2E+3 1E-6 3E-9 2E-5 2E-4

(64.0 h) W, see 177Re - 2E+3 9E-7 3E-9 - -

75 Rhenium-184m D, see 177Re 2E+3 3E+3 1E-6 4E-9 3E-5 3E-4

W, see 177Re - 4E+2 2E-7 6E-10 - -

75 Rhenium-184 D, see 177Re 2E+3 4E+3 1E-6 5E-9 3E-5 3E-4

W, see 177Re - 1E+3 6E-7 2E-9 - -

75 Rhenium-186m D, see 177Re 1E+3 2E+3 7E-7 - - -

St wall St wall
(2E+3) (2E+3) - 3E-9 2E-5 2E-4

W, see 177Re - 2E+2 6E-8 2E-10 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

75 Rhenium-186 D, see 177Re 2E+3 3E+3 1E-6 4E-9 3E-5 3E-4

W, see 177Re - 2E+3 7E-7 2E-9 - -

75 Rhenium-187 D, see 177Re 6E+5 8E+5 4E-4 - 8E-3 8E-2

St wall
- (9E+5) - 1E-6 - -

W, see 177Re - 1E+5 4E-5 1E-7 - -

75 Rhenium-188m2 D, see 177Re 8E+4 1E+5 6E-5 2E-7 1E-3 1E-2

W, see 177Re - 1E+5 6E-5 2E-7 - -

75 Rhenium-188 D, see 177Re 2E+3 3E+3 1E-6 4E-9 2E-5 2E-4

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

W, see 177Re - 3E+3 1E-4 4E-9 - -

75 Rhenium-189 D, see 177Re 3E+3 5E+3 2E-6 7E-9 4E-5 4E-4

W, see 177Re - 4E+3 2E-6 6E-9 - -

76 Osmium-1802 D, all compounds except those given for W 1E+5 4E+5 2E-4 4E-7 1E-3 1E-2
and Y

W, halides and nitrates - 5E+5 2E-4 7E-7 - -

Y, oxides and hydroxides - 5E+5 2E-4 6E-7 - -

76 Osmium-1812 D, see 180 Os 1E+4 4E+4 2E-5 6E-8 2E-4 2E-3

W, see 180Os - 5E+4 2E-5 6E-8 - -

Y, see 180Os - 4E+4 2E-5 6E-8 - -

76 Osmium-182 D, see 180Os 2E+3 6E+3 2E-6 8E-9 3E-5 3E-4

W, see 180Os - 4E+3 2E-6 6E-9 - -

Y, see 180Os - 4E+3 2E-6 6E-9 - -

76 Osmium-185 D, see 180Os 2E+3 5E+2 2E-7 7E-10 3E-5 3E-4

W, see 180Os - 8E+2 3E-7 1E-9 - -

Y, see 180Os - 8E+2 3E-7 1E-9 - -

76 Osmium-189m D, see 180Os 8E+4 2E+5 1E-4 3E-7 1E-3 1E-2

W, see 180Os - 2E+5 9E-5 3E-7 - -

Y, see 180Os - 2E+5 7E-5 2E-7 - -

76 Osmium-191m D, see 180Os 1E+4 3E+4 1E-5 4E-8 2E-4 2E-3

W, see 180Os - 2E+4 8E-6 3E-8 - -

Y, see 180Os - 2E+4 7E-6 2E-8 - -

76 Osmium-191 D, see 180Os 2E+5 2E+3 9E-7 3E-9 - -

LLI wall
(3E+3) - - - 3E-5 3E-4
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

W, see 180Os - 2E+3 7E-7 2E-9 - -

Y, see 180Os - 1E+3 6E-7 2E-9 - -

76 Osmium-193 D, see 180Os 2E+3 5E+3 2E-6 6E-9 - -

LLI wall
(2E+3) - - - 2E-5 2E-4

W, see 180Os - 3E+3 1E-6 4E-9 - -

Y, see 180Os - 3E+3 1E-6 4E-9 - -

76 Osmium-194 D, see 180Os 4E+2 4E+1 2E-8 6E-11 - -

LLI wall
(6E+2) - - - 8E-6 8E-5

W, see 180Os - 6E+1 2E-8 8E-11 - -

Y, see 180Os - 8E+0 E- 39 1E-11 - -

77 Iridium-1822 D, all compounds except those given for W 4E+4 1E+5 6E-5 2E-7 - -
and Y

St wall
(4E+4) - - - 6E-4 6E-3

W, halides, nitrates, and metallic iridium - 2E+5 6E-5 2E-7 - -

Y, oxides and hydroxides - 1E+5 5E-5 2E-7 - -

77 Iridium-184 D, see 182Ir 8E+3 2E+4 1E-5 3E-8 1E-4 1E-3

W, see 182Ir - 3E+4 1E-5 5E-8 - -

Y, see 182Ir - 3E+4 1E-5 4E-8 - -

77 Iridium-185 D, see 182Ir 5E+3 1E+4 5E-6 2E-8 7E-5 7E-4

W, see 182Ir - 1E+4 5E-6 2E-8 - -

Y, see 182Ir - 1E+4 4E-6 1E-8 - -

77 Iridium-186 D, see 182Ir 2E+3 8E+3 3E-6 1E-8 3E-5 3E-4

W, see 182Ir - 6E+3 3E-6 3E-9 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

Y, see 182Ir - 6E+3 2E-6 8E-9 - -

77 Iridium-187 D, see 182Ir 1E+4 3E+4 1E-5 5E-8 1E-4 13

W, see 182Ir - 3E+4 1E-5 4E-8 - -

Y, see 182Ir - 3E+4 1E-5 4E-8 - -

77 Iridium-188 D, see 182Ir 2E+3 5E+3 2E-6 6E-9 3E-5 3E-4

W, see 182Ir - 4E+5 1E-6 5E-9 - -

Y, see 182Ir - 3E+3 1E-6 5E-9 - -

77 Iridium-189 D, see 182Ir 5E+3 5E+3 2E-6 7E-9 - -

LLI wall
(5E+3) - - - 7E-5 7E-4

W, see 182Ir - 4E+3 2E-6 5E-9 - -

Y, see 182Ir - 4E+3 1E-6 5E-9 - -

77 Iridium-190m2 D, see 182Ir 2E+6 2E+5 8E-5 3E-7 2E-3 2E-2

W, see 182Ir - 2E+5 9E-5 3E-7 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

Y, see 182Ir - 2E+5 8E-5 3E-7 - -

77 Iridium-190 D, see 182Ir 1E+3 9E+2 4E-7 1E-9 1E-5 1E-4

W, see 182Ir - 1E+3 4E-7 1E-9 - -

Y, see 182Ir - 9E+2 4E-7 1E-9 - -

77 Iridium-192m D, see 182Ir 3E+3 9E+1 4E-8 1E-10 4E-5 4E-4

W, see 182Ir - 2E+2 9E-8 3E-10 - -

Y, see 182Ir - 2E+1 6E-9 2E-11 - -

77 Iridium-192 D, see 182Ir 9E+2 3E+2 1E-7 4E-10 1E-5 1E-4

W, see 182Ir - 4E+2 2E-7 6E-10 - -

Y, see 182Ir - 2E+2 9E-8 3E-10 - -

77 Iridium-194m D, see 182Ir 6E+3 9E+1 4E-7 1E-10 9E-6 9E-5

W, see 182Ir - 2E+2 7E-8 2E-10 - -

Y, see 182Ir - 1E+2 4E-8 1E-10 - -

77 Iridium-194 D, see 182Ir 1E+3 3E+3 1E-6 4E-9 1E-5 1E-4

W, see 182Ir - 2E+3 9E-7 3E-9 - -

Y, see 182Ir - 2E+3 8E-7 3E-9 - -

77 Iridium-195m D, see 182Ir 8E+3 2E+4 1E-5 3E-8 1E-4 1E-3

W, see 182Ir - 2E+4 1E-5 4E-8 - -

Y, see 182Ir - 24 9E-6 3E-8 - -

77 Iridium-195 D, see 182Ir 1E+4 44 2E-5 6E-8 2E-4 2E-3

W, see 182Ir - 54 2E-5 7E-8 - -

Y, see 182Ir - 44 2E-5 6E-8 - -

78 Platinum-186 D, all compounds 1E+4 44 2E-5 5E-8 2E-4 2E-3

78 Platinum-188 D, all compounds 2E+3 23 7E-7 2E-9 2E-5 2E-4

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

78 Platinum-189 D, all compounds 1E+4 34 1E-5 4E-8 1E-4 1E-3

78 Platinum-191 D, all compounds 4E+3 83 4E-6 1E-8 5E-5 5E-4

78 Platinum-193m D, all compounds 3E+3 63 3E-6 8E-9 - -

LLI wall
(3E+4) - - - 4E-6 4E-4

78 Platinum-193 D, all compounds 4E+4 24 1E-5 3E-8 - -

LLI wall
(5E+4) - - - 6E-4 6E-3

78 Platinum-195m D, all compounds 2E+3 4E+3 2E-6 6E-9 - -

LLI wall
(2E+3) - - - 3E-5 3E-4

78 Platinum-197m2 D, all compounds 2E+4 4E+4 2E-5 6E-8 2E-4 2E-3

78 Platinum-197 D, all compounds 3E+3 1E+4 1E-8 4E-5 4E-4

78 Platinum-1992 D, all compounds 5E+4 1E+5 6E-5 2E-7 7E-4 7E-3

78 Platinum-200 D, all compounds 1E+3 3E+3 1E-6 5E-9 2E-5 24

79 Gold-193 D, all compounds except those given for W 9E+3 3E+4 1E-5 4E-8 1E-4 1E-3
and Y

W, halides and nitrates - 2E+4 9E-6 3E-8 - -

Y, oxides and hydroxides - 2E+4 8E-6 3E-8 - -

79 Gold-194 D, see 193Au 3E+3 8E+3 3E-6 1E-8 4E-5 4E-4

W, see 193Au - 5E+3 2E-6 8E-9 - -

Y, see 193Au - 5E+3 2E-6 7E-9 - -

79 Gold-195 D, see 193Au 5E+3 1E+4 5E-6 2E-8 7E-5 7E-4

W, see 193Au - 1E+3 6E-7 2E-9 - -

Y, see 193Au - 4E+2 2E-7 6E-10 - -

79 Gold-198m D, see 193Au 1E+3 3E+3 1E-6 4E-9 1E-5 1E-4

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

W, see 193Au - 1E+3 5E-7 2E-9 - -

Y, see 193Au - 1E+3 5E-7 2E-9 - -

79 Gold-198 D, see 193Au 1E+3 4E+3 2E-6 5E-9 2E-5 2E-4

W, see 193Au - 2E+3 8E-7 3E-9 - -

Y, see 193Au - 2E+3 7E-7 2E-9 - -

79 Gold-199 D, see 193Au 3E+3 9E+3 4E-6 1E-8 - -

LLI wall
(3E+3) - - - 4E-6 4E-4

W, see 193Au - 4E+3 2E-6 6E-9 - -

Y, see 193Au - 4E+3 2E-6 5E-9 - -

79 Gold-200m D, see 193Au 1E+3 4E+3 1E-6 5E-9 2E-5 2E-4

W, see 193Au - 3E+3 1E-6 4E-9 - -

Y, see 193Au - 2E+4 1E-6 3E-9 - -

79 Gold-2002 D, see 193Au 3E+4 6E+4 3E-5 9E-8 4E-4 4E-3

W, see 193Au - 8E+4 3E-5 1E-7 - -

Y, see 193Au - 7E+4 3E-5 1E-7 - -

79 Gold-2012 D, see 193Au 7E+4 2E+5 9E-5 3E-7 - -

St wall
(9E+4) - - - 1E-3 1E-2

W, see 193Au - 2E+5 1E-4 3E-7 - -

Y, see 193Au - 2E+5 9E-5 3E-7 - -

80 Mercury-193m Vapor - 8E+3 4E-6 1E-8 - -

Organic D 4E+3 1E+4 5E-6 2E-8 6E-5 6E-4

D, sulfates 3E+3 9E+3 4E-6 1E-8 4E-5 4E-4

W, oxides, hydroxides, halides, nitrates, - 8E+3 3E-6 1E-8 - -

and sulfides
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

80 Mercury-193 Vapor - 3E+4 1E-5 4E-8 - -

Organic D 2E+4 6E+4 3E-5 9E-8 3E-4 3E-3

D, see 193mHg 2E+4 4E+4 2E-5 6E-8 2E-4 2E-3

W, see 193mHg - 4E+4 2E-5 6E-8 - -

80 Mercury-194 Vapor - 3E+1 1E-8 4E-11 - -

Organic D 2E+1 3E+1 1E-8 4E-11 2E-7 2E-6

D, see 193mHg 8E+2 4E+1 2E-8 6E-11 1E-5 1E-4

W, see 193mHg - 1E+2 5E-8 2E-10 - -

80 Mercury-195m Vapor - 4E+3 2E-6 3E-9 - -

Organic D 3E+3 6E+3 3E-6 8E-9 4E-5 4E-4

D, see 193mHg 2E+3 5E+3 2E-6 7E-9 3E-5 3E-4

W, see 193mHg - 4E+3 2E-6 5E-9 - -

80 Mercury-195 Vapor - 3E+4 1E-5 4E-8 - -

Organic D 2E+4 5E+4 2E-5 6E-8 2E-4 2E-3

D, see 193mHg 1E+4 4E+4 1E-5 5E-8 2E-4 2E-3

W, see 193mHg - 3E+4 1E-5 5E-8 - -

80 Mercury-197m Vapor - 5E+3 2E-6 7E-9 - -

Organic D 4E+3 9E+3 4E-6 1E-8 5E-5 5E-4

D, see 193mHg 3E+3 7E+3 3E-6 1E-8 4E-5 4E-4

W, see 193mHg - 5E+3 2E-6 7E-9 - -

80 Mercury-197 Vapor - 8E+3 4E-6 1E-8 - -

Organic D 7E+3 1E+4 6E-6 2E-8 9E-5 9E-4

D, see 193mHg 6E+3 1E+4 5E-6 2E-8 8E-5 8E-4

W, see 193mHg - 9E+3 4E-6 1E-8 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

80 Mercury-199m2 Vapor - 8E+4 3E-5 1E-7 - -

Organic D 6E+4 2E+5 7E-5 2E-7 - -

St wall
(1E+5) - - - 1E-3 1E-2

D, see 193mHg 6E+4 1E+5 6E-5 2E-8 8E-4 8E-3

W, see 193mHg - 2E+5 7E-5 2E-7 - -

80 Mercury-203 Vapor - 8E+2 4E-7 1E-9 - -

Organic D 5E+2 8E+2 3E-7 1E-9 7E-6 7E-5

D, see 193mHg 2E+3 1E+3 5E-7 2E-9 3E-5 3E-4

W, see 193mHg - 1E+3 5E-7 2E-9 - -

81 Thallium-194m2 D, all compounds 6E+4 2E+5 6E-5 2E-7 - -

(St wall
7E+4) - - - 1E-3 1E-2

81 Thallium-1942 D, all compounds 3E+5 6E+5 2E-4 8E-7 - -

St wall
(3E+5) - - - 4E-5 4E-2

81 Thallium-1952 D, all compounds 6E+4 1E+5 5E-5 2E-7 9E-4 9E-3

81 Thallium-197 D, all compounds 7E+4 1E+5 5E-5 2E-7 1E-3 1E-2

81 Thallium-198m2 D, all compounds 3E+4 5E+4 2E-5 8E-8 4E-4 4E-3

81 Thallium-198 D, all compounds 2E+4 3E+4 1E-5 5E-8 3E-4 3E-3

81 Thallium-199 D, all compounds 6E+4 8E+4 4E-5 1E-7 9E-4 9E-3

81 Thallium-200 D, all compounds 8E+3 1E+4 5E-6 2E-8 1E-4 1E-2

81 Thallium-201 D, all compounds 2E+4 2E+4 9E-6 3E-8 2E-4 2E-3

81 Thallium-202 D, all compounds 4E+3 5E+3 2E-6 7E-9 5E-5 5E-4

81 Thallium-204 D, all compounds 2E+3 2E+3 9E-7 3E-9 2E-5 2E-4

82 Lead-195m2 D, all compounds 6E+4 2E+5 8E-5 3E-7 8E-4 8E-3

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

82 Lead-198 D, all compounds 3E+4 6E+4 3E-5 9E-8 4E-4 4E-3

82 Lead-1992 D, all compounds 2E+4 7E+4 3E-5 1E-7 3E-4 3E-3

82 Lead-200 D, all compounds 3E+3 6E+3 3E-6 9E-9 4E-5 4E-4

82 Lead-201 D, all compounds 7E+3 2E+4 86 38 14 13

82 Lead-202m D, all compounds 9E+3 3E+4 1E-5 4E-8 1E-4 1E-3

82 Lead-202 D, all compounds 1E+2 5E+1 2E-8 7E-11 2E-6 2E-5

82 Lead-203 D, all compounds 5E+3 9E+3 4E-6 1E-8 7E-5 7E-4

82 Lead-205 D, all compounds 4E+3 1E+3 6E-7 2E-9 5E-5 5E-4

82 Lead-209 D, all compounds 2E+4 6E+4 2E-5 8E-8 3E-4 3E-3

82 Lead-210 D, all compounds 6E+1 2E+1 1E-10 - - -

Bone surf Bone surf
(1E+0) (4E-1) - 6E-13 1E-8 1E-7

82 Lead-2112 D, all compounds 1E+4 5E+2 3E-7 9E-10 2E-4 2E-3

82 Lead-212 D, all compounds 8E+1 3E+1 1E-8 5E-11 - -

Bone surf
(1E+2) - - - 2E-6 2E-5

82 Lead-2142 D, all compounds 9E+3 8E+2 3E-7 1E-9 1E-4 1E-3

83 Bismuth-2002 D, nitrates 3E+4 8E+4 4E-5 1E-7 4E-4 4E-3

W, all other compounds - 1E+5 4E-5 1E-7 - -

83 Bismuth-2012 D, see 200Bi 1E+4 3E+4 1E-5 4E-8 2E-4 2E-3

W, see 200Bi - 4E+4 2E-5 5E-8 - -

83 Bismuth-2022 D, see 200Bi 1E+4 4E+4 2E-5 6E-8 2E-4 2E-3

W, see 200Bi - 8E+4 3E-5 1E-7 - -

83 Bismuth-203 D, see 200Bi 2E+3 7E+3 3E-6 9E-9 3E-5 3E-4

W, see 200Bi - 6E+3 36 9E-9 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

83 Bismuth-205 D, see 200Bi 1E+3 3E+3 1E-6 3E-9 2E-5 2E-4

W, see 200Bi - 1E+3 5E-7 2E-9 - -

83 Bismuth-206 D, see 200Bi 6E+2 1E+3 6E-7 2E-9 9E-6 9E-5

W, see 200Bi - 9E+2 4E-7 1E-9 - -

83 Bismuth-207 D, see 200Bi 1E+3 2E+3 7E-7 2E-9 1E-5 1E-4

W, see 200Bi - 4E+2 1E-7 5E-10 - -

83 Bismuth-210m D, see 200Bi 4E+1 5E+0 2E-9 - - -

Kidneys Kidneys
(6E+1) (6E+0) - 9E-12 8E-7 8E-6

W, see 200Bi - 7E+1 3E-10 9E-13 - -

83 Bismuth-210 D, see 200Bi 8E+2 2E+2 1E-7 - 1E-5 1E-4

Kidneys
- (4E+2) - 5E-10 - -

W, see 200Bi - 3E+1 1E-8 4E-11 - -

83 Bismuth-2122 D, see 200Bi 5E+3 2E+2 1E-7 3E-10 7E-5 7E-4

W, see 200Bi - 3E+2 1E-7 4E-10 - -

83 Bismuth-2132 D, see 200Bi 7E+3 3E+2 1E-7 4E-10 1E-4 1E-3

W, see 200Bi - 4E+2 1E-7 5E-10 - -

83 Bismuth-2142 D, see 200Bi 2E+4 8E+2 3E-7 1E-9 - -

St wall
(2E+4) - - - 3E-4 3E-3

W, see 200Bi - 9E+2 4E-7 1E-9 - -

84 Polonium-2032 D, all compounds except those given for W 3E+4 6E+4 3E-5 9E-8 3E-4 3E-3

W, oxides, hydroxides, and nitrates - 9E+4 4E-5 1E-7 - -

84 Polonium-2052 D, see 203Po 2E+4 4E+4 2E-5 5E-8 3E-4 3E-3

W, see 203Po - 7E+4 3E-5 1E-7 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

84 Polonium-207 D, see 203Po 8E+3 3E+4 1E-5 3E-8 1E-4 1E-3

W, see 203Po - 3E+4 1E-5 4E-8 - -

84 Polonium-210 D, see 203Po 3E+0 6E+1 3E-10 9E-13 4E-8 4E-7

W, see 203Po - 6E+1 3E-10 9E-13 - -

85 Astatine-2072 D, halides 6E+3 3E+3 1E-6 4E-9 8E-5 8E-4

W - 2E+3 9E-7 3E-9 - -

85 Astatine-211 D, halides 1E+2 8E+1 3E-8 1E-10 2E-6 2E-5

W - 5E+1 2E-8 8E-11 - -

86 Radon-220 With daughters removed - 2E+4 7E-6 2E-8 - -

With daughters present - 2E+1 9E-9 3E-11 - -

(or 12 (or 1.0
WLM) WL)

86 Radon-222 With daughters removed - 1E+4 4E-6 1E-8 - -

With daughters present - 1E+2 3E-8 1E-10 - -

(or 4 (or 0.33
working working
level level)
months)

87 Francium-2222 D, all compounds 2E+3 5E+2 2E-7 6E-10 3E-5 3E-4

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

87 Francium-2232 D, all compounds 6E+2 8E+2 3E-7 1E-9 8E-6 8E-5

88 Radium-223 W, all compounds 5E+0 7E+1 3E-10 9E-13 - -

Bone surf
(9E+0) - - - 1E-7 1E-6

88 Radium-224 W, all compounds 8E+0 2E+0 7E-10 2E-12 - -

Bone surf
(2E+1) - - - 2E-7 2E-6

88 Radium-225 W, all compounds 8E+0 7E+1 3E-10 9E-13 - -

Bone surf
(2E+1) - - - 2E-7 2E-6

88 Radium-226 W, all compounds 2E+0 6E+1 3E-10 9E-13 - -

Bone surf
(5E+0) - - - 6E-8 6E-7

88 Radium-2272 W, all compounds 2E+4 1E+4 6E-6 - - -

Bone surf Bone surf
(2E+4) (2E+4) - 3E-8 3E-4 3E-3

88 Radium-228 W, all compounds 2E+0 1E+0 5E-10 2E-12 - -

Bone surf
(4E+0) - - - 6E-8 6E-7

89 Actinium-224 D, all compounds except those given for W 2E+3 3E+1 1E-8 - - -
and Y
LLI wall Bone surf
(2E+3) (4E+1) - 5E-11 3E-5 3E-4

W, halides and nitrates - 5E+1 2E-8 7E-11 - -

Y, oxides and hydroxides - 5E+1 2E-8 6E-11 - -

89 Actinium-225 D, see 224Ac 5E+1 3E+1 1E-10 - - -

LLI wall Bone surf
(5E+1) (5E-1) - 7E-13 7E-7 7E-6

W, see 224Ac - 6E+1 3E-10 9E-13 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

Y, see 224Ac - 6E+1 3E-10 9E-13 - -

89 Actinium-226 D, see 224Ac 1E+2 3E+0 1E-9 - - -

LLI wall Bone surf
(1E+2) (4E+0) - 5E-12 2E-6 2E-5

W, see 224Ac - 5E+0 2E-9 7E-12 - -

Y, see 224Ac - 5E+0 2E-9 6E-12 - -

89 Actinium-227 D, see 224Ac 2E+1 4E+4 2E-13 - - -

Bone surf Bone surf
(4E-1) (8E-4) - 1E-15 5E-9 5E-8

W, see 224Ac - 2E+3 7E-13 - - -

Bone surf
- (3E-3) - 4E-15 - -

Y, see 224Ac - 4E+3 2E-12 6E-15 - -

89 Actinium-228 D, see 224Ac 2E+3 9E+0 4E-9 - 3E-5 3E-4

Bone surf
- (2E+1) - 2E-11 - -

W, see 224Ac - 4E+1 2E-8 - - -

Bone surf
- (6E+1) - 8E-11 - -

Y, see 224Ac - 4E+1 2E-8 6E-11 - -

90 Thorium-2262 W, all compounds except those given for Y 5E+3 2E+2 6E-8 2E-10 - -
St wall
(5E+3) - - - 7E-5 7E-4

Y, oxides and hydroxides - 1 E+ 5E-8 2E-10 - -

90 Thorium-227 W, see 226Th 1E+2 3E+1 1E-10 5E-13 2E-6 2E-5

Y, see 226Th - 3E+1 1E-10 5E-13 - -

90 Thorium-228 W, see 226Th 6E+0 1E+2 4E-12 - - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)
Bone surf Bone surf
(1E+1) (2E-2) - 3E-14 2E-7 2E-6

Y, see 226Th - 2E+2 7E-12 2E-14 - -

90 Thorium-229 W, see 226Th 6E+1 9E+4 4E-13 - - -

Bone surf Bone surf
(1E+0) (2E-3) - 3E-15 2E-8 2E-7

Y, see 226Th - 2E+3 1E-14 - - -

Bone surf
- (3E-3) - 4E-15 - -

90 Thorium-230 W, see 226Th 4E+0 6E+3 3E-12 - - -

Bone surf Bone surf
(9E+0) (2E-2) - 2E-14 1E-7 1E-6

Y, see 226Th - 2E+2 6E-12 - - -

Bone surf
- (2E-2) - 3E-14 - -
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

90 Thorium-231 W, see 226Th 4E+3 6E+3 3E-6 9E-9 5E-5 5E-4

Y, see 226Th - 6E+3 3E-6 9E-9 - -

90 Thorium-232 W, see 226Th 7E+1 1E+3 5E-13 - - -

Bone surf Bone surf
(2E+0) (3E-3) - 4E-15 3E-8 3E-7

Y, see 226Th - 3E+3 1E-12 - - -

Bone surf
- (4E-3) - 6E-15 - -

90 Thorium-234 W, see 226Th 3E+2 2E+2 8E-8 3E-10 - -

LLI wall
(4E+2) - - - 5E-6 5E-5

Y, see 226Th - 2E+2 6E-8 2E-10 - -

91 Protactinium-2272 W, all compounds except those given for Y 4E+3 1E+2 5E-8 2E-10 5E-5 5E-4

Y, oxides and hydroxides - 1E+2 4E-8 1E-10 - -

91 Protactinium-228 W, see 227Pa 1E+3 1E+1 5E-9 - 2E-5 2E-4

Bone surf
- (2E+1) - 3E-11 - -

Y, see 227Pa - 1E+1 5E-9 2E-11 - -

91 Protactinium-230 W, see 227Pa 6E+2 5E+0 2E-9 7E-12 - -

Bone surf
(9E+2) - - - 1E-5 1E-4

Y, see 227Pa - 4E+0 1E-9 5E-12 - -

91 Protactinium-231 W, see 227Pa 2E+1 2E+3 E- 613 - - -

Bone surf Bone surf
(5E-1) (4E-3) - 6E-15 6E-9 6E-8

Y, see 227Pa - 4E+3 E- 212 - - -

Bone surf
- (6E-3) - 8E-15 - -
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

91 Protactinium-232 W, see 227 Pa E+ 13 2E+1 E- 99 - 2E-5 2E-4

Bone surf
- (6E+1) - 8E-11 - -

Y, see 227Pa - E+ 61 E- 28 - - -
Bone surf
- (7E+1) - 1E-10 - -

91 Protactinium-233 W, see 227Pa 1E+3 7E+2 E- 37 1E-9 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)
LLI wall
(2E+3) - - - 2E-5 2E-4

Y, see 227Pa - 6E+2 2E-7 8E-10 - -

91 Protactinium-234 W, see 227Pa 2E+3 8E+3 E- 36 1E-8 3E-5 3E-4

Y, see 227Pa - 7E+3 E- 36 E- 99 - -

92 Uranium-230 D, UF6 , UO2F2 , UO2(NO3 )2 4E+0 4E+1 2E-10 - - -

Bone surf Bone surf
(6E+0) (6E-1) - 8E-13 8E-8 8E-7

W, UO3 , UF4, UCl4 - 4E+1 1E-0 5E-13 - -

Y, UO2 , U3O8 - 3E+1 1E-10 4E-13 - -

92 Uranium-231 D, see 230U 5E+3 8E+3 3E-6 1E-8 - -

LLI wall
(4E+3) - - - 6E-5 6E-4

W, see 230U - E+ 63 2E-6 8E-9 - -

Y, see 230U - 5E+3 2E-6 6E-9 - -

92 Uranium-232 D, see 230U 2E+0 2E+1 9E-11 - - -

Bone surf Bone surf
(4E+0) (4E-1) - 6E-13 6E-8 6E-7

W, see 230U - 4E+1 2E-10 5E-13 - -

Y, see 230U - 8E+3 3E-12 1E-14 - -

92 Uranium-233 D, see 230U 1E+1 1E+0 5E-10 - - -

Bone surf Bone surf
(2E+1) (2E+0) - 3E-12 3E-7 3E-6

W, see 230U - 7E+1 3E-10 1E-12 - -

Y, see 230U - E+ 42 2E-11 5E-14 - -

92 Uranium-2343 D, see 230U 1E+1 1E+0 5E-10 - - -

Bone surf Bone surf
(2E+1) (2E+0) - 3E-12 3E-7 3E-6
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

W, see 230U - 7E+1 3E-10 1E-12 - -

Y, see 230U - 4E+2 2E-11 5E-14 - -

92 Uranium-2353 D, see 230U 1E+1 1E+0 6E-10 - - -

Bone surf Bone surf
(2E+1) (2E+0) - 3E-12 3E-7 3E-6

W, see 230U - 8E+1 3E-10 1E-12 - -

Y, see 230U - 4E+2 2E-11 6E-14 - -

92 Uranium-236 D, see 230U 1E+1 1E+0 5E-10 - - -

Bone surf Bone surf
(2E+1) (2E+0) - 3E-12 3E-7 3E-6

W, see 230U - E+ 81 3E-10 1E-12 - -

Y, see 230U - 4E+2 2E-11 6E-14 - -

92 Uranium-237 D, see 230U 2E+3 3E+3 1E-6 4E-9 - -

LLI wall
(2E+3) - - - 3E-5 3E-4

W, see 230U - 2E+3 7E-7 2E-9 - -

Y, see 230U - 2E+3 E- 67 2E-9 - -

92 Uranium-2383 D, see 230U 1E+1 1E+0 6E-10 - - -

Bone surf Bone surf
(2E+1) (2E+0) - 3E-12 3E-7 3E-6

W, see 230U - 8E+1 3E-10 1E-12 - -

Y, see 230U - 4E+1 2E-11 6E-14 - -

92 Uranium-2392 D, see 230U 7E+4 2E+5 8E-5 3E-7 9E-4 9E-3

W, see 230U - 2E+5 7E-5 2E-7 - -

Y, see 230U - 2E+5 6E-5 2E-7 - -

92 Uranium-240 D, see 230U 1E+3 4E+3 2E-6 5E-9 2E-5 2E-4

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

W, see 230U - 3E+3 1E-6 4E-9 - -

Y, see 230U - 2E+3 1E-6 3E-9 - -

92 Uranium-natural3 D, see 230U 1E+1 1E+0 5E-10 - - -

Bone surf Bone surf
(2E+1) (2E+0) - 3E-12 3E-7 3E-6

W, see 230U - 8E+1 3E-10 9E-13 - -

Y, see 230U - 5E+2 2E-11 9E-14 - -

93 Neptunium-2322 W, all compounds 1E+5 2E+3 7E-7 2E-3 2E-2

Bone surf
- (5E+2) - 6E-9 - -

93 Neptunium-2332 W, all compounds 8E+5 3E+6 1E-2 4E-6 1E-2 4E-4

93 Neptunium-234 W, all compounds 2E+3 3E+3 1E-6 E- 49 3E-5 3E-4

93 Neptunium-235 W, all compounds 2E+4 8E+2 3E-7 - - -

LLI wall Bone surf
(2E+4) (1E+3) - 2E-9 3E-4 3E-3

93 Neptunium-236 W, all compounds 3E+0 2E+2 9E-12 - - -

(1.15E+5 y) Bone surf Bone surf
(6E+0) (5E-2) - 8E-14 9E-8 9E-7

93 Neptunium-236 W, all compounds 3E+3 E+ 31 1E-8 - - -

(22.5 h) Bone surf Bone surf
(4E+3) (7E+1) - 1E-10 55 E- 5E-4

93 Neptunium-237 W, all compounds 5E+1 4E+3 2E-12 - - -

Bone surf Bone surf
(1E+0) (1E-2) - 1E-4 28 E- 2E-7

93 Neptunium-238 W, all compounds 1E+3 6E+1 3E-8 2E-5 2E-4

Bone surf
- (2E+2) - 2E-10 - -

93 Neptunium-239 W, all compounds E+ 23 2E+3 9E-7 3E-9 - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)
LLI wall
(2E+3) - - - 2E-5 2E-4

93 Neptunium-2402 W, all compounds 2E+4 8E+4 3E-5 1E-7 3E-4 3E-3

94 Plutonium-234 W, all compounds except PuO2 8E+3 2E+2 9E-8 3E-10 1E-4 1E-3

Y, PuO2 - 2E+2 8E-8 3E-10 - -

94 Plutonium-2352 W, see 234Pu 9E+5 3E+6 1E-3 4E-6 1E-2 1E-1

Y, see 234Pu - 36 1E-3 3E-6 - -

94 Plutonium-236 W, see 234Pu 2E+0 2E+2 8E-12 - - -

Bone surf Bone surf
(4E+0) (4E-2) - 5E-14 6E-8 6E-7

Y, see 234Pu - 4E+2 2E-11 6E-14 - -

94 Plutonium-237 W, see 234Pu 1E+4 3E+3 1E-6 5E-9 2E-4 2E-3

Y, see 234Pu - 3E+3 1E-6 4E-9 - -

94 Plutonium-238 W, see 234Pu 9E+1 7E+3 3E-12 - - -

Bone surf Bone surf
(2E+0) (1E-2) - 2E-14 2E-8 2E-7

Y, see 234Pu - 2E+2 8E-12 2E-14 - -

94 Plutonium-239 W, see 234Pu 8E+1 6E+3 3E-12 - - -

Bone surf Bone surf
(1E+0) (1E-2) - 2E-14 2E-8 2E-7

Y, see 234Pu - 2E+2 7E-12 - - -

Bone surf
- (2E-2) - 2E-14 - -

94 Plutonium-240 W, see 234Pu 8E+1 6E+3 3E-12 - - -

Bone surf Bone surf
(1E+0) (1E-2) - 2E-14 2E-8 2E-7

Y, see 234Pu - 2E+2 7E-12 - - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)
Bone surf
- (2E-2) - 2E-14 - -

94 Plutonium-241 W, see 234 Pu E+ 41 3E+1 1E-10 - - -

Bone surf Bone surf
(7E+1) (6E-1) - 8E-13 1E-6 1E-5

Y, see 234Pu - 8E+1 3E-10 - - -

Bone surf
- (1E+0) - 1E-12 - -

94 Plutonium-242 W, see 234Pu 8E+1 E+ 73 3E-12 - - -

Bone surf Bone surf
(1E+0) (1E-2) - 2E-14 2E-8 2E-7

Y, see 234Pu - 2E+2 7E-12 - - -

Bone surf
- (2E-2) - 2E-14 - -

94 Plutonium-243 W, see 234Pu 2E+4 4E+4 2E-5 5E-8 2E-4 2E-3

Y, see 234Pu - 4E+4 2E-5 5E-8 - -

94 Plutonium-244 W, see 234 Pu E+ 81 7E+3 3E-12 - - -

Bone surf Bone surf
(2E+0) (1E-2) - 2E-14 2E-8 2E-7

Y, see 234Pu - 2E+2 7E-12 - - -

Bone surf
- (2E-2) - 2E-14 - -

94 Plutonium-245 W, see 234Pu 2E+3 5E+3 2E-6 6E-9 3E-5 3E-4

Y, see 234Pu - 4E+3 2E-6 6E-9 - -

94 Plutonium-246 W, see 234Pu 4E+2 3E+2 1E-7 4E-10 - -

LLI wall
(4E+2) - - - 6E-6 6E-5

Y, see 234Pu - 3E+2 1E-7 4E-10 - -

95 Americium-2372 W, all compounds 8E+4 3E+5 1E-4 4E-7 1E-3

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

95 Americium-2382 W, all compounds 4E+4 3E+3 1E-6 - 5E-4 5E-3

Bone surf
- (6E+3) - 9E-9 - -

95 Americium-239 W, all compounds 5E+3 1E+4 E- 56 2E-8 7E-5 7E-4

95 Americium-240 W, all compounds 2E+3 3E+3 1E-6 4E-9 3E-5 3E-4

95 Americium-241 W, all compounds 8E+1 6E+5 3E-12 - - -

Bone surf Bone surf
(1E+0) (1E-2) - 2E-14 2E-8 2E-7

95 Americium-242m W, all compounds 8E+1 6E+3 3E-12 - - -

Bone surf Bone surf
(1E+0) (1E-2) - 2E-14 2E-8 2E-7

95 Americium-242 W, all compounds 4E+3 8E+1 4E-8 - 5E-5 5E-4

Bone surf
- (9E+1) - 1E-10 - -

95 Americium-243 W, all compounds E+ 81 6E+3 3E-12 - - -

Bone surf Bone surf
(1E+0) (1E-2) - 2E-14 2E-8 2E-7

95 Americium-244m2 W, all compounds 6E+4 E+ 43 2E-6 - - -

St wall Bone surf
(8E+4) (7E+3) - 1E-8 1E-3 12 E-

95 Americium-244 W, all compounds 3E+3 2E+2 E- 88 - 4E-5 4E-4

Bone surf
- (3E+2) - 4E-10 - -

95 Americium-245 W, all compounds 3E+4 8E+4 3E-5 1E-7 4E-4 4E-3

95 Americium-246m2 W, all compounds 5E+4 2E+5 E- 85 3E-7 - -

St wall
(6E+4) - - - 8E-4 8E-3

95 Americium-2462 W, all compounds 3E+4 1E+5 4E-5 1E-7 4E-4 4E-3

96 Curium-238 W, all compounds 2E+4 1E+3 5E-7 2E-9 2E-4 2E-3

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

96 Curium-240 W, all compounds 6E+1 6E+1 2E-10 - - -

Bone surf Bone surf
(8E+1) (6E-1) - 9E-13 1E-6 1E-5

96 Curium-241 W, all compounds 1E+3 3E+1 1E-8 - 2E-5 2E-4

Bone surf
- (4E+1) - 5E-11 - -

96 Curium-242 W, all compounds 3E+1 3E+1 1E-10 - - -

Bone surf Bone surf
(5E+1) (3E-1) - 4E-13 7E-7 7E-6

96 Curium-243 W, all compounds 1E+0 9E+3 4E-12 - - -

Bone surf Bone surf
(2E+0) (2E-2) - 2E-14 3E-8 3E-7

96 Curium-244 W, all compounds 1E+0 1E+2 5E-12 - - -

Bone surf Bone surf
(3E+0) (2E-2) - 3E-14 3E-8 3E-7

96 Curium-245 W, all compounds 7E+1 6E+3 3E-12 - - -

Bone surf Bone surf
(1E+0) (1E-2) - 2E-14 2E-8 2E-7

96 Curium-246 W, all compounds 7E+1 6E+3 E- 312 - - -

Bone surf Bone surf
(1E+0) (1E-2) - 2E-14 2E-8 2E-7

96 Curium-247 W, all compounds 8E+1 6E+3 3E-12 - - -

Bone surf Bone surf
(1E+0) (1E-2) - 2E-14 2E-8 2E-7

96 Curium-248 W, all compounds 2E+1 2E+3 7E-12 - - -

Bone surf Bone surf
(4E-1) (3E-3) - 4E-15 5E-9 5E-8

96 Curium-2492 W, all compounds 5E+4 2E+4 7E-6 - 7E-4 7E-3

Bone surf
- (3E+4) - 4E-8 - -
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

96 Curium-250 W, all compounds 4E+2 3E+4 1E-13 - - -

Bone surf Bone surf
(6E-2) (5E-4) - 8E-16 9E-10 9E-9

97 Berkelium-245 W, all compounds 2E+3 1E+3 E- 68 E- 29 3E-5 3E-4

97 Berkelium-246 W, all compounds 3E+3 3E+3 1E-6 4E-9 4E-5 4E-4

97 Berkelium-247 W, all compounds 5E+1 4E+3 2E-12 - - -

Bone surf Bone surf
(1E+0) (9E-3) - 1E-14 2E-8 2E-7

97 Berkelium-249 W, all compounds 2E+2 2E+0 7E-10 - - -

Bone surf Bone surf
(5E+2) (4E+0) - 5E-12 6E-6 6E-5

97 Berkelium-250 W, all compounds 9E+3 3E+2 1E-7 – 1E-4 1E-3

- Bone surf - 1E-9 - -

(7E+2)

98 Californium-2442 W, all compounds except those given for Y 3E+4 6E+2 2E-7 8E-10 - -
St wall
(3E+4) - - - 4E-4 4E-3

Y, oxides and hydroxides - 6E+2 2E-7 8E-10 - -

98 Californium-246 W, see 244Cf 4E+2 9E+0 4E-9 1E-11 5E-6 5E-5

Y, see 244Cf - 9E+0 4E-9 1E-11 - -

98 Californium-248 W, see 244Cf 8E+0 6E+2 3E-11 - - -

Bone surf Bone surf
(2E+1) (1E-1) - 2E-13 2E-7 2E-6

Y, see 244Cf - 1E+1 4E-11 1E-12 - -

98 Californium-249 W, see 244Cf 5E+1 4E+3 2E-12 - - -

Bone surf Bone surf
(1E+0) (9E-3) - 1E-14 2E-8 2E-7

Y, see 244Cf - 1E+2 4E-12 - - -

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)
Bone surf
- (1E-2) - 2E-14 - -

98 Californium-250 W, see 244Cf 1E+0 9E+3 4E-12 - - -

Bone surf Bone surf
(2E+0) (2E-2) - 3E-14 3E-8 3E-7

Y, see 244Cf - 3E+2 1E-11 4E-14 - -

98 Californium-251 W, see 244Cf 5E+1 4E+3 2E-12 - - -

Bone surf Bone surf
(1E+0) (9E-3) - 1E-14 2E-7

Y, see 244Cf - 1E+2 4E-12 - - -

Bone surf
- (1E-2) - 2E-14 - -

98 Californium-252 W, see 244Cf 2E+0 2E+2 8E-12 - - -

Bone surf Bone surf
(5E+0) (4E-2) - 5E-14 7E-8 7E-7

Y, see 244Cf - 3E+2 1E-11 5E-14 - -

98 Californium-253 W, see 244Cf 2E+2 2E+0 8E-10 3E-12 - -

Bone surf
(4E+2) - - - 5E-6 5E-5

Y, see 244Cf - 2E+0 7E-10 2E-12 - -

98 Californium-254 W, see 244Cf 2E+0 2E+2 9E-12 3E-14 3E-8 3E-7

Y, see 244Cf - 2E+2 2E-14 - -

99 Einsteinium-250 W, all compounds 4E+4 5E+2 2E-7 6E-5 6E-3

Bone surf
- (1E+3) - 2E-9 - -

99 Einsteinium-251 W, all compounds 7E+3 9E+2 4E-7 - 1E-4 1E-3

Bone surf
- (1E+3) - 2E-9 - -

99 Einsteinium-253 W, all compounds 2E+2 1E+0 6E-10 2E-12 2E-6 2E-5

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table II Table III

Table I Effluent Releases to
Occupational Values Concentrations Sewers
Col. 1 Col. 2 Col. 3 Col. 1 Col. 2
oral Monthly
Ingestion Inhalation Average
Concen-
Atomic ALI ALI DAC Air Water tration
No. Radionuclide Class (µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

99 Einsteinium-254m W, all compounds 3E+2 1E+1 4E-9 1E-11 - -

LLI wall
(3E+2) - - - 4E-6 4E-5

99 Einsteinium-254 W, all compounds 8E+0 7E+2 2E-11 - - -

Bone surf Bone surf
(2E+1) (1E-1) - 2E-13 2E-7 2E-6

100 Fermium-252 W, all compounds 5E+2 1E+1 5E-9 2E-11 6E-6 6E-5

100 Fermium-253 W, all compounds 1E+3 1E+1 4E-9 1E-11 1E-5 1E-4

100 Fermium-254 W, all compounds 3E+3 9E+1 4E-8 1E-10 4E-5 4E-4

100 Fermium-255 W, all compounds 5E+2 2E+1 9E-9 3E-11 7E-6 7E-5

100 Fermium-257 W, all compounds 2E+1 2E+1 7E-11 - - -

Bone surf Bone surf
(4E+1) (2E-1) - 3E-13 5E-7 5E-6

101 Mendelevium-257 W, all compounds 7E+3 8E+1 4E-8 - 1E-4 1E-3

Bone surf
- (9E+1) - 1E-10 - -

101 Mendelevium-258 W, all compounds 3E+1 2E+1 1E-10 - - -

Bone surf Bone surf
(5E+1) (3E-1) - 5E-13 6E-7 6E-6

- Any single radionuclide not listed above with decay mode other
than alpha emission or spontaneous fission and with radioactive
half- life less than 2 hours Submersion1 - 2E+2 E- 17 1E-9 - -

- Any single radionuclide not listed above with decay mode other
than alpha emission or spontaneous fis- sion and with radioactive
half- life greater than 2 hours - 2E+1 1E-10 1E-12 1E-8 1E-7

- Any single radionuclide not listed above that decays by alpha

emission or spontaneous fission, or any mixture for which either
the identity or the concentration of any radio- nuclide in the
mixture is not known - 4E+4 2E-13 1E-15 2E-9 2E-8
FOOTNOTES:
1
"Submersion" means that values given are for submersion in a hemispherical semi-infinite cloud
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

of airborne material.
2
These radionuclides have radiological half-lives of less than 2 hours. The total effective dose
equivalent received during operations with these radionuclides might include a significant
contribution from external exposure. The DAC values for all radionuclides, other than those
designated Class "Submersion," are based upon the committed effective dose equivalent due to
the intake of the radionuclide into the body and do NOT include potentially significant
contributions to dose equivalent from external exposures. The licensee may substitute 1E-7
:Ci/ml for the listed DAC to account for the submersion dose prospectively, but should use
individual monitoring devices or other radiation measuring instruments that measure external
exposure to demonstrate compliance with the limits (see 105 CMR 120.213).
3
For soluble mixtures of U-238, U-234, and U-235 in air, chemical toxicity may be the limiting
factor (see 105 CMR 120.211(E)). If the percent by weight (enrichment) of U-235 is not greater
than 5, the concentration value for a 40-hour workweek is 0.2 milligrams uranium per cubic meter
of air average. For any enrichment, the product of the average concentration and time of
exposure during a 40-hour workweek shall not exceed 8E-3 (SA) :Ci-hr/ml, where SA is the
specific activity of the uranium inhaled. The specific activity for natural uranium is 6.77E-7
curies per gram U. The specific activity for other mixtures of U-238, U-235, and U-234, if not
known, shall be:

SA = 3.6E-7 curies/gram U U-depleted

SA = [0.4 + .38 (enrichment) + 0.0034 (enrichment)2] E-6 , enrichment > 0.72

where enrichment is the percentage by weight of U-235, expressed as percent.

NOTE:
1. If the identity of each radionuclide in a mixture is known but the concentration of one or more
of the radionuclides in the mixture is not known, the DAC for the mixture shall be the most
restrictive DAC of any radionuclide in the mixture.

2. If the identity of each radionuclide in the mixture is not known, but it is known that certain
radionuclides specified in this appendix are not present in the mixture, the inhalation ALI, DAC,
and effluent and sewage concentrations for the mixture are the lowest values specified in this
appendix for any radionuclide that is not known to be absent from the mixture; or
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Table I Table II Table III

Effluent Releases to
Occupational Values Concentrations Sewers
Col.1 Col. 2 Col. 3 Col.1 Col. 2

Oral Monthly
Ingestion Inhalation Average
ALI ALI DAC Air Water Concentration
(µCi) (µCi) (µCi/ml) (µCi/ml) (µCi/ml) (µCi/ml)

If it is known that Ac-227-D and Cm-250-W are not present - 0 3.00 - - -

e-13

If, in addition, it is known that Ac-227-W,Y, Th-229-W,Y, Th- - 0.00 3.00 - - -

230-W, Th-232-W,Y, Pa-231-W,Y, Np-237-W, Pu-239-W, Pu- 7 e-12
240-W, Pu-242-W, Am-241-W, Am-242m-W, Am-243-W, Cm-
245-W, Cm-246-W, Cm-247-W, Cm-248-W, Bk-247-W, Cf-
249-W, and Cf-251-W are not present

If, in addition, it is known that Sm-146-W, Sm-147-W, Gd-148- - 0.07 3.00 - - -

D,W, Gd-152-D,W, Th-228-W,Y, Th-230-Y, U-232-Y, U-233- e-11
Y, U-234-Y, U-235-Y, U-236-Y, U-238-Y, Np-236-W, Pu-
236-W,Y, Pu-238-W,Y, Pu-239-Y, Pu-240-Y, Pu-242-Y, Pu-
244-W,Y, Cm-243-W, Cm-244-W, Cf-248-W, Cf-249-Y, Cf-
250-W,Y, Cf-251-Y, Cf-252-W,Y, and Cf-254-W,Y are not
present

Bi-210m-W, Po-210-D,W, Ra-223-W, Ra-225-W, Ra-226-W, - 0.7 3.00 - - -

Ac-225-D,W,Y, Th-227-W,Y, U-230-D,W,Y, U-232-D,W, Pu- e-10
241-W, Cm-240-W, Cm-242-W, Cf-248-Y, Es-254-W, Fm-
257-W, and Md-258-W are not present

If, in addition, it is known that Si-32-Y, Ti-44-Y, Fe-60-D, Sr- - 7 3.00 - - -

90-Y, Zr-93-D, Cd-113m-D, Cd-113-D, In-115-D,W, La-138- e-09
D, Lu-176-W, Hf-178m-D,W, Hf-182-D,W, Bi-210m-D, Ra-
224-W, Ra-228-W, Ac-226-D,W,Y, Pa-230-W,Y, U-233-D,W,
U-234-D,W, U-235-D,W, U-236-D,W, U-238-D,W, Pu-241-Y,
Bk-249-W, Cf-253-W,Y, and Es-253-W are not present

If it is known that Ac-227-D,W,Y, Th-229-W,Y, Th-232-W,Y, - - - 1.00 - -

Pa-231-W,Y, Cm-248-W, and Cm-250-W are not present e-14

If, in addition, it is known that Sm-146-W, Gd-148-D,W, Gd- - - - 1.00 - -

152-D, Th-228-W,Y, Th-230-W,Y, U-232-Y, U-233-Y, U-234- e-13
Y, U-235-Y, U-236-Y, U-238-Y, U-Nat-Y, Np-236-W, Np-
237-W, Pu-236-W,Y, Pu-238-W,Y, Pu-239-W,Y, Pu-240-W,Y,
Pu-242-W,Y, Pu-244-W,Y, Am-241-W, Am-242m-W, Am-
243-W, Cm-243-W, Cm-244-W, Cm-245-W, Cm-246-W, Cm-
247-W, Bk-247-W, Cf-249-W,Y, Cf-250-W,Y, Cf-251-W,Y,
Cf-252-W,Y, and Cf-254-W,Y are not present
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

If, in addition, it is known that Sm-147-W, Gd-152-W, Pb-210- - - - 1.00 - -

D, Bi-210m-W, Po-210-D,W, Ra-223-W, Ra-225-W, Ra-226- e-12
W, Ac-225-D,W,Y, Th-227-W,Y, U-230-D,W,Y, U-232-D,W,
U-Nat-W, Pu-241-W, Cm-240-W, Cm-242-W, Cf-248-W,Y,
Es-254-W, Fm-257-W, and Md-258-W are not present

If, in addition it is known that Fe-60, Sr-90, Cd-113m, Cd-113, - - - - 0 0.00

In-115, I-129, Cs-134, Sm-145, Sm-147, Gd-148, Gd-152, Hg- 001
194 (organic), Bi-210m, Ra-223, Ra-224, Ra-225, Ac-225, Th-
228, Th-230, U-233, U-234, U-235, U-236, U-238, U-Nat, Cm-
242, Cf-248, Es-254, Fm-257, and Md-258 are not present

3. If a mixture of radionuclides consists of uranium and its daughters in ore dust (10 :m AMAD
particle distribution assumed) prior to chemical separation of the uranium from the ore, the
following values may be used for the DAC of the mixture: 6E-11 :Ci of gross alpha activity
from uranium-238, uranium-234, thorium-230, and radium-226 per milliliter of air; 3E-11 :Ci
of natural uranium per milliliter of air; or 45 micrograms of natural uranium per cubic meter of
air.

4. If the identity and concentration of each radionuclide in a mixture are known, the limiting
values should be derived as follows: determine, for each radionuclide in the mixture, the ratio
between the concentration present in the mixture and the concentration otherwise established in
105 CMR 120.296: Appendix B for the specific radionuclide when not in a mixture. The sum
of such ratios for all of the radionuclides in the mixture may not exceed "1" (i.e., "unity").
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.296: continued

Example: If radionuclides "A," "B," and "C" are present in concentrations CA, CB, and CC,
and if the applicable DACs are DACA, DACB, and DACC, respectively, then the concentrations
shall be limited so that the following relationship exists:

C A CB CC
+
1+ #
DACA DACB DACC
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.297: Appendix C -- Quantities1 of Licensed Material Requiring Labeling

__________________________________________________________________________
Radionuclide Quantity Radionuclide Quantity
(:Ci) (:Ci)
__________________________________________________________________________
Hydrogen-3 1,000 Manganese-53 1,000
Beryllium-7 1,000 Manganese-54 100
Beryllium-10 1 Manganese-56 1,000
Carbon-11 1,000 Iron-52 100
Carbon-14 100 Iron-55 100
Fluorine-18 1,000 Iron-59 10
Sodium-22 10 Iron-60 1
Sodium-24 100 Cobalt-55 100
Magnesium-28 100 Cobalt-56 10
Aluminum-26 10 Cobalt-57 100
Silicon-31 1,000 Cobalt-58m 1,000
Silicon-32 1 Cobalt-58 100
Phosphorus-32 10 Cobalt-60m 1,000
Phosphorus-33 100 Cobalt-60 1
Sulfur-35 100 Cobalt-61 1,000
Chlorine-36 10 Cobalt-62m 1,000
Chlorine-38 1,000 Nickel-56 100
Chlorine-39 1,000 Nickel-57 100
Argon-39 1,000 Nickel-59 100
Argon-41 1,000 Nickel-63 100
Potassium-40 100 Nickel-65 1,000
Potassium-42 1,000 Nickel-66 10
Potassium-43 1,000 Copper-60 1,000
Potassium-44 1,000 Copper-61 1,000
Potassium-45 1,000 Copper-64 1,000
Calcium-41 100 Copper-67 1,000
Calcium-45 100 Zinc-62 100
Calcium-47 100 Zinc-63 1,000
Scandium-43 1,000 Zinc-65 10
Scandium-44m 100 Zinc-69m 100
Scandium-44 100 Zinc-69 1,000
Scandium-46 10 Zinc-71m 1,000
Scandium-47 100 Zinc-72 100
Scandium-48 100 Gallium-65 1,000
Scandium-49 1,000 Gallium-66 100
Titanium-44 1 Gallium-67 1,000
Titanium-45 1,000 Gallium-68 1,000
Vanadium-47 1,000 Gallium-70 1,000
Vanadium-48 100 Gallium-72 100
Vanadium-49 1,000 Gallium-73 1,000
Chromium-48 1,000 Germanium-66 1,000
Chromium-49 1,000 Germanium-67 1,000
Chromium-51 1,000 Germanium-68 10
Manganese-51 1,000 Germanium-69 1,000
Manganese-52m 1,000 Germanium-71 1,000
Manganese-52 100 Germanium-75 1,000
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.297: continued

__________________________________________________________________________
Radionuclide Quantity Radionuclide Quantity
(:Ci) (:Ci)
__________________________________________________________________________

Germanium-77 1,000 Rubidium-86 100

Germanium-78 1,000 Rubidium-87 100
Arsenic-69 1,000 Rubidium-88 1,000
Arsenic-70 1,000 Rubidium-89 1,000
Arsenic-71 100 Strontium-80 100
Arsenic-72 100 Strontium-81 1,000
Arsenic-73 100 Strontium-83 100
Arsenic-74 100 Strontium-85m 1,000
Arsenic-76 100 Strontium-85 100
Arsenic-77 100 Strontium-87m 1,000
Arsenic-78 1,000 Strontium-89 10
Selenium-70 1,000 Strontium-90 0.1
Selenium-73m 1,000 Strontium-91 100
Selenium-73 100 Strontium-92 100
Selenium-75 100 Yttrium-86m 1,000
Selenium-79 100 Yttrium-86 100
Selenium-81m 1,000 Yttrium-87 100
Selenium-81 1,000 Yttrium-88 10
Selenium-83 1,000 Yttrium-90m 1,000
Bromine-74m 1,000 Yttrium-90 10
Bromine-74 1,000 Yttrium-91m 1,000
Bromine-75 1,000 Yttrium-91 10
Bromine-76 100 Yttrium-92 100
Bromine-77 1,000 Yttrium-93 100
Bromine-80m 1,000 Yttrium-94 1,000
Bromine-80 1,000 Yttrium-95 1,000
Bromine-82 100 Zirconium-86 100
Bromine-83 1,000 Zirconium-88 10
Bromine-84 1,000 Zirconium-89 100
Krypton-74 1,000 Zirconium-93 1
Krypton-76 1,000 Zirconium-95 10
Krypton-77 1,000 Zirconium-97 100
Krypton-79 1,000 Niobium-88 1,000
Krypton-81 1,000 Niobium-89m (66 min) 1,000
Krypton-83m 1,000 Niobium-89 (122 min) 1,000
Krypton-85m 1,000 Niobium-90 100
Krypton-85 1,000 Niobium-93m 10
Krypton-87 1,000 Niobium-94 1
Krypton-88 1,000 Niobium-95m 10
Rubidium-79 1,000 Niobium-95 100
Rubidium-81m 1,000 Niobium-96 100
Rubidium-81 1,000 Niobium-97 1,000
Rubidium-82m 1,000 Niobium-98 1,000
Rubidium-83 100 Molybdenum-90 100
Rubidium-84 100 Molybdenum-93m 100
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.297: continued

__________________________________________________________________________
Radionuclide Quantity Radionuclide Quantity
(:Ci) (:Ci)
__________________________________________________________________________

Molybdenum-93 10 Silver-11Om 10
Molybdenum-99 100 Silver-111 100
Molybdenum-101 1,000 Silver-112 100
Technetium-93m 1,000 Silver-115 1,000
Technetium-93 1,000 Cadmium-104 1,000
Technetium-94m 1,000 Cadmium-107 1,000
Technetium-94 1,000 Cadmium-109 1
Technetium-96m 1,000 Cadmium-113m 0.1
Technetium-96 100 Cadmium-113 100
Technetium-97m 100 Cadmium-115m 10
Technetium-97 1,000 Cadmium-115 100
Technetium-98 10 Cadmium-117m 1,000
Technetium-99m 1,000 Cadmium-117 1,000
Technetium-99 100 Indium-109 1,000
Technetium-101 1,000 Indium-110m (69.1m) 1,000
Technetium-104 1,000 Indium-11O (4.9h) 1,000
Ruthenium-94 1,000 Indium-111 100
Ruthenium-97 1,000 Indium-112 1,000
Ruthenium-103 100 Indium-113m 1,000
Ruthenium-105 1,000 Indium-114m 10
Ruthenium-106 1 Indium-115m 1,000
Rhodium-99m 1,000 Indium-115 100
Rhodium-99 100 Indium-116m 1,000
Rhodium-100 100 Indium-117m 1,000
Rhodium-101m 1,000 Indium-117 1,000
Rhodium-101 10 Indium-119m 1,000
Rhodium-102m 10 Tin-110 100
Rhodium-102 10 Tin-111 1,000
Rhodium-103m 1,000 Tin-113 100
Rhodium-105 100 Tin-117m 100
Rhodium-106m 1,000 Tin-119m 100
Rhodium-107 1,000 Tin-121m 100
Palladium-100 100 Tin-121 1,000
Palladium-101 1,000 Tin-123m 1,000
Palladium-103 100 Tin-123 10
Palladium-107 10 Tin-125 10
Palladium-109 100 Tin-126 10
Silver-102 1,000 Tin-127 1,000
Silver-103 1,000 Tin-128 1,000
Silver-104m 1,000 Antimony-115 1,000
Silver-104 1,000 Antimony-116m 1,000
Silver-105 100 Antimony-116 1,000
Silver-106m 100 Antimony-117 1,000
Silver-106 1,000 Antimony-118m 1,000
Silver-108m 1 Antimony-119 1,000
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.297: continued

__________________________________________________________________________
Radionuclide Quantity Radionuclide Quantity
(:Ci) (:Ci)
__________________________________________________________________________

Antimony-120 (16m) 1,000 Iodine-135 100

Antimony-120 (5.76d) 100 Xenon-120 1,000
Antimony-122 100 Xenon-121 1,000
Antimony-124m 1,000 Xenon-122 1,000
Antimony-124 10 Xenon-123 1,000
Antimony-125 100 Xenon-125 1,000
Antimony-126m 1,000 Xenon-127 1,000
Antimony-126 100 Xenon-129m 1,000
Antimony-127 100 Xenon-131m 1,000
Antimony-128 (10.4m) 1,000 Xenon-133m 1,000
Antimony-128 (9.O1h) 100 Xenon-133 1,000
Antimony-129 100 Xenon-135m 1,000
Antimony-130 1,000 Xenon-135 1,000
Antimony-131 1,000 Xenon-138 1,000
Tellurium-116 1,000 Cesium-125 1,000
Tellurium-121m 10 Cesium-127 1,000
Tellurium-121 100 Cesium-129 1,000
Tellurium-123m 10 Cesium-130 1,000
Tellurium-123 100 Cesium-131 1,000
Tellurium-125m 10 Cesium-132 100
Tellurium-127m 10 Cesium-134m 1,000
Tellurium-127 1,000 Cesium-134 10
Tellurium-129m 10 Cesium-135m 1,000
Tellurium-129 1,000 Cesium-135 100
Tellurium-131m 10 Cesium-136 10
Tellurium-131 100 Cesium-137 10
Tellurium-132 10 Cesium-138 1,000
Tellurium-133m 100 Barium-126 1,000
Tellurium-133 1,000 Barium-128 100
Tellurium-134 1,000 Barium-131m 1,000
Iodine-120m 1,000 Barium-131 100
Iodine-120 100 Barium-133m 100
Iodine-121 1,000 Barium-133 100
Iodine-123 100 Barium-135m 100
Iodine-124 10 Barium-139 1,000
Iodine-125 1 Barium-140 100
Iodine-126 1 Barium-141 1,000
Iodine-128 1,000 Barium-142 1,000
Iodine-129 1 Lanthanum-131 1,000
Iodine-130 10 Lanthanum-132 100
Iodine-131 1 Lanthanum-135 1,000
Iodine-132m 100 Lanthanum-137 10
Iodine-132 100 Lanthanum-138 100
Iodine-133 10 Lanthanum-140 100
Iodine-134 1,000 Lanthanum-141 100
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.297: continued

__________________________________________________________________________
Radionuclide Quantity Radionuclide Quantity
(:Ci) (:Ci)
__________________________________________________________________________

Lanthanum-142 1,000 Samarium-151 10

Lanthanum-143 1,000 Samarium-153 100
Cerium-134 100 Samarium-155 1,000
Cerium-135 100 Samarium-156 1,000
Cerium-137m 100 Europium-145 100
Cerium-137 1,000 Europium-146 100
Cerium-139 100 Europium-147 100
Cerium-141 100 Europium-148 10
Cerium-143 100 Europium-149 100
Cerium-144 1 Europium-150 (12.62h) 100
Praseodymium-136 1,000 Europium-150 (34.2y) 1
Praseodymium-137 1,000 Europium-152m 100
Praseodymium-138m 1,000 Europium-152 1
Praseodymium-139 1,000 Europium-154 1
Praseodymium-142m 1,000 Europium-155 10
Praseodymium-142 100 Europium-156 100
Praseodymium-143 100 Europium-157 100
Praseodymium-144 1,000 Europium-158 1,000
Praseodymium-145 100 Gadolinium-145 1,000
Praseodymium-147 1,000 Gadolinium-146 10
Neodymium-136 1,000 Gadolinium-147 100
Neodymium-138 100 Gadolinium-148 0.001
Neodymium-139m 1,000 Gadolinium-149 100
Neodymium-139 1,000 Gadolinium-151 10
Neodymium-141 1,000 Gadolinium-152 100
Neodymium-147 100 Gadolinium-153 10
Neodymium-149 1,000 Gadolinium-159 100
Neodymium-151 1,000 Terbium-147 1,000
Promethium-141 1,000 Terbium-149 100
Promethium-143 100 Terbium-150 1,000
Promethium-144 10 Terbium-151 100
Promethium-145 10 Terbium-153 1,000
Promethium-146 1 Terbium-154 100
Promethium-147 10 Terbium-155 1,000
Promethium-148m 10 Terbium-156m (5.Oh) 1,000
Promethium-148 10 Terbium-156m (24.4h) 1,000
Promethium-149 100 Terbium-156 100
Promethium-150 1,000 Terbium-157 10
Promethium-151 100 Terbium-158 1
Samarium-141m 1,000 Terbium-160 10
Samarium-141 1,000 Terbium-161 100
Samarium-142 1,000 Dysprosium-155 1,000
Samarium-145 100 Dysprosium-157 1,000
Samarium-146 1 Dysprosium-159 100
Samarium-147 100 Dysprosium-165 1,000
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.297: continued

__________________________________________________________________________
Radionuclide Quantity Radionuclide Quantity
(:Ci) (:Ci)
__________________________________________________________________________

Dysprosium-166 100 Lutetium-179 1,000

Holmium-155 1,000 Hafnium-170 100
Holmium-157 1,000 Hafnium-172 1
Holmium-159 1,000 Hafnium-173 1,000
Holmium-161 1,000 Hafnium-175 100
Holmium-162m 1,000 Hafnium-177m 1,000
Holmium-162 1,000 Hafnium-178m 0.1
Holmium-164m 1,000 Hafnium-179m 10
Holmium-164 1,000 Hafnium-180m 1,000
Holmium-166m 1 Hafnium-181 10
Holmium-166 100 Hafnium-182m 1,000
Holmium-167 1,000 Hafnium-182 0.1
Erbium-161 1,000 Hafnium-183 1,000
Erbium-165 1,000 Hafnium-184 100
Erbium-169 100 Tantalum-172 1,000
Erbium-171 100 Tantalum-173 1,000
Erbium-172 100 Tantalum-174 1,000
Thulium-162 1,000 Tantalum-175 1,000
Thulium-166 100 Tantalum-176 100
Thulium-167 100 Tantalum-177 1,000
Thulium-170 10 Tantalum-178 1,000
Thulium-171 10 Tantalum-179 100
Thulium-172 100 Tantalum-180m 1,000
Thulium-173 100 Tantalum-180 100
Thulium-175 1,000 Tantalum-182m 1,000
Ytterbium-162 1,000 Tantalum-182 10
Ytterbium-166 100 Tantalum-183 100
Ytterbium-167 1,000 Tantalum-184 100
Ytterbium-169 100 Tantalum-185 1,000
Ytterbium-175 100 Tantalum-186 1,000
Ytterbium-177 1,000 Tungsten-176 1,000
Ytterbium-178 1,000 Tungsten-177 1,000
Lutetium-169 100 Tungsten-178 1,000
Lutetium-170 100 Tungsten-179 1,000
Lutetium-171 100 Tungsten-181 1,000
Lutetium-172 100 Tungsten-185 100
Lutetium-173 10 Tungsten-187 100
Lutetium-174m 10 Tungsten-188 10
Lutetium-174 10 Rhenium-177 1,000
Lutetium-176m 1,000 Rhenium-178 1,000
Lutetium-176 100 Rhenium-181 1,000
Lutetium-177m 10 Rhenium-182 (12.7h) 1,000
Lutetium-177 100 Rhenium-182 (64.Oh) 100
Lutetium-178m 1,000 Rhenium-184m 10
Lutetium-178 1,000 Rhenium-184 100
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.297: continued

__________________________________________________________________________
Radionuclide Quantity Radionuclide Quantity
(:Ci) (:Ci)
__________________________________________________________________________

Rhenium-186m 10 Gold-198 100

Rhenium-186 100 Gold-199 100
Rhenium-187 1,000 Gold-200m 100
Rhenium-188m 1,000 Gold-200 1,000
Rhenium-188 100 Gold-201 1,000
Rhenium-189 100 Mercury-193m 100
Osmium-180 1,000 Mercury-193 1,000
Osmium-181 1,000 Mercury-194 1
Osmium-182 100 Mercury-195m 100
Osmium-185 100 Mercury-195 1,000
Osmium-189m 1,000 Mercury-197m 100
Osmium-191m 1,000 Mercury-197 1,000
Osmium-191 100 Mercury-199m 1,000
Osmium-193 100 Mercury-203 100
Osmium-194 1 Thallium-194m 1,000
Iridium-182 1,000 Thallium-194 1,000
Iridium-184 1,000 Thallium-195 1,000
Iridium-185 1,000 Thallium-197 1,000
Iridium-186 100 Thallium-198m 1,000
Iridium-187 1,000 Thallium-198 1,000
Iridium-188 100 Thallium-199 1,000
Iridium-189 100 Thallium-201 1,000
Iridium-190m 1,000 Thallium-200 1,000
Iridium-190 100 Thallium-202 100
Iridium-192m (1.4m) 10 Thallium-204 100
Iridium-192 (73.8d) 1 Lead-195m 1,000
Iridium-194m 10 Lead-198 1,000
Iridium-194 100 Lead-199 1,000
Iridium-195m 1,000 Lead-200 100
Iridium-195 1,000 Lead-201 1,000
Platinum-186 1,000 Lead-202m 1,000
Platinum-188 100 Lead-202 10
Platinum-189 1,000 Lead-203 1,000
Platinum-191 100 Lead-205 100
Platinum-193m 100 Lead-209 1,000
Platinum-193 1,000 Lead-210 0.0
Platinum-195m 100 Lead-211 100
Platinum-197m 1,000 Lead-212 1
Platinum-197 100 Lead-214 100
Platinum-199 1,000 Bismuth-200 1,000
Platinum-200 100 Bismuth-201 1,000
Gold-193 1,000 Bismuth-202 1,000
Gold-194 100 Bismuth-203 100
Gold-195 10 Bismuth-205 100
Gold-198m 100 Bismuth-206 100
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.297: continued

__________________________________________________________________________
Radionuclide Quantity Radionuclide Quantity
(:Ci) (:Ci)
__________________________________________________________________________

Bismuth-207 10 Uranium-232 0.001

Bismuth-210m 0.1 Uranium-233 0.001
Bismuth-210 1 Uranium-234 0.001
Bismuth-212 10 Uranium-235 0.001
Bismuth-213 10 Uranium-236 0.001
Bismuth-214 100 Uranium-237 100
Polonium-203 1,000 Uranium-238 100
Polonium-205 1,000 Uranium-239 1,000
Polonium-207 1,000 Uranium-240 100
Polonium-210 0.1 Uranium-natural 100
Astatine-207 100 Neptunium-232 100
Astatine-211 10 Neptunium-233 1,000
Radon-220 1 Neptunium-234 100
Radon-222 1 Neptunium-235 100
Francium-222 100 Neptunium-236 (1.15E+5y) 0.001
Francium-223 100 Neptunium-236 (22.5h) 1
Radium-223 0.1 Neptunium-237 0.001
Radium-224 0.1 Neptunium-238 10
Radium-225 0.1 Neptunium-239 100
Radium-226 0.1 Neptunium-240 1,000
Radium-227 1,000 Plutonium-234 10
Radium-228 0.1 Plutonium-235 1,000
Actinium-224 1 Plutonium-236 0.001
Actinium-225 0.01 Plutonium-237 100
Actinium-226 0.1 Plutonium-238 0.001
Actinium-227 0.001 Plutonium-239 0.001
Actinium-228 1 Plutonium-240 0.001
Thorium-226 10 Plutonium-241 0.01
Thorium-227 0.01 Plutonium-242 0.001
Thorium-228 0.001 Plutonium-243 1,000
Thorium-229 0.001 Plutonium-244 0.001
Thorium-230 0.001 Plutonium-245 100
Thorium-231 100 Americium-237 1,000
Thorium-232 100 Americium-238 100
Thorium-234 10 Americium-239 1,000
Thorium-natural 100 Americium-240 100
Protactinium-227 10 Americium-241 0.001
Protactinium-228 1 Americium-242m 0.001
Protactinium-230 0.1 Americium-242 10
Protactinium-231 0.001 Americium-243 0.001
Protactinium-232 1 Americium-244m 100
Protactinium-233 100 Americium-244 10
Protactinium-234 100 Americium-245 1,000
Uranium-230 0.01 Americium-246m 1,000
Uranium-231 100 Americium-246 1,000
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.297: continued

__________________________________________________________________________
Radionuclide Quantity Radionuclide Quantity
(:Ci) (:Ci)
__________________________________________________________________________

Curium-238 100 Californium-249 0.001

Curium-240 0.1 Californium-250 0.001
Curium-241 1 Californium-251 0.001
Curium-242 0.01 Californium-252 0.001
Curium-243 0.001 Californium-253 0.1
Curium-244 0.001 Californium-254 0.001
Curium-245 0.001 Einsteinium-250 100
Curium-246 0.001 Einsteinium-251 100
Curium-247 0.001 Einsteinium-253 0.1
Curium-248 0.001 Einsteinium-254m 1
Curium-249 1,000 Einsteinium-254 0.01
Berkelium-245 100 Fermium-252 1
Berkelium-246 100 Fermium-253 1
Berkelium-247 0.001 Fermium-254 10
Berkelium-249 0.1 Fermium-255 1
Berkelium-250 10 Fermium-257 0.01
Californium-244 100 Mendelevium-257 10
Californium-246 1 Mendelevium-258 0.01
Californium-248 0.01
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.297: continued

__________________________________________________________________________
Radionuclide Quantity Radionuclide Quantity
(:Ci) (:Ci)
__________________________________________________________________________

Any alpha-emitting Any radionuclide

radionuclide not other than alpha-
listed above or emitting radionuclides
mixtures of alpha not listed above, or
emitters of unknown mixtures of beta
composition 0.001 emitters of unknown
composition 0.01

NOTE: For purposes of 105 CMR 120.242(E), 120.245(A), and 120.281(A) where there is
involved a combination of radionuclides in known amounts, the limit for the combination should
be derived as follows: determine, for each radionuclide in the combination, the ratio between the
quantity present in the combination and the limit otherwise established for the specific radionuclide
when not in combination. The sum of such ratios for all radionuclides in the combination may not
exceed "1" -- that is, unity.
1
The quantities listed above were derived by taking 1/10th of the most restrictive ALI listed in
105 CMR 120.296: Appendix B, Table I, Columns 1 and 2, rounding to the nearest factor of
10, and constraining the values listed between 0.001 and 1,000 microcuries (37 becquerels and
37 megabecquerels). Values of 100 microcuries (3.7 megabecquerels) have been assigned for
radionuclides having a radioactive half-life in excess of 109 years, except rhenium, 1,000
microcuries (37 megabecquerels), to take into account their low specific activity.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.298: Appendix D - Nationally Tracked Source Thresholds

The Terabecquerel (TBq) values are the regulatory standard. The curie (Ci) values specified are
obtained by converting from the TBq value. The curie values are provided for practical usefulness only
and are rounded after conversion.

Radioactive material Category 1(TBq) Category 1(Ci) Category 2(TBq) Category 2(Ci)
Actinium-227 20 540 0.2 5.4
Americium-241 60 1600 0.6 16
Americium-241/Be 60 1600 0.6 16
Californium-252 20 540 0.2 5.4
Cobalt-60 30 810 0.3 8.1
Curium-244 50 1400 0.5 14
Cesium-137 100 2700 1 27
Gadolinium-153 1000 27000 10 270
Iridium-192 80 2200 0.8 22
Plutonium-238 60 1600 0.6 16
Plutonium-239/Be 60 1600 0.6 16
Polonium-210 60 1600 0.6 16
Promethium-147 40000 1100000 400 11000
Radium-226 40 1100 0.4 11
Selenium-75 200 5400 2 54
Strontium-90 1000 27000 10 270
Thorium-228 20 540 0.2 5.4
Thorium-229 20 540 0.2 5.4
Thulium-170 20000 540000 200 5400
Ytterbium-169 300 8100 3 81
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.299: Appendix E -- Classification and Characteristics of Low-level Radioactive Waste

(A) Classification of Radioactive Waste for Land Disposal.

(1) Considerations. Determination of the classification of radioactive waste involves two
considerations. First, consideration must be given to the concentration of long-lived radionuclides
(and their shorter-lived precursors) whose potential hazard will persist long after such precautions
as institutional controls, improved waste form, and deeper disposal have ceased to be effective.
These precautions delay the time when long-lived radionuclides could cause exposures. In addition,
the magnitude of the potential dose is limited by the concentration and availability of the
radionuclide at the time of exposure. Second, consideration must be given to the concentration of
shorter-lived radionuclides for which requirements on institutional controls, waste form, and
disposal methods are effective.
(2) Classes of Waste.
(a) Class A waste is waste that is usually segregated from other waste classes at the disposal
site. The physical form and characteristics of Class A waste must meet the minimum
requirements set forth in 105 CMR 120.299(B)(1). If Class A waste also meets the stability
requirements set forth in 105 CMR 120.299(B)(2), it is not necessary to segregate the waste for
disposal.
(b) Class B waste is waste that must meet more rigorous requirements on waste form to ensure
stability after disposal. The physical form and characteristics of Class B waste must meet both
the minimum and stability requirements set forth in 105 CMR 120.299(B).
(c) Class C waste is waste that not only must meet more rigorous requirements on waste form
to ensure stability but also requires additional measures at the disposal facility to protect against
inadvertent intrusion. The physical form and characteristics of Class C waste must meet both
the minimum and stability requirements set forth in 105 CMR 120.299(B).
(3) Classification Determined by Long-lived Radionuclides. If the radioactive waste contains only
radionuclides listed in Table I, classification shall be determined as follows:
(a) If the concentration does not exceed 0.1 times the value in Table I, the waste is Class A.
(b) If the concentration exceeds 0.1 times the value in Table I, but does not exceed the value
in Table I, the waste is Class C.
(c) If the concentration exceeds the value in Table I, the waste is not generally acceptable for
disposal at a facility licensed by the Agency.
(d) For wastes containing mixtures of radionuclides listed in Table I, the total concentration
shall be determined by the sum of fractions rule described in 105 CMR 120.299(A)(7).

TABLE I

Concentration
Radionuclide curie/cubic metera nanocurie/gramb

C-14 8.0
C-14 in activated metal 80.0
Ni-59 in activated metal 220.0
Nb-94 in activated metal 0.2
Tc-99 3.0
I-129 0.08
Alpha emitting transuranic
radionuclides with half-
life greater than five
years 100.0
Pu-241 3,500.0
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Cm-242 20,000.0
Ra-226 100.0
a
To convert the Ci/m3 values to gigabecquerel (GBq) per cubic meter, multiply the Ci/m3 value by
37.
b
To convert the nCi/g values to becquerel (Bq) per gram, multiply the nCi/g value by 37.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.299: continued

(4) Classification Determined by Short-lived Radionuclides. If the waste does not contain any of
the radionuclides listed in Table I, classification shall be determined based on the concentrations
shown in Table II. However, as specified in 105 CMR 120.299(A)(6), if radioactive waste does
not contain any nuclides listed in either Table I or II, it is Class A.
(a) If the concentration does not exceed the value in Column 1, the waste is Class A.
(b) If the concentration exceeds the value in Column 1 but does not exceed the value in
Column 2, the waste is Class B.
(c) If the concentration exceeds the value in Column 2 but does not exceed the value in
Column 3, the waste is Class C.
(d) If the concentration exceeds the value in Column 3, the waste is not generally acceptable
for near-surface disposal.
(e) For wastes containing mixtures of the radionuclides listed in Table II, the total
concentration shall be determined by the sum of fractions rule described in 105 CMR
120.299(A)(7).

TABLE II

Radionuclide Concentration, curie/cubic meter*

Column 1 Column 2 Column 3

Total of all radio-

nuclides with less
than 5-year half-
life 700.0 * *
H-3 40.0 * *
Co-60 700.0 * *
Ni-63 3.5 70.0 700.0
Ni-63 in activated
metal 35.0 700.0 7000.0
Sr-90 0.04 150.0 7000.0
Cs-137 1.0 44.0 4600.0

* AGENCY NOTE: To convert the Ci/m3 value to gigabecquerel (GBq) per cubic meter,
multiply the Ci/m3 value by 37. There are no limits established for these radionuclides in
Class B or C wastes. Practical considerations such as the effects of external radiation and
internal heat generation on transportation, handling, and disposal will limit the concentrations
for these wastes. These wastes shall be Class B unless the concentrations of other
radionuclides in Table II determine the waste to be Class C independent of these
radionuclides.

(5) Classification Determined by Both Long- and Short-lived Radionuclides. If the

radioactive waste contains a mixture of radionuclides, some of which are listed in Table I and
some of which are listed in Table II, classification shall be determined as follows:
(a) If the concentration of a radionuclide listed in Table I is less than 0.1 times the value
listed in Table I, the class shall be that determined by the concentration of radionuclides
listed in Table II.
(b) If the concentration of a radionuclide listed in Table I exceeds 0.1 times the value
listed in Table I, but does not exceed the value in Table I, the waste shall be Class C,
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

provided the concentration of radionuclides listed in Table II does not exceed the value
shown in Column 3 of Table II.
(6) Classification of Wastes with Radionuclides other than those Listed in Tables I and II.
If the waste does not contain any radionuclides listed in either Table I or II, it is Class A.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.299: continued

(7) The Sum of the Fractions Rule for Mixtures of Radionuclides. For determining
classification for waste that contains a mixture of radionuclides, it is necessary to determine
the sum of fractions by dividing each radionuclide's concentration by the appropriate limit and
adding the resulting values. The appropriate limits must all be taken from the same column
of the same table. The sum of the fractions for the column must be less than 1.0 if the waste
class is to be determined by that column. Example: A waste contains Sr-90 in a
concentration of 1.85 TBq/m3 (50 Ci/m3) and Cs-137 in a concentration of 814 GBq/m3 (22
Ci/m3). Since the concentrations both exceed the values in Column 1, Table II, they must be
compared to Column 2 values. For Sr-90 fraction, 50/150 = 0.33., for Cs-137 fraction, 22/44
= 0.5; the sum of the fractions = 0.83. Since the sum is less than 1.0, the waste is Class B.
(8) Determination of Concentrations in Wastes. The concentration of a radionuclide may
be determined by indirect methods such as use of scaling factors which relate the inferred
concentration of one radionuclide to another that is measured, or radionuclide material
accountability, if there is reasonable assurance that the indirect methods can be correlated
with actual measurements. The concentration of a radionuclide may be averaged over the
volume of the waste, or weight of the waste if the units are expressed as becquerel (nanocurie)
per gram.

(B) Radioactive Waste Characteristics.

(1) The following are minimum requirements for all classes of waste and are intended to
facilitate handling and provide protection of health and safety of personnel at the disposal site.
(a) Wastes shall be packaged in conformance with the conditions of the license issued
to the site operator to which the waste will be shipped. Where the conditions of the site
license are more restrictive than the provisions of Part D, the site license conditions shall
govern.
(b) Wastes shall not be packaged for disposal in cardboard or fiberboard boxes.
(c) Liquid waste shall be packaged in sufficient absorbent material to absorb twice the
volume of the liquid.
(d) Solid waste containing liquid shall contain as little freestanding and noncorrosive
liquid as is reasonably achievable, but in no case shall the liquid exceed 1% of the
volume.
(e) Waste shall not be readily capable of detonation or of explosive decomposition or
reaction at normal pressures and temperatures, or of explosive reaction with water.
(f) Waste shall not contain, or be capable of generating, quantities of toxic gases, vapors,
or fumes harmful to persons transporting, handling, or disposing of the waste. This does
not apply to radioactive gaseous waste packaged in accordance with 105 CMR
120.299(B)(1)(h).
(g) Waste must not be pyrophoric. Pyrophoric materials contained in wastes shall be
treated, prepared, and packaged to be nonflammable.
(h) Wastes in a gaseous form shall be packaged at an absolute pressure that does not
exceed 1.5 atmospheres at 20°C. Total activity shall not exceed 3.7 TBq (100 Ci) per
container.
(i) Wastes containing hazardous, biological, pathogenic, or infectious material shall be
treated to reduce to the maximum extent practicable the potential hazard from the
nonradiological materials.
(2) The following requirements are intended to provide stability of the waste. Stability is
intended to ensure that the waste does not degrade and affect overall stability of the site
through slumping, collapse, or other failure of the disposal unit and thereby lead to water
infiltration. Stability is also a factor in limiting exposure to an inadvertent intruder, since it
provides a recognizable and nondispersible waste.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(a) Waste shall have structural stability. A structurally stable waste form will generally
maintain its physical dimensions and its form, under the expected disposal conditions
such as weight of overburden and compaction equipment, the presence of moisture, and
microbial activity, and internal factors such as radiation effects and chemical changes.
Structural stability can be provided by the waste form itself, processing the waste to a
stable form, or placing the waste in a disposal container or structure that provides stability
after disposal.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.299: continued

(b) Notwithstanding the provisions in 105 CMR 120.299(B)(1)(c) and (d), liquid
wastes, or wastes containing liquid, shall be converted into a form that contains as little
freestanding and noncorrosive liquid as is reasonably achievable, but in no case shall the
liquid exceed 1% of the volume of the waste when the waste is in a disposal container
designed to ensure stability, or 0.5% of the volume of the waste for waste processed to
a stable form.
(c) Void spaces within the waste and between the waste and its package shall be
reduced to the extent practicable.

(C) Labeling. Each package of waste shall be clearly labeled to identify whether it is Class A,
Class B, or Class C waste, in accordance with 105 CMR 120.299(A).

120.300: RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC

OPERATIONS

120.301: Purpose and Scope

(A) Establish radiation safety requirements for persons using sources of radiation for industrial
radiography,

(B) Apply to all licensees and registrants who use sources of radiation for industrial
radiography,

(C) Apply to sealed radioactive sources and radiation machines, except for those regulations
clearly applicable only to sealed radioactive sources; and,

(D) Supplement, but do not replace, other applicable requirements of 105 CMR 120.000.

120.302: Definitions

As used in 105 CMR 120.300, the following definitions apply:

Annual Refresher Safety Training means a review conducted or provided by the licensee or
registrant for its employees on radiation safety aspects of industrial radiography. The review
may include, as appropriate, the results of internal audits, new procedures or equipment, new or
revised regulations, accidents or errors that have been observed, and should also provide
opportunities for employees to ask safety questions.

ANSI means American National Standards Institute.

Associated Equipment means equipment that is used in conjunction with a radiographic exposure
device to make radiographic exposures that drives, guides, or comes in contact with the source,
(such as, guide tube, control tube, control cable (drive cable), removable source stop, "J" tube
and collimator when it is used as an exposure head)

Cabinet Radiography means industrial radiography conducted in an enclosure or cabinet so

shielded that doses to individual members of the public at every location on the exterior meet the
limitations specified in 105 CMR 120.221(A).

Cabinet X-Ray System means an x-ray system with the x-ray tube installed in an enclosure
which, independent of existing architectural structures except the floor on which it may be
placed, is intended to:
(1) Contain at least that portion of a material being irradiated;
(2) Provide radiation attenuation; and,
(3) Exclude personnel from its interior during generation of x radiation.
Included are all x-ray systems designed primarily for the inspection of carry-on baggage at
airline, railroad, and bus terminals, and in similar facilities.
An x-ray tube used within a shielded part of a building, or x-ray equipment which may
temporarily or occasionally incorporate portable shielding, is not considered a cabinet x-ray
system.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.302: continued

Certification means the authorization by the Massachusetts Radiation Control Program (Agency)
of an individual to perform industrial radiography in the Commonwealth of Massachusetts.

Certification Identification (ID) Card means the document issued by the Agency to individuals
who have completed the requirements stated in 105 CMR 120.320(B).

Certified Cabinet X-ray System means an x-ray system which has been certified in accordance
with 21 CFR 1010.2 as being manufactured and assembled pursuant to the provisions of 21 CFR
1020.40.

Certified Industrial Radiographer means an individual who has met prescribed training and
experience requirements and has passed an approved examination and is authorized by the
Agency, pursuant to 105 CMR 120.321(H)(1), to perform industrial radiography.

Certifying Entity means an independent certifying organization or an Agreement State whose

industrial radiographer certification program has been reviewed and found to have met the
applicable parts of Appendix A of 10 CFR Part 34 for radioactive materials; or an independent
certifying organization or radiation control agency whose x-ray/or combination certification
requirements have been reviewed and found to be equivalent to criteria established by CRCPD.

Collimator means a small radiation shield of lead or other heavy metal which is placed on the
end of a guide tube or directly onto a radiographic exposure device to restrict the size of the
radiation beam when the sealed source is cranked into position to make a radiographic exposure.

Control Cable (Drive Cable) means the cable that is connected to the source assembly and used
to drive the source from and return it to the shielded position.

Control Mechanism (Drive Mechanism) means a device that enables the source assembly to be
moved from and returned to the shielded position. A drive mechanism is also known as a crank
assembly.

Control Tube means a protective sheath for guiding the drive cable. The control tube connects
the drive mechanism to the radiographic exposure device.

Crank-out Device means the cable, protective sheath, and hand crank used to move the sealed
source from the shielded to the unshielded position to make an industrial radiographic exposure.

Enclosed Radiography means industrial radiography conducted in an enclosed cabinet or room

and includes cabinet radiography and shielded room radiography.

Exposure Head (Source Stop) means a device that locates the gamma radiography sealed source
in the selected working position. An exposure head is also known as a source stop.

Guide Tube means a flexible or rigid tube, such as a "J" tube, for guiding the source assembly
and the attached control cable from the exposure device to the exposure head. The guide tube
may also include the connections necessary for attachment to the exposure device and to the
exposure head.

Independent Certifying Organization means an independent organization that meets all of the
applicable parts of Appendix A of 10 CFR Part 34 for radioactive materials, and/or comparable
criteria for x-ray/combination established by CRCPD.

Industrial Radiography means the examination of the macroscopic structure of materials by

nondestructive methods using sources of radiation derived from radioactive materials or radiation
machines. For purposes of 105 CMR 120.300, industrial radiography does not include
radiography performed with Lixiscopes or cabinet x-ray systems, nor does it include computed
tomography or computer-based digital radiography in which the useful beam of radiation is
collimated to detectors.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.302: continued

Industrial Radiography -Radiation Machines means the process of performing industrial

radiography using radiation producing machines.

Industrial Radiography -Radioactive Materials means the process of performing industrial

radiography using radioactive materials.

Lay-barge Radiography means industrial radiography performed on any water vessel used for
laying pipe.

Lixiscope means a portable light-intensified imaging device using iodine-125 as a sealed source.

Lock-out Survey means a radiation survey performed to determine that a sealed source is in its
shielded position. The lock-out survey is performed before moving the radiographic exposure
device or source changer to a new location or securing the radiographic exposure device or
source changer.

Offshore Platform Radiography means industrial radiography conducted from a platform over
a body of water.

Permanent Radiographic Installation means an installation or structure designed or intended for

radiography and in which radiography is regularly performed and meets all the requirements of
105 CMR 120.319

Personnel Monitoring Badge means a whole body individual monitoring device that meets the
requirements of 105 CMR 120.323(B).

Personal Supervision means supervision provided by a Certified Industrial Radiographer who

is physically present at the site where sources of radiation and associated equipment are being
used, visually evaluating the Radiographer Trainee and in such proximity that immediate
assistance can be given if required.

Radiation Machine means any device capable of producing ionizing radiation except those which
produce radiation only from radioactive material.

Radiation Safety Officer means an individual named by the licensee or registrant who has a
knowledge of, responsibility for, and authority to enforce appropriate radiation protection rules,
standards, and practices on behalf of the licensee and/or registrant and who meets the
requirements of 105 CMR 120.380 and 120.005.

Radiographer means any individual who has successfully completed the training, testing and
documentation requirements of 105 CMR 120.320(B), and who performs or personally
supervises industrial radiographic operations and who is responsible to the licensee or registrant
for assuring compliance with the requirements of 105 CMR 120.000 and all license and/or
certificate of registration conditions.

Radiographer Trainee means any individual who has successfully completed the training and
testing requirements of 105 CMR 120.320(A) and who uses sources of radiation and related
handling tools or radiation survey instruments under the personal supervision of a radiographer
trainer.

Radiographic Exposure Device (Camera or Projector) means any instrument containing a sealed
source fastened or contained therein, in which the sealed source or shielding thereof may be
moved, or otherwise changed, from a shielded to unshielded position for purposes of making a
radiographic exposure.

Radiographic Personnel means any radiographer or radiographer trainee.

Sealed Source (Pill) means any radioactive material that is used as a source of radiation and is
encased in a capsule designed to prevent leakage or escape of the radioactive material.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.302: continued

Shielded Position means the location within the radiographic exposure device or source changer
where the sealed source is secured and restricted from movement.

S-tube means a tube through which the radioactive source travels when inside a radiographic
exposure device.

Shielded-room Radiography means industrial radiography conducted in a room so shielded that

radiation levels at every location on the exterior meet the limitations specified in 105 CMR
120.221(A).

Source Assembly (Pigtail) means a component to which the sealed source is affixed or in which
the sealed source is contained. The source assembly includes the sealed source.

Source Changer means a device designed and used for replacement of sealed sources in
radiographic exposure devices, including those source changers also used for transporting and
storage of sealed sources.

Source Stop see “Exposure Head”.

Storage Area means any location, facility, or vehicle which is used to store, to transport, or to
secure a radiographic exposure device, a storage container, or a sealed source when it is not in
use and which is locked or has a physical barrier to prevent accidental exposure, tampering with,
or unauthorized removal of the device, machine, container, or sealed source.

Storage Container means a device other than a source changer in which sealed sources are stored.

Temporary Job Site means any location where industrial radiography is performed other than the
location(s) listed in a specific license or certificate of registration.

Transport Container means a package that is designed to provide radiation safety and security
when sealed sources are transported and meets all applicable requirements of the U.S.
Department of Transportation.

Underwater Radiography means industrial radiography performed when the radiographic

exposure device and/or related equipment are beneath the surface of the water.

120.303: Exemptions

(A) Certified cabinet x-ray systems are exempt from the requirements of 105 CMR 120.300
except for the requirements of 105 CMR 120.337(C) and (D).

(B) Industrial uses of lixiscopes are exempt from the rules in 105 CMR 120.300. Lixiscope use
is regulated under 105 CMR 120.100.

120.305: Licensing and Registration Requirements for Industrial Radiographic Operations

The Agency will approve an application for a specific license for the use of licensed material
or a registration for use of radiation machines if the applicant meets the following requirements:

(A) The applicant satisfies the general requirements specified in 105 CMR 120.020 for
radiation machine facilities or 105 CMR 120.100 for radioactive material, as applicable, and any
special requirements contained in 105 CMR 120.300;

(B) The applicant submits an adequate program for training radiographers and radiographer
trainees that meets the requirements of 105 CMR 120.320;

(C) The applicant submits procedures for verifying and documenting the certification status of
radiographers and for ensuring that the certification of individuals acting as radiographers
remains valid;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.305: continued

(D) The applicant submits written operating and emergency procedures as described in 105
CMR 120.325;

(E) The applicant submits a description of a program for inspections of the job performance of
each radiographer and radiographer trainee at intervals not to exceed six months as described in
105 CMR 120.320(C);

(F) The applicant submits a description of the applicant's overall organizational structure as it
applies to the radiation safety responsibilities in industrial radiography, including specified
delegation of authority and responsibility;

(G) The applicant submits the qualifications of the individual(s) designated as the radiation
safety officer as described in 105 CMR 120.380(B) and potential designees responsible for
ensuring that the licensee’s radiation safety program is implemented in accordance with
approved procedures;

(H) If an applicant intends to perform leak testing of sealed sources or exposure devices
containing depleted uranium (DU) shielding, the applicant must describe the procedures for
performing the test and analyzing the samples. The description must include the:
(1) Methods of collecting the samples;
(2) Instruments to be used;
(3) Methods of analyzing the samples; and
(4) Pertinent experience of the person who will analyze the wipe samples.

(I) If the applicant intends to perform calibrations of survey instruments and alarming
ratemeters, the applicant must describe methods to be used and the experience of the person(s)
who will perform the calibrations. All calibrations must be performed according to the
procedures described and at the intervals prescribed in 105 CMR 120.314 and 120.323(B)(8);

(J) the applicant identifies and describes the location(s) of all field stations and permanent
radiographic installations; and

(K) The applicant identifies the location(s) where all records required by 105 CMR 120.300 and
other parts of 105 CMR 120.000 will be maintained.

120.310: Records of Receipt, Transfer, and Disposal of Sources of Radiation

Each licensee and registrant shall maintain records showing the receipt, transfer, and disposal
of sources of radiation. These records shall include the date, the individual making the record,
the radionuclide, number of curies, and make, model, and serial number of each source of
radiation and device, as appropriate. Records shall be maintained for Agency inspection until
disposal is authorized by the Agency.

120.311: Limits on Levels of Radiation for Radiographic Exposure Devices, Source Changers, and
Transport Containers

The maximum exposure rate limits for storage containers and source changers are 2 mSv/hr
(200 mrem/hr) at any exterior surface, and 0.1 mSv/hr (10 mrem/hr) at one meter from any
exterior surface with the sealed source in the shielded position.

120.312: Locking of Sources of Radiation, Storage Containers and Source Changers

(A) The control panel of each radiation machine shall be equipped with a locking device which
will prevent the unauthorized use of an x-ray system or the accidental production of radiation.
The radiation machine shall be kept locked and the key removed at all times except when under
the direct visual surveillance of a radiographer or radiographer trainee, or an individual
specifically authorized by the Agency.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.312: continued

(B) Each radiographic exposure device must have a lock or outer lockable container designed
to prevent unauthorized or accidental removal of the sealed source from its shielded position.
The exposure device and/or its container must be kept locked and, if a keyed lock, the key
removed at all times when not under the direct surveillance of a radiographer or radiographer
trainee, or an individual specifically authorized by the Agency except at permanent radiograhic
installations as stated in 105 CMR 120.319. In addition, during radiographic operations the
sealed source assembly must be secured in the shielded position each time the source is returned
to that position.

(C) Each sealed storage container and source changer must have a lock or outer lockable
container designed to prevent unauthorized or accidental removal of the sealed source from its
shielded position. Storage containers and source changers must be kept locked, and if a keyed
lock the key removed when containing sealed sources except when under the direct surveillance
of a radiographer or a radiographer trainee.

(D) The sealed source shall be secured in its shielded position by locking the exposure device
or securing the remote control each time the sealed source is returned to its shielded position.
Then a survey shall be performed to determine that the sealed source is in the shielded position
pursuant to 105 CMR 120.333(B).

120.314: Radiation Survey Instruments

(A) The licensee or registrant shall maintain sufficient calibrated and operable radiation survey
instruments to make physical radiation surveys as required by 105 CMR 120.300 and
120.225(A). Instrumentation required by 105 CMR 120.300 shall have a range from 0.02
mSv/hr (2 mrem/hr) through 0.01 Sv/hr (1 rem/hr).

(B) Each radiation survey instrument shall be calibrated:

(1) By a person licensed or registered by the Agency, another Agreement State, a Licensing
State, or the U.S. Nuclear Regulatory Commission to perform such service;
(2) At energies appropriate for the licensee's or registrant's use;
(3) At intervals not to exceed six months and after each instrument servicing other than
battery replacement;
(4) To demonstrate an accuracy within plus or minus 20%; and
(5) At two points located approximately a and b of full-scale on each scale for linear scale
instruments; at midrange of each decade, and at two points of at least one decade for
logarithmic scale instruments; and for digital instruments, at three points between 0.02 and
10 mSv/hr (2 and 1,000 mrem/hr).

(C) Records of these calibrations shall be maintained for Agency inspection for five years after
the calibration date.

(D) Each radiation survey instrument shall be checked with a radiation source at the beginning
of each day of use and at the beginning of each work shift to ensure it is operating properly.

120.315: Performance Requirements for Industrial Radiography Equipment

(A) Conformance with ANSI Standards. Equipment used in industrial radiographic operations
shall meet the following minimum criteria:
(1) Each radiographic exposure device, source assembly, sealed source, and associated
equipment shall meet the criteria set forth by ANSI N432-1980: Radiological Safety for the
Design and Construction of Apparatus for Gamma Radiography, (published as NBS
Handbook 136, issued January 1981). This publication may be purchased from the American
National Standards Institute, Inc., 25 West 43rd Street, New York, New York 10036;
Telephone: (212) 642–4900.
(2) Radiation machines manufactured after January 10, 1992 used in industrial radiographic
operations shall be certified at the time of manufacture to meet the criteria set forth by ANSI
N537- 1976, except accelerators used in industrial radiography.
(3) All radiographic exposure devices and associated equipment in use after
January 10, 1996, must comply with the requirements of 105 CMR 120.315.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.315: continued

(4) In lieu of 105 CMR 120.315(A)(1), equipment used in industrial radiographic operations
need not comply with § 8.9.2(c) of the Endurance Test in ANSI N432-1980, if the prototype
equipment has been tested using a torque value representative of the torque that an individual
using the radiography equipment can realistically exert on the lever or crankshaft of the drive
mechanism.
(5) Engineering analysis may be submitted by a licensee to demonstrate the applicability
of previously performed testing on similar individual radiography equipment components.
Upon review, the agency may find this an acceptable alternative to actual testing of the
component in accordance with 105 CMR 120.315(A)(1).
(6) In addition to the requirements specified in 105 CMR 120.315(A)(1), the following
requirements apply to radiographic exposure devices, source changers, source assemblies,
sealed sources and associated equipment.
(a) The licensee shall ensure that each radiographic exposure device has attached to it
a durable, legible, clearly visible label bearing the:
1. Chemical symbol and mass number of the radionuclide in the device;
2. Activity and the date on which this activity was last measured;
3. Model or product code and serial number of the sealed source;
4. Name of the manufacturer of the sealed source; and,
5. Licensee's name, address, and telephone number.
(b) Radiographic exposure devices intended for use as Type B packages must meet the
applicable transportation requirements of 10 CFR part 71.
(c) Opening, repair or modification of radiographic exposure devices, source changers,
and source assemblies and associated equipment is prohibited, unless approved by the
Agency, the U.S. Nuclear Regulatory Commission (NRC) or Agreement State.
(7) Modification of any exposure devices and associated equipment is prohibited, unless the
design of any replacement component, including source holder, source assembly, controls
or guide tubes would not compromise the design safety features of the system.

(B) Labeling Storage, and Transportation

(1) The licensee may not use a radiographic exposure device source changer or a container
to store radioactive material unless the radiographic exposure device source changer or the
storage container has securely attached to it a durable, legible, and clearly visible label
bearing the standard trefoil radiation caution symbol conventional colors, i.e., magenta,
purple or black on a yellow background, having a minimum diameter of 25 mm, and the
wording:
"CAUTION. RADIOACTIVE MATERIAL. NOTIFY CIVIL AUTHORITIES (OR
NAME OF COMPANY)" or "DANGER. RADIOACTIVE MATERIAL. NOTIFY
CIVIL AUTHORITIES (OR NAME OF COMPANY)."
(2) The licensee may not transport radioactive material unless the material is packaged, and
the package is labeled, marked, and accompanied with appropriate shipping papers in
accordance with 105 CMR 120.770
(3) Radiographic exposure devices, source changers, storage containers, and radiation
machines, must be physically secured to prevent tampering or removal by unauthorized
personnel. The licensee shall store radioactive material in a manner that will minimize
danger from explosion or fire.
(4) The licensee shall lock and physically secure the transport package containing
radioactive material in the transporting vehicle to prevent accidental loss, tampering, or
unauthorized removal.
(5) The licensee’s or registrant’s name and city or town where the main business office is
located shall be prominently displayed with a durable, clearly visible label(s) on both sides
of all vehicles used to transport radioactive material or radiation machines for temporary job
site use.

(C) Performance Requirements. In addition to the requirements specified in 105 CMR

120.315(A) and (B), the following requirements apply to radiographic exposure devices, source
assemblies, and associated equipment that allow the source to be moved out of the device for
routine operations or to source changers:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.315: continued

(1) The coupling between the source assembly and the control cable must be designed in
such a manner that the source assembly will not become disconnected if cranked outside the
guide tube. The coupling must be such that it cannot be unintentionally disconnected under
normal and reasonably foreseeable abnormal conditions.
(2) The device must automatically secure the source assembly when it is cranked back into
the fully shielded position within the device. This securing system may only be released by
means of a deliberate operation on the exposure device.
(3) The outlet fittings, lock box, and drive cable fittings on each radiographic exposure
device must be equipped with safety plugs or covers which must be installed during storage
and transportation to protect the source assembly from water, mud, sand or other foreign
matter.
(4) Each sealed source or source assembly must have attached to it or engraved on it, a
durable, legible, visible label with the words:
"DANGER -- RADIOACTIVE."
The label must not interfere with the safe operation of the exposure device or associated
equipment.
(5) The guide tube must be able to withstand a crushing test that closely approximates the
crushing forces that are likely to be encountered during use, and be able to withstand a
kinking resistance test that closely approximates the kinking forces that are likely to be
encountered during use.
(6) Guide tubes must be used when moving the source out of the device.
(7) An exposure head, endcap, or similar device designed to prevent the source assembly
from passing out of the end of the guide tube shall be attached to the outermost end of the
guide tube during radiographic operations.
(8) The guide tube exposure head connection must be able to withstand the tensile test for
control units specified in ANSI N432-1980.
(9) Source changers must provide a system for ensuring that the source will not be
accidentally withdrawn from the changer when connecting or disconnecting the drive cable
to or from a source assembly.

(D) Leak Testing and Replacement of Sealed Sources.

(1) The replacement of any sealed source fastened to or contained in a radiographic
exposure device and leak testing of any sealed source must be performed by persons
authorized to do so by the Agency, the Nuclear Regulatory Commission, or another
Agreement State.
(2) The opening, repair, or modification of any sealed source must be performed by persons
specifically authorized to do so by the Agency, the Nuclear Regulatory Commission, or
another Agreement State.
(3) Each licensee who uses a sealed source shall have the source tested for leakage at
intervals not to exceed six months. The leak testing of the source must be performed using
a method approved by the Agency, the Nuclear Regulatory Commission, or by another
Agreement State. The wipe sample should be taken from the nearest accessible point to the
sealed source where contamination might accumulate. The wipe sample must be analyzed
for radioactive contamination. The analysis must be capable of detecting the presence of 185
becquerels (0.005 mCi) of radioactive material on the test sample and must be performed by
a person specifically authorized by the Agency, the Nuclear Regulatory Commission, or
another Agreement State to perform the analysis. The license shall maintain the records of
the leak tests for inspection by the Agency for five years after it is made.
(4) Unless a sealed source is accompanied by a certificate from the transferor that shows
that it has been leak tested within six months before the transfer, it may not be used by the
licensee until tested for leakage. Sealed sources that are in storage and not in use do not
require leak testing, but must be tested before use or transfer to another person if the interval
of storage exceeds six months.
(5) Any test conducted pursuant to 105 CMR 120.315(D)(1) and (2) which reveals the
presence of 185 Bq (0.005 microcuries) or more of removable radioactive material shall be
considered evidence that the sealed source is leaking. The licensee shall immediately
withdraw the equipment involved from use and shall cause it to be decontaminated and
repaired or to be disposed of in accordance with regulations of the Agency. Within five days
after obtaining results of the test, the licensee shall file a report with the Agency describing
the equipment involved, the test results, and the corrective action taken.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.315: continued

(6) Each exposure device using DU shielding and an "S" tube configuration shall be tested
for DU contamination at intervals not to exceed 12 months. The analysis must be capable of
detecting the presence of 185 Bq (0.005 microcuries) of radioactive material on the test
sample and must be performed by a person specifically authorized by the Commission or an
Agreement State to perform the analysis. Should such testing reveal the presence of DU
contamination, the exposure device must be removed from use until an evaluation of the
wear of the S-tube has been made. Should the evaluation reveal that the S-tube is worn
through, the device may not be used again. DU shielded devices do not have to be tested for
DU contamination while in storage and not in use. Before using or transferring such a
device, however, the device must be tested for DU contamination, if the interval of storage
exceeds 12 months. Each licensee shall maintain records of leak testing of sealed sources
and devices containing DU. The licensee shall retain each record for agency inspection for
five years from the date of the leak test.
(7) An applicant or licensee who desires to conduct its own tests for leakage or
contamination shall establish procedures to be followed when testing sealed sources for
leakage or contamination and shall submit a description of such procedures to the Agency
for approval. The description shall include the:
(a) Instrumentation to be used;
(b) Method of performing the tests; and
(c) Pertinent experience of the individual(s) who will perform the test.

120.316: Quarterly Inventory

(A) Each licensee or registrant shall conduct a physical inventory at intervals not to exceed
three months to account for all sources of radiation, and for devices containing depleted uranium
received and possessed under the license or registration.

(B) The licensee or registrant shall maintain records of the quarterly inventory in accordance
with 105 CMR 120.364.

120.317: Utilization Logs

Each licensee and registrant shall maintain current logs of the use of each source of radiation.
The logs shall include:

(A) A unique identification (e.g., serial number) of each radiation machine, each radiographic
exposure device in which a sealed source is located, and each sealed source;

(B) The name of the radiographer using the source of radiation;

(C) The location(s) where each source of radiation is used and dates of use; and,

(D) The date(s) each source of radiation is removed from storage and returned to storage. For
fixed installations, the date(s) each source of radiation is energized or used and the number of
exposures made. Utilization logs may be kept on form MRCP 120.300-2, Utilization Log, or on
clear, legible records containing all the information required by 105 CMR 120.317(A) through
(D). Copies of utilization logs shall be maintained for Agency inspection for five years. The
records shall be kept at the location specified by the license or certificate of registration.

120.318: Inspection and Maintenance of Radiation Machines, Radiographic Exposure Devices, Transport
and Storage Containers, Associated Equipment, Source Changers, and Survey Instruments

(A) The radiographer shall perform visual and operability checks on survey meters, radiation
machines, radiographic exposure devices, transport and storage containers, associated equipment
and source changers before each day’s use, or work shift, to ensure that:
(1) The equipment is in good working condition;
(2) The sources are adequately shielded; and,
(3) Required labeling is present.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.318: continued

(B) Survey instrument operability must be performed using check sources or other appropriate
means.

(C) If equipment problems are found, the equipment must be removed from service until
repaired.

(D) Each licensee or registrant shall have written procedures for and perform inspection and
routine maintenance of radiation machines, radiographic exposure devices, source changers,
associated equipment, transport and storage containers, and survey instruments at intervals not
to exceed three months or before the first use thereafter to ensure the proper functioning of
components important to safety. If equipment problems are found, the equipment must be
removed from service until repaired.

(E) The licensee’s inspection and maintenance program must include procedures to assure that
Type B packages are shipped and maintained in accordance with the certificate of compliance
or other approval.

(F) Records of equipment problems and of any maintenance performed under 105 CMR
120.318 must be made in accordance with 105 CMR 120.366

120.319: Permanent Radiographic Installations

(A) Permanent radiographic installations shall have high radiation area entrance controls of the
type described in 105 CMR 120.227(A)(2) and (3) and (B).

(B) Each entrance that is used for personnel access to the high radiation area shall have both
conspicuous visible and audible warning signals to warn of the presence of radiation. The visible
signal shall be activated by radiation. The audible signal shall be activated when an attempt is
made to enter the installation while the source is exposed.

(C) The control device or alarm system shall be tested for proper operation with a source of
radiation at the beginning of each day of equipment use. The test shall include a check for the
visible and/or audible signals. Entrance control devices that reduce the radiation level upon entry
as described in 105 CMR 120.227(A)(1) shall be tested monthly. If a control device or alarm
system is operating improperly, it shall be immediately labeled as defective and repaired within
seven calendar days. The facility may continue to be used during this seven-day period, provided
the licensee or registrant implements the continuous surveillance requirements of 105 CMR
120.331, ensures that radiographic personnel use an alarming ratemeter, and complies with the
requirements of 105 CMR 120.330(B). Records of these tests shall be maintained for Agency
inspection for five years.

RADIATION SAFETY REQUIREMENTS

120.320: Training and Testing

(A) Radiographer Trainee Requirements. The licensee or registrant shall not permit any
individual to act as a radiographer trainee until the individual
(1) has received copies of and instructions in the requirements described in 105 CMR
120.300 and the applicable sections of 105 CMR 120.100, 120.200, 120.750 , and applicable
DOT regulations as referenced in 105 CMR 120.770, a copy of the license or certificate of
registration issued to the licensee or registrant and copies of and instructions in the licensee’s
or registrant’s operating and emergency procedures;
(2) has demonstrated an understanding of items in 105 CMR 120.320(A)(1) by successful
completion of a written or oral examination, administered by the licensee or registrant;
(3) has been instructed in the use of the licensee’s or registrant’s sources of radiation,
radiographic exposure devices, associated equipment, related handling tools and radiation
survey instruments that may be employed in industrial radiographic assignments; and
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.320: continued

(4) has demonstrated, to the satisfaction of the licensee or registrant, an understanding of

the instructions provided pursuant to 105 CMR 120.320(A)(2) and (3) as evidenced by
successful completion of a written or oral test and a field examination on the subjects
covered.

(B) Radiographer Requirements. The licensee or registrant shall not permit any individual to
act as a radiographer until the individual:
(1) has completed a course of at least 40 hours on the applicable subjects outlined in 105
CMR 120.320(G). The course shall be one that has been accepted by the Agency, another
radiation control agency or the NRC;
(2) has completed hands-on experience as a radiographer trainee under the personal
supervision, as specified in 105 CMR 120.326, of one or more radiographers:
(a) Hands-on experience in addition to on the job training consisting of hands-on
experience shall include at least minimum of two months (320 hours) of active
participation in the performance of industrial radiography utilizing radioactive material
and/or one month (160 hours) of active participation in the performance of industrial
radiography utilizing radiation machines.
(b) Individuals performing industrial radiography utilizing radioactive materials and
radiation machines must complete both segments of hands-on experience.
(3) has successfully completed within the last five years the appropriate agency-administerd
examination as prescribed in 105 CMR 120.321. Or the appropriate examination of another
certifying entity that affords the same or comparable certification standards of 105 CMR
120.320(B);
(4) Possess a current certification ID card issued in accordance with 105 CMR 120.321(H)
or by another certifying entity that affords the same or comparable certification standards as
those afforded by 105 CMR 120.320(B);
(5) Once an individual has completed the requirements of 105 CMR 120.320(B)(4), the
licensee or registrant is not required to submit the documentation referenced in 105 CMR
120.320(B)(1) and (2).

(C) In addition, the licensee or registrant may not permit any individual to act as a radiographer
until the individual:
(1) has received copies of and instruction in the requirements described in 105 CMR
120.300 and the applicable sections of 105 CMR 120.100, 120.200, 120.750 , and applicable
DOT regulations as referenced in 105 CMR 120.770, in the license or registration under
which the radiographer's assistant will perform industrial radiography, and the licensee's or
registrant’s operating and emergency procedures;
(2) has demonstrated an understanding of items in 105 CMR 120.320(C)(1) by successful
completion of a written or oral examination administered by the licensee or registrant;
(3) Has received training in the use and daily inspection of the registrant’s radiation survey
instruments, the registrant’s radiation machines, or the licensee's radiographic exposure
devices, associated equipment and related handling tools; and,
(4) Has demonstrated competence in the use of the equipment described in 105 CMR
120.320(C)(3) by successful completion of a practical examination administered by the
licensee or registrant.

(D) The licensee or registrant shall provide annual refresher safety training for each
radiographer and radiographer's assistant at intervals not to exceed 12 months.

(E) Except as provided in 105 CMR 120.320(E)(4), the radiation safety officer or designee shall
conduct an inspection program of the job performance of each radiographer and radiographer
trainee to ensure that the Agency’s regulations, license or registration requirements, and
operating and emergency procedures are followed. The inspection program must:
(1) Include observation of the performance of each radiographer and radiographer trainee
during an actual industrial radiographic operation, at intervals not to exceed six months; and,
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.320: continued

(2) Provide that, if a radiographer or a radiographer trainee has not participated in an

industrial radiographic operation for more than six months since the last inspection, the
radiographer must demonstrate knowledge of the training requirements of 105 CMR
120.320(C)(3) and the radiographer's assistant must demonstrate knowledge of the training
requirements of 105 CMR 120.320(A)(3) by a practical examination administered by the
licensee or registrant before these individuals can next participate in a radiographic
operation.
(3) The Agency may consider alternatives in those situations where the individual serves
as both radiographer and radiation safety officer.
(4) In those operations where a single individual serves as both radiographer and radiation
safety officer, and performs all radiography operations, an inspection program is not required.

(F) The licensee or registrant shall maintain records of the above training to include certification
documents, written, oral and practical examinations, refresher safety training and inspections of
job performance in accordance with 105 CMR 120.367.

(G) The licensee or registrant shall include the following subjects, as applicable, that are
required in 105 CMR 120 320(B)(1):
(1) Fundamentals of radiation safety including:
(a) Characteristics of gamma and x-radiation;
(b) Units of radiation dose and quantity of radioactivity;
(c) Significance of dose to include: radiation protection standards, biological effects of
radiation dose, and case histories of industrial radiography incidents;
(d) Levels of radiation from sources of radiation; and,
(e) Methods of controlling radiation dose (time, distance, and shielding);
(2) Radiation detection instruments including:
(a) Use, operation, calibration, and limitations of radiation survey instruments;
(b) Survey techniques; and,
(c) Use of personnel monitoring equipment to include as a minimum, film badges,
TLDs OSLs, pocket dosimeters, alarming ratemeters and electronic personal dosimeters;
(3) Equipment to be used including:
(a) Operation and control of radiographic exposure equipment, remote handling
equipment, and storage and transport containers, including pictures or models of source
assemblies (pigtails);
(b) Operation and control of radiation machines;
(c) Storage, control, and disposal of sources of radiation; and,
(d) Inspection and maintenance of equipment.
(4) The requirements of pertinent state and federal regulations; and,
(5) Generic written operating and emergency procedures.

120.321: Applications and Examinations

(A) Any individual applying to the Agency for certification to perform industrial radiography
shall:
(1) submit a complete and legible application on forms prescribed and furnished by the
Agency.
(2) pay the appropriate non-refundable fee in accordance with 105 CMR 120.321(J) .
(3) meet the examination requirements set forth in 105 CMR 120.321(D) or satisfy the
requirements for certification based on reciprocity as set forth in 105 CMR 120.321(K); and,
(4) provide evidence that the requirements for the given category and class for which
certification is sought have been met.

(B) Application. The appropriate fee shall accompany the application when filing with the
Agency. An application shall be deemed filed on the date that it is received by the Agency or
on the date that it is postmarked by the United States Postal Service.

(C) Categories of Certification.

(1) The Agency shall certify individuals to perform industrial radiography as Certified
Industrial Radiographer.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.321: continued

(2) Each certification issued shall include a class endorsement for the type of industrial
radiography authorized. Such class endorsements are limited to:
(a) Radioactive Materials;
(b) Radiation Machines; or
(c) Radioactive Materials and Radiation Machines.

(D) Examination Requirements. An individual who seeks certification as a Certified Industrial

Radiographer must have passed, prior to application for certification, a written examination
appropriate to the category of certification sought in accordance with 105 CMR 120.321(E). An
individual seeking certification as a Certified Industrial Radiographer must pass, within 12
months prior to application for certification, a written examination appropriate to the category
and class of certification sought in accordance with 105 CMR 120.321(G).

(E) Examination. The Agency shall accept results of examinations given by certifying entities
as defined in 105 CMR 120.302.

(F) Approved Training Program. Industrial radiographer training programs shall be approved
by the Agency. The Agency shall recognize training programs approved by certifying entities.

(G) Experience Requirements for Certification. Applicants for certification to perform

industrial radiography shall have a minimum of experience appropriate to each category and
class of industrial radiography as follows:
Certified Industrial Radiographer
(1) Radioactive Materials............................................. 200 hrs
(2) Radiation Machines ............................................... 120 hrs
(3) Both Radioactive Materials and Radiation .......... 320 hrs
Machines of which not less than 200 hours shall be with radioactive materials and not less
than 120 hours shall be with radiation machines.

(H) Requirements for Issuance of Certification. The Agency shall certify in a category and class
of industrial radiography any individual who has satisfied the following requirements: Certified
Industrial Radiographer:
(1) Submitted an application for certification on a form prescribed by the Department;
(2) Submitted the application fee specified in 105 CMR 120.321(J)(1);
(3) Passed an examination as required by 105 CMR 120.321(D) or satisfies the
requirements or certification based on reciprocity as set forth in 105 CMR 120.321(K); and,
(4) Completed the required hours of experience in industrial radiography as specified in 105
CMR 120.321(G) or satisfies the requirements for certification based on reciprocity as set
forth in 105 CMR 120.321(K)

(I) Duration of Certification. The duration of certification issued by the Agency shall be:
Certified Industrial Radiographer ....................... five years

(J) Fees.
(1) The application fees for certification shall be non-refundable and shall be as specified
for Certified Idustrial Radiographer.
(2) The appropriate fees shall accompany the application when filing with the Agency.

(K) Reciprocity.
(1) The Agency shall issue certification to an applicant who has been certified in another
state or jurisdiction provided that:
(a) The applicant holds a valid certification in the appropriate category issued by
another state or jurisdiction;
(b) The jurisdiction that issued the certification is a certifying entity.
(c) The applicant presents a copy of the certification document issued by the other
jurisdiction to the Agency; and
(d) The applicant submits the application fee in accordance with 105 CMR
120.321(J)(1).
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.321: continued

(2) Individuals who are certified by reciprocity shall either:

(a) Maintain the certification upon which the reciprocal certification was issued; or
(b) Satisfy the requirements of 105 CMR 120.321(H) prior to the expiration of the
certification upon which reciprocal certification was issued.

(L) Requirements for Renewal of Certification.

(1) Prerequisites:
(a) An individual shall submit an application for re-examination and renewal of
certification at least six months prior to the expiration date of certification. The Agency
shall waive this requirement if the applicant satisfies the requirements of 105 CMR
120.321(A). An individual may not legally perform industrial radiography without valid
certification.
(b) Each applicant shall submit a complete and legible application with the fee for
renewal of certification in accordance with 105 CMR 120.321(A).
(2) Re-examination. Applicants for renewal of certification shall meet the requirements of
105 CMR 120.321(H)(1) including re-examination as described in 105 CMR 120.321(L)(1).
(3) An I.D. card shall be issued to each person who successfully completes the examination
prescribed in 105 CMR 120.321(E).
(4 ) Each person's I.D. card shall contain his/her photograph. The Agency will take the
photograph at the time the examination is administered.
(5) The I.D. card remains the property of the Commonwealth of Massachusetts and may be
revoked or suspended under the provisions of 105 CMR 120.322.
(6) A fee of $15.00 shall be paid to the Agency for each replacement of a lost I.D. card.

120.322: Revocation or Suspension of an I.D. Card

(A) Any radiographer who violates 105 CMR 120.000 may be required to show cause at a
formal hearing why his/her I.D. card should not be revoked or suspended.

(B) When an Agency order has been issued for an industrial radiographer to cease and desist
from the use of radioactive material or revoking or suspending his/her I.D. card, the industrial
radiographer shall surrender the I.D. card to the Agency until such time as the order is changed
or the suspension expires.

(C) The Agency may act to suspend or revoke an individual's certification for any one or a
combination of the following causes:
(1) Knowingly causing a material misstatement or misrepresentation to be made in the
application for initial certification or renewal of certification if such misstatement or
misrepresentation would impair the Agency's ability to assess and evaluate the applicant's
qualifications for certification pursuant to 105 CMR 120.321;
(2) Knowingly falsifying records of employees when such falsification would impair the
Agency's ability to assess and evaluate the applicant's qualifications for certification pursuant
to 105 CMR 120.321;
(3) Willfully evading the statute or regulations pertaining to certification, or willfully aiding
another person in evading such statute or regulations pertaining to certification;
(4) Exhibiting significant or repeated incompetence in the performance of industrial
radiography duties;
(5) Performing industrial radiography in such a manner that requirements of 105 CMR
120.300 are violated resulting in a threat to health and safety of the individual, other workers
or the public;
(6) Having had a similar certification suspended or revoked if the grounds for that
suspension or revocation are the same or equivalent to one or more grounds for suspension
or revocation as set forth in 105 CMR 120.016(C);
(7) Failure to maintain the out-of-state certification upon which certification by reciprocity
was issued;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.322: continued

(D) If, based upon any of the grounds in 105 CMR 120.322(C), the Agency determines that
action to suspend or revoke certification is warranted, the Agency shall notify the individual and
shall provide an opportunity for a hearing in accordance with 801 CMR 1.01 et seq. An
opportunity for a hearing shall be provided before the Agency takes action to suspend or revoke
an individual's certification unless the Agency finds that an immediate suspension of certification
is required to protect against immediate danger to the public health or safety, in which case the
Agency shall suspend an individual's certification pending a hearing.

(E) If the Agency finds that removal of certification is warranted, the usual action shall be a
suspension of certification for up to one year. The term of suspension may be reduced by the
Director of the Radiation Control Program, upon the recommendation of the hearing officer, if
the hearing officer finds, based upon evidence presented to him/her during a hearing, that the
conditions leading to the Preliminary Order for Suspension can be cured in less than one year.
However, if the Agency finds that the causes are of a serious or continuous nature, such as past
actions which posed an immediate threat to occupational or public health or safety, deficiencies
that cannot be cured within one year, the Agency shall revoke the individual's certification.

(F) When an individual's certification is suspended or revoked, the individual shall surrender
his/her certification document to the Agency until the termination of the suspension period or
until reissuance of the certification.

(G) An individual whose certification has been revoked may seek reinstatement of certification
by filing with the Agency a petition for reinstatement. Such petition may be filed one year or
more after the beginning of the revocation period.

120.323: Personnel Monitoring

(A) The personnel monitoring program shall meet the applicable requirements of 105 CMR
120.200.

(B) When performing industrial radiographic operations the following shall apply:
(1) The licensee or registrant shall not permit an individual to act as a radiographer, or
radiographer trainee unless each individual wears, on the trunk of the body at all times during
radiographic operations, a combination of a direct-reading pocket dosimeter or an electronic
personal dosimeter, an alarming ratemeter, and a personnel monitoring badge that is
processed and evaluated by an accredited NVLAP processor. At permanent radiography
installations where other appropriate alarming or warning devices are in routine use, the
wearing of an alarming ratemeter is not required.
(2) Pocket dosimeters shall meet the criteria in ANSI N13.5-1972 and shall have a range
of zero to two millisieverts (zero to 200 millirems).
(3) Pocket dosimeters shall be recharged at the start of each work shift.
(4) Exposure indicated by each pocket dosimeter shall be recorded at the beginning of and
at the end of each work shift.
(5) If an individual's pocket dosimeter is discharged beyond its range (i.e., goes "off-scale"),
or if an individual’s electronic personal dosimeter reads greater than two millisieverts (200
mrem), industrial radiographic operations by that individual shall cease and the individual's
personnel monitoring badge shall be processed immediately. The individual shall not return
to work with sources of radiation until a determination of his/her radiation exposure has been
made.
(6) Each personnel monitoring badge shall be assigned to and worn by only one individual.
(7) If a personnel monitoring badge is lost or damaged, the worker shall cease work
immediately until a replacement personnel monitoring badge is provided and the exposure
is calculated for the time period from issuance to loss or damage of the personnel monitoring
badge.
(8) Each alarm dosimeter must:
(a) Be checked to ensure that the alarm functions properly (sounds) prior to use at the
start of each shift.
(b) Emit an alarm signal at a preset dose rate of five mSv/hr (500 mr/hr).
(c) Require special means to change the preset alarm function; and
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.323: continued

(d) Be tested at periods not to exceed one year for correct response to radiation.
Acceptable dosimeters must alarm within plus or minus 20% of the true radiation dose
rate.

(C) Records of pocket dosimeter readings of personnel exposures shall be maintained for five
years by the licensee or registrant for Agency inspection. If the dosimeter readings were used
to determine external radiation dose (i.e., no TLD, OSL or film badge exposure records exist),
the records shall be maintained until the Agency authorizes disposal.

(D) Pocket dosimeters shall be checked for correct response to radiation at periods not to
exceed one year. Acceptable dosimeters shall read within plus or minus 20% of the true
radiation exposure. Records of pocket dosimeter calibrations shall be maintained for five years
by the licensee or registrant for Agency inspection.

(E) Processors of film badge, TLD and OSL devices must be certified by the NVLAP.

120.325: Operating and Emergency Procedures

(A) Operating and emergency procedures must include, as a minimum, instructions in the
following:
(1) Appropriate handling and use of sources of radiation for industrial radiography so that
no person is likely to be exposed to radiation doses in excess of the limits established in 105
CMR 120.200;
(2) Methods and occasions for conducting radiation surveys;
(3) Methods for posting and controlling access to radiographic areas;
(4) Methods and occasions for locking and securing sources of radiation;
(5) Personnel monitoring and the use of personnel monitoring equipment;
(6) Transporting equipment to field locations, including packing of radiographic exposure
devices and storage containers in the vehicles, placarding of vehicles when required, and
control of the equipment during transportation as described in 105 CMR 120.770;
(7) The inspection, maintenance, and operability checks of radiographic exposure devices
and associated equipment, radiation machines, survey instruments, alarming ratemeters,
transport containers, and storage containers and source changers;
(8) Steps that must be taken immediately by radiography personnel in the event a pocket
dosimeter is found to be off-scale or an alarming ratemeter alarms unexpectedly;
(9) The procedure(s) for identifying and reporting defects and noncompliance, as required
by 105 CMR 120.385;
(10) The procedure for notifying proper persons in the event of an accident or incident;
(11) Minimizing exposure of persons in the event of an accident or incident, including a
source disconnect, a transport accident, or loss of a source of radiation;
(12) Source recovery procedure if licensee will perform source recoveries;
(13) Maintenance of records; and,
(14) The procedures for calculating exposures as required by 105 CMR 120.323(B), when
a personnel monitoring badge is lost or damaged.

(B) The licensee or registrant shall maintain copies of current operating and emergency
procedures in accordance with 105 CMR120.367 and 105 CMR120.371.

120.326: Supervision of Radiographer Trainee

The radiographer’s assistant shall be under the personal supervision of a radiographer when
using sources of radiation, including radiation machines, radiographic exposure devices,
associated equipment, or related handling tools, or while conducting radiation surveys required
by 105 CMR 120.333(B) to determine that the sealed source has returned to the shielded position
or the radiation machine has stopped producing radiation after an exposure. The personal
supervision must include:

(A) The radiographer's physical presence at the site where the sources of radiation are being
used;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.326: continued

(B) The availability of the radiographer to give immediate assistance if required; and

(C) he radiographer's direct observation of the trainee's performance of the operations referred
to in this section.

120.328: Conducting Industrial Radiographic Operations

(A) Whenever radiography is performed at a location other than a permanent radiographic

installation, the radiographer must be accompanied by at least one other qualified radiographer
or an individual who has at a minimum met the requirements of 105 CMR120.320(C). The
additional qualified individual shall observe the operations and be capable of providing
immediate assistance to prevent unauthorized entry. Radiography may not be performed if only
one qualified individual is present.

(B) All radiographic operations must be conducted in a permanent radiographic installation

unless otherwise specifically authorized by the Agency.

(C) Except when physically impossible, collimators shall be used in industrial radiographic
operations that use radiographic exposure devices that allow the source to be moved out of the
device.

(D) A licensee or registrant may conduct lay-barge, offshore platform, or underwater

radiography only if procedures have been approved by the Agency, the Nuclear Regulatory
Commission, or by another Agreement State.

120.331: Surveillance

(A) During each industrial radiographic operation, a radiographer or radiographer trainee shall
maintain visual surveillance of the operation to protect against unauthorized entry into a radiation
area or high radiation area, except where the high radiation area is equipped with a control device
or alarm system as described in 105 CMR 120.227(A) or (B).

(B) Radiographic exposure devices shall not be left unattended except when in storage or
physically secured against unauthorized removal.

(C) The sealed source shall be secured and immobilized in its shielded position in the
radiographic exposure device with an appropriate locking or latching mechanism each time the
sealed source is returned to its shielded position.

(D) Notwithstanding the requirements of 105 CMR 120.243(A), High Radiation Area warnings
may be placed at the periphery of the Radiation Area, or at the perimeter of access control.

120.332: Posting

Areas in which industrial radiography is being performed shall be posted conspicuously in

accordance with 105 CMR 120.200 including:

(A) Radiation Areas. Each radiation area shall be posted conspicuously with a sign or signs
displaying the radiation symbol and the words:

CAUTION (OR DANGER)

RADIATION AREA

Radiation Area means any area, accessible to individuals, in which radiation levels could result
in an individual receiving a dose equivalent in excess of 0.05 mSv (0.005 rem) in one hour at 30
centimeters from the source of radiation or from any surface that the radiation penetrates.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.332: continued

(B) High Radiation Area. Each high radiation area shall be posted conspicuously with a sign
or signs displaying the radiation symbol and the words:

CAUTION (OR DANGER)

HIGH RADIATION AREA

High Radiation Area means an area, accessible to individuals, in which radiation levels could
result in an individual receiving a dose equivalent in excess of one mSv (0.1 rem) in one hour
at 30 centimeters from any source of radiation or from any surface that the radiation penetrates.

(C) Ropes and/or barriers shall be used as necessary to prevent unauthorized entry to radiation
areas.

(D) Notwithstanding the requirements of 105 CMR 120.242(A), each radiation area may be
posted in accordance with 105 CMR 120.242(B), i.e., High Radiation Area warnings may be
placed at the periphery of the controlled area.

120.333: Radiation Surveys and Survey Records

(A) No radiographic operation shall be conducted unless at least one calibrated and operable
radiation survey meter, as described in 105 CMR 120.314, is available and used at each site
where radiographic exposures are made.

(B) A survey with a radiation survey instrument shall be made after each radiographic exposure
to determine that the sealed source has been returned to its shielded position. The entire
circumference of the radiographic exposure device, including the source guide tube and
collimator if provided, shall be surveyed.

(C) A survey shall be made of the storage area as defined in 105 CMR 120.302 whenever a
radiographic exposure device is being placed in storage.

(D) A physical radiation survey shall be made after each radiographic exposure using radiation
machines to determine that the machine is "off."

(E) (1) All potential radiation areas in which industrial radiographic operations are to be
performed shall be posted in accordance with 105 CMR 120.332, based on calculated dose
rates, before industrial radiographic operations begin. An area survey shall be performed
during the first radiographic exposure (i.e., with the sealed source in the exposed position)
to confirm that 105 CMR 120.332 requirements have been met and that unrestricted areas
do not have radiation levels in excess of the limits specified in 105 CMR 120.221(A).
Surveys to confirm the extent of the High Radiation Area, one mSv/hr (100 mr/hr), within
the Radiation Area should not be undertaken.
(2) Each time the exposure device is relocated and/or the exposed position of the sealed
source is changed, the requirements of 105 CMR 120.333(E)(1) shall be met.
(3) The requirements of 105 CMR 120.333(E)(2) do not apply to pipeline industrial
radiographic operations when the conditions of exposure including, but not limited to, the
radiographic exposure device, duration of exposure, source strength, pipe size, and pipe
thickness remain constant.

(F) A survey with a radiation survey instrument shall be made to determine that the sealed
source has been returned to its shielded position any time a radiographic exposure device is
placed in storage. The entire circumference of the radiographic exposure device, including the
source guide tube and collimator if provided, shall be surveyed.

(G) If a vehicle is to be used for storage of radioactive material, a vehicle survey shall be
performed after securing radioactive material in the vehicle and before transport to ensure that
radiation levels do not exceed the limits specified in 105 CMR 120.221(A) at the exterior surface
of the vehicle.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.333: continued

(H) Surveys shall be performed on storage containers to ensure that radiation levels do not
exceed the limits specified in 105 CMR 120.221(A). These surveys shall be performed initially
with the maximum amount of radioactive material present in the storage location and thereafter
at the time of the quarterly inventory and whenever storage conditions change.

(I) A survey meeting the requirements of 105 CMR 120.333(F) shall be performed on the
radiographic exposure device and the source changer after every sealed source exchange.

(J) Records shall be kept of the surveys required by 105 CMR 120.333(E), (F), (G), (H), (I) and
105 CMR 120.318(A). These records shall be maintained for Agency inspection for five years
after completion of the survey. If a survey was used to determine an individual's exposure due
to loss of personnel monitoring data, the records of the survey shall be maintained until the
Agency authorizes disposal.

120.334: Records Required at Temporary Job Sites

Each licensee and registrant conducting industrial radiography at a temporary job site shall
have the following records available at that site for Agency inspection:

(A) The appropriate license or certificate of registration or equivalent document;

(B) The appropriate operating and emergency procedures;

(C) The applicable Agency rules;

(D) The survey records required pursuant to 105 CMR 120.333 for the period of operation at
the site;

(E) The daily pocket dosimeter records for the period of operation at the site; and,

(F) The most recent records of instrument and device calibration and source leak tests.
Acceptable records include tags or labels which are attached to the devices or survey instruments
and decay charts for sources which have been manufactured within the last six months.

120.337: Special Requirements and Exemptions for Enclosed Radiography

(A) Systems for enclosed radiography, including shielded-room radiography and cabinet x-ray
systems not otherwise exempted, shall comply with all applicable requirements of 105 CMR
120.300.

(B) Systems for enclosed radiography designed to allow admittance of individuals shall be
evaluated at intervals not to exceed one year to ensure compliance with the applicable
requirements of 105 CMR 120.300, 120.221(A) and 120.222. Records of these evaluations shall
be maintained for Agency inspection for five years after the evaluation.

(C) Certified cabinet x-ray systems are exempt from the requirements of 105 CMR 120.300
except that:
(1) The registrant shall comply with the requirements of 105 CMR 120.020 and 120.200.
(2) Tests for proper operation of interlocks must be conducted and recorded in accordance
with 105 CMR 120.319. Records of these tests shall be maintained for Agency inspection
until disposal is authorized by the Agency.
(3) The registrant shall perform an evaluation to determine compliance with 21 CFR
1020.40 at intervals not to exceed one year. Records of these evaluations shall be maintained
for Agency inspection for five years after the evaluation.

(D) Certified cabinet x-ray systems shall be maintained in compliance with 21 CFR 1020.40
and no modification may be made to the system unless prior agency approval has been granted
by the Agency pursuant to 105 CMR 120.020.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.340: Underwater and Lay-barge Radiography

(A) Underwater and/or lay-barge radiography shall not be performed unless specifically
authorized in a license issued by the agency in accordance with 105 CMR 120.360.

(B) In addition to the other requirements of 105 CMR 120.300, the following requirements
apply to the performance of lay-barge radiography:
(1) Cobalt-60 sources with activities in excess of 740 GBq (20 Ci) (nominal) and
iridium-192 sources with activities in excess of 3.70 TBq (100 Ci) (nominal) shall not be
used in the performance of offshore platform or lay-barge radiography.
(2) Collimators shall be used for all industrial radiographic operations performed on
lay-barges.

120.350: Prohibitions

(A) Industrial radiography performed with a sealed source that is not fastened to or contained
in a radiographic exposure device (fishpole technique) is prohibited unless specifically
authorized in a license issued by the agency.

(B) Retrieval of disconnected sources or sources that cannot be returned by normal means to
a fully shielded position or automatically secured in the radiographic exposure device, shall not
be performed unless specifically authorized by a license condition.

RECORDKEEPING REQUIREMENTS

120.360: Records for Industrial Radiography

Each licensee or registrant shall maintain a copy of its license or registration, documents
incorporated by reference, and amendments to each of these items until superseded by new
documents approved by the Agency, or until the Agency terminates the license or registration.

120.361: Records of Receipt, Transfer, and Disposal of Sources of Radiation

(A) Each licensee or registrant shall maintain records showing the receipts, transfers and
disposal of sealed sources, devices using DU for shielding, and radiation machines, and retain
each record for five years after it is made.

(B) These records must include the date, the name of the individual making the record,
radionuclide, number of becquerels (curies) or mass (for DU), and manufacturer, model, and
serial number of each source of radiation and/or device, as appropriate.

120.362: Records of Radiation Survey Instruments

Each licensee or registrant shall maintain records of the calibrations of its radiation survey
instruments that are required under 105 CMR 120.314 and retain each record for three years after
it is made.

120.363: Records of Leak Testing of Sealed Sources and Devices Containing DU

Each licensee shall maintain records of leak test results for sealed sources and for devices
containing DU. The results must be stated in units of becquerels (mCi). The licensee shall retain
each record for five years after it is made or until the source in storage is removed.

120.364: Records of Quarterly Inventory

(A) Each licensee or registrant shall maintain records of the quarterly inventory of sources of
radiation, including devices containing depleted uranium as required by 105 CMR 120.316 and
retain each record for five years.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.364: continued

(B) The record must include the date of the inventory, name of the individual conducting the
inventory, radionuclide, number of becquerels (curies) or mass (for DU) in each device, location
of sources of radiation and/or devices, and manufacturer, model, and serial number of each
source of radiation and/or device, as appropriate.

120.365 Utilization Logs

Each licensee and registrant shall maintain current logs of the use of each source of radiation.
The logs shall include:

(A) A unique identification (e.g., serial number) of each radiation machine, each radiographic
exposure device in which a sealed source is located, and each sealed source;

(B) The name of the radiographer using the source of radiation;

(C) The location(s) where each source of radiation is used and dates of use; and,

(D) The date(s) each source of radiation is removed from storage and returned to storage. For
fixed installations, the date(s) each source of radiation is energized or used and the number of
exposures made. Utilization logs may be kept on form MRCP 120.300-2, Utilization Log, or on
clear, legible records containing all the information required by 105 CMR 120.365(A) through
(D). Copies of utilization logs shall be maintained for Agency inspection for five years. The
records shall be kept at the location specified by the license or certificate of registration.

120.366: Records of Inspections and Maintenance of Radiation Machines, Radiographic Exposure Devices,
Transport and Storage Containers, associated Equipment, Source Changers, and Survey
Instruments

(A) Each licensee or registrant shall maintain records specified in 105 CMR 120.318 of
equipment problems found in daily checks and quarterly inspections of radiation machines,
radiographic exposure devices, transport and storage containers, associated equipment, source
changers, and survey instruments; and retain each record for three years after it is made.

(B) The record must include the date of check or inspection, name of inspector, equipment
involved, any problems found, and what repair and/or maintenance, if any, was performed.

120.367: Records of Alarm System and Entrance Control Tests at Permanent Radiographic Installations

Each licensee or registrant shall maintain records of alarm system and entrance control device
tests required by 105 CMR 120.319 and retain each record for three years after it is made.

120.368: Records of Training and Certification

Each licensee or registrant shall maintain the following records for five years:

(A) Records of training of each radiographer and each radiographer trainee. The record must
include radiographer certification documents and verification of certification status, copies of
written tests and the dates of oral and practical examinations administered by the licensee or
registrant, the names of individuals conducting and receiving the oral and practical examinations,
and a list of items tested and the results of the oral and practical examinations; and,

(B) Records of annual refresher safety training and semi-annual inspections of job performance
for each radiographer and each radiographer's assistant. The records must list the topics
discussed during the refresher safety training, the dates the annual refresher safety training was
conducted, and names of the instructors and attendees. For inspections of job performance, the
records must also include a list showing the items checked and any non-compliance observed
by the radiation safety officer or designee.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.369: Copies of Operating and Emergency Procedures

Each licensee or registrant shall maintain a copy of current operating and emergency
procedures until the Agency terminates the license or registration. Superseded material must be
retained for five years after the change is made.

120.370: Records of Personnel Monitoring

Each licensee or registrant shall maintain the following exposure records specified in 105
CMR 120.323:

(A) Direct reading dosimeter readings and yearly operability checks required by 105 CMR
120.323(B)(8) for five years after the record is made;

(B) Records of alarming ratemeter calibrations for five years after the record is made;

(C) Reports received from the personnel monitoring badge processor until the Agency
terminates the license or registration; and,

(D) Records of estimates of exposures as a result of off-scale personal direct reading

dosimeters, or lost or damaged personnel monitoring badges until the Agency terminates the
license or registration.

120.371: Records of Radiation Surveys

Each licensee or registrant shall maintain a record of each survey as specified in 105 CMR
120.333(E). Each record must be maintained for five years after it is made.

120.372: Form of Records

Each record required by 105 CMR 120.360 through 120.372 must be legible throughout the
specified retention period. The record may be the original or a reproduced copy or a microform
provided that the copy or microform is authenticated by authorized personnel and that the
microform is capable of reproducing a clear copy throughout the required retention period. The
record may also be stored in electronic media with the capability for producing legible, accurate,
and complete records during the required retention period. Records, such as letters, drawings,
and specifications, must include all pertinent information, such as stamps, initials, and
signatures. The licensee or registrant shall maintain adequate safeguards against tampering with
and loss of records.

120.373: Location of Documents and Records

(A) Each licensee or registrant shall maintain copies of records required by 105 CMR 120.300
and other applicable Parts of 120.CMR 120.000 at the location specified in 105 CMR
120.305(K).

(B) Each licensee or registrant shall also maintain current copies of the following documents
and records sufficient to demonstrate compliance at each applicable field station and each
temporary jobsite;
(1) The license or registration authorizing the use of sources of radiation;
(2) A copy of 105 CMR120.001 105 CMR120.200, 105 CMR120.300 and 105 CMR
120.750;
(3) Utilization logs for each source of radiation dispatched from that location as required
by 105 CMR120.317;
(4) Records of equipment problems identified in daily checks of equipment as required by
105 CMR120.366(A);
(5) Records of alarm system and entrance control checks required by 105 CMR120.366, if
applicable;
(6) Records of dosimeter readings as required by 105 CMR120.369;
(7) Operating and emergency procedures as required by 105 CMR120.325;
(8) Evidence of the latest calibration of the radiation survey instruments in use at the site,
as required by 105 CMR120.362;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.373: continued

(9) Evidence of the latest calibrations of alarming ratemeters and operability checks of
dosimeters as required by 105 CMR120.369;
(10) Survey records as required by 105 CMR120.370, for the period of operation at the site;
(11) The shipping papers for the transportation of radioactive materials required by 105
CMR 120.770; and,
(12) When operating under reciprocity pursuant to 105 CMR120.100, a copy of the
applicable State license or registration, or Nuclear Regulatory Commission license
authorizing the use of sources of radiation

120.380: Radiation Safety Officer

The radiation safety officer shall ensure that radiation safety activities are being performed
in accordance with approved procedures and regulatory requirements in the daily operation of
the licensee's or registrant’s program.

(A) The minimum qualifications, training, and experience for radiation safety officers for
industrial radiography are as follows:
(1) Completion of the training and testing requirements of 105 CMR 120.320(B);
(2) 2000 hours of hands-on experience as a qualified radiographer in industrial radiographic
operations; and,
(3) Formal training in the establishment and maintenance of a radiation protection program.

(B) The Agency will consider alternatives when the radiation safety officer has appropriate
training and experience in the field of ionizing radiation, and in addition, has adequate
experience and knowledge with respect to the establishment and maintenance of a radiation
safety protection program.

(C) The specific duties of the RSO include, but are not limited to, the following:
(1) To establish and oversee operating, emergency, and ALARA procedures as required by
105 CMR 120.200, and to review them regularly to ensure that the procedures are current and
conform to Agency regulations and to the license or registration conditions;
(2) To oversee and approve all phases of the training program for radiographic personnel
so that appropriate and effective radiation protection practices are taught;
(3) To ensure that required radiation surveys and leak tests are performed and documented
in accordance with 105 CMR 120.000, including any corrective measures when levels of
radiation exceed established limits;
(4) To ensure that personnel monitoring devices are calibrated and used properly by
occupationally-exposed personnel, that records are kept of the monitoring results, and that
timely notifications are made as required by 105 CMR 120.200;
(5) To ensure that any required interlock switches and warning signals are functioning and
that radiation signs, ropes, and barriers are properly posted and positioned;
(6) To investigate and report to the Agency each known or suspected case of radiation
exposure to an individual or radiation level detected in excess of limits established by these
rules and each theft or loss of source(s) of radiation, to determine the cause, and to take steps
to prevent its recurrence;
(7) To have a thorough knowledge of management policies and administrative procedures
of the licensee or registrant;
(8) To assume control and have the authority to institute corrective actions including
shutdown of operations when necessary in emergency situations or unsafe conditions;
(9) To maintain records as required by 105 CMR 120.000.
(10) To ensure the proper storing, labeling, transport, and use of exposure devices and
sources of radiation;
(11) To ensure that quarterly inventory and inspection and maintenance programs are
performed in accordance with 105 CMR 120.316 and 120.318; and,
(12) To ensure that personnel are complying with 105 CMR 120.000, the conditions of the
license or the registration, and the operating and emergency procedures of the licensee or
registrant.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.385: Notification of Incidents

(A) The Agency shall be notified of the loss or theft of sources of radiation, overexposures, and
excessive levels in accordance with 105 CMR 120.281, 120.282, 120.283, and 120.288.

(B) In addition, each licensee or registrant shall submit a written report within 30 days to the
Agency whenever one of the following events occurs:
(1) A source assembly cannot be returned to the fully-shielded position and properly
secured;
(2) The source assembly becomes unintentionally disconnected from the drive cable;
(3) Any component critical to safe operation of the radiographic exposure device fails to
properly perform its intended function; or,
(4) An indicator on a radiation-producing machine fails to show that radiation is being
produced, an exposure switch fails to terminate production of radiation when turned to the
off position, or a safety interlock fails to terminate x-ray production.

(C) The licensee or registrant shall include the following information in each report submitted
in accordance with 105 CMR 120.385(B):
(1) A description of the equipment problem;
(2) Cause of each incident, if known;
(3) Manufacturer and model number of equipment involved in the incident;
(4) Location, time, and date of the incident;
(5) Actions taken to establish normal operations;
(6) Corrective actions taken or planned to prevent recurrence; and,
(7) Names and qualifications of personnel involved in the incident.

120.390: Reciprocity

All reciprocal recognition of licenses and certificates of registration by the Agency will be
granted in accordance with 105 CMR 120.190 and 120.033.

120.400: X-RAYS IN THE HEALING ARTS

120.401: Purpose and Scope

105 CMR 120.400 establishes requirements, for which a registrant is responsible, for use of
x-ray equipment by or under the supervision of an individual authorized by and licensed in
accordance with Commonwealth statutes to engage in the healing arts or veterinary medicine.
The provisions of 105 CMR 120.400 are in addition to, and not in substitution for, other
applicable provisions of 105 CMR 120.000.

120.402: Definitions

As used in 105 CMR 120.400, the following definitions apply:

Accessible Surface means the external surface of the enclosure or housing provided by the
manufacturer.

Accessory Component means:

(1) A component used with diagnostic x-ray systems, such as a cradle or film changer, that
is not necessary for the compliance of the system with applicable provisions of 105 CMR
120.400 but which requires an initial determination of compatibility with the system; or
(2) A component necessary for compliance of the system with applicable provisions of
105 CMR 120.400 but which may be interchanged with similar compatible components
without affecting the system's compliance, such as one of a set of interchangeable
beam-limiting devices; or
(3) A component compatible with all x-ray systems with which it may be used and that does
not require compatibility or installation instructions, such as a tabletop cassette holder.

Added Filtration means any filtration which is in addition to the inherent filtration.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.402: continued

Air Kerma means kerma in air (see definition of Kerma)

Air Kerma Rate (AKR) means the air kerma per unit time.

Aluminum Equivalent means the thickness of type 1100 aluminum alloy1 affording the same
attenuation, under specified conditions, as the material in question.

Approved Provider means a post-secondary institution of higher learning, a provider approved

by the American Society of Radiologic Technologists (ASRT), a provider of Category I CME
approved by the American Academy of Physician Assistants (AAPA), a provider accredited by
the Accreditation Council for Continuing Medical Education (ACCME) or ACCME-recognized
state medical society (SMS), a provider of Category 1 CME approved by the American Medical
Association (AMA), or other recognized national continuing medical education approval body
approved by the Agency.

Assembler means any person engaged in the business of assembling, replacing, or installing one
or more components into an x-ray system or subsystem. The term includes the owner of an x-ray
system or his or her employee or agent who assembles components into an x-ray system that is
subsequently used to provide professional or commercial services.

Attenuation Block means a block or stack, having dimensions 20 centimeters by 20 centimeters

by 3.8 centimeters, of type 1100 aluminum alloy1 or other materials having equivalent
attenuation.

Automatic Exposure Control (AEC) means a device which automatically controls one or more
technique factors in order to obtain at a preselected location(s) a required quantity of radiation
(Includes devices such as phototimers and ion chambers).

Automatic Exposure Rate Control (AERC) means a device which automatically controls one or
more technique factors in order to obtain, at a preselected location(s), a required quantity of
radiation per unit time.

Barrier (See Protective Barrier).

Beam Axis means a line from the source through the centers of the x-ray fields.

Beam-limiting Device means a device which provides a means to restrict the dimensions of the
x-ray field.

Bone Densitometry System means a medical device which uses electronically-produced ionizing
radiation to determine the density of bone structures of human patients.

C-arm Fluoroscope means a fluoroscopic x-ray system in which the image receptor and x-ray
tube housing assembly are connected or coordinated. Such a system allows a change in the
direction of the beam axis with respect to the patient without moving the patient.

Cantilevered Tabletop means a tabletop designed such that the unsupported portion can be
extended at least 100 cm beyond the support.

Cassette Holder means a device, other than a spot-film device, that supports and/or fixes the
position of an x-ray film [imaging] cassette during an x-ray exposure.

Cephalometric Device means a device intended for the radiographic visualization and
measurement of the dimensions of the human head.

S)))))))))))))))))))))Q
1
The nominal chemical composition of type 1100 aluminum alloy is 99.00% minimum
aluminum, 0.12% copper.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.402: continued

Certified Components means components of x-ray systems which are subject to regulations
promulgated under Public Law 90-602, the Radiation Control for Health and Safety Act of 1968.

Certified System means any x-ray system which has one or more certified component(s).

Changeable Filters means any filter, exclusive of inherent filtration, which can be removed from
the useful beam through any electronic, mechanical, or physical process.

Coefficient of Variation or C means the ratio of the standard deviation to the mean value of a
population of observations. It is estimated using the following equation:

where

s = Estimated standard deviation of the population.

X = Mean value of observations in sample.
Xi = ith observation in sample.
n = Number of observations in sample.

Computed Tomography means the production of a tomogram by the acquisition and computer
processing of x-ray transmission data.

Contact Therapy System means an x-ray system used for therapy with the x-ray tube port placed
in contact with or within five centimeters of the surface being treated.

Control Panel means that part of the x-ray control upon which are mounted the switches, knobs,
pushbuttons, and other hardware necessary for manually setting the technique factors.

Contrast Scale (CS) means the change in the linear attenuation coefficient per CTN relative to
water; that is:

µx - µw
CS =
(CTN)x - (CTN)w

where:

µx = linear attenuation coefficient of the material of interest

µw = linear attenuation coefficient of water

(CTN)x = CTN of the material of interest

(CTN)w = CTN of water

Cooling Curve means the graphical relationship between heat units stored and cooling time.

CR means: Computed Radiography, an indirect type of imaging system. The receptor used
within a CR cassette is called a photostimulable imaging plate and it absorbs the radiation
exiting the patient. The exposed plate is processed in a CR reader, where the absorbed energy
is extracted. The resultant latent image data is converted from an analog to a digital signal and
a digital image is created.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.402: continued

Cradle means:
(1) A removable device which supports and may restrain a patient above an x-ray table; or
(2) A device;
(a) Whose patient support structure is interposed between the patient and the image
receptor during normal use;
(b) Which is equipped with means for patient restraint; and
(c) Which is capable of rotation about its long (longitudinal) axis.

CT means computed tomography; the production of a tomogram by the acquisition and

computer processing of x-ray transmission data.

CT Condition of Operation means all selectable parameters governing the operation of a CT

x-ray system including, but not limited to, nominal tomographic section thickness, filtration, and
the technique factors as defined in 105 CMR 120.400.

CT Gantry means the tube housing assemblies, beam-limiting devices, detectors, and the
supporting structures and frames which hold these components.

CT Number (CTN) means the number used to represent the x-ray attenuation associated with
each elemental area of the CT image, that is:

k (µx - µw)
CTN =
µw

where:

k = contrast (a value of 1,000 is assigned when the Hounsefield scale of CTN is

used)

µx = linear attenuation coefficient of the material of interest

µw = linear attenuation of water

Cumulative Air Kerma means the total air kerma accrued from the beginning of an examination
or procedure and includes all contributions from fluoroscopic and radiographic irradiation.

Dead-man Switch means a switch so constructed that a circuit closing contact can be maintained
only by continuous pressure on the switch by the operator.

Detector (See Radiation Detector).

Diagnostic Source Assembly means the tube housing assembly with a beam-limiting device
attached.

Diagnostic X-ray System means an x-ray system designed for irradiation of any part of the
human (or animal) body for the purpose of diagnosis or visualization.

Diagnostic X-ray Imaging System means an assemblage of components for the generation,
emission, and reception of x-ray and the transformation, storage, and visual display of the
resultant x-ray image.

Direct Scattered Radiation means that scattered radiation which has been deviated in direction
only by materials irradiated by the useful beam (See Scattered Radiation).

Dose means the absorbed dose as defined by the International Commission on Radiation Units
and Measurements. The absorbed dose, D, is the quotient of de by dm, where de is the mean
energy imparted to matter of mass dm; thus D=de/dm, in units of J/kg, where the special name
of the unit of absorbed dose is gray (Gy).
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.402: continued

DR means Direct Radiography or Digital Radiography, is a form of x-ray imaging where digital
x-ray sensors are used instead of traditional photographic film.

Elemental Area means the smallest area within a tomogram for which the x-ray attenuation
properties of a body are depicted.

Entrance Exposure Rate means the Exposure per unit time at the point where the center of the
useful beam enters the patient.

Equipment (See X-ray Equipment).

Exposure (X) means the quotient of dQ by dm where dQ is the absolute value of the total charge
of the ions of one sign produced in air when all the electrons and positrons liberated or created
by photons in air of mass dm are completely stopped in air; thus X=dQ/dm, in units of C/kg.
A second meaning of exposure is the process or condition during which the x-ray tube produces
x-ray radiation.

Facility means the location within one building or vehicle and under the same administrative
control at which one or more x-ray equipment systems are installed or located for the purpose
of diagnosis or treatment.

Field Emission Equipment means equipment which uses an x-ray tube in which electron
emission from the cathode is due solely to the action of an electric field.

Filter means material placed in the useful beam to absorb preferentially selected radiations.

Fluoroscopic Air Kerma Display Devices means separate devices, subsystems, or components
that provide the display of AKR and cumulative air kerma, respectively. They include radiation
detectors, if any, electronic and computer components, associated software, and data displays.

Fluoroscopic Imaging Assembly means a subsystem in which x-ray photons produce a

fluoroscopic images or radiographic images recorded from the fluoroscopic image receptor. It
includes the image receptor(s) such as the image intensifier and spot-film device, electrical
interlocks, if any, and structural material providing linkage between the image receptor and
diagnostic source assembly.

Fluoroscopic Irradiation Time means the cumulative duration during an examination or

procedure of operator-applied continuous pressure to the device, enabling x-ray tube activation
in any fluoroscopic mode of operation.

Fluoroscopic Procedure means the production and display of serial x-ray images for the purpose
of observing real-time motion of anatomical structures.

Fluoroscopy means a technique for generating x-ray images and presenting them simultaneously
and continuously as visible images. This term has the same meaning as the term "radioscopy"
in the standards of the International Electrotechnical Commission.

Focal Spot (Actual) means the area projected on the anode of the x-ray tube by the electrons
accelerated from the cathode and from which the useful beam originates.

General Purpose Radiographic X-ray System means any radiographic x-ray system which, by
design, is not limited to radiographic examination of specific anatomical regions.

Gonad Shield means a protective barrier for the testes or ovaries.

Half-value Layer means the thickness of specified material which attenuate the beam of
radiation to an extent such that the exposure rate is reduced to one-half of its original value. In
105 CMR 120.402: Half-value Layer, the contribution of all scattered radiation, other than any
which might be present initially in the beam concerned, is deemed to be excluded.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.402: continued

Hand-held X-ray Equipment means x-ray equipment that is designed to be hand-held during
operation.

Healing Arts Screening means the testing of human beings using x-ray machines for the
detection or evaluation of health indications when such tests are not specifically and individually
ordered by a licensed practitioner of the healing arts legally authorized by the Commonwealth
of Massachusetts to prescribe such x-ray tests for the purpose of diagnosis or treatment. to
prescribe such x-ray tests for the purpose of diagnosis or treatment.

Heat Unit means a unit of energy equal to the product of the peak kilovoltage, milliamperes, and
seconds, i.e., kVp x mA x second.

HVL (See Half-value Layer).

Image Intensifier means a device, installed in its housing, which instantaneously converts an
x-ray pattern into a corresponding light image of higher energy density.

Image Receptor means any device, such as a fluorescent screen, radiographic film, x-ray image
intensifier tube, solid-state detector, or gaseous detector which transforms incident x-ray
photons either into a visible image or into another form which can be made into a visible image
by further transformations. In those cases where means are provided to preselect a portion of
the image receptor, the term "image receptor" shall mean the preselected portion of the device.

Inherent Filtration means the filtration of the useful beam provided by the permanently installed
components of the tube housing assembly.

Interventional Procedures means procedures that utilize imaging for guidance. Imaging
includes, but is not limited to, fluoroscopy and CT.

Irradiation means the exposure of matter to ionizing radiation.

Isocenter means the center of the smallest sphere through which the beam axis passes when the
equipment moves through a full range of rotations about its common center.

Kerma means the quantity defined by the International Commission on Radiation Units and
Measurements. The kerma, K, is the quotient of dEtr by dm, where dEtr is the sum of the initial
kinetic energies of all the charged participles liberated by uncharged particles in a mass dm of
material; thus K=dEtr/dm, in units of J/kg, where the special name for the unit of kerma is gray
(Gy). When the material is air, the quantity is referred to as "air kerma."

Kilovolts Peak (See Peak Tube Potential).

kV means kilovolts.

kVp (See Peak Tube Potential).

kWs means kilowatt second.

Last Image Hold (LIH) radiograph means an image obtained either by retaining one or more
fluoroscopic images, which may be temporarily integrated, at the end of a fluoroscopic exposure
or by initiating a separate and distinct radiographic exposure automatically and immediately in
conjunction with termination of the fluoroscopic exposure.

Lateral Fluoroscope means the x-ray tube and image receptor combination in a biplane system
dedicated to the lateral projection. It consists of the lateral x-ray tube housing assembly and the
lateral image receptor that are fixed in position relative to the table with the x-ray beam axis
parallel to the plane of the table.

Lead Equivalent means the thickness of lead affording the same attenuation, under specified
conditions, as the material in question.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.402: continued

Leakage Radiation means radiation emanating from the diagnostic or therapeutic source
assembly except for:
(1) The useful beam; and,
(2) Radiation produced when the exposure switch or timer is not activated.

Leakage Technique Factors means the technique factors associated with the diagnostic or
therapeutic source assembly which are used in measuring leakage radiation. They are defined
as follows:
(1) For diagnostic source assemblies intended for capacitor energy storage equipment, the
maximum-rated peak tube potential and the maximum-rated number of exposures in an hour
for operation at the maximum-rated peak tube potential with the quantity of charge per
exposure being ten millicoulombs, i.e., ten milliampere seconds, or the minimum obtainable
from the unit, whichever is larger.
(2) For diagnostic source assemblies intended for field emission equipment rated for pulsed
operation, the maximum-rated peak tube potential and the maximum-rated number of x-ray
pulses in an hour for operation at the maximum-rated peak tube potential.
(3) For all other diagnostic or therapeutic source assemblies, the maximum-rated peak tube
potential and the maximum-rated continuous tube current for the maximum-rated peak tube
potential.

Linear Attenuation Coefficient (µ) means the quotient of dN/N by d1 when dN/N is the fraction
of uncharged ionizing radiation that experience interactions in traveling a distance d1 in a
specific material.

Light Field means that area of the intersection of the light beam from the beam-limiting device
and one of the set of planes parallel to and including the plane of the image receptor, whose
perimeter is the locus of points at which the illumination is one-fourth of the maximum in the
intersection.

Line-voltage Regulation means the difference between the no- load and the load line potentials
expressed as a percent of the load line potential. It is calculated using the following equation:
Percent line-voltage regulation = 100 (Vn-Vl)/Vl
where
Vn = No-load line potential and
Vl = Load line potential.

mA means milliampere.

mAs means milliampere second.

Maximum Line Current means the root-mean-square current in the supply line of an x-ray
machine operating at its maximum rating.

Mobile X-ray Equipment (See X-ray Equipment).

Mode of Operation means, for fluoroscopic systems, a distinct method of fluoroscopy or

radiography provided by the manufacturer and selected with a set of several technique factors
or other control settings uniquely associated with the mode. The set of distinct technique factors
and control settings for the mode may be selected by the operation of a single control. Examples
of distinct modes of operation include normal fluoroscopy (analog or digital), high-level control
fluoroscopy, cineradiography (analog and digital), digital subtraction angiography, electronic
radiography using the fluoroscopic image receptor, and photospot recording. In a specific mode
of operation, certain system variables affecting kerma, AKR, or image quality, such as image
magnification, x-ray field size, pulse rate, pulse duration, number of pulses, source-image
receptor distance (SID), or optical aperture, may be adjustable or may vary; their variation per
se does not comprise a mode of operation different from the one that has been selected.

Movable Tabletop means a tabletop which, when assembled for use, is capable of movement
with respect to its supporting structure within the plane of the tabletop.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.402: continued

Multiple Tomogram System means a computed tomography x-ray system which obtains x-ray
transmission data simultaneously during a single scan to produce more than one tomogram.

Nominal Tomographic Section Thickness means the full-width at half-maximum of the

sensitivity profile taken at the center of the cross sectional volume over which x-ray
transmission data are collected.

Nurse Practitioner means a person licensed as a Registered Nurse by the Massachusetts Board
in Nursing pursuant to M.G.L. c. 112, § 74, who is authorized by such Board to practice in an
advanced practice nursing role as a nurse practitioner pursuant to M.G.L. c. 112, § 80B, and
244 CMR 4.00: The Practice of Nursing in the Expanded Role.

NVLAP means National Voluntary Laboratory Accreditation Program.

Patient means an individual subjected to healing arts examination, diagnosis, or treatment.

PBL See 105 CMR 120.402: Positive Beam Limitation.

Peak Tube Potential means the maximum value of the potential difference across the x-ray tube
during an exposure.

Phantom means a volume of material behaving in a manner similar to tissue with respect to the
attenuation and scattering of radiation. This requires that both the atomic number (Z) and the
density of the material be similar to that of tissue.

Phototimer means a method for controlling radiation exposures to image receptors by the
amount of radiation which reaches a radiation monitoring device(s). The radiation monitoring
device(s) is part of an electronic circuit which controls the duration of time the tube is activated
(See Automatic Exposure Control).

Physician Assistant means a person licensed as a physician assistant by the Massachusetts Board
of Registration in Physician Assistants pursuant to M.G.L. c. 112, § 9I.

PID (See "Position indicating device").

Portable X-ray Equipment (See X-ray Equipment).

Position Indicating Device means a device on dental x-ray equipment used to indicate the beam
position and to establish a definite source-surface (skin) distance. It may or may not incorporate
or serve as a bean-limiting device.

Positive Beam Limitation means the automatic or semi-automatic adjustment of an x-ray beam
to the size of the selected image receptor, whereby exposures cannot be made without such
adjustment.

Post-secondary Institution of Higher Education means a degree granting institution duly

accredited by an accrediting agency recognized by the United States Department of Education.

Practitioner of the Healing Arts means an individual licensed to practice healing arts by the
Commonwealth of Massachusetts.

Primary Protective Barrier (See Protective Barrier).

Protective Apron means an apron made of radiation absorbing materials used to reduce radiation
exposure.

Protective Barrier means a barrier of radiation absorbing material(s) used to reduce radiation
exposure. The types of protective barriers are as follows:
(1) "Primary protective barrier" means the material, excluding filters, placed in the useful
beam;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.402: continued

(2) "Secondary protective barrier" means a barrier sufficient to attenuate the stray radiation.

Protective Glove means a glove made of radiation absorbing materials used to reduce radiation
exposure.

Pulsed Mode means operation of the x-ray system such that the x-ray tube current is pulsed by
the x-ray control to produce one or more exposure intervals of duration less than ½ second.

Qualified Medical Physicist means an individual is:

(1) Registered with the Agency, under the provisions of 105 CMR 120.026, as a provider
of radiation services in the area of calibration and compliance surveys and,
(2) Is certified by the American Board of Radiology in:
(a) Therapeutic medical physics; or
(b) Diagnostic medical physics; or
(c) Nuclear medical physics; or
(3) Is certified by the American Board of Medical Physics; or
(4) Is certified by the Canadian College of Medical Physics; or
(5) Hold a master's or doctor's degree in physics, biophysics, radiological physics,
Radiological Science, Nuclear Physics, health physics, or other catagory approved by the
Agency.

Radiation Detector means a device which in the presence of radiation provides a signal or other
indication suitable for use in measuring one or more quantities of incident radiation.

Radiation Therapy Simulation System means a radiographic or fluoroscopic x-ray system

intended for localizing the volume to be exposed during radiation therapy and confirming the
position and size of the therapeutic irradiation field.

Radiograph means an image receptor on which the image is created directly or indirectly by an
x-ray pattern and results in a permanent record.

Radiography means a technique for generating and recording an x-ray pattern for the purpose
of providing the user with an image(s) after termination of the exposure.

Radiographic Imaging System means any system whereby a permanent or semi-permanent

image is recorded on an image receptor by the action of ionizing radiation.

Rated Line Voltage means the range of potentials, in volts, of the supply line specified by the
manufacturer at which the x-ray machine is designed to operate.

Rated Output Current means the maximum allowable load current of the x-ray high-voltage
generator.

Rating means the operating limits as specified by the component manufacturer.

Recording means producing a retrievable form of an image resulting from x-ray photons.

Reference Plane means a plane which is displaced from and parallel to the tomographic plane.

Routine means diagnostic procedures utilizing x-ray equipment that are performed at least
weekly.

Scan means the complete process of collecting x-ray transmission data for the production of a
tomogram. Data can be collected simultaneously during a single scan for the production of one
or more tomogram.

Scan Increment means the amount of relative displacement of the patient with respect to the CT
x-ray system between successive scans measured along the direction of such displacement.

Scan Sequence means a preselected set of two or more scans performed consecutively under
preselected CT conditions of operation.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.402: continued

Scan Time means the period of time between the beginning and end of x-ray transmission data
accumulation for a single scan.

Scattered Radiation means radiation that, during passage through matter, has been deviated in
direction (See Direct Scattered Radiation).

Secondary Dose Monitoring System means a system which will terminate irradiation in the
event of failure of the primary system.

Secondary Protective Barrier (See Protective Barrier).

Shutter means a device attached to the tube housing assembly which can totally intercept the
useful beam and which has a lead equivalency not less than that of the tube housing assembly.

SID (See Source-image Receptor Distance).

Single Tomogram System means a CT x-ray system which obtains x-ray transmission data
during a scan to produce a single tomogram.

Solid State X-ray Imaging Device means an assembly, typically in a rectangular panel
configuration, that intercepts x-ray photons and converts the photon energy into a modulated
electronic signal representative of the x-ray intensity over the area of the imaging device. The
electronic signal is then used to create an image for display and/or storage.

Source means the focal spot of the x-ray tube.

Source-image Receptor Distance means the distance from the source to the center of the input
surface of the image receptor.

Source-skin Distance (SSD) means the distance from the source to the center of the entrant x-ray
field in the plane tangent to the patient skin surface.

Spot Film means a radiograph which is made during a fluoroscopic examination to permanently
record conditions which exist during that fluoroscopic procedure.

Spot-film Device means a device intended to transport and/or position a radiographic image
receptor between the x-ray source and fluoroscopic image receptor. It includes a device
intended to hold a cassette over the input end of the fluoroscopic image receptor for the purpose
of producing a radiograph.

SSD means the distance from the source to the center of the entrant x-ray field in the plan
tangent to the patient skin surface.

Stationary Tabletop means a tabletop which, when assembled for use, is incapable of movement
with respect to its supporting structure within the plane of the tabletop.

Stationary X-ray Equipment (See X-ray Equipment).

Stray Radiation means the sum of leakage and scattered radiation.

Supervising Physician means a physician who holds a full license issued by the Board of
Registration in Medicine and who supervises all professional activities of a physician assistant
in accordance with 243 CMR 2.08 and 263 CMR 5.00. For the purposes of 105 CMR 120.405,
a supervising physician shall meet the requirements of 120.405(K)(1)(a) or (b).

Technique Factors means the conditions of operation. They are specified as follows:
(1) For capacitor energy storage equipment, peak tube potential in kV and quantity of
charge in mAs;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.402: continued

(2) For field emission equipment rated for pulsed operation, peak tube potential in kV and
number of x-ray pulses;
(3) For CT equipment designed for pulsed operations, peaktube potential in kV, scan time
in seconds, and either tube current in milliamperes (mA), x-ray pulse width in seconds, and
the number of x-ray pulses per scan or the product of tube current, x-ray pulse width, and
the number of x-ray pulses in mAs;
(4) For CT equipment not designed for pulsed operation, peak tube potential in kV, and
either tube current in mA and scan time in seconds or the product of tube current and
exposure time in mAs and the scan time when the scan time and exposure time are
equivalent; and,
(5) For all other equipment, peak tube potential in kV and either tube current in mA and
exposure time in seconds, or the product of tube current and exposure time in mAs.

Termination of Irradiation means the stopping of irradiation in a fashion which will not permit
continuance of irradiation without the resetting of operating conditions at the control panel.

Tomogram means the depiction of the x-ray attenuation properties of a section through the body.

Tomographic Plane means that geometric plane which is identified as corresponding to the
output tomogram.

Tomographic Section means the volume of an object whose attenuation properties are imaged
in a tomogram.

Tube means an x-ray tube, unless otherwise specified.

Tube Housing Assembly means the tube housing with tube installed. It includes high-voltage
and/or filament transformers and other appropriate elements when such are contained within the
tube housing.

Tube Rating Chart means the set of curves which specify the rated limits of operation of the tube
in terms of the technique factors.

Useful Beam means the radiation emanating from the tube housing port or the radiation head
and passing through the aperture of the beam limiting device when the exposure controls are in
a mode to cause the system to produce radiation.

Variable-aperture Beam-limiting Device means a beam-limiting device which has capacity for
stepless adjustment of the x-ray field size at a given SID.

Visible Area means that portion of the input surface of the image receptor over which incident
x-ray photons are producing a visible image.

X-ray Exposure Control means a device, switch, button, or other similar means by which an
operator initiates and/or terminates the radiation exposure. The x-ray exposure control may
include such associated equipment as timers and back-up timers.

X-ray Control means a device which controls input power to the x-ray high-voltage generator
and/or the x-ray tube. It includes equipment such as timers, phototimer, automatic brightness
stabilizers, and similar devices, which control the technique factors of an x-ray exposure.

X-ray Equipment means an x-ray system, subsystem, or component thereof. Types of x-ray
equipment are as follows:
(1) "Mobile X-ray Equipment" means x-ray equipment mounted on a permanent base with
wheels and/or casters for moving while completely assembled.
(2) "Portable X-ray Equipment" means x-ray equipment designed to be hand-carried.
(3) "Stationary X-ray Equipment" means x-ray equipment which is installed in a fixed
location.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.402: continued

X-ray Field means that area of the intersection of the useful beam and any one of the set of
planes parallel to and including the plane of the image receptor, whose perimeter is the locus
of points at which the AKR is ¼ of the maximum in the intersection.

X-ray High-voltage Generator means a device which transforms electrical energy from the
potential supplied by the x-ray control to the tube operating potential. The device may also
include means for transforming alternating current to direct current, filament transformers for
the x-ray tube(s), high voltage switches, electrical protective devices, and other appropriate
elements.

X-ray System means an assemblage of components for the controlled production of x-rays. It
includes minimally an x-ray high-voltage generator, an x-ray control, a tube housing assembly,
a beam-limiting device, and the necessary supporting structures. Additional components which
function with the system are considered integral parts of the system.

X-ray Table means a patient support device with its patient support structure (tabletop)
interposed between the patient and the image receptor during radiography and/or fluoroscopy.
This includes, but is not limited to, any stretcher equipped with a radiolucent panel and any table
equipped with a cassette tray (or buckey), cassette tunnel, image intensifier, or spot-film device
beneath the tabletop.

X-ray Tube means any electron tube which is designed to be used primarily for the production
of x-rays.

120.403: General Requirements

(A) Administrative Controls.

(1) Registrant. The registrant shall be responsible for directing the operation of the x-ray
system(s) under his administrative control. The registrant or the registrant's agent shall
assure that the requirements of 105 CMR 120.403(A)(1) are met in the operation of the x-ray
system(s).
(a) An x-ray system which does not meet the provisions of 105 CMR 120.400 shall not
be operated for diagnostic or therapeutic purposes, unless otherwise approved by the
Radiation Control Program.
(b) Individuals who shall be operating the x-ray systems shall meet the requirements
of 105 CMR 125.000: Licensing of Radiologic Technologists.
(c) A chart shall be provided in the vicinity of the diagnostic x-ray system's control
panel which specifies, for all examinations performed with that system, the following
information:
1. Patient's body size and anatomical size, or body part thickness, or age (for
pediatrics), versus technique factors to be utilized;
2. Type and size of the image receptor to be used;
3. Type and size of the image receptor combination to be used; if any
4. Source to image receptor distance to be used (except for dental intra-oral
radiography); and
5. Type and location of placement of patient shielding (e.g. gonad, etc.) to be used.
(d) The registrant of a facility shall create and make available to x-ray operators written
safety procedures, including patient holding and any restrictions of the operating
technique required for the safe operation of the particular x-ray system. The operator
shall be able to demonstrate familiarity with these procedures. These procedures shall
be reviewed, updated, and documented annually by management.
(e) Except for patients who cannot be moved out of the room, only the staff, ancillary
personnel, and parents of pediatric patients whose presence might be required for the
medical procedure or training shall be in the room or area during the radiographic
exposure. Other than the patient being examined:
1. All individuals shall be positioned such that no part of the body will be struck
by the useful beam unless protected by 0.5 millimeter lead equivalent.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.403: continued

2. The x-ray operator, other staff, ancillary personnel, and other persons required
for the medical procedure shall be protected from the direct scatter radiation by
protective aprons or whole body protective barriers of not less than 0.25 millimeter
lead equivalent. For interventional procedures, lead glasses shall be used.
3. Human patients who cannot be removed from the room shall be protected from
the direct scatter radiation by whole body protective barriers of 0.25 millimeter lead
equivalent or shall be so positioned that the nearest portion of the body is at least
two meters from both the tube head and the nearest edge of the image receptor.
(f) Gonad shielding of not less than 0.50 millimeter lead equivalent shall be used for
patients, who have not passed the reproductive age, during radiographic procedures in
which the gonads are in the useful beam, except for cases in which this would interfere
with the diagnostic procedure.
(g) Individuals shall not be exposed to the useful beam except for healing arts purposes
and unless such exposure has been authorized by a licensed practitioner of the healing
arts. This provision specifically prohibits deliberate exposure for the following purposes:
1. Exposure of an individual for training, demonstration, or other non-healing-arts
purposes; and
2. exposure of an individual for the purpose of healing arts screening except as
authorized by 105 CMR 120.403(A)(1)(k).
(h) When a patient or image receptor must be provided with auxiliary support during
a radiation exposure:
1. Mechanical holding devices shall be used when the technique permits. The
written safety procedures, required by 105 CMR 120.403(A)(1)(d), shall list
individual projections, specific patient conditions, or psychological development
level where holding devices cannot be utilized;
2. Written safety procedures, as required by 105 CMR 120.403(A)(1)(d), shall
indicate the requirements for selecting a holder and the procedure the holder shall
follow;
3. The human holder shall be instructed in personal radiation safety and protected
as required by 105 CMR 120.403(A)(1)(e);
4. No individual shall be used routinely to hold film or patients;
5. In those cases where the patient must hold the film, except during intraoral
examinations, any portion of the body other than the area of clinical interest struck
by the useful beam shall be protected by not less than 0.5 millimeter lead equivalent
material; and,
6. Each facility shall have leaded aprons and gloves available in sufficient numbers
to provide protection to all personnel who are involved with x-ray operations and
who are otherwise not shielded.
(i) Procedures and auxiliary equipment designed to minimize patient and personnel
exposure commensurate with the needed diagnostic information shall be utilized.
1. An imaging system of appropriate speed consistent with the diagnostic objective
of the examinations shall be used. Film cassettes without intensifying screens shall
not be used for any routine diagnostic radiological imaging, with the exception of
veterinary radiography and standard film packets for intra-oral use in dental
radiography.
2. The radiation exposure to the patient shall be the minimum exposure required
to produce images of good diagnostic quality.
3. Protective equipment including aprons, gloves, and shields shall be x-rayed
annually for defects, such as holes, cracks, and tears to assure reliability and
integrity. A record of this test shall be maintained for inspection by the Radiation
Control Program. If such defect is found, equipment shall be replaced or removed
from service until repaired or replaced.
4. Radiographic systems other than fluoroscopic, dental intra-oral, or veterinarian
systems shall not be utilized in procedures where the source to patient distance is
less than 30 centimeters.
5. Mammographic procedures shall only be performed on special purpose
mammographic equipment.
6. Mobile or portable radiographic systems shall only be used for examinations
where it is impractical to transfer the patient(s) to a stationary x-ray installation.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.403: continued

7. If grids are used between the patient and the image receptor to decrease scatter
to the film and improve contrast, the grid shall:
a. Be positioned properly, i.e., tube facing the right direction, and grid centered
to the central ray;
b. If the grid is of the focused type, be of the proper focal distance for the SIDs
being used.
(j) All occupationally exposed individuals are subject to the requirements of 105 CMR
120.211, 120.215, 120.217 and 120.218.
(k) If the facility ceases to operate, the Registrant or Responsible person of the facility
must notify the Radiation Control Program within 15 days. Included in this notification,
is the name and address of the person who disposed of the x-ray unit.
(2) The registrant of the facility shall ensure that the equipment is in safe operating
condition:
(a) when it is first installed and prior to use on patients;
(b) after any major changes or replacement of parts and prior to use on patients:
(c) by having physics surveys, calibrations and preventative maintenance such physics
surveys and preventative maintenance shall be made annually:
1. The physics surveys shall be performed by a qualified medical physicist;
2. The preventative maintenance or calibration shall be performed by a registered
service provider as specified in 105 CMR 120.026.
(d) Physics surveys shall be reviewed and signed within a reasonable time of
completion of the tests but no longer than 30 days of completion of the tests by a
qualified medical physicist and a responsible person at the facility or responsible
physician, and any necessary corrective action shall be implemented within 30 days.
(e) Records of calibrations and preventative maintenance shall be maintained at the
facility for three years.
(3) Information and Maintenance Record and Associated Information. The registrant of
a facility shall maintain the following information for each x-ray system for inspection by
the Radiation Control Program:
(a) Model and serial numbers of all major components, and user’s manuals for those
components;
(b) Records of installation, surveys, calibrations, maintenance, and modifications
performed on the x-ray system(s) after the effective date of 105 CMR 120.000 with the
names of persons who performed such services;
(c) A copy of the service providers certificate of registration shall be maintained by the
facility.
(d) A scale drawing provided by a registered service provider or qualified medical
physicist of the room in which a stationary x-ray system is located with such drawing
indicating the current use of areas adjacent to the room and an estimation of the extent
of occupancy by an individual in such areas. In addition, the drawing shall include:
1. The results of a survey for radiation levels present at the operator's position and
at pertinent points outside the room at specified test conditions; or
2. The type and thickness of materials, or lead equivalency, of each protective
barrier; and,
(e) A copy of all correspondence with this Radiation Control Program regarding that
x-ray system.
(4) X-ray Utilization Log. Each facility shall maintain a record containing the patient's
name, the type of examinations, and the dates the examinations were performed. When the
patient or film must be provided with human auxiliary support, the name of the human
holder shall be recorded.
(5) Radiograph and Record Retention. Radiographs shall be retained for at least a
minimum of five years following last visit of the patient. The written reports become a part
of the patient's medical record and are to be retained for 20 years following last visit of
patient.
(6) Quality Assurance Program.
(a) All registrants of diagnostic x-ray imaging equipment shall establish and maintain
a quality assurance program consisting of quality control assessments addressing at least
the following items:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.403: continued

1. Written standard operating procedures on radiation protection and the practice

of radiologic technology reviewed, updated, and documented annually by
management.
2. Employee review and written acknowledgement of standard operating proce-
dures and policies on radiation protection and the practice of radiologic technology
shall be documented annually.
3. Credentialling of practitioners, medical physicists, and x-ray equipment
operators.
4. Film Processing equipment:
a. Compliance with 105 CMR 120.403(C);
b. Film processor performance to include medium density, density difference,
and base + fog;
c. Darkroom fog;
5. Radiographic equipment:
a. Compliance with performance standards in 105 CMR 120.404 and 120.406;
b. Entrance skin exposure rates of selected patient examinations;
c. Image printing and viewing equipment;
d. Measurement of low and high contrast resolution; and
e. Radiation protection.
6. Fluoroscopic equipment:
a. Compliance with performance standards in 105 CMR 120.405;
b. Entrance skin exposure rates of selected patient examinations;
c. Image printing and viewing equipment;
d. Measurement of low and high contrast resolution; and
e. Radiation protection.
7. Computerized tomography equipment:
a. Compliance with performance standards in 105 CMR 120.409;
b. CT number;
c. Low contrast and high contrast resolution;
d. Dosimetry of selected patient examinations to include pediatric patients if
applicable;
e. Image printing and viewing equipment; and
f. Radiation protection.
8. Bone densitometry equipment: Compliance with requirements in 105 CMR
120.410.
9. Structural shielding for new facilities with x-ray equipment:
a. Pre-construction shielding design and evaluation; and
b. Post-construction radiation protection survey.
10. Structural shielding for modifying use or equipment in existing facility:
a. Re-evaluation of shielding design; and
b. Post-modification radiation protection survey.
(b) The registrant of a facility shall assign qualified personnel to fully implement the
quality assurance program.
(c) Quality control assessments may be assigned to qualified personnel who possess
the requisite training and/or experience.
(d) Quality control assessments shall be conducted by or under the direction of, a
qualified medical physicist.
(e) The registrant of a facility and/or qualified medical physicist shall determine the
frequency of quality control tests but shall not be less stringent than the manufacturers
recommendations.
(f) The quality assurance program shall be in written form and available for review by
the Agency.
(g) Equipment used for compliance with the provisions of 105 CMR 120.403(6) shall
be properly calibrated and maintained in accordance with accepted professional
standards.
105 CMR 120.403(A)(6) does not pertain to quality assurance for mammography
equipment see 105 CMR 127.000.
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120.403: continued

(7) Healing Arts Radiologic Screening. Any person proposing to conduct a healing arts
screening program shall not initiate such a program without prior approval of the Radiation
Control Program. When requesting such approval, that person shall submit the information
outlined in 105 CMR 120.421: Appendix B. If any information submitted to the Radiation
Control Program becomes invalid or outdated, the Radiation Control Program shall be
immediately notified.

(B) Plan Review.

(1) Prior to construction, the floor plans and equipment arrangement of all new
installations, or modifications of existing installations, utilizing x-rays for diagnostic or
therapeutic purposes shall be submitted to the Radiation Control Program for review and
approval. The required information is denoted in 105 CMR 120.420: Appendix A and
105 CMR 120.422: Appendix B, unless specifically exempted.
(2) The Radiation Control Program may require the applicant to utilize the services of a
qualified expert to determine the shielding requirements prior to the plan review and
approval.
(3) The approval of such plans shall not preclude the requirement of additional
modifications should a subsequent analysis of operating conditions indicate the possibility
of an individual receiving a dose in excess of the limits prescribed in 105 CMR 120.211,
120.217, 120.218 and 120.221.

(C) X-ray Film Processing Facilities and Practices.

(1) Each installation using a radiographic x-ray system and using analog image receptors
(e.g. radiographic film) shall have available suitable equipment for handling and processing
radiographic film in accordance with the following provisions:
(a) Manually developed film:
1. Processing tanks shall be constructed of mechanically rigid, corrosion resistant
material; and
2. The temperature of solutions in the tanks shall be maintained within the range
of 60oF to 80oF (16oC to 27oC). Film shall be developed in accordance with the time-
temperature relationships recommended by the film manufacturer, or, in the absence
of such recommendations, with the following time-temperature chart:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.403: continued

Time-Temperature Chart
Thermometer Reading Minimum
(Degrees) Developing Time
o
C o
F (Minutes)

26.7 80 2
26.1 79 2
25.6 78 2½
25.0 77 2½
24.4 76 3
23.9 75 3
23.3 74 3½
22.8 73 3½
22.2 72 4
21.7 71 4
21.1 70 4½
20.6 69 4½
20.0 68 5
19.4 67 5½
18.9 66 5½
18.3 65 6
17.8 64 6½
17.2 63 7
16.7 62 8
16.1 61 8½
15.6 60 9½

3. Devices shall be utilized which will indicate the actual temperature of the
developer and signal the passage of a preset time appropriate to the developing time
required.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.403: continued

(b) Automatic processors and other closed processing systems:

(1) Films shall be developed in accordance with the time-temperature relationships
recommended by the film manufacturer; in the absence of such recommendations,
the film shall be developed using the following chart:

Developer Temperature Minimum

Immersion Timea/
o o
C F Seconds
35.5 96 19
35.0 95 20
34.5 94 21
34.0 93 22
33.5 92 23
33.0 91 24
32 .0 90 25
31.5 89 26
31.0 88 27
30.5 87 28
30.0 86 29
29.5 85 30
a/
Immersion time only, no crossover time included.

2. The specified developer temperature and immersion time shall be posted in the
darkroom or on the automatic processor.
(c) Processing deviations from the requirements of 105 CMR 120.403(C)(1) shall be
documented by the registrant in such manner that the requirements are shown to be met
or exceeded (e.g., extended processing, and special rapid chemistry). The requirements
of 105 CMR 120.403(C)(1)(c) apply only to film processors routinely used in processing
diagnostic x-ray images.
(d) Quality Assurance tests for the processor shall be performed on days being used.
(e) Test tools for quality assurance tests for the processor shall include the following:
1. Densitometer
2. Sensitometer
3. Thermometer
4. Film
(f) Daily film processor quality assurance tests shall include: Checking solution
temperatures.
1. The developer temperature shall be as recommended by the film manufacturer.
2. Mercury thermometers are prohibited for determining solution temperatures.
(g) Determination and recording of the speed step. Maximum control limits shall not
exceed ± 0.15 optical density (OD).
(h) Calculation and recording of the contrast index or density difference. Maximum
control limits shall not exceed ± 0.15 optical density (OD).
(i) Measuring and plotting the Base + Fog. Maximum base plus fog density shall not
exceed 0.25 optical density (OD).
(j) Chemistry replenishment rates shall be measured and recorded semi-annually.
(k) Processor sensitometric tests results including speed index, contrast index, and base
plus fog shall be plotted on control charts.
(l) Operating levels and control limits for processor quality assurance tests shall be
indicated on the control chart.
(m) Quality assurance records shall be maintained for a minimum of 24 months and
readily available for review by representatives of the Department.
(n) Each facility shall take corrective action when Quality Assurance test do not meet
the requirements in 105 CMR 120.403(C).
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.403: continued

(2) Other Requirements:

(a) Pass boxes, if provided, shall be so constructed as to exclude light from the
darkroom when cassettes are placed in or removed from the boxes, and shall incorporate
adequate shielding from stray radiation to prevent exposure of undeveloped film.
(b) The darkroom shall be light tight and use proper safelighting such that any film type
in use exposed in a cassette to x-radiation sufficient to produce an optical density from
one to two when processed shall not suffer an increase in density greater than 0.1 (0.05
for mammography) when exposed in the darkroom for two minutes with all safelights
on. If used, daylight film handling boxes shall preclude fogging of the film.
1. Quality assurance tests for darkroom integrity shall be performed at least semi-
annually.
2. Each facility shall use pre-exposed film for performing quality assurance tests.
3. No smoking or eating is permitted in the darkroom.
4. The darkroom shall be kept free of dust.
5. Counter tops, floors, and processing feed trays shall be cleaned daily before any
films are handled or processed.
(c) Darkrooms typically used by more than one individual shall be provided a method
to prevent accidental entry while undeveloped films are being handled or processed.
(d) Film shall be stored in a cool, dry place and shall be protected from exposure to
stray radiation. Film in open packages shall be stored in a light tight container.
(e) Film cassettes and intensifying screens shall be kept free of artifacts and shall be
cleaned regularly and replaced as necessary to best assure radiographs of good diagnostic
quality.
(f) Screens shall be cleaned at intervals not to exceed one month with a screen cleaner
recommended by the screen manufacturer. A copy of this requirement shall be kept in
the darkroom.
(g) Outdated x-ray film shall not be used for diagnostic radiographs, unless the film has
been stored in accordance with the manufacturer's recommendations and a sample of the
film passes a sensitometric test for normal ranges of base plus fog and speed.
(h) Film developing solutions shall be prepared in accordance with the directions given
by the manufacturer, and shall be maintained in strength by replenishment or renewal
so that full development is accomplished within the time specified by the manufacturer.

120.404: General Requirements for All Diagnostic X-ray Systems

In addition to other requirements of 105 CMR 120.400, all diagnostic x-ray systems shall
meet the following requirements:

(A) Warning Label. The control panel containing the main power switch shall bear the
warning statement, legible and accessible to view: "WARNING: This x-ray unit may be
dangerous to patient and operator unless safe exposure factors and operating instructions are
observed."

(B) Battery Charge Indicator. On battery-powered x-ray generators, visual means shall be
provided on the control panel to indicate whether the battery is in a state of charge adequate for
proper operation.

(C) Leakage Radiation from the Diagnostic Source Assembly. The leakage radiation from the
diagnostic source assembly measured at a distance of one meter in any direction from the source
shall not exceed 100 milliroentgen (25.8 µC/kg) in one hour when the x-ray tube is operated at
its leakage technique factors. Compliance shall be determined by measurements averaged over
an area of 100 square centimeters with no linear dimension greater than 20 centimeters.

(D) Radiation from Components Other Than the Diagnostic Source Assembly. The radiation
emitted by a component other than the diagnostic source assembly shall not exceed two
milliroentgen (0.516 µC/kg) in one hour at five centimeters from any accessible surface of the
component when it is operated in an assembled x-ray system under any conditions for which it
was designed. Compliance shall be determined by measurements averaged over an area of 100
square centimeters with no linear dimension greater than 20 centimeters.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.404: continued

(E) Beam Quality.

(1) Half-value Layer.
(a) The half-value layer of the useful beam for a given x-ray tube potential shall not be
less than the values shown in Table I. If it is necessary to determine such half-value
layer at an x-ray tube potential which is not listed in Table I, linear interpolation or
extrapolation may be made.
(b) For capacitor energy storage equipment, compliance with the requirements of
105 CMR 120.404(E) shall be determined with the system fully charged and a setting
of ten mAs for each exposure.
(c) The required minimal aluminum equivalent filtration shall include the filtration
contributed by all materials which are always present between the source and the patient.
(2) Filtration Controls. For x-ray systems which have variable kVp and variable filtration
for the useful beam, a device shall link the kVp selector with the filter(s) and shall prevent
an exposure unless the minimum amount of filtration required by 105 CMR 120.404(E)(1)
is in the useful beam for the given kVp which has been selected.

Specified Dental Systems \1\

TABLE I
X-Ray Tube Voltage (kilovolt peak)
Design Operating Measured Operating Minimum HVL (mm in Aluminum)
Range Potential
Specified Other Other
Dental X-Ray X-Ray
Systems1 Systems2 Systems3

Below 51 30 1.5 0.3 0.3

40 1.5 0.4 0.4
50 1.5 0.5 0.5
51 to 70 51 1.5 1.2 1.3
60 1.5 1.3 1.5
70 1.5 1.5 1.8
Above 70 71 2.1 2.1 2.5
80 2.3 2.3 2.9
90 2.5 2.5 3.2
100 2.7 2.7 3.6
110 3.0 3.0 3.9
120 3.2 3.2 4.3
130 3.5 3.5 4.7
140 3.8 3.8 5.0
150 4.1 4.1 5.4

1
Dental x-ray systems designed for use with intraoral image receptors and manufactured after
December 1, 1980.
2
Dental x-ray systems designed for use with intraoral image receptors and manufactured
before or on December 1, 1980, and all other x-ray systems subject to 105 CMR 120.404
and manufactured before June 10, 2006.
3
All x-ray systems, except dental x-ray systems designed for use with intraoral image
receptors, subject to 105 CMR 120.404 and manufactured on or after June 10, 2006.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.404: continued

(F) Multiple Tubes. Where two or more radiographic tubes are controlled by one exposure
switch, the tube or tubes which have been selected shall be clearly indicated prior to initiation
of the exposure. This indication shall be both on the x-ray control panel and at or near the tube
housing assembly which has been selected.

(G) Mechanical Support of Tube Housing Assembly. The tube housing assembly supports
shall be adjusted such that the tube housing assembly will remain stable during an exposure
unless tube housing movement is a designed function of the x-ray system.

(H) Technique Indicators.

(1) The technique factors to be used during an exposure shall be indicated before the
exposure begins. If automatic Exposure controls are used, the technique factors which are
set prior to the exposure shall be indicated.
(2) The requirement of 105 CMR 120.404(H)(1) may be met by permanent markings on
equipment having fixed technique factors. Indication of technique factors shall be visible
from the operator's position except in the case of spot films made by the fluoroscopist.

(I) Maintaining Compliance Diagnostic x-ray systems and their associated components used
on humans and certified pursuant to the Federal X-Ray Equipment Performance Standard
(21 CFR Part 1020) shall be maintained in compliance with applicable requirements of that
standard.

(J) Locks. All positioning locking, holding, and centering devices on x-ray systems
components and systems shall function as intended.

120.405: Fluoroscopic X-ray Systems

Fluoroscopic X-ray Systems shall be installed and maintained to comply with the Federal
Performance Standard for Fluoroscopic Equipment, 21 CFR 1020.32 and shall also meet the
following requirements except 21 CFR 1020.32 shall prevail should there be a conflict.

(A) Limitation of Useful Beam.

(1) Primary Barrier.
(a) The fluoroscopic imaging assembly shall be provided with a primary protective
barrier which intercepts the entire cross section of the useful beam at any SID.
(b) The x-ray tube used for fluoroscopy shall not produce x-rays unless the barrier is
in position to intercept the entire useful beam.
(c) Radiation therapy simulation systems shall be exempt from 105 CMR 120.405(A)
provided the systems are intended only for remote control operation.

(2) Fluoroscopic Beam Limitation.

(a) For certified fluoroscopic systems with or without a spot film device, neither the
length nor the width of the x-ray field in the plane of the image receptor shall exceed
that of the visible area of the image receptor by more than 3% of the SID. The sum of
the excess length and the excess width shall be no greater than 4% of the SID.
(b) For uncertified fluoroscopic systems with a spot film device, the x-ray beam with
the shutters fully opened (during fluoroscopy or spot filming) shall be no larger than the
largest spot film size for which the device is designed. Measurements shall be made at
the minimum SID available but at no less than 20 centimeters table top to the film plane
distance.
(c) For uncertified fluoroscopic systems without a spot film device, the requirements
of 120.405(A)(2)(a) apply.
1. Means shall be provided to permit further limitation of the field. Beam-limiting
devices manufactured after May 22, 1979, and incorporated in equipment with a
variable SID and/or a visible area of greater than 300 square centimeters shall be
provided with means for stepless adjustment of the x-ray field;
2. All equipment with a fixed SID and a visible area of 300 square centimeters or
less shall be provided with either stepless adjustment of the x-ray field or with
means to further limit the x-ray field size at the plane of the image receptor to 125
square centimeters or less;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.405: continued

3. If provided, stepless adjustment shall, at the greatest SID, provide continuous

field sizes from the maximum attainable to a field size of five centimeters by five
centimeters or less;
4. For equipment manufactured after February 25, 1978, when the angle between
the image receptor and beam axis is variable, means shall be provided to indicate
when the axis of the x-ray beam is perpendicular to the plane of the image receptor;
and,
5. For rectangular x-ray fields used with circular image receptors, the error in
alignment shall be determined along the length and width dimensions of the x-ray
field which pass through the center of the visible area of the image receptor.
(d) For fluoroscopic equipment manufactured on or after June 10, 2006, other than
radiation simulation systems, the maximum area of the x-ray field in the plane of the
image receptor shall conform with one of the following requirements:
1. When any linear dimension of the visible area of the image receptor measured
through the center of the visible area is less than or equal to 34 cm in any direction,
at least 80% of the area of the x-ray field overlaps the visible area of the image
receptor; or
2. When any linear dimension of the visible area of the image receptor measured
through the center of the visible area is greater than 34 cm in any direction, the x-ray
field measured along the direction of greatest misalignment with the visible area of
the image receptor does not extend beyond the edge of the visible area of the image
receptor by more than two cm.
(3) Spot-film Beam limitation. Spot-film devices shall meet the following requirements:
(a) Means shall be provided between the source and the patient for adjustment of the
x-ray field size in the plane of the film to the size of that portion of the film which has
been selected on the spot film selector. Such adjustment shall be automatically
accomplished except when the x-ray field size in the plane of the film is smaller than
that of the selected portion of the film. For spot film devices manufactured after
June 21, 1979, if the x-ray field size is less than the size of the selected portion of the
film, the means for adjustment of the field size shall be only at the operator's option;
(b) Neither the length nor the width of the x-ray field in the plane of the image receptor
shall differ from the corresponding dimensions of the selected portion of the image
receptor by more than 3% of the SID when adjusted for full coverage of the selected
portion of the image receptor. The sum, without regard to sign, of the length and width
differences shall not exceed 4% of the SID;
(c) It shall be possible to adjust the x-ray field size in the plane of the film to a size
smaller than the selected portion of the film. The minimum field size at the greatest SID
shall be equal to, or less than, five centimeters by five centimeters;
(d) The center of the x-ray field in the plane of the film shall be aligned with the center
of the selected portion of the film to within 2% of the SID; and,
(e) On spot-film devices manufactured after February 25, 1978, if the angle between
the plane of the image receptor and beam axis is variable, means shall be provided to
indicate when the axis of the x-ray beam is perpendicular to the plane of the image
receptor, and compliance shall be determined with the beam axis indicated to be
perpendicular to the plane of the image receptor.
(4) Override. If a means exists to override any of the automatic x-ray field size adjustments
required in 105 CMR 120.405(A)(2), that means:
(a) Shall be designed for use only in the event of system failure;
(b) Shall incorporate a signal visible at the fluoroscopist's position which will indicate
whenever the automatic field size adjustment is overridden; and,
(c) Shall be clearly and durably labeled as follows:

FOR X-RAY FIELD

LIMITATION SYSTEM FAILURE

(B) Activation of the Fluoroscopic Tube. X-ray production in the fluoroscopic mode shall be
controlled by a device which requires continuous pressure by the fluoroscopist for the entire
time of any exposure. When recording serial fluoroscopic images, the fluoroscopist shall be
able to terminate the x-ray exposure(s) at any time, but means may be provided to permit
completion of any single exposure of the series in process.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.405: continued

(C) Air Kerma Rates.

(1) Fluoroscopic Equipment Manufactured Before May 19, 1995.
(a) Fluoroscopic equipment which is provided with automatic exposure rate control
shall not be operable at any combination of tube potential and current which will result
in AKR in excess of 88 mGy per minute (ten roentgens) per minute at the point where
the center of the useful beam enters the patient, except:
1. During recording of fluoroscopic images; or
2. When provided with optional high level control, the equipment shall not be
operable at any combination of tube potential and current which will result in an
AKR in excess of ten roentgens (88 mGy) per minute at the point where the center
of the useful beam enters the patient unless the high level control is activated.
Special means of activation of high level controls shall be required. The high level
control shall only be operable when continuous manual activation is provided by the
operator. A continuous signal audible to the fluoroscopist shall indicate that the high
level control is being employed.
(b) Fluoroscopic equipment which is not provided with automatic exposure rate control
shall not be operable at any combination of tube potential and current which will result
in AKR in excess of 44 mGy (five roentgens) per minute at the point where the center
of the useful beam enters the patient, except:
1. During recording of fluoroscopic images; or
2. When an optional high level control is activated. Special means of activation of
high level controls shall be required. The high level control shall only be operable
when continuous manual activation is provided by the operator. A continuous signal
audible to the fluoroscopist shall indicate that the high level control is being
employed.
(c) Fluoroscopic equipment which is provided with both automatic exposure rate
control mode and a manual mode shall not be operable at any combination of tube
potential and current which shall result in an AKR in excess of 88 mGy (ten roentgens)
per minute in either mode at the point where the center of the useful beam enters the
patient, except:
1. During recording of fluoroscopic images; or
2. When the mode or modes have an optional high level control, in which case that
mode or modes shall not be operable at any combination of tube potential and
current which shall result in an AKR in excess of 88 mGy (ten roentgens) per minute
at the point where the center of the useful beam enters the patient, unless high level
control is activated. Special means of activation of high level controls shall be
required. The high level control shall only be operable when continuous manual
activation is provided by the operator. A continuous signal audible to the
fluoroscopist shall indicate that the high level control is being employed.
(2) Fluoroscopic Equipment Manufactured On or After May 19, 1995.
(a) Shall be equipped with automatic exposure rate control if operable at any
combination of tube potential and current that results in an AKR greater than 44 mGy
per minute (five R/min exposure rate) at the measurement point specified in 105 CMR
120.405(C)(3). Provision for manual selection of technique factors may be provided.
(b) Shall not be operable at any combination of tube potential and current that will
result in an AKR in excess of 88 mGy per minute (ten R/min exposure rate) at the
measurement point specified in 105 CMR 120.405(C)(3).
(c) Exceptions:
1. For equipment manufactured prior to June 10, 2006, during the recording of
images from a fluoroscopic image receptor using photographic film or a video
camera when the x-ray source is operated in a pulsed mode.
2. For equipment manufactured on or after June 10, 2006, during the recording of
images from the fluoroscopic image receptor for the purpose of providing the user
with a recorded image(s) after termination of the exposure. Such recording does not
include images resulting from a last-image-hold feature that are not recorded.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.405: continued

3. When a mode of operation has an optional high-level control and the control is
activated, in which case the equipment shall not be operable at any combination of
tube potential and current that will result in an AKR in excess of 176 mGy per
minute (20 R/min exposure rate) at the measurement point specified in 105 CMR
120.405(C)(3). Special means of activation of high-level controls shall be required.
The high-level control shall be operable only when continuous manual activation is
provided by the operator. A continuous signal audible to the fluoroscopist shall
indicate that the high-level control is employed.
(3) Compliance with the requirements of 105 CMR 120.405(C) shall be determined as
follows:
(a) If the source is below the table, the AKR shall be measured one centimeter above
the tabletop or cradle.
(b) If the source is above the table, the AKR shall be measured at 30 centimeters above
the tabletop with the end of the beam-limiting device or spacer positioned as closely as
possible to the point of measurement.
(c) For a C-arm type of fluoroscope, the AKR shall be measured 30 centimeters from
the input surface of the fluoroscopic imaging assembly, with the source positioned at any
available SID, provided that the end of the beam-limiting device or spacer is no closer
than 30 centimeters from the input surface of the fluoroscopic imaging assembly;
(d) For a lateral type fluoroscope, the air kerma rate shall be measured at a point 15
centimeters from the centerline of the x-ray table and in the direction of the x-ray source
with the end of the beam-limiting device or spacer positioned as closely as possible to
the point of measurement. If the tabletop is movable, it shall be positioned as closely
as possible to the lateral x-ray source, with the end of the beam-limiting device or spacer
no closer than 15 centimeters to the centerline of the x-ray table.
(e) In a C-arm type of fluoroscope having an SID less than 45 cm, the AKR shall be
measured at the minimum SSD.
(4) The registrant of a facility or responsible person at the facility shall have a qualified
medical physicist perform periodic measurement of AKR for both typical and maximum
values as follows:
(a) Such measurements shall be made annually or after any maintenance of the system
which might affect the AKR;
(b) If the fluoroscope does not display the AKR of the current patient in view of the
operator when the fluoroscopy trigger is depressed, results of these measurements shall
be posted where any fluoroscopist may have ready access to such results while using the
fluoroscope and in the record required in 105 CMR 120.403(A)(2)(b). The
measurement results shall be stated in coulombs per kilogram (roentgens) per minute
and include the technique factors used in determining such results. The name of the
individual performing the measurements and the date the measurements were performed
shall be included in the results;
(c) Conditions of periodic measurement of typical AKR are as follows:
1. The measurement shall be made under the conditions that satisfy the
requirements of 105 CMR 120.405(C)(1)(c);
2. The kVp, mA, and/or other selectable parameters shall be adjusted to those
settings typical of clinical use for an abdominal patient;
3. The x-ray system that incorporates automatic Exposure rate control shall have
sufficient attenuative material placed in the useful beam to produce a milliamperage
and/or kilovoltage to satisfy the conditions of 105 CMR 120.405(C)(1)(e)3.; and
(d) Conditions of periodic measurement of maximum AKR are as follows:
1. The measurement shall be made under the conditions that satisfy the
requirements of 105 CMR 120.405(C)(1)(c);
2. The kVp, mA and/or other selectable parameters shall be adjusted to those
settings which give the maximum AKR;
3. The x-ray system(s) that incorporates automatic exposure rate control shall have
sufficient attentuative material placed in the useful beam to produce the maximum
AKR of the system.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.405: continued

(D) Barrier Transmitted Radiation Rate Limits.

(1) The AKR due to transmission through the primary protective barrier with the
attenuation block in the useful beam, combined with radiation from the image intensifier,
if provided, shall not exceed two milliroentgen (0.516 µC/kg) per hour at ten centimeters
from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the
image receptor for each roentgen per minute of AKR.
(2) Measuring Compliance of Barrier Transmission.
(a) The AKR due to transmission through the primary protective barrier combined
with radiation from the image intensifier shall be determined by measurements averaged
over an area of 100 square centimeters with no linear dimension greater than
20 centimeters.
(b) If the source is below the tabletop, the measurement shall be made with the input
surface of the fluoroscopic imaging assembly positioned 30 centimeters above the
tabletop.
(c) If the source is above the tabletop and the SID is variable, the measurement shall
be made with the end of the beam-limiting device or spacer as close to the tabletop as
it can be placed, provided that it shall not be closer than 30 centimeters.
(d) Movable grids and compression devices shall be removed from the useful beam
during the measurement.
(e) The attenuation block shall be positioned in the useful beam ten centimeters from
the point of measurement of AKR and between this point and the input surface of the
fluoroscopic imaging assembly.

(E) Indication of Potential and Current. During fluoroscopy and cinefluorography the kV and
the mA shall be continuously indicated.

(F) Source-to-skin Distance.

(1) Means shall be provided to limit the source-skin distance to not less than 38 cm on
stationary fluoroscopes and to not less than 30 cm on mobile and portable fluoroscopes. In
addition, for fluoroscopes intended for specific surgical application that would be prohibited
at the source-skin distances specified in 105 CMR 120.405(D)(1), provisions may be made
for operating at shorter source-skin distances but in no case less than 20 cm.
(2) For stationary, mobile, or portable C-arm fluoroscopic systems manufactured on or after
June 10, 2006, having a maximum source-image receptor distance of less than 45 cm, means
shall be provided to limit the source-skin distance to not less than 19 cm. Such systems
shall be labeled for extremity use only. In addition, for those systems intended for specific
surgical application that would be prohibited at the source-skin distance specified in
105 CMR 120.405(F)(2), provisions may be made for operation at shorter source-skin
distances but in no case less than ten cm.

(G) Fluoroscopic Timer.

(1) Fluoroscopic Equipment Manufactured Before June 10, 2006:
(a) Means shall be provided to preset the cumulative on-time of the fluoroscopic x-ray
tube. The maximum cumulative time of the timing device shall not exceed five minutes
without resetting.
(b) A signal audible to the fluoroscopist shall indicate the completion of any preset
cumulative on-time. Such signal shall continue to sound while x-rays are produced until
the timing device is reset.
(2) For x-ray controls manufactured on or after June 10, 2006, there shall be provided for
each fluoroscopic tube:
(a) A display of the fluoroscopic irradiation time at the fluoroscopist's working
position. This display shall function independently of the audible signal described in
105 CMR 120.405(G)(2). The following requirements apply:
1. When the x-ray tube is activated, the fluoroscopic irradiation time in minutes and
tenths of minutes shall be continuously displayed and updated at least once every six
seconds.
2. The fluoroscopic irradiation time shall also be displayed within six seconds of
termination of an exposure and remain displayed until reset.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.405: continued

3. Means shall be provided to reset the display to zero prior to the beginning of a
new examination or procedure.
(b) A signal audible to the fluoroscopist shall sound for each passage of five minutes
of fluoroscopic irradiation time during an examination or procedure. The signal shall
sound until manually reset or, if automatically reset, for at least two seconds.

(H) Control of Scattered Radiation.

(1) Fluoroscopic table designs when combined with procedures utilized shall be such that
no unprotected part of any staff or ancillary individual's body shall be exposed to
unattenuated scattered radiation which originates from under the table. The attenuation
required shall be not less than 0.25 millimeter lead equivalent.
(2) Equipment configuration when combined with procedures shall be such that no portion
of any staff or ancillary individual's body, except the extremities, shall be exposed to the
unattenuated scattered radiation emanating from above the tabletop unless that individual:
(a) Is at least 120 centimeters from the center of the useful beam; or
(b) The radiation has passed through not less than 0.25 millimeter lead equivalent
material including, but not limited to, drapes, Bucky-slot cover panel, or self-supporting
curtains, in addition to any lead equivalency provided by the protective apron referred
to in 105 CMR 120.403(A)(1)(e).
(3) The Agency may grant exemptions to 105 CMR 120.405(H)(2) where a sterile field will
not permit the use of the normal protective barriers. Where the use of prefitted sterilized
covers for the barriers is practical, the Agency shall not permit such exemption. See
105 CMR 120.423: Appendix D for a suggested list of fluoroscopic procedures where such
exemptions will be automatically granted.

(I) Radiation Therapy Simulation Systems. Radiation therapy simulation systems shall be
exempt from all the requirements of 105 CMR 120.405(A), (C), (D) and (G) provided that:
(1) Such systems are designed and used in such a manner that no individual other than the
patient is in the x-ray room during periods of time when the system is producing x-rays; and,
(2) Systems which do not meet the requirements of 105 CMR 120.405(G) are provided
with a means of indicating the cumulative time that an individual patient has been exposed
to x-rays. Procedures shall require in such cases that the timer be reset between
examinations.

(J) Spot film Exposure Reproducibility. Fluoroscopic systems equipped with spot film
(radiographic) modes shall meet the exposure reproducibility requirements when operating in
the spot film mode.

(K) Operator Qualifications.

(1) The Registrant of a facility shall ensure that only the following health care providers
shall be allowed to operate fluoroscopic x-ray systems:
(a) Licensed physicians who are board-certified in radiology;
(b) Licensed physicians who are not board-certified in radiology provided that they
have been trained in the following subjects:
1. Principles and operation of the fluoroscopic x-ray system;
2. Biological effects of x-ray;
3. Principles of radiation protection;
4. Fluoroscopic outputs;
5. High level control options;
6. Dose reduction techniques for fluoroscopic x-ray systems; and
7. Application requirements of 105 CMR 120.000.
(c) Radiologic technologists who are licensed in accordance with 105 CMR 125.000
and have been trained in the safe use of fluoroscopic x-ray systems; and
(d) Physician assistants who are licensed in accordance with M.G.L. c. 112, § 9I, and
263 CMR 3.00: Registration of Individual Physician Assistants, and who meet the
requirements of 105 CMR 120.405(K)(2).
(2) The Registrant of a facility shall ensure that a physician assistant delegated the
performance of specified fluoroscopic procedures by a supervising physician has submitted
documentation of the following to the facility:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.405: continued

(a) Successful completion of the education and clinical training specified in 105 CMR
120.405(K)(3) offered by an approved provider;
(b) a passing score on an examination offered by the American Registry of Radiologic
Technologists (ARRT) or equivalent exam approved by the Agency covering the
educational and clinical requirements specified in 105 CMR 120.405(K)(3);
(c) a written and signed statement from the physician assistant's supervising physician,
who meets the requirements of 105 CMR 120.405(K)(1)(a) or (b), verifying the
physician assistant's competency to perform specified fluoroscopic procedures; and
(d) a written practice agreement between the physician assistant and his or her
supervising physician as set forth in regulations of the Board of Registration in Medicine
at 243 CMR 2.08 and of the Board of Registration of Physician Assistants in 263 CMR
5.00: Scope of Practice and Employment of Physician Assistants.
(3) The education and clinical training required by 105 CMR 120.405(K)(2)(a) shall
consist of the following:
(a) Didactic Content
1. Digital image acquisition and display;
2. Contrast media;
3. Fluoroscopic unit operation and safety;
4. Image analysis;
5. Radiation biology;
6. Radiation production and characteristics; and
7. Radiation protection.
(b) Clinical Component
1. Clinical competency requirement: 40 clinical hours performing fluoroscopic
procedures in a fluoroscopic suite under the direct supervision of a physician who
meets the requirements of 105 CMR 120.405(K)(1)(a) or (b), a medical physicist,
or a radiography educator. "Direct supervision," as used in 105 CMR
120.405(K)(3), means physically present where the fluoroscopic procedure is being
performed and immediately available and able to provide assistance and direction
throughout the procedure;
2. Fluoroscopic device orientation: safe and proper manipulation of the
fluoroscopic device.
(4) The Registrant of the facility and/or responsible person at the facility shall maintain all
records relating to compliance with the education and clinical training requirements for the
current year and the previous four years.
(5) The facility shall establish policies and procedures for limiting the performance of
fluoroscopic procedures to only those health care providers who have met the requirements
of 105 CMR 120.405(K) and who have been granted privileges for the use of fluoroscopy
based on their demonstrated competency in the performance of fluoroscopic procedures.
(6) The Registrant of the facility shall ensure that all physicians who are not board certified
in radiology and who perform fluoroscopic procedures complete two hours of training in
Radiation Safety/Radiation Protection on an annual basis, and that all physicians who are
not board certified in radiology who supervise the performance of fluoroscopic procedures
complete a total of four hours of Radiation Safety/Radiation Protection training on an annual
basis. The facility shall maintain all records relating to compliance with this training
requirement for the current year and the previous four years.
(7) The Registrant of a facility shall ensure that licensed radiologic technologists and
licensed physician assistants who perform fluoroscopic procedures have satisfied all related
continuing education requirements as required by their respective licensing boards, and shall
maintain records documenting completion of such continuing education requirements by
radiologic technologists and physician assistants for five years.
(8) In addition to any other reporting requirements, the facility shall immediately, and no
later than 24 hours after discovery, report to the Agency any incident at the facility involving
fluoroscopic procedures that seriously affects the health and safety of a patient or that causes
serious physical injury to a patient due to radiation exposure.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.405: continued

(9) Nothing in 105 CMR 120.405(K) shall prohibit nurse practitioners from practicing
within their lawful scope of practice, including functioning as first assistants during cardiac
catheterization procedures in accordance with 105 CMR 130.900: Standards for Operation
of Hospital-based Cardiac Catheterization Services, and the Board of Registration in
Nursing Advisory Ruling Number 0201, Nurse Practitioner as First Assistant in Cardiac
Catherization, provided that the physician who is the primary operator, as defined in
105 CMR 130.910, is qualified to operate fluoroscopic x-ray systems pursuant to 105 CMR
120.405(K)(1)(a) or (b).

(L) Patient Dose Evaluation.

(1) Each facility performing fluoroscopically-guided interventional and CT fluoro
procedures shall conduct patient dose evaluation for any procedure that has a reasonable
probability of resulting in a deterministic injury as further defined in 105 CMR
120.405(L)(5).
(2) Records documenting that policies and procedures have been developed to determine
that those procedures that have a potential to result in patient doses exceeding the threshold
for injury have been established to reduce the probability of such exposures and that
appropriate action occurs for patients receiving doses that warrant follow-up.
(3) The facility shall have a patient dose monitoring procedures in place. When the
fluoroscopy unit is equipped with an Air-Kerma dose readout, the recording of this value
shall suffice as a patient dose record.
(4) The facility shall document in the patient’s medical record an estimate of the absorbed
dose to the skin.
(5) Any cumulative absorbed dose to the skin equal to or greater than 2 Gy (200 rads) shall
be noted in the patient’s medical record and reviewed by the Radiation Safety Committee.
(6) Each facility that use fluoroscopic x-ray systems shall maintain a record of the
cumulative fluoroscopic exposure time used and the number of spot films for each
examination. This record shall indicate patient identification, type of examination, date of
examination, and operator’s name. The record shall be maintained for five years.

(M) Equipment Operation.

(1) Radiological technology students shall not be allowed to operate fluoroscopic x-ray
systems unless directly supervised by a licensed practitioner of the healing arts or a licensed
Radiological Technologist.
(2) Overhead fluoroscopy shall not be used as a positioning tool for general purpose
radiographic examinations.

(N) Mini-C-Arms. 105 CMR 120.405 includes Mini-C-Arms.

120.406: Diagnostic X-ray Systems

(A) Beam Limitation Except for Mammographic Systems. The useful beam shall be limited
to the area of clinical interest. This shall be deemed to have been met if a positive beam limiting
device meeting manufacturer's specifications and the requirements of 105 CMR 120.406(G)(2)
has been properly used or if evidence of collimation is shown on at least three sides or three
corners of the film (for example, projections from the shutters of the collimator, cone cutting
at the corners, or borders at the film's edge).
(1) General Purpose Stationary and Mobile X-ray Systems, Including Veterinary Systems
(Other than Portable) Installed After December 31, 1997.
(a) Only x-ray systems provided with a means for independent stepless adjustment of
at least two dimensions of the x-ray field shall be used;
(b) A method shall be provided for visually defining the perimeter of the x-ray field.
The total misalignment of the edges of the visually defined field with the respective
edges of the x-ray field along either the length or width of the visually defined field shall
not exceed 2% of the distance from the source to the center of the visually defined field
when the surface upon which it appears is perpendicular to the axis of the x-ray beam;
(c) The Agency may grant an exemption on non-certified x-ray systems to 105 CMR
120.406(A)(1)(a); and,
(d) Provided the registrant makes a written application for such exemption and in that
application:
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120.406: continued

1. Demonstrates it is impractical to comply with 105 CMR 120.406(A)(1)(a) and

(b); and,
2. The purpose of 105 CMR 120.406(A)(1)(a) and (b) will be met by other
methods.
(2) Additional Requirements for Stationary General Purpose X-ray Systems. In addition
to the requirements of 105 CMR 120.406, all stationary general purpose x-ray systems, both
certified and non-certified shall meet the following requirements:
(a) A method shall be provided to indicate when the axis of the x-ray beam is
perpendicular to the plane of the image receptor, to align the center of the x-ray field
with respect to the center of the image receptor to within two percent of the SID, and to
indicate the SID to within 2%;
(b) The beam-limiting device shall indicate numerically the field size in the plane of
the image receptor to which it is adjusted; and,
(c) Indication of field size dimensions and SID's shall be specified in inches and/or
centimeters, and shall be such that aperture adjustments result in x-ray field dimensions
in the plane of the image receptor which correspond to those indicated by the
beam-limiting device to within 2% of the SID when the beam axis is indicated to be
perpendicular to the plane of the image receptor.
(3) X-ray Systems Designed for One Image Receptor Size. Radiographic equipment
designed for only one image receptor size at a fixed SID shall be provided with means to
limit the field at the plane of the image receptor to dimensions no greater than those of the
image receptor, and to align the center of the x-ray field with the center of the image
receptor to within 2% of the SID, or shall be provided with means to both size and align the
x-ray field such that the x-ray field at the plane of the image receptor does not extend
beyond any edge of the image receptor.
(4) Radiographic Systems Other Than Those Designated in 105 CMR 120.406(A)(1)
through (3).
(a) Means shall be provided to limit the x-ray field in the plane of the image receptor
so that such field does not exceed each dimension of the image receptor by more than
2% of the SID when the axis of the x-ray beam is perpendicular to the plane of the image
receptor.
(b) Means shall be provided to align the center of the x-ray field with the center of the
image receptor to within 2% of the SID, or means shall be provided to both size and
align the x-ray field such that the x-ray field at the plane of the image receptor does not
extend beyond any edge of the image receptor. Compliance shall be determined with the
axis of the x-ray beam perpendicular to the plane of the image receptor.
(c) 105 CMR 120.406(A)(4)(a) and (b) may be met with a system that meets the
requirements for a general purpose x-ray system as specified in 105 CMR 120.406(A)(1)
or, when alignment means are also provided, may be met with either:
1. An assortment of removable, fixed-aperture, beam-limiting devices sufficient to
meet the requirement for each combination of image receptor size and SID for which
the unit is designed with each such device having clear and permanent markings to
indicate the image receptor size and SID for which it is designed; or,
2. A beam-limiting device having multiple fixed apertures sufficient to meet the
requirement for each combination of image receptor size and SID for which the unit
is designed. Permanent, clearly legible markings shall indicate the image receptor
size and SID for which each aperture is designed and shall indicate which aperture
is in position for use.

(B) Radiation Exposure Control.

(1) Timers. Means shall be provided to initiate the radiation exposure by a deliberate
action on the part of the operator, such as the depression of a switch. Radiation exposure
shall not be initiated without such an action. In addition, it shall not be possible to initiate
an exposure when the timer is set to a "zero" or "off" position if either position is provided.
(2) Exposure Indication. Means shall be provided for visual indication observable at or
from the operator's protected position whenever x-rays are produced. In addition, a signal
audible to the operator shall indicate that the exposure has terminated.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.406: continued

(3) Exposure Termination. Means shall be provided to terminate the exposure at a preset
time interval, preset product of current and time, a preset number of pulses, or a preset
radiation exposure to the image receptor. Except for dental panoramic systems, termination
of an exposure shall cause automatic resetting of the timer to its initial setting or to "zero."
(a) Manual Exposure Control.
An x-ray control shall be incorporated into each x-ray system such that an exposure can
be terminated by the operator at any time except for:
1. Exposure of ½ second or less; or,
2. During serial radiography when means shall be provided to permit completion
of any single exposure of the series in process.
(b) Automatic Exposure Controls. When an automatic Exposure control is provided:
1. Indication shall be made on the control panel when this mode of operation is
selected;
2. If the x-ray tube potential is equal to or greater than 50 kVp, the minimum
exposure time for field emission equipment rated for pulsed operation shall be equal
to or less than a time interval equivalent to two pulses;
3. The minimum exposure time for all equipment other than that specified in
105 CMR 120.406(B)(3)(b)2. shall be equal to or less than 1/60 second or a time
interval required to deliver five mAs, whichever is greater;
4. Either the product of peak x-ray tube potential, current, and exposure time shall
be limited to not more than 60 kWs per exposure, or the product of x-ray tube
current and exposure time shall be limited to not more than 600 mAs per exposure
except that, when the x-ray tube potential is less than 50 kVp, the product of x-ray
tube current and exposure time shall be limited to not more than 2000 mAs per
exposure; and,
5. A visible signal shall indicate when an exposure has been terminated at the limits
required by 105 CMR 120.406(B)(3)(b)4., and manual resetting shall be required
before further automatically timed exposures can be made.
(4) Exposure Duration (Timer) Linearity. For systems having independent selection of
exposure time settings, the average ratios (Xi) of exposure to the indicated timer setting, in
units of C kg-1s-1 (mR/s), obtained at any two clinically used timer settings shall not differ
by more than 0.10 times their sum. This is written as:

(X1 - X2) # 0.1 (X1 + X2)

where X1 and X2 are the average C kg-1s-1 (mR/s) values.

(5) Exposure Control Location. The x-ray exposure control shall be so placed that the
operator can view the patient while making any exposure.
(6) Operator Protection, Except Veterinary Systems.
(a) Stationary Systems. Stationary x-ray systems shall be required to have the x-ray
control permanently mounted in a protected area so that the operator is required to
remain in that protected area during the entire exposure.
(b) Mobile and Portable Systems. Mobile and portable x-ray systems which are:
1. Used continuously for greater than one week in the same location, i.e., a room
or suite, shall meet the requirements of 105 CMR 120.406(B)(6)(a);
2. Used for less than one week at the same location shall be provided with either
a protective barrier at least 6.5 feet (two m) high for operator protection during
exposure, or means shall be provided to allow the operator to be at least nine feet
(2.7 m) from the tube housing assembly during the exposure.
3. The x-ray control shall provide visual indication observable at or from the
operator's protected position whenever x-rays are produced. In addition, a signal
audible to the operator shall indicate that the exposure has terminated.
(7) Exposure Reproducibility. When all techniques factors are held constant, including
control panel selections associated with exposure control systems, the coefficient of
variation of exposure for both manual and automatic exposure control systems shall not
exceed 0.05. This requirement applies to clinically used techniques.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.406: continued

(C) Source-to-skin Distance. All mobile or portable radiographic systems shall be provided
with means to limit the source-to-skin distance to equal to or greater than 30 centimeters, except
for veterinary systems.

(D) Radiation from Capacitor Energy Storage Equipment in Standby Status. Radiation emitted
from the x-ray tube when the exposure switch or timer is not activated shall not exceed a rate
of two milliroentgen (0.516 µC/kg) per hour at five centimeters from any accessible surface of
the diagnostic source assembly, with the beam-limiting device fully open.

(E) Accuracy. Deviation of measured technique factors from indicated values of kVp and
exposure time shall not exceed the limits specified for that system by its manufacturer. In the
absence of manufacturer's specifications, the deviation shall not exceed 10% of the indicated
value for kVp and 20% for time.

(F) mA/mAs Linearity. The following requirements apply when the equipment is operated on
a power supply as specified by the manufacturer for any fixed x-ray tube potential within the
range of 40% to 100% of the maximum rated:
(1) Equipment Having Independent Selection of X-ray Tube Current (mA). The average
ratios (Xi) of air kerma to the indicated milliampere-seconds product (C kg-1 mAs-1 (or
mR/mAs)) obtained at any two consecutive tube current settings shall not differ by more
than 0.10 times their sum:

X1-X2 < 0.10 (X1+X2)

where X1 and X2 are the average values obtained at each of two consecutive tube current
settings, or at two settings differing by no more than a factor of two where the tube current
selection is continuous.

(2) Equipment Having a Combined X-ray Tube Current-exposure Time Product (mAs)
Selector. The average ratios (Xi) of air kerma to the indicated milliampere-seconds product,
in units of C kg-1 mAs-1 (or mR/mAs), obtained at any two consecutive mAs selector settings
shall not differ by more than 0.10 times their sum:

X1-X2 < 0.10 (X1 +X2)

where X1 and X2 are the average values obtained at any two mAs selector settings, or at two
settings differing by no more than a factor of two where the mAs selector provides
continuous selection.

(3) Measuring Compliance. Determination of compliance shall be based on three

exposures taken within a time period of one hour, at each of the two settings. These two
settings may include any two focal spot sizes except where one is equal to or less than 0.45
millimeters and the other is greater than 0.45 millimeters. For purposes of this requirement,
focal spot size is the nominal focal spot size specified by the x-ray tube manufacturer.

(G) Additional Requirements Applicable to Certified Systems Only. Diagnostic x-ray systems
incorporating one or more certified component(s) shall be required to comply with the following
additional requirement(s) which relate to that certified component(s).
(1) Beam Limitation for Portable X-ray Systems. Beam limitation for portable x-ray
systems shall meet the beam limitation requirements of 105 CMR 120.406(A)(1).
(2) Field Limitation and Alignment on Stationary General Purpose X-ray Systems. For
stationary, general purpose x-ray systems which contain a tube housing assembly, an x-ray
control, and, for those systems so equipped, a table, all certified in accordance with 21 CFR
1020.30(C):
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.406: continued

(a) Means shall be provided for positive beam limitation which will, at the SID for
which the device is designed, either cause automatic adjustment of the x-ray field in the
plane of the image receptor to the image receptor size within five seconds after insertion
of the image receptor or, if adjustment is accomplished automatically in a time interval
greater than five seconds or is manual, will prevent production of x-rays until such
adjustment is completed. For the SID at which the device is not intended to operate, the
device shall prevent the production of x-rays.
(b) The x-ray field size in the plane of the image receptor, whether automatically or
manually adjusted, shall be such that neither the length nor the width of the x-ray field
differs from that of the image receptor by greater than 2% of the SID and that the sum
of the length and width differences without regard to sign be no greater than 3% of the
SID when the equipment indicates that the beam axis is perpendicular to the plane of the
image receptor.
(c) The radiographic system shall be capable of operation, at the discretion of the
operator, such that the field size at the image receptor can be adjusted to a size smaller
than the image receptor. The minimum field size at a distance of 100 centimeters shall
be equal to or less than five by five centimeters. Return to positive beam limitation as
specified in 105 CMR 120.406(F)(6)(a) and (b) shall occur upon a change in image
receptor.
(d) Positive beam limitation may be bypassed when radiography is conducted which
does not use the cassette tray or permanently mounted vertical cassette holder, or when
either the beam axis or table angulation is not within 10° of the horizontal or vertical
during any part of the exposure, or during stereoscopic radiography. If the bypass mode
is provided, return to positive beam limitation shall be automatic.
(e) A capability may be provided for overriding positive beam limitation in the event
of system failure or to perform special procedures which cannot be performed in the
positive mode. If so provided, a key shall be required to override the positive mode It
shall be impossible to remove the key while the positive mode is overridden.
(3) Timers. Except for dental panoramic systems, termination of exposure shall cause
automatic resetting of the timer to its initial setting or to "zero."
(4) Transmission Limit for Image Receptor Supporting Devices Used for Mammography.
For x-ray systems manufactured after September 5, 1978 which are designed only for
mammography, the transmission of the primary beam through any image receptor support
provided with the system shall be limited such that the Exposure five centimeters from any
accessible surface beyond the plane of the image receptor supporting device does not exceed
0.1 milliroentgen (25.8 C/kg) for each activation of the tube. Exposure shall be measured
with the system operated at the minimum SID for which it is designed. Compliance shall
be determined at the maximum rated peak tube potential for the system and at the maximum
rated product of tube current and exposure time (mAs) for that peak tube potential.
Compliance shall be determined by measurements averaged over an area of 100 square
centimeters with no linear dimension greater than 20 centimeters.

(H) Any facility that utilizes a CR or DR system shall follow the manufacturer's
recommendations for Quality Assurance and Quality Control.
(1) All Quality Control tests and results shall be documented.
(2) Quality assurance and quality control records shall be maintained for a minimum of 24
months and readily available for review by representatives of the Department.

120.407: Dental Radiographic Systems

(A) General Requirements.

(1) Timers. Means shall be provided to terminate the exposure at a preset time interval,
preset product of current and time, a preset number of pulses, or a preset radiation exposure
to the image receptor. In addition, it shall not be possible to make an exposure when the
timer is set to a "zero" or "off" position if either position is provided.
(2) Reproducibility. With a timer setting of 0.3 second or less, the average exposure period
(T) shall be greater than or equal to five times the maximum exposure period (Tmax) minus
the minimum exposure period (Tmin) when 4 timer tests are performed:

T > 5(Tmax - Tmin)

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.407: continued

(3) X-ray Control.

(a) An x-ray control shall be incorporated into each x-ray system such that an exposure
can be terminated by the operator at any time, except for exposures of 0.5 second or less.
(b) The exposure switch shall be of the dead-man type.
(c) Each x-ray control shall be located in such a way as to permit the operator to remain
in an area of less than two millirems in any one hour during the entire exposure.
(4) Exposure Reproducibility. The coefficient of variation shall not exceed 0.10 when all
technique factors are held constant. This requirement shall be deemed to have been met if,
when four Exposures are made at identical technique factors, the value of the average
Exposure (E) is greater than or equal to five times the maximum Exposure (Emax) minus the
minimum Exposure (Emin):

E > 5(Emax - Emin)

(B) Additional Requirements for Dental Intraoral Systems.

(1) Source-to-skin Distance (SSD). X-ray systems designed for use with an intraoral image
receptor shall be provided with means to limit SSD to not less than:
(a) 18 centimeters if operable above 50 kVp; or,
(b) ten centimeters if not operable above 50 kVp.
(2) Field Limitation.
(a) Radiographic systems designed for use with an intraoral image receptor shall be
provided with means to limit the x-ray beam such that the x-ray field, at the minimum
SSD. shall be containable in a circle having a diameter of no more than seven
centimeters.
(b) An open-ended beam-indicating device shall be used.

(C) Additional Requirements for Dental Extraoral System Field Limitation.

(1) Dental rotational panoramic systems shall be provided with means to limit the x-ray
beam to the imaging slit in the transverse axis and shall not exceed a total of 0.5 inch larger
than the imaging slit in the vertical axis.
(2) All other dental extraoral radiographic systems (e.g., cephalometric) shall be provided
with means to both size and align the x-ray field so that it does not exceed beyond any edge
of the image receptor by more than 2% of the SID.

(D) Additional Requirements Applicable to Certified Systems Only. Only diagnostic x-ray
systems incorporating one or more certified component(s) shall be required to comply with the
following additional requirement(s) which relate to that certified component(s).
(1) Reproducibility. When the equipment is operated on an adequate power supply as
specified by the manufacturer, the estimated coefficient of variation of radiation Exposure
shall be no greater than 0.05, for any specific combination of selected technique factors.
(2) Linearity. When the equipment allows a choice of x-ray tube current settings and is
operated on a power supply as specified by the manufacturer in accordance with the
requirements of applicable Federal standards, for any fixed x-ray tube potential within the
range of 40 to 100% of the maximum rating, the average ratios of Exposure to the indicated
milliampere-seconds product obtained at any 2% consecutive tube current settings shall not
differ by more than 0.10 times their sum:

X1-X2 # 0.10 (X1 + X2)

where: X1 and X2 are the average mR/mAs values obtained at each of two consecutive tube
current settings.

(3) Accuracy. Deviation of technique factors from indicated values shall not exceed the
limits specified for that system by its manufacturer.
(4) Timers. Termination of exposure shall cause automatic resetting of the timer to its
initial setting or to "zero".
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.407: continued

(5) Beam Quality. All certified dental x-ray systems manufactured on and after
December 1, 1980, shall have a minimum half-value layer not less than 1.5 millimeters
aluminum equivalent. Systems operating above 70 kVp are subject to the filtration
requirements of 105 CMR 120.404(E)(1).

(E) Additional Operation Controls for Dental Radiographic Systems.

(1) Film holding devices shall be used except in individual cases in which the practitioner
has determined that such holding are contraindicated. Written safety procedures required
by 105 CMR 120.400 shall state the criteria under which the exception shall apply.
(2) The tube housing support shall be constructed and adjusted so that the tube housing
shall not drift from its set position during an exposure. Neither the tube housing nor the
support housing shall be hand-held during an exposure.
(3) The operator shall stand at least six feet from the useful beam or behind a protective
barrier. Where a protective barrier is utilized, a viewing system shall be used.
(4) Individuals who operate only dental radiographic systems are exempt from the
personnel monitoring requirements of 105 CMR 120.211.
(5) Protective equipment -aprons and shields-shall be checked annually for defects, such
as holes, cracks, and tears to assure reliability and integrity and documentation shall be kept
for five years.
(6) Thyroid shields shall be used on all patients, when applicable.
(7) The registrant of the facility shall ensure that the equipment is in safe operating
condition:
(a) when it is first installed and prior to use on patients;
(b) after any major changes or replacement of parts and prior to use on patients:
(c) by having calibrations and preventative maintenance:
1. such preventative maintenance or calibrations shall not exceed three years
2. the preventative maintenance or calibrations shall be performed by a registered
service provider as specified in 105 CMR 120.026.
(d) Preventative maintenance and calibrations shall be reviewed and signed within a
reasonable time of completion of the tests but no longer than 30 days of completion of
the tests by the licensed dentist, and any necessary corrective action shall be
implemented within 30 days.
(e) Records of the last two calibrations and preventative maintenance shall be
maintained at the facility.

(F) Hand-held Intraoral Dental Radiographic Units.

(1) For all uses:
(a) Operators of hand-held intraoral dental radiographic units shall be specifically
trained to operate such equipment.
(b) When operating a hand-held intraoral dental radiographic unit, operators shall wear
a lead apron and thyroid collar, unless otherwise authorized by the Agency or a qualified
health or medical physicist.
(c) A hand-held intraoral dental radiographic unit shall be held without any motion
during a patient examination. A tube stand may be utilized to immobilize a hand-held
intraoral dental radiographic unit during patient examination.
(d) Unless otherwise authorized by the Agency, a hand-held intraoral dental
radiographic unit shall be used with a secondary radiation block.
(e) The operator shall ensure there are no bystanders within a radius of at least six feet
from the patient being examined with a hand-held intraoral radiographic unit.
(2) Additional requirements for operatories in permanent facilities:
(a) Hand-held intraoral dental radiographic units shall be used for patient examinations
in dental operatories that meet the structural shielding requirements specified by the
Agency or by a qualified health or medical physicist.
(b) Hand-held intraoral dental radiographic units shall not be used for patient
examinations in hallways and waiting rooms.

(G) Cone Beam 3-D Dental Imaging Systems.

(1) Facilities shall maintain documentation of applications from the manufacturer;
(2) Operators of the unit shall be a:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.407: continued

(a) Licensed Dentist or

(b) Licensed Hygienist or Certified Dental Assistant
(3) All facilities that use a Cone Beam CT unit shall follow the manufacturer's
recommendations for Quality Control;
(4) All facilities shall perform calibrations and preventative maintenance annually.
(5) Preventative maintenance, surveys, and calibrations shall be reviewed and signed within
a reasonable time of completion of the tests but no longer than 30 days of completion of the
tests by a qualified medical physicist and the licensed dentist and any necessary corrective
action shall be implemented within 30 days.

120.408: Veterinary X-ray Systems

(A) Equipment.
(1) Technique and Exposure Indicators.
(a) The technique factors to be used during an exposure shall be indicated before the
exposure begins. If automatic exposure controls are used, the technique factors which
are set prior to the exposure shall be indicated.
(b) The requirements of 105 CMR 120.408(A)(1) may be met by permanent markings
on equipment having fixed technique factors. Indication of technique factors shall be
visible from the operator's position except in the case of spot films made by the
fluoroscopist.
(c) The x-ray control shall provide visual indication of the production of x-rays
observable at or from the operator's protected position whenever x-rays are produced.
(2) The leakage radiation from the diagnostic source assembly measured at a distance of
one meter in any direction from the source shall not exceed 100 milliroentgen in one hour
when the x-ray tube is operated at its leakage technique factors. Measurement is averaged
over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.
(3) The useful beam shall be restricted to the area of clinical interest and no larger than the
size of the image receptor.
(4) Collimating devices shall be provided and shall limit the beam to the area of the image
receptor to within 2% of the SID, and shall provide the same degree of protection as is
required of the housing.
(5) The half-value layer of the useful beam shall not be less than 0.5 millimeters aluminum
equivalent for machines operating up to 50 kVp, 1.5 millimeters and 70 kVp, and two
millimeters aluminum equivalent for machines operating above 70 kVp.
(6) A device shall be provided to terminate the exposure after a preset time or Exposure.
(7) A dead-man type of exposure switch shall be provided, together with an exposure cord
of sufficient length, so that the operator can stand out of the useful beam and at least six feet
from the animal during all x-ray exposures.
(8) The coefficient of variation of Exposure shall not exceed 0.10 when all technique
factors are held constant. This requirement shall be deemed to have been met if, when four
Exposures are made at identical technique factors, the value of the average Exposure (E) is
greater than or equal to five times the maximum Exposure (Emax) minus the minimum
Exposure (Emin):

E $ 5 (Emax - Emin)

(9) The primary beam shall be aligned with the film by using specified techniques in the
facility's operating procedures.
(10) Fluoroscopic, CT, and therapy systems used in veterinary facilities shall meet the
requirements of 105 CMR 120.405, 120.409 and 120.410 respectively, except the aural
communications of 105 CMR 120.400, 120.422: Appendix C, 120.409(B)(1) and
120.410(B)(1).
(11) Portable machines shall be used in a manner which complies with 105 CMR 120.000.

(B) Structural Shielding. All wall, ceiling, and floor areas shall be equivalent to or provided
with applicable protective barriers to assure compliance with 105 CMR 120.211, 120.221 and
120.222.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.408: continued

(C) Additional Operational Controls for Veterinary Facilities.

(1) All exams and retakes shall be ordered by the veterinarian.
(2) The x-ray tube shall not be held by any individual during radiographic exposures.
(3) Unless required to restrain an animal, the operator shall stand at least six feet away
from the useful beam and the animal during radiographic exposures.
(4) No individual, other than the operator, shall be in the x-ray room or area while
exposures are being made unless such individual's assistance is required.
(5) When an animal must be held in position during radiography, mechanical supporting
or restraining devices shall be used when technique permits.
(6) A pregnant female shall not hold or restrain an animal.

120.409: Computed Tomography (CT) X-ray Systems

Any facility offering CT services after April 30, 2011 shall have ACR accreditation.

Definitions. In addition to the definitions provided in 105 CMR 120.402, the following
definitions shall be applicable

Computed Tomography Dose Index (CTDI) means the integral of the dose profile along a line
perpendicular to the tomographic plane divided by the product of the nominal tomographic
section thickness and the number of tomograms produced in a single scan, that is:

where:
z = Position along a line perpendicular to the tomographic plane;

D(z) = Dose at position z;

T = Nominal tomographic section thickness;

n = Number of tomograms produced in a single scan.

Computed Tomography Dose Index (CTDI) assumes that the dose profile is centered around z=0
and that, for a multiple tomogram system, the scan increment between adjacent scans is nT.

CT Dosimetry Phantom means the phantom used for determination of the dose delivered by a
CT x-ray system. The phantom shall be a right circular cylinder of polymethl-methacrylate of
density 1.19±0.01 grams per cubic centimeter. The phantom shall be at least 14 centimeters in
length and shall have diameters of 32.0 centimeters for testing any CT system designed to image
any section of the body (whole body scanners) and 16.0 centimeters for any system designed to
image the head (head scanners) or for any whole body scanner operated in the head scanning
mode. The phantom shall provide means for the placement of a dosimeter(s) along its axis of
rotation and along a line parallel to the axis of rotation 1.0 centimeter from the outer surface and
within the phantom. Means for the placement of a dosimeter(s) or alignment device at other
locations may be provided for convenience. Any effect on the doses measured due to the
removal of phantom material to accommodate dosimeters shall be accounted for through
appropriate corrections to the reported data or included in the statement of maximum deviation
for the values obtained using the phantom.

Dose Profile means the dose as a function of position along a line.

Modulation Transfer Function means the modulus of the Fourier transform of the impulse
response of the system.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.409: continued

Noise means the standard deviation of the fluctuations in CTN expressed as a percentage of the
attenuation coefficient of water. Its estimate (Sn) is calculated using the following expression:

where:

= Linear attenuation coefficient of the material of interest.

= Linear attenuation coefficient of water.

= Standard deviation of the CTN of picture elements in a specified area of the CT

image.

Picture Element means an elemental area of a tomogram.

Remanufacturing means modifying a CT system in such a way that the resulting dose and
imaging performance become substantially equivalent to any CT x-ray system manufactured by
the original manufacturer on or after November 29, 1984. Any reference in 105 CMR 120.408
to manufacture, manufacturer, or manufacturing includes remanufacture, remanufacturing,
respectively.

Sensitivity Profile means the relative response of the CT x-ray system as a function of position
along a line perpendicular to the tomographic plane.

Single Tomogram System means a CT x-ray system which obtains x-ray transmission data
during a scan to produce a single tomogram.

(A) Equipment Requirements.

(1) Tomographic Plane Indication and Alignment.
(a) For any single tomogram system, means shall be provided to permit visual
determination of the tomographic plane or a reference plane offset from the tomographic
plane.
(b) For any multiple tomogram system, means shall be provided to permit visual
determination of the location of a reference plane. The reference plane can be offset from
the location of the tomographic planes.
(c) If a device using a light source is used to satisfy 105 CMR 120.409(A)(1)(a) or (b),
the light source shall provide illumination levels sufficient to permit visual determination
of the location of the tomographic plane or reference plane under ambient light
conditions of up to 500 lux
(2) Indication of CT Conditions of Operation. The CT x-ray system shall be designed such
that the CT conditions of operation to be used during a scan or a scan sequence are indicated
prior to the initiation of a scan or a scan sequence. On equipment having all or some of these
conditions of operation at fixed values, this requirement may be met by permanent markings.
Indication of CT conditions of operation shall be visible from any position from which scan
initiation is possible.
(3) Initiation of Operation.
(a) The x-ray control and gantry shall provide visual indication whenever x-rays are
produced and, if applicable, whether the shutter is open or closed.
(b) Means shall be provided to require operator initiation of each individual scan or
series of scans.
(c) All emergency buttons/switches shall be clearly labeled as to their functions.
(4) Termination of Exposure.
(a) Means shall be provided to terminate the x-ray exposure automatically by either
de-energizing the x-ray source or shuttering the x-ray beam in the event of equipment
failure affecting data collection. Such termination shall occur within an interval that
limits the total scan time to no more than 110% of its preset value through the use of
either a backup timer or devices which monitor equipment function.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.409: continued

(b) A visible signal shall indicate when the x-ray exposure has been terminated through
the means required by 105 CMR 120.409(A)(4)(a).
(c) The operator shall be able to terminate the x-ray exposure at any time during a scan,
or series of scans under x-ray system control, of greater than 0.5 second duration.
Termination of the x-ray exposure shall necessitate resetting of the CT conditions of
operation prior to initiation of another scan.
(5) Extraneous Radiation. The system shall perform such that the radiation produced
adjacent to the tube housing assembly, including the tube port, during periods of time that
scans are not being performed does not exceed the levels permitted by 105 CMR 120.404(C).
(6) Additional Requirements Applicable to CT X-ray Systems Containing a Gantry
Manufactured after September 3, 1985.
(a) The total error in the indicated location of the tomographic plane or reference plane
shall not exceed five millimeters.
(b) If the x-ray production period is less than 0.5 second, the indication of x-ray
production shall be actuated for at least 0.5 seconds. Indicators at or near the gantry shall
be discernible from any point external to the patient opening where insertion of any part
of the human body into the primary beam is possible.
(c) The deviation of indicated scan increment versus actual increment shall not exceed
to within one millimeter with any mass from zero to 100 kilograms resting on the support
device. The patient support device shall be incremented from a typical starting position
to the maximum incremented distance or 30 centimeters, whichever is less, and then
returned to the starting position. Measurement of actual versus indicated scan increment
can be taken anywhere along this travel.

(B) Facility Design Requirements.

(1) Aural Communication. Provision shall be made for two-way aural communication
between the patient and the operator at the control panel.
(2) Viewing System.
(a) Windows, mirrors, closed-circuit television, or an equivalent shall be provided to
permit continuous observation of the patient during irradiation and shall be so located
that the operator can observe the patient from the control panel.
(b) When the primary viewing system is by electronic means, an alternate viewing
system (which may be electronic) shall be available for use in the event of failure of the
primary viewing system.

(C) Dose Measurements, Spot Checks, Surveys, and Calibrations.

(1) Dose Measurements.
(a) Dose measurements of the radiation output of the CT x-ray system shall be
performed by a qualified medical physicist.
(b) Dose measurements of a CT x-ray system shall be performed at intervals specified
by a qualified medical physicist and after any change or replacement of components
which, in the opinion of a qualified medical physicist, could cause a change in the
radiation output.
(c) Measurements of the radiation output of a CT x-ray system shall be performed with
a calibrated dosimetry system. The dosimetry system shall have been calibrated or inter
compared with a calibrated chamber within the preceding two years. The calibration of
such system shall be traceable to a national standard.
(d) Calibration procedures shall be in writing. Records of calibration performed shall
be maintained for inspection by the Radiation Control Program.
(2) Spot Checks.
(a) Spot check procedures shall be in writing and developed by a qualified medical
physicist.
(b) All spot checks shall be included in the calibration required by 105 CMR
120.409(C)(1), and otherwise at time intervals and system conditions specified by a
qualified medical physicist.
(c) Spot checks shall include acquisition of images obtained with the phantoms using
the same processing mode and CT conditions of operation as are used to perform dose
measurements required by 105 CMR 120.409(C)(1). The images shall be retained until
a new dose measurement is performed in two forms as follow:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.409: continued

1. Photographic copies of the images obtained from the image display device; and
2. Images stored in digital form of the most recent spot check on a storage medium
compatible with the CT x-ray system.
(d) The spot-check procedures shall incorporate the use of a CT dosimetry phantom
which has a capability of providing an indication of contrast scale, noise, nominal
tomographic section thickness, the resolution capability of the system for low and high
contrast objects, and measuring the mean CTN for water or other reference material.
(e) Written records of the spot checks performed shall be maintained for inspection by
the Agency.
(3) Surveys .
(a) All CT x-ray systems installed after March 3, 2012 and those systems not previously
surveyed shall have a survey made by a qualified medical physicist. In addition, such
surveys shall be done after any change in the facility or equipment which might cause a
significant increase in radiation hazard.
(b) The registrant of the facility [licensee] shall obtain a written report of the survey
from the qualified medical physicist, and a copy of the report shall be made available to
the Agency upon request.
(4) Physics Evaluations.
(a) The physics evaluation of the radiation output of the CT x-ray system shall be
performed by a qualified medical physicist.
(b) The physics evaluation of a CT x-ray system shall be performed after initial
installation and before use on human patients, annually or at intervals specified by a
qualified medical physicist, and after any change or replacement of components which,
in the opinion of the qualified medical physicist, could cause a change in the radiation
output.
(c) The physics evaluation of the radiation output of a CT x-ray system shall be
performed with a calibrated dosimetry system. The physics evaluation of such system
shall be traceable to a national standard. The dosimetry system shall have been calibrated
within the preceding two years.
(d) CT dosimetry phantom(s) shall be used in determining the radiation output of a CT
x-ray system. Such phantom(s) shall meet the following specifications and conditions
of use:
1. CT dosimetry phantom(s) shall be right circular cylinders of polymethyl
methacrylate of density 1.19 plus or minus 0.01 grams per cubic centimeter. The
phantom(s) shall be at least 14 centimeters in length and shall have diameters of 32.0
centimeters for testing CT x-ray systems designed to image any section of the body
and 16.0 centimeters for systems designed to image the head or for whole body
scanners operated in the head scanning mode;
2. CT dosimetry phantom(s) shall provide means for the placement of a dosimeter(s)
along the axis of rotation and along a line parallel to the axis of rotation 1.0
centimeter from the outer surface and within the phantom. Means for the placement
of dosimeters or alignment devices at other locations may be provided;
3. Any effects on the doses measured due to the removal of phantom material to
accommodate dosimeters shall be accounted for through appropriate corrections to
the reported data or included in the statement of maximum deviation for the values
obtained using the phantom;
4. All dose measurements shall be performed with the CT dosimetry phantom
placed on the patient couch or support device without additional attenuation materials
present.
(e) The physics evaluation shall be required for each type of head, body, or whole-body
scan performed at the facility.
(f) Physics evaluation shall meet the following requirements:
1. The dose profile along the center axis of the CT dosimetry phantom for the
minimum, maximum, and midrange values of the nominal tomographic section
thickness used by the registrant shall be measurable. Where less than three nominal
tomographic thicknesses can be selected, the dose profile determination shall be
performed for each available nominal tomographic section thickness;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.409: continued

2. The CTDi2 along the two axes specified in 105 CMR 120.409(C)(4)(d)2. shall be
measured. The CT dosimetry phantom shall be oriented so that the measurement
point 1.0 centimeter from the outer surface and within the phantom is in the same
angular position within the gantry as the point of maximum surface CTDI identified.
The CT conditions of operation shall correspond to typical values used by the
registrant.
3. The spot checks specified in 105 CMR 120.409(C)(2) shall be made.

(D) Additional Operational Controls for CT X-Ray Systems.

(1) The CT x-ray system shall only be operated by an individual who has been specifically
trained in its operation and who holds a valid Massachusetts license in radiologic technology.
(2) Information shall be available at the control panel or in a specified location regarding
the operation and calibration of the system. The information shall contain:
(a) Dates of the latest calibration and spot checks and the location within the facility
where the results of those tests may be obtained;
(b) The results of at least the most recent checks conducted on the system; and,
(c) The distance, in millimeters, between the tomographic plane and the reference plane,
if a reference plane is utilized.
(3) If the calibration or spot check of the CT x-ray system identifies that a system operating
parameter has exceeded a tolerance established by the qualified medical physicist, use of the
CT x-ray system on patients shall be limited to those uses permitted by established written
instructions of the qualified medical physicist.
(4) Quarterly reviews shall be conducted of dose protocols being used at the facility.
(5) Dose indicators shall be included in the patient's medical record.

(E) Mini CT Units.

(1) All facilities that use a Mini CT unit shall follow the manufacturer's recommendations
for Quality Control.
(2) Operators of Mini CT units shall be:
(a) Licensed physician; or
(b) Licensed as a Radiologic Technologist.
(3) Each facility shall maintain the records of applications from the manufacturer.

120.410: Bone Densitometry

(A) Bone Densitometry Systems shall be:

(1) Certified by the manufacturer pursuant to the Medical Device Act and Subchapter C
– Electronic Product Radiation Control (EPRC) of Chapter V of the Federal Food, Drug and
Cosmetic Act.;
(2) Registered in accordance with 105 CMR 120.020;
(3) Maintained and operated in accordance with the manufacturer's specifications.

(B) Equipment Requirements. Systems with stepless collimators shall be provided with means
to both size and align the x-ray field such that the x-ray field at the plane of the image receptor
does not extend beyond 2% of the SID.

(C) Operators of Bone Densitometry Systems shall be:

(1) Licensed as a radiologic technologist [by the Agency]; or
(2) A licensed physician; or
(3) International Society For Clinical Densitometry certified as a bone densitometry
technologist; or
(4) ARRT certified in Bone Density

________________________
2
For the purpose of determining the CTDI, the manufacturer's statment as to the nominal
tomographic section thickness for that particular system may be utilized.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.410: continued

(D) During the Operation of any Bone Densitometry System:

(1) The operator, ancillary personnel, and members of the general public shall be positioned
at least one meter from the patient and bone densitometry system during the examination.
(2) The operator shall advise the patient that the bone densitometry examination is a type
of x-ray procedure.

(E) The Manufacturer's Quality Assurance and Quality Control programs shall be followed.

(F) The registrant of the facility shall keep maintenance records for bone densitometry systems.
These records shall be maintained for inspection by the Agency for three years.

(G) Bone Densitometry on Human Patients Shall be Conducted Only:

(1) Under a prescription of a licensed practitioner of the healing arts; or
(2) Under a screening program approved by the Agency.

(H) Any person proposing to conduct a bone densitometry screening program shall submit the
information outlined in 105 CMR 120.421: Appendix B and include the name and address of the
individual who will interpret the screening results.

(I) 105 CMR 120.010 includes CT units that are designed for bone density.

120.420: Appendix A -- Radiation Shielding and Safety Requirements

In order for the Radiation Control Program to provide an evaluation, and official approval
on shielding requirements for a radiation installation, the following must be submitted. The
plans shall show as a minimum the following:

(A) The normal location of the x-ray system's radiation port, the port's travel and transverse
limits, general direction(s) of the useful beam; locations of any windows and doors; the location
of the operator's booth and the location of the x-ray control panel.

(B) The structural composition and thickness or lead equivalent of all walls, doors, partitions,
floor and ceiling of the room(s) concerned.

(C) The dimensions of the room(s) concerned.

(D) The type of occupancy of all adjacent areas inclusive of space above and below the room(s)
concerned. If there is any exterior wall, show distance to the closest area(s) where it is likely that
individuals will be present.

(E) The make and model of the x-ray equipment.

(F) The typical type of examination(s) and treatment(s) which will be performed with the
equipment.

(G) Information on the anticipated workload of the x-ray system(s).

(H) An interlock and/or warning light shall be installed at all egresses. For diagnostic x-ray
installations, the warning light shall be wired to the rotor of the x-ray system.

(I) All basic assumptions used to determine the shielding requirements in developing these
plans shall be submitted with these plans.

120.421: Appendix B -- Information to be Submitted by Persons Proposing to Conduct Healing Arts

Screening

Persons requesting that the Agency approve a healing arts screening program shall submit
the following information and evaluation:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.421: continued

(A) Name and address of the applicant and, where applicable, the names and addresses of
agents within this Commonwealth.

(B) Diseases or conditions for which the x-ray examinations are to be used in diagnoses.

(C) A detailed description of the x-ray examinations proposed in the screening program.

(D) Description of the population to be examined in the screening program, i.e., age, sex,
physical condition, and other appropriate information.

(E) An evaluation of any known alternate methods not involving ionizing radiation, which
would achieve the goals of the screening program and why these methods are not used instead
of the x-ray examinations.

(F) An evaluation by a qualified expert of the x-ray system(s) to be used in the screening
program. The evaluation by the qualified expert shall show that such system(s) do satisfy all
requirements of 105 CMR 120.000.

(G) A description of the diagnostic film quality control program.

(H) A copy of the technique charts for the x-ray examination procedures to be used.

(I) The qualifications of each individual who will be operating the x-ray system(s).

(J) The qualifications of the individual who will be supervising the operators of the x-ray
system(s). The extent of supervision and the method of work performance evaluation shall be
specified.

(K) The name and address of the individual who will interpret the radiograph(s).

(L) Procedures to be used in advising the individuals screened and their practitioner of the
healing arts or healthcare provider of the results of the screening procedure and any further
medical needs indicated.

(M) The duration of the screening program.

120.422: Appendix C -- Design Requirements for an Operator's Booth

(A) Space Requirements

(1) The operator shall be allotted not less than 7.5 square feet (0.697 m2) of unobstructed
floor space in the booth.
(2) The operator's booth may be any geometric configuration with no dimension of less than
two feet (0.61 m).
(3) The space shall be allotted excluding any encumbrance by the x-ray control panel, such
as overhang, cables or other similar encroachments.
(4) The booth shall be located or constructed such that unattenuated direct scatter radiation
originating in the examination table or at the wall cassette shall not reach the operator's
station in the booth.

(B) Structural Requirements

(1) The booth walls shall be permanently fixed barriers of at least seven feet (2.13 m) high.
(2) When a door or movable panel is used as an integral part of the booth structure, it must
have an interlock which will prevent an exposure when the door or panel is not closed.
(3) Shielding shall be provided to maintain exposure inside the booth equal to or less than
two mR per week.

(C) X-ray Control Placement. The x-ray exposure switch for the system shall be fixed within
the booth and;
(1) Shall be at least 40 inches (1.02 m) from any open edge of the booth and;
(2) Shall allow the operator to use the majority of the available viewing windows.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.422: continued

(D) Viewing System Requirements.

(1) Each booth shall have at least one viewing device which will:
(a) Be so placed that the operator can view the patient during any exposure; and,
(b) The device should be so placed that the operator can have full view of any occupant
of the room and should be so placed that the operator can view any entry into the room.
If any door that allows access to the room cannot be seen from the booth, then that door
must have an interlock controlling the exposure, which will prevent the exposure if the
door is not closed.
(2) When the viewing system is a window, the following requirements also apply:
(a) The viewing area shall be at least one square foot (0.0929 m2).
(b) The design of the booth shall be such that the operator's expected position when
viewing the patient and operating the x-ray system is at least 18 inches (0.457m) from
the edge of the booth.
(c) The material constituting the window shall have at least the same lead equivalence
as that required in the booth's walls in which it is mounted.
(3) When the viewing system is by mirrors, the mirror(s) shall be so located as to
accomplish the general requirements of 105 CMR 120.422: Appendix C(A)(4).
(4) When the viewing system is by electronic means:
(a) The camera shall be so located as to accomplish the general requirements of
105 CMR 120.421: Appendix C(A)(4); and,
(b) There shall be an alternate viewing system as a backup for the primary system.
(c) Means shall be provided for the operator to be able to orally communicate with the
patient at all times.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.423: Appendix D – Exemptions from Shielding for Certain Fluoroscopic Procedures

(A) Angiograms

(B) Arthrograms

(C) Biliary drainage procedures

(D) Fluoroscopic biopsy procedures

(E) Myelograms

(F) Percutaneous cholangiograms

(G) Percutaneous nephrostomies

(H) Sinograms or fistulograms

(I) T-tube cholangiograms

120.430: THERAPEUTIC RADIATION MACHINES IN THE HEALING ARTS

120.431: Purpose and Scope

(A) 105 CMR 120.430 establishes requirements, for which the registrant is responsible, for use
of therapeutic radiation machines. The provisions of 105 CMR 120.430 are in addition to, and
not in substitution for, other applicable provisions of 105 CMR 120.000.

(B) The use of therapeutic radiation machines shall be by, or under the supervision of, a
licensed practitioner of the healing arts who meets the training/experience criteria established
by 105 CMR 120.433(C).

120.432: Definitions

As used in 105 CMR 120.430, the following definitions apply:

Absorbed Dose (D) means the mean energy imparted by ionizing radiation to matter. Absorbed
dose is determined as the quotient of dE by dM, where dE is the mean energy imparted by
ionizing radiation to matter of mass dM. The SI unit of absorbed dose is joule per kilogram and
the special name of the unit of absorbed dose is the gray (Gy). The previously used special unit
of absorbed dose (rad) is being replaced by the gray.

Absorbed Dose Rate means absorbed dose per unit time, for machines with timers, or dose
monitor unit per unit time for linear accelerators.

Accessible Surface means surface of equipment or of an equipment part that can be easily or
accidentally touched by persons without the use of a tool.

Added Filtration means any filtration which is in addition to the inherent filtration.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.432: continued

Air Kerma (K) means the kinetic energy released in air by ionizing radiation. Kerma is
determined as the quotient of dE by dM, where dE is the sum of the initial kinetic energies of all
the charged ionizing particles liberated by uncharged ionizing particles in air of mass dM. The
SI unit of air kerma is joule per kilogram and the special name for the unit of kerma is the gray
(Gy).

Barrier (See Protective Barrier in 105 CMR 120.005).

Beam Axis means the axis of rotation of the beam limiting device.

Beam-limiting Device means a field defining collimator, integral to the therapeutic radiation
machine, which provides a means to restrict the dimensions of the useful beam.

Beam Monitoring System means a system designed and installed in the radiation head to detect
and measure the radiation present in the useful beam.

Beam Scattering Foil means a thin piece of material (usually metallic) placed in the beam to
scatter a beam of electrons in order to provide a more uniform electron distribution in the useful
beam.

Bent Beam Linear Accelerator means a linear accelerator geometry in which the accelerated
electron beam must change direction by passing through a bending magnet.

Certified Health Physicist means and individual certified by the American Board of Health
Physics as a health physicist.

Changeable Filters means any filter, exclusive of inherent filtration, which can be removed from
the useful beam through any electronic, mechanical, or physical process.

Contact Therapy System means a therapeutic radiation machine with a short target to skin
distance (TSD), usually less than five centimeters.

Conventional Simulator means any x-ray system designed to reproduce the geometric conditions
of the radiation therapy equipment.

Detector (See Radiation Detector in 105 CMR 120.402).

Dose Monitor Unit (DMU) means a unit response from the beam monitoring system from which
the absorbed dose can be calculated.

Dosimetry System means a device which can measure radiation dose.

Electronic Brachytherapy means a method of radiation therapy using an electrically generated

source of ionizing radiation to deliver a radiation dose at a distance of up to a few centimeters
by intracavitary, intraluminal or interstitial application, or by applications with the source in
contact with the body surface or very close to the body surface.

Electronic Brachytherapy Device means the system used to produce and deliver therapeutic
radiation including the x-ray tube, the control mechanism, the cooling system, and the power
source.

Electronic Brachytherapy Source means the x-ray tube component used in an electronic
brachytherapy device.

External Beam Radiation Therapy means therapeutic irradiation in which the source of radiation
is at a distance from the body.

Field-flattening Filter means a filter used to flatten the absorbed dose rate over the radiation field.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.432: continued

Filter means material placed in the useful beam to change beam quality in therapeutic radiation
machines subject to 105 CMR 120.436.

Gantry means that part of a radiation therapy system supporting and allowing movements of the
radiation head about a center of rotation.

Gray (Gy) means the SI unit of absorbed dose, kerma, and specific energy imparted equal to one
joule per kilogram. The previous unit of absorbed dose (rad) is being replaced by the gray. [one
Gy=100 rad].

Intensity Modulated Radiation Therapy (IMRT) means radiation therapy that uses non-uniform
radiation beam intensities which have been determined by various computer-based optimization
techniques.

Interlock means a device preventing the start or continued operation of equipment unless certain
predetermined conditions prevail.

Interruption of Irradiation means the stopping of irradiation with the possibility of continuing
irradiation without resetting of operating conditions at the control panel.

Isocenter means the center of the sphere through which the useful beam axis passes while the
gantry moves through its full range of motions.

Leakage Radiation means radiation emanating from the radiation therapy system except for the
useful beam.

Light Field means the area illuminated by light, simulating the radiation field.

mA means milliampere.

Megavolt (MV) [Mega Electron Volt (MeV)] means the energy equal to that acquired by a
particle with one electron charge in passing through a potential difference of one million volts
in a vacuum. [Note: current convention is to use MV for photons and MeV for electrons.]

Mobile Electronic Brachytherapy Service means transportation of an electronic brachytherapy

device to provide electronic brachytherapy at an address that is not the address of record.

Monitor Unit (MU) (See Dose Monitor Unit).

Moving Beam Radiation Therapy means radiation therapy with any planned displacement of
radiation field or patient relative to each other, or with any planned change of absorbed dose
distribution. It includes arc, skip, conformal, intensity modulation and rotational therapy.

Nominal Treatment Distance means:

(a) For electron irradiation, the distance from the scattering foil, virtual source, or exit
window of the electron beam to the entrance surface of the irradiated object along the central
axis of the useful beam.
(b) For x-ray irradiation, the virtual source or target to isocenter distance along the central
axis of the useful beam. For non-isocentric equipment, this distance shall be that specified
by the manufacturer.

Peak Tube Potential means the maximum value of the potential difference across the x-ray tube
during an exposure.

Periodic Quality Assurance Check means a procedure which is performed to ensure that a
previous calibration continues to be valid.

Prescribed Dose means the total dose and dose per fraction as documented in the written
directive.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

420.432: continued

Primary Dose Monitoring System means a system which will monitor the useful beam during
irradiation and which will terminate irradiation when a pre-selected number of dose monitor
units have been delivered.

Primary Protective Barrier (See 105 CMR 120.005: Protective Barrier).

Qualified Medical Physicist means an individual qualified in accordance with 105 CMR
120.433(D).

Radiation Field (See Useful Beam)

Radiation Head means the structure from which the useful beam emerges.

Redundant Beam Monitoring System means a combination of two dose monitoring systems in
which each system is designed to terminate irradiation in accordance with a pre-selected number
of dose monitor units.

Secondary Dose Monitoring System means a system which will terminate irradiation in the event
of failure of the primary dose monitoring system.

Secondary Protective Barrier (See Protective Barrier in 105 CMR 120.005).

Simulator (Radiation Therapy Simulation System) means any x ray system intended for
localizing the volume to be exposed during radiation therapy and establishing the position and
size of the therapeutic irradiation field. (See: Conventional Simulator and Virtual Simulator.)

Source means the region and/or material from which the radiation emanates.

Source-skin Distance (SSD) (See Target-skin Distance).

Stationary Beam Radiation Therapy means radiation therapy without displacement of one or
more mechanical axes relative to the patient during irradiation.

Stray Radiation means the sum of leakage and scattered radiation.

Target means that part of an x-ray tube or accelerator onto which is directed a beam of
accelerated particles to produce ionizing radiation or other particles.

Target-skin Distance (TSD) means the distance measured along the beam axis from the target
to the surface of the irradiated object or patient.

Tenth-value Layer (TVL) means the thickness of a specified material which attenuates X-
radiation or gamma radiation to an extent such that the air kerma rate, exposure rate or absorbed
dose rate is reduced to one-tenth of the value measured without the material at the same point.

Termination of Irradiation means the stopping of irradiation in a fashion which will not permit
continuance of irradiation without the resetting of operating conditions at the control panel.

Therapeutic Radiation Machine means x-ray or electron-producing equipment designed and used
for external beam radiation therapy. For the purpose of 105 CMR 120.000, devices used to
administer electronic brachytherapy shall also be considered therapeutic radiation machines.

Tube means an x-ray tube, unless otherwise specified.

Tube Housing Assembly means the tube housing with tube installed. It includes high-voltage
and/or filament transformers and other appropriate elements when such are contained within the
tube housing.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.432: continued

Useful Beam means the radiation emanating from the tube housing port or the radiation head and
passing through the aperture of the beam limiting device when the exposure controls are in a
mode to cause the therapeutic radiation machine to produce radiation.

Virtual Simulator means a computed tomography (CT) unit used in conjunction with relevant
software which recreates the treatment machine; and that allows import, manipulation, display,
and storage of images from CT and/or other imaging modalities.

Virtual Source means a point from which radiation appears to originate.

Wedge Filter means a filter which effects continuous change in transmission over all or a part
of the useful beam.

Written Directive means an order, such as a physician’s prescription, in writing, by an authorized

user for the administration of radiation to a specific patient or human research subject, as
specified in 105 CMR 120.435(A).

X-ray Tube means any electron tube which is designed to be used primarily for the production
of x-rays.

120.433: General Administrative Requirements for Facilities Using Therapeutic Radiation Machines

(A) Administrative Controls. The registrant shall be responsible for directing the operation of
the therapeutic radiation machines which have been registered with the Agency. The registrant
or the registrant's agent shall ensure that the requirements of 105 CMR 120.430 are met in the
operation of the therapeutic radiation machine(s).

(B) Prohibition A therapeutic radiation machine which does not meet the provisions of
105 CMR 120.000 shall not be used for irradiation of patients.

(C) Training for Therapeutic Radiation Machine Authorized Users The registrant for any
therapeutic radiation machine subject to 105 CMR 120.436 or 120.437 shall require the
authorized user to be a physician who:
(1) Is certified in:
(a) Radiology or therapeutic radiology by the American Board of Radiology; or
(b) Radiation oncology by the American Osteopathic Board of Radiology; or
(c) Radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty
of Radiology" or "Fellow of the Royal College of Radiology"; or
(d) Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons.
(2) Is in the active practice of therapeutic radiology, and has completed 200 hours of
instruction in basic radiation techniques applicable to the use of an external beam radiation
therapy unit, 500 hours of supervised work experience, and a minimum of three years of
supervised clinical experience.
(a) To satisfy the requirement for instruction in 105 CMR 120.433(C)(2), the classroom
and laboratory training shall include:
1. Radiation physics and instrumentation;
2. Radiation protection;
3. Mathematics pertaining to the use and measurement of ionization radiation; and
4. Radiation biology.
(b) To satisfy the requirement for supervised work experience, training shall be under
the supervision of an authorized user and shall include:
1. Review of the full calibration measurements and periodic quality assurance
checks;
2. Evaluation of prepared treatment plans and calculation of treatment times/patient
treatment settings;
3. Using administrative controls to prevent misadministrations;
4. Implementing emergency procedures to be followed in the event of the abnormal
operation of a external beam radiation therapy unit or console; and,
5. Checking and using radiation survey meters.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.433: continued

(c) To satisfy the requirement for a period of supervised clinical experience, training
shall include one year in a formal training program approved by the Residency Review
Committee for Radiology of the Accreditation Council for Graduate Medical Education
or the Committee on Postdoctoral Training of the American Osteopathic Association and
an additional year years of clinical experience in therapeutic radiology under the
supervision of an authorized user. The supervised clinical experience shall include:
1. Examining individuals and reviewing their case histories to determine their
suitability for external beam radiation therapy treatment, and any limitations/
contraindications;
2. Selecting proper dose and how it is to be administered;
3. Calculating thetherapeutic radiation machine doses and collaborating with the
authorized user in the review of patients' progress and consideration of the need to
modify originally prescribed doses and/or treatment plans as warranted by patients'
reaction to radiation; and,
4. Post administration follow up and review of case histories.
(d) Notwithstanding the requirements of 105 CMR 120.433(C)(1) and (2), the registrant
for any therapeutic radiation machine subject to 105 CMR 120.436 may also submit the
training of the prospective authorized user physician for Agency review on a case by case
basis.
(e) A physician shall not act as an authorized user for any therapeutic radiation machine
until such time as said physician's training has been reviewed and approved by the
Agency.

(D) Training for Qualified Medical Physicist for Radiation Therapy. The registrant for any
therapeutic radiation machine subject to 105 CMR 120.436 or 120.437 shall require the
Qualified Medical Physicist to:
(1) Be registered with the Agency, under the provisions of 105 CMR 120.026, as a provider
of radiation services in the area of calibration and compliance surveys of external beam
radiation therapy units; and,
(2) Be certified by the American Board of Radiology in:
(a) Therapeutic radiological physics; or
(b) Roentgen-ray and gamma-ray physics; or
(c) X-ray and radium physics; or
(d) Radiological physics; or,
(3) Be certified by the American Board of Medical Physics in Radiation Oncology Physics;
or,
(4) Be certified by the Canadian College of Medical Physics.

(E) Qualifications of Operators.

(1) Individuals who will be operating a therapeutic radiation machine for medical use shall
possess a valid Massachusetts License as a Radiologic Technologists in Radiation Therapy.
(2) The names and the respective training records of all personnel currently operating a
therapeutic radiation machine shall be kept on file at the facility. Information on former
operators shall be retained for a period of at least two years beyond the last date they were
authorized to operate a therapeutic radiation machine at that facility.

(F) Written safety procedures and rules shall be developed by a Qualified Medical Physicist and
shall be available in the control area of a therapeutic radiation machine, including any restrictions
required for the safe operation of the particular therapeutic radiation machine. The operator shall
be able to demonstrate familiarity with these rules.

(G) Individuals shall not be exposed to the useful beam except for medical therapy purposes
and unless such exposure has been ordered in writing by an authorized user meeting the
requirements of 105 CMR 120.433(C) who is specifically identified on the Certificate of
Registration. 105 CMR 120.433(G) specifically prohibits deliberate exposure of an individual
for training, demonstration or other non-healing-arts purposes.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.433: continued

(H) Visiting Authorized User. Notwithstanding the provisions of 105 CMR 120.433(G), a
registrant may permit any physician to act as a visiting authorized user under the term of the
registrant's Certificate of Registration for up to 60 days per calendar year under the following
conditions:
(1) The visiting authorized user has the prior written permission of the registrant's
management and, if the use occurs on behalf of an institution, the institution's Radiation
Safety Committee; and
(2) The visiting authorized user meets the requirements established for authorized user(s)
in 105 CMR 120.433(C)(1) and (2); and
(3) The registrant maintains copies of all records specified by 105 CMR 120.433(H) for five
years from the date of the last visit.

(I) All individuals associated with the operation of a therapeutic radiation machine shall be
instructed in and shall comply with the provisions of the registrant's written directive program.
In addition to the requirements of 105 CMR 120.430, these individuals are also subject to the
requirements of 105 CMR 120.201 and 120.205.

(J) Information and Maintenance Record and Associated Information. The registrant shall
maintain the following information in a separate file or package for each therapeutic radiation
machine, for inspection by the Agency:
(1) Report of acceptance testing;
(2) Records of all surveys, calibrations, and periodic quality assurance checks of the
therapeutic radiation machine required by 105 CMR 120.430, as well as the name(s) of
person(s) who performed such activities;
(3) Records of maintenance and/or modifications performed on the therapeutic radiation
machine after July 9, 1999, as well as the name(s) of person(s) who performed such services;
(4) Signature of the Radiation therapy Physicist or Authorized User authorizing the return
of therapeutic radiation machine to clinical use after service, repair, or upgrade.

(K) Records Retention. All records required by 105 CMR 120.430 shall be retained until
disposal is authorized by the Agency unless another retention period is specifically authorized
in 105 CMR 120.430. All required records shall be retained in an active file from at least the
time of generation until the next Agency inspection. Any required record generated prior to the
last Agency inspection may be microfilmed or otherwise archived as long as a complete copy of
said record can be retrieved until such time as the Agency authorizes final disposal.

120.434 General Technical Requirements for Facilities Using Therapeutic Radiation Machines

(A) Protection Surveys.

(1) The registrant shall ensure that radiation protection surveys of all new facilities, and
existing facilities not previously surveyed, are performed with an operable radiation
measurement survey instrument calibrated in accordance with 105 CMR 120.438. The
radiation protection survey shall be performed by, or under the direction of, a Qualified
Medical Physicist or a Certified Health Physicist and shall verify that, with the therapeutic
radiation machine in a "BEAM-ON" condition, with the largest clinically available treatment
field and with a scattering phantom in the useful beam of radiation. The following standards
must be met and recorded:
(a) Radiation levels in restricted areas are not likely to cause personnel exposures in
excess of the limits specified in 105 CMR 120.211(A); and,
(b) Radiation levels in unrestricted areas do not exceed the limits specified in 105 CMR
120.221(A) and (B).
(2) In addition to the requirements of 105 CMR 120.434(A)(1), a radiation protection
survey shall also be performed prior to any subsequent medical use and:
(a) After making any structural or composite modifications to the treatment room
shielding;
(b) After making any changes in the location of the therapeutic radiation machine within
the treatment room;
(c) After relocating the therapeutic radiation machine; or
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.434: continued

(d) Before using the therapeutic radiation machine in a manner that could result in
increased radiation levels in areas outside the external beam radiation therapy treatment
room.
(3) The survey record shall indicate all instances where the facility, in the opinion of the
Qualified Medical Physicist or a Certified Health Physicist, is in violation of applicable
regulations. The survey record shall also include the date of the measurements, the reason
the survey is required, the manufacturer's name, model number and serial number of the
therapeutic radiation machine, the instrument(s) used to measure radiation levels, a plan of
the areas surrounding the treatment room that were surveyed, the measured dose rate at
several points in each area expressed in microsieverts or millirems per hour, the calculated
maximum level of radiation over a period of one week for each restricted and unrestricted
area, and the signature of the individual responsible for conducting the survey;
(4) If the results of the surveys required by 105 CMR 120.434(A)(1) or (2) indicate any
radiation levels in excess of the respective limit specified in 105 CMR 120.434(A)(1), the
registrant shall lock the control in the "OFF" position and not use the unit:
(a) Except as may be necessary to repair, replace, or test the therapeutic radiation
machine, the therapeutic radiation machine shielding, or the treatment room shielding;
or
(b) Until the registrant has received a specific exemption from the Agency.

(B) Modification of Radiation Therapy Unit or Room Before Beginning a Treatment Program.
If the survey required by 105 CMR 120.434(A) indicates that an individual in an unrestricted
area may be exposed to levels of radiation greater than those permitted by 105 CMR 120.221(A)
and (B), before beginning the treatment program the registrant shall:
(1) Either equip the unit with beam direction interlocks or add additional radiation shielding
to ensure compliance with 105 CMR 120.221(A) and (B);
(2) Perform the survey required by 105 CMR 120.434(A) again; and,
(3) Include in the report required by 105 CMR 120.434(D) the results of the initial survey,
a description of the modification made to comply with 105 CMR 120.434(B)(1), and the
results of the second survey; or,
(4) Request and receive a registration amendment under 105 CMR 120.221(C). that
authorizes radiation levels in unrestricted areas greater than those permitted by 105 CMR
120.221(A) and (B).

(C) Dosimetry Equipment.

(1) The registrant shall have a calibrated dosimetry system available for use. The system
shall have been calibrated by the National Institute for Standards and Technology (NIST) or
by an American Association of Physicists in Medicine (AAPM) Accredited Dosimetry
Calibration Laboratory (ADCL). The calibration shall have been performed within the
previous 24 months and after any servicing that may have affected system calibration.
(a) For beams with energies greater than one MV (one MeV), the dosimetry system
shall have been calibrated for Cobalt-60;
(b) For beams with energies equal to or less than one MV (one MeV), the dosimetry
system shall have been calibrated at an energy (energy range) appropriate for the
radiation being measured;
(2) The registrant shall have available for use a dosimetry system for quality assurance
check measurements. To meet this requirement, the system may be compared with a system
that has been calibrated in accordance with 105 CMR 120.434(C)(1) This comparison shall
have been performed within the previous 12 months and after each servicing that may have
affected system calibration. The quality assurance check system may be the same system
used to meet the requirement in 105 CMR 120.434(C)(1);
(3) The registrant shall maintain a record of each dosimetry system calibration,
intercomparison, and comparison for the duration of the license and/or registration. For each
calibration, intercomparison, or comparison, the record shall include the date, the model
numbers and serial numbers of the instruments that were calibrated, inter-compared, or
compared as required by 105 CMR 120.434(C)(1) and (2), the correction factors that were
determined, the names of the individuals who performed the calibration, intercomparison,
or comparison, and evidence that the intercomparison was performed by, or under the direct
supervision and in the physical presence of, a Qualified Medical Physicist.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.434: continued

(D) Reports of External Beam Radiation Therapy Surveys and Measurements. The registrant
for any therapeutic radiation machine subject to 105 CMR 120.436 or 120.437 shall furnish a
copy of the records required in 105 CMR 120.434(A) and (B) to the Agency within 30 days
following completion of the action that initiated the record requirement.

120.435: Written Directives

(A) A written directive, as defined in 105 CMR 120.432, must be dated and signed by an
authorized user prior to the administration of radiation.
If, because of the emergent nature of the patient's condition, a delay in order to provide a
written directive would jeopardize the patient's health, an oral directive will be acceptable,
provided that the information contained in the oral directive is documented as soon as possible
in writing in the patient's record and a written directive is prepared within 48 hours of the oral
directive.

(B) The written directive must contain the patient or human research subject’s name, the type
and energy of the beam, the total dose, dose per fraction, treatment target volume, and number
of fractions.

(C)(1) A written revision to an existing written directive may be made provided that the
revision is dated and signed by an authorized user prior to the administration of the external
beam dose, or the next fractional dose.
If because of the patient’s condition, a delay in the order to provide a written revision to
an existing written directive would jeopardize the patient’s health, an oral revision to an
existing written directive will be acceptable, provided that the oral revision is documented
as soon as possible in writing in the patient’s record and a revised written directive is signed
by an authorized user within 48 hours of the oral revision.
(2) The registrant shall retain a copy of the written directive for three years.

(D) Procedures for Administrations of Doses of Radiation. The registrant shall develop,
implement, and maintain written procedures to provide high confidence that:
(1) Prior to the administration of each course of radiation treatments, the patient’s or human
research subject’s identity is verified by more than one method as the individual named in
the written directive;
(2) Each administration is in accordance with the written directive;
(3) Therapeutic radiation machine approved isodose plan and related calculations are in
accordance with the respective written directives by:
(a) Checking both manual and computer generated dose calculations to verify they are
correct and in accordance with the written directive approved by the authorized user and
reviewed by the qualified medical physicist; and
(b) Verifying that any computer-generated calculations are correctly transferred into the
consoles of authorized therapeutic medical units;
(4) Any unintended deviation from the written directive is identified, evaluated and
appropriate action is taken; and
(5) The registrant retains a copy of the procedures for administrations for the duration of the
registration.

(E) Reports and Notification of Medical Events.

(1) Other than events that result from intervention by a patient or human research subject,
a registrant shall report any event in which the administration of radiation from a radiation
therapy machine results in:
(a) A dose that differs from the prescribed dose by more than 0.05 Sv (five rem)
effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem)
shallow dose equivalent to the skin; and either
1. The total dose delivered differs from the prescribed dose by 20% or more;
2. The calculated weekly administered dose differs from the weekly prescribed dose
by 30% or more; or
3. For a planned treatment course of three or fewer fractions and the calculated total
administered dose differs from the total prescribed dose by more than 10% of the
total prescribed dose; or
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.435: continued

4. The fractionated dose delivered differs from the prescribed dose, for a single
fraction, by 50% or more.
(b) A dose that exceeds 0.05 Sv (five rem) effective dose equivalent, 0.5 Sv (50 rem)
to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin from any of
the following:
1. An administration of a dose or dosage to the wrong individual or human research
subject; or
2. An administration of a dose delivered by the wrong mode of treatment;
(c) A dose to the skin or an organ or tissue other than the treatment site that exceeds by
0.5 Sv (50 rem) to an organ or tissue and 50% of the dose expected from the
administration defined in the written directive.
(2) A registrant shall report any event resulting from intervention of a patient or human
research subject in which the administration of external beam radiation results, or will result
in, unintended permanent functional damage to an organ or a physiological system as
determined by a physician.
(3) The registrant shall notify the Agency by telephone no later than the next calendar day
after discovery of the medical event.
(4) The registrant shall submit a written report to the Agency within 15 days after discovery
of the medical event.
(a) The written report must include:
1. The registrant's name;
2. The name of the prescribing physician;
3. A brief description of the event;
4. Why the event occurred;
5. The effect, if any, on the individual(s) who received the administration;
6. Actions, if any, that have been taken, or are planned, to prevent recurrence;
7. Certification that the registrant notified the individual (or the individual's
responsible relative or guardian), and if not, why not.
(b) The report may not contain the individual's name or any other information that could
lead to identification of the individual.
(5) The registrant shall provide notification of the medical event to the referring physician
and also notify the individual who is the subject of the medical event no later than 24 hours
after its discovery, unless the referring physician personally informs the registrant either that
he or she will inform the individual or that, based on medical judgment, telling the individual
would be harmful. The registrant is not required to notify the individual without first
consulting the referring physician. If the referring physician or the affected individual cannot
be reached within 24 hours, the registrant shall notify the individual as soon as possible
thereafter. The registrant may not delay any appropriate medical care for the individual,
including any necessary remedial care as a result of the medical event because of any delay
in notification. To meet the requirements of this paragraph, the notification of the individual
who is the subject of the medical event may be made instead to that individual’s responsible
relative or guardian. If a verbal notification is made, the registrant shall inform the
individual, or appropriate responsible relative or guardian, that a written description of the
event can be obtained from the registrant upon request. The registrant shall provide such a
written description if requested.
(6) Aside from the notification requirement, nothing in 105 CMR 120.435 affects any rights
or duties of registrants and physicians in relation to each other, to individuals affected by the
medical event or to that individual's responsible relatives or guardians.
(7) A licensee shall retain a record of a medical event in accordance with 105 CMR
120.435(E). A copy of the record required under 105 CMR 120.435(E) shall be provided to
the referring physician if other than the registrant, within 15 days after discovery of the
medical event.

(F) Records of Medical Events. A registrant shall retain a record of medical events reported
in accordance with 105 CMR 120.435(E) for three years. The record must contain the licensee’s
name; names of the individuals involved; the social security number or other identification
number if one has been assigned, of the individual who is the subject of the medical event;
medical event a brief description of the event; why it occurred; the effect, if any, on the
individual; the actions, if any, taken, or planned, to prevent recurrence; and, whether the
registrant notified the individual (or the individual’s responsible relative or guardian) and, if not,
whether such failure to notify was based on guidance from the referring physician.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.436: Therapeutic Radiation Machines of Less than 500 kV

(A) Leakage Radiation. When the x-ray tube is operated at its maximum rated tube current for
the maximum kV, the leakage air kerma rate shall not exceed the value specified at the distance
specified for that classification of therapeutic radiation machine:
(1) 5-50 kV Systems. The leakage air kerma rate measured at any position five centimeters
from the tube housing assembly shall not exceed one mGy (100 mrad) in any one hour.
(2) >50 and <500 kV Systems. The leakage air kerma rate measured at a distance of one
meter from the target in any direction shall not exceed one cGy (one rad) in any one hour.
This air kerma rate measurement may be averaged over areas no larger than 100 square
centimeters. In addition, the air kerma rate at a distance of five centimeters from the surface
of the tube housing assembly shall not exceed 30 cGy (30 rad) per hour.
(3) For each therapeutic radiation machine, the registrant shall determine, or obtain from
the manufacturer, the leakage radiation existing at the positions specified in 105 CMR
120.436(A)(1) and (2) for the specified operating conditions. Records on leakage radiation
measurements shall be maintained at the installation for inspection by the Agency.

(B) Permanent Beam Limiting Devices. Permanent diaphragms or cones used for limiting the
useful beam shall provide at least the same degree of attenuation as required for the tube housing
assembly.

(C) Adjustable or Removable Beam Limiting Devices.

(1) All adjustable or removable beam limiting devices, diaphragms, cones or blocks shall
not transmit more than 5% of the useful beam for the most penetrating beam used;
(2) When adjustable beam limiting devices are used, the position and shape of the radiation
field shall be indicated by a light beam.

(D) Filter System. The filter system shall be so designed that:

(1) Filters can not be accidentally displaced at any possible tube orientation;
(2) For equipment installed after July 9, 1999, an interlock system prevents irradiation if the
proper filter is not in place;
(3) The air kerma rate at a distance of one meter from the filter shall not exceed one cGy
(one rad) per hour under any operating conditions; and,
(4) Each filter shall be marked as to its material of construction and its thickness.

(E) Tube Immobilization.

(1) The x-ray tube shall be so mounted that it can not accidentally turn or slide with respect
to the housing aperture; and
(2) The tube housing assembly shall be capable of being immobilized for stationary portal
treatments.

(F) Source Marking. The tube housing assembly shall be so marked that it is possible to
determine the location of the source to within five millimeters, and such marking shall be readily
accessible for use during calibration procedures.

(G) Beam Block. Contact therapy tube housing assemblies shall have a removable shield of
material, equivalent in attenuation to 0.5 millimeters of lead at 100 kV, which can be positioned
over the entire useful beam exit port during periods when the beam is not in use.

(H) Timer. A suitable irradiation control device shall be provided to terminate the irradiation
after a pre-set time interval.
(1) A timer which has a display shall be provided at the treatment control panel. The timer
shall have a pre-set time selector and an elapsed time or time remaining indicator;
(2) The timer shall be a cumulative timer which activates with an indication of
"BEAM-ON" and retains its reading after irradiation is interrupted or terminated. After
irradiation is terminated and before irradiation can be reinitiated, it shall be necessary to reset
the elapsed time indicator;
(3) The timer shall terminate irradiation when a pre-selected time has elapsed, if any dose
monitoring system present has not previously terminated irradiation;
(4) The timer shall permit accurate pre-setting and determination of exposure times as short
as one second;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.436: continued

(5) The timer shall not permit an exposure if set at zero;

(6) The timer shall not activate until the shutter is opened when irradiation is controlled by
a shutter mechanism unless calibration includes a timer error correction to compensate for
mechanical lag; and,
(7) The timer and back-up timer if present shall be accurate to within 1% of the selected
value or one second, whichever is greater.

(I) Control Panel Functions. The control panel, in addition to the displays required by other
provisions in 105 CMR 120.436, shall have:
(1) An indication of whether electrical power is available at the control panel and if
activation of the x-ray tube is possible;
(2) An indication of whether x-rays are being produced;
(3) Means for indicating x-ray tube potential and current;
(4) The means for terminating an exposure at any time;
(5) A locking device which will prevent unauthorized use of the therapeutic radiation
machine; and
(6) For therapeutic radiation machines manufactured after July 9, 1999, a positive display
of specific filter(s) in the beam.

(J) Multiple Tubes. When a control panel is capable of energizing more than one x-ray tube:
(1) It shall only be allowable to activate one X-ray tube at any time;
(2) There shall be an indication at the control panel identifying which x-ray tube is
activated; and
(3) There shall be an indication at the tube housing assembly when that tube is energized.

(K) Target-to-skin Distance (TSD). There shall be a means of determining the central axis TSD
to within one centimeter and of reproducing this measurement to within two millimeters
thereafter.

(L) Shutters. Unless it is possible to bring the x-ray output to the prescribed exposure
parameters within five seconds after the x-ray "ON" switch is energized, the beam shall be
attenuated by a shutter having a lead equivalency not less than that of the tube housing assembly.
In addition, after the unit is at operating parameters, the shutter shall be controlled by the
operator from the control panel. An indication of shutter position shall appear at the control
panel.

(M) Low-filtration X-ray Tubes. Each therapeutic radiation machine equipped with a beryllium
or other low-filtration window shall be clearly labeled as such upon the tube housing assembly
and shall be provided with a permanent warning device on the control panel that is activated
when no additional filtration is present, to indicate that the dose rate is very high.

(N) Facility Design Requirements for Therapeutic Radiation Machines Capable of Operating
in the Range 50 kV to 500 kV. In addition to shielding adequate to meet requirements of
105 CMR 120.439, the treatment room shall meet the following design requirements:
(1) Aural Communication. Provision shall be made for continuous two-way aural
communication between the patient and the operator at the control panel;
(2) Viewing Systems. Provision shall be made to permit continuous observation of the
patient during irradiation and the viewing system shall be so located that the operator can
observe the patient from the control panel. The therapeutic radiation machine shall not be
used for patient irradiation unless at least one viewing system is operational.

(O) Additional Requirements. Treatment rooms which contain a therapeutic radiation machine
capable of operating above 150 kV shall meet the following additional requirements:
(1) All protective barriers shall be fixed except for entrance doors or beam interceptors;
(2) The control panel shall be located outside the treatment room or inside the treatment
room within a totally enclosed booth with protective barrier walls, door(s), ceiling and floor;
(3) Interlocks shall be provided such that all entrance doors, including doors to any interior
booths, shall be closed before treatment can be initiated or continued. If the radiation beam
is interrupted by any door opening, it shall not be possible to restore the machine to operation
without closing the door and reinitiating irradiation by manual action at the control panel;
and
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

140.436: continued

(4) When any door referred to in 105 CMR 120.436(O)(3) is opened while the x-ray tube
is activated, the air kerma rate at a distance of one meter from the source shall be reduced to
less than 1 mGy (100 mrad) per hour.

(P) Full Calibration Measurements.

(1) Full calibration of a therapeutic radiation machine subject to 105 CMR 120.436 shall
be performed by, or under the direct supervision of, a Qualified Medical Physicist:
(a) Before the first medical use following installation or reinstallation of the therapeutic
radiation machine;
(b) At intervals not exceeding one year; and
(c) Before medical use under the following conditions:
1. Whenever quality assurance check measurements indicate that the radiation
output differs by more than 5% from the value obtained at the last full calibration and
the difference cannot be reconciled; and
2. Following any component replacement, major repair, or modification of
components that could significantly affect the characteristics of the radiation beam.
(d) Notwithstanding the requirements of 105 CMR 120.436(P)(1)(c):
1. Full calibration of therapeutic radiation machines with multi-energy capabilities
is required only for those modes and/or energies that are not within their acceptable
range; and
2. If the repair, replacement or modification does not affect all energies, full
calibration shall be performed on the affected energy that is in most frequent clinical
use at the facility. The remaining energies may be validated with quality assurance
check procedures against the criteria in 105 CMR 120.436(P)(1)(c)1.
(2) To satisfy the requirement of 105 CMR 120.436(P)(1), full calibration shall include all
measurements recommended for annual calibration by NCRP Report 69, "Dosimetry of
X-ray and Gamma Ray Beams for Radiation Therapy in the Energy Range 10 keV to 50
MeV" (1981).
(3) The registrant shall maintain a record of each calibration for the duration of the
registration. The record shall include the date of the calibration, the manufacturer's name,
model number, and serial number for both the therapeutic radiation machine and the X-ray
tube, the model numbers and serial numbers of the instruments used to calibrate the
therapeutic radiation machine, and the signature of the Qualified Medical Physicist
responsible for performing the calibration.

(Q) Periodic Quality Assurance Checks.

(1) Periodic quality assurance checks shall be performed on therapeutic radiation machines
subject to 105 CMR 120.436, which are capable of operation at greater than or equal to 50
kV.
(2) To satisfy the requirement of 105 CMR 120.436(Q)(1), quality assurance checks shall
meet the following requirements:
(a) The registrant shall perform quality assurance checks in accordance with written
procedures established by the Qualified Medical Physicist; and
(b) The quality assurance check procedures shall specify the frequency at which tests
or measurements are to be performed. The quality assurance check procedures shall
specify that the quality assurance check shall be performed during the calibration
specified in 105 CMR 120.436(P)(1). They shall also state the acceptable tolerance for
each parameter measured in the quality assurance check, when compared to the value for
that parameter determined in the calibration specified in 105 CMR 120.436(P)(1), shall
be stated.
(3) The cause for a parameter exceeding a tolerance set by the Qualified Medical Physicist
shall be investigated and corrected before the system is used for patient irradiation;
(4) Whenever a quality assurance check indicates a significant change in the operating
characteristics of a system, as specified in the Qualified Medical Physicist's quality assurance
check procedures, the system shall be recalibrated as required in 105 CMR 120.436(P)(1);
(5) The registrant shall use the dosimetry system described in 105 CMR 120.434(C)(2) to
make the quality assurance check required in 105 CMR 120.436(Q)(2);
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.436: continued

(6) The registrant shall have the Qualified Medical Physicist review and sign the results of
each radiation output quality assurance check within 30 days of the date that the check was
performed;
(7) The registrant shall ensure that safety quality assurance checks of therapeutic radiation
machines subject to 105 CMR 120.436 are performed at intervals not to exceed 30 days;
(8) Notwithstanding the requirements of 105 CMR 120.436(Q)(6) and (7), the registrant
shall ensure that no therapeutic radiation machine is used to administer radiation to humans
unless the quality assurance checks required by 105 CMR 120.436(Q)(6) and (7) have been
performed within one month period immediately prior to said administration;
(9) To satisfy the requirement of 105 CMR 120.436(Q)(7), safety quality assurance checks
shall ensure proper operation of:
(a) Electrical interlocks at each external beam radiation therapy room entrance;
(b) Proper operation of the "BEAM-ON" and termination switches;
(c) Beam condition indicator lights on the access door(s), control console, and in the
radiation therapy room;
(d) Viewing systems;
(e) If applicable, electrically operated treatment room doors activated from inside and
outside the treatment room;
(10) The registrant shall maintain a record of each quality assurance check required by
105 CMR 120.436(Q)(1) and (7) for three years. The record shall include the date of the
quality assurance check, the manufacturer's name, model number, and serial number for the
therapeutic radiation machine, the manufacturer's name, model number and serial number
of the instrument(s) used to measure the radiation output of the therapeutic radiation
machine, and the signature of the individual who performed the periodic quality assurance
check.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.436: continued

(R) Operating Procedures.

(1) The therapeutic radiation machine shall not be used for irradiation of patients unless and
until the requirements of 105 CMR 120.436(P) and (Q) have been met;
(2) Therapeutic radiation machines shall not be left unattended unless secured pursuant to
105 CMR 120.436(I)(5);
(3) Mechanical supporting or restraining devices shall be used when a patient must be held
in position for radiation therapy;
(4) The tube housing assembly shall not be held by an individual during operation unless
the assembly is designed to require such holding and the peak tube potential of the system
does not exceed 50 kV. In such cases, the holder shall wear protective gloves and apron of
not less than 0.5 millimeters lead equivalency at 100 kV;
(5) A copy of the current operating and emergency procedures shall be maintained at the
therapeutic radiation machine control console; and
(6) No individual other than the patient shall be in the treatment room during exposures
from therapeutic radiation machines operating above 150 kV. At energies less than or equal
to 150 kV, any individual, other than the patient, in the treatment room shall be protected by
a barrier sufficient to meet the requirements of 105 CMR 120.211.

(S) Possession of Survey Instrument(s). Each facility location authorized to use a therapeutic
radiation machine in accordance with 105 CMR 120.436 shall possess appropriately calibrated
portable monitoring equipment. As a minimum, such equipment shall include a portable
radiation measurement survey instrument capable of measuring dose rates over the range ten µSv
(one mrem) per hour to ten mSv (1000 mrem) per hour. The survey instrument(s) shall be
operable and calibrated in accordance with 105 CMR 120.438.

120.437: Therapeutic Radiation Machines - Photon Therapy Systems (500 kV and Above) and Electron
Therapy Systems (500 keV and Above)

(A) Possession of Survey Instrument(s). Each facility location authorized to use a therapeutic
radiation machine in accordance with 105 CMR 120.437 shall possess appropriately calibrated
portable monitoring equipment. As a minimum, such equipment shall include a portable
radiation measurement survey instrument capable of measuring dose rates over the range ten Sv
(one mrem) per hour to ten mSv (1000 mrem) per hour. The survey instrument(s) shall be
operable and calibrated in accordance with 105 CMR 120.438.

(B) Leakage Radiation Outside the Maximum Useful Beam in Photon and Electron Modes.
(1) The absorbed dose due to leakage radiation (excluding neutrons) at any point outside
the maximum sized useful beam, but within a circular plane of radius two meters which is
perpendicular to and centered on the central axis of the useful beam at the nominal treatment
distance (i.e. patient plane), shall not exceed a maximum of 0.2% and an average of 0.1% of
the absorbed dose on the central axis of the beam at the nominal treatment distance.
Measurements shall be averaged over an area not exceeding 100 square centimeters at a
minimum of 16 points uniformly distributed in the plane;
(2) Except for the area defined in 105 CMR 120.437(B)(1), the absorbed dose due to
leakage radiation (excluding neutrons) at one meter from the electron path between the
electron source and the target or electron window shall not exceed 0.5% of the absorbed dose
on the central axis of the beam at the nominal treatment distance. Measurements shall be
averaged over an area not exceeding 100 square centimeters;
(3) For equipment manufactured after July 9, 1999, the neutron absorbed dose outside the
useful beam shall be in compliance with International Electrotechnical Commission (IEC)
Document 601-2-1 (most current revision); and
(4) For each therapeutic radiation machine, the registrant shall determine, or obtain from
the manufacturer, the leakage radiation existing at the positions specified in 105 CMR
120.437(B)(1) through (B)(3) for the specified operating conditions. Records on leakage
radiation measurements shall be maintained at the installation for inspection by the Agency.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.437: continued

(C) Leakage Radiation Through Beam Limiting Devices.

(1) Photon Radiation. The secondary collimators shall attenuate the useful beam such that
at the nominal treatment distance, the maximum absorbed dose anywhere in the area shielded
by the beam limiting device(s) shall not exceed 2% (averaged over a one cm squared area)
of the maximum absorbed dose on the central axis of the useful beam measured in a 100 cm2
radiation field, or maximum available field size if less than 100 cm2;
(2) Electron Radiation. All adjustable or interchangeable electron applicators shall
attenuate the radiation, including but not limited to photon radiation generated by electrons
incident on the beam limiting device and electron applicator and other parts of the radiation
head, such that the absorbed dose in a plane perpendicular to the central axis of the useful
beam at the nominal treatment distance shall not exceed:
(a) A maximum of 2% and average of 0.5% of the absorbed dose on the central axis of
the useful beam at the nominal treatment distance. This limit shall apply beyond a line
seven centimeters outside the periphery of the useful beam; and
(b) A maximum of 10% of the absorbed dose on the central axis of the useful beam at
the nominal treatment distance. This limit shall apply beyond a line two centimeters
outside the periphery of the useful beam.
(3) Measurement of Leakage Radiation.
(a) Photon Radiation. Measurements of leakage radiation through the beam limiting
devices shall be made with the beam limiting devices closed and any residual aperture
blocked by at least two tenth value layers of suitable absorbing material. In the case of
overlapping beam limiting devices, the leakage radiation through each set shall be
measured independently at the depth of maximum dose. Measurements shall be made
using a radiation detector of area not exceeding ten square centimeters;
(b) Electron Radiation. Measurements of leakage radiation through the electron
applicators shall be made with the electron beam directed into the air and using a
radiation detector of area up to but not exceeding one square centimeter suitably
protected against radiation which has been scattered from material beyond the radiation
detector. Measurements shall be made using one centimeter of water equivalent build
up material.

(D) Filters/Wedges.
(1) Each wedge filter which is removable from the system shall be clearly marked with an
identification number. For removable wedge filters, the nominal wedge angle shall appear
on the wedge or wedge tray (if permanently mounted to the tray). If the wedge or wedge tray
is significantly damaged, the wedge transmission factor shall be redetermined;
(2) If the absorbed dose rate information required by 105 CMR 120.437(I) relates
exclusively to operation with a field flattening filter or beam scattering foil in place, such foil
or filter shall be removable only by the use of tools;
(3) For equipment manufactured after the effective date of these regulations which utilize
a system of wedge filters, interchangeable field flattening filters, or interchangeable beam
scattering foils:
(a) Irradiation shall not be possible until a selection of a filter or a positive selection to
use "no filter" has been made at the treatment control panel, either manually or
automatically;
(b) An interlock system shall be provided to prevent irradiation if the filter selected is
not in the correct position;
(c) A display shall be provided at the treatment control panel showing the wedge
filter(s), interchangeable field flattening filter(s), and/or interchangeable beam scattering
foil(s) in use; and
(d) An interlock shall be provided to prevent irradiation if any filter and/or beam
scattering foil selection operation carried out in the treatment room does not agree with
the filter and/or beam scattering foil selection operation carried out at the treatment
control panel.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.437: continued

(E) X-ray/Neutron Contamination of the Useful Beam. For equipment manufactured after the
effective date of these regulations, the registrant shall determine during acceptance testing, or
obtain from the manufacturer, data sufficient to ensure that x-ray stray radiation in the useful
electron beam, absorbed dose at the surface during x-ray irradiation and stray neutron radiation
in the useful x-ray beam are in compliance with International Electrotechnical Commission (IEC)
Document 601-2-1 (most current revision).

(F) Beam Monitors. All therapeutic radiation machines subject to 105 CMR 120.437 shall be
provided with redundant beam monitoring systems. The sensors for these systems shall be fixed
in the useful beam during treatment to indicate the dose monitor unit rate.
(1) Equipment manufactured after the effective date of these regulations shall be provided
with at least two independently powered integrating dose meters. Alternatively, common
elements may be used if the production of radiation is terminated upon failure of any
common element.
(2) Equipment manufactured on or before the effective date of these regulations shall be
provided with at least one radiation detector. This detector shall be incorporated into a useful
beam monitoring system;
(3) The detector and the system into which that detector is incorporated shall meet the
following requirements:
(a) Each detector shall be removable only with tools and, if movable, shall be
interlocked to prevent incorrect positioning;
(b) Each detector shall form part of a beam monitoring system from whose readings in
dose monitor units the absorbed dose at a reference point can be calculated;
(c) Each beam monitoring system shall be capable of independently monitoring,
interrupting, and terminating irradiation; and
(d) For equipment manufactured after the effective date of these regulations, the design
of the beam monitoring systems shall ensure that the:
1. Malfunctioning of one system shall not affect the correct functioning of the other
system(s); and
2. Failure of either system shall terminate irradiation or prevent the initiation of
radiation.
(e) Each beam monitoring system shall have a legible display at the treatment control
panel. For equipment manufactured after the effective date of these regulations, each
display shall:
1. Maintain a reading until intentionally reset;
2. Have only one scale and no electrical or mechanical scale multiplying factors;
3. Utilize a design such that increasing dose is displayed by increasing numbers; and
4. In the event of power failure, the beam monitoring information required in 105
CMR 120.437(F)(3)(e)3. displayed at the control panel at the time of failure shall be
retrievable in at least one system for a 20 minute period of time.

(G) Beam Symmetry.

(1) Bent-beam linear accelerators subject to 105 CMR 120.437 shall be provided with
auxiliary device(s) to monitor beam symmetry;
(2) The device(s) referenced in 105 CMR 120.437(G)(1) shall be able to detect field
asymmetry greater than 10%; and
(3) The device(s) referenced in 105 CMR 120.437(G)(1) shall be configured to terminate
irradiation if the specifications in 105 CMR 120.437(G)(2) can not be maintained.

(H) Selection and Display of Dose Monitor Units.

(1) Irradiation shall not be possible until a new selection of a number of dose monitor units
has been made at the treatment control panel;
(2) The pre-selected number of dose monitor units shall be displayed at the treatment
control panel until reset manually for the next irradiation;
(3) After termination of irradiation, it shall be necessary to reset the dosimeter display
before subsequent treatment can be initiated; and
(4) For equipment manufactured after the effective date of these regulations, after
termination of irradiation, it shall be necessary for the operator to reset the pre-selected dose
monitor units before irradiation can be initiated.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.437: continued

(I) Air Kerma Rate/Absorbed Dose Rate. For equipment manufactured after October 6, 2006,
a system shall be provided from whose readings the air kerma rate or absorbed dose rate at a
reference point can be calculated. [The radiation detectors specified in 105 CMR 120.437(F)
may form part of this system.] In addition:
(1) The dose monitor unit rate shall be displayed at the treatment control panel;
(2) If the equipment can deliver under any conditions an air kerma rate or absorbed dose
rate at the nominal treatment distance more than twice the maximum value specified by the
manufacturer, a device shall be provided which terminates irradiation when the air kerma rate
or absorbed dose rate exceeds a value twice the specified maximum. The dose rate at which
the irradiation will be terminated shall be a record maintained by the registrant;
(3) If the equipment can deliver under any fault condition(s) an air kerma rate or absorbed
dose rate at the nominal treatment distance more than ten times the maximum value specified
by the manufacturer, a device shall be provided to prevent the air kerma rate or absorbed
dose rate anywhere in the radiation field from exceeding twice the specified maximum value
and to terminate irradiation if the excess absorbed dose at the nominal treatment distance
exceeds four Gy (400 rad); and
(4) For each therapeutic radiation machine, the registrant shall determine, or obtain from
the manufacturer, the maximum value(s) specified in 105 CMR 120.437(I)(2) and (I)(3) for
the specified operating conditions. Records of these maximum value(s) shall be maintained
at the installation for inspection by the Agency.

(J) Termination of Irradiation by the Beam Monitoring System or Systems During Stationary
Beam Radiation Therapy.
(1) Each primary system shall terminate irradiation when the pre-selected number of dose
monitor units has been detected by the system;
(2) If the original design of the equipment included a secondary dose monitoring system,
that system shall be capable of terminating irradiation when not more than 15% or 40 dose
monitor units above the pre-selected number of dose monitor units set at the control panel
has been detected by the secondary dose monitoring system; and
(3) For equipment manufactured after July 9, 1999, an indicator on the control panel shall
show which monitoring system has terminated irradiation.

(K) Termination of Irradiation. It shall be possible to terminate irradiation and equipment

movement or go from an interruption condition to termination condition at any time from the
operator's position at the treatment control panel.

(L) Interruption of Irradiation. If a therapeutic radiation machine has an interrupt mode, it shall
be possible to interrupt irradiation and equipment movements at any time from the treatment
control panel. Following an interruption it shall be possible to restart irradiation by operator
action without any reselection of operating conditions. If any change is made of a pre-selected
value during an interruption, irradiation and equipment movements shall be automatically
terminated.

(M) Timer. A suitable irradiation control device shall be provided to terminate the irradiation
after a pre-set time interval.
(1) A timer shall be provided which has a display at the treatment control panel. The timer
shall have a pre-set time selector and an elapsed time indicator;
(2) The timer shall be a cumulative timer which activates with an indication of
"BEAM-ON" and retains its reading after irradiation is interrupted or terminated. After
irradiation is terminated and before irradiation can be reinitiated, it shall be necessary to reset
the elapsed time indicator;
(3) The timer shall terminate irradiation when a pre-selected time has elapsed, if the dose
monitoring systems have not previously terminated irradiation.

(N) Selection of Radiation Type. Equipment capable of both x-ray therapy and electron therapy
shall meet the following additional requirements:
(1) Irradiation shall not be possible until a selection of radiation type (x-rays or electrons)
has been made at the treatment control panel;
(2) The radiation type selected shall be displayed at the treatment control panel before and
during irradiation;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.437: continued

(3) An interlock system shall be provided to ensure that the equipment can principally emit
only the radiation modality which has been selected;
(4) An interlock system shall be provided to prevent irradiation with x-rays, except to obtain
an image, when electron applicators are fitted;
(5) An interlock system shall be provided to prevent irradiation with electrons when
accessories specific for x-ray therapy are fitted; and
(6) An interlock system shall be provided to prevent irradiation if any selected operations
carried out in the treatment room do not agree with the selected operations carried out at the
treatment control panel.

(O) Selection of Energy. Equipment capable of generating radiation beams of different energies
shall meet the following requirements:
(1) Irradiation shall not be possible until a selection of energy has been made at the
treatment control panel;
(2) The nominal energy value selected shall be displayed at the treatment control panel until
reset manually for the next irradiation. After termination of irradiation, it shall be necessary
to reset the nominal energy value selected before subsequent treatment can be initiated;
(3) Irradiation shall not be possible until the appropriate flattening filter or scattering foil
for the selected energy is in its proper location; and
(4) For equipment manufactured after July 9, 1999, the selection of energy shall be in
compliance with International Electrotechnical Commission (IEC) Document 601-2-1 (most
current revision).

(P) Selection of Stationary Beam Radiation Therapy or Moving Beam Radiation Therapy.
Therapeutic radiation machines capable of both stationary beam radiation therapy and moving
beam radiation therapy shall meet the following requirements:
(1) Irradiation shall not be possible until a selection of stationary beam radiation therapy or
moving beam radiation therapy has been made at the treatment control panel;
(2) The mode of operation shall be displayed at the treatment control panel;
(3) An interlock system shall be provided to ensure that the equipment can operate only in
the mode which has been selected;
(4) An interlock system shall be provided to prevent irradiation if any selected parameter
in the treatment room does not agree with the selected parameter at the treatment control
panel;
(5) Moving beam radiation therapy shall be controlled to obtain the selected relationships
between incremental dose monitor units and incremental movement. For equipment
manufactured after July 9, 1999:
(a) An interlock system shall be provided to terminate irradiation if the number of dose
monitor units delivered in any 10° of rotation or one cm of linear motion differs by more
than 20% from the selected value;
(b) Where angle terminates the irradiation in moving beam radiation therapy, the dose
monitor units delivered shall differ by less than 5% from the dose monitor unit value
selected;
(c) An interlock shall be provided to prevent motion of more than 5° or one cm beyond
the selected limits during moving beam radiation therapy;
(d) An interlock shall be provided to require that a selection of direction be made at the
treatment control panel in all units which are capable of both clockwise and
counter-clockwise moving beam radiation therapy.
(e) Moving beam radiation therapy shall be controlled with both primary position
sensors and secondary position sensors to obtain the selected relationships between
incremental dose monitor units and incremental movement.
(6) Where the beam monitor system terminates the irradiation in moving beam radiation
therapy, the termination of irradiation shall be as required by 105 CMR 120.437(J); and
(7) For equipment manufactured after July 9, 1999, an interlock system shall be provided
to terminate irradiation if movement:
(a) Occurs during stationary beam radiation therapy; or
(b) Does not start or stops during moving beam radiation therapy unless such stoppage
is a pre-planned function.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.437: continued

(Q) Facility Design Requirements for Therapeutic Radiation Machines Operating above 500
kV. In addition to shielding adequate to meet requirements of 105 CMR 120.439, the following
design requirements are made:
(1) Protective Barriers. All protective barriers shall be fixed, except for access doors to the
treatment room or movable beam interceptors;
(2) Control Panel. In addition to other requirements specified in 105 CMR 120.430, the
control panel shall also:
(a) Be located outside the treatment room;
(b) Provide an indication of whether electrical power is available at the control panel
and if activation of the radiation is possible;
(c) Provide an indication of whether radiation is being produced; and
(d) Include an access control (locking) device which will prevent unauthorized use of
the therapeutic radiation machine;
(3) Viewing Systems. Windows, mirrors, closed-circuit television or an equivalent viewing
system shall be provided to permit continuous observation of the patient following
positioning and during irradiation and shall be so located that the operator may observe the
patient from the treatment control panel. The therapeutic radiation machine shall not be used
for patient irradiation unless at least one viewing system is operational;
(4) Aural Communications. Provision shall be made for continuous two-way aural
communication between the patient and the operator at the control panel. The therapeutic
radiation machine shall not be used for irradiation of patients unless continuous two-way
aural communication is possible;
(5) Room Entrances. Treatment room entrances shall be provided with warning lights in
a readily observable position near the outside of all access doors, which will indicate when
the useful beam is "ON" and when it is "OFF";
(6) Entrance Interlocks. Interlocks shall be provided such that all access controls are
activated before treatment can be initiated or continued. If the radiation beam is interrupted
by any access control, it shall not be possible to restore the machine to operation without
resetting the access control and reinitiating irradiation by manual action at the control panel;
(7) Beam Interceptor Interlocks. If the shielding material in any protective barrier requires
the presence of a beam interceptor to ensure compliance with 105 CMR 120.221(A) and (B),
interlocks shall be provided to prevent the production of radiation, unless the beam
interceptor is in place, whenever the useful beam is directed at the designated barrier(s);
(8) Sliding Shielding Doors. Registrants with treatment rooms which utilize sliding
shielding doors or other doors so massive that they may become jammed in the case of
catastrophe will have in place an emergency plan to address such failure. In addition:
(a) Each door to a treatment room installed after July 9, 1999 will be equipped with an
independent means of opening operable by a single able individual;
(b) Each sliding door installed after July 91, 1999 will be equipped with an electronic
sensor which will immediately stop and disable the door closer (or reverse its motion)
in the event of an imminent collision between the door and a person or object in its path.
(9) Emergency Cutoff Switches. At least three emergency power cutoff switch shall be
located in the radiation therapy room and shall terminate all equipment electrical power
including radiation and mechanical motion. This switch is in addition to the termination
switch required by 105 CMR 120.437(K). All emergency power cutoff switches shall include
a manual reset so that the therapeutic radiation machine cannot be restarted from the unit's
control console without resetting the emergency cutoff switch;
(10) Safety Interlocks. All safety interlocks shall be designed so that any defect or
component failure in the safety interlock system prevents or terminates operation of the
therapeutic radiation machine; and
(11) Surveys for Residual Radiation. Surveys for residual activity shall be conducted on
all therapeutic radiation machines capable of generating photon and electron energies above
10 MV prior to machining, removing, or working on therapeutic radiation machine
components which may have become activated due to photo-neutron production.

(R) Qualified Medical Physicist Support.

(1) The services of a Qualified Medical Physicist shall be required in facilities having
therapeutic radiation machines with energies of 500 kV and above. The Qualified Medical
Physicist shall be responsible for:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.437: continued

(a) Full calibration(s) required by 105 CMR 120.437(T) and protection surveys required
by 105 CMR 120.434(A);
(b) Supervision and review of dosimetry;
(c) Beam data acquisition and transfer for computerized dosimetry, and supervision of
its use;
(d) Quality assurance, including quality assurance check review required by 105 CMR
120.437(U)(5);
(e) Consultation with the authorized user in treatment planning, as needed; and
(f) Perform calculations/assessments regarding medical events.
(2) Radiation therapy facilities shall have a minimum of one half-time qualified medical
physicist available on a regular, on going, basis. In addition, radiation therapy facilities will
have a minimum of one full time equivalent qualified medical physicist for every 500 total
patients per year.
(3) If the Qualified Medical Physicist is not a full-time employee of the registrant, the
operating procedures required by 105 CMR 120.437(S) shall also specifically address how
the Qualified Medical Physicist is to be contacted for problems or emergencies, as well as
the specific actions, if any, to be taken until the Qualified Medical Physicist can be contacted.

(S) Operating Procedures.

(1) No individual, other than the patient, shall be in the treatment room during treatment or
during any irradiation for testing or calibration purposes;
(2) Therapeutic radiation machines shall not be made available for medical use unless the
requirements of 105 CMR 120.434(A), 120.437(T) and (U) have been met;
(3) Therapeutic radiation machines, when not in operation, shall be secured to prevent
unauthorized use;
(4) When adjustable beam limiting devices are used, the position and shape of the radiation
field shall be indicated by a light field.
(5) If a patient must be held in position during treatment, mechanical supporting or
restraining devices shall be used; and
(6) A copy of the current operating and emergency procedures shall be maintained at the
therapeutic radiation machine control console.

(T) Acceptance Testing, Commissioning and Full Calibration Measurements.

(1) Acceptance testing, commissioning and full calibration of a therapeutic radiation
machine subject to 105 CMR 120.437 shall be performed by, or under the direct supervision
of, a Qualified Medical Physicist.
(2) Acceptance testing and commissioning shall be performed in accordance with "AAPM
Code of Practice for Radiotherapy Accelerators: Report of AAPM Radiation Therapy Task
Group 45" or most current AAPM recommendation or most current AAPM published
recommendations and shall be conducted before the first medical use following installation
or reinstallation of the therapeutic radiation machine.
(3) Full calibration shall include measurement of all parameters required by Table II of
"Comprehensive QA for Radiation Oncology: Report of AAPM Radiation Therapy
Committee Task Group 40" or the most current AAPM published recommendations and shall
be performed in accordance with "AAPM Code of Practice for Radiotherapy Accelerators:
Report of AAPM Radiation Therapy Task Group 45" or most current AAPM
recommendation or the most current AAPM published recommendations. Although it shall
not be necessary to complete all elements of a full calibration at the same time, all parameters
(for all energies) shall be completed at intervals not exceeding 12 calendar months, unless
a more frequent interval is required in Table II.
(4) The Qualified Medical Physicist shall perform all elements of a full calibration
necessary to determine that all parameters are within acceptable limits:
(a) Whenever quality assurance check measurements indicate that the radiation output
differs by more than 5% from the value obtained at the last full calibration and the
difference cannot be reconciled. Therapeutic radiation machines with multi-energy
and/or multi-mode capabilities shall only require measurements for those modes and/or
energies that are not within their acceptable range; and
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.437: continued

(b) Following any component replacement, major repair, or modification of components

that could significantly affect the characteristics of the radiation beam. If the repair,
replacement or modification does not affect all modes and/or energies, measurements
shall be performed on the effected mode/energy that is in most frequent clinical use at
the facility. The remaining energies/modes may be validated with quality assurance
check procedures against the criteria in 105 CMR 120.437(T)(4)(a).
(5) The registrant shall maintain a record of each calibration in an auditable form for the
duration of the registration. The record shall include the date of the calibration, the
manufacturer's name, model number, and serial number for the therapeutic radiation
machine, the model numbers and serial numbers of the instruments used to calibrate the
therapeutic radiation machine, and the signature of the Qualified Medical Physicist
responsible for performing the calibration.

(U) Periodic Quality Assurance Checks.

(1) Periodic quality assurance checks shall be performed on all therapeutic radiation
machines subject to 105 CMR 120.437 at intervals not to exceed those specified in
"Comprehensive QA for Radiation Oncology: Report of AAPM Radiation Therapy
Committee Task Group 40" or the most current AAPM published recommendations;
(2) To satisfy the requirement of 105 CMR 120.437(U)(1), quality assurance checks shall
include determination of central axis radiation output and a representative sampling of
periodic quality assurance checks contained in "Comprehensive QA for Radiation Oncology:
Report of AAPM Radiation Therapy Committee Task Group 40" or the most current AAPM
published recommendations. Representative sampling shall include all referenced periodic
quality assurance checks in an interval not to exceed 12 consecutive calendar months;
(3) The registrant shall use a dosimetry system which has been inter-compared within the
previous 12 months with the dosimetry system described in 105 CMR 120.434(C)(1) to make
the periodic quality assurance checks required in 105 CMR 120.437(U)(2);
(4) The registrant shall perform periodic quality assurance checks required by 105 CMR
120.437(U)(1) in accordance with procedures established by the Qualified Medical Physicist;
(5) The registrant shall review the results of each periodic radiation output check according
to the following procedures:
(a) The authorized user and Qualified Medical Physicist shall be immediately notified
if any parameter is not within its acceptable tolerance. The therapeutic radiation machine
shall not be made available for subsequent medical use until the Qualified Medical
Physicist has determined that all parameters are within their acceptable tolerances;
(b) If all quality assurance check parameters appear to be within their acceptable range,
the quality assurance check shall be reviewed and signed by either the authorized user or
Qualified Medical Physicist within three treatment days; and
(c) The Qualified Medical Physicist shall review and sign the results of each radiation
output quality assurance check at intervals not to exceed 30 days.
(6) Therapeutic radiation machines subject to 105 CMR 120.437 shall have safety quality
assurance checks listed in the most currently published recommendations of reports of the
AAPM Radiation Therapy Committee Task Group 40 at intervals not to exceed the
frequencies recommended therein;
(7) To satisfy the requirement of 105 CMR 120.437(U)(6), safety quality assurance checks
shall ensure proper operation of:
(a) Electrical interlocks at each external beam radiation therapy room entrance;
(b) Proper operation of the "BEAM-ON", interrupt and termination switches;
(c) Beam condition indicator lights on the access doors, control console, and in the
radiation therapy room;
(d) Viewing systems;
(e) Electrically operated treatment room door(s) from inside and outside the treatment
room;
(f) At least one emergency power cutoff switch. If more than one emergency power
cutoff switch is installed and not all switches are tested at once, each switch shall be
tested on a rotating basis. Safety quality assurance checks of the emergency power cutoff
switches may be conducted at the end of the treatment day in order to minimize possible
stability problems with the therapeutic radiation machine.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.437: continued

(8) The registrant shall promptly repair any system identified in 105 CMR 120.437(U)(7)
that is not operating properly; and
(9) The registrant shall maintain a record of each quality assurance check required by
105 CMR 120.437(U)(1) and (7) for three years. The record shall include the date of the
quality assurance check, the manufacturer's name, model number, and serial number for the
therapeutic radiation machine, the manufacturer's name, model number and serial number
of the instrument(s) used to measure the radiation output of the therapeutic radiation
machine, and the signature of the individual who performed the periodic quality assurance
check.

(V) Quality Assurance Checks for IMRT shall:

(1) Include commissioning and testing of the treatment planning and delivery systems,
routine quality assurance of the delivery system, and patient-specific validation of treatment
plans [Note: IMRT is a rapidly evolving modality and the QA program shall also evolve to
handle new issues that arise.]; and
(2) Be performed in accordance with "Dosimetry Tools and Techniques for IMRT - The
report of AAPM Task Group 120" (2010), or current AAPM Recommendation"; and
(3) Be performed in accordance with the manufacturer's contractual specifications.

120.438: Calibration of Survey Instruments

(A) The registrant shall ensure that the survey instruments used to show compliance with
105 CMR 120.430 have been calibrated before first use, at intervals not to exceed 12 months,
and following repair.

(B) To satisfy the requirements of 105 CMR 120.438(A), the registrant shall:
(1) Calibrate all required scale readings up to ten mSv (1000 mrem) per hour with an
appropriate radiation source that is traceable to the National Institute of Standards and
Technology (NIST);
(2) Calibrate at least two points on each scale to be calibrated. These points should be at
approximately a and b of full-scale; and
(3) Calibrate automatically ranging digital display survey instruments at no less than one
point on each decade and at no less than two points on one of these decades. These points
should be at approximately a and b of the decade.

(C) To satisfy the requirements of 105 CMR 120.438(B), the registrant shall:
(1) Consider a point as calibrated if the indicated dose rate differs from the calculated dose
rate by not more than 10%; and,
(2) Consider a point as calibrated if the indicated dose rate differs from the calculated dose
rate by not more than 20% if a correction factor or graph is conspicuously attached to the
instrument.

(D) The registrant shall retain a record of each calibration required in 105 CMR 120.438(A) for
three years. The record shall include:
(1) A description of the calibration procedure; and
(2) A description of the source used and the certified dose rates from the source, and the
rates indicated by the instrument being calibrated, the correction factors deduced from the
calibration data, the signature of the individual who performed the calibration, and the date
of calibration.

(E) The registrant may obtain the services of individuals licensed by the Agency, the U.S.
Nuclear Regulatory Commission, an Agreement State, or a Licensing State to perform
calibrations of survey instruments. Records of calibrations which contain information required
by 105 CMR 120.438(D) shall be maintained by the registrant.

120.439: Shielding and Safety Design Requirements

(A) Each therapeutic radiation machine subject to 105 CMR 120.436 or 120.437 shall be
provided with such primary and/or secondary barriers as are necessary to ensure compliance with
105 CMR 120.211 and 120.221.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.439: continued

(B) Facility design information for all new installations of a therapeutic radiation machine or
installations of a therapeutic radiation machine of higher energy into a room not previously
approved for that energy shall be submitted for Agency approval prior to actual installation of
the therapeutic radiation machine. The minimum facility design information that must be
submitted is contained in 105 CMR 120.440: Appendix A.

(C) Quality Assurance For Radiation Therapy Simulation Systems.

(1) Quality assurance for a conventional or virtual simulator shall include acceptance testing
and periodic verification of system performance; and
(2) Be performed in accordance with "Comprehensive QA for Radiation Oncology: Report
of AAPM Radiation Therapy Committee Task Group No.40: AAPM Report No. 46" for a
conventional simulator; or
(3) Be performed in accordance with "Quality assurance for computed tomography
simulators and the computed tomography-simulation process: Report of the AAPM
Radiation Therapy Committee Task Group No. 66: AAPM Report No. 83" for a virtual
simulator.

120.440: Appendix A: Information on Radiation Shielding Required for Plan Reviews

I. ALL THERAPEUTIC RADIATION MACHINES

A. Basic facility information including: name, telephone number and Agency registration
number of the individual responsible for preparation of the shielding plan; name and telephone
number of the facility supervisor; and the street address [including room number] of the
therapeutic radiation machine facility. The plan should also indicate whether this is a new
structure or a modification to existing structure(s).

B. All wall, floor, and ceiling areas struck by the useful beam shall have primary barriers.

C. Secondary barriers shall be provided in all wall, floor, and ceiling areas not having primary
barriers.

II. THERAPEUTIC RADIATION MACHINES UP TO 150 kV (PHOTONS ONLY)

In addition to the requirements listed in Section I above, therapeutic radiation machine facilities
which produce only photons with a maximum energy less than or equal to 150 kV shall submit
shielding plans which contain, as a minimum, the following additional information:

A. Equipment specifications, including the manufacturer and model number of the therapeutic
radiation machine, as well as the maximum technique factors.

B. Maximum design workload for the facility including total weekly radiation output,
[expressed in gray (rad) or air kerma at one meter], total beam-on time per day or week, the
average treatment time per patient, along with the anticipated number of patients to be treated
per day or week.

C. A facility blueprint/drawing indicating: scale [0.25 inch = one foot is typical]; direction of
North; normal location of the therapeutic radiation machine's radiation port(s); the port's travel
and traverse limits; general direction(s) of the useful beam; locations of any windows and doors;
and the location of the therapeutic radiation machine control panel. If the control panel is located
inside the therapeutic radiation machine treatment room, the location of the operator's booth shall
be noted on the plan and the operator's station at the control panel shall be behind a protective
barrier sufficient to ensure compliance with 105 CMR 120.211.

D. The structural composition and thickness or lead/concrete equivalent of all walls, doors,
partitions, floor, and ceiling of the room(s) concerned.

E. The type of occupancy of all adjacent areas inclusive of space above and below the room(s)
concerned. If there is an exterior wall, show distance to the closest area(s) where it is likely that
individuals may be present.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.440: continued

F. At least one example calculation which shows the methodology used to determine the
amount of shielding required for each physical condition [ie: primary and secondary/leakage
barriers, restricted and unrestricted areas, entry door(s)] and shielding material in the facility.

(1) If commercial software is used to generate shielding requirements, please also identify
the software used and the version/ revision date.

(2) If the software used to generate shielding requirements is not in the open literature,
please also submit quality control sample calculations to verify the result obtained with the
software.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.440: continued

III. THERAPEUTIC RADIATION MACHINES OVER 150 kV

In addition to the requirements listed in Section I above, therapeutic radiation machine facilities
which produce photons with a maximum energy in excess of 150 kV and/or electrons shall
submit shielding plans which contain, as a minimum, the following additional information:

A. Equipment specifications including the manufacturer and model number of the therapeutic
radiation machine, and gray (rad) at the isocenter and the energy(s) and type(s) of radiation
produced [ie: photon, electron]. The target to isocenter distance shall be specified.

B. Maximum design workload for the facility including total weekly radiation output [expressed
in gray (rad) at one meter], total beam-on time per day or week, the average treatment time per
patient, along with the anticipated number of patients to be treated per day or week.

C. Facility blueprint/drawing [including both floor plan and elevation views] indicating relative
orientation of the therapeutic radiation machine, scale [0.25 inch = one foot is typical], type(s),
thickness and minimum density of shielding material(s), direction of North, the locations and
size of all penetrations through each shielding barrier [ceiling, walls and floor], as well as details
of the door(s) and maze.

D. The structural composition and thickness or concrete equivalent of all walls, doors,
partitions, floor, and ceiling of the room(s) concerned.

E. The type of occupancy of all adjacent areas inclusive of space above and below the room(s)
concerned. If there is an exterior wall, show distance to the closest area(s) where it is likely that
individuals may be present.

F. Description of all assumptions that were in shielding calculations including, but not limited
to, design energy [ie: room may be designed for six MV unit although only a four MV unit is
currently proposed], work-load, presence of integral beam-stop in unit, occupancy and use(s) of
adjacent areas, fraction of time that useful beam will intercept each permanent barrier [walls,
floor and ceiling] and "allowed" radiation exposure in both restricted and unrestricted areas.

G. At least one example calculation which shows the methodology used to determine the
amount of shielding required for each physical condition [ie: primary and secondary/leakage
barriers, restricted and unrestricted areas, small angle scatter, entry door(s) and maze] and
shielding material in the facility.

(1) If commercial software is used to generate shielding requirements, also identify the
software used and the version/ revision date.

(2) If the software used to generate shielding requirements is not in the open literature, also
submit quality control sample calculations to verify the result obtained with the software.

IV. NEUTRON SHIELDING

In addition to the requirements listed in Section III above, therapeutic radiation machine facilities
which are capable of operating above ten MV shall submit shielding plans which contain, as a
minimum, the following additional information:

A. The structural composition, thickness, minimum density and location of all neutron shielding
material.

B. Description of all assumptions that were used in neutron shielding calculations including,
but not limited to, neutron spectra as a function of energy, neutron fluence rate, absorbed dose
and dose equivalent (due to neutrons) in both restricted and unrestricted areas.

C. At least one example calculation which shows the methodology used to determine the
amount of neutron shielding required for each physical condition [ie: restricted and unrestricted
areas, entry door(s) and maze] and neutron shielding material utilized in the facility.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.440: continued

(1) If commercial software is used to generate shielding requirements, also identify the
software used and the version/ revision date.

(2) If the software used to generate shielding requirements is not in the open literature, also
submit quality control sample calculations to verify the result obtained with the software.

D. The method(s) and instrumentation which will be used to verify the adequacy of all neutron
shielding installed in the facility.

V. REFERENCES

A. NCRP Report 49, "Structural Shielding Design and Evaluation for Medical Use of X Rays
and Gamma Rays of Energies Up to 10 MeV" (1976).

B. NCRP Report 51, "Radiation Protection Design Guidelines for 0.1-100 MeV Particle
Accelerator Facilities" (1977).

C. NCRP Report 79, "Neutron Contamination from Medical Electron Accelerators" (1984).

120.500: USE OF RADIONUCLIDES IN THE HEALING ARTS

GENERAL INFORMATION

120.501: Purpose and Scope

105 CMR 120.500 establishes requirements and provisions for the production, preparation,
compounding and use of radionuclides in the healing arts and for issuance of licenses authorizing
these activities. These requirements and provisions provide for the radiation safety of workers,
the general public, patients, and human research subjects. The requirements and provisions of
105 CMR 120.500 are in addition to, and not in substitution for, others in 105 CMR 120.000.
The requirements and provisions of 105 CMR 120.000 apply to applicants and licensees subject
to 105 CMR 120.500 unless specifically exempted. (See exemption in 105 CMR 120.104(C)(5)).

120.502: Definitions

As used in 105 CMR 120.500, the following definitions apply:

Address of Use means the building or buildings that are identified on the license and where
radioactive material may be produced, prepared, received, used, or stored.

Area of Use means a portion of a physical structure that has been set aside for the purpose of
producing, preparing, receiving, using, or storing radioactive material.

Authorized Medical Physicist means an individual who:

(1) Meets the requirements in 105 CMR 120.525(A) and 120.529; or
(2) Is identified as a medical physicist or teletherapy physicist on:
(a) A specific medical use license or equivalent permit issued by the Agency, Nuclear
Regulatory Commission or Agreement State;
(b) A permit issued by the Agency, Nuclear Regulatory Commission or Agreement
State medical use license of broad scope that is authorized to permit the use of
radioactive material;
(c) A medical use permit issued by a NRC master material licensee; or
(d) A permit issued by a NRC master material license broad scope medical use
permittee.

Authorized Nuclear Pharmacist means a pharmacist as defined in 105 CMR 120 005 who:
(1) Meets the requirements in 105 CMR 120.526(A) and 120.529; or
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.502: continued

(2) Is identified as an authorized nuclear pharmacist on:

(a) A specific license issued by NRC or Agreement State that authorizes medical use
or the practice of nuclear pharmacy;
(b) A permit issued by a NRC master material licensee that authorizes medical use or
the practice of nuclear pharmacy;
(c) A permit issued by a NRC or Agreement State broad scope medical use licensee that
authorizes medical use or the practice of nuclear pharmacy; or
(d) A permit issued by a NRC master material license broad scope medical use
permittee that authorizes medical use or the practice of nuclear pharmacy; or
(3) Is identified as an authorized nuclear pharmacist by a commercial nuclear pharmacy that
has been authorized to identify authorized nuclear pharmacists; or
(4) Is designated as an authorized nuclear pharmacist in accordance with 105 CMR
120.128(J)(2)(d).

Authorized User means a physician, dentist, or podiatrist who:

(1) Meets the requirements in 105 CMR 120.529 and 120.546(A), 120.551(A), 120.556(A),
120.557(A), 120.558(A), 120.566(A), 120.569(A), or 120.587(A); or
(2) Identified as an authorized user on:
(a) A NRC or Agreement State license that authorizes the medical use of byproduct
material;
(b) A permit issued by a NRC master material licensee that is authorized to permit the
medical use of byproduct material;
(c) A permit issued by a NRC or Agreement State specific licensee of broad scope that
is authorized to permit the medical use of byproduct material; or
(d) A permit issued by a NRC master material license broad scope permittee that is
authorized to permit the medical use of byproduct material.

Brachytherapy means a method of radiation therapy in which sources are utilized to deliver a
radiation dose at a distance of up to a few centimeters, by surface, intracavitary, intraluminal or
interstitial application.

Brachytherapy Source means a radioactive source or a manufacturer-assembled source train or

a combination of these sources that is designed to deliver a therapeutic dose within a distance
of a few centimeters.

Client’s Address means the address of use or a temporary jobsite for the purpose of providing
mobile medical service in accordance with 105 CMR 120.541.

Dedicated Check Source means a radioactive source that is used to assure the constant operation
of a radiation detection or measurement device over several months or years. This source may
also be used for other purposes.

Dentist means an individual licensed by the Commonwealth to practice dentistry.

Diagnostic Clinical Procedures Manual means a collection of written procedures that describes
each method (and other instructions and precautions) by which the licensee performs diagnostic
clinical procedures; where each diagnostic clinical procedure has been approved by the
authorized user and includes the radiopharmaceutical, dosage, and route of administration.

High Dose-rate Remote Afterloader (HDR) means a device that remotely delivers a dose rate
in excess of 12 gray (1200 rads) per hour at the treatment site.

Low Dose-rate Remote Afterloader (LDR) means a device that remotely delivers a dose rate of
less than or equal to two gray (200 rads) per hour at the treatment site.

Management means the chief executive officer or other individual having the authority to
manage, direct, or administer the licensee’s activities, or those persons’ delegate or delegates.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.502: continued

Manual Brachytherapy means a type of therapy in which brachytherapy sources are manually
applied or inserted.

Medical Institution means an organization in which several medical disciplines are practiced.

Medical Use means the intentional internal or external administration of radioactive material,
or the radiation from radioactive material to patients or human research subjects under the
supervision of an authorized user.

Medium Dose-rate Remote Afterloader (MDR) means a device that remotely delivers a dose rate
of greater than two gray (200 rads), but less than, or equal to, 12 gray (1200 rads) per hour at the
treatment site.

Mobile Medical Service means the transportation of radioactive material and its medical use at
the client’s address.

Output means the Exposure rate, dose rate, or a quantity related in a known manner to these rates
from a brachytherapy source or a teletherapy, remote afterloader, or gamma stereotactic radio-
surgery unit for a specified set of exposure conditions.

Patient Intervention means actions by the patient or human research subject, whether intentional
or unintentional, such as dislodging or removing treatment devices or prematurely terminating
the administration.

Preceptor means an individual who provides, directs, or verifies the training and experience
required for an individual to become an authorized user, an authorized medical physicist, an
authorized nuclear pharmacist, or a Radiation Safety Officer.

Prescribed Dosage means the quantity of a radiopharmaceutical activity as documented:

(1) In a written directive as specified in 105 CMR 120.521; or
(2) In accordance with the directions of the authorized user for procedures performed
pursuant to 105 CMR 120.544, 120.547 and 120.552.

Prescribed Dose means:

(1) For gamma stereotactic radiosurgery, the total dose as documented in the written
directive; or
(2) For teletherapy, the total dose and dose per fraction as documented in the written
directive; or
(3) For manual brachytherapy, either the total source strength and exposure time, or the total
dose, as documented in the written directive; or
(4) For remote brachytherapy afterloaders, the total dose and dose per fraction as
documented in the written directive.

Pulsed Dose-rate Remote Afterloader (PDR) means a special type of remote afterloading device
that uses a single source capable of delivering dose rates in the “high dose-rate” range, but:
(1) Is approximately one-tenth of the activity of typical high dose-rate remote afterloader
sources; and
(2) Is used to simulate the radiobiology of a low dose rate treatment by inserting the source
for a given fraction of each hour.

Radiation Safety Officer means an individual who:

(1) Meets the requirements in 105 CMR 120.524(A) or (C)(1) and 120.529; or
(2) Is identified as a Radiation Safety Officer on:
(a) A specific medical use license issued by NRC or Agreement State; or
(b) A medical use permit issued by NRC master material license.

Sealed Source means any radioactive material that is encased in a capsule designed to prevent
leakage or escape of the radioactive material.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.502: continued

Sealed Source and Device Registry means the national registry that contains all the registration
certificates, generated by both Nuclear Regulatory Commission and the Agreement States, that
summarize the radiation safety information for the sealed sources and devices and describe the
licensing and use conditions approved for the product.

Stereotactic Radiosurgery means the use of external radiation in conjunction with a stereotactic
guidance device to precisely deliver a dose to a tissue volume.

Structured Educational Program means an educational program designed to impart particular

knowledge and practical education through interrelated studies and supervised training.

Teletherapy as used in 105 CMR 120.500, means a method of radiation therapy in which
collimated gamma rays are delivered at a distance from the patient or human research subject.

Temporary Jobsite means a location where mobile medical services are conducted other than
those location(s) of use authorized on the license.

Therapeutic Dosage means a dosage of unsealed radioactive material that is intended to deliver
a radiation dose to a patient or human research subject for palliative or curative treatment.

Therapeutic Dose means a radiation dose delivered from a sealed source containing radioactive
material to a patient or human research subject for palliative or curative treatment.

Treatment Site means the anatomical description of the tissue intended to receive a radiation
dose, as described in a written directive.

Type of Use means use of radioactive material as specified under 105 CMR 120.544, 120.547,
120.552, 120.559, 120.569, 120.570 or 120.589.

Unit Dosage means a dosage that:

(1) Is obtained or prepared in accordance with 105 CMR 120.544, 120.547, 120.552; and,
(2) Is to be administered as a single dosage to a patient or human research subject without
any further manipulation of the dosage after it is initially prepared.

Visiting Authorized User means an authorized user who is not identified on the license of the
licensee being visited.

Written Directive means an authorized user’s written order for the administration of radioactive
material or radiation from radioactive material to a specific patient or human research subject,
as specified in 105 CMR 120.521.

120.503: Maintenance of Records

Each record required by 105 CMR 120.500 must be legible throughout the retention period
specified by each Agency regulation. The record may be the original, a reproduced copy, or a
microform provided that the copy or microform is authenticated by authorized personnel and the
microform is capable of producing a clear copy throughout the required retention period. The
record may also be stored in electronic media with the capability for producing legible, accurate,
and complete records during the required retention period. Records such as letters, drawings,
and specifications, must include all pertinent information such as stamps, initials, and signatures.
The licensee shall maintain adequate safeguards against tampering with and loss of records.

120.504: Provisions for Research Involving Human Subjects

A licensee may conduct research involving human subjects using radioactive material
provided:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.504: continued

(A) That the research is conducted, funded, supported, or regulated by a Federal agency which
has implemented the Federal Policy for the Protection of Human Subjects. Otherwise, a licensee
shall apply for and receive approval of a specific amendment to its Agency license before
conducting such research. Both types of licensees shall, at a minimum, obtain prior informed
consent from the human subjects and obtain prior review and approval of the research activities
by an "Institutional Review Board" in accordance with the meaning of these terms as defined and
described in the Federal Policy for the Protection of Human Subjects;

(B) The research involving human subjects authorized in 105 CMR 120.504(A) shall be
conducted using radioactive material authorized for medical use in the license; and

(C) Nothing in 105 CMR 120.504 relieves licensees from complying with the other
requirements in 105 CMR 120.500.

(D) FDA, Other Federal, and State Requirements. Nothing in 105 CMR 120.500 relieves the
licensee from complying with applicable U.S. Food and Drug Administration, other Federal, and
State requirements governing radioactive drugs or devices.

120.505: Implementation

(A) A licensee shall implement the provisions in 105 CMR 120.500 on October 6, 2006.

(B) When a requirement in 105 CMR 120.500 differs from the requirement in an existing
license condition, the requirement in 105 CMR 120.500 shall govern.

(C) Any existing license condition that is not affected by a requirement in 105 CMR 120.500
remains in effect until there is a license amendment or license renewal.

(D) If a license condition exempted a licensee from a provision of 105 CMR 120.500 on
October 6, 2006, it will continue to exempt a licensee from the corresponding provision in
105 CMR 120.500.

(E) If a license condition cites provisions in 105 CMR 120.500 that will be deleted on
October 6, 2006, then the license condition remains in effect until there is a license amendment
or license renewal that modifies or removes this condition.

(F) Licensees shall continue to comply with any license condition that requires it to implement
procedures required by 105 CMR 120.573, 120.579, 120.580 and 120.581 until there is a license
amendment or renewal that modifies the license condition.

120.506: License Required

(A) A person shall only manufacture, produce, prepare, compound, acquire, receive, possess,
use, or transfer radioactive material for medical use in accordance with a specific license issued
by the Agency, the Nuclear Regulatory Commission or an Agreement State, or as allowed in
105 CMR 120.506(B)(1) or (2)

(B) (1) Unless prohibited by license condition, an individual may receive, possess, use, or
transfer radioactive material in accordance with 105 CMR 120.500 under the supervision of
an authorized user as provided in 105 CMR 120.519.
(2) Unless prohibited by license condition, an individual may prepare unsealed radioactive
material for medical use in accordance with 105 CMR 120.500 under the supervision of an
authorized nuclear pharmacist or an authorized user as provided in 105 CMR 120.519.

120.507: Application for License, Amendments, or Renewal

(A) An application must be signed by the applicant's or licensee's management.

(B) An application for a license for medical use of radioactive material as described in
105 CMR 120.544, 120.547, 120.552, 120.559, 120.568, 120.570 or 120.589 must be made by:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.507: continued

(1) Filing an original and one copy of Agency application form MRCP 120.100- 4 that
includes the facility diagram, equipment, and training, experience and qualifications of the
Radiation safety Officer, authorized user(s), authorized medical physicist(s), and authorized
nuclear pharmacist(s), and
(2) Submitting procedures required by 105 CMR 120.522, 120.531, 120.573, 120.579,
120.580 and 120.581, as applicable.

(C) A request for a license amendment or renewal must be made by:

(1) Submitting an original and one copy of either:
(a) Agency form MRCP 120.100- 4; or
(b) a letter requesting the amendment or renewal; and
(2) Submitting procedures required by 105 CMR 120.522, 120.531, 120.573, 120.579,
120.580 and 120.581, as applicable.

(D) In addition to the requirements in 105 CMR 120.507(B) and (C), an application for a
license or amendment for medical use of radioactive material as described in 105 CMR 120.589
must also include information regarding any radiation safety aspects of the medical use of the
material that is not addressed in 105 CMR 120.501 through 120.543, as well as any specific
information on:
(1) Radiation safety precautions and instructions;
(2) Training and experience of proposed users;
(3) Methodology for measurement of dosages or doses to be administered to patients or
human research subjects; and
(4) Calibration, maintenance, and repair of instruments and equipment necessary for
radiation safety.

(E) The applicant or licensee shall also provide any other information requested by the Agency
in its review of the application.

(F) An applicant that satisfies the requirements specified in 105 CMR 120.127(B) may apply
for a Type A specific license of broad scope.

120.508: License Amendments

A licensee shall apply for and must receive a license amendment:

(A) Before it receives, prepares or uses radioactive material for a type of use that is permitted
under 105 CMR 120.500, but that is not authorized on the licensee's current license issued
pursuant to 105 CMR 120.500;

(B) Before permitting anyone, except a visiting authorized user, a visiting authorized medical
physicist or visiting authorized nuclear pharmacist described in 105 CMR 120.511, to work as
an authorized user, authorized medical physicist or an authorized nuclear pharmacist,
respectively, under the license except an individual who is:
(1) for an authorized user, an individual who meets the requirements in 105 CMR 120.529
and 120.546(A), 120.551(A), 120.556(A), 120.557(A), 120.558(A), 120.566(A), 120.567,
120.569(A), or 120.587(A);
(2) for an authorized nuclear pharmacist, an individual who meets the requirements in
105 CMR 120.526(A) and 120.529;
(3) for an authorized medical physicist, an individual who meets the requirements in
105 CMR 120.525(A) and 120.529;
(4) identified as an authorized user or an authorized nuclear pharmacist or authorized
medical physicist on an Agency, or the U.S. Nuclear Regulatory Commission or Agreement
State license that authorizes the use of radioactive material in medical use or in the practice
of nuclear pharmacy, respectively; or,
(5) identified as an authorized user or an authorized nuclear pharmacist or authorized
medical physicist on a permit issued by the Agency, or the U.S. Nuclear Regulatory
Commission or Agreement State specific licensee of broad scope that is authorized to permit
the use of radioactive material in medical use or the practice of nuclear pharmacy,
respectively;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.508: continued

(C) Before changing a Radiation Safety Officer, except as provided in 105 CMR 120.515(C).

(D) Before receiving radioactive material in excess of the amount, or in a different physical or
chemical form than is authorized on the license;

(E) Before adding to or changing the areas of use identified in the application or on the license,
except as specified in 105 CMR 120.509; and

(F) Before changing the address(es) of use identified in the application or on the license;

(G) Before changing statements, representations, and procedures which are incorporated into
the license; and

(H) Before releasing licensed facilities for unrestricted use.

120.509: Notifications

(A) A licensee shall provide to the Agency a copy of the board certification, the Agency, NRC,
Agreement State license, or the permit issued by a licensee of broad scope for each individual
no later than 30 days after the date that the licensee permits the individual to work as an
authorized user or an authorized nuclear pharmacist pursuant to 105 CMR 120.508(B).

(B) A licensee shall notify the Agency by letter no later than 30 days after:
(1) An authorized user, an authorized nuclear pharmacist, a Radiation Safety Officer or an
authorized medical physicist permanently discontinues performance of duties under the
license or has a name change;
(2) The licensee's mailing address changes;
(3) The licensee’s name changes, but the name change does not constitute a transfer of
control of the license as described in 105 CMR 120.131(B); or,
(4) The licensee has added to or changed the areas where radioactive material is used in
accordance with 105 CMR 120.544 and 120.547.

120.510: Exemptions Regarding Type A Specific Licenses of Broad Scope

A licensee possessing a Type A specific license of broad scope for medical use is exempt
from:

(A) The provisions of 105 CMR 120.507(D) regarding the need to file an amendment to the
license for medical use of radioactive material as described in 105 CMR 120.589;

(B) The provisions of 105 CMR 120.508(B) regarding the need to file an amendment before
permitting anyone to work as an authorized user, an authorized nuclear pharmacist or authorized
medical physicist under the license;

(C) The provisions of 105 CMR 120.508(E) regarding additions to or changes in the areas of
use at the addresses specified in the license;

(D) The provisions of 105 CMR 120.509(A) regarding notification to the Agency for new
authorized users, new authorized nuclear pharmacists and new authorized medical physicists;
and,

(E) The provisions of 105 CMR 120.523(A) regarding suppliers for sealed sources.

120.511: License Issuance

(A) The Agency shall issue a license for the medical use of radioactive material if:
(1) The applicant has filed Agency application form MRCP 120.100- 4 in accordance with
the instructions in 105 CMR 120.507;
(2) The applicant has paid any applicable fee;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.511: continued

(3) The applicant meets the requirements of 105 CMR 120.100; and
(4) The Agency finds the applicant equipped and committed to observe the safety standards
established by the Agency in these regulations for the protection of the public health and
safety.

(B) The Agency shall issue a license for mobile services if the applicant:
(1) Meets the requirements in 105 CMR 120.511(A); and,
(2) Assures that individuals to whom radioactive drugs or radiation from implants
containing radioactive material will be administered, may be released following treatment
in accordance with 105 CMR 120.540.

120.513: Specific Exemptions

The Agency may, upon application of any interested person or upon its own initiative, grant such
exemptions from the regulations in 105 CMR 120.500 as it determines are authorized by law and
will not endanger life or property or the common defense and security and are otherwise in the
public interest.

GENERAL ADMINISTRATIVE REQUIREMENTS

120.515: Authority and Responsibilities for the Radiation Protection Program

(A) In addition to the radiation protection program requirements of 105 CMR 120.210, a
licensee’s management must approve in writing:
(1) Requests for license application, renewal, or amendments before submittal to the
Agency;
(2) Any individual before allowing that individual to work as an authorized user, authorized
nuclear pharmacist or authorized medical physicist; and
(3) Radiation protection program changes that do not require a license amendment and are
permitted under 105 CMR 120.517.

(B) A licensee's management shall appoint a Radiation Safety Officer, who agrees in writing
to be responsible for implementing the radiation protection program. The licensee, through the
Radiation Safety Officer, shall ensure that radiation safety activities are being performed in
accordance with licensee-approved procedures and regulatory requirements.

(C) For up to 60 days each year, a licensee may permit an authorized user or an individual
qualified to be a radiation safety officer to function as a temporary Radiation Safety Officer and
to perform the functions of a Radiation Safety Officer, as provided in 105 CMR 120.515(E),
provided the licensee takes the actions required in 105 CMR 120.515(B), (D), (E) and (H). A
licensee may simultaneously appoint more than one temporary RSO, if needed, to ensure that the
licensee has a temporary RSO that satisfies the requirements to be an RSO for each of the
different uses of radioactive material permitted by the license.

(D) A licensee shall establish the authority, duties, and responsibilities of the Radiation Safety
Officer in writing.

(E) A licensee shall provide the Radiation Safety Officer sufficient authority, organizational
freedom, time, resources, and management prerogative, to:
(1) Identify radiation safety problems;
(2) Initiate, recommend, or provide corrective actions;
(3) Stop unsafe operations; and,
(4) Verify implementation of corrective actions.

(F) Licensees that are authorized for two or more different types of radioactive material use
under 105 CMR 120.552, 120.559, 120.570, and 120.589, or two or more types of units under
105 CMR 120.570 shall establish a Radiation Safety Committee to oversee all uses of
radioactive material permitted by the license. The Committee must include an authorized user
of each type of use permitted by the license, the Radiation Safety Officer, a representative of the
nursing service, and a representative of management who is neither an authorized user nor a
Radiation Safety Officer, and may include other members as the licensee deems appropriate.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.515: continued

(G) A licensee's Radiation Safety Committee shall meet as necessary, but at a minimum shall
meet at intervals not to exceed six months. The licensee shall maintain minutes of each meeting
in accordance with 105 CMR 120.590(A).

(H) A licensee shall retain a record of actions taken pursuant to 105 CMR 120.515(A), (B) and
(D) in accordance with 105 CMR 120.590(A).

120.517: Radiation Protection Program Changes

(A) A licensee may revise its radiation protection program without Agency approval if:
(1) The revision does not require an amendment under 105 CMR 120.508;
(2) The revision is in compliance with the regulations and the license;
(3) The revision has been reviewed and approved by the Radiation Safety Officer, licensee
management and licensee’s Radiation Safety Committee (if applicable); and,
(4) The affected individuals are instructed on the revised program before the changes are
implemented.

(B) A licensee shall retain a record of each change in accordance with 105 CMR 120.590(B).

120.518: Duties of Authorized User and Authorized Medical Physicist

120.519: Supervision

(A) A licensee that permits the receipt, possession, use, or transfer of radioactive material by
an individual under the supervision of an authorized user as allowed by 105 CMR 120.506(B)(1)
shall:
(1) In addition to the requirements in 105 CMR 120.753, instruct the supervised individual
in the licensee’s written radiation protection procedures, written directive procedures in
105 CMR 120.500, and license conditions with respect to the use of radioactive material;
(2) Require the supervised individual to follow the instructions of the supervising
authorized user for medical uses of radioactive material, written radiation protection
procedures, written directive procedures, regulations of 105 CMR 120.500, and license
conditions with respect to the medical use of radioactive material; and
(3) Require that only those individuals permitted under state and local regulations and
specifically trained, and designated by the authorized user, be permitted to administer
radionuclides or radiation to patients or human research subjects.

(B) A licensee that permits the preparation of radioactive material for medical use by an
individual under the supervision of an authorized nuclear pharmacist or physician who is an
authorized user, as allowed by 105 CMR 120.506(B)(2), shall:
(1) Instruct the supervised individual in the preparation of radioactive material for medical
use, as appropriate to that individual’s involvement with radioactive material; and
(2) Require the supervised individual to follow the instructions of the supervising
authorized user or authorized nuclear pharmacist regarding the preparation of radioactive
material for medical use, the written radiation protection procedures in 105 CMR 120.500,
and license conditions.

(C) Unless physical presence as described in other sections of 105 CMR 120.500 is required,
a licensee that permits supervised activities under 105 CMR 120.519(A) and (B) shall require
an authorized user to be immediately available (by telephone within ten minutes) to
communicate with the supervised individual, and able to be physically present within one hour
of notification; and

(D) A licensee that permits supervised activities under 105 CMR 120.519(A) and (B) is
responsible for the acts and omissions of the supervised individual.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.520: Visiting Authorized User, Visiting Authorized Nuclear Pharmacist or Visiting Medical Physicist

(A) A licensee may permit any visiting authorized user, visiting authorized nuclear pharmacist
or visiting authorized medical physicist to work as an authorized user, authorized nuclear
pharmacist or medical physicist, respectively, under the terms of the licensee's license for 60 days
each year if:
(1) The visiting authorized user, the visiting authorized nuclear pharmacist or the visiting
authorized medical physicist has the prior written permission of the licensee's management
and, if the work is performed on behalf of an institution, the institution's Radiation Safety
Committee;
(2) The licensee has a copy of an Agency, Agreement State, or U.S. Nuclear Regulatory
Commission license that identifies the visiting authorized user, the visiting authorized
nuclear pharmacist or the visiting authorized medical physicist by name as an authorized user
for medical use, as an authorized nuclear pharmacist, or as an authorized medical physicist
respectively; and
(3) Only those procedures for which the visiting authorized user is specifically authorized
by an Agency, Agreement State, or U.S. Nuclear Regulatory Commission license are
performed by that individual.

(B) A licensee need not apply for a license amendment in order to permit a visiting authorized
user, a visiting authorized nuclear pharmacist or a visiting authorized medical physicist to use
licensed material as described in 105 CMR 120.520(A).

(C) A licensee shall retain copies of the records specified in 105 CMR 120.520(A), as specified
in 105 CMR 120.590(A).

120.521: Written Directives

(A) A written directive must be dated and signed by an authorized user prior to administration
of I-131 sodium iodide greater than 1.11 megabecquerel (30 :Ci), any therapeutic dosage of
radioactive material or any therapeutic dose of radiation from radioactive material.
If, because of the emergent nature of the patient's condition, a delay in order to provide a
written directive would jeopardize the patient's health, an oral directive will be acceptable,
provided that the information contained in the oral directive is documented as soon as possible
in writing in the patient's record and a written directive is prepared within 48 hours of the oral
directive.

(B) The written directive must contain the patient or human research subject's name and the
following:
(1) For an administration of a dosage of radioactive drug containing radioactive material,
the radioactive drug containing radioactive material, dosage, and route of administration;
(2) For gamma stereotactic radiosurgery, the total dose, treatment site, and number of target
coordinate settings per treatment for each anatomically distinct treatment site;
(3) For teletherapy, the total dose, dose per fraction, number of fractions, and treatment site;
(4) For high dose rate remote afterloading brachytherapy, the radionuclide, treatment site,
dose per fraction, number of fractions, and total dose; or
(5) For all other brachytherapy including LDR, MDR, and PDR:
(a) Prior to implantation: treatment site, the radionuclide, and dose; and,
(b) After implantation but prior to completion of the procedure: the radioisotope,
treatment site, number of sources, and total source strength and exposure time (or, the
total dose).

(C) A written revision to an existing written directive may be made provided that the revision
is dated and signed by an authorized user prior to the administration of the dosage of radioactive
drug containing radioactive material, the brachytherapy dose, the gamma stereotactic
radiosurgery dose, the teletherapy dose, or the next fractional dose.
If, because of the patient's condition, a delay in order to provide a written revision to an
existing written directive would jeopardize the patient's health, an oral revision to an existing
written directive will be acceptable, provided that the oral revision is documented as soon as
possible in the patient's record and a revised written directive is signed by the authorized user
within 48 hours of the oral revision.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.521: continued

(D) The licensee shall retain the written directive in accordance with 105 CMR 120.590(C).

120.522: Procedures for Administrations Requiring a Written Directive

(A) For any administration requiring a written directive, the licensee shall develop, implement,
and maintain written procedures to provide high confidence that:
(1) The patient's or human research subject's identity is verified before each administration;
and
(2) Each administration is in accordance with the written directive.

(B) The procedures required by 105 CMR 120.522(A) must, at a minimum, address the
following items that are applicable for the licensee's use of radioactive material:
(1) Verifying the identity of the patient or human research subject;
(2) Verifying that the specific details of the administration are in accordance with the
treatment plan, if applicable, and the written directive;
(3) Checking both manual and computer-generated dose calculations; and
(4) Verifying that any computer-generated dose calculations are correctly transferred into
the consoles of therapeutic medical units authorized by 105 CMR 120.570 or 120.589.

120.523: Suppliers for Sealed Sources or Devices Containing Sealed Sources for Medical Use

For medical use, a licensee may only use:

(A) Sealed sources or devices initially manufactured, labeled, packaged, and distributed in
accordance with a license issued pursuant to 105 CMR 120.100 and 120.128(L) or the equivalent
requirements of the Nuclear Regulatory Commission or an Agreement State; or

(B) Sealed sources or devices non-commercially transferred from a 10 CFR Part 35 licensee
or an Agreement State medical use licensee.

(C) Teletherapy sources manufactured and distributed in accordance with a license issued
pursuant to 105 CMR 120.100 or the equivalent requirements of the Nuclear Regulatory
Commission, an Agreement State or a Licensing State.

120.524: Training for Radiation Safety Officer

Except as provided in 105 CMR 120.528, the licensee shall require an individual fulfilling
the responsibilities of the Radiation Safety Officer (RSO) as provided in 105 CMR 120.515 to
be an individual who:

(A) Is certified by a speciality board whose certification process includes all of the requirements
in 105 CMR 120.524(D) and (E) and whose certification has been recognized by the Nuclear
Regulatory Commission or an Agreement State. (The names of board certifications which have
been recognized by the Commission or an Agreement State will be posted on the NRC's Web
page.) To have its certification process recognized, a specialty board shall require all candidates
for certification to:
(1) (a) Hold a bachelor's or graduate degree from an accredited college or university in
physical science or engineering or biological science with a minimum of 20 college
credits in physical science;
(b) Have five or more years of professional experience in health physics (graduate
training may be substituted for no more than two years of the required experience)
including at least three years in applied health physics; and
(c) Pass an examination administered by diplomates of the specialty board, which
evaluates knowledge and competence in radiation physics and instrumentation, radiation
protection, mathematics pertaining to the use and measurement of radioactivity, radiation
biology, and radiation dosimetry; or
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.524: continued

(2) (a) Hold a master's or doctor's degree in physics, medical physics, other physical
science, engineering, or applied mathematics from an accredited college or university;
(b) Have two years of full-time practical training and/or supervised experience in
medical physics.
1. Under the supervision of a medical physicist who is certified in medical physics
by a specialty board recognized by the Nuclear Regulatory Commission or an
Agreement State; or
2. In clinical nuclear medicine facilities providing diagnostic and/or therapeutic
services under the direction of physicians who meet the requirements for authorized
users in 105 CMR 120.528, 120.551 or 120.556;
3. Pass an examination, administered by diplomates of the specialty board, that
assesses knowledge and competence in clinical diagnostic radiological or nuclear
medicine physics and in radiation safety; or

(B) (1) Has completed a structured educational program consisting of both:

(a) 200 hours of classroom and laboratory training in the following areas:
1. Radiation physics and instrumentation;
2. Radiation protection;
3. Mathematics pertaining to the use and measurement of radioactivity;
4. Radiation biology; and,
5. Radiation dosimetry; and,
(b) One year of full time experience under the supervision of the individual identified
as the Radiation Safety Officer on an Agency, Agreement State, or U.S. Nuclear
Regulatory Commission license that authorizes similar type(s) of use(s) of radioactive
material involving the following:
1. Shipping, receiving and performing related radiation surveys;
2. Using and performing checks for proper operation of dose calibrators, survey
meters, and instruments used to measure radionuclides;
3. Securing and controlling radioactive material;
4. Using administrative controls to avoid mistakes in the administration of
radioactive material;
5. Using procedures to prevent or minimize radioactive contamination and using
proper decontamination procedures;
6. Using emergency procedures to control radioactive material;
7. Disposing of radioactive material; or
(2) Training and Experience for Radiation Safety Officer [Reserved]

(C)(1) Is a medical physicist who has been certified by a specialty board whose certification
process has been recognized by the Nuclear Regulatory Commission or an Agreement State
under 105 CMR 120.525(A) and has experience in radiation safety for similar types of use
of byproduct material for which the licensee is seeking the approval of the individual as
Radiation Safety Officer and who meets the requirements in 105 CMR 120.524(D) and (E);
or
(2) Is an authorized user, authorized medical physicist, or authorized nuclear pharmacist
identified on the licensee's license and has experience with the radiation safety aspects of
similar types of use of byproduct material for which the individual has Radiation Safety
Officer responsibilities; and,

(D) Has obtained written attestation, signed by a preceptor Radiation Safety Officer, that the
individual has satisfactorily completed the requirements in 105 CMR 120.524(E) and in
105 CMR 120.524(A)(1)(a) and (b) or (A)(2)(a) and (b) or (B)(1) or (C)(1) or (2), and has
achieved a level of radiation safety knowledge sufficient to function independently as a Radiation
Safety Officer for a medical use licensee; and

(E) Has training in the radiation safety, regulatory issues, and emergency procedures for the
types of use for which a licensee seeks approval. This training requirement may be satisfied by
completing training that is supervised by a Radiation Safety Officer, authorized medical
physicist, authorized nuclear pharmacist, or authorized user, as appropriate, who is authorized
for the type(s) of use for which the licensee is seeking approval.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.525: Training for Authorized Medical Physicist

The licensee shall require the authorized medical physicist to be an individual who:

(A) Is certified by a speciality board whose certification process has been recognized by the
Nuclear Regulatory Commission or an Agreement State and who meets the requirements in
105 CMR 120.525(B)(2) and (C). (The names of board certifications which have been
recognized by the Commission or an Agreement State will be posted on the NRC's Web page.)
To have its certification process recognized, a specialty board shall require all candidates for
certification to:
(1) Hold a master's or doctor's degree in physics, medical physics, other physical science,
engineering, or applied mathematics from an accredited college or university;
(2) Have two years of full-time practical training and/or supervised experience in medical
physics;
(a) Under the supervision of a medical physicist who is certified in medical physics by
a specialty board recognized by the Commission or an Agreement State; or
(b) In clinical radiation facilities providing high-energy, external beam therapy (photons
and electrons with energies greater than or equal to 1 million electron volts) and
brachytherapy services under the direction of physicians who meet the requirements for
authorized users in 105 CMR 120.528, 120.566 or 120.587; and
(3) Pass an examination, administered by diplomates of the specialty board, that assesses
knowledge and competence in clinical radiation therapy, radiation safety, calibration, quality
assurance, and treatment planning for external beam therapy, brachytherapy, and stereotactic
radiosurgery; or

(B)(1) Holds a master's or doctor's degree in physics, medical physics, other physical science,
engineering, or applied mathematics from an accredited college or university; and has
completed one year of full-time training in medical physics and an additional year of fulltime
work experience under the supervision of an individual who meets the requirements for an
authorized medical physicist for the type(s) of use for which the individual is seeking
authorization. This training and work experience must be conducted in clinical radiation
facilities that provide high-energy, external beam therapy (photons and electrons with
energies greater than or equal to one million electron volts) and brachytherapy services and
must include:
(a) Performing sealed source leak tests and inventories;
(b) Performing decay corrections;
(c) Performing full calibration and periodic spot checks of external beam treatment
units, stereotactic radiosurgery units, and remote afterloading units as applicable; and
(d) Conducting radiation surveys around external beam treatment units, stereotactic
radiosurgery units, and remote afterloading units as applicable; and
(2) Has obtained written attestation that the individual has satisfactorily completed the
requirements in 105 CMR 120.525(C) and 105 CMR 120.525(A)(1) and (2), or
120.525(B)(1) and (C), and has achieved a level of competency sufficient to function
independently as an authorized medical physicist for each type of therapeutic medical unit
for which the individual is requesting authorized medical physicist status. The written
attestation must be signed by a preceptor authorized medical physicist who meets the
requirements in 105 CMR 120.525, 120.528, or equivalent Nuclear Regulatory Commission
or Agreement State requirements for an authorized medical physicist for each type of
therapeutic medical unit for which the individual is requesting authorized medical physicist
status; and

(C) Has training for the type(s) of use for which authorization is sought that includes hands-on
device operation, safety procedures, clinical use, and the operation of a treatment planning
system. This training requirement may be satisfied by satisfactorily completing either a training
program provided by the vendor or by training supervised by an authorized medical physicist
authorized for the type(s) of use for which the individual is seeking authorization.

120.526: Training for an Authorized Nuclear Pharmacist

Except as provided in 105 CMR 120.528, the licensee shall require the authorized nuclear
pharmacist to be a pharmacist who:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.526: continued

(A) Is certified by a specialty board whose certification process has been recognized by the
Nuclear Regulatory Commission or an Agreement State and who meets the requirements in
105 CMR 120.526(B)(2). (The names of board certifications which have been recognized by the
Nuclear Regulatory Commission or an Agreement State will be posted on the NRC's Web page.)
To have its certification process recognized, a specialty board shall require all candidates for
certification to:
(1) Have graduated from a pharmacy program accredited by the American Council on
Pharmaceutical Education (ACPE) or have passed the Foreign Pharmacy Graduate
Examination Committee (FPGEC) examination;
(2) Hold a current, active license to practice pharmacy;
(3) Provide evidence of having acquired at least 4000 hours of training/experience in
nuclear pharmacy practice. Academic training may be substituted for no more than 2000
hours of the required training and experience; and
(4) Pass an examination in nuclear pharmacy administered by diplomates of the specialty
board, that assesses knowledge and competency in procurement, compounding, quality
assurance, dispensing, distribution, health and safety, radiation safety, provision of
information and consultation, monitoring patient outcomes, research and development; or

(B) (1) Has completed 700 hours in a structured educational program consisting of both:
(a) 200 hours of classroom and laboratory training in the following areas:
1. Radiation physics and instrumentation;
2. Radiation protection;
3. Mathematics pertaining to the use and measurement of radioactivity;
4. Radiation biology; and
5. Chemistry of radioactive material for medical use; and
(b) Supervised practical experience in a nuclear pharmacy involving:
1. Shipping, receiving, and performing related radiation surveys;
2. Using and performing checks for proper operation of dose calibrators, survey
meters, and, if appropriate, instruments used to measure alpha- or beta-emitting
radionuclides;
3. Calculating, assaying, and safely preparing dosages for patients or human
research subjects;
4. Using administrative controls to avoid medical events in the administration of
radioactive material; and
5. Using procedures to prevent or minimize radioactive contamination and using
proper decontamination procedures; and
(2) Has obtained written attestation, signed by a preceptor authorized nuclear pharmacist,
that the individual has satisfactorily completed the requirements in 105 CMR 120.526(A)(1)
through (3) or 120.526(B)(1) and has achieved a level of competency sufficient to function
independently as an authorized nuclear pharmacist.

120.528: Training for Experienced Radiation Safety Officer, Teletherapy or Medical Physicist, Authorized
Medical Physicist, Authorized User, Nuclear Pharmacist, and Authorized Nuclear Pharmacist

(A)(1) An individual identified as a Radiation Safety Officer, a teletherapy or medical

physicist, or a nuclear pharmacist on a Nuclear Regulatory Commission, an Agreement State
license or on a permit issued by a Nuclear Regulatory Commission or Agreement State broad
scope licensee or master material license permit or by a master material license permittee of
broad scope before October 24, 2002 need not comply with the training requirements of
105 CMR 120.524 through 120.526, respectively.
(2) An individual identified as a Radiation Safety Officer, an authorized medical physicist,
or an authorized nuclear pharmacist on a Nuclear Regulatory Commission, an Agreement
State license or a permit issued by a Nuclear Regulatory Commission or Agreement State
broad scope licensee or master material license permit or by a master material license
permittee of broad scope between October 24, 2002 and April 29, 2005 need not comply with
the training requirements of 105 CMR 120.524 through 120.526, respectively.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.528: continued

(3) A Radiation Safety Officer, a medical physicist, or a nuclear pharmacist, who used only
accelerator-producedradioactive materials, discrete sources of radium-226, or both, for
medical uses or in the practice of nuclear pharmacy at a Federal Government agency or
Federally recognized Indian Tribe before November 30, 2007 or at all other locations of use
before August 8, 2009, or an earlier date as noticed by the NRC, need not comply with the
training requirements of 105 CMR 120.524 through 120.526, respectively, when performing
the same uses. A nuclear pharmacist, who prepared only radioactive drugs containing
accelerator-produced radioactive materials, or a medical physicist, who used only
accelerator-produced radioactive materials, at the locations and time period identified in
105 CMR 120.528, qualifies as an authorized nuclear pharmacist or an authorized medical
physicist, respectively, for those materials and uses performed before these dates, for
purposes of 105 CMR 120.500.

(B)(1) Physicians, dentists, or podiatrists identified as authorized users for the medical use of
radioactive material on a Nuclear Regulatory Commission or Agreement State license or on
a permit issued by a Nuclear Regulatory Commission or Agreement State broad scope
licensee, or a permit issued by a Nuclear Regulatory Commission master material license
broad scope permittee before October 24, 2002 who perform only those medical uses for
which they were authorized on that date need not comply with the training requirements of
105 CMR 120.546, 120.551, 120.556 through 120.558, 120.566, 120.567, 120.569 and
120.587.
(2) Physicians, dentists, or podiatrists identified as authorized users for the medical use of
radioactive material on a Nuclear Regulatory Commission or Agreement State license or on
a permit issued by a Nuclear Regulatory Commission or Agreement State broad scope
licensee, or a permit issued by a Nuclear Regulatory Commission master material license
broad scope permittee who perform only those medical uses for which they were authorized
between October 24, 2002, and April 29, 2005, need not comply with the training
requirements of 105 CMR 120.546, 120.551, 120.556 through 120.558, 120.566, 120.567,
120.569 and 120.587.
(3) Physicians, dentists, or podiatrists who used only accelerator-produced radioactive
materials, discrete sources of radium-226, or both, for medical uses performed at a
Government agency or Federally recognized Indian Tribe before November 30, 2007 or at
all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC,
need not comply with the training requirements of 105 CMR 120.546, 120.551, 120.556
through 120.558, 120.566, 120.567, 120.569 and 120.587 when performing the same
medical uses. A physician, dentist, or podiatrist, who used only accelerator-produced
radioactive materials, discrete sources of radium-226, or both, for medical uses at the
locations and time period identified in 105 CMR 120.528(B)(3), qualifies as an authorized
user for those materials and uses performed before these dates, for purposes of 105 CMR
120.500.

(C) Individuals who need not comply with training requirements as described in 105 CMR
120.528 may serve as preceptors for, and supervisors of, applicants seeking authorization on
Agency licenses for the same uses for which these individuals are authorized.

120.529: Recentness of Training

The training and experience specified in 105 CMR 120.500 must have been obtained within
the seven years preceding the date of application or the individual must have had related
continuing education and experience since the required training and experience was completed.

GENERAL TECHNICAL REQUIREMENTS

120.531: Quality Control of Diagnostic Equipment

Each licensee shall establish written quality control procedures for all diagnostic equipment
used for radionuclide studies. As a minimum, quality control procedures and frequencies shall
be those recommended by equipment manufacturers or procedures which have been approved
by the Agency. The licensee shall conduct quality control procedures in accordance with written
procedures.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.532: Possession, Use, and Calibration of Instruments Used to Measure the Activity of Unsealed
Radioactive Material

(A) For direct measurements performed in accordance with 105 CMR 120.534, a licensee shall
possess and use instrumentation to measure the activity of unsealed radioactive materials prior
to administration to each patient or human research subject.

(B) A licensee shall calibrate the instrumentation required in 105 CMR 120.532(A) in
accordance with nationally recognized standards or the manufacturer’s instructions.

(C) A licensee shall retain a record of each instrument calibration required by 105 CMR
120.532 in accordance with 105 CMR 120.590(F).

120.533: Calibration of Survey Instruments

(A) A licensee shall ensure that the survey instruments used to show compliance with 105 CMR
120.200 and 120.500 have been calibrated before first use, annually, and following repair.

(B) To satisfy the requirements of 105 CMR 120.533(A), the licensee shall:
(1) Calibrate all required scale readings up to ten millisieverts (1000 mrem) per hour with
a radiation source;
(2) Have each radiation survey instrument calibrated:
(a) At energies appropriate for use and at intervals not to exceed 12 months or after
instrument servicing, except for battery changes;
(b) For linear scale instruments, at two points located approximately a and b of full-
scale on each scale; for logarithmic scale instruments, at mid-range of each decade, and
at two points of at least one decade; and for digital instruments, at three points between
0.02 and ten millisieverts (two and 1000 mrem) per hour; and
(c) For dose rate instruments, so that an accuracy within plus or minus 20% of the true
radiation dose rate can be demonstrated at each point checked.
(3) Conspicuously note on the instrument the date of calibration.

(C) The licensee shall not use survey instruments if the difference between the indicated
exposure rate and the calculated exposure rate is greater than 20%.

(E) The licensee shall retain a record of each survey instrument calibration in accordance with
105 CMR 120.590(G).

120.534: Determination of Dosages of Unsealed Radioactive Material for Medical Use

(A) A licensee shall determine and record the activity of each dosage prior to medical use.

(B) For a unit dosage, this determination must be made either by direct measurement or by a
decay correction, based on the measurement made by a manufacturer or preparer licensed
pursuant to 105 CMR 120.128(J) or equivalent provisions of the Nuclear Regulatory
Commission, or an Agreement State.

(C) For other than unit dosages, this determination must be made by direct measurement of
radioactivity or by a combination of measurements of radioactivity and mathematical
calculations or combination of volumetric measurements and mathematical calculations, based
on the measurement made by a manufacturer or preparer licensed pursuant to 105 CMR
120.128(J) or equivalent provisions of the Nuclear Regulatory Commission, or an Agreement
State.

(D) Unless otherwise directed by the authorized user, a licensee shall not use a dosage if the
dosage differs from the prescribed dosage by more than 20%.

(E) A licensee shall retain a record of the dosage determination required by 105 CMR 120.534
in accordance with 105 CMR 120.590(H).
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.535: Authorization for Calibration, Transmission and Reference Sources

Any person authorized by 105 CMR 120.506 for medical use of radioactive material may
receive, possess, and use the following radioactive material for check, calibration and reference
use:

(A) Sealed sources manufactured and distributed by persons specifically licensed pursuant to
105 CMR 120.128(L) or equivalent provisions of the U.S. Nuclear Regulatory Commission,
Agreement State or Licensing State and that do not exceed 1.11 gigabecquerels (30 mCi) each;

(B) Any radioactive material with a half-life of 120 days or less in individual amounts not to
exceed 555 megabecquerels (15 mCi);

(C) Any radioactive material with a half life greater than 120 days in individual amounts not
to exceed the smaller of 7.4 megabecquerels (200 :Ci) or 1000 times the quantity in 105 CMR
120.196: Appendix B, Table 1; and

(D) Technetium-99m in amounts as needed.

120.536: Requirements for Possession of Sealed Sources and Brachytherapy Sources

(A) A licensee in possession of any sealed source or brachytherapy source shall follow the
radiation safety and handling instructions supplied by the manufacturer or equivalent instructions
approved by the Agency.

(B) A licensee in possession of a sealed source shall:

(1) Test the source for leakage before its first use unless the licensee has a certificate from
the supplier indicating that the source was tested within six months before transfer to the
licensee; and,
(2) Test the source for leakage at intervals not to exceed six months or at intervals approved
by the Agency, another Agreement State, a Licensing State or the U.S. Nuclear Regulatory
Commission in the Sealed Source and Device Registry.

(C) To satisfy the leak test requirements of 105 CMR 120.536(B), the licensee shall measure
the sample so that the leak test can detect the presence of 185 becquerels (0.005 :Ci) of
radioactive material in the sample. If the leak test reveals the presence of 185 becquerels (0.005
:Ci) or more of removable contamination, the licensee shall:
(1) Immediately withdraw the sealed source from use and store, repair or dispose of it in
accordance with the requirements of 105 CMR 120.100 and 120.200; and,
(2) File a report with the Agency within five days of receiving the leak test results with the
Agency describing the equipment involved, the test results, and the action taken.

(D) A licensee shall retain leak test records in accordance with 105 CMR 120.590(I)(1).

(E) A licensee in possession of a sealed source or brachytherapy source, except for gamma
stereotactic radiosurgery sources, shall conduct a semi-annual physical inventory of all such
sources. The licensee shall retain each inventory record in accordance with 105 CMR
120.590(I)(2).

120.537: Labeling of Vials and Syringes

Each syringe and vial that contains a radioactive drug shall be labeled to identify the
radioactive drug. Each syringe shield and vial shield shall also be labeled unless the label on the
syringe or vial is visible when shielded.

120.539: Surveys for Ambient Radiation Dose Rate and Contamination

(A) In addition to the surveys required by 105 CMR 120.200, a licensee shall survey with a
radiation detection survey instrument at the end of each day of use all areas where unsealed
radioactive material requiring a written directive was prepared for use or administered.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.539: continued

(B) A licensee does not need to perform the surveys required in 105 CMR 120.539(A) in area(s)
where patients or human research subjects are confined when they can not be released pursuant
to 105 CMR 120.540.

(C) A licensee shall retain a record of each survey in accordance with 105 CMR 120.590(J).

120.540: Release of Individuals Containing Unsealed Radioactive Material or Implants Containing

Radioactive Material

(A) A licensee may authorize the release from its control of any individual who has been
administered unsealed radioactive material or implants containing radioactive material if the total
effective dose equivalent to any other individual from exposure to the released individual is not
likely to exceed five millisievert (0.5 rem). [NOTE: NRC Regulatory Guide, NUREG-1566,
Vol. 9, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About
Medical Licenses, describes methods for calculating doses to other individuals and contains
tables of activities not likely to cause doses exceeding five millisieverts (0.5 rem).]

(B) For patients administered radioactive material for which a written directive is required, a
licensee shall provide the released individual, or the individual's parent or guardian, with oral and
written instructions on actions recommended to maintain doses to other individuals as low as is
reasonably achievable if the total effective dose equivalent to any other individual is likely to
exceed one millisievert (0.1 rem). If the total effective dose equivalent to a breast-feeding infant
or child could exceed one millisievert (0.1 rem) assuming there were no interruption of breast-
feeding, the instructions shall also include:
(1) Guidance on the interruption or discontinuation of breast-feeding; and
(2) Information on the potential consequences, if any, of failure to follow the guidance.

(C) The licensee shall maintain a record of the basis for authorizing the release of an individual
in accordance with 105 CMR 120.590(K)(1).

(D) The licensee shall maintain a record of instructions provided to breast-feeding women in
accordance with 105 CMR 120.590(K)(2).

(E) The licensee shall immediately notify the Agency in accordance with 105 CMR 120.594(D)
if a patient departs prior to an authorized release.

120.541: Provision of Mobile Medical Service

The Agency may license mobile medical services and/or clients of such services. The mobile
medical service shall be licensed if the service receives, uses or possesses radioactive material.
The client of the mobile medical service shall be licensed if the client receives or possesses
radioactive material to be used by a mobile medical service.

(A) A licensee providing mobile medical service shall:

(1) Obtain a letter signed by the management of each location where services are rendered
that authorizes use of radioactive material at the client’s address of use and clearly delineates
the authority and responsibility of the licensee and the client. If the client is licensed, the
letter shall document procedures for notification, receipt, storage and documentation of
transfer of radioactive material delivered to the client's location for use by the mobile medical
service;
(2) Check instruments used to measure the activity of unsealed radioactive material for
proper function before medical use at each client’s address or on each day of use, whichever
is more frequent. At a minimum, the check for proper function required by 105 CMR
120.541(A)(2) must include a constancy check;
(3) Check survey instruments for proper operation with a dedicated check source before use
at each client’s address; and,
(4) Before leaving a client’s address, survey all areas of use to ensure compliance with the
requirements in 105 CMR 120.200.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.541: continued

(B) A mobile medical service shall not have radioactive material delivered directly from the
manufacturer or the distributor to the client, unless the client has a license. Radioactive material
delivered to the client shall be received and handled in conformance with the client's license.

(C) A mobile medical service shall inform the client's management who is on site at each
client's address of use at the time that radioactive material is being administered.

(D) A mobile medical service licensee shall maintain all records required by 105 CMR 120.200
and 120.500 at a location within the Agency's jurisdiction that is:
(1) A single address:
(a) identified as the records retention location; and,
(b) staffed at all reasonable hours by individual(s) authorized to provide the Agency
with access for purposes of inspection; or
(2) When no address is identified on the license for records retention, the mobile unit:
(a) identified in the license; and,
(b) whose current client's address schedule and location schedule is reported to the
Agency.

(E) A licensee providing mobile medical services shall:

(1) Retain the letter required in 105 CMR 120.541(A)(1) in accordance with 105 CMR
120.590(L); and
(2) Retain a record of each survey required by 105 CMR 120.541(A)(4) in accordance with
105 CMR 120.590(L).

(F) Use radioactive gases only in areas of use and under conditions which have been evaluated
and approved by the Agency for compliance with airborne release standards.

120.542: Storage of Volatiles and Gases

(A) A licensee shall store volatile radiopharmaceuticals and radioactive gases in a radiation
shield and container.

(B) A licensee shall store and use a multidose container in a properly functioning fume hood.

(C) A licensee who administers radioactive aerosols or gases shall do so with a system that will
keep airborne concentrations within the limits prescribed in 105 CMR 120.200.

(D) The system shall either be directly vented to the atmosphere through an air exhaust or
provide for collection and decay or disposal of the aerosol or gas in a shielded container.

(E) A licensee shall check the operation of collection systems monthly. Records of these
checks shall be maintained for three years.

120.543: Decay-in-storage

(A) A licensee may hold radioactive material with a physical half-life of less than 120 days (or
longer, if the Agency has approved it) for decay-in-storage before disposal without regard to its
radioactivity if the licensee:
(1) Monitors radioactive material at the surface and determines that its radioactivity cannot
be distinguished from the background radiation level with an appropriate radiation detection
survey instrument set on its most sensitive scale and with no interposed shielding;
(2) Removes or obliterates all radiation labels except for radiation labels on materials that
are within containers and that will be managed as biomedical waste after they have been
released from the licensee; and
(3) Separates and monitors each generator column individually with all radiation shielding
removed to ensure that its contents have decayed to background radiation level before
disposal.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.543: continued

(B) For radioactive material disposed in accordance with 105 CMR 120.543(A), the licensee
shall retain a record of each disposal in accordance with 105 CMR 120.590(M).

SPECIFIC REQUIREMENTS FOR THE USE OF RADIOACTIVE MATERIAL FOR

UPTAKE, DILUTION, OR EXCRETION STUDIES

120.544: Use of Unsealed Radioactive Material for Uptake, Dilution, or Excretion Studies for which a
Written Directive is not Required

A licensee may use any unsealed radioactive material, in quantities that do not require a
written directive, for a diagnostic use involving measurements of uptake, dilution, or excretion:

(A)(1) Obtained from a manufacturer or preparer licensed pursuant to 105 CMR 120 128(J) or
equivalent regulations of another Agreement State, or the Nuclear Regulatory Commission;
or
(2) A PET radioactive drug producer licensed under 105 CMR 120.100 or equivalent
regulations of the Nuclear Regulatory Commission or equivalent Agreement State
requirements; or

(B) Excluding production PET radionuclides, prepared by:

(1) an authorized nuclear pharmacist;
(2) A physician who is an authorized user and who meets the requirements specified in
105 CMR 120.551, or 120.556 and 120.551(C)(1)(b)7.; or
(3) An individual under the supervision, as specified in 105 CMR 120.519, of the
authorized nuclear pharmacist in 105 CMR 120.544(B)(1) or the physician who is an
authorized user in 105 CMR 120.544(B)(2); or

(C) Obtained from and prepared by an Agency, Nuclear Regulatory Commission, Agreement
State licensee for use in research in accordance with a Radioactive Drug Research Committee-
approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or

(D) Prepared by the licensee in accordance with a Radioactive Drug Research Committee-
approved application or an Investigational New Drug (IND) protocol accepted by FDA for use
in research.

120.545: Possession of Survey Instrument

A licensee authorized to use radioactive material for uptake, dilution, and excretion studies
shall possess a portable radiation detection survey instrument capable of detecting dose rates
over the range one microsievert (0.1 mrem) per hour to 1000 microsieverts (100 mrems) per
hour. The instrument shall be operable and calibrated in accordance with 105 CMR 120.533.

120.546: Training for Uptake, Dilution, and Excretion Studies

Except as provided in 105 CMR 120.528, the licensee shall require an authorized user of an
unsealed radioactive material for the uses authorized under 105 CMR 120.544 to be a physician
who:

(A) Is certified by a medical specialty board whose certification process has been recognized
by the Nuclear Regulatory Commission or an Agreement State and who meets the requirements
in 105 CMR 120.546(C)(2). (The names of board certifications which have been recognized by
the Nuclear Regulatory Commission or an Agreement State will be posted on the NRC's Web
page.) To have its certification process recognized, a specialty board shall require all candidates
for certification to:
(1) Complete 60 hours of training and experience in basic radionuclide handling techniques
and radiation safety applicable to the medical use of unsealed byproduct material for uptake,
dilution, and excretion studies as described in 105 CMR 120.546(C)(1)(a) through (b)6.; and
(2) Pass an examination, administered by diplomates of the specialty board, that assesses
knowledge and competence in radiation safety, radionuclide handling, and quality control;
or
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.546: continued

(B) Is an authorized user under 105 CMR 120.551 or 120.556, or equivalent Agreement State
or Nuclear Regulatory Commission requirements; or

(C) (1) Has completed 60 hours of training and experience, including a minimum of eight
hours of classroom and laboratory training, in basic radionuclide handling techniques
applicable to the medical use of unsealed radioactive material for uptake, dilution, and
excretion studies. The training and experience must include:
(a) Classroom and laboratory training in the following areas:
1. Radiation physics and instrumentation;
2. Radiation protection;
3. Mathematics pertaining to the use and measurement of radioactivity;
4. Chemistry of radioactive material for medical use; and
5. Radiation biology; and
(b) Work experience, under the supervision of an authorized user who meets the
requirements 105 CMR 120.528, 120.546,120.551 or 120.556 or equivalent Agreement
State, or Nuclear Regulatory Commission requirements, involving:
1. Ordering, receiving, and unpacking radioactive materials safely and performing
the related radiation surveys;
2. Performing quality control procedures on instruments used to determine the
activity of dosages and performing checks for proper operation of survey meters;
3. Calculating, measuring, and safely preparing patient or human research subject
dosages;
4. Using administrative controls to prevent a medical event involving the use of
unsealed radioactive material;
5. Using procedures to contain spilled radioactive material safely and using proper
decontamination procedures;
6. Administering dosages to patients or human research subjects; and
(2) Has obtained written attestation, signed by a preceptor authorized user, who meets the
requirements in 105 CMR 120.528, 120.546, 120.551 or 120.556 or equivalent Agreement
State, or Nuclear Regulatory Commission requirements, that the individual has satisfactorily
completed the requirements in 105 CMR 120.546(A)(1) or (C)(1) and has achieved a level
of competency sufficient to independently function as an authorized user for the medical uses
authorized under 105 CMR 120 544.

SPECIFIC REQUIREMENTS FOR THE USE OF UNSEALED BYPRODUCT MATERIAL

WRITTEN DIRECTIVE NOT REQUIRED

120.547: Use of Unsealed Byproduct Material for Imaging and Localization Studies for which a Written
Directive is not Required

A licensee may use, for imaging and localization studies, any radioactive material prepared
for medical use, in quantities that do not require a written directive as described in 105 CMR
120.521 that is:

(A) Obtained from:

(1) A manufacturer or preparer licensed pursuant to 105 CMR 120.128(J) or equivalent
regulations of another Agreement State, or the Nuclear Regulatory Commission;
(2) A PET radioactive drug producer licensed under 105 CMR 120.100 or equivalent
regulations of the Nuclear Regulatory Commission or equivalent Agreement State
requirements; or

(B) Excluding production PET radionuclides prepared by:

(1) An authorized nuclear pharmacist;
(2) A physician who is an authorized user and who meets the requirements specified in
105 CMR 120.551 or 120.556 and 120.551(C)(1)(b)7.; or
(3) An individual under the supervision, as specified in 105 CMR 120.519, of the
authorized nuclear pharmacist in 105 CMR 120.547(B)(1) or the physician who is an
authorized user in 105 CMR 120.547(B)(2); or
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.547: continued

(C) Obtained from and prepared by an Agency, Nuclear Regulatory Commission, Agreement
State licensee for use in research in accordance with a Radioactive Drug Research Committee-
approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or

(D) Prepared by the licensee in accordance with a Radioactive Drug Research Committee-
approved application or an Investigational New Drug (IND) protocol accepted by FDA.

(E) Provided the conditions of 105 CMR 120.542 are met, a licensee may use radioactive
aerosols or gases if specific application is made to and approved by the Agency.

120.548: Radionuclide Contaminants

(A) A licensee shall not administer to humans a radiopharmaceutical containing:

(1) more than 0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m
(0.15 :Ci of Mo-99 per mCi of Tc-99m);
(2) more than 0.02 kilobecquerel of strontium-82 per megabecquerel of rubidium-82
chloride injection (0.02 :Ci of Sr-82 per mCi of Rb-82 chloride);
(3) more than 0.2 kilobecquerel of strontium-85 per megabecquerel of rubidium-82 chloride
injection (0.2 :Ci of Sr-85 per mCi of Rb-82).

(B) To demonstrate compliance with 105 CMR 120.548(A), the licensee preparing radioactive
drugs from radionuclide generators shall:
(1) Measure the concentration of radionuclide contaminant in the first eluate after receipt
of a molybdenum-99/technetium-99m generator;
(2) Measure the concentration of radionuclide contaminant in each eluate or extract, as
appropriate for other generator systems.

(C) A licensee who must measure radionuclide contaminant concentration shall retain a record
of each measurement in accordance with 105 CMR 120.590(N).

(D) A licensee shall report immediately to the Agency each occurrence of radionuclide
contaminant concentration exceeding the limits specified in 105 CMR 120.548(A).

120.551: Training for Imaging and Localization Studies

Except as provided in 105 CMR 120.528, the licensee shall require an authorized user of
unsealed radioactive material for the uses authorized under 105 CMR 120.547 to be a physician
who:

(A) Is certified by a medical specialty board whose certification process has been recognized
by the Nuclear Regulatory Commission or an Agreement State and who meets the requirements
in 105 CMR 120.551(C)(2). (The names of board certifications which have been recognized by
the Commission or an Agreement State will be posted on the NRC's Web page.) To have its
certification process recognized, a specialty board shall require all candidates for certification
to:
(1) Complete 700 hours of training and experience in basic radionuclide handling
techniques and radiation safety applicable to the medical use of unsealed byproduct material
for imaging and localization studies as described in105 CMR 120.551(C)(1)(a) through (b)7.;
and
(2) Pass an examination, administered by diplomates of the specialty board, which assesses
knowledge and competence in radiation safety, radionuclide handling, and quality control;
or

(B) Is an authorized user under 105 CMR 120.556 and meets the requirements of 105 CMR
120.551(C)(1)(b)7., or equivalent Agreement State or Nuclear Regulatory Commission
requirements; or
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.551: continued

(C)(1) Has completed 700 hours of training and experience, including a minimum of 80
hours of classroom and laboratory training, in basic radionuclide handling techniques
applicable to the medical use of unsealed radioactive material for imaging and localization
studies; the training and experience must include, at a minimum:
(a) Classroom and laboratory training in the following areas:
1. Radiation physics and instrumentation;
2. Radiation protection;
3. Mathematics pertaining to the use and measurement of radioactivity;
4. Chemistry of radioactive material for medical use;
5. Radiation biology; and
(b) Work experience, under the supervision of an authorized user who meets the
requirements of 105 CMR 120.528, 120.551, or 120.556 and 120.551(C)(1)(b)7. or
equivalent Agreement State, or Nuclear Regulatory Commission requirements, involving:
1. Ordering, receiving, and unpacking radioactive materials safely and performing
the related radiation surveys;
2. Performing quality control procedures on instruments used to determine the
activity of dosages and performing checks for proper operation of survey meters;
3. Calculating, measuring, and safely preparing patient or human research subject
dosages;
4. Using administrative controls to prevent a medical event involving the use of
unsealed radioactive material;
5. Using procedures to contain spilled radioactive material safely and using proper
decontamination procedures;
6. Administering dosages of radioactive drugs to patients or human research
subjects;
7. Eluting generator systems appropriate for preparation of radioactive drugs for
imaging and localization studies, measuring and testing the eluate for radionuclidic
purity, and processing the eluate with reagent kits to prepare labeled radioactive
drugs; and
(2) Has obtained written attestation, signed by a preceptor authorized user, who meets the
requirements in 105 CMR 120.528, 120.551 or 120.556 and 120.551(C)(1)(b)7., or
equivalent Agreement State, or Nuclear Regulatory Commission requirements, that the
individual has satisfactorily completed the requirements in 105 CMR 120.551(A)(1) or
(C)(1) and has achieved a level of competency sufficient to independently function as an
authorized user for the medical uses authorized under 105 CMR 120.544 and 120.547.

SPECIFIC REQUIREMENTS FOR THE USE OF UNSEALED BYPRODUCT MATERIAL

WRITTEN DIRECTIVE REQUIRED

120.552: Use of Unsealed Byproduct Material for which a Written Directive is Required

A licensee may use any unsealed radioactive material for diagnostic or therapeutic medical
use for which a written directive is required that has been:

(A) Obtained from a manufacturer or preparer licensed in accordance with 105 CMR
120128(J); or

(B) Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and
who meets the requirements specified in 105 CMR 120.551 or 120.556, or an individual under
the supervision of either as specified in 105 CMR 120 519; or

(C) Obtained from and prepared by an Agency, Nuclear Regulatory Commission, or Agreement
State licensee in accordance with a Radioactive Drug Research Committee-approved protocol
or an Investigational New Drug (IND) protocol accepted by the FDA for use in research; or

(D) Prepared by the licensee in accordance with a Radioactive Drug Research Committee-
approved application or an IND protocol accepted by FDA for use in research.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.553: Safety Instruction

In addition to the requirements of 105 CMR 120.753:

(A) A licensee shall provide radiation safety instruction, initially and at least annually, to
personnel caring for patients or human research subjects who have received therapy with with
a radioactive drug, and cannot be released in accordance with 105 CMR 120.540. To satisfy the
requirement in 105 CMR 120.553(A), the instruction must be commensurate with the duties of
the personnel and include:
(1) Patient or human research subject control;
(2) Visitor control to include the following:
(a) Routine visitation to hospitalized individuals in accordance with 105 CMR
120.221(A)(1) and (C);
(b) Contamination control;
(c) Waste control; and
(d) Notification of the RSO, or his or her designee, and the authorized user if the patient
or the human research subject has a medical emergency or dies.

(B) A licensee shall retain a record of individuals receiving instruction in accordance with
105 CMR 120.590(P).

120.554: Safety Precautions

(A) For each patient or human research subject receiving radiopharmaceutical therapy and
hospitalized for compliance with 105 CMR 120.540, a licensee shall:
(1) Quarter the patient or the human research subject either in:
(a) A private room with a private sanitary facility; or
(b) A room, with a private sanitary facility, with another individual who also has
received similar radiopharmaceutical therapy and who cannot be released in accordance
with 105 CMR 120.540; and
(2) Visibly post the patient's or human research subject's door with a "Radioactive
Materials" sign and note on the door or on the patient's or human research subject's chart
where and how long visitors may stay in the patient's or human research subject's room; and
(3) Either monitor material and items removed from the patient's or human research
subject's room to determine that any contamination cannot be distinguished from the natural
background radiation level with a radiation detection survey instrument set on its most
sensitive scale and with no interposed shielding, or handle these materials and items as
radioactive waste.

(B) The Radiation Safety Officer, or his or her designee, and the authorized user shall be
notified immediately if the hospitalized patient or human research subject dies or has a medical
emergency.

120.556: Training for Use of Unsealed Byproduct Material for which a Written Directive is Required

Except as provided in 105 CMR 120.528, the licensee shall require an authorized user of
radioactive material for the uses authorized under 105 CMR 120.552 to be a physician who:

(A) Is certified by a medical specialty board whose certification process has been recognized
by the Nuclear Regulatory Commission or an Agreement State and who meets the requirements
in 105 CMR 120.556(B)(1)(b)7. and (2). (Specialty boards whose certification processes have
been recognized by the Nuclear Regulatory Commission or an Agreement State will be posted
on the NRC's Web page.) To be recognized, a specialty board shall require all candidates for
certification to:
(1) Successfully complete residency training in a radiation therapy or nuclear medicine
training program or a program in a related medical specialty. These residency training
programs must include 700 hours of training and experience as described in 105 CMR
120.556(B)(1)(a) through (b)5.. Eligible training programs must be approved by the
Residency Review Committee of the Accreditation Council for Graduate Medical Education,
the Royal College of Physicians and Surgeons of Canada, or the Committee on Post-graduate
Training of the American Osteopathic Association; and
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.556: continued

(2) Pass an examination, administered by diplomates of the specialty board, which tests
knowledge and competence in radiation safety, radionuclide handling, quality assurance, and
clinical use of unsealed byproduct material for which a written directive is required; or

(B)(1) Has completed 700 hours of training and experience, including a minimum of 200
hours of classroom and laboratory training, in basic radionuclide handling techniques
applicable to the medical use of unsealed byproduct material requiring a written directive.
The training and experience must include:
(a) Classroom and laboratory training in the following areas:
1. Radiation physics and instrumentation;
2. Radiation protection;
3. Mathematics pertaining to the use and measurement of radioactivity;
4. Chemistry of byproduct material for medical use;
5. Radiation biology; and
(b) Work experience, under the supervision of an authorized user who meets the
requirements in 105 CMR 120.528, 120.556 or equivalent Agreement State, or Nuclear
Regulatory Commission requirements. A supervising authorized user, who meets the
requirements in 105 CMR 120.556(B), must also have experience in administering
dosages in the same dosage category or categories (i.e.,105 CMR 120.556(B)(1)(b)7.) as
the individual requesting authorized user status. The work experience must involve:
1. Ordering, receiving, and unpacking radioactive materials safely and performing
the related radiation surveys;
2. Performing quality control procedures on instruments used to determine the
activity of dosages and performing checks for proper operation of survey meters;
3. Calculating, measuring, and safely preparing patient or human research subject
dosages;
4. Using administrative controls to prevent a medical event involving the use of
unsealed radioactive material;
5. Using procedures to contain spilled radioactive material safely and using proper
decontamination procedures;
7. Administering dosages of radioactive drugs to patients or human research
subjects involving a minimum of three casess in each of the following categories for
which the individual is requesting authorized user status.
a. Oral administration of less than or equal to 1.22 gigabecquerels (33
millicuries) of sodium iodide I-131, for which a written directive is required;
b. Oral administration of greater than 1.22 gigabecquerels (33 millicuries) of
sodium iodide I-131 [Note: Experience with at least three cases in category (b)
also satisfies the requirement in category (a)];
c. Parenteral administration of any beta emitter or a photon-emitting
radionuclide with a photon energy less than 150 keV, for which a written
directive is required; and/or
d. Parenteral administration of any other radionuclide for which a written
directive is required; and
(2) Has obtained written attestation that the individual has satisfactorily completed the
requirements in 105 CMR 120.556(A)(1) and (B)(1)(b)7. or 120.556(B)(1) and has achieved
a level of competency sufficient to independently function as an authorized user for the
medical uses authorized under 105 CMR 120.552. The written attestation must be signed
by a preceptor authorized user, who meets the requirements of 105 CMR 120.528, 120.556
or equivalent Nuclear Regulatory Commission or Agreement State requirements. The
preceptor authorized user, who meets the requirements of 105 CMR 120.556(B), must have
experience in administering dosages in the same dosage category or categories listed in
105 CMR 120.556(B)(1)(b)7. as the individual requesting authorized user status.

120.557: Training for the Oral Administration of Sodium Iodide I-131 in Quantities Less than or Equal to
1.22 Gigabequerels (33 millicurie) for which a Written Directive is Required

Except as provided in 105 CMR 120.528, the licensee shall require an authorized user for
the oral administration of sodium iodide I-131 in quantities less than or equal to 1.22
gigabecquerels (33 millicuries), for which a written directive is required, to be a physician who:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.557: continued

(A) Is certified by a medical specialty board whose certification process includes all of the
requirements in 105 CMR 120.557(C)(1) and (2) and whose certification has been recognized
by an Agreement State or the Nuclear Regulatory Commission and who meets the requirements
in 105 CMR 120.557(C)(3). (The names of board certifications which have been recognized by
the Commission or an Agreement State will be posted on the NRC's Web page.); or

(B) Is an authorized user under 105 CMR 120.556, for uses listed in 105 CMR
120.556(B)(1)(b)7.a. or b., and 120.558 or equivalent Agreement State or Nuclear Regulatory
Commission requirements; or

(C)(1) Has successfully completed 80 hours classroom and laboratory training, applicable to
the medical use of sodium iodide I-131 for procedures requiring a written directive; the
training must include:
(a) Radiation physics and instrumentation;
(b) Radiation protection;
(c) Mathematics pertaining to the use and measurement of radioactivity;
(d) Chemistry of radioactive material for medical use; and,
(e) Radiation biology; and
(2) Has work experience, under the supervision of an authorized user who meets the
requirements in 105 CMR 120.528, 120.556, 120.557, 120.558, or equivalent Agreement
State, or Nuclear Regulatory Commission requirements. A supervising authorized user who
meets the requirements of 105 CMR 120.556(B) must also have experience in administering
dosages as specified in 105 CMR 120.556(B)(1)(b)7.a. or b. The work experience must
involve:
(a) Ordering, receiving, and unpacking radioactive materials safely and performing the
related radiation surveys;
(b) Performing quality control procedures on instruments used to determine the activity
of dosages and performing checks for proper operation of survey meters;
(c) Calculating, measuring, and safely preparing patient or human research subject
dosages;
(d) Using administrative controls to prevent a medical event involving the use of
unsealed radioactive material;
(e) Using procedures to contain spilled byproduct material safely and using proper
decontamination procedures;
(f) Administering dosages to patients or human research subjects that includes at least
three cases involving the oral administration of less than or equal to 1.22 gigabecquerels
(33 millicuries) of sodium iodide I-131; and
(3) Has obtained written attestation that the individual has satisfactorily completed the
requirements in 105 CMR 120.557(C)(1) and (2), and has achieved a level of competency
sufficient to independently function as an authorized user for medical uses authorized under
105 CMR 120.552. The written attestation must be signed by a preceptor authorized user,
who meets the requirements of 105 CMR 120.528, 120.556, 120.557, 120.558, or equivalent
Agreement State or Nuclear Regulatory Commission requirements. A preceptor authorized
user who meets the requirements of 105 CMR 120.556(B), must also have experience in
administering dosages as specified in 105 CMR 120.556(B)(1)(b)7.a. or 105 CMR
120.556(B)(1)(b)7.b.

120.558: Training for the Oral Administration of Sodium Iodide I-131 in Quantities Greater than 1.22
Gigabequerels (33 millicurie) for which a Written Directive is Required

Except as provided in 105 CMR 120.528, the licensee shall require an authorized user for
the oral administration of sodium iodide I-131 in quantities greater than 1.22 gigabecquerels (33
millicuries), for which a written directive is required, to be a physician who:

(A) Is certified by a medical specialty board whose certification process includes all of the
requirements in 105 CMR 120.558(C)(1) and (2) and whose certification has been recognized
by an Agreement State or the Nuclear Regulatory Commission, and who meets the requirements
in 120.558(C)(3). (The names of board certifications which have been recognized by the Nuclear
Regulatory Commission or an Agreement State will be posted on the NRC's Web page.); or
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.558: continued

(B) Is an authorized user under 105 CMR 120.556, for uses listed in 105 CMR
120.556(B)(1)(b)7.b. or equivalent Agreement State, or Nuclear Regulatory Commission
requirements; or

(C)(1) Has successfully completed 80 hours classroom and laboratory training, applicable to
the medical use of sodium iodide I-131 for procedures requiring a written directive. The
training must include:
(a) Radiation physics and instrumentation;
(b) Radiation protection;
(c) Mathematics pertaining to the use and measurement of radioactivity;
(d) Chemistry of radioactive material for medical use; and,
(e) Radiation biology; and,
(2) Has work experience, under the supervision of an authorized user who meets the
requirements in 105 CMR 120.528, 120.556, or 120.558, or equivalent Agreement State, or
Nuclear Regulatory Commission requirements. A supervising authorized user who meets
the requirements of 105 CMR 120.556(B), must also have experience in administering
dosages as specified in 105 CMR 120.556(B)(1)(b)7.b.; the work experience must involve:
(a) Ordering, receiving, and unpacking radioactive materials safely and performing the
related radiation surveys;
(b) Performing quality control procedures on instruments used to determine the activity
of dosages and performing checks for proper operation of survey meters;
(c) Calculating, measuring, and safely preparing patient or human research subject
dosages;
(d) Using administrative controls to prevent a medical event involving the use of
byproduct material;
(e) Using procedures to contain spilled radioactive material safely and using proper
decontamination procedures;
(f) Administering dosages to patients or human research subjects that includes at least
three cases involving the oral administration greater than 1.22 gigabecquerels (33
millicuries) of sodium iodide I-131; and
(3) Has obtained written attestation that the individual has satisfactorily completed the
requirements in 105 CMR 120.558(C)(1) and (2), and has achieved a level of competency
sufficient to independently function as an authorized user for medical uses authorized under
105 CMR 120.552. The written attestation must be signed by a preceptor authorized user,
who meets the requirements of 105 CMR 120.528, 120.556, 120.558, or equivalent
Agreement State or Nuclear Regulatory Commission requirements. A preceptor authorized
user, who meets the requirements of 105 CMR 120.556(B), must also have experience in
administering dosages as specified in 105 CMR 120.556(B)(1)(b)7.b.

120.558A: Training for the Parenteral Administration of Unsealed Byproduct Material Requiring a Written
Directive

Except as provided in 105 CMR 120.528, the licensee shall require an authorized user for
the parenteral administration requiring a written directive, to be a physician who:

(A) Is an authorized user under 105 CMR 120.556 for uses listed in 105 CMR
120.556(B)(1)(b)7.c. or d., or equivalent Agreement State, or Nuclear Regulatory Commission
requirements; or

(B) Is an authorized user under 105 CMR 120.566, 120.587, or equivalent Agreement State, or
Nuclear Regulatory commission requirements and who meets the requirements in 105 CMR
120.558A(D); or

(C) Is certified by a medical specialty board whose certification process has been recognized
under 105 CMR 120.566 or 120.587 or by the Nuclear Regulatory Commission or an Agreement
State, and who meets the requirements in 105 CMR 120.558A(D).
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.558A: continued

(D)(1) Has successfully completed 80 hours of classroom and laboratory training, applicable
to parenteral administrations, for which a written directive is required, of any beta emitter,
or any photon-emitting radionuclide with a photon energy less than 150 keV, and/or
parenteral administration of any other radionuclide for which a written directive is required.
The training must include:
(a) Radiation physics and instrumentation;
(b) Radiation protection;
(c) Mathematics pertaining to the use and measurement of radioactivity;
(d) Chemistry of byproduct material for medical use; and,
(e) Radiation biology; and
(2) Has work experience, under the supervision of an authorized user who meets the
requirements in 105 CMR 120.528, 120.556, 120.558A, or equivalent Agreement State, or
Nuclear Regulatory Commission requirements, in the parenteral administration, for which
a written directive is required, of any beta emitter, or any photon-emitting radionuclide with
a photon energy less than 150 keV, and/or parenteral administration of any other radionuclide
for which a written directive is required. A supervising authorized user who meets the
requirements in 105 CMR 120.556 must have experience in administering dosages as
specified in 105 CMR 120.556(B)(1)(b)7.c.. and/or d. The work experience must involve:
(a) Ordering, receiving, and unpacking radioactive materials safely and performing the
related radiation surveys;
(b) Performing quality control procedures on instruments used to determine the activity
of dosages and performing checks for proper operation of survey meters;
(c) Calculating, measuring, and safely preparing patient or human research subject
dosages;
(d) Using administrative controls to prevent a medical event involving the use of
unsealed byproduct material;
(e) Using procedures to contain spilled byproduct material safely and using proper
decontamination procedures;
(f) Administering dosages to patients or human research subjects that includes at least
three cases involving the parenteral administration, for which a written directive is
required, of any beta emitter, or any photon-emitting radionuclide with a photon energy
less than 150 keV and/or at least three cases involving the parenteral administration of
any other radionuclide, for which a written directive is required; and
(3) Has obtained written attestation that the individual has satisfactorily completed the
requirements in 105 CMR 120.558A(B) or (C), and has achieved a level of competency
sufficient to function independently as an authorized user for the parenteral administration
of unsealed byproduct material requiring a written directive. The written attestation must be
signed by a preceptor authorized user who meets the requirements in 105 CMR 120.528,
120.556, 120.558A, or equivalent Agreement State, or Nuclear Regulatory Commission
requirements. A preceptor authorized user, who meets the requirements in 105 CMR 120.556
must have experience in administering dosages as specified in 105 CMR
120.556(B)(1)(b)7.c. and/or d.

MANUAL BRACHYTHERAPY

120.559: Use of Sealed Sources for Manual Brachytherapy

A licensee shall use only brachytherapy sources for therapeutic medical uses:

(A) As approved in the Sealed Source and Device Registry; or

(B) In research in accordance with an effective Investigational Device Exemption (IDE)

application accepted by the FDA provided the requirements of 105 CMR 120.523(A) are met.

120.560: Surveys After Source Implant and Removal

(A) Immediately after implanting sources in a patient or a human research subject, the licensee
shall perform a survey to locate and account for all sources that have not been implanted.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.560: continued

(B) Immediately after removing the last temporary implant source from a patient or a human
research subject, the licensee shall make a survey of the patient or the human research subject
with a radiation detection survey instrument to confirm that all sources have been removed.

(C) A licensee shall retain a record of the surveys in accordance with 105 CMR 120.590(Q).

120.561: Brachytherapy Sources Accountability

(A) A licensee shall maintain accountability at all times for all brachytherapy sources in storage
or use.

(B) Promptly after removing sources from a patient or a human research subject, a licensee shall
return brachytherapy sources to a secure storage area.

(C) A licensee shall maintain a record of the brachytherapy source accountability in accordance
with 105 CMR 120.592(A).

120.562: Safety Instruction

In addition to the requirements of 105 CMR 120.753:

(A) The licensee shall provide radiation safety instruction, initially and at least annually, to
personnel caring for patients or human research subject that are undergoing brachytherapy and
cannot be released in accordance with 105 CMR 120 540. Instruction must be commensurate
with the duties of the personnel and shall include the following:
(1) Size and appearance of the brachytherapy sources;
(2) Safe handling and shielding instructions;
(3) Patient or human research subject control;
(4) Visitor control, including both;
(a) Routine visitation of hospitalized individuals in accordance with 105 CMR
120.221(A)(1);
(b) Visitation authorized in accordance with 105 CMR 120.221(C); and
(5) Notification of the Radiation Safety Officer, or his or her designee, and an authorized
user if the patient or human research subject dies or has a medical emergency.
(6) A licensee shall retain a record of individuals receiving instruction in accordance with
105 CMR 120.590(P).

120.563: Safety Precautions for Patients or Human Research Subjects Receiving Brachytherapy

(A) For each patient or human research subject receiving brachytherapy and cannot be released
in accordance with 105 CMR 120.540, a licensee shall:
(1) Not place the patient or human research subject in the same room as an individual who
is not receiving brachytherapy;
(2) Visibly post the patient's or human research subject's door with a "Radioactive
Materials" sign and note on the door or the patient's or human research subject's chart where
and how long visitors may stay in the patient's or human research subject's room.

(B) A licensee shall have emergency response equipment available near each treatment room
to respond to a source that inadvertently becomes:
(1) Dislodged from the patient; or
(2) Lodged within the patient following removal of the source applicators.

(C) The Radiation Safety Officer, or his or her designee, and the authorized user shall be
notified immediately if the hospitalized patient or human research subject dies or has a medical
emergency.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.564: Calibration Measurement of Brachytherapy Sealed Sources

(A) Prior to the first medical use of a brachytherapy sealed source on or after October 6, 2006,
a licensee shall perform the following:
(1) Determine the source output or activity using a dosimetry system that meets the
requirements of 105 CMR 120.575(A);
(2) Determine source positioning accuracy within applicators; and
(3) Use published protocols accepted by nationally recognized bodies to meet the
requirements of 105 CMR 120.564(A)(1) and (2).

(B) A licensee may use measurements provided by the source manufacturer [or by a calibration
laboratory accredited by the American Association of Physicists in Medicine] that are made in
accordance with 105 CMR 120.564(A).

(C) A licensee shall mathematically correct the outputs or activities determined in 105 CMR
120.564(A) for physical decay at intervals consistent with 1.0% physical decay.

(D) An authorized medical physicist shall perform or review the calculation measurements
made pursuant to 105 CMR 120.564(A), (B), or (C).

(E) Only an authorized medical physicist shall calculate the activity of each strontium-90 source
that is used to determine the treatment times for ophthalmic treatments. The decay must be
based on the activity determined in accordance with paragraphs 105 CMR 120.564(A) through
(C).

(F) A licensee shall retain a record of each calibration in accordance with 105 CMR
120.592(B).

(G) A licensee shall retain a record of decay calculations required by 105 CMR 120.564(E) in
accordance with 105 CMR 120.592(C).

120.565: Therapy-related Computer Systems

The licensee shall perform acceptance testing on the treatment planning system in accordance
with published protocols accepted by nationally recognized bodies. At a minimum, the
acceptance testing must include, as applicable, verification of:

(A) The source-specific input parameters required by the dose calculation algorithm;

(B) The accuracy of dose, dwell time, and treatment time calculations at representative points.
The licensee shall perform regular quality assurance testing on the treatment planning computer.
Said testing shall be in accordance with TG40 or current AAPM recommendation.

(C) The accuracy of isodose plots and graphic displays; and

(D) The accuracy of the software used to determine radioactive source positions from
radiographic images.

120.566: Training for Use of Manual Brachytherapy Sources

Except as provided in 105 CMR 120.528, the licensee shall require an authorized user of a
manual brachytherapy source for the uses authorized under 105 CMR 120.559 to be a physician
who:

(A) Is certified by a medical specialty board whose certification process has been recognized
by an Agreement State or the Nuclear Regulatory Commission, and who meets the requirements
in 105 CMR 120.566(B)(3) (The names of board certifications which have been recognized by
the Commission or an Agreement State will be posted on the NRC's Web page.) To have its
certification process recognized, a specialty board shall require all candidates for certification
to:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.566: continued

(1) Successfully complete a minimum of three years of residency training in a radiation

oncology program approved by the Residency Review Committee of the Accreditation
Council for Graduate Medical Education or the Royal College of Physicians and Surgeons
of Canada or the Committee on Post-Graduate Training of the American Osteopathic
Association; and
(2) Pass an examination, administered by diplomates of the specialty board, that tests
knowledge and competence in radiation safety, radionuclide handling, treatment planning,
quality assurance, and clinical use of manual brachytherapy; or

(B) (1) Has completed a structured educational program in basic radionuclide handling
techniques applicable to the use of manual brachytherapy sources that includes:
(a) 200 hours of classroom and laboratory training in the following areas:
1. Radiation physics and instrumentation;
2. Radiation protection;
3. Mathematics pertaining to the use and measurement of radioactivity; and,
4. Radiation biology; and
(b) 500 hours work experience, under the supervision of an authorized user who meets
the requirements in 105 CMR 120.528, 120.566 or equivalent Agreement State, or
Nuclear Regulatory Commission requirements at a medical institution, involving:
1. Ordering, receiving, and unpacking radioactive materials safely and performing the
related radiation surveys;
2. Checking survey meters for proper operation;
3. Preparing, implanting, and removing brachytherapy sources;
4. Maintaining running inventories of material on hand;
5. Using administrative controls to prevent a medical event involving the use of
byproduct material;
6. Using emergency procedures to control byproduct material; and
(2) Has completed three years of supervised clinical experience in radiation oncology, under
an authorized user who meets the requirements in 105 CMR 120.528, 120.566 or equivalent
Agreement State or Nuclear Regulatory Commission requirements, as part of a formal
training program approved by the Residency Review Committee for Radiation Oncology of
the Accreditation Council for Graduate Medical Education or the Royal College of
Physicians and Surgeons of Canada or the Committee on Postdoctoral Training of the
American Osteopathic Association. This experience may be obtained concurrently with the
supervised work experience required by 105 CMR 120.566(B)(1)(b); and
(3) Has obtained written attestation, signed by a preceptor authorized user, who meets the
requirements in 105 CMR 120.528, 120.566 or equivalent Agreement State or Nuclear
Regulatory Commission requirements, that the individual has satisfactorily completed the
requirements in 105 CMR 120.566(A)(1), or (B)(1) and (2) and has achieved a level of
competency sufficient to independently function as an authorized user of manual
brachytherapy sources for the medical uses authorized under 105 CMR 120.559.

120.567: Training for Ophthalmic Use of Strontium-90

Except as provided in 105 CMR 120.528, the licensee shall require an authorized user of a
strontium-90 source for ophthalmic uses authorized under 105 CMR 120.559 to be a physician
who:

(A) Is an authorized user under 105 CMR 120.566 or equivalent Agreement State or Nuclear
Regulatory Commission requirements; or

(B)(1) Has completed 24 hours of classroom and laboratory training applicable to the medical
use of strontium-90 for ophthalmic radiotherapy. The training must include:
(a) Radiation physics and instrumentation;
(b) Radiation protection;
(c) Mathematics pertaining to the use and measurement of radioactivity;
(d) Radiation biology; and
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.567: continued

(2) Supervised clinical training in ophthalmic radiotherapy under the supervision of an

authorized user who meets the requirements in 105 CMR 120.566 or 120.567, and that
includes the use of strontium-90 for ophthalmic treatment of five individuals that includes:
(a) Examination of each individual to be treated;
(b) Calculation of the dose to be administered;
(c) Administration of the dose;
(d) Follow-up and review of each individual’s case history; and
(3) Has obtained written attestation, signed by a preceptor authorized user, who meets the
requirements in 105 CMR 120.528, 120.566, 120.567 or equivalent Agreement State or
Nuclear Regulatory Commission requirements, that the individual has satisfactorily
completed the requirements in 105 CMR 120.567(B) and has achieved a level of competency
sufficient to independently function as an authorized user of strontium-90 for ophthalmic use.

SEALED SOURCES FOR DIAGNOSIS

120.568: Sealed Sources for Diagnosis

A licensee shall use only sealed source for diagnostic medical uses.

(A) Approved in the Sealed Source and Device Registry; and

(B) Handled in accordance with the manufacturer’s radiation safety instructions.

120.569: Training for Use of Sealed Sources for Diagnosis

Except as provided in 105 CMR 120.528, the licensee shall require an authorized user of a
diagnostic sealed source for use in a device authorized under 105 CMR 120.568 to be a
physician, dentist, or podiatrist who:

(A) Is certified by a medical specialty board whose certification process includes all of the
requirements in 105 CMR 120.569(B) and (C) and whose certification has been recognized by
an Agreement State or the Nuclear Regulatory Commission. (The names of board certifications
which have been recognized by the Commission or an Agreement State will be posted on the
NRC's Web page.); or

(B) Has completed eight hours of classroom and laboratory training in basic radionuclide
handling techniques specifically applicable to the use of the device that includes:
(1) Radiation physics and instrumentation;
(2) Radiation protection;
(3) Mathematics pertaining to the use and measurement of radioactivity; and,
(4) Radiation biology; and,

(C) Has completed training in the use of the device for the uses requested.

PHOTON EMITTING REMOTE AFTERLOADER UNITS,

TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS

120.570: Use of Sealed Sources in a Remote Afterloader Unit, Teletherapy Unit, or Gamma Stereotactic
Radiosurgery Unit

A licensee shall use sealed sources in photon emitting remote afterloader units, teletherapy
units, or gamma stereotactic units for therapeutic medical uses:

(A) As approved in the Sealed Source and Device Registry; or

(B) In research in accordance with an effective Investigational Device Exemption (IDE)

application accepted by the FDA provided the requirements of 105 CMR 120.523(A) are met.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.571: Surveys of Patients and Human Research Subjects Treated with Remote Afterloader Unit

(A) Before releasing a patient or a human research subject from licensee control, a licensee
shall survey the patient or the human research subject and the remote afterloader unit with a
portable radiation detection survey instrument to confirm that the source(s) has been removed
from the patient or human research subject and returned to the safe, shielded position.

(B) A licensee shall retain a record of the surveys in accordance with 105 CMR 120.590(Q).

120.572: Installation, Maintenance, Adjustment, and Repair

(A) Only a person specifically licensed by the Agency, the U.S. Nuclear Regulatory
Commission, or an Agreement State shall install, maintain, adjust, or repair a remote afterloader
unit, teletherapy unit, or gamma stereotactic radiosurgery unit that involves work on the source(s)
shielding, the source(s) drive unit, or other electronic or mechanical component that could
expose the source(s), reduce the shielding around the source(s), or compromise the radiation
safety of the unit or the source(s).

(B) Except for low dose-rate remote afterloader units, only a person specifically licensed by the
Agency, an Agreement State, or the Nuclear Regulatory Commission shall install, replace,
relocate, or remove a sealed source or source contained in other remote afterloader units,
teletherapy units, or gamma stereotactic radiosurgery units.

(C) For a low dose-rate remote afterloader unit, only a person specifically licensed by the
Agency, an Agreement State, or the Nuclear Regulatory Commission, or an authorized medical
physicist shall install, replace, relocate, or remove a sealed source(s) contained in the unit.

(D) A licensee shall retain a record of the installation, maintenance, adjustment and repair done
on remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units in
accordance with 105 CMR 120.592(D).

120.573: Safety Procedures and Instructions for Remote Afterloader Units, Teletherapy Units, and Gamma
Stereotactic Radiosurgery Units

(A) A licensee shall:

(1) Secure the unit, the console, the console keys, and the treatment room when not in use
or is unattended;
(2) Permit only individuals approved by authorized user, Radiation Safety Officer, or
authorized medical physicist to be present in the treatment room during treatment with the
source(s);
(3) Prevent dual operation of more than one radiation producing device in a treatment room,
if applicable; and
(4) Develop, implement, and maintain written procedures for responding to an abnormal
situation when the operator is unable to place the source(s) in the shielded position, or
remove the patient or human research subject from the radiation field with controls from
outside the treatment room. This procedure must include:
(a) Instructions for responding to equipment failures and the names of the individuals
responsible for implementing corrective actions;
(b) The process for restricting access to and posting of the treatment area to minimize
the risk of inadvertent exposure; and
(c) The names and telephone numbers of the authorized users, the authorized medical
physicist, and the Radiation Safety Officer to be contacted if the unit or console operates
abnormally.

(B) A copy of the procedures required by 105 CMR 120 573(A)(4) must be physically located
at the unit console.

(C) A licensee shall post instructions at the unit console to inform the operator of:
(1) The location of the procedures required by 105 CMR 120 573(A)(4); and
(2) The names and telephone numbers of the authorized users, the authorized medical
physicist, and the Radiation Safety Officer to be contacted if the unit or console operates
abnormally.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.573: continued

(D) A licensee shall provide instruction, initially and at least annually, to all individuals who
operate the unit, as appropriate to the individual'’s assigned duties, in:
(1) The procedures identified in 105 CMR 120 573(A)(4); and
(2) the operating procedures for the unit.

(E) A licensee shall ensure that operators, authorized medical physicists, and authorized users
participate in drills of the emergency procedures, initially and at least annually.

(F) A licensee shall retain a record of individuals receiving instruction required by 105 CMR
120.573(D), in accordance with 105 CMR 120.590(P).

120.574: Safety Precautions for Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic
Radiosurgery Units

(A) A licensee shall control access to the treatment room by a door at each entrance.

(B) A licensee shall equip each entrance to the treatment room with an electrical interlock
system that will:
(1) Prevent the operator from initiating the treatment cycle unless each treatment room
entrance door is closed;
(2) Cause the source(s) to be shielded promptly when an entrance door is opened; and
(3) Prevent the source(s) from being exposed following an interlock interruption until all
treatment room entrance doors are closed and the source(s) on-off control is reset at the
console.

(C) A licensee shall require any individual entering the treatment room to assure, through the
use of appropriate radiation monitors, that radiation levels have returned to ambient levels.

(D) Except for low-dose remote afterloader units, a licensee shall construct or equip each
treatment room with viewing and intercom systems to permit continuous observation of the
patient or the human research subject from the treatment console during irradiation.

(E) For licensed activities where sources are placed within the patient's or human research
subject's body, a licensee shall only conduct treatments which allow for expeditious removal of
a decoupled or jammed source.

(F) In addition to the requirements specified in 105 CMR 120.574(A) through (E), a licensee
shall:
(1) For low dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader units,
require:
(a) An authorized medical physicist and either an authorized user or a physician, under
the supervision of an authorized user, who has been trained in the operation and
emergency response for the unit to be physically present during the initiation of all
patient treatments involving the unit; and,
(b) An authorized medical physicist and either an authorized user or an individual,
under the supervision of an authorized user, who has been trained to remove the source
applicator(s) in the event of an emergency involving the unit, to be immediately available
during continuation of all patient treatments involving the unit.
(2) For high dose-rate remote afterloader units, require:
(a) An authorized user and an authorized medical physicist to be physically present
during the initiation of all patient treatments involving the unit; and
(b) An authorized medical physicist and either an authorized user or a physician, under
the supervision of an authorized user, who has been trained in the operation and
emergency response for the unit, to be physically present during continuation of all
patient treatments involving the unit.
(3) For gamma stereotactic radiosurgery units, require an authorized user and an authorized
medical physicist to be physically present throughout all patient treatments involving the
unit.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.574: continued

(4) Notify the Radiation Safety Officer, or his or her designee, and an authorized user as
soon as possible, if the patient or human research subject has a medical emergency and,
immediately, if the patient dies.

(G) A licensee shall have emergency response equipment available near each treatment room,
to respond to a source that inadvertently:
(1) Remains in the unshielded position; or
(2) Lodges within the patient following completion of the treatment.

120.575: Dosimetry Equipment

(A) Except for low dose-rate remote afterloader sources where the source output or activity is
determined by the manufacturer, a licensee shall have a calibrated dosimetry system available
for use. To satisfy this requirement, one of the following two conditions must be met.
(1) The system must have been calibrated using a system or source traceable to the National
Institute of Standards and Technology (NIST) and published protocols accepted by nationally
recognized bodies; or by a calibration laboratory accredited by the American Association of
Physicists in Medicine (AAPM). The calibration must have been performed within the
previous two years and after any servicing that may have affected system calibration; or
(2) The system must have been calibrated within the previous four years; 18 to 30 months
after that calibration, the system must have been intercompared with another dosimetry
system that was calibrated within the past 24 months by NIST or by a calibration laboratory
accredited by the AAPM. The results of the intercomparison must have indicated that the
calibration factor of the licensee's system had not changed by more than 2%. The licensee
may not use the intercomparison result to change the calibration factor. When
intercomparing dosimetry systems to be used for calibrating sealed sources for therapeutic
units, the licensee shall use a comparable unit with beam attenuators or collimators, as
applicable, and sources of the same radionuclide as the source used at the licensee's facility.

(B) The licensee shall have available for use a dosimetry system for spot-check output
measurements, if applicable. To satisfy this requirement, the system may be compared with a
system that has been calibrated in accordance with 105 CMR 120.575(A). This comparison must
have been performed within the previous year and after each servicing that may have affected
system calibration. The spot-check system may be the same system used to meet the requirement
in 105 CMR 120.575(A).

(C) The licensee shall retain a record of each calibration, intercomparison, and comparison in
accordance with 105 CMR 120.592(E).

120.576: Full Calibration Measurements on Teletherapy Units

(A) A licensee authorized to use a teletherapy unit for medical use shall perform full calibration
measurements on each teletherapy unit:
(1) Before the first medical use of the unit; and
(2) Before medical use under the following conditions:
(a) Whenever spot-check measurements indicate that the output differs by more than 5%
from the output obtained at the last full calibration corrected mathematically for
radioactive decay;
(b) Following replacement of the source or following reinstallation of the teletherapy
unit in a new location; and,
(c) Following any repair of the teletherapy unit that includes removal of the source or
major repair of the components associated with the source exposure assembly; and,
(3) At intervals not exceeding one year.

(B) To satisfy the requirement of 105 CMR 120.576(A), full calibration measurements shall
include determination of:
(1) The output within 3% for the range of field sizes and for the distance or range of
distances used for medical use;
(2) The coincidence of the radiation field and the field indicated by the light beam localizing
device;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.576: continued

(3) The uniformity of the radiation field and its dependence on the orientation of the useful
beam;
(4) Timer accuracy;
(5) "On-off" error; and,
(6) The accuracy of all distance measuring and localization devices in medical use.

(C) A licensee shall use the dosimetry system described in 105 CMR 120.575(A) to measure
the output for one set of exposure conditions. The remaining radiation measurements required
in 105 CMR 120.576(B)(1) may then be made using a dosimetry system that indicates relative
dose rates.

(D) A licensee shall make full calibration measurements required by 105 CMR 120.576(A) in
accordance with published protocols accepted by nationally recognized bodies.

(E) A licensee shall correct mathematically the outputs determined in 105 CMR 120.576(B)(1)
for physical decay for intervals not exceeding one month for cobalt-60 and intervals not
exceeding six months for cesium-137, or at intervals consistent with 1% decay for all other
nuclides.

(F) Full calibration measurements required by 105 CMR 120.576(A) and physical decay
corrections required by 105 CMR 120.576(E) shall be performed by the authorized medical
physicist.

(G) A licensee shall retain a record of each calibration in accordance with 105 CMR
120.592(F).

120.577: Full Calibration Measurements on Remote Afterloader Units

(A) A licensee authorized to use a remote afterloader unit for medical use shall perform full
calibration measurements on each unit:
(1) Before the first medical use of the unit; and
(2) Before medical use under the following conditions:
(a) Following replacement of the source or following reinstallation of the unit in a new
location outside the facility; and
(b) Following any repair of the unit that includes removal of the source or major repair
of the components associated with the source exposure assembly; and
(3) At intervals not exceeding one quarter for high dose-rate, medium dose-rate, and pulsed
dose-rate remote afterloader units with sources whose half-life exceeds 75 days; and
(4) At intervals not exceeding one year for low dose-rate remote afterloader units.

(B) To satisfy the requirement of 105 CMR 120.577(A), full calibration measurements shall
include, as applicable, determination of:
(1) the output within +/- 5%;
(2) Source position accuracy to within +/- 1 millimeter;
(3) Source retraction with backup battery upon power failure;
(4) Length of the source transfer tubes;
(5) Timer accuracy and linearity over the typical range of use;
(6) Length of applicators; and
(7) Function of the source transfer tubes, applicators, and transfer tube-applicator interfaces.

(C) In addition to the requirements for full calibrations for low dose-rate remote afterloader
units in 105 CMR 120.577(B), a licensee shall perform an autoradiograph of the source(s) to
verify inventory and source(s) arrangement at intervals not exceeding one quarter.

(D) A licensee shall use the dosimetry system described in 105 CMR 120.575(A) to measure
the output.

(E) A licensee shall make full calibration measurements required by 105 CMR 120.577(A) in
accordance with published protocols accepted by nationally recognized bodies.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.577: continued

(F) For low dose-rate remote afterloader units, a licensee may use measurements provided by
the source manufacturer that are made in accordance with 105 CMR 120.577(A) through (E).

(G) A licensee shall mathematically correct the outputs determined in 105 CMR 120.577(B)(1)
for physical decay at intervals consistent with 1% physical decay.

(H) Full calibration measurements required by 105 CMR 120.577(A) and physical decay
corrections required by 105 CMR 120.577(G) must be performed by the authorized medical
physicist.

(I) A licensee shall retain a record of each calibration in accordance with 105 CMR 120.592(F).

120.578: Full Calibration Measurements on Gamma Stereotactic Radiosurgery Units

(A) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall
perform full calibration measurements on each unit:
(1) Before the first medical use of the unit; and
(2) Before medical use under the following conditions:
(a) Whenever spot-check measurements indicate that the output differs by more than 5%
from the output obtained at the last full calibration corrected mathematically for
radioactive decay;
(b) Following replacement of the sources or following reinstallation of the gamma
stereotactic radiosurgery unit in a new location; and,
(c) Following any repair of the gamma stereotactic radiosurgery unit that includes
removal of the sources or major repair of the components associated with the source
assembly; and,
(3) At intervals not exceeding one year, with the exception that relative helmet factors need
only be determined before the first medical use of a helmet and following any damage to a
helmet.

(B) To satisfy the requirement of 105 CMR 120.578(A), full calibration measurements shall
include determination of:
(1) The output within ± 3%;
(2) Relative helmet factors;
(3) Isocenter coincidence;
(4) Timer accuracy and linearity over the range of use;
(5) On-off error;
(6) Trunnion centricity;
(7) Treatment table retraction mechanism, using backup battery power or hydraulic backups
with the unit off;
(8) Helmet microswitchs;
(9) Emergency timing circuits; and,
(10) Stereotactic frames and localizing devices (trunnions).

(C) A licensee shall use the dosimetry system described in 105 CMR 120.575(A) to measure
the output for one set of exposure conditions. The remaining radiation measurements required
in 105 CMR 120.578(B)(1) may be made using a dosimetry system that indicates relative dose
rates.

(D) A licensee shall make full calibration measurements required by 105 CMR 120.578(A) in
accordance with published protocols accepted by nationally recognized bodies.

(E) A licensee shall mathematically correct the outputs determined in 105 CMR 120.578(B)(1)
at intervals not exceeding one month for cobalt-60 and at intervals consistent with 1% physical
decay for all other radionuclides.

(F) Full calibration measurements required by 105 CMR 120.578(A) and physical decay
corrections required by 105 CMR 120.578(E) must be performed by the authorized medical
physicist.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.578: continued

(G) A licensee shall retain a record of each calibration in accordance with 105 CMR
120.592(F).

120.579: Periodic Spot-checks for Teletherapy Units

(A) A licensee authorized to use teletherapy units for medical use shall perform output
spot-checks on each teletherapy unit once in each calendar month that include determination of:
(1) Timer accuracy, and timer linearity over the range of use;
(2) "On-off" error;
(3) The coincidence of the radiation field and the field indicated by the light beam localizing
device;
(4) The accuracy of all distance measuring and localization devices used for medical use;
(5) The output for one typical set of operating conditions measured with the dosimetry
system described in 105 CMR 120.575(B); and
(6) The difference between the measurement made in 105 CMR 120.579(A)(5) and the
anticipated output, expressed as a percentage of the anticipated output (i.e., the value
obtained at last full calibration corrected mathematically for physical decay).

(B) A licensee shall perform measurements required by 105 CMR 120.579(A) in accordance
with procedures established by the authorized medical physicist. That individual need not
actually perform the output spot-check measurements.

(C) A licensee shall have the authorized medical physicist review the results of each output
spot-check within 15 days. The authorized medical physicist shall promptly notify the licensee
in writing of the results of each output spot-check.

(D) A licensee authorized to use a teletherapy unit for medical use shall perform safety
spot-checks of each teletherapy facility once in each calendar month and after each source
installation to assure proper operation of:
(1) Electrical interlocks at each teletherapy room entrance;
(2) Electrical or mechanical stops installed for the purpose of limiting use of the primary
beam of radiation restriction of source housing angulation or elevation, carriage or stand
travel, and operation of the beam "on-off" mechanism;
(3) Source exposure indicator lights on the teletherapy unit, on the control console, and in
the facility;
(4) Viewing and intercom systems;
(5) Treatment room doors from inside and outside the treatment room; and,
(6) Electrically assisted treatment room doors with the teletherapy unit electrical power
turned "off".

(E) If the results of the checks required in 105 CMR 120.579(D) indicate the malfunction of any
system, a licensee shall lock the control console in the off position and not use the unit except
as may be necessary to repair, replace, or check the malfunctioning system.

(F) A licensee shall retain a record of each spot-check required by 105 CMR 120.579(A) and
(D), in accordance with 105 CMR 120.592(G).

120.580: Periodic Spot-checks for Remote Afterloader Units

(A) A licensee authorized to use remote afterloader units for medical use shall perform
spot-checks on each remote afterloader facility and on each unit:
(1) At the beginning of each day of use of a high dose-rate, medium dose-rate or pulsed
dose-rate remote afterloader unit;
(2) Prior to each patient treatment with a low dose-rate remote afterloader unit; and
(3) After each source installation.

(B) A licensee shall have the authorized medical physicist establish written procedures for
performing the spot-checks required in 105 CMR 120.580(A). The authorized medical physicist
need not actually perform the spot-check measurements.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.580: continued

(C) A licensee shall have the authorized medical physicist review the results of each output
spot-check within 15 days. The authorized medical physicist shall promptly notify the licensee
in writing of the results of each output spot-check.

(D) To satisfy the requirement of 105 CMR 120.580(A), spot-checks must, at a minimum,
assure proper operation of:
(1) Electrical interlocks at each remote afterloader unit room entrance;
(2) Source exposure indicator lights on the remote afterloader unit, on the control console,
and in the facility;
(3) Viewing and intercom systems in each high dose-rate, medium dose-rate and pulsed
dose-rate remote afterloader facility;
(4) Emergency response equipment;
(5) Radiation monitors used to indicate the source position;
(6) Timer accuracy;
(7) Clock (date and time) in the unit's computer; and
(8) Decayed source(s) activity in the unit's computer.

(E) If the results of the checks required in 105 CMR 120.580(D) indicate the malfunction of any
system, a licensee shall lock the control console in the off position and not use the unit except
as may be necessary to repair, replace, or check the malfunctioning system.

(F) A licensee shall retain a record of each spot-check required by 105 CMR 120.580(D), in
accordance with 105 CMR 120.592(H).

120.581: Periodic Spot-checks for Gamma Stereotactic Radiosurgery Units

(A) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall
perform spot-checks on each gamma stereotactic radiosurgery facility and on each unit:
(1) Monthly;
(2) At the beginning of each day of use; and
(3) After each source installation.

(B) A licensee shall have the authorized medical physicist:

(1) Establish written procedures for performing the spot-checks required in 105 CMR
120.581(A); and
(2) Review the results of each spot-check required by 105 CMR 120.581(A)(1) within 15
days of the check. The authorized medical physicist need not actually perform the spot-check
measurements. The authorized medical physicist shall notify the licensee as soon as
possible, in writing, of the results of the spot check.

(C) To satisfy the requirement of 105 CMR 120.581(A)(1), spot-checks must, at a minimum:
(1) Assure proper operation of:
(a) Treatment table retraction mechanism, using backup battery power or hydraulic
backups with the unit off;
(b) Helmet microswitchs;
(c) Emergency timing circuits; and
(d) Stereotactic frames and localizing devices (trunnions).
(2) Determine:
(a) The output for one typical set of operating conditions measured with the dosimetry
system described in 105 CMR 120.575(B);
(b) The difference between the measurement made in 105 CMR 120.581(C)(2)(a) and
the anticipated output, expressed as a percentage of the anticipated output (i.e., the value
obtained at last full calibration corrected mathematically for physical decay);
(c) Source output against computer calculation;
(d) Timer accuracy and linearity over the range of use;
(e) On-off error; and
(f) Trunnion centricity.

(D) To satisfy the requirements of 105 CMR 120.581(A)(2) and (3), spot-checks must assure
proper operation of:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.581: continued

(1) Electrical interlocks at each gamma stereotactic radiosurgery room entrance

(2) Source exposure indicator lights on the gamma stereotactic radiosurgery unit, on the
control console, and in the facility;
(3) Viewing and intercom systems;
(4) Timer termination;
(5) Radiation monitors used to indicate room exposure; and,
(6) Emergency off buttons.

(E) A licensee shall arrange for prompt repair of any system identified in 105 CMR 120.581(C)
that is not operating properly.

(F) If the results of the checks required in 105 CMR 120.581(D) indicate the malfunction of any
system, a licensee shall lock the control console in the off position and not use the unit except
as may be necessary to repair, replace, or check the malfunctioning system.

(G) A licensee shall retain a record of each check required by 105 CMR 120.581(C) and (D)
in accordance with 105 CMR 120.592(I).

120.582: Additional Technical Requirements for Mobile Remote Afterloader Units

(A) A licensee providing mobile remote afterloader service shall:

(1) Check survey instruments for consistent response before medical use at each address of
use or on each day of use, whichever is more frequent; and
(2) Account for all sources before departure from a client’s address of use.

(B) In addition to the periodic spot-checks required by 105 CMR 120.580, a licensee authorized
to use mobile afterloaders for medical use shall perform checks on each remote afterloader unit
before use at each address of use. At a minimum, checks must be made to verify the operation
of:
(1) Electrical interlocks on treatment area access points;
(2) Source exposure indicator lights on the remote afterloader unit, on the control console,
and in the facility;
(3) Viewing and intercom systems;
(4) Applicators, source transfer tubes, and transfer tube-applicator interfaces;
(5) Radiation monitors used to indicate room exposures;
(6) Source positioning (accuracy); and
(7) Radiation monitors used to indicate whether the source has returned to a safe shielded
position.

(C) In addition to the requirements for checks in 105 CMR 120.582(B), a licensee shall ensure
overall proper operation of the remote afterloader unit by conducting a simulated cycle of
treatment before use at each address of use.

(D) If the results of the checks required in 105 CMR 120.582(B) indicate the malfunction of
any system, a licensee shall lock the control console in the off position and not use the unit
except as may be necessary to repair, replace, or check the malfunctioning system.

(E) A licensee shall retain a record of each check required by 105 CMR 120.582(B) in
accordance with 105 CMR 120.592(J).

120.583: Radiation Surveys

(A) In addition to the survey requirements in 105 CMR 120.225, a person licensed pursuant to
105 CMR 120.500 shall make surveys to ensure that the maximum radiation levels and average
radiation levels from the surface of the main source safe with the source(s) in the shielded
position does not exceed the levels stated in the Sealed Source and Device Registry.

(B) The licensee shall make the survey required by 105 CMR 120.583(A) at installation of a
new source and following repairs to the source(s) shielding, the source(s) driving unit, or other
electronic or mechanical component that could expose the source, reduce the shielding around
the source(s), or compromise the radiation safety of the unit or the source(s).
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.583: continued

(C) A licensee shall retain a record of the radiation surveys required in 105 CMR 120.583(A)
in accordance with 105 CMR 120.592(K).

120.584: Five Year Inspection for Teletherapy and Gamma Stereotactic Radiosurgery Units

(A) A licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully
inspected and serviced during teletherapy source replacement or at intervals not to exceed five
years, whichever comes first, to assure proper functioning of the source exposure mechanism.

(B) This inspection and servicing may only be performed by persons specifically licensed to do
so by the Agency, an Agreement State, or the U.S. Nuclear Regulatory Commission.

(C) A licensee shall maintain a record of the inspection and servicing in accordance with
105 CMR 120.592(L).

120.585: Therapy-related Computer Systems

The licensee shall perform acceptance testing on the treatment planning system in accordance
with published protocols accepted by nationally recognized bodies. At a minimum, the
acceptance testing must include, as applicable, verification of:

(A) The source-specific input parameters required by the dose calculation algorithm;

(B) The accuracy of dose, dwell time, and treatment time calculations at representative points.
The licensee shall perform regular quality assurance testing on the treatment planning computer.
Said testing shall be in accordance with TG40 or current AAPM recommendation.

(C) The accuracy of isodose plots and graphic displays;

(D) The accuracy of the software used to determine radioactive source positions from
radiographic images; and

(E) The accuracy of electronic transfer of the treatment delivery parameters to the treatment
delivery unit from the treatment planning system.

120.587: Training for Use of Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic
Radiosurgery Units

Except as provided in 105 CMR 120.528, the licensee shall require an authorized user of a
sealed source for a use authorized under 105 CMR 120.570 to be a physician who:

(A) Is certified by a medical specialty board whose certification process has been recognized
by an Agreement State or the Nuclear Regulatory Commission and who meets the requirements
in 105 CMR 120.587(B)(3) and (C). (The names of board certifications which have been
recognized by the Commission or an Agreement State will be posted on the NRC's web page.)
To have its certification process recognized, a specialty board shall require all candidates for
certification to:
(1) Successfully complete a minimum of three years of residency training in a radiation
therapy program approved by the Residency Review Committee of the Accreditation Council
for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada
or the Committee on Post-graduate Training of the American Osteopathic Association; and
(2) Pass an examination, administered by diplomates of the specialty board, which tests
knowledge and competence in radiation safety, radionuclide handling, treatment planning,
quality assurance, and clinical use of stereotactic radiosurgery, remote afterloaders and
external beam therapy; or

(B) (1) Has completed a structured educational program in basic radionuclide techniques
applicable to the use of a sealed source in a therapeutic medical unit that includes:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.587: continued

(a) 200 hours of classroom and laboratory training in the following areas:
1. Radiation physics and instrumentation;
2. Radiation protection;
3. Mathematics pertaining to the use and measurement of radioactivity;
4. Radiation biology; and
(b) 500 hours of work experience, under the supervision of an authorized user who
meets the requirements in 105 CMR 120.528, 120.587 or equivalent Agreement State or
Nuclear Regulatory Commission requirements at a medical institution, involving:
1. Reviewing full calibration measurements and periodic spot checks;
2. Preparing treatment plans and calculating treatment doses and times;
3. Using administrative controls to prevent a medical event involving the use of
radioactive material;
4. Implementing emergency procedures to be followed in the event of the abnormal
operation of the medical unit or console;
5. Checking and using survey meters;
6. Selecting the proper dose and how it is to be administered; and
(2) Has completed three years of supervised clinical experience in radiation therapy, under
an authorized user who meets the requirements in 105 CMR 120.528, 120.587 or equivalent
Agreement State or Nuclear Regulatory Commission requirements, as part of a formal
training program approved by the Residency Review Committee for Radiation Oncology of
the Accreditation Council for Graduate Medical Education or the Royal College of
Physicians and Surgeons of Canada or the Committee on Postdoctoral Training of the
American Osteopathic Association. This experience may be obtained concurrently with the
supervised work experience required by 105 CMR 120.587(B)(1)(b); and
(3) Has obtained written attestation, that the individual has satisfactorily completed the
requirements in 105 CMR 120.587(A)(1) or (B)(1) and (2), and 120.587(C) and has achieved
a level of competency sufficient to function independently as an authorized user of each type
of therapeutic medical unit for which the individual is requesting authorize user status. The
written attestation must be signed by a preceptor authorized user, who meets the
requirements in 105 CMR 120.528, 120.587, or equivalent Agreement State or Nuclear
Regulatory requirements for an authorized user for each type therapeutic medical unit for
which the individual is requesting authorized user status; and

(C) Has received training in device operation, safety procedures, and clinical use for the type(s)
of use for which authorization is sought. This training requirement may be satisfied by
satisfactory completion of a training program provided by the vendor for new users or by
receiving training supervised by an authorized user or authorized medical physicist, as
appropriate, who is authorized for the type(s) of use for which the individual is seeking
authorization.

OTHER MEDICAL USES OF RADIOACTIVE MATERIAL OR RADIATION

FROM RADIOACTIVE MATERIAL

120.589: Other Medical Uses of Radioactive Material or Radiation from Radioactive Material

A licensee may use radioactive material or a radiation source approved for medical use that
is not specifically addressed in 105 CMR 120.500 if:

(A) The applicant or licensee has submitted the information required by 105 CMR 120.507(B)
through (D); and

(B) The applicant or licensee has received written approval from the Agency in a license and
uses the material in accordance with 105 CMR 120.000 and specific conditions the agency
considers necessary for the medical use of the material.

RECORDS

120.590: Requirements for Record Keeping

(A) Records of Authority and Responsibilities for Radiation Protection Programs.

(1) A licensee shall retain a record of actions taken by the licensee’s management in
accordance with 105 CMR 120.515(A) for five years. The record must include a summary
of the actions taken and a signature of licensee management.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.590: continued

(2) The licensee shall retain a current copy of the authorities, duties and responsibilities of
the Radiation Safety Officer as required by 105 CMR 120.515(D), and a signed copy of the
Radiation Safety Officer’s agreement to be responsible for implementing the radiation safety
program, as required by 105 CMR 120.515(B) The record must include the signature of the
Radiation Safety Officer and licensee management.

(B) Records of Radiation Protection Program Safety Changes. A licensee shall retain a record
of each radiation protection program change made in accordance with 105 CMR 120.517(A) for
five years. The record must include a copy of the old and new procedures; the effective date of
the change; and the signature of the licensee management that reviewed and approved the
change.

(C) Records of Written Directives. A licensee shall retain a copy of each written directive as
required by 105 CMR 120.521 for three years.

(D) Records of Medical Events. A licensee shall retain a record of medical events reported in
accordance with 105 CMR 120.594(A) for three years. The record must contain the licensee’s
name; names of the individuals involved; the social security number or other identification
number if one has been assigned, of the individual who is the subject of the medical event;
medical event a brief description of the event; why it occurred; the effect, if any, on the
individual; the actions, if any, taken, or planned, to prevent recurrence; and, whether the licensee
notified the individual (or the individual’s responsible relative or guardian) and, if not, whether
such failure to notify was based on guidance from the referring physician.

(E) Record of a Dose to an Embryo/Fetus or a Nursing Child. A licensee shall retain a record
of a dose to an embryo/fetus or a nursing child reported in accordance with 105 CMR
120.594(B) for three years. The record must contain the licensee’s name; names of all the
individuals involved; social security number or other identification number if one has been
assigned of the embryo/fetus or nursing child who is the subject of the event; a brief description
of the event; why it occurred; the effect, if any, on the embryo/fetus or nursing child; the actions,
if any, taken, or planned, to prevent recurrence; and whether the licensee notified the pregnant
individual or mother (or the mother’s or child’s responsible relative or guardian) and, if not,
whether such failure to notify was based on guidance from the referring physician.

(F) Records of Calibrations of Instruments Used to Measure the Activity of Unsealed

Radioactive Material. A licensee shall maintain a record of instrument calibrations required by
105 CMR 120.532 for three years. The records must include the model and serial number of the
instrument, the date of the calibration, the results of the calibration, and the name of the
individual who performed the calibration.

(G) Records of Survey Instrument Calibrations. A licensee shall maintain a record of

instrument calibrations required by 105 CMR 120.533 for three years. The record must include
the model and serial number of the instrument, the date of the calibration, the results of the
calibration, and the name of the individual who performed the calibration.

(H) Records of Dosages of Unsealed Radioactive Material for Medical Use. A licensee shall
maintain a record of dosage determinations required by 105 CMR 120.534 for three years. The
record must contain the radioactive drug; the patient’s or human research subject's name, or
identification number if one has been assigned; prescribed dosage; the determined dosage, or a
notation that the total activity is less than 1.1 MBq (30 :Ci); the date and time of the dosage
determination; and the name of the individual who determined the dosage.

(I) Records of Possession of Sealed Sources and Brachytherapy Sources.

(1) A licensee shall retain a record of the leak test required by 105 CMR 120.536(B) for
three years. The record must contain the model number, and serial number if one has been
assigned, of each source tested, the identity of each source radionuclide and its estimated
activity, the results of the test, the date of the test, and the name of the individual who
performed the test.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.590: continued

(2) A licensee shall retain a record of the semi-annual physical inventory of sealed sources
and brachytherapy sources required by 105 CMR 120.536(E) for three years. The inventory
record must contain the model number of each source, and serial number if one has been
assigned, the identity of each source radionuclide and its nominal activity, the location of
each source, and the name of the individual who performed the inventory.

(J) Records of Surveys for Ambient Radiation Exposure Rate. A licensee shall retain a record
of each survey required by 105 CMR 120.539 for three years. The record must include the date
of the survey, the results of the survey, the instrument used to make the survey, and the name of
the individual who performed the survey.

(K) Records of the Release of Individuals Containing Radioactive Drugs or Implants

Containing Radioactive Material.
(1) A licensee shall retain a record, signed by the authorized user, of the basis for
authorizing the release of an individual, for three years after the date of release, if the total
effective dose equivalent is calculated by:
(a) Using the retained activity rather than the activity administered;
(b) Using an occupancy factor less than 0.25 at one meter;
(c) Using the biological or effective half-life; or
(d) Considering the shielding by tissue.
(2) A licensee shall retain a record, for three years after the date of release, that the
instructions required by 105 CMR 120.540(B) were provided to a breast-feeding woman [if
the radiation dose to the infant or child from continued breast-feeding could result in a total
effective dose equivalent exceeding five mSv (0.5 rem)].

(L) Records of Administrative and Technical Requirements that Apply to the Provision of
Mobile Services.
(1) A licensee shall retain a copy of the letter(s) that permits the use of radioactive material
at a client’s address of use, as required by 105 CMR 120.541(A)(1), for three years after the
last provision of service.
(2) A licensee shall retain the record of each survey required by 105 CMR 120.541(A)(4)
for three years. The record must include the date of the survey, the results of the survey, the
instrument used to make the survey, and the name of the individual who performed the
survey.

(M) Records of Decay-in-storage. A licensee shall maintain records of the disposal of licensed
materials, as required by 105 CMR 120.543, for three years. The record must include the date
of the disposal, the survey instrument used, the background radiation level, the radiation level
measured at the surface of each waste container, and the name of the individual who performed
the survey.

(N) Records of Radionuclide Purity. A licensee shall maintain a record of the radionuclide
contaminant concentration tests required by 105 CMR 120.548 for three years. The record must
include, for each measured elution of radionuclide used to prepare a radioactive drug, the ratio
of the measures expressed as kilobecquerel of contaminant per megabecquerel of desired
radionuclide (microcuries/millicurie), or microgram of contaminant per megabecquerel of
desired radionuclide (microgram/millicurie), the time and date of the measurement, and the name
of the individual who made the measurement.

(P) Records of Safety Instruction and Training. A licensee shall maintain a record of safety
instructions and training required by 105 CMR 120.553, 120.562 and 120.573 for three years.
The record must include a list of the topics covered, the date of the instruction or training, the
name(s) of the attendee(s), and the name(s) of the individual(s) who provided the instruction.

(Q) Records of Radiation Surveys of Patients and Human Research Subjects. A licensee shall
maintain a record of the surveys required by 105 CMR 120.560 and 120.571 for three years.
Each record must include the date and results of the survey, the survey instrument used, and the
name of the individual who made the survey.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.592: Requirements for Record Keeping Pertaining to the Use of Sealed Sources

(A) Records of Brachytherapy Source Inventory.

(1) A licensee shall maintain a record of brachytherapy source accountability required by
105 CMR 120.561 for three years.
(2) For temporary implants, the record must include:
(a) The number and activity of sources removed from storage, the time and date they
were removed from storage, the name of the individual who removed them from storage,
and the location of use; and
(b) The number and activity of sources not implanted, the time and date they were
returned to storage, and the name of the individual who returned them from storage.
(3) For permanent implants, the record must include:
(a) The number and activity of sources removed from storage, the date they were
removed from storage, and the name of the individual who removed them from storage;
(b) The number and activity of sources returned to storage, the date they were returned
to storage, and the name of the individual who returned them to storage; and
(c) The number and activity of sources permanently implanted in the patient or human
research subject.

(B) Records of Calibration Measurements on Brachytherapy Sources. A licensee shall maintain

a record of the calibrations on brachytherapy sources required by 105 CMR 120.564 for three
years after the last use of the source. The record must include the date of the calibration; the
manufacturer's name, model number, and serial number for the source and the instruments used
to calibrate the source; the source output or activity; source positioning accuracy within
applicators; and the signature of the authorized medical physicist.

(C) Records of Decay of Strontium-90 Sources for Opthalmic Treatments. A licensee shall
maintain a record of the activity of a strontium-90 source required by 105 CMR 120.564. The
record must include the date and initial activity of the source as determined under 105 CMR
120.564, and for each decay calculation, the date and the source activity.

(D) Records of Installation, Maintenance, Adjustment, and Repair. A licensee shall retain a
record of the installation, maintenance, adjustment, and repair of remote afterloader units,
teletherapy units, and gamma stereotactic radiosurgery units as required by 105 CMR 120.572
for three years. For each installation, maintenance, adjustment and repair, the record must
include the date, description of the service, and name(s) of the individual(s) who performed the
work.

(E) Records of Dosimetry Equipment.

(1) A licensee shall retain a record of the calibration, intercomparison, and comparisons of
its dosimetry equipment done in accordance with 105 CMR 120.575 for the duration of the
license.
(2) For each calibration, intercomparison, or comparison, the record must include:
(a) The date;
(b) The manufacturer’s name, model numbers and serial numbers of the instruments that
were calibrated, intercompared, or compared as required by 105 CMR 120.575(A) and
(B);
(c) The correction factor that was determined from the calibration or comparison or the
apparent correction factor that was determined from an intercomparison; and
(d) The names of the individuals who performed the calibration, intercomparison, or
comparison.

(F) Records of Teletherapy, Remote Afterloader, and Gamma Stereotactic Radiosurgery Full
Calibrations.
(1) A licensee shall maintain a record of the teletherapy, remote afterloader, and gamma
stereotactic radiosurgery full calibrations required by 105 CMR 120.576, 120.577 and
120.578 for three years.
(2) The record must include:
(a) The date of the calibration;
(b) The manufacturer's name, model number, and serial number for the teletherapy,
remote afterloader, and gamma stereotactic radiosurgery unit(s), the source(s), and
instruments used to calibrate the unit;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.592: continued

(c) The results and assessments of the full calibrations;

(d) The results of the autoradiograph required for low dose-rate remote afterloader units;
and
(e) The signature of the authorized medical physicist who performed the full calibration.

(G) Records of Periodic Spot-checks for Teletherapy Units.

(1) A licensee shall retain a record of each periodic spot-check for teletherapy units required
by 105 CMR 120.579 for three years.
(2) The record must include:
(a) The date of the spot-check;
(b) The manufacturer's name, model number, and serial number for the teletherapy unit,
source and instrument used to measure the output of the teletherapy unit;
(c) An assessment of timer linearity and constancy;
(d) The calculated on-off error;
(e) A determination of the coincidence of the radiation field and the field indicated by
the light beam localizing device;
(f) The determined accuracy of each distance measuring and localization device;
(g) The difference between the anticipated output and the measured output;
(h) Notations indicating the operability of each entrance door electrical interlock, each
electrical or mechanical stop, each source exposure indicator light, and the viewing and
intercom system and doors; and
(i) The name of the individual who performed the periodic spot-check and the signature
of the authorized medical physicist who reviewed the record of the spot-check.

(H) Records of Periodic Spot-checks for Remote Afterloader Units.

(1) A licensee shall retain a record of each spot-check for remote afterloader units required
by 105 CMR 120.580 for three years.
(2) The record must include, as applicable:
(a) The date of the spot-check;
(b) The manufacturer's name, model number, and serial number for the remote
afterloader unit and source;
(c) An assessment of timer accuracy;
(d) Notations indicating the operability of each entrance door electrical interlock,
radiation monitors, source exposure indicator lights, viewing and intercom systems, and
clock and decayed source activity in the unit’s computer; and
(e) The name of the individual who performed the periodic spot-check and the signature
of the authorized medical physicist who reviewed the record of the spot-check.

(I) Records of Periodic Spot-checks for Gamma Stereotactic Radiosurgery Units.

(1) A licensee shall retain a record of each spot-check for gamma stereotactic radiosurgery
units required by 105 CMR 120.581 for three years.
(2) The record must include:
(a) The date of the spot-check;
(b) The manufacturer's name, model number, and serial number for the gamma
stereotactic radiosurgery unit and the instrument used to measure the output of the unit;
(c) An assessment of timer linearity and accuracy;
(d) The calculated on-off error;
(e) A determination of trunnion centricity;
(f) The difference between the anticipated output and the measured output;
(g) An assessment of source output against computer calculations;
(h) Notations indicating the operability of radiation monitors, helmet microswitchs,
emergency timing circuits, emergency off buttons, electrical interlocks, source exposure
indicator lights, viewing and intercom systems, timer termination, treatment table
retraction mechanism, and stereotactic frames and localizing devices (trunnions); and
(i) The name of the individual who performed the periodic spot-check and the signature
of the authorized medical physicist who reviewed the record of the spot-check.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.592: continued

(J) Records of Additional Technical Requirements for Mobile Remote Afterloader Units.
(1) A licensee shall retain a record of each check for mobile remote afterloader units
required by 105 CMR 120.582 for three years.
(2) The record must include:
(a) The date of the check;
(b) The manufacturer's name, model number, and serial number of the remote
afterloader unit;
(c) Notations accounting for all sources before the licensee departs from a facility;
(d) Notations indicating the operability of each entrance door electrical interlock,
radiation monitors, source exposure indicator lights, viewing and intercom system,
applicators and source transfer tubes, and source positioning accuracy; and
(e) The signature of the individual who performed the check and the signature of the
authorized medical physicist who reviewed the record of the spot-check.

(K) Records of Surveys of Therapeutic Treatment Units.

(1) A licensee shall maintain a record of radiation surveys of treatment units made in
accordance with 105 CMR 120.583 for the duration of use of the unit.
(2) The record must include:
(a) The date of the measurements;
(b) The manufacturer's name, model number and serial number of the treatment unit,
source, and instrument used to measure radiation levels;
(c) Each dose rate measured around the source while the unit is in the off position and
the average of all measurements; and
(d) The signature of the individual who performed the test.

(L) Records of Five-year Inspection for Teletherapy and Gamma Stereotactic Surgery Units.
(1) A licensee shall maintain a record of the five-year inspections for teletherapy and
gamma stereotactic radiosurgery units required by 105 CMR 120.584 for the duration of use
of the unit.
(2) The record must contain:
(a) The inspector's radioactive materials license number;
(b) The date of inspection;
(c) The manufacturer's name and model number and serial number of both the treatment
unit and source;
(d) A list of components inspected and serviced, and the type of service; and
(f) The signature of the inspector.

REPORTS

120.594: Reports and Notifications

(A) Reports and Notifications of Medical Events.

(1) Other than events that result from intervention by a patient or human research subject,
a licensee shall report any event in which the administration of radioactive material or
radiation from radioactive material results in:
(a) A dose that differs from the prescribed dose by more than 0.05 Sv (five rem)
effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem)
shallow dose equivalent to the skin; and either
1. The total dose delivered differs from the prescribed dose by 20% or more;
2. The total dosage delivered differs from the prescribed dosage by 20% or more or
falls outside the prescribed dosage range; or
3. The fractionated dose delivered differs from the prescribed dose, for a single
fraction, by 50% or more.
(b) A dose that exceeds 0.05 Sv (five rem) effective dose equivalent, 0.5 Sv (50 rem)
to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin from any of
the following:
1. An administration of a wrong radioactive drug;
2. An administration of a radioactive drug containing radioactive material by the
wrong route of administration;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.594: continued

3. An administration of a dose or dosage to the wrong individual or human research

subject;
4. An administration of a dose or dosage delivered by the wrong mode of treatment;
or
5. A leaking sealed source.
(c) A dose to the skin or an organ or tissue other than the treatment site that exceeds by
0.5 Sv (50 rem) to an organ or tissue and 50% of the dose expected from the
administration defined in the written directive (excluding, for permanent implants, seeds
that were implanted in the correct site but migrated outside the treatment site).
(2) A licensee shall report any event resulting from intervention of a patient or human
research subject in which the administration of radioactive material or radiation from
radioactive material results, or will result in, unintended permanent functional damage to an
organ or a physiological system, as determined by a physician.
(3) The licensee shall notify the Agency by telephone no later than the next calendar day
after discovery of the medical event.
(4) The licensee shall submit a written report to the Agency within 15 days after discovery
of the medical event.
(a) The written report must include:
1. The licensee's name;
2. The name of the prescribing physician;
3. A brief description of the event;
4. Why the event occurred;
5. The effect, if any, on the individual(s) who received the administration;
6. Actions, if any, that have been taken, or are planned, to prevent recurrence;
7. Certification that the licensee notified the individual (or the individual's
responsible relative or guardian), and if not, why not.
(b) The report may not contain the individual's name or any other information that could
lead to identification of the individual.
(5) The licensee shall provide notification of the medical event to the referring physician
and also notify the individual who is the subject of the medical event no later than 24 hours
after its discovery, unless the referring physician personally informs the licensee either that
he or she will inform the individual or that, based on medical judgment, telling the individual
would be harmful. The licensee is not required to notify the individual without first
consulting the referring physician. If the referring physician or the affected individual cannot
be reached within 24 hours, the licensee shall notify the individual as soon as possible
thereafter. The licensee may not delay any appropriate medical care for the individual,
including any necessary remedial care as a result of the medical event because of any delay
in notification. To meet the requirements of 105 CMR 120.504(A)(5), the notification of the
individual who is the subject of the medical event may be made instead to that individual’s
responsible relative or guardian. If a verbal notification is made, the licensee shall inform
the individual, or appropriate responsible relative or guardian, that a written description of
the event can be obtained from the licensee upon request. The licensee shall provide such
a written description if requested.
(6) Aside from the notification requirement, nothing in 105 CMR 120.594 affects any rights
or duties of licensees and physicians in relation to each other, to individuals affected by the
medical event or to that individual's responsible relatives or guardians.
(7) A licensee shall retain a record of a medical event in accordance with 105 CMR
120.590(D). A copy of the record required under 105 CMR 120.590(D) shall be provided
to the referring physician if other than the licensee, within 15 days after discovery of the
medical event.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.594: continued

(B) Report and Notification of a Dose to an Embryo/Fetus or a Nursing Child.

(1) A licensee shall report any dose to an embryo/fetus that is greater than five mSv (500
mrem) dose equivalent that is a result of an administration of radioactive material or
radiation from radioactive material to a pregnant individual unless the dose to the
embryo/fetus was specifically approved, in advance, by the authorized user.
(2) A licensee shall report any dose to a nursing child, that was not specifically approved,
in advance, by the authorized user, that is a result of an administration of radioactive material
to a breast feeding individual that:
(a) Is greater than five mSv (500 mrem) total effective dose equivalent; or
(b) Has resulted in unintended permanent functional damage to an organ or a
physiological system of the child, as determined by a physician.
(3) The licensee shall notify by telephone the Agency no later than the next calendar day
after discovery of a dose to the embryo/fetus or nursing child that requires a report in
105 CMR 120.594(B)(1) or 105 CMR 120.594(B)(2).
(4) The licensee shall submit a written report to the Agency within 15 days after discovery
of a dose to the embryo/fetus or nursing child that requires a report in 105 CMR
120.594(B)(1) or 105 CMR 120.594(B)(2).
(a) The written report must include:
1. The licensee's name;
2. The name of the prescribing physician;
3. A brief description of the event;
4. Why the event occurred;
5. The effect on the embryo/fetus or the nursing child;
6. What actions, if any, have been taken, or are planned, to prevent recurrence; and
7. Certification that the licensee notified the pregnant individual or mother (or the
mother’s or child’s responsible relative or guardian), and if not, why not.
(b) The report must not contain the individual's or child’s name or any other information
that could lead to identification of the individual or child.
(5) The licensee shall notify the referring physician and also notify the pregnant individual
or mother, both hereafter referred to as the mother, no later than 24 hours after of discovery
of an event that would require reporting under 105 CMR 120.594(B)(1) or (2), unless the
referring physician personally informs the licensee either that he or she will inform the
mother or that, based on medical judgment, telling the mother would be harmful. The
licensee is not required to notify the mother without first consulting with the referring
physician. If the referring physician or mother cannot be reached within 24 hours, the
licensee shall make the appropriate notifications as soon as possible thereafter. The licensee
may not delay any appropriate medical care for the embryo/fetus or for the nursing child,
including any necessary remedial care as a result of the event because of any delay in
notification. To meet the requirements of this paragraph, the notification may be made to the
mother’s or child’s responsible relative or guardian instead of the mother, when appropriate.
If a verbal notification is made, the licensee shall inform the mother, or the mother’s or
child’s responsible relative or guardian, that a written description of the event can be
obtained from the licensee upon request. The licensee shall provide such a written
description if requested.
(6) A licensee shall retain a record of a dose to an embryo/fetus or a nursing child in
accordance with 105 CMR 120.590(E). A copy of the record required under 105 CMR
120.590(E) shall be provided to the referring physician, if other than the licensee, within 15
days after discovery of the event.

(C) Reports of Leaking Sources. A licensee shall file a report with the Agency within five days
if a leakage test required by 105 CMR 120.536 reveals the presence of 185 Becquerel (0.005
mCi) or more of removable contamination. The written report must include the model number
and serial number if assigned, of the leaking source; the radionuclide and its estimated activity;
the results of the test; the date of the test; and the action taken.

(D) Reports of Patient Departure Prior to Authorized Release.

(1) The licensee shall notify the Agency by telephone immediately upon discovery that a
patient or human research subject has departed from the licensee's facility without
authorization under 105 CMR 120.540(A).
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.594: continued

(2) The licensee shall submit a written report to the Agency within 30 days after discovery
of the unauthorized departure. The written report must include:
(a) The licensee's name;
(b) The date and time of the unauthorized departure;
(c) The projected date and time when release would have occurred;
(d) The general location address of the patient's or human research subject's home or
anticipated destination following departure;
(e) The radionuclide, chemical and physical form and calculated activity at time of
release;
(f) The apparent reason(s) for the departure prior to authorized release; and,
(g) A description of any changes in the licensee's patient release criteria or patient
instructions that are designed to avoid a recurrence of such an event.

(E) Notification of Deceased Patients or Human Research Subjects Containing Radioactive

Material.
(1) The licensee shall notify the Agency by telephone immediately upon discovery that a
patient or human research subject containing radioactive material has died, and it is possible
that any individual could receive exposures in excess of 105 CMR 120.221 as a result of the
deceased's body.
(2) The licensee shall submit a written report to the Agency within 30 days after discovery
that the patient or human research subject referenced in 105 CMR 120.594(E)(1) has died.
The written report must include:
(a) The licensee's name;
(b) The date of death;
(c) The radionuclide, chemical and physical form and calculated activity at time of
death; and
(d) The names (or titles) and address(es) of known individuals who might have received
exposures exceeding five mSv (500 mrem).

120.600: RADIATION SAFETY REQUIREMENTS FOR ANALYTICAL X-RAY EQUIPMENT

120.601: Purpose and Scope

105 CMR 120.600 provides special requirements for analytical x-ray equipment. The
requirements of 105 CMR 120.600 are in addition to, and not in substitution for, applicable
requirements in other Sections of 105 CMR 120.000.

120.602: Definitions

As used in 105 CMR 120.600, the following definitions apply:

Analytical X-ray Equipment means equipment used for x-ray diffraction or fluorescence analysis.

Analytical X-ray System means a group of components utilizing x or gamma rays to determine
the elemental composition or to examine the microstructure of materials.

Fail-safe Characteristics mean a design feature which causes beam port shutters to close, or
otherwise prevents emergence of the primary beam, upon the failure of a safety or warning
device.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Local Components mean part of an analytical x-ray system and include areas that are struck by
x-rays such as radiation source housings, port and shutter assemblies, collimators, sample
holders, cameras, goniometers, detectors, and shielding, but do not include power supplies,
transformers, amplifiers, readout devices, and control panels.

Normal Operating Procedures mean step-by-step instructions necessary to accomplish the

analysis. These procedures shall include sample insertion and manipulation, equipment
alignment, routine maintenance by the registrant (or licensee), and data recording procedures,
which are related to radiation safety.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.602: continued

Open-beam Configuration means an analytical x-ray system in which an individual could

accidently place some part of his body in the primary beam path during normal operation.

Primary Beam means radiation which passes through an aperture of the source housing by a
direct path from the x-ray tube or a radioactive source located in the radiation source housing.

120.603: Equipment Requirements

(A) Safety Device. A device which prevents the entry of any portion of an individual's body
into the primary x-ray beam path or which causes the beam to be shut off upon entry into its path
shall be provided on all open-beam configurations. A registrant [or licensee] may apply to the
Agency for an exemption from the requirement of a safety device. Such application shall
include:
(1) A description of the various safety devices that have been evaluated;
(2) The reason each of these devices cannot be used; and,
(3) A description of the alternative methods that will be employed to minimize the
possibility of an accidental exposure, including procedures to assure that operators and others
in the area will be informed of the absence of safety devices.

(B) Warning Devices.

(1) Open-beam configurations shall be provided with a readily discernible indication of:
(a) X-ray tube "on-off" status located near the radiation source housing, if the primary
beam is controlled in this manner; and/or,
(b) Shutter "open-closed" status located near each port on the radiation source housing,
if the primary beam is controlled in this manner.
(2) Warning devices shall be labeled so that their purpose is easily identified. On
equipment installed after the effective date of 105 CMR 120.600, warning devices shall have
fail-safe characteristics.

(C) Ports. Unused ports on radiation source housings shall be secured in the closed position
in a manner which will prevent casual opening.

(D) Labeling. All analytical x-ray equipment shall be labeled with a readily discernible sign
or signs bearing the radiation symbol and the words:
(1) "CAUTION - HIGH INTENSITY X-RAY BEAM", or words having a similar intent,
on the x-ray source housing; and,
(2) "CAUTION RADIATION - THIS EQUIPMENT PRODUCES RADIATION WHEN
ENERGIZED", or words having a similar intent, near any switch that energizes an x-ray tube
if the radiation source is an x-ray tube; or,
(3) "CAUTION - RADIOACTIVE MATERIAL", or words having a similar intent, on the
source housing in accordance with 105 CMR 120.237 and 120.238 if the radiation source is
a radionuclide.

(E) Shutters. On open-beam configurations installed after the effective date of 105 CMR
120.600, each port on the radiation source housing shall be equipped with a shutter that cannot
be opened unless a collimator or a coupling has been connected to the port.

(F) Warning Lights.

(1) An easily visible warning light labeled with the words "X-RAY ON", or words having
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

a similar intent, shall be located:

(a) Near any switch that energizes an x-ray tube and shall be illuminated only when the
tube is energized; or,
(b) In the case of a radioactive source, near any switch that opens a housing shutter and
shall be illuminated only when the shutter is open.
(2) On equipment installed after the effective date of 105 CMR 120.600, warning lights
shall have fail-safe characteristics.

(G) Radiation Source Housing. Each radiation source housing shall be subject to the following
requirements:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.603: continued

(1) Each x-ray tube housing shall be equipped with an interlock that shuts off the tube if it
is removed from the radiation source housing or if the housing is disassembled.
(2) Each radioactive source housing or port cover or each x-ray tube housing shall be so
constructed that, with all shutters closed, the radiation measured at a distance of five
centimeters from its surface is not capable of producing a dose in excess of 2.5 millirems
(0.025 mSv) in one hour. For systems utilizing x-ray tubes, this limit shall be met at any
specified tube rating.

(H) Generator Cabinet. Each x-ray generator shall be supplied with a protective cabinet which
limits leakage radiation measured at a distance of five centimeters from its surface such that it
is not capable of producing a dose in excess of 0.25 millirem (2.5 µSv) in one hour.

120.604: Area Requirements

(A) Radiation Levels. The local components of an analytical x-ray system shall be located and
arranged and shall include sufficient shielding or access control such that no radiation levels
exist in any area surrounding the local component group which could result in a dose to an
individual present therein in excess of the dose limits given in 105 CMR 120.221. For systems
utilizing x-ray tubes, these levels shall be met at any specified tube rating.

(B) Surveys.
(1) Radiation surveys, as required by 105 CMR 120.222, of all analytical x-ray systems
sufficient to show compliance with 105 CMR 120.604(A) shall be performed:
(a) Upon installation of the equipment, and at least once every 12 months thereafter;
(b) Following any change in the initial arrangement, number, or type of local
components in the system;
(c) Following any maintenance requiring the disassembly or removal of a local
component in the system;
(d) During the performance of maintenance and alignment procedures if the procedures
require the presence of a primary x-ray beam when any local component in the system
is disassembled or removed;
(e) Any time a visual inspection of the local components in the system reveals an
abnormal condition; and,
(f) Whenever personnel monitoring devices show a significant increase over the
previous monitoring period or the readings are approaching the limits specified in
105 CMR 120.211.
(2) Radiation survey measurements shall not be required if a registrant [or licensee] can
demonstrate compliance with 105 CMR 120.604(A) to the satisfaction of the Agency.

(C) Posting. Each area or room containing analytical x-ray equipment shall be conspicuously
posted with a sign or signs bearing the radiation symbol and the words "CAUTION - X-RAY
EQUIPMENT" or words having a similar intent in accordance with 105 CMR 120.238.

120.605: Operating Requirements

(A) Procedures. Normal operating procedures shall be written and available to all analytical
x-ray equipment workers. No individual shall be permitted to operate analytical x-ray equipment
in any manner other than that specified in the procedures unless such individual has obtained
written approval of the radiation safety officer.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(B) Bypassing. No individual shall bypass a safety device or interlock unless such individual
has obtained the approval of the radiation safety officer. Such approval shall be for a specified
period of time. When a safety device or interlock has been bypassed, a readily discernible sign
bearing the words "SAFETY DEVICE NOT WORKING", or words having a similar intent, shall
be placed on the radiation source housing.

(C) Repair or Modification of X-ray Tube Systems. Except as specified in 105 CMR
120.605(B), no operation involving removal of covers, shielding materials or tube housings or
modifications to shutters, collimators, or beam stops shall be performed without ascertaining that
the tube is off and will remain off until safe conditions have been restored. The main switch,
rather than interlocks, shall be used for routine shutdown in preparation for repairs.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.605: continued

(D) Radioactive Source Replacement, Testing, or Repair. Radioactive source housings shall
be opened for source replacement, leak testing, or other maintenance or repair procedures only
by individuals authorized to specifically conduct such procedures under a license issued by the
U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State.

120.606: Personnel Requirements

(A) Instruction. No individual shall be permitted to operate or maintain analytical x-ray

equipment unless such individual has received instruction in and demonstrated competence as
to:
(1) Identification of radiation hazards associated with the use of the equipment;
(2) Significance of the various radiation warning, safety devices, and interlocks
incorporated into the equipment, or the reasons they have not been installed on certain pieces
of equipment and the extra precautions required in such cases;
(3) Proper operating procedures for the equipment;
(4) Recognition of symptoms of an acute localized exposure; and,
(5) Proper procedures for reporting an actual or suspected exposure.

(B) Personnel Monitoring.

(1) Finger or wrist dosimetric devices shall be provided to and shall be used by:
(a) Analytical x-ray equipment workers using systems having an open-beam
configuration and not equipped with a safety device; and,
(b) Personnel maintaining analytical x-ray equipment if the maintenance procedures
require the presence of a primary x-ray beam when any local component in the analytical
x-ray system is disassembled or removed.
(2) Reported dose values shall not be used for the purpose of determining compliance with
105 CMR 120.200 unless evaluated by a qualified expert.

120.620: LICENSING AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS

120.621: Purpose and Scope

(A) 105 CMR 120.620 contains requirements for the issuance of a license authorizing the use
of sealed sources containing radioactive materials in irradiators used to irradiate objects or
materials using gamma radiation. 105 CMR 120.620 also contains radiation safety requirements
for operating irradiators. The requirements of 105 CMR 120.620 are in addition to other
requirements of 105 CMR 120.000. In particular, the provisions of 105 CMR 120.001, 120.100,
120.200, 120.750 and 120.770 apply to applications and licenses subject to 105 CMR 120.620.
Nothing in 105 CMR 120.620 relieves the licensee from complying with other applicable
Federal, State and local regulations governing the siting, zoning, land use, and building code
requirements for industrial facilities.

(B) 105 CMR 120.620 applies to panoramic irradiators that have either dry or wet storage of
the radioactive sealed sources and to underwater irradiators in which both the source and the
product being irradiated are under water. Irradiators whose dose rates exceed five grays (500
rads) per hour at one meter from the radioactive sealed sources in air or in water, as applicable
for the irradiator type, are covered by 105 CMR 120.620.

(C) 105 CMR 120.620 does not apply to self-contained dry-source-storage irradiators (those
in which both the source and the area subject to irradiation are contained within a device and are
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

not accessible by personnel), medical radiology or teletherapy, radiography (the irradiation of

materials for nondestructive testing purposes), gauging, or open-field (agricultural) irradiations.

120.622: Definitions

Annually means either:

(1) at intervals not to exceed one year; or
(2) once per year, at about the same time each year (plus or minus one month).
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.622: continued

Doubly Encapsulated Sealed Source means a sealed source in which the radioactive material is
sealed within a capsule and that capsule is sealed within another capsule.

Irradiator means a facility that uses radioactive sealed sources for the irradiation of objects or
materials and in which radiation doses rates exceeding five grays (500 rads) per hour exist at one
meter from the sealed radioactive sources in air or water, as applicable for the irradiator type, but
does not include irradiators in which both the sealed source and the area subject to irradiation
are contained within a device and are not accessible to personnel.

Irradiator Operator means an individual who has successfully completed the training and testing
described in 105 CMR 120.671 and is authorized by the terms of the license to operate the
irradiator without a supervisor present.

Panoramic Dry-source-storage Irradiator means an irradiator in which the irradiations occur in

air in areas potentially accessible to personnel and in which the sources are stored in shields
made of solid materials. The term includes beam-type dry-source-storage irradiators in which
only narrow beam of radiation is produced for performing irradiations.

Panoramic Irradiator means an irradiator in which the irradiations are done in air in areas
potentially accessible to personnel. The term includes beam-type irradiators.

Panoramic Wet-source-storage Irradiator means an irradiator in which the irradiations occur in

air in areas potentially accessible to personnel and in which the sources are stored under water
in a storage pool.

Pool Irradiator means any irradiator at which the sources are stored or used in a pool of water
including panoramic wet-source-storage irradiators and underwater irradiators.

Product Conveyor System means a system for moving the product to be irradiated to, from, and
within the area where irradiation takes place.

Radiation Room means a shielded room in which irradiations take place. Underwater irradiators
do not have radiation rooms.

Sealed Source means any radioactive material that is used as a source of radiation and is encased
in a capsule designed to prevent leakage or escape of the byproduct material.

Seismic Area means any area where the probability of horizontal acceleration in rock more than
0.3 times the acceleration of gravity in 250 years is greater than 10%, as designated by the U.S.
Geological Survey.

Underwater Irradiator means an irradiator in which the sources always remain shielded under
water and humans do not have access to the sealed sources or the space subject to irradiation
without entering the pool.

120.631: Application for a Specific License

(A) Applications for specific licenses shall be filed in duplicate on a form prescribed by the
Agency.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(B) The Agency may, at any time after the filing of the original applications and before issuance
of the license, require further statements in order to enable the Agency to determine whether the
application should be granted or denied.

(C) Each application shall be signed by the applicant or licensee, or a person duly authorized
to act for and on the applicant's or licensee's behalf.

(D) An application for a license may include a request for a license authorizing one or more
activities. The Agency may require the issuance of separate specific licenses for those activities.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.631: continued

(E) Applications and documents submitted to the Agency may be made available for public
inspection except that the Agency may withhold any document or part thereof from public
inspection in accordance with 105 CMR 120.010. The Agency may also request additional
information after the license has been issued to enable the Agency to determine whether the
license should be modified or revoked.

(F) Each application for a specific license, unless otherwise exempted by the Agency, shall be
accompanied by the fee prescribed by the Executive Office for Administration and Finance.

120.633: Specific Licenses for Irradiators

The Agency will approve an application for a specific license for the use of licensed material
in an irradiator if the applicant meets the requirements contained in 105 CMR 120.633.

(A) The applicant shall satisfy the general requirements specified in 105 CMR 120.100 and the
requirements contained in 105 CMR 120.620.

(B) The application must describe the training provided to irradiator operators including:
(1) Classroom training;
(2) On-the-job or simulator training;
(3) Safety reviews;
(4) Means employed by the applicant to test each operator's understanding of the Agency's
regulations and licensing requirements and the irradiator operating, safety, and emergency
procedures; and
(5) Minimum training and experience of personnel who may provide training.

(C) The application must include an outline of the written operating, safety, and emergency
procedures listed in 105 CMR 120.673 that describes the radiation safety aspects of the
procedures.

(D) The application must describe the organizational structure for managing the irradiator,
specifically the radiation safety responsibilities and authorities of the radiation safety officer and
those management personnel who have important radiation safety responsibilities or authorities.
In particular, the application must specify who, within the management structure, has the
authority to stop unsafe operations. The application must also describe the training and
experience required for the position of radiation safety officer.

(E) The application must include a description of the access control systems required by 105
CMR 120.643, the radiation monitors required by 105 CMR 120.649, the method of detecting
leaking sources required by 105 CMR 120.679, including the sensitivity of the method, and a
diagram of the facility that shows the locations of all required interlocks and radiation monitors.

(F) If the applicant intends to perform leak testing of dry-source-storage sealed sources, the
applicant shall establish procedures for leak testing and submit a description of these procedures
to the Agency. The description must include the:
(1) instruments to be used;
(2) methods of performing the analysis; and,
(3) pertinent experience of the individual who analyzes the samples.

(G) If licensee personnel are to load or unload sources, the applicant shall describe the
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

qualifications and training of the personnel and the procedures to be used. If the applicant
intends to contract for source loading or unloading at its facility, the loading or unloading must
be done by an organization specifically authorized by the Agency, the Commission, an
Agreement State, or a Licensing State to load or unload irradiator sources.

(H) The applicant shall describe the inspection and maintenance checks, including the
frequency of the checks required by 105 CMR 120.681.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.635: Commencement of Construction

Commencement of construction of a new irradiator may not occur prior to the submission
to the Agency of both an application for a license for the irradiator and the prescribed fee. As
used in 105 CMR 120.620 through 120.693, the terms "commencement of construction" and
"construction" are defined in 105 CMR 120.102. Any activities undertaken prior to the issuance
of a license are entirely at the risk of the applicant and have no bearing on the issuance of a
license with respect to the requirements of M.G.L. c. 111, §§ 3, 5M, 5N, 5O, and 5P, rules,
regulations, and orders issued under M.G.L. c. 111, §§ 3, 5M, 5N, 5O, and 5P.

120.637: Applications for Exemptions

Any application for a license or for amendment of a license authorizing use of a teletherapy-
type unit for irradiation of materials or objects may include proposed alternatives for the
requirements of this part. The Agency will approve the proposed alternatives if the applicant
provides adequate rationale for the proposed alternatives and demonstrates that they are likely
to provide an adequate level of safety for workers and the public.

120.639: Request for Written Statements

Each license is issued with the condition that the licensee will, at any time before expiration
of the license, upon the Agency's request, submit written statement to enable the Agency to
determine whether the license should be modified, suspended, or revoked.

120.641: Performance Criteria for Sealed Sources

(A) Requirements for sealed sources installed after July 1, 1993:

(1) Must have been registered in accordance with 105 CMR 120.128(N);
(2) Must be doubly encapsulated;
(3) Must use radioactive material that is as nondispersible as practical and that is as
insoluble as practical if the source is used in a wet-source-storage or wet-source-change
irradiator;
(4) Must be encapsulated in a material resistant to general corrosion and to localized
corrosion, such as 316L stainless steel or other material with equivalent resistance if the
sources are for use in irradiator pools; and,
(5) In prototype testing of the sealed source, must have been leak tested and found leak-free
after each of the tests described in 105 CMR 120.641(B) through (G).

(B) Temperature: The test source must be held at -40°C for 20 minutes, 600°C for one hour,
and then be subjected to thermal shock test with a temperature drop from 600°C to 20°C within
15 seconds.

(C) Pressure: The test source must be twice subjected for at least five minutes to an external
pressure (absolute) of two million newtons per square meter.

(D) Impact: A 2-kilogram steel weight, 2.5 centimeters in diameter, must be dropped from a
height of one meter onto the test source.

(E) Vibration: The test source must be subjected three times for ten minutes each to vibrations
sweeping from 25 hertz to 500 hertz with a peak amplitude of five times the acceleration of
gravity. In addition, each test source must be vibrated for 30 minutes at each resonant frequency
found.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(F) Puncture: A 50-gram weight and pin, 0.3-centimeter pin diameter, must be dropped from
a height of one meter onto the test source.

(G) Bend: If the length of the source is more than 15 times larger than the minimum cross-
sectional dimension, the test source must be subjected to a force of 2000 newtons at its center
equidistant from two support cylinders, the distance between which is ten times the minimum
cross-sectional dimension of the source.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.643: Access Control

(A) Each entrance to a radiation room at a panoramic irradiator must have a door or other
physical barrier to prevent inadvertent entry of personnel if the sources are not in the shielded
position. Product conveyor systems may serve as barriers as long as they reliably and
consistently function as a barrier. It must not be possible to move the sources out of their
shielded position if the door or barrier is open. Opening the door or barrier while the sources are
exposed must cause the sources to return promptly to the shielded position. The personnel
entrance door or barrier must have a lock that is operated by the same key used to move the
sources. The doors and barriers must not prevent any individual in the radiation room from
leaving.

(B) In addition, each entrance to a radiation room at a panoramic irradiator must have an
independent backup access control to detect personnel entry while the sources are exposed.
Detection of entry while the sources are exposed must cause the sources to return to their fully
shielded position and must also activate a visible and audible alarm to make the individual
entering the room aware of the hazard. The alarm must also alert at least one other individual
who is onsite of the entry. That individual shall be trained on how to respond to the alarm and
prepared to promptly render or summon assistance.

(C) A radiation monitor must be provided to detect the presence of high radiation levels in the
radiation room of a panoramic irradiator before personnel entry. The monitor must be integrated
with personnel access door locks to prevent room access when radiation levels are high.
Attempted personnel entry while the monitor measures high radiation levels, must activate the
alarm described in 105 CMR 120.643(B). The monitor may be located in the entrance (normally
referred to as the maze) but not in the direct radiation beam.

(D) Before the sources move from their shielded position in a panoramic irradiator, the source
control must automatically activate conspicuous visible and audible alarms to alert people in the
radiation room that the sources will be moved from their shielded position. The alarms must
give individuals enough time to leave the room before the sources leave the shielded position.

(E) Each radiation room at a panoramic irradiator must have a clearly visible and readily
accessible control that would allow an individual in the room to make the sources return to their
fully shielded position.

(F) Each radiation room of a panoramic irradiator must contain a control that prevents the
sources from moving from the shielded position unless the control has been activated and the
door or barrier to the radiation room has been closed within a preset time after activation of the
control.

(G) Each entrance to the radiation room of a panoramic irradiator and each entrance to the area
within the personnel access barrier of an underwater irradiator must be posted as required by 105
CMR 120.238. Radiation postings for panoramic irradiators must comply with the posting
requirements of 105 CMR 120.238, except that signs may be removed, covered, or otherwise
made inoperative when the sources are fully shielded.

(H) If the radiation room of a panoramic irradiator has roof plugs or other movable shielding,
it must not be possible to operate the irradiator unless the shielding is in its proper location. The
requirement may be met by interlocks that prevent operation if shielding is not placed properly
or by an operating procedure requiring inspection of shielding before operating.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(I) Underwater irradiators must have a personnel access barrier around the pool which must
be locked to prevent access when the irradiator is not attended. Only operators and facility
management may have access to keys to the personnel access barrier. There must be an intrusion
alarm to detect unauthorized entry when the personnel access barrier is locked. Activation of the
intrusion alarm must alert an individual (not necessarily onsite) who is prepared to respond or
summon assistance.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.645: Shielding

(A) The radiation dose rate in areas that are normally occupied during operation of a panoramic
irradiator may not exceed 0.02 millisievert (two millirems) per hour at any location 30
centimeters or more from the wall of the room when the sources are exposed. The dose rate must
be averaged over an area not to exceed 100 square centimeters having no linear dimension
greater than 20 centimeters. Areas where the radiation dose rate exceeds 0.02 millisievert (two
millirems) per hour must be locked, roped off, or posted.

(B) The radiation dose at 30 centimeters over the edge of the pool of a pool irradiator may not
exceed 0.02 millisievert (two millirems) per hour when the sources are in the fully shielded
position.

(C) The radiation dose rate a one meter from the shield of a dry-source-storage panoramic
irradiator when the source is shielded may not exceed 0.02 millisievert (two millirems) per hour
and at five centimeters from the shield may not exceed 0.2 millisievert (20 millirems) per hour.

120.647: Fire Protection

(A) The radiation room at a panoramic irradiator must have heat and smoke detectors. The
detectors must activate an audible alarm. The alarm must be capable of alerting a person who
is prepared to summon assistance promptly. The sources must automatically become fully
shielded if a fire is detected.

(B) The radiation room at a panoramic irradiator must be equipped with a fire extinguishing
system capable of extinguishing a fire without the entry of personnel into the room. The system
for the radiation room must have a shut-off valve to control flooding into unrestricted areas.

120.649: Radiation Monitors

(A) Irradiators with automatic product conveyor systems must have a radiation monitor with
an audible alarm located to detect loose radioactive sources that are carried toward the product
exit. If the monitor detects a source, an alarm must sound and product conveyors must stop
automatically. The alarm must be capable of alerting an individual in the facility who is prepared
to summon assistance. Underwater irradiators in which the product moves within an enclosed
stationary tube are exempt from the requirements of 105 CMR 120.649(A).

(B) Underwater irradiators that are not in a shielded radiation room must have a radiation
monitor over the pool to detect abnormal radiation levels. The monitor must have an audible
alarm and a visible indicator at entrances to the personnel access barrier around the pool. The
audible alarm may have a manual shut-off. The alarm must be capable of alerting an individual
who is prepared to respond promptly.

120.651: Control of Source Movement

(A) The mechanism that moves the sources of a panoramic irradiator must require a key to
actuate. Actuation of the mechanism must cause an audible signal to indicate that the sources
are leaving the shielded position. Only one key may be in use at any time, and only operators
or facility management may possess it. The key must be attached to a portable radiation survey
meter by a chain or cable. The lock for source control must be designed so that the key may not
be removed if the sources are in an unshielded position. The door to the radiation room must
require the same key.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(B) The console of a panoramic irradiator must have a source position indicator that indicates
when the sources are in the fully shielded position, when they are in transit, and when the sources
are exposed.

(C) The control console of a panoramic irradiator must have a control that promptly returns the
sources to the shielded position.

(D) Each control for a panoramic irradiator must be clearly marked as to its function.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.653: Irradiator Pools

(A) For licenses initially issued after July 1, 1993, irradiator pools must either:
(1) Have a water-tight stainless steel liner or a liner metallurgically compatible with other
components in the pool; or
(2) Be constructed so that there is a low likelihood of substantial leakage and have a surface
designed to facilitate decontamination. In either case, the licensee shall have a method to
safely store the sources during repairs of the pool.

(B) For licenses initially issued after July 1, 1993, irradiator pools must have no outlets more
than 0.5 meter below the normal low water level that could allow water to drain out of the pool.
Pipes that have intakes more than 0.5 meter below the normal low water level and that could act
as siphons must have siphon breakers to prevent the siphoning of pool water.

(C) A means must be provided to replenish water losses from the pool.

(D) A visible indicator must be provided in a clearly visible location to indicate if the pool
water level is below the normal low water level or above the normal high water level.

(E) Irradiator pools must be equipped with a purification system designed to be capable of
maintaining the water during normal operation at a conductivity of 20 microsiemens per
centimeter or less and with a clarity so that the sources can be seen clearly.

(F) A physical barrier, such as a railing or cover, must be used around or over irradiator pools
during normal operation to prevent personnel from accidentally falling into the pool. The barrier
may be removed during maintenance, inspection, and service operations.

(G) If long-handled tools or poles are used in irradiator pools, the radiation dose rate on the
handling areas of the tools may not exceed 0.02 millisievert (two millirems) per hour.

120.655: Source Rack Protection

If the product to be irradiated moves on a product conveyor system, the source rack and the
mechanism that moves the rack must be protected by a carrier or guides to prevent products and
product carriers from hitting or touching the rack or mechanism.

120.657: Power Failures

(A) If electrical power at a panoramic irradiator is lost for longer than ten seconds, the sources
must automatically return to the shielded position.

(B) The lock on the door of the radiation room of a panoramic irradiator must remain locked
in the event of a power failure.

(C) During a power failure, the area of any irradiator where sources are located may be entered
only when using an operable and calibrated radiation survey meter.

120.659: Design Requirements

Irradiators whose construction began after July 1, 1993, must meet the design requirements of
105 CMR 120.659.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(A) Shielding: For panoramic irradiators, the licensee shall design shielding walls to meet
generally accepted building code requirements for reinforced concrete and design the walls, wall
penetrations, and entranceways to meet the radiation shielding requirements of 105 CMR
120.645. If the irradiator will use more than five million curies (2 x 1017 becquerels) of activity,
the licensee shall evaluate the effects of heating of the shielding walls by the irradiator sources.

(B) Foundations: For panoramic irradiators, the licensee shall design the foundation, with
consideration given to soil characteristics, to ensure it is adequate to support the weight of the
facility shield walls.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.659: continued

(C) Pool Integrity: For pool irradiators, the licensee shall design the pool to assure that it is leak
resistant, that it is strong enough to bear the weight of the pool water and shipping casks, that a
dropped cask would not fall on sealed sources, that all outlets or pipes meet the requirements of
105 CMR 120.653(B), and that metal components are metallurgically compatible with other
components in the pool.

(D) Water Handling System: For pool irradiators, the licensee shall verify that the design of
the water purification system is adequate to meet the requirements of 105 CMR 120.653(E). The
system must be designed so that water leaking from the system does not drain to unrestricted
areas without being monitored.

(E) Radiation Monitors: For all irradiators, the licensee shall evaluate the location and
sensitivity of the monitor to detect sources carried by the product conveyor system as required
by 105 CMR 120.649(A). The licensee shall verify that the product conveyor is designed to stop
before a source on the product conveyor would cause a radiation overexposure to any person.
For pool irradiators, if the licensee uses radiation monitors to detect contamination under
105 CMR 120.679(B), the licensee shall verify that the design of radiation monitoring systems
to detect pool contamination includes sensitive detectors located close to where contamination
is likely to concentrate.

(F) Source Rack: For pool irradiators, the licensee shall verify that there are no crevices on the
source or between the source and source holder that would promote corrosion on a critical area
of the source. For panoramic irradiators, the licensee shall determine that source rack drops due
to loss of power will not damage the source rack and that source rack drops due to failure of
cables (or alternate means of support) will not cause loss of integrity of sealed sources. For
panoramic irradiators, the licensee shall review the design of the mechanism that moves the
sources to assure that the likelihood of a stuck source is low and that, if the rack sticks, a means
exists to free it with minimal risk to personnel.

(G) Access Control: For panoramic irradiators, the licensee shall verify from the design and
logic diagram that the access control system will meet the requirements of 105 CMR 120.643.

(H) Fire Protection: For panoramic irradiators, the licensee shall verify that the number,
locations, and spacing of the smoke and heat detectors are appropriate to detect fires and that the
detectors are protected from mechanical and radiation damage. The licensee shall verify that the
design of the fire extinguishing system provides the necessary discharge patterns, densities, and
flow characteristics for complete coverage of the radiation room and that the system is protected
from mechanical and radiation damage.

(I) Source Return: For panoramic irradiators, the licensee shall verify that the source rack will
automatically return to the fully shielded position if offsite power is lost for more than ten
seconds.

(J) Seismic: For panoramic irradiators to be built in seismic areas, the licensee shall design the
reinforced concrete radiation shields to retain their integrity in the event of an earthquake by
designing to the seismic requirements of an appropriate source such as American Concrete
Institute Standard ACI 318-89, Building Code Requirements for Reinforced Concrete, Chapter
21, Special Provisions for Seismic Design, or local building codes, if current.

(K) Wiring: For panoramic irradiators, the licensee shall verify that electrical wiring and
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

electrical equipment in the radiation room are selected to minimize failures due to prolonged
exposure to radiation.

120.661: Construction Monitoring and Acceptance Testing

The requirements of 105 CMR 120.661 must be met for irradiators whose construction began
after July 1, 1993. The requirements must be met prior to loading sources.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.661: continued

(A) Shielding: For panoramic irradiators, the licensee shall monitor the construction of the
shielding to verify that its construction meets design specifications and generally accepted
building code requirements for reinforced concrete.

(B) Foundations: For panoramic irradiators, the licensee shall monitor the construction of the
foundations for verify that their construction meets design specifications.

(C) Pool Integrity: For pool irradiators, the licensee shall verify that the pool meets design
specifications and shall test the integrity of the pool. The licensee shall verify that outlets and
pipes meet the requirements of 105 CMR 120.653(B).

(D) Water Handling System: For pool irradiators, the licensee shall verify that the water
purification system, the conductivity meter, and the water level indicators operate properly.

(E) Radiation Monitors: For all irradiators, the licensee shall verify the proper operation of the
monitor to detect sources carried on the product conveyor system and the related alarms and
interlocks required by 105 CMR 120.649(A). For pool irradiators, the licensee shall verify the
proper operation of the radiation monitors and the related alarm if used to meet 105 CMR
120.679(B). For underwater irradiators, the licensee shall verify the proper operation of the over-
the-pool monitor, alarms, and interlocks required by 105 CMR 120.649(B).

(F) Source Rack: For panoramic irradiators, the licensee shall test the movement of the source
racks for proper operation prior to source loading; testing must include source rack lowering due
to simulated loss of power. For all irradiators with product conveyor systems, the licensee shall
observe and test the operation of the conveyor system to assure that the requirements in 105
CMR 120.655 are met for protection of the source rack and the mechanism that moves the rack;
testing must include tests of any limit switches and interlocks used to protect the source rack and
mechanism that moves that rack from moving product carriers.

(G) Access Control: For panoramic irradiators, the licensee shall test the completed access
control system to assure that it functions as designed and that all alarms, controls, and interlocks
work properly.

(H) Fire Protection: For panoramic irradiators, the licensee shall test the ability of the heat and
smoke detectors to detect a fire, to activate alarms, and to cause the source rack to automatically
become fully shielded. The licensee shall test the operability of the fire extinguishing system.

(I) Source Return: For panoramic irradiators, the licensee shall demonstrate that the source
racks can be returned to their fully shielded positions without offsite power.

(J) Computer Systems: For panoramic irradiators that use a computer system to control the
access control system, the licensee shall verify that the access control system will operate
properly if offsite power is lost and shall verify that the computer has security features that
prevent an irradiator operator from commanding the computer to override the access control
system when it is required to be operable.

(K) Wiring: For panoramic irradiators, the licensee shall verify that the electrical wiring and
electrical equipment that were installed meet the design specifications.

120.671: Training
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(A) Before an individual is permitted to operate an irradiator without a supervisor present, the
individual must be instructed in:
(1) The fundamentals of radiation protection applied to irradiators (including the differences
between external radiation and radioactive contamination, units of radiation dose, dose
limits, why large radiation doses must be avoided, how shielding and access controls prevent
large doses, how an irradiator is designed to prevent contamination, the proper use of survey
meters and personnel dosimeters, other radiation safety features of an irradiator, and the basic
function of the irradiator);
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.671: continued

(2) The requirements of 105 CMR 120.620 and 120.750 that are relevant to the irradiator;
(3) The operation of the irradiator;
(4) Those operating, safety, and emergency procedures listed in 105 CMR 120.673 that the
individual is responsible for performing; and
(5) Case histories of accidents or problems involving irradiators.

(B) Before an individual is permitted to operate an irradiator without a supervisor present, the
individual shall pass a written test on the instruction received consisting primarily of questions
based on the licensee's operating, safety, and emergency procedures that the individual is
responsible for performing and other operations necessary to safely operate the irradiator without
supervision.

(C) Before an individual is permitted to operate an irradiator without a supervisor present, the
individual must have received on-the-job training or simulator training in the use of the irradiator
as described in the license application. The individual shall also demonstrate the ability to
perform those portions of the operating, safety, and emergency procedures that he or she is to
perform.

(D) The licensee shall conduct safety reviews for irradiator operators at least annually. The
licensee shall give each operator a brief written test on the information. Each safety review must
include, to the extent appropriate, each of the following:
(1) Changes in operating, safety, and emergency procedures since the last review, if any;
(2) Changes in rules and license conditions since the last review, if any;
(3) Reports on recent accidents, mistakes, or problems that have occurred at irradiators, if
any;
(4) Relevant results of inspections of operator safety performance;
(5) Relevant results of the facility's inspection and maintenance checks; and
(6) A drill to practice an emergency or abnormal event procedure.

(E) The licensee shall evaluate the safety performance of each irradiator operator at least
annually to ensure that regulations, license conditions, and operating, safety, and emergency
procedures are followed. The licensee shall discuss the results of the evaluation with the
operator and shall instruct the operator on how to correct any mistakes or deficiencies observed.

(F) Individuals who will be permitted unescorted access to the radiation room of the irradiator
or the area around the pool of an underwater irradiator, but who have not received the training
required for operators and the radiation safety officer, shall be instructed and tested in any
precautions they should take to avoid radiation exposure, any procedures or parts of procedures
listed in 105 CMR 120.673 that they are expected to perform or comply with, and their proper
response to alarms required in this part. Tests may be oral.

(G) Individuals who must be prepared to respond to alarms required by 105 CMR 120.643(B)
and (I), 105 CMR 120.647(A), 120.649(A) and (B), and 120.679(B) shall be trained and tested
on how to respond. Each individual shall be retested at least once a year. Tests may be oral.

120.673: Operating, Safety, and Emergency Procedures

(A) The licensee shall have and follow written operating procedures for:
(1) Operation of the irradiator, including entering and leaving the radiation room;
(2) Use of personnel dosimeters;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(3) Surveying the shielding of panoramic irradiators;

(4) Monitoring pool water for contamination while the water is in the pool and before
release of pool water to unrestricted areas;
(5) Leak testing of sources;
(6) Inspection and maintenance checks required by 105 CMR 120.681;
(7) Loading, unloading, and repositioning sources, if the operations will be performed by
the licensee; and,
(8) Inspection of movable shielding required by 105 CMR 120.643(H), if applicable.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.673: continued

(B) The licensee shall have and follow emergency or abnormal event procedures, appropriate
for the irradiator type, for:
(1) Sources stuck in the unshielded position;
(2) Personnel overexposures;
(3) A radiation alarm from the product exit portal monitor or pool monitor;
(4) Detection of leaking sources, pool contamination, or alarm caused by contamination of
pool water;
(5) A low or high water level indicator, an abnormal water loss, or leakage from the source
storage pool;
(6) A prolonged loss of electrical power;
(7) A fire alarm or explosion in the radiation room;
(8) An alarm indicating unauthorized entry into the radiation room, area around pool, or
another alarmed area;
(9) Natural phenomena, including an earthquake, a tornado, flooding, or other phenomena
as appropriate for the geographical location of the facility; and,
(10) The jamming of automatic conveyor systems.

(C) The licensee may revise operating, safety, and emergency procedures without Agency
approval only if all of the following conditions are met:
(1) The revisions do not reduce the safety of the facility;
(2) The revisions are consistent with the outline or summary of procedures submitted with
the license application;
(3) The revisions have been reviewed and approved by the radiation safety officer; and
(4) The users or operators are instructed and tested on the revised procedures before they
are put into use.

120.675: Personnel Monitoring

(A) Irradiator operators shall wear a personnel dosimeter that is processed and evaluated by an
accredited National Voluntary Laboratory Accreditation Program (NVLAP) processor while
operating a panoramic irradiator or while in the area around the pool of an underwater irradiator.
The personnel dosimeter processor must be accredited by the National Voluntary Laboratory
Accreditation Program for high energy photons in the normal and accident dose ranges) see 105
CMR 120.225(C)). Each personnel dosimeter must be assigned to and worn by only one
individual. Film badges must be processed at least monthly, and other personnel dosimeters
must be processed at least quarterly.

(B) Other individuals who enter the radiation room of a panoramic irradiator shall wear a
dosimeter, which may be a pocket dosimeter. For groups of visitors, only two people who enter
the radiation room are required to wear dosimeters. If pocket dosimeters are used to meet the
requirements of 105 CMR 120 675(B), a check of their response to radiation must be done at
least annually. Acceptable dosimeters must read within ±30% of the true radiation dose.

120.677: Radiation Surveys

(A) A radiation survey of the area outside the shielding of the radiation room of a panoramic
irradiator must be conducted with the sources in the exposed position before the facility starts
to operate. A radiation survey of the area above the pool of pool irradiators must be conducted
after the sources are loaded but before the facility starts to operate. Additional radiation surveys
of the shielding must be performed at intervals not to exceed three years and before resuming
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

operation after addition of new sources or any modification to the radiation room shielding or
structure that might increase dose rates.

(B) If the radiation levels specified in 105 CMR 120.645 are exceeded, the facility must be
modified to comply with the requirements in 105 CMR 120.645.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.677: continued

(C) Portable radiation survey meters must be calibrated at least annually to an accuracy of ±20%
for the gamma energy of the sources in use. The calibration must be done at two points on each
scale or, for digital instruments, at one point per decade over the range that will be used.
Portable radiation survey meters must be of a type that does not saturate and read zero at high
radiation dose rates.

(D) Water from the irradiator pool, other potentially contaminated liquids, and sediments from
pool vacuuming must be monitored for radioactive contamination before release to unrestricted
areas. Radioactive concentrations must not exceed those specified in 105 CMR 120.296:
Appendix B, Table II, Column 2 or Table III, Annual Limits on Intake (ALIs) and Derived Air
Concentrations (DACs) of Radionuclides for Occupational Exposure; Effluent Concentrations;
Concentrations for Release to Sewerage.

(E) Before releasing resins for unrestricted use, they must be monitored before release in an area
with a background level less than 0.5 microsievert (0.05 millirem) per hour. The resins may be
released only if the survey does not detect radiation levels above background radiation levels.
The survey meter used must be capable of detecting radiation levels of 0.5 microsievert (0.05
millirem) per hour.

120.679: Detection of Leaking Sources

(A) Each dry-source-storage sealed source must be tested for leakage at intervals not to exceed
six months using a leak test kit or method approved by the Agency, the Commission, an
Agreement State, or a Licensing State. In the absence of a certificate from a transferor that a test
has been made within the six months before the transfer, the sealed source may not be used until
tested. The test must be capable of detecting the presence of 200 becquerels (0.005 microcurie)
of radioactive material and must be performed by a person approved by the Agency, the
Commission, an Agreement State, or a Licensing State to perform the test.

(B) For pool irradiators, sources may not be put into the pool unless the licensee tests the
sources for leaks or has a certificate from a transferor that leak test has been done within the six
months before the transfer. Water from the pool must be checked for contamination each day
the irradiator operates. The check may be done either by using a radiation monitor on a pool
water circulating system or by analysis of a sample of pool water. If a check for contamination
is done by analysis of a sample of pool water, the results of the analysis must be available within
24 hours. If the licensee uses a radiation monitor on a pool water circulating system, the
detection of above normal radiation levels must activate an alarm. The alarm set-point must be
set as low as practical, but high enough to avoid false alarms. The licensee may reset the alarm
set-point to a higher level if necessary to operate the pool water purification system to clear up
contamination in the pool if specifically provided for in written emergency procedures.

(C) If a leaking source is detected, the licensee shall arrange to remove the leaking source from
service and have it decontaminated, repaired, or disposed of by an Agency, Commission,
Agreement State, or Licensing State licensee that is authorized to perform these functions. The
licensee shall promptly check its personnel, equipment, facilities, and irradiated product for
radioactive contamination. No product may be shipped until the product has been checked and
found free of contamination. If a product has been shipped that may have been inadvertently
contaminated, the licensee shall arrange to locate and survey that product for contamination. If
any personnel are found to be contaminated, decontamination must be performed promptly. If
contaminated equipment, facilities, or products are found, the licensee shall arrange to have them
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

decontaminated or disposed of by an Agency, Commission, Agreement State, or Licensing State

licensee that is authorized to perform these functions. If a pool is contaminated, the licensee
shall arrange to clean the pool until the contamination levels do not exceed the appropriate
concentration in 105 CMR 120.296: Appendix B, Table II, Column 2. (See 105 CMR 120.282
for reporting requirements.)
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.681: Inspection and Maintenance

(A) The licensee shall perform inspection and maintenance checks that include, as a minimum,
each of the following at the frequency specified in the license or license application:
(1) Operability of each aspect of the access control system required by 105 CMR 120.643.
(2) Functioning of the source position indicator required by 105 CMR 120.651(B).
(3) Operability of the radiation monitor for radioactive contamination in pool water required
by 105 CMR 120.679(B) using a radiation check source, if applicable.
(4) Operability of the over-pool radiation monitor at underwater irradiators as required by
105 CMR 120.649(B).
(5) Operability of the product exit monitor required by 105 CMR 120.649(A).
(6) Operability of the emergency source return control required by 105 CMR 120.651(C).
(7) Leak-tightness of systems through which pool water circulates (visual inspection).
(8) Operability of the heat and smoke detectors and extinguisher system required by 105
CMR 120.647 (but without turning extinguishers on).
(9) Operability of the means of pool water replenishment required by 105 CMR 120.653(C).
(10) Operability of the indicators of high and low pool water levels required by 105 CMR
120.653(D).
(11) Operability of the intrusion alarm required by 105 CMR 120.643(I), if applicable.
(12) Functioning and wear of the system, mechanisms, and cables used to raise and lower
sources.
(13) Condition of the barrier to prevent products from hitting the sources or source
mechanism as required by 105 CMR 120.655.
(14) Amount of water added to the pool to determine if the pool is leaking.
(15) Electrical wiring on required safety systems for radiation damage.
(16) Pool water conductivity measurements and analysis as required by 105 CMR
120.683(B).

(B) Malfunctions and defects found during inspection and maintenance checks must be repaired
without undue delay.

120.683: Pool Water Purity

(A) Pool water purification system must be run sufficiently to maintain the conductivity of the
pool water below 20 microsiemens per centimeter under normal circumstances. If pool water
conductivity rises above 20 microsiemens per centimeter, the licensee shall take prompt actions
to lower the pool water conductivity and shall take corrective actions to prevent future
recurrences.

(B) The licensee shall measure the pool water conductivity frequently enough, but no less than
weekly, to assure that the conductivity remains below 20 microsiemens per centimeter.
Conductivity meters must be calibrated at least annually.

120.685: Attendance During Operation

(A) Both an irradiator operator and at least one other individual, who is trained on how to
respond and prepared to promptly render or summon assistance if the access control alarm
sounds, shall be present onsite:
(1) Whenever the irradiator is operated using an automatic product conveyor system; and
(2) Whenever the product is moved into or out of the radiation room when the irradiator is
operated in a batch mode.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(B) At a panoramic irradiator at which static irradiations (no movement of the product) are
occurring, a person who has received the training on how to respond to alarms described in 105
CMR 120.671(G) must be onsite.

(C) At an underwater irradiator, an irradiator operator must be present at the facility whenever
the product is moved into or out of the pool. Individuals who move the product into or out of
the pool of an underwater irradiator need not be qualified as irradiator operators; however, they
must have received the training described in 105 CMR 120.671(F) and (G). Static irradiations
may be performed without a person present at the facility.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.687: Entering and Leaving the Radiation Room

(A) Upon first entering the radiation room of a panoramic irradiator after an irradiation, the
irradiator operator shall use a survey meter to determine that the source has returned to its fully
shielded position. The operator shall check the functioning of the survey meter with a radiation
check source prior to entry.

(B) Before exiting from and locking the door to the radiation room of a panoramic irradiator
prior to a planned irradiation, the irradiator operator shall:
(1) Visually inspect the entire radiation room to verify that no one else is in it; and
(2) Activate a control in the radiation room that permits the sources to be moved from the
shielded position only if the door to the radiation room is locked within a preset time after
setting the control.

(C) During a power failure, the area around the pool of an underwater irradiator may not be
entered without using an operable and calibrated radiation survey meter unless the over-the-pool
monitor required by 105 CMR 120.649(B) is operating with backup power.

120.689: Irradiation of Explosive or Flammable Materials

(A) Irradiation of explosive material is prohibited unless the licensee has received prior written
authorization from the Agency. Authorization will not be granted unless the licensee can
demonstrate that detonation of the explosive would not rupture the sealed sources, injure
personnel, damage safety systems, or cause radiation overexposures of personnel.

(B) Irradiation of more than small quantities of flammable material (flash point below 140°F)
is prohibited in panoramic irradiators unless the licensee has received prior written authorization
from the Agency. Authorization will not be granted unless the licensee can demonstrate that a
fire in the radiation room could be controlled without damage to sealed sources or safety systems
and without radiation overexposures of personnel.

120.691 Records and Retention Periods

The licensee shall maintain the following records at the irradiator for the periods specified.

(A) A copy of the license, license conditions, documents incorporated into a license by
reference, and amendments thereto until superseded by new documents or until the Agency
terminates the license for documents not superseded.

(B) Records of each individual's training, tests, and safety reviews provided to meet the
requirements of 105 CMR 120.671(A), (B), (C), (D), (F), and (G) until three years after the
individual terminates work.

(C) Records of the annual evaluations of the safety performance of irradiator operators required
by 105 CMR 120.671(E) for three years after the evaluation.

(D) A copy of the current operating, safety, and emergency procedures required by 105 CMR
120.673 until superseded or the Agency terminates the license. Records of the radiation safety
officer's review and approval of changes in procedures as required by 105 CMR 120.673(C)(3)
retained for three years from the date of the change.

(E) Evaluations of personnel dosimeters required by 105 CMR 120.675 until the Agency
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

terminates the license.

(F) Records of radiation surveys required by 105 CMR 120.677 for three years from the date
of the survey.

(G) Records of radiation survey meter calibrations required by 105 CMR 120.677 and pool
water conductivity meter calibrations required by 105 CMR 120.683(B) until three years from
the date of calibration.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.691: continued

(H) Records of the results of leak tests required by 105 CMR 120.679(A) and the results of
contamination checks required by 105 CMR 120.679(B) for five years from the date of each test.

(I) Records of inspection and maintenance checks required by 105 CMR 120.681 for three
years.

(J) Records of major malfunctions, significant defects, operating difficulties or irregularities,

and major operating problems that involve required radiation safety equipment for three years
after repairs are completed.

(K) Records of the receipt, transfer and disposal, of all licensed sealed sources as required by
105 CMR 120.009 and 120.140.

(L) Records on the design checks required by 105 CMR 120.659 and the construction control
checks as required by 105 CMR 120.661 until the license is terminated. The records must be
signed and dated. The title or qualification of the person signing must be included.

(M) Records related to decommissioning of the irradiator as required by 105 CMR

120.125(C)(1)(g).

120.693: Reports

(A) In addition to the reporting requirements in other parts of 105 CMR 120.000, the licensee
shall report the following events if not reported under other parts of 105 CMR 120.000:
(1) Source stuck in an unshielded position.
(2) Any fire or explosion in a radiation room.
(3) Damage to the source racks.
(4) Failure of the cable or drive mechanism used to move the source racks.
(5) Inoperability of the access control system.
(6) Detection of radiation source by the product exit monitor.
(7) Detection of radioactive contamination attributable to licensed radioactive material.
(8) Structural damage to the pool liner or walls.
(9) Abnormal water loss or leakage from the source storage pool.
(10) Pool water conductivity exceeding 100 microsiemens per centimeter.

(B) The report must include a telephone report within 24 hours as described in 105 CMR
120.142(C)(1), and a written report within 30 days as described in 105 CMR 120.142(C)(2).

120.700: RADIATION SAFETY REQUIREMENTS FOR PARTICLE ACCELERATORS

120.701: Purpose and Scope

(A) 105 CMR 120.700 establishes procedures for the registration and the use of particle
accelerators.

(B) In addition to the requirements of 105 CMR 120.700, all registrants are subject to the
requirements of 105 CMR 120.001, 120.020, 120.750, 120.100 and 120.200. Registrants
engaged in industrial radiographic operations are subject to the requirements of 105 CMR
120.300, and registrants engaged in the healing arts are subject to the requirements of 105 CMR
120.430 and/or 105 CMR 120.500, and registrants engaged in wireline operations are subject to
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

105 CMR 120.900. Registrants whose operations result in the production of radioactive material
are subject to the requirements of 105 CMR 120.100.

120.702: Registration Requirements

No person shall receive, possess, use, transfer, own, or acquire a particle accelerator except
as authorized in a registration issued pursuant to 105 CMR 120.020 or 120.100.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.703: General Requirements for the Issuance of a Registration for Particle Accelerators

In addition to the requirements of 105 CMR 120.020 or 120.100, a registration application

for use of a particle accelerator will be approved only if the Agency determines that:

(A) The applicant is qualified by reason of training and experience to use the accelerator in
question for the purpose requested in accordance with 105 CMR 120.700, 120.200 and 120.750
in such a manner as to minimize danger to public health and safety or property;

(B) The applicant's proposed or existing equipment, facilities, and operating and emergency
procedures are adequate to protect health and minimize danger to public health and safety or
property;

(C) The issuance of the registration will not be inimical to the health and safety of the public,
and the applicant satisfies any applicable special requirement in 105 CMR 120.704;

(D) The applicant has appointed a radiation safety officer;

(E) The applicant and/or the applicant's staff has substantial experience in the use of particle
accelerators and training sufficient for application to its intended uses;

(F) The applicant has established a radiation safety committee to approve, in advance, proposals
for uses of particle accelerators, whenever deemed necessary by the Agency; and,

(G) The applicant has an adequate training program for operators of particle accelerators.

120.704: Human Use of Particle Accelerators

In addition to the requirements of 105 CMR 120.020, a registration for use of a particle
accelerator in the healing arts will be issued only if the applicant or registrant meets the
requirements of 105 CMR 120.430 “THERAPEUTIC RADIATION MACHINES”.

120.705: Limitations

(A) No registrant shall permit any individual to act as an operator of a particle accelerator until
such individual:
(1) Has been instructed in radiation safety and shall have demonstrated an understanding
thereof;
(2) Has received copies of and instruction in 105 CMR 120.700 and the applicable
requirements of 105 CMR 120.200 and 120.750, pertinent registration conditions and the
registrant's operating and emergency procedures, and shall have demonstrated understanding
thereof; and,
(3) Has demonstrated competence to use the particle accelerator, related equipment, and
survey instruments which will be employed.

(B) The radiation safety committee or the radiation safety officer shall have the authority to
terminate the operations at a particle accelerator facility if such action is deemed necessary to
minimize danger to public health and safety or property.

120.706: Shielding and Safety Design Requirements

(A) A qualified expert, acceptable to the Agency, shall be consulted in the design of a particle
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

accelerator installation and called upon to perform a radiation survey when the accelerator is first
capable of producing radiation.

(B) Each particle accelerator installation shall be provided with such primary and/or secondary
barriers as are necessary to assure compliance with 105 CMR 120.211 and 120.221.

120.707: Particle Accelerator Controls and Interlock Systems

(A) Instrumentation, readouts, and controls on the particle accelerator control console shall be
clearly identified and easily discernible.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.707: continued

(B) Each entrance into a target room or other high radiation area shall be provided with a safety
interlock that shuts down the machine under conditions of barrier penetration.

(C) Each safety interlock shall be on a circuit which shall allow it to operate independently of
all other safety interlocks.

(D) All safety interlocks shall be designed so that any defect or component failure in the safety
interlock system prevents operation of the accelerator.

(E) When a safety interlock system has been tripped, it shall only be possible to resume
operation of the accelerator by manually resetting controls at the position where the safety
interlock has been tripped and, lastly, at the main control console.

(F) A scram button or other emergency power cutoff switch shall be located and easily
identifiable in all high radiation areas. Such a cutoff switch shall include a manual reset so that
the accelerator cannot be restarted from the accelerator control console without resetting the
cutoff switch.

120.708: Warning Devices

(A) Each location designated as high radiation area, and each entrance to such location, shall
be equipped with easily observable warning lights that operate when, and only when, radiation
is being produced.

(B) Except in facilities designed for human exposure, each high radiation area shall have an
audible warning device which shall be activated for 15 seconds prior to the possible creation of
prompt radiation. Such warning device shall be clearly discernible in all high radiation areas.

(C) Barriers, temporary or otherwise, and pathways leading to high radiation areas shall be
posted in accordance with 105 CMR 120.227 and 120.247.

120.709: Operating Procedures

(A) Particle accelerators, when not in operation, shall be secured to prevent unauthorized use.

(B) The safety interlock system shall not be used to turn off the accelerator beam except in an
emergency.

(C) All safety and warning devices, including interlocks, shall be checked for proper operation
at intervals not to exceed three months. Results of such tests shall be maintained at the
accelerator facility for inspection by the Agency.

(D) Electrical circuit diagrams of the accelerator and the associated safety interlock systems
shall be kept current and maintained for inspection by the Agency and shall be available to the
operator at each accelerator facility.

(E) If, for any reason, it is necessary to intentionally bypass a safety interlock or interlocks, such
action shall be:
(1) Authorized by the radiation safety committee and/or radiation safety officer;
(2) Recorded in a permanent log and a notice posted at the accelerator control console; and,
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(3) Terminated as soon as possible.

(F) A copy of the current operating and the emergency procedures shall be maintained at the
accelerator control panel.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.710: Radiation Monitoring Requirements

(A) There shall be available at each particle accelerator facility appropriate portable monitoring
equipment which is operable and has been appropriately calibrated for the radiations being
produced at the facility. Such equipment shall be tested for proper operation before use or once
every three months, whichever is the lesser.

(B) A radiation protection survey shall be performed and documented by a qualified expert,
acceptable to the Agency, when changes have been made in shielding, operation, equipment, or
occupancy of adjacent areas.

(C) Radiation levels in all high radiation areas shall be continuously monitored. The
monitoring devices shall be electrically independent of the accelerator control and safety
interlock systems and capable of providing a readout at the control panel.

(D) All area monitors shall be calibrated at intervals not to exceed one year and after each
servicing and repair.

(E) Whenever applicable, periodic surveys shall be made to determine the amount of airborne
particulate radioactivity present.

(F) Whenever applicable, periodic smear surveys shall be made to determine the degree of
contamination.

(G) All surveys shall be made in accordance with the written procedures established by a
qualified expert, acceptable to the Agency, or the radiation safety officer.

(H) Records of all radiation protection surveys, calibrations, and instrumentation tests shall be
maintained at the accelerator facility for inspection by the Agency.

120.711: Ventilation Systems

(A) Ventilation systems shall be provided to ensure that personnel entering any area where
airborne radioactivity may be produced will not be exposed to airborne radioactive material in
excess of those limits specified in 120.296: Appendix B, Table I.

(B) A registrant, as required by 105 CMR 120.221, shall not vent, release, or otherwise
discharge airborne radioactive material to an unrestricted area which exceeds the limits specified
in 105 CMR 120.296: Appendix B, Table II, except as authorized pursuant to 105 CMR
120.221(A)(3) or 120.222(C). For purposes of 105 CMR 120.711(B), concentrations may be
averaged over a period not greater than one year. Every effort should be made to maintain
releases of radioactive material to unrestricted areas as far below these limits as is reasonably
achievable.

120.750: NOTICES, INSTRUCTIONS, AND REPORTS TO WORKERS; INSPECTIONS

120.751: Purpose and Scope

105 CMR 120.750 establishes requirements for notices, instructions and reports by licensees
or registrants to individuals engaged in activities under a license or registration and options
available to such individuals in connection with Agency inspections of licensees or registrants
to ascertain compliance with the provisions of M.G.L. c. 111, §§ 3, 5M, 5N, 5O, and 5P and
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

regulations, orders, and licenses issued thereunder regarding radiological working conditions.
105 CMR 120.750 applies to all persons who receive, possess, use, own, or transfer sources of
radiation registered with or licensed by the Agency pursuant to 105 CMR 120.020 and 105 CMR
120.100.

120.752: Posting of Notices to Workers

(A) Each licensee or registrant shall post current copies of the following documents:
(1) 105 CMR 120.750 and in 105 CMR 120.200;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.752: continued

(2) The license, certificate of registration, conditions or documents incorporated into the
license by reference and amendments thereto;
(3) The operating procedures applicable to activities under the license or registration; and,
(4) Any notice of violation involving radiological working conditions, proposed imposition
of civil penalty, or order issued pursuant to 105 CMR 120.001, and any response from the
licensee or registrant.

(B) If posting of a document specified in 105 CMR 120.752(A)(1), (2), or (3) is not practicable,
the licensee or registrant may post a notice which describes the document and states where it may
be examined.

(C) Form MRCP 120.750-1 "Notice to Employees" shall be posted by each licensee or
registrant as required by 105 CMR 120.000.

(D) Agency documents posted pursuant to 105 CMR 120.752(A)(4) shall be posted within
five working days after receipt of the documents from the Agency; the licensee's or registrant's
response, if any, shall be posted within five working days after dispatch from the licensee or
registrant. Such documents shall remain posted for a minimum of five working days or until
action correcting the violation has been completed, whichever is later.

(E) Documents, notices, or forms posted pursuant to 105 CMR 120.752 shall appear in a
sufficient number of places to permit individuals engaged in work under the license or
registration to observe them on the way to or from any particular work location to which the
document applies, shall be conspicuous, and shall be replaced if defaced or altered.

120.753: Instructions to Workers

(A) All individuals who in the course of employment are likely to receive in a year an
occupational dose in excess of one mSv (100 mrem)
(1) shall be kept informed of the storage, transfer, or use of sources of radiation in the
licensee's or registrant's workplace;
(2) shall be instructed in the health protection problems associated with exposure to
radiation or radioactive material to the individual and potential offspring, in precautions or
procedures to minimize exposure, and in the purposes and functions of protective devices
employed;
(3) Shall be instructed in, and instructed to observe, to the extent within the worker's
control, the applicable provisions of 105 CMR 120.000 and licenses for the protection of
personnel from exposures to radiation or radioactive material;
(4) Shall be instructed of their responsibility to report promptly to the licensee or registrant
any condition which may constitute, lead to, or cause a violation of the Act, 105 CMR
120.000, and licenses or unnecessary exposure to radiation or radioactive material;
(5) Shall be instructed in the appropriate response to warnings made in the event of any
unusual occurrence or malfunction that may involve exposure to radiation or radioactive
material; and,
(6) Shall be advised as to the radiation exposure reports which workers shall be furnished
pursuant to 105 CMR 120.754.

(B) In determining those individuals subject to the requirements of 105 CMR 120.753(A),
licensees must take into consideration assigned activities during normal and abnormal situations
involving exposure to radiation and/or radioactive material which can reasonably be expected
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

to occur during the life of a licensed facility. The extent of these instructions shall be
commensurate with potential radiological health protection problems present in the workplace.

120.754: Notifications and Reports to Individuals

(A) Radiation exposure data for an individual and the results of any measurements, analyses,
and calculations of radioactive material deposited or retained in the body of an individual shall
be reported to the individual as specified in 105 CMR 120.750. The information reported shall
include data and results obtained pursuant to 105 CMR 120.000, orders, or license conditions,
as shown in records maintained by the licensee or registrant pursuant to 105 CMR 120.267.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.754: continued

Each notification and report shall:

(1) Be in writing;
(2) Include appropriate identifying data such as the name of the licensee or registrant, the
name of the individual, and the individual's social security number;
(3) Include the individual's exposure information; and,
(4) Contain the following statement:
"This report is furnished to you under the provisions of 105 CMR 120.750. You should
preserve this report for future reference."

(B) Each licensee or registrant shall furnish to each worker annually a written report of the
worker's exposure to radiation or radioactive material as shown in records maintained by the
licensee or registrant pursuant to 105 CMR 120.267. The licensee shall provide an annual report
to each individual monitored under 105 CMR 120.226 of the dose received in that monitoring
year if:
(1) The individual's occupational dose exceeds one mSv (100 mrem) TEDE or one mSv
(100 mrem) to any individual organ or tissue; or
(2) The individual requests his or her annual dose report.

(C) Each licensee or registrant shall furnish a written report of the worker's exposure to sources
of radiation at the request of a worker formerly engaged in activities controlled by the licensee
or registrant. The report shall include the dose record for each year the worker was required to
be monitored pursuant to 105 CMR 120.226. Such report shall be furnished within 30 days from
the date of the request, or within 30 days after the dose of the individual has been determined by
the licensee or registrant, whichever is later. The report shall cover the period of time that the
worker's activities involved exposure to sources of radiation and shall include the dates and
locations of work under the license or registration in which the worker participated during this
period.

(D) When a licensee or registrant is required pursuant to 105 CMR 120.282, 120.283 or
120.284 to report to the Agency any exposure of an individual to radiation or radioactive
material, the licensee or the registrant shall also provide the individual a report on his or her
exposure data included in the report to the Agency. Such reports shall be transmitted at a time
not later than the transmittal to the Agency.

(E) At the request of a worker who is terminating employment with the licensee or registrant
in work involving exposure to radiation or radioactive material, during the current year, each
licensee or registrant shall provide at termination to each such worker, or to the worker's
designee, a written report regarding the radiation dose received by that worker from operations
of the licensee or registrant during the current year or fraction thereof. If the most recent
individual monitoring results are not available at that time, a written estimate of the dose shall
be provided together with a clear indication that this is an estimate.

120.755: Presence of Representatives of Licensees or Registrants and Workers During Inspection

(A) Each licensee or registrant shall afford to the Agency at all reasonable times opportunity
to inspect materials, machines, activities, facilities, premises, and records pursuant to 105 CMR
120.000.

(B) During an inspection, Agency inspectors may consult privately with workers as specified
in 105 CMR 120.756. The licensee or registrant may accompany Agency inspectors during other
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

phases of an inspection.

(C) If, at the time of inspection, an individual has been authorized by the workers to represent
them during Agency inspections, the licensee or registrant shall notify the inspectors of such
authorization and shall give the workers' representative an opportunity to accompany the
inspectors during the inspection of physical working conditions.

(D) Each worker’s representative shall be routinely engaged in work under control of the
licensee or registrant and shall have received instructions as specified in 105 CMR 120.753.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.755: continued

(E) Different representatives of licensees or registrants and workers may accompany the
inspectors during different phases of an inspection if there is no resulting interference with the
conduct of the inspection. However, only one workers' representative at a time may accompany
the inspectors.

(F) With the approval of the licensee or registrant and the workers' representative, an individual
who is not routinely engaged in work under control of the licensee or registrant, for example, a
consultant to the licensee or registrant or to the workers' representative, shall be afforded the
opportunity to accompany Agency inspectors during the inspection of physical working
conditions.

(G) Notwithstanding the other provisions of 105 CMR 120.755, Agency inspectors are
authorized to refuse to permit accompaniment by any individual who deliberately interferes with
a fair and orderly inspection. With regard to areas containing information classified by an
agency of the U.S. Government in the interest of national security, an individual who
accompanies an inspector may have access to such information only if authorized to do so. With
regard to any area containing proprietary information, the workers' representative for that area
shall be an individual previously authorized by the licensee or registrant to enter that area.

120.756: Consultation with Workers During Inspections

(A) Agency inspectors may consult privately with workers concerning matters of occupational
radiation protection and other matters related to applicable provisions of 105 CMR 120.000 and
licenses to the extent the inspectors deem necessary for the conduct of an effective and thorough
inspection.

(B) During the course of an inspection, any worker may bring privately to the attention of the
inspectors, either orally or in writing, any past or present condition which the worker has reason
to believe may have contributed to or caused any violation of M.G.L. c. 111, §§, 5N, and 5P, 105
CMR 120.000, or license condition, or any unnecessary exposure of an individual to sources of
radiation under the licensee's or registrant's control. Any such notice in writing shall comply
with the requirements of 105 CMR 120.757(A).

(C) The provisions of 105 CMR 120.756(B) shall not be interpreted as authorization to
disregard instructions pursuant to 105 CMR 120.753.

120.757: Requests by Workers for Inspections

(A) Any worker or representative of workers believing that a violation of the Act, 105 CMR
120.000, or license conditions exists or has occurred in work under a license or registration with
regard to radiological working conditions in which the worker is engaged may request an
inspection by giving notice of the alleged violation to the Agency. Any such notice shall be in
writing, shall set forth the specific grounds for the notice, and shall be signed by the worker or
representative of the workers. A copy shall be provided to the licensee or registrant by the
Agency no later than at the time of inspection except that, upon the request of the worker giving
such notice, his name and the name of individuals referred to therein shall not appear in such
copy or on any record published, released, or made available by the Agency, except for good
cause shown.

(B) If, upon receipt of such notice, the Agency determines that the complaint meets the
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

requirements set forth in 105 CMR 120.757(A), and that there are reasonable grounds to believe
that the alleged violation exists or has occurred, an inspection shall be made as soon as
practicable to determine if such alleged violation exists or has occurred. Inspections pursuant
to 105 CMR 120.757 need not be limited to matters referred to in the complaint.

(C) No licensee, registrant, or contractor or subcontractor of a licensee or registrant shall

discharge or in any manner discriminate against any worker because such worker has filed any
complaint or instituted or caused to be instituted any proceeding under 105 CMR 120.000 or has
testified or is about to testify in any such proceeding or because of the exercise by such worker
on behalf of himself or others of any option afforded by 105 CMR 120.750.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.758: Inspections not Warranted; Informal Review

(A) (1) If the Agency determines, with respect to a complaint under 105 CMR 120.757, that
an inspection is not warranted because there are no reasonable grounds to believe that a
violation exists or has occurred, the Agency shall notify the complainant in writing of such
determination. The complainant may obtain review of such determination by submitting a
written statement of position with the Department. The Department will provide the licensee
or registrant with a copy of such statement by certified mail, excluding, at the request of the
complainant, the name of the complainant. The licensee or registrant may submit an
opposing written statement of position with the Department. The Department will provide
the complainant with a copy of such statement by certified mail.
(2) Upon the request of the complainant, the Department may hold an informal conference
in which the complainant and the licensee or registrant may, orally present their views. An
informal conference may also be held at the request of the licensee or registrant, but
disclosure of the identity of the complainant will be made only following receipt of written
authorization from the complainant. After considering all written and oral views presented,
the Department shall affirm, modify, or reverse the determination of the Agency and furnish
the complainant and the licensee or registrant a written notification of the decision and the
reason therefor.

(B) If the Agency determines that an inspection is not warranted because the requirements of
105 CMR 120.757(A) have not been met, the complainant shall be notified in writing of such
determination. Such determination shall be without prejudice to the filing of a new complaint
meeting the requirements of 105 CMR 120.757(A).

120.760: Emergency Plans

The user should formulate suitable emergency plans as may be indicated to protect his
employees and the public against potential hazards due to his specific source(s), and should make
known the details and existence of such plans to the Agency and such other public agencies
having a concern; including, but not limited to, boards of health, fire departments and police
departments.

120.770: TRANSPORTATION OF RADIOACTIVE MATERIAL

120.771: Purpose and Scope

(A) 105 CMR 120.770 establishes requirements for packaging, preparation for shipment, and
transportation of licensed material.

(B) The packaging and transport of licensed material are also subject to other sections of
105 CMR 120.000 and to the regulations of other agencies (such as the United States Department
of Transportation, the United States Postal Service and the United States Nuclear Regulatory
Commission) having jurisdiction over means of transport. The requirements of 105 CMR
120.770 are in addition to, and not in substitution for, other requirements

(C) 105 CMR 120.770 applies to any licensee authorized by specific or general license issued
by the Agency to receive, possess, use, or transfer licensed material, if the licensee delivers that
material to a carrier for transport, transports the material outside the site of usage as specified in
the Agency license, or transports that material on public highways. No provision of 105 CMR
120.770 authorizes possession of licensed material.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(D) Exemptions from the requirement for license in 105 CMR 120.773 are specified in
105 CMR 120.775. General licenses for which no NRC package approval is required are issued
in 105 CMR 120.780 through 120.782. The general license in 105 CMR 120.777 requires that
an NRC certificate of compliance or other package approval be issued for the package to be used
under this general license. The transport of licensed material or delivery of licensed material to
a carrier for transport is subject to the operating control and procedures requirements of
105 CMR 120.784 through 120.790, to the quality assurance requirements of 105 CMR 120.791
through 120.797, and to the general provisions of 105 CMR 120.771 through 120.774, including
referenced United States Department of Transportation regulations.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.771: continued

(E) 105 CMR 120.770 applies to any person required to obtaina certificate of compliance or an
approved compliance plan from the NRC pursuant to 10 CFR 76 if the person delivers
radioactive material to a common or contract carrier for transport or transports the material
outside the confines of the person's plant or other authorized place of use.

120.772: Definitions

The following terms are as defined here for the purpose of 105 CMR 120.770. To ensure
compatibility with international transportation standards, all limits in this part are given in terms
of dual units: The International System of Units (SI) followed or preceded by U.S. standard or
customary units. The U.S. customary units are not exact equivalents but are rounded to a
convenient value, providing a functionally equivalent unit. For the purpose of 105 CMR
120.770, either unit may be used.

A1 means the maximum activity of special form radioactive material permitted in a Type A
package. This value is either listed in 105 CMR 120.798: Appendix A, Table A-1, or may be
derived in accordance with the procedures prescribed in 105 CMR 120.798: Appendix A.

A2 means the maximum activity of radioactive material, other than special form material, LSA,
and SCO material, permitted in a Type A package. This value is either listed in 105 CMR
120.798: Appendix A, Table A-1, or may be derived in accordance with the procedures
prescribed in 105 CMR 120.798: Appendix A.

Carrier means a person engaged in the transportation of passengers or property by land or water
as a common, contract, or private carrier, or by civil aircraft.

Certificate Holder means a person who has been issued a certificate of compliance or other
package approval by the Commission.

Certificate of Compliance (CoC) means the certificate issued by the Commission under 10 CFR
71 Subpart D which approves the design of a package for the transportation of radioactive
material.

Consignment means each shipment of a package or groups of packages or load of radioactive

material offered by a shipper for transport.

Contamination means the presence of a radioactive substance on a surface in quantities in excess

of 0.4 Bq/cm2 (1 x 10-5 :Ci/cm2) for beta and gamma emitters and low toxicity alpha emitters,
or 0.04 Bq/cm2 (1 x 10-6 :Ci/cm2) for all other alpha emitters.
(1) Fixed Contamination means contamination that cannot be removed from a surface
during normal conditions of transport.
(2) Non-fixed Contamination means contamination that can be removed from a surface
during normal conditions of transport.

Conveyance means:
(1) For transport by public highway or rail any transport vehicle or large freight container;
(2) For transport by water any vessel, or any hold, compartment, or defined deck area of a
vessel including any transport vehicle on board the vessel; and
(3) For transport by any aircraft.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Criticality Safety Index (CSI) means the dimensionless number (rounded up to the next tenth)
assigned to and placed on the label of a fissile material package, to designate the degree of
control of accumulation of packages, overpacks or freight containers containing fissile material
during transportation. Determination of the criticality safety index is described in 105 CMR
120.781 and 120.782, and 10 CFR 71.59. The criticality safety index for an overpack, freight
container, consignment or conveyance containing fissile material packages is the arithmetic sum
of the criticality safety indices of all the fissile material packages contained within the overpack,
freight container, consignment or conveyance.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.772: continued

Deuterium means, for the purposes of 10 CFR 71.15 and 71.22, deuterium and any deuterium
compounds, including heavy water, in which the ratio of deuterium atoms to hydrogen atoms
exceeds 1:5000.

DOT means the U.S. Department of Transportation.

Exclusive Use means the sole use by a single consignor of a conveyance for which all initial,
intermediate, and final loading and unloading are carried out in accordance with the direction of
the consignor or consignee. The consignor and the carrier must ensure that any loading or
unloading is performed by personnel having radiological training and resources appropriate for
safe handling of the consignment. The consignor must issue specific instructions, in writing, for
maintenance of exclusive use shipment controls, and include them with the shipping paper
information provided to the carrier by the consignor.

Fissile Material means the radionuclides uranium-233, uranium-235, plutonium-239, and

plutonium-241, or any combination of these radionuclides. Fissile material means the fissile
nuclides themselves, not material containing fissile nuclides. Unirradiated natural uranium and
depleted uranium, and natural uranium or depleted uranium that has been irradiated in thermal
reactors only are not included in 105 CMR 120.772: Fissile Material. 1 Certain exclusions from
fissile material controls are provided in 105 CMR 120.775.

Graphite means, for the purposes of 105 CMR 120.775 and 120.781, graphite with a boron
equivalent content less than five parts per million and density greater than 1.5 grams per cubic
centimeter.

Indian Tribe means an Indian or Alaska Native Tribe, band, nation, pueblo, village, or
community that the Secretary of the Interior acknowledges to exist as an Indian Tribe pursuant
to the Federally Recognized Indian Tribe List Act of 1994, 25 U.S.C. 479a.

Low Specific Activity (LSA) Material means radioactive material with limited specific activity
which is nonfissile or is excepted under 105 CMR 120.775(D), and which satisfies the
descriptions and limits set forth in 105 CMR 120.772: Low Specific Activity (LSA) Material(1)
through (3). Shielding materials surrounding the LSA material may not be considered in
determining the estimated average specific activity of the package contents. The LSA material
must be in one of three groups:
(1) LSA-I.
(a) Uranium and thorium ores, concentrates of uranium and thorium ores, and other ores
containing naturally occurring radionuclides that are intended to be processed for the use
of these radionuclides;
(b) Natural uranium, depleted uranium, natural thorium or their compounds or mixtures,
provided they are unirradiated and in solid or liquid form;
(c) Radioactive material, other than fissile material, for which the A2 value is unlimited;
or
(d) Other radioactive material in which the activity is distributed throughout and the
estimated average specific activity does not exceed 30 times the value for exempt
material activity concentration determined in accordance with 105 CMR
120.798: Appendix A.
(2) LSA-II.
(a) Water with tritium concentration up to 0.8 TBq/liter (20.0 Ci/liter); or
(b) Other radioactive material in which the activity is distributed throughout and the
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

estimated average specific activity does not exceed 10-4 A2/g for solids and gases, and 10-5
A2/g for liquids.
(3) LSA-III. Solids (e.g., consolidated wastes, activated materials), excluding powders, that
satisfy the requirements of 10 CFR 71.77, in which:

S))))))))))))))))))))))))))))))))Q
1
Agency jurisdiction extends only to “special nuclear material in quantities not sufficient to
form a critical mass” as defined in 105 CMR 120.005.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.772: continued

(a) The radioactive material is distributed throughout a solid or a collection of solid

objects, or is essentially uniformly distributed in a solid compact binding agent (such as
concrete, bitumen, ceramic, etc.);
(b) The radioactive material is relatively insoluble, or it is intrinsically contained in a
relatively insoluble material, so that, even under loss of packaging, the loss of radioactive
material per package by leaching, when placed in water for seven days, will not exceed
0.1 A2; and
(c) The estimated average specific activity of the solid, excluding any shielding
material, does not exceed 2 x 10-3 A2/g.

Low Toxicity Alpha Emitters means natural uranium, depleted uranium, natural thorium;
uranium-235, uranium-238, thorium-232, thorium-228 or thorium-230 when contained in ores
or physical or chemical concentrates; or alpha emitters with a half-life of less than ten days.

Maximun Normal Operating Pressure means the maximum gauge pressure that would develop
in the containment system in a period of one year under the heat condition specified in 10 CFR
71.71(c)(1), in the absence of venting, external cooling by an ancillary system, or operational
controls during transport.

Natural Thorium means thorium with the naturally occurring distribution of thorium isotopes
(essentially 100 weight percent thorium-232).

Normal Form Radioactive Material means radioactive material which has not been demonstrated
to qualify as special form radioactive material.

Nuclear Waste means a quantity of source, byproduct or special nuclear material required to be
in US Nuclear Regulatory Commission-approved specification packaging while transported to,
through or across a state boundary to a disposal site, or to a collection point for transport to a
disposal site.

Package means the packaging together with its radioactive contents as presented for transport.
(1) Fissile material package or Type AF package, Type BF package, Type B(U)F package,
or Type B(M)F package means a fissile material packaging together with its fissile material
contents.
(2) Type A package means a Type A packaging together with its radioactive contents. A
Type A package is defined and must comply with the DOT regulations in 49 CFR Part 173.
(3) Type B package means a Type B packaging together with its radioactive contents. On
approval, a Type B package design is designated by NRC as B(U) unless the package has a
maximum normal operating pressure of more than 700 kPa (100 lbs./in2) gauge or a pressure
relief device that would allow the release of radioactive material to the environment under
the tests specified in 10 CFR 71.73 (hypothetical accident conditions), in which case it will
receive a designation B(M). B(U) refers to the need for unilateral approval of international
shipments; B(M) refers to the need for multilateral approval of international shipments.
There is no distinction made in how packages with these designations may be used in
domestic transportation. To determine their distinction for international transportation, see
DOT regulations in 49 CFR Part 173. A Type B package approved before
September 6, 1983, was designated only as Type B. Limitations on its use are specified in
10 CFR 71.19.

Packaging means the assembly of components necessary to ensure compliance with the
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

packaging requirements of 49 CFR Part 173. It may consist of one or more receptacles,
absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for
cooling or absorbing mechanical shocks. The vehicle, tie-down system, and auxiliary equipment
may be designated as part of the packaging.

Regulations of the U.S. Department of Transportation (DOT) means the regulations in 49 CFR
Parts 100 through 189 and Parts 390 through 397.

Regulations of the U.S. Nuclear Regulatory Commission (NRC) means the regulations in
10 CFR 71 for purposes of 105 CMR 120.770.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.772: continued

Specific Activity of a radionuclide means the activity of a radionuclide per unit mass of that
nuclide. The specific activity of a material in which the radionuclide is essentially uniformly
distributed is the activity per unit mass of the material.

Surface Contaminated Object (SCO) means a solid object that is not itself classed as radioactive
material, but which has radioactive material distributed on any of its surfaces. SCO must be in
one of two groups with surface activity not exceeding the following limits:
(1) SCO-I: A solid object on which:
(a) The non-fixed contamination on the accessible surface averaged over 300 cm2 (or
the area of the surface if less than 300 cm2) does not exceed four Bq/cm2 (10-4
microcurie/cm2) for beta and gamma and low toxicity alpha emitters, or 0.4 Bq/cm2 (10-5
microcurie/cm2) for all other alpha emitters;
(b) The fixed contamination on the accessible surface averaged over 300 cm2 (or the
area of the surface if less than 300 cm2) does not exceed 4x104 Bq/cm2 (1.0
microcurie/cm2) for beta and gamma and low toxicity alpha emitters, or 4x103 Bq/cm2
(0.1 microcurie/cm2) for all other alpha emitters; and
(c) The non-fixed contamination plus the fixed contamination on the inaccessible
surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not
exceed 4x104 Bq/cm2 (one microcurie/cm2) for beta and gamma and low toxicity alpha
emitters, or 4x103 Bq/cm2 (0.1 microcurie/cm2) for all other alpha emitters.
(2) SCO-II: A solid object on which the limits for SCO-I are exceeded and on which:
(a) The non-fixed contamination on the accessible surface averaged over 300 cm2 (or
the area of the surface if less than 300 cm2) does not exceed 400 Bq/cm2 (10-2
microcurie/cm2) for beta and gamma and low toxicity alpha emitters or 40 Bq/cm2 (10-3
microcurie/cm2) for all other alpha emitters;
(b) The fixed contamination on the accessible surface averaged over 300 cm2 (or the
area of the surface if less than 300 cm2) does not exceed 8x105 Bq/cm2 (20
microcuries/cm2) for beta and gamma and low toxicity alpha emitters, or 8x104 Bq/cm2
(two microcuries/cm2) for all other alpha emitters; and
(c) The non-fixed contamination plus the fixed contamination on the inaccessible
surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not
exceed 8x105 Bq/cm2 (20 microcuries/cm2) for beta and gamma and low toxicity alpha
emitters, or 8x104 Bq/cm2 (two microcuries/cm2) for all other alpha emitters.

Transport Index means the dimensionless number (rounded up to the next tenth) placed on the
label of a package to designate the degree of control to be exercised by the carrier during
transportation. The transport index is the number determined by multiplying the maximum
radiation level in millisievert (mSv) per hour at one meter (3.3 ft.) from the external surface of
the package by 100 (equivalent to the maximum radiation level in millirem per hour at one meter
(3.3 ft.).

Tribal Official means the highest ranking individual that represents Tribal leadership, such as
the Chief, President, or Tribal Council leadership.

Type A Quantity means a quantity of radioactive material, the aggregate radioactivity of which
does not exceed A1 for special form radioactive material or A2 for normal form radioactive
material, where A1 and A2 are given in 105 CMR 120.798: Appendix A or may be determined
by procedures described in 105 CMR 120.798: Appendix A.

Type B Quantity means a quantity of radioactive material greater than a Type A quantity.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Unirradiated Uranium means uranium containing not more than 2 x 103 Bq of plutonium per
gram of uranium-235, not more than 9 x 106 Bq of fission products per gram of uranium-235,
and not more than 5 x 10-3 g of uranium-236 per gram of uranium-235.

Uranium - Natural, Depleted, Enriched.

(1) Natural Uranium means uranium (which may be chemically separated) with the
naturally occurring distribution of uranium isotopes (approximately 0.711 weight percent
uranium-235, and the remainder by weight essentially uranium-238).
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.772: continued

(2) Depleted Uranium means uranium containing less uranium-235 than the naturally
occurring distribution of uranium isotopes.
(3) Enriched Uranium means uranium containing more uranium-235 than the naturally
occurring distribution of uranium isotopes.

GENERAL REGULATORY PROVISIONS

120.773: Requirement for License

Except as authorized in a general license or a specific license issued by the Agency, or as

exempted in 105 CMR 120.775, no licensee may:

(A) Deliver licensed material to a carrier for transport; or

(B) Transport licensed material.

120.774: Transportation of Licensed Material

(A) Each licensee who transports licensed material outside the site of usage, as specified in the
Agency license, or where transport is on public highways, or who delivers licensed material to
a carrier for transport, shall comply with the applicable requirements of the U.S. Department of
Transportation regulations in 49 CFR Parts 107, 171 through 180, and 390 through 397,
appropriate to the mode of transport.
(1) The licensee shall particularly note DOT regulations in the following areas:
(a) Packaging - 49 CFR Part 173: Subparts A and B and I.
(b) Marking and labeling - 49 CFR Part 172: Subpart D, §§ 172.400 through 172.407,
§§ 172.436 through 172.441, and Subpart E.
(c) Placarding - 49 CFR Part 172: Subpart F, especially §§ 172.500 through 172.519,
172.556, and Appendices B and C.
(d) Accident reporting - 49 CFR Part 171: §§ 171.15 and 171.16.
(e) Shipping papers and emergency information - 49 CFR Part 172: Subparts C and G.
(f) Hazardous material employee training - 49 CFR Part 172: Subpart H.
(g) Security plans - 49 CFR Part 172: Subpart I.
(h) Hazardous material shipper/carrier registration - 49 CFR Part 107: Subpart G.
(2) The licensee shall also note DOT regulations pertaining to the following modes of
transportation:
(a) Rail - 49 CFR Part 174: Subparts A through D, and K.
(b) Air - 49 CFR Part 175.
(c) Vessel - 49 CFR Part 176: Subparts A through F and M.
(d) Public Highway - 49 CFR Part 177 and Parts 390 through 397.
(3) Assure that any special instructions needed to safely open the package are sent to or
have been made available to the consignee in accordance with 105 CMR 120.242(E).

(B) If, for any reason, the regulations of the U.S. Department of Transportation are not
applicable to a shipment of licensed material, the licensee shall conform to the standards and
requirements of 49 CFR Parts 107, 171 through 180 and 390 through 397 appropriate to the
mode of transport to the same extent as if the shipment was subject to the regulations. A request
for modification, waiver, or exemption from those requirements, and any notification referred
to in those requirements, must be filed with, or made to, the Director, Radiation Control
Program.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.775: Exemptions

(A) Any physician licensed by a State to dispense drugs in the practice of medicine is exempt
from 105 CMR 120.774 with respect to transport by the physician of licensed material for use
in the practice of medicine. However, any physician operating under 105 CMR 120.775 must
be licensed under 10 CFR Part 35 or the equivalent Agreement State regulations.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.775: continued

(B) Common and contract carriers, freight forwarders, and warehouse workers who are subject
to the requirements of the U.S. Department of Transportation in 49 CFR 170 through 189 or the
U.S. Postal Service in the Postal Service Manual (Domestic Mail Manual), Section 124.3
incorporated by reference, 39 CFR 111.11 (1974), and the U.S. Postal Service are exempt from
the requirements of 105 CMR 120.770 to the extent that they transport or store radioactive
material in the regular course of their carriage for others or storage incident thereto. Common
and contract carriers who are not subject to the requirements of the U.S. Department of
Transportation or U.S. Postal Service are subject to 105 CMR 120.773 and other applicable
requirements of 105 CMR 120.000.

(C) A licensee is exempt from all requirements of 105 CMR 120.770, with respect to shipment
or carriage of the following low-level materials:
(1) Natural material and ores containing naturally occurring radionuclides that are either in
their natural state, or have only been processed for purposes other than for the extraction of
the radionuclides, and which are not intended to be processed for the use of these
radionuclides, provided the activity concentration of the material does not exceed ten times
the applicable radionuclide activity concentration values specified in 105 CMR
120.798: Appendix A, Table A-2, or Table A-3.
(2) Materials for which the activity concentration is not greater than the activity
concentration values specified in 105 CMR 120.798: Appendix A, Table A-2, or Table A-3,
or for which the consignment activity is not greater than the limit for an exempt consignment
found in 105 CMR 120.798: Appendix A, Table A-2, or Table A-3.
(3) Non-radioactive solid objects with radioactive substances present on any surfaces in
quantities not in excess of the levels cited in the definition of contamination in 105 CMR
120.772.

(D) Fissile materials meeting one of the following requirements are exempt from the
classification as fissile material and from the fissile material package standards of 10 CFR 71.55
and 10 CFR 71.59, but are subject to all other requirements of 10 CFR 71, except as noted.
(1) Individual package containing two grams or less fissile material.
(2) Individual or bulk packaging containing 15 grams or less of fissile material provided
the package has at least 200 grams of solid nonfissile material for every gram of fissile
material. Lead, beryllium, graphite, and hydrogenous material enriched in deuterium may
be present in the package but must not be included in determining the required mass for solid
nonfissile material.
(3) (a) Low concentrations of solid fissile material commingled with solid nonfissile
material, provided that:
1. There is at least 2000 grams of solid nonfissile material for every gram of fissile
material, and
2. There is no more than 180 grams of fissile material distributed within 360 kg of
contiguous nonfissile material.
(b) Lead, beryllium, graphite, and hydrogenous material enriched in deuterium may be
present in the package but must not be included in determining the required mass of solid
nonfissile material.
(4) Uranium enriched in uranium-235 to a maximum of 1% by weight, and with total
plutonium and uranium-233 content of up to 1% of the mass of uranium-235, provided that
the mass of any beryllium, graphite, and hydrogenous material enriched in deuterium
constitutes less than 5% of the uranium mass, and that the fissile material is distributed
homogeneously and does not form a lattice arrangement within the package.
(5) Liquid solutions of uranyl nitrate enriched in uranium-235 to a maximum of 2% by
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

mass, with a total plutonium and uranium-233 content not exceeding 0.002% of the mass of
uranium, and with a minimum nitrogen to uranium atomic ratio (N/U) of two. The material
must be contained in at least a DOT Type A package.
(6) Packages containing, individually, a total plutonium mass of not more than 1000 grams,
of which not more than 20% by mass may consist of plutonium-239, plutonium-241, or any
combination of these radionuclides.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.776: General Licenses for Carriers

(A) A general license is hereby issued to any common or contract carrier not exempt under
105 CMR 120.775 to receive, possess, transport, and store radioactive material in the regular
course of their carriage for others or storage incident thereto, provided the transportation and
storage is in accordance with the applicable requirements, appropriate to the mode of transport,
of the U.S. Department of Transportation insofar as such requirements relate to the loading and
storage of packages, placarding of the transporting vehicle, and incident reporting.3

(B) A general license is hereby issued to any private carrier to transport radioactive material,
provided the transportation is in accordance with the applicable requirements, appropriate to the
mode of transport, of the U.S. Department of Transportation insofar as such requirements relate
to the loading and storage of packages, placarding of the transporting vehicle, and incident
reporting.3

(C) Persons who transport radioactive material pursuant to the general licenses in 105 CMR
120.776(A) or (B) are exempt from the requirements of 105 CMR 120.200 and 120.750 to the
extent that they transport radioactive material.

120.777: General License: Nuclear Regulatory Commission - Approved Packages

(A) A general license is hereby issued to any licensee of the Agency to transport, or to deliver
to a carrier for transport, licensed material in a package for which a license, certificate of
compliance, or other approval has been issued by the Nuclear Regulatory Commission.

(B) This general license applies only to a licensee who has a quality assurance program
approved by the Agency as satisfying the provisions of 105 CMR 120.791 through 120.797.

(C) Each licensee issued a general license under 105 CMR 120.777(A) shall:
(1) Maintain a copy of the NRC issued certificate of compliance, or other approval by the
Nuclear Regulatory Commission of the package, and the drawings and other documents
referenced in the approval relating to the use and maintenance of the packaging and to the
actions to be taken prior to shipment;
(2) Comply with the terms and conditions of the license, certificate, or other approval by
the Nuclear Regulatory Commission, as applicable, and the applicable requirements of
105 CMR 120.771 through 120.774 and 105 CMR 120.784 through 120.797; and
(3) Submit in writing before the first use of the package to: ATTN: Document Control
Desk, Director, Division of Spent Fuel Storage and Transportation, Office of Nuclear
Material Safety and Safeguards, using an appropriate method listed in 10 CFR 71.1(a), the
licensee's name and license number and the package identification number specified in the
package approval.

(D) The general license in 105 CMR 120.777(A) applies only when the package approval
authorizes use of the package under this general license.

(E) For a Type B or fissile material package, the design of which was approved by the Nuclear
Regulatory Commission before April 1, 1996, the general license is subject to the additional
restrictions of 10 CFR 71.19.

120.779: General License: U.S. Department of Transportation Specification Container

(A) A general license is issued to any licensee to transport, or to deliver to a carrier for
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

transport, licensed material in a specification container for fissile material or for a Type B
quantity of radioactive material as specified in 49 CFR Parts 173 and 178.

(B) This general license applies only to a licensee who:

S)))))))))))))))))))))))))))))))Q
3
Notification of an incident shall be filed with, or made to, the Agency as prescribed in
49 CFR, regardless of, and in addition to, notification made to U.S. Department of
Transportation or other agencies.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.779: continued

(1) Has a copy of the specification;

(2) Complies with the terms and conditions of the specification and the applicable
requirements of 105 CMR 120.770; and
(3) Has a quality assurance program as required by 105 CMR 120.791.

(C) This general license in 105 CMR 120.779(A) is subject to the limitation that the
specification container may not be used for a shipment to a location outside the United States
except by multilateral approval as defined in 49 CFR 173.403.

(D) The general license specified in 105 CMR 120.779 expires on October 1, 2008.

120.780: General License - Use of Foreign Approved Package

(A) A general license is issued to any licensee of the Agency to transport, or to deliver to a
carrier for transport, licensed material in a package, the design of which has been approved in
a foreign national competent authority certificate which has been revalidated by the U.S.
Department of Transportation as meeting the applicable requirements of 49 CFR 171.23.

(B) This general license applies only to shipments made to or from locations outside the United
States.

(C) Except as otherwise provided in 105 CMR 120.780, the general license applies only to a
licensee who has a quality assurance program approved by the Agency as satisfying the
applicable provisions of 105 CMR 120.791 through 120.797.

(D) Each licensee issued a general license under 105 CMR 120.780(A) shall:
(1) Maintain a copy of the applicable certificate, the revalidation, and the drawings and
other documents referenced in the certificate, relating to the use and maintenance of the
packaging and to the actions to be taken before shipment; and
(2) Comply with the terms and conditions of the certificate and revalidation, and with the
applicable requirements of 105 CMR 120.771 through 120.774 and 105 CMR 120.784
through 120.797.

120.781: General License: Fissile Material, Limited Quantity per Package

(A) A general license is hereby issued to any licensee to transport fissile material, or to deliver
fissile material to a carrier for transport, if the material is shipped in accordance with 105 CMR
120.781. The fissile material need not be contained in a package which meets the standards of
10 CFR 71 Subparts E and F; however, the material must be contained in a Type A package. The
Type A package must also meet the DOT requirements of 49 CFR 173.417(a).

(B) The general license applies only to a licensee who has a quality assurance program
approved by the Agency as satisfying the provisions of 105 CMR 120.791 through 120.797.

(C) The general license applies only when a package's contents:

(1) Contain less than a Type A quantity of fissile material; and
(2) Contain less than 500 total grams of beryllium, graphite, or hydrogenous material
enriched in deuterium.

(D) The general license applies only to packages containing fissile material that are labeled with
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

a CSI which:
(1) Has been determined in accordance with 105 CMR 120.781(E);
(2) Has a value less than or equal to ten; and
(3) For a shipment of multiple packages containing fissile material, the sum of the CSIs
must be less than or equal to 50 (for shipment on a nonexclusive use conveyance) and less
than or equal to 100 (for shipment on an exclusive use conveyance).
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.781: continued

(E)(1) The value for the CSI must be greater than or equal to the number calculated by the
following equation:

(2) The
calculated CSI must be rounded up to the first decimal place;
(3) The values of X, Y, and Z used in the CSI equation must be taken from Tables I or II,
as appropriate;
(4) If Table II is used to obtain the value of X, then the values for the terms in the equation
for uranium-233 and plutonium must be assumed to be zero; and
(5) Table I values for X, Y, and Z must be used to determine the CSI if:
(a) Uranium-233 is present in the package;
(b) The mass of plutonium exceeds 1% of the mass of uranium-235;
(c) The uranium is of unknown uranium-235 enrichment or greater than 24 weight
percent enrichment; or
(d) Substances having a moderating effectiveness (i.e., an average hydrogen density
greater than H2O) (e.g., certain hydrocarbon oils or plastics) are present in any form,
except as polyethylene used for packing or wrapping.

TABLE I – Mass Limits for General License Packages Containing Mixed Quantities
of Fissile Material or Uranium-235 of Unknown Enrichment per 105 CMR 120.781(E)

Fissile M aterials Fissile material mass mixed with Fissile material mass mixed with
moderating substances having an average moderating substances having an
hydrogen density less than or equal to H 2O average hydrogen density greater than
(grams) H 2O a (grams)

235
U (X) 60 38

233
U (Y) 43 27

239 241
Pu or Pu (Z) 37 24

a
When mixtures of moderating substances are present, the lower mass limits shall be used if more than 15%
of the moderating substance has an average hydrogen density greater than H2O.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.781: continued

Table II – Mass Limits for General License Packages Containing Uranium-235

of Known Enrichment per 105 CMR 120.781(E)
235 235
Uranium Enrichment in W eight Percent of U Fissile M aterial Mass of U (X) (grams)
Not Exceeding

24 60

20 63

15 67

11 72

10 76

9.5 78

9 81

8.5 82

8 85

7.5 88

7 90

6.5 93

6 97

5.5 102

5 108

4.5 114

4 120

3.5 132

3 150

2.5 180

2 246

1.5 408

1.35 480

1 1,020

0.92 1,800
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.782: General License: Plutonium Beryllium Special Form Material

(A) A general license is issued to any licensee to transport fissile material in the form of
plutonium beryllium (Pu Be) special form sealed sources, or to deliver Pu Be sealed sources to
a carrier for transport, if the material is shipped in accordance with 105 CMR 120.782. This
material need not be contained in a package which meets the standards of subparts E and F of
10 CFR 71; however, the material must be contained in a Type A package. The Type A package
must also meet the DOT requirements of 49 CFR 173.417(a).

(B) The general license applies only to a licensee who has a quality assurance program
approved by the Agency as satisfying the provisions of 105 CMR 120.791 through 120.797.

(C) The general license applies only when a package's contents:

(1) Contain no more than a Type A quantity of radioactive material; and,
(2) Contain less than 1000 g of plutonium, provided that: plutonium-239, plutonium-241,
or any combination of these radionuclides, constitutes less than 240 g of the total quantity
of plutonium in the package.

(D) The general license applies only to packages labeled with a CSI which:
(1) Has been determined in accordance with 105 CMR 120.782(E);
(2) Has a value less than or equal to 100; and,
(3) For a shipment of multiple packages containing Pu Be sealed sources, the sum of the
CSIs must be less than or equal to 50 (for shipment on a nonexclusive use conveyance) and
less than or equal to 100 (for shipment on an exclusive use conveyance).

(E)(1) The value for the CSI must be greater than or equal to the number calculated by the
following equation:

(2) The
calculated CSI must be rounded up to the first decimal place.

PACKAGE APPROVAL STANDARDS

120.783: External Radiation Standards for All Packages

(A) Except as provided in 105 CMR 120.783(B), each package of radioactive materials offered
for transportation must be designed and prepared for shipment so that under conditions normally
incident to transportation the radiation level does not exceed 2 mSv/hr (200 mrem/hr) at any
point on the external surface of the package, and the transport index does not exceed ten.

(B) A package that exceeds the radiation level limits specified in 105 CMR 120.783(A) must
be transported by exclusive use shipment only, and the radiation levels for such shipment must
not exceed the following during transportation:
(1) 2 mSv/h (200 mrem/h) on the external surface of the package, unless the following
conditions are met, in which case the limit is 10 mSv/h (1000 mrem/h):
(a) The shipment is made in a closed transport vehicle;
(b) The package is secured within the vehicle so that its position remains fixed during
transportation; and,
(c) There are no loading or unloading operations between the beginning and end of the
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

transportation;
(2) 2 mSv/h (200 mrem/h) at any point on the outer surface of the vehicle, including the top
and underside of the vehicle; or in the case of a flat-bed style vehicle, at any point on the
vertical planes projected from the outer edges of the vehicle, on the upper surface of the load
or enclosure, if used, and on the lower external surface of the vehicle; and
(3) 0.1 mSv/h (10 mrem/h) at any point two meters (80 in.) from the outer lateral surfaces
of the vehicle (excluding the top and underside of the vehicle); or in the case of a flat-bed
style vehicle, at any point two meters (6.6 ft.) from the vertical planes projected by the outer
edges of the vehicle (excluding the top and underside of the vehicle); and
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.783: continued

(4) 0.02 mSv/h (2 mrem/h) in any normally occupied space, except that this provision does
not apply to private carriers, if exposed personnel under their control wear radiation
dosimetry devices in conformance with 105 CMR 120.226.

(C) For shipments made under the provisions of 105 CMR 120.783(B), the shipper shall
provide specific written instructions to the carrier for maintenance of the exclusive use shipment
controls. The instructions must be included with the shipping paper information.

(D) The written instructions required for exclusive use shipments must be sufficient so that,
when followed, they will cause the carrier to avoid actions that will unnecessarily delay delivery
or unnecessarily result in increased radiation levels or radiation exposures to transport workers
or members of the general public.

OPERATING CONTROLS AND PROCEDURES

120.784: Assumptions as to Unknown Properties of Fissile Material

When the isotopic abundance, mass, concentration, degree of irradiation, degree of

moderation, or other pertinent property of fissile material in any package is not known, the
licensee shall package the fissile material as if the unknown properties have credible values that
will cause the maximum neutron multiplication.

120.785: Preliminary Determinations

Prior to the first use of any packaging for the shipment of licensed material, the licensee shall
ascertain that the determinations in 10 CFR 71.85(a) through (c) have been made.

120.786: Routine Determinations

Prior to each shipment of licensed material, the licensee shall ensure that the package with
its contents satisfies applicable requirements of 10 CFR 71 and of the license. The licensee shall
determine that:

(A) The package is proper for the contents to be shipped;

(B) The package is in unimpaired physical condition except for superficial defects such as
marks or dents;

(C) Each closure device of the packaging, including any required gasket, is properly installed
and secured and free of defects;

(D) Any system for containing liquid is adequately sealed and has adequate space or other
specified provision for expansion of the liquid;

(E) Any pressure relief device is operable and set in accordance with written procedures;

(F) The package has been loaded and closed in accordance with written procedures;

(G) For fissile material, any moderator or neutron absorber, if required, is present and in proper
condition;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

(H) Any structural part of the package which could be used to lift or tie down the package
during transport is rendered inoperable for that purpose unless it satisfies design requirements
specified in 10 CFR 71.45;

(I) The level of non-fixed (removable) radioactive contamination on the external surfaces of
each package offered for shipment is as low as reasonably achievable, and within the limits
specified in DOT regulations in 49 CFR 173.443;

(J) External radiation levels around the package and around the vehicle, if applicable, will not
exceed the limits specified in 10 CFR 71.47 at any time during transportation; and
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.786: continued

(K) Accessible package surface temperatures will not exceed the limits specified in 10 CFR
71.43(g) at any time during transportation.

120.787: Air Transport of Plutonium

Notwithstanding the provisions of any general licenses and notwithstanding any exemptions
stated directly in 105 CMR 120.770 or included indirectly by citation of the U.S. Department of
Transportation regulations, as may be applicable, the licensee shall assure that plutonium in any
form, whether for import, export, or domestic shipment, is not transported by air, or delivered
to a carrier for air transport, unless:

(A) The plutonium is contained in a medical device designed for individual human application;

(B) The plutonium is contained in a material in which the specific activity is not greater than
or equal to the activity concentration values for plutonium specified in 105 CMR 120.798:
Appendix A, Table A-2, and in which the radioactivity is essentially uniformly distributed;

(C) The plutonium is shipped in a single package containing no more than an A2 quantity of
plutonium in any isotope or form and is shipped in accordance with 105 CMR 120.774;

(D) The plutonium is shipped in a package specifically authorized (in the Certificate of
Compliance issued by the Nuclear Regulatory Commission for that package) for the shipment
of plutonium by air; or

(E) For a shipment of plutonium by air which is subject to105 CMR 120.787(D), the licensee
shall, through special arrangement with the carrier, require compliance with 49 CFR 175.704,
U.S. Department of Transportation regulations applicable to the air transport of plutonium.

(F) Nothing in 105 CMR 120.787 is to be interpreted as removing or diminishing the

requirements of 10 CFR 73.24.

120.788: Opening Instructions

Before delivery of a package to a carrier for transport, the licensee shall ensure that any
special instructions needed to safely open the package have been sent to, or otherwise made
available to, the consignee for the consignee’s use in accordance with 105 CMR 120.242(E).

120.789: Records

(A) Each licensee shall maintain, for a period of three years after shipment, a record of each
shipment of licensed material not exempt under 105 CMR 120.775(C), showing where
applicable:
(1) Identification of the packaging by model number and serial number;
(2) Verification that there are no significant defects in the packaging, as shipped;
(3) Volume and identification of coolant;
(4) Type and quantity of licensed material in each package, and the total quantity of each
shipment;
(5) For each item of irradiated fissile material:
(a) Identification by model number and serial number;
(b) Irradiation and decay history to the extent appropriate to demonstrate that its nuclear
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

and thermal characteristics comply with license conditions; and

(c) Any abnormal or unusual condition relevant to radiation safety;
(6) Date of the shipment;
(7) For fissile packages and for Type B packages, any special controls exercised;
(8) Name and address of the transferee;
(9) Address to which the shipment was made; and
(10) Results of the determinations required by 105 CMR 120.786 and by the conditions of
the package approval.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.789: continued

(B) The licensee shall make available to the Agency for inspection, upon reasonable notice, all
records required by 105 CMR 120.770 through 120.798. Records are only valid if stamped,
initialed, or signed and dated by authorized personnel, or otherwise authenticated.

(C) The licensee shall maintain sufficient written records to furnish evidence of the quality of
packaging. The records to be maintained include: results of the determinations required by
105 CMR 120.785; design, fabrication, and assembly records; results of reviews, inspections,
tests, and audits; results of monitoring work performance and materials analyses; and results of
maintenance, modification, and repair activities. Inspection, test, and audit records must identify
the inspector or data recorder, the type of observation, the results, the acceptability, and the
action taken in connection with any deficiencies noted. These records must be retained for three
years after the life of the packaging to which they apply.

120.790: Advance Notification of Shipment of Nuclear Waste

(A)(1) As specified in 105 CMR 120.790(B) through (D), each licensee shall provide advance
notification to the governor of a State, or the governor's designee, of the shipment of licensed
material, within or across the boundary of the State, before the transport, or delivery to a
carrier, for transport, of licensed material outside the confines of the licensee's plant or other
place of use or storage.
(2) As specified in 105 CMR 120.790(B) through (D) each licensee shall provide advance
notification to the Tribal official of participating Tribes referenced in 105 CMR
120.790(C)(3)(c), or the official's designee, of the shipment of licensed material, within or
across the boundary of the Tribe's reservation, before the transport, or delivery to a carrier,
for transport, of licensed material outside the confines of the licensee's plant or other place
of use or storage.

(B) Advance notification is required under 105 CMR 120.790 for shipment of licensed material
meeting the following three conditions:
(1) The licensed material is required by 10 CFR 71 to be in Type B packaging for
transportation;
(2) The licensed material is being transported into, within, or through a state en route to a
disposal facility or to a collection point for transport to a disposal facility; and
(3) The quantity of licensed material in a single package exceeds the least of the following:
(a) 3000 times the A1 value of the radionuclides as specified in 105 CMR 120.798:
Appendix A, Table A-1 for special form radioactive material;
(b) 3000 times the A2 value of the radionuclides as specified in 105 CMR 120.798:
Appendix A, Table A-1 for normal form radioactive material; or
(c) 1000 TBq (27,000 Ci).

(C) Procedures for Submitting Advance Notification.

(1) The notification must be made in writing to the office of each appropriate governor or
governor's designee, the office of each appropriate Tribal official or Tribal official's designee,
and to the Director of the Agency.
(2) A notification delivered by mail must be postmarked at least seven days before the
beginning of the seven-day period during which departure of the shipment is estimated to
occur.
(3) A notification delivered by any other means than mail must reach the office of the
governor or of the governor's designee or the Tribal official or Tribal official's designee at
least four days before the beginning of the seven-day period during which departure of the
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

shipment is estimated to occur.

(a) A list of the names and mailing addresses of the governors' designees receiving
advance notification of transportation of nuclear waste was published in the Federal
Register on June 30, 1995 (60 FR 34306).
(b) Contact information for each State, including telephone and mailing addresses of
governors and governors’ designees, and participating Tribes, including telephone and
mailing addresses of Tribal officials and Tribal official’s designees, is available on the
NRC website at: https://scp.nrc.gov/special/designee.pdf.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.790: continued

(c) A list of the names and mailing addresses of the governors' designees and Tribal
officials' designees of participating Tribes is available on request from the Director,
Division of Material Safety, State, Tribal, and Rulemaking Programs, Office of Nuclear
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC
20555-0001.
(4) The licensee shall retain a copy of the notification as a record for three years.

(D) Information to Be Furnished in Advance Notification of Shipment. Each advance

notification of shipment of nuclear waste must contain the following information:
(1) The name, address, and telephone number of the shipper, carrier, and receiver of the
nuclear waste shipment;
(2) A description of the nuclear waste contained in the shipment, as specified in the
regulations of DOT in 49 CFR 172.202 and 172.203(d);
(3) The point of origin of the shipment and the seven-day period during which departure of
the shipment is estimated to occur;
(4) The seven-day period during which arrival of the shipment at State boundaries or Tribal
reservation boundaries is estimated to occur;
(5) The destination of the shipment, and the seven-day period during which arrival of the
shipment is estimated to occur; and
(6) A point of contact, with a telephone number, for current shipment information.

(E) Revision Notice. A licensee who finds that schedule information previously furnished to
a governor or governor's designee or a Tribal official or Tribal official's designee, in accordance
with 105 CMR 120.790, will not be met, shall telephone a responsible individual in the office
of the governor of the State or of the governor's designee or the Tribal official or the Tribal
official's designee and inform that individual of the extent of the delay beyond the schedule
originally reported. The licensee shall maintain a record of the name of the individual contacted
for three years.

(F) Cancellation Notice.

(1) Each licensee who cancels a nuclear waste shipment for which advance notification has
been sent shall send a cancellation notice to the governor of each State or to the governor's
designee previously notified, each Tribal official or to the Tribal official's designee
previously notified, and to the Director of the Agency.
(2) The licensee shall state in the notice that it is a cancellation and identify the advance
notification that is being canceled. The licensee shall retain a copy of the notice as a record
for three years.

QUALITY ASSURANCE

120.791: Quality Assurance Requirements

(A) Purpose. 105 CMR 120.791 through 120.797 describes quality assurance requirements
applying to design, purchase, fabrication, handling, shipping, storing, cleaning, assembly,
inspection, testing, operation, maintenance, repair, and modification of components of packaging
that are important to safety. As used in 105 CMR 120.791 through 120.797, "quality assurance"
comprises all those planned and systematic actions necessary to provide adequate confidence that
a system or component will perform satisfactorily in service. Quality assurance includes quality
control, which comprises those quality assurance actions related to control of the physical
characteristics and quality of the material or component to predetermined requirements. Each
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

licensee is responsible for the quality assurance requirements that apply to its use of a
packaging for the shipment of licensed material subject to 105 CMR 120.791 through 120.797.

(B) Establishment of Program. Each licensee shall establish, maintain, and execute a quality
assurance program satisfying each of the applicable criteria of 105 CMR 120.791 through
120.797 and satisfying any specific provisions that are applicable to the licensee's activities
including procurement of packaging. The licensee shall execute the applicable criteria in a
graded approach to an extent that is commensurate with the quality assurance requirement's
importance to safety.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.791: continued

(C) Approval of Program. Before the use of any package for the shipment of licensed material
subject to 105 CMR 120.791 through 120.797, each licensee shall obtain Agency approval of its
quality assurance program. Using an appropriate method listed in 105 CMR 120.013, each
licensee shall file a description of its quality assurance program, including a discussion of which
requirements of 105 CMR 120.791 through 120.797 are applicable and how they will be
satisfied, by submitting the description to the Agency.

(D) Radiography Containers. A program for transport container inspection and maintenance
limited to radiographic exposure devices, source changers, or packages transporting these devices
and meeting the requirements of 10 CFR 34.31(b) or equivalent Agreement State requirement,
is deemed to satisfy the requirements of 105 CMR 120.777(B) and 120.791(B).

120.792: Quality Assurance Organization

(A) The licensee shall be responsible for the establishment and execution of the quality
assurance program. The licensee may delegate to others, such as contractors, agents, or
consultants, the work of establishing and executing the quality assurance program, or any part
of the quality assurance program, but shall retain responsibility for the program. These activities
include performing the functions associated with attaining quality objectives and the quality
assurance functions.

(B) The quality assurance functions are:

(1) Assuring that an appropriate quality assurance program is established and effectively
executed; and
(2) Verifying, by procedures such as checking, auditing, and inspection, that activities
affecting the functions that are important to safety have been correctly performed.

120.793: Quality Assurance Program

(A) The licensee shall establish, at the earliest practicable time consistent with the schedule for
accomplishing the activities, a quality assurance program that complies with the requirements
of 105 CMR 120.791 through 120.797. The licensee shall document the quality assurance
program by written procedures or instructions and shall carry out the program in accordance with
those procedures throughout the period during which the packaging is used. The licensee shall
identify the material and components to be covered by the quality assurance program, the major
organizations participating in the program, and the designated functions of these organizations.

(B) The licensee shall base the requirements and procedures of its quality assurance program
on the following considerations concerning the complexity and proposed use of the package and
its components:
(1) The impact of malfunction or failure of the item to safety;
(2) The design and fabrication complexity or uniqueness of the item;
(3) The need for special controls and surveillance over processes and equipment;
(4) The degree to which functional compliance can be demonstrated by inspection or test;
and
(5) The quality history and degree of standardization of the item.

(C) The licensee shall provide for indoctrination and training of personnel performing activities
affecting quality, as necessary to assure that suitable proficiency is achieved and maintained.
The licensee shall review the status and adequacy of the quality assurance program at established
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

intervals. Management of other organizations participating in the quality assurance program

shall review regularly the status and adequacy of that part of the quality assurance program they
are executing.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.794: Changes to Quality Assurance Program

(A) Each quality assurance program approval holder shall submit, in accordance with 105 CMR
120.013, a description of a proposed change to its Agency-approved quality assurance program
that will reduce commitments in the program description as approved by the Agency. The
quality assurance program approval holder shall not implement the change before receiving
Agency approval. The description of a proposed change to the Agency-approved quality
assurance program must identify the change, the reason for the change, and the basis for
concluding that the revised program incorporating the change continues to satisfy the applicable
requirements of 105 CMR 120.791 through 120.797.

(B) Each quality assurance program approval holder may change a previously approved quality
assurance program without prior Agency approval, if the change does not reduce the
commitments in the quality assurance program previously approved by the Agency. Changes
to the quality assurance program that do not reduce the commitments shall be submitted to the
Agency every 24 months, in accordance with 105 CMR 120.013. In addition to quality assurance
program changes involving administrative improvements and clarifications, spelling corrections,
and non-substantive changes to punctuation or editorial items, the following changes are not
considered reductions in commitment:
(1) The use of a quality assurance standard approved by the Agency that is more recent than
the quality assurance standard in the applicant's current quality assurance program at the time
of the change;
(2) The use of generic organizational position titles that clearly denote the position function,
supplemented as necessary by descriptive text, rather than specific titles, provided that there
is no substantive change to either the functions of the position or reporting responsibilities;
(3) The use of generic organizational charts to indicate functional relationships, authorities,
and responsibilities, or alternatively, the use of descriptive text, provided that there is no
substantive change to the functional relationships, authorities, or responsibilities;
(4) The elimination of quality assurance program information that duplicates language in
quality assurance regulatory guides and quality assurance standards to which the quality
assurance program approval holder has committed to on record; and
(5) Organizational revisions that ensure that persons and organizations performing quality
assurance functions continue to have the requisite authority and organizational freedom,
including sufficient independence from cost and schedule when opposed to safety
considerations.

(C) Each quality assurance program approval holder shall maintain records of quality assurance
program changes.

120.795: Corrective Action

The licensee shall establish measures to assure that conditions adverse to quality, such as
deficiencies, deviations, defective material and equipment, and nonconformances, are promptly
identified and corrected. In the case of a significant condition adverse to quality, the measures
must assure that the cause of the condition is determined and corrective action taken to preclude
repetition. The identification of the significant condition adverse to quality, the cause of the
condition, and the corrective action taken must be documented and reported to appropriate levels
of management.

120.796: Quality Assurance Records

The licensee shall maintain sufficient written records to describe the activities affecting
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

quality. These records must include changes to the quality assurance program as required by
105 CMR 120.794. The records must include the instructions or procedures that establish a
records retention program that is consistent with applicable regulations and designates factors
such as duration, location, and assigned responsibility. The licensee shall retain these records
for three years beyond the date when the licensee last engaged in the activity for which the
quality assurance program was developed. If any portion of the quality assurance program,
written procedures or instructions is superseded, the licensee shall retain the superseded material
for three years after it is superseded.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.797: Audits

The licensee shall carry out a comprehensive system of planned and periodic audits to verify
compliance with all aspects of the quality assurance program and to determine the effectiveness
of the program. The audits must be performed in accordance with written procedures or
checklists by appropriately trained personnel not having direct responsibilities in the areas being
audited. Audited results must be documented and reviewed by management having
responsibility in the area audited. Follow-up action, including reaudit of deficient areas, must
be taken where indicated.

120.798: Appendix A – Determination of A1 and A2

I. Values of A1 and A2 for individual radionuclides, which are the bases for many activity limits
elsewhere in 105 CMR 120.000 are given in Table A-1. The curie (Ci) values specified are
obtained by converting from the Terabecquerel (TBq) figure. The Terabecquerel values are
the regulatory standard. The curie values are for information only and are not intended to be
the regulatory standard. Where values of A1 or A2 are unlimited, it is for radiation control
purposes only. For nuclear criticality safety, some materials are subject to controls placed
on fissile material.

II. (a) For individual radionuclides whose identities are known, but which are not listed in
Table A-1, the A1 and A2 values contained in Table A-3 may be used. Otherwise, the
licensee shall obtain prior Agency approval of the A1 and A2 values for radionuclides not
listed in Table A-1, before shipping the material.
(b) For individual radionuclides whose identities are known, but which are not listed in
Table A-2, the exempt material activity concentration and exempt consignment activity
values contained in Table A-3 may be used. Otherwise, the licensee shall obtain prior
Agency approval of the exempt material activity concentration and exempt consignment
activity values for radionuclides not listed in Table A-2, before shipping the material.
(c) The licensee shall submit requests for prior approval, described in Appendix AII(a)
and II(b), to the Agency, in accordance with 105 CMR 120.013.

III. In the calculations of A1 and A2 for a radionuclide not in Table A-1, a single radioactive
decay chain, in which radionuclides are present in their naturally occurring proportions,
and in which no daughter nuclide has a half-life either longer than ten days, or longer
than that of the parent nuclide, shall be considered as a single radionuclide, and the
activity to be taken into account, and the A1 or A2 value to be applied, shall be those
corresponding to the parent nuclide of that chain. In the case of radioactive decay chains
in which any daughter nuclide has a half-life either longer than ten days, or greater than
that of the parent nuclide, the parent and those daughter nuclides shall be considered as
mixtures of different nuclides.

IV. For mixtures of radionuclides whose identities and respective activities are known, the
following conditions apply:

(a) For special form radioactive material, the maximum quantity transported in a Type
A package is as follows:

where B(i) is the activity of radionuclide i in special form, and A1(i) is the A1 value for
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

radionuclide i.

(b) For normal form radioactive material, the maximum quantity transported in a Type
A package is as follows:

where B(i) is the activity of radionuclide i in normal form, and A2(i) is the A2 value for
radionuclide i.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

(c) If the package contains both special and normal form radioactive material, the
activity that may be transported in a Type A package is as follows:

where B(i) is the activity of radionuclide i as special form radioactive material, A1(i) is
the A1 value for radionuclide i, C(j) is the activity of radionuclide j as normal form
radioactive material, and A2(j) is the A2 value for radionuclide j.

(d) Alternatively, the A1 value for mixtures of special form material may be determined
as follows:

where f(i) is the fraction of activity for radionuclide i in the mixture and A1(i) is the
appropriate A1 value for radionuclide i.

(e) Alternatively, the A2 value for mixtures of normal form material may be determined
as follows:

where f(i) is the fraction for radioactivity for radionuclide i in the mixture and A2(i) is the
appropriate A2 value for radioradionuclide i.

(f) The exempt activity concentration for mixtures of nuclides may be determined as
follows:

Exempt activity concentration for mixture

where f(i) is the fraction of activity of radionuclide i in the mixture, and [A](i) is the
activity concentration for exempt material containing radionuclide i.

(g) The activity limit for an exempt consignment for mixtures of radionuclides may be
determined as follows:

Exempt consignment activity limit for mixture

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

where f(i) is the fraction of activity of radionuclide i in the mixture, and A(i) is the
activity limit for exempt consignments for radionuclide i.

V. (a) When the identity of each radionuclide is known, but the individual activities of some
of the radionuclides are not known, the radionuclides may be grouped, and the lowest A1 or
A2 value, as appropriate, for the radionuclides in each group may be used in applying the
formulas in paragraph IV. Groups may be based on the total alpha activity and the total
beta/gamma activity when these are known, using the lowest A1 or A2 values for the alpha
emitters and beta/gamma emitters.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

(b) When the identity of each radionuclide is known but the individual activities of some
of the radionuclides are not known, the radionuclides may be grouped and the lowest [A]
(activity concentration for exempt material) or A (activity limit for exempt consignment)
value, as appropriate, for the radionuclides in each group may be used in applying the
formulas in paragraph IV of this appendix. Groups may be based on the total alpha activity
and the total beta/gamma activity when these are known, using the lowest [A] or A values
for the alpha emitters and beta/gamma emitters, respectively.

Table A - 1: A1 and A2 VALUES FOR RADIONUCLIDES

Specific activity
Symbol of Element and
A1 (TBq) A1 (Ci)b A2 (TBq) A2 (Ci)b (TBq/g) (Ci/g)
radionuclides atomic number
Ac-225 (a) Actinium (89) 8.0X10-1 2.2X101 6.0X10-3 1.6X10-1 2.1X103 5.8X104
Ac-227 (a) 9.0X10-1 2.4X101 9.0X10-5 2.4X10-3 2.7X100 7.2X101
Ac-228 6.0X10-1 1.6X101 5.0X10-1 1.4X101 8.4X104 2.2X106
Ag-105 Silver (47) 2X100 5.4X101 2X100 5.4X101 1.1X103 3.0X104
Ag-108m (a) 7.0X10-1 1.9X101 7.0X10-1 1.9X101 9.7X10-1 2.6X101
Ag-110m (a) 4.0X10-1 1.1X101 4.0X10-1 1.1X101 1.8X102 4.7X103
Ag-111 2.0X100 5.4X101 6.0X10-1 1.6X101 5.8X103 1.6X105
Al-26 Aluminum (13) 1.0X10-1 2.7X100 1.0X10-1 2.7X100 7.0X10-4 1.9X10-2
Am-241 Americium (95) 1.0X101 2.7X102 1.0X10-3 2.7X10-2 1.3X10-1 3.4X100
Am-242m (a) 1.0X101 2.7X102 1.0X10-3 2.7X10-2 3.6X10-1 1.0X101
Am-243 (a) 5.0X100 1.4X102 1.0X10-3 2.7X10-2 7.4X10-3 2.0X10-1
Ar-37 Argon (18) 4.0X101 1.1X103 4.0X101 1.1X103 3.7X103 9.9X104
Ar-39 4.0X101 1.1X103 2.0X101 5.4X102 1.3X100 3.4X101
Ar-41 3.0X10-1 8.1X100 3.0X10-1 8.1X100 1.5X106 4.2X107
As-72 Arsenic (33) 3.0X10-1 8.1X100 3.0X10-1 8.1X100 6.2X104 1.7X106
As-73 4.0X101 1.1X103 4.0X101 1.1X103 8.2X102 2.2X104
As-74 1.0X100 2.7X101 9.0X10-1 2.4X101 3.7X103 9.9X104
As-76 3.0X10-1 8.1X100 3.0X10-1 8.1X100 5.8X104 1.6X106
As-77 2.0X101 5.4X102 7.0X10-1 1.9X101 3.9X104 1.0X106
At-211 (a) Astatine (85) 2.0X101 5.4X102 5.0X10-1 1.4X101 7.6X104 2.1X106
Au-193 Gold (79) 7.0X100 1.9X102 2.0X100 5.4X101 3.4X104 9.2X105
Au-194 1.0X100 2.7X101 1.0X100 2.7X101 1.5X104 4.1X105
Au-195 Gold (79) 1.0X101 2.7X102 6.0X100 1.6X102 1.4X102 3.7X103
Au-198 1.0X100 2.7X101 6.0X10-1 1.6X101 9.0X103 2.4X105
Au-199 1.0X101 2.7X102 6.0X10-1 1.6X101 7.7X103 2.1X105
Ba-131 (a) Barium (56) 2.0X100 5.4X101 2.0X100 5.4X101 3.1X103 8.4X104
Ba-133 3.0X100 8.1X101 3.0X100 8.1X101 9.4X100 2.6X102
Ba-133m 2.0X101 5.4X102 6.0X10-1 1.6X101 2.2X104 6.1X105
Ba-140 (a) 5.0X10-1 1.4X101 3.0X10-1 8.1X100 2.7X103 7.3X104
Be-7 Beryllium (4) 2.0X101 5.4X102 2.0X101 5.4X102 1.3X104 3.5X105
Be-10 4.0X101 1.1X103 6.0X10-1 1.6X101 8.3X10-4 2.2X10-2
Bi-205 Bismuth (83) 7.0X10-1 1.9X101 7.0X10-1 1.9X101 1.5X103 4.2X104
Bi-206 3.0X10-1 8.1X100 3.0X10-1 8.1X100 3.8X103 1.0X105
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Specific activity
Symbol of Element and
A1 (TBq) A1 (Ci)b A2 (TBq) A2 (Ci)b (TBq/g) (Ci/g)
radionuclides atomic number
Bi-207 7.0X10-1 1.9X101 7.0X10-1 1.9X101 1.9X100 5.2X101
Bi-210 1.0X100 2.7X101 6.0X10-1 1.6X101 4.6X103 1.2X105
Bi-210m(a) 6.0X10-1 1.6X101 2.0X10-2 5.4X10-1 2.1X10-5 5.7X10-4
Bi-212 (a) 7.0X10-1 1.9X101 6.0X10-1 1.6X101 5.4X105 1.5X107
Bk-247 Berkelium (97) 8.0X100 2.2X102 8.0X10-4 2.2X10-2 3.8X10-2 1.0X100
Bk-249 (a) 4.0X101 1.1X103 3.0X10-1 8.1X100 6.1X101 1.6X103
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

Table A - 1: A1 and A2 VALUES FOR RADIONUCLIDES (continued)

Specific activity
Symbol of Element and
A1 (TBq) A1 (Ci)b A2 (TBq) A2 (Ci)b (TBq/g) (Ci/g)
radionuclides atomic number
Br-76 Bromine (35) 4.0X10-1 1.1X101 4.0X10-1 1.1X101 9.4X104 2.5X106
Br-77 3.0X100 8.1X101 3.0X100 8.1X101 2.6X104 7.1X105
Br-82 4.0X10-1 1.1X101 4.0X10-1 1.1X101 4.0X104 1.1X106
C-11 Carbon (6) 1.0X100 2.7X101 6.0X10-1 1.6X101 3.1X107 8.4X108
C-14 4.0X101 1.1X103 3.0X100 8.1X101 1.6X10-1 4.5X100
Ca-41 Calcium (20) Unlimited Unlimited Unlimited Unlimited 3.1X10-3 8.5X10-2
Ca-45 4.0X101 1.1X103 1.0X100 2.7X101 6.6X102 1.8X104
Ca-47 (a) 3.0X100 8.1X101 3.0X10-1 8.1X100 2.3X104 6.1X105
Cd-109 Cadmium (48) 3.0X101 8.1X102 2.0X100 5.4X101 9.6X101 2.6X103
Cd-113m 4.0X101 1.1X103 5.0X10-1 1.4X101 8.3X100 2.2X102
Cd-115 (a) 3.0X100 8.1X101 4.0X10-1 1.1X101 1.9X104 5.1X105
Cd-115m 5.0X10-1 1.4X101 5.0X10-1 1.4X101 9.4X102 2.5X104
Ce-139 Cerium (58) 7.0X100 1.9X102 2.0X100 5.4X101 2.5X102 6.8X103
Ce-141 2.0X101 5.4X102 6.0X10-1 1.6X101 1.1X103 2.8X104
Ce-143 9.0X10-1 2.4X101 6.0X10-1 1.6X101 2.5X104 6.6X105
Ce-144 (a) 2.0X10-1 5.4X100 2.0X10-1 5.4X100 1.2X102 3.2X103
Cf-248 Californium (98) 4.0X101 1.1X103 6.0X10-3 1.6X10-1 5.8X101 1.6X103
Cf-249 3.0X100 8.1X101 8.0X10-4 2.2X10-2 1.5X10-1 4.1X100
Cf-250 2.0X101 5.4X102 2.0X10-3 5.4X10-2 4.0X100 1.1X102
Cf-251 7.0X100 1.9X102 7.0X10-4 1.9X10-2 5.9X10-2 1.6X100
Cf-252 1.0X10-1 2.7X100 3.0X10-3 8.1X10-2 2.0X101 5.4X102
Cf-253 (a) 4.0X101 1.1X103 4.0X10-2 1.1X100 1.1X103 2.9X104
Cf-254 1.0X10-3 2.7X10-2 1.0X10-3 2.7X10-2 3.1X102 8.5X103
Cl-36 Chlorine (17) 1.0X101 2.7X102 6.0X10-1 1.6X101 1.2X10-3 3.3X10-2
Cl-38 2.0X10-1 5.4X100 2.0X10-1 5.4X100 4.9X106 1.3X108
Cm-240 Curium (96) 4.0X101 1.1X103 2.0X10-2 5.4X10-1 7.5X102 2.0X104
Cm-241 2.0X100 5.4X101 1.0X100 2.7X101 6.1X102 1.7X104
Cm-242 Curium (96) 4.0X101 1.1X103 1.0X10-2 2.7X10-1 1.2X102 3.3X103
Cm-243 9.0X100 2.4X102 1.0X10-3 2.7X10-2 1.9X10-3 5.2X101
Cm-244 2.0X101 5.4X102 2.0X10-3 5.4X10-2 3.0X100 8.1X101
Cm-245 9.0X100 2.4X102 9.0X10-4 2.4X10-2 6.4X10-3 1.7X10-1
Cm-246 9.0X100 2.4X102 9.0X10-4 2.4X10-2 1.1X10-2 3.1X10-1
Cm-247 (a) 3.0X100 8.1X101 1.0X10-3 2.7X10-2 3.4X10-6 9.3X10-5
Cm-248 2.0X10-2 5.4X10-1 3.0X10-4 8.1X10-3 1.6X10-4 4.2X10-3
Co-55 Cobalt (27) 5.0X10-1 1.4X101 5.0X10-1 1.4X101 1.1X105 3.1X106
Co-56 3.0X10-1 8.1X100 3.0X10-1 8.1X100 1.1X103 3.0X104
Co-57 1.0X101 2.7X102 1.0X101 2.7X102 3.1X102 8.4X103
Co-58 1.0X100 2.7X101 1.0X100 2.7X101 1.2X103 3.2X104
Co-58m 4.0X101 1.1X103 4.0X101 1.1X103 2.2X105 5.9X106
Co-60 4.0X10-1 1.1X101 4.0X10-1 1.1X101 4.2X101 1.1X103
Cr-51 Chromium (24) 3.0X101 8.1X102 3.0X101 8.1X102 3.4X103 9.2X104
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

Table A - 1: A1 and A2 VALUES FOR RADIONUCLIDES (continued)

Specific activity
Symbol of Element and
A1 (TBq) A1 (Ci)b A2 (TBq) A2 (Ci)b (TBq/g) (Ci/g)
radionuclides atomic number
Cs-129 Cesium (55) 4.0X100 1.1X102 4.0X100 1.1X102 2.8X104 7.6X105
Cs-131 3.0X101 8.1X102 3.0X101 8.1X102 3.8X103 1.0X105
Cs-132 1.0X100 2.7X101 1.0X100 2.7X101 5.7X103 1.5X105
Cs-134 7.0X10-1 1.9X101 7.0X10-1 1.9X101 4.8X101 1.3X103
Cs-134m 4.0X101 1.1X103 6.0X10-1 1.6X101 3.0X105 8.0X106
Cs-135 4.0X101 1.1X103 1.0X100 2.7X101 4.3X10-5 1.2X10-3
Cs-136 5.0X10-1 1.4X101 5.0X10-1 1.4X101 2.7X103 7.3X104
Cs-137 (a) 2.0X100 5.4X101 6.0X10-1 1.6X101 3.2X100 8.7X101
Cu-64 Copper (29) 6.0X100 1.6X102 1.0X100 2.7X101 1.4X105 3.9X106
Cu-67 1.0X101 2.7X102 7.0X10-1 1.9X101 2.8X104 7.6X105
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

Table A - 1: A1 and A2 VALUES FOR RADIONUCLIDES (continued)

Specific activity
Symbol of Element and
A1 (TBq) A1 (Ci)b A2 (TBq) A2 (Ci)b (TBq/g) (Ci/g)
radionuclides atomic number
Dy-159 Dysprosium (66) 2.0X101 5.4X102 2.0X101 5.4X102 2.1X102 5.7X103
Dy-165 9.0X10-1 2.4X101 6.0X10-1 1.6X101 3.0X105 8.2X106
Dy-166 (a) 9.0X10-1 2.4X101 3.0X10-1 8.1X100 8.6X103 2.3X105
Er-169 Erbium (68) 4.0X101 1.1X103 1.0X100 2.7X101 3.1X103 8.3X104
Er-171 8.0X10-1 2.2X101 5.0X10-1 1.4X101 9.0X104 2.4X106
Eu-147 Europium (63) 2.0X100 5.4X101 2.0X100 5.4X101 1.4X103 3.7X104
Eu-148 5.0X10-1 1.4X101 5.0X10-1 1.4X101 6.0X102 1.6X104
Eu-149 2.0X101 5.4X102 2.0X101 5.4X102 3.5X102 9.4X103
Eu-150 (short-lived) 2.0X100 5.4X101 7.0X10-1 1.9X101 6.1X104 1.6X106
Eu-150 (long-lived) 7.0X10-1 1.9X101 7.0X10-1 1.9X101 6.1X104 1.6X106
Eu-152 1.0X100 2.7X101 1.0X100 2.7X101 6.5X100 1.8X102
Eu-152m 8.0X10-1 2.2X101 8.0X10-1 2.2X101 8.2X104 2.2X106
Eu-154 9.0X10-1 2.4X101 6.0X10-1 1.6X101 9.8X100 2.6X102
Eu-155 2.0X101 5.4X102 3.0X100 8.1X101 1.8X101 4.9X102
Eu-156 7.0X10-1 1.9X101 7.0X10-1 1.9X101 2.0X103 5.5X104
F-18 Fluorine (9) 1.0X100 2.7X101 6.0X10-1 1.6X101 3.5X106 9.5X107
Fe-52 (a) Iron (26) 3.0X10-1 8.1X100 3.0X10-1 8.1X100 2.7X105 7.3X106
Fe-55 4.0X101 1.1X103 4.0X101 1.1X103 8.8X101 2.4X103
Fe-59 9.0X10-1 2.4X101 9.0X10-1 2.4X101 1.8X103 5.0X104
Fe-60 (a) 4.0X101 1.1X103 2.0X10-1 5.4X100 7.4X10-4 2.0X10-2
Ga-67 Gallium (31) 7.0X100 1.9X102 3.0X100 8.1X101 2.2X104 6.0X105
Ga-68 5.0X10-1 1.4X101 5.0X10-1 1.4X101 1.5X106 4.1X107
Ga-72 4.0X10-1 1.1X101 4.0X10-1 1.1X101 1.1X105 3.1X106
Gd-146 (a) Gadolinium (64) 5.0X10-1 1.4X101 5.0X10-1 1.4X101 6.9X102 1.9X104
Gd-148 2.0X101 5.4X102 2.0X10-3 5.4X10-2 1.2X100 3.2X101
Gd-153 1.0X101 2.7X102 9.0X100 2.4X102 1.3X102 3.5X103
Gd-159 3.0X100 8.1X101 6.0X10-1 1.6X101 3.9X104 1.1X106
Ge-68 (a) Germanium (32) 5.0X10-1 1.4X101 5.0X10-1 1.4X101 2.6X102 7.1X103
Ge-71 4.0X101 1.1X103 4.0X101 1.1X103 5.8X103 1.6X105
Ge-77 3.0X10-1 8.1X100 3.0X10-1 8.1X100 1.3X105 3.6X106
Hf-172 (a) Hafnium (72) 6.0X10-1 1.6X101 6.0X10-1 1.6X101 4.1X101 1.1X103
Hf-175 3.0X100 8.1X101 3.0X100 8.1X101 3.9X102 1.1X104
Hf-181 2.0X100 5.4X101 5.0X10-1 1.4X101 6.3X102 1.7X104
Hf-182 Unlimited Unlimited Unlimited Unlimited 8.1X10-6 2.2X10-4
Hg-194 (a) Mercury (80) 1.0X100 2.7X101 1.0X100 2.7X101 1.3X10-1 3.5X100
Hg-195m (a) 3.0X100 8.1X101 7.0X10-1 1.9X101 1.5X104 4.0X105
Hg-197 2.0X101 5.4X102 1.0X101 2.7X102 9.2X103 2.5X105
Hg-197m 1.0X101 2.7X102 4.0X10-1 1.1X101 2.5X104 6.7X105
Hg-203 5.0X100 1.4X102 1 2.7X101 5.1X102 1.4X104
Ho-166 Holmium (67) 4.0X10-1 1.1X101 4.0X10-1 1.1X101 2.6X104 7.0X105
Ho-166m 6.0X10-1 1.6X101 5.0X10-1 1.4X101 6.6X10-2 1.8X100
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

Table A - 1: A1 and A2 VALUES FOR RADIONUCLIDES (continued)

Specific activity
Symbol of Element and
A1 (TBq) A1 (Ci)b A2 (TBq) A2 (Ci)b (TBq/g) (Ci/g)
radionuclides atomic number
I-123 Iodine (53) 6.0X100 1.6X102 3.0X100 8.1X101 7.1X104 1.9X106
I-124 1.0X100 2.7X101 1.0X100 2.7X101 9.3X103 2.5X105
I-125 2.0X101 5.4X102 3.0X100 8.1X101 6.4X102 1.7X104
I-126 2.0X100 5.4X101 1.0X100 2.7X101 2.9X103 8.0X104
I-129 Unlimited Unlimited Unlimited Unlimited 6.5X10-6 1.8X10-4
I-131 3.0X100 8.1X101 7.0X10-1 1.9X101 4.6X103 1.2X105
I-132 4.0X10-1 1.1X101 4.0X10-1 1.1X101 3.8X105 1.0X107
I-133 7.0X10-1 1.9X101 6.0X10-1 1.6X101 4.2X104 1.1X106
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

Table A - 1: A1 and A2 VALUES FOR RADIONUCLIDES (continued)

Specific activity
Symbol of Element and
A1 (TBq) A1 (Ci)b A2 (TBq) A2 (Ci)b (TBq/g) (Ci/g)
radionuclides atomic number
I-134 3.0X10-1 8.1X100 3.0X10-1 8.1X100 9.9X105 2.7X107
I-135 (a) 6.0X10-1 1.6X101 6.0X10-1 1.6X101 1.3X105 3.5X106
In-111 Indium (49) 3.0X100 8.1X101 3.0X100 8.1X101 1.5X104 4.2X105
In-113m 4.0X100 1.1X102 2.0X100 5.4X101 6.2X105 1.7X107
In-114m (a) 1.0X101 2.7X102 5.0X10-1 1.4X101 8.6X102 2.3X104
In-115m 7.0X100 1.9X102 1.0X100 2.7X101 2.2X105 6.1X106
Ir-189 (a) Iridium (77) 1.0X101 2.7X102 1.0X101 2.7X102 1.9X103 5.2X104
Ir-190 7.0X10-1 1.9X101 7.0X10-1 1.9X101 2.3X103 6.2X104
(c)
Ir-192 1.0X100 (c)
2.7X101 6.0X10-1 1.6X101 3.4X102 9.2X103
Ir-194 3.0X10-1 8.1X100 3.0X10-1 8.1X100 3.1X104 8.4X105
K-40 Potassium (19) 9.0X10-1 2.4X101 9.0X10-1 2.4X101 2.4X10-7 6.4X10-6
K-42 2.0X10-1 5.4X100 2.0X10-1 5.4X100 2.2X105 6.0X106
K-43 7.0X10-1 1.9X101 6.0X10-1 1.6X101 1.2X105 3.3X106
Kr-79 Krypton (36) 4.0X100 1.1X102 2.0X100 5.4X101 4.2X104 1.1X106
Kr-81 4.0X101 1.1X103 4.0X101 1.1X103 7.8X10-4 2.1X10-2
Kr-85 1.0X101 2.7X102 1.0X101 2.7X102 1.5X101 3.9X102
Kr-85m 8.0X100 2.2X102 3.0X100 8.1X101 3.0X105 8.2X106
Kr-87 2.0X10-1 5.4X100 2.0X10-1 5.4X100 1.0X106 2.8X107
La-137 Lanthanum (57) 3.0X101 8.1X102 6.0X100 1.6X102 1.6X10-3 4.4X10-2
La-140 4.0X10-1 1.1X101 4.0X10-1 1.1X101 2.1X104 5.6X105
Lu-172 Lutetium (71) 6.0X10-1 1.6X101 6.0X10-1 1.6X101 4.2X103 1.1X105
Lu-173 8.0X100 2.2X102 8.0X100 2.2X102 5.6X101 1.5X103
Lu-174 9.0X100 2.4X102 9.0X100 2.4X102 2.3X101 6.2X102
Lu-174m 2.0X101 5.4X102 1.0X101 2.7X102 2.0X102 5.3X103
Lu-177 3.0X101 8.1X102 7.0X10-1 1.9X101 4.1X103 1.1X105
Mg-28 (a) Magnesium (12) 3.0X10-1 8.1X100 3.0X10-1 8.1X100 2.0X105 5.4X106
Mn-52 Manganese (25) 3.0X10-1 8.1X100 3.0X10-1 8.1X100 1.6X104 4.4X105
Mn-53 Unlimited Unlimited Unlimited Unlimited 6.8X10-5 1.8X10-3
Mn-54 1.0X100 2.7X101 1.0X100 2.7X101 2.9X102 7.7X103
Mn-56 3.0X10-1 8.1X100 3.0X10-1 8.1X100 8.0X105 2.2X107
Mo-93 Molybdenum (42) 4.0X101 1.1X103 2.0X101 5.4X102 4.1X10-2 1.1X100
Mo-99 (a) (h) 1.0X100 2.7X101 6.0X10-1 1.6X101 1.8X104 4.8X105
N-13 Nitrogen (7) 9.0X10-1 2.4X101 6.0X10-1 1.6X101 5.4X107 1.5X109
Na-22 Sodium (11) 5.0X10-1 1.4X101 5.0X10-1 1.4X101 2.3X102 6.3X103
Na-24 2.0X10-1 5.4X100 2.0X10-1 5.4X100 3.2X105 8.7X106
Nb-93m Niobium (41) 4.0X101 1.1X103 3.0X101 8.1X102 8.8X100 2.4X102
Nb-94 7.0X10-1 1.9X101 7.0X10-1 1.9X101 6.9X10-3 1.9X10-1
Nb-95 1.0X100 2.7X101 1.0X100 2.7X101 1.5X103 3.9X104
Nb-97 9.0X10-1 2.4X101 6.0X10-1 1.6X101 9.9X105 2.7X107
Nd-147 Neodymium (60) 6.0X100 1.6X102 6.0X10-1 1.6X101 3.0X103 8.1X104
Nd-149 6.0X10-1 1.6X101 5.0X10-1 1.4X101 4.5X105 1.2X107
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

Table A - 1: A1 and A2 VALUES FOR RADIONUCLIDES (continued)

Specific activity
Symbol of Element and
A1 (TBq) A1 (Ci)b A2 (TBq) A2 (Ci)b (TBq/g) (Ci/g)
radionuclides atomic number
Ni-59 Nickel (28) Unlimited Unlimited Unlimited Unlimited 3.0X10-3 8.0X10-2
Ni-63 4.0X101 1.1X103 3.0X101 8.1X102 2.1X100 5.7X101
Ni-65 4.0X10-1 1.1X101 4.0X10-1 1.1X101 7.1X105 1.9X107
Np-235 Neptunium (93) 4.0X101 1.1X103 4.0X101 1.1X103 5.2X101 1.4X103
Np-236 (short-lived) 2.0X101 5.4X102 2.0X100 5.4X101 4.7X10-4 1.3X10-2
Np-236 (long-lived) 9.0X100 2.4X102 2.0X102 5.4X10-1 4.7X10-4 1.3X10-2
Np-237 2.0X101 5.4X102 2.0X10-3 5.4X10-2 2.6X10-5 7.1X10-4
Np-239 7.0X100 1.9X102 4.0X10-1 1.1X101 8.6X103 2.3X105
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

Table A - 1: A1 and A2 VALUES FOR RADIONUCLIDES (continued)

Specific activity
Symbol of Element and
A1 (TBq) A1 (Ci)b A2 (TBq) A2 (Ci)b (TBq/g) (Ci/g)
radionuclides atomic number
Os-185 Osmium (76) 1.0X100 2.7X101 1.0X100 2.7X101 2.8X102 7.5X103
Os-191 1.0X101 2.7X102 2.0X100 5.4X101 1.6X103 4.4X104
Os-191m 4.0X101 1.1X103 3.0X101 8.1X102 4.6X104 1.3X106
Os-193 2.0X100 5.4X101 6.0X10-1 1.6X101 2.0X104 5.3X105
Os-194 (a) 3.0X10-1 8.1X100 3.0X10-1 8.1X100 1.1X101 3.1X102
P-32 Phosphorus (15) 5.0X10-1 1.4X101 5.0X10-1 1.4X101 1.1X104 2.9X105
P-33 4.0X101 1.1X103 1.0X100 2.7X101 5.8X103 1.6X105
Pa-230 (a) Protactinium (91) 2.0X100 5.4X101 7.0X10-2 1.9X100 1.2X103 3.3X104
Pa-231 4.0X100 1.1X102 4.0X10-4 1.1X10-2 1.7X10-3 4.7X10-2
Pa-233 5.0X100 1.4X102 7.0X10-1 1.9X101 7.7X102 2.1X104
Pb-201 Lead (82) 1.0X100 2.7X101 1.0X100 2.7X101 6.2X104 1.7X106
Pb-202 4.0X101 1.1X103 2.0X101 5.4X102 1.2X10-4 3.4X10-3
Pb-203 4.0X100 1.1X102 3.0X100 8.1X101 1.1X104 3.0X105
Pb-205 Unlimited Unlimited Unlimited Unlimited 4.5X10-6 1.2X10-4
Pb-210 (a) 1.0X100 2.7X101 5.0X10-2 1.4X100 2.8X100 7.6X101
Pb-212 (a) 7.0X10-1 1.9X101 2.0X10-1 5.4X100 5.1X104 1.4X106
Pd-103 (a) Palladium (46) 4.0X101 1.1X103 4.0X101 1.1X103 2.8X103 7.5X104
Pd-107 Unlimited Unlimited Unlimited Unlimited 1.9X10-5 5.1X10-4
Pd-109 2.0X100 5.4X101 5.0X10-1 1.4X101 7.9X104 2.1X106
Pm-143 Promethium (61) 3.0X100 8.1X101 3.0X100 8.1X101 1.3X102 3.4X103
Pm-144 7.0X10-1 1.9X101 7.0X10-1 1.9X101 9.2X101 2.5X103
Pm-145 3.0X101 8.1X102 1.0X101 2.7X102 5.2X100 1.4X102
Pm-147 4.0X101 1.1X103 2.0X100 5.4X101 3.4X101 9.3X102
Pm-148m (a) 8.0X10-1 2.2X101 7.0X10-1 1.9X101 7.9X102 2.1X104
Pm-149 2.0X100 5.4X101 6.0X10-1 1.6X101 1.5X104 4.0X105
Pm-151 2.0X100 5.4X101 6.0X10-1 1.6X101 2.7X104 7.3X105
Po-210 Polonium (84) 4.0X101 1.1X103 2.0X10-2 5.4X10-1 1.7X102 4.5X103
Pr-142 Praseodymium (59) 4.0X10-1 1.1X101 4.0X10-1 1.1X101 4.3X104 1.2X106
Pr-143 3.0X100 8.1X101 6.0X10-1 1.6X101 2.5X103 6.7X104
Pt-188 (a) Platinum (78) 1.0X100 2.7X101 8.0X10-1 2.2X101 2.5X103 6.8X104
Pt-191 4.0X100 1.1X102 3.0X100 8.1X101 8.7X103 2.4X105
Pt-193 4.0X101 1.1X103 4.0X101 1.1X103 1.4X100 3.7X101
Pt-193m 4.0X101 1.1X103 5.0X10-1 1.4X101 5.8X103 1.6X105
Pt-195m 1.0X101 2.7X102 5.0X10-1 1.4X101 6.2X103 1.7X105
Pt-197 2.0X101 5.4X102 6.0X10-1 1.6X101 3.2X104 8.7X105
Pt-197m 1.0X101 2.7X102 6.0X10-1 1.6X101 3.7X105 1.0X107
Pu-236 Plutonium (94) 3.0X101 8.1X102 3.0X10-3 8.1X10-2 2.0X101 5.3X102
Pu-237 2.0X101 5.4X102 2.0X101 5.4X102 4.5X102 1.2X104
Pu-238 1.0X101 2.7X102 1.0X10-3 2.7X10-2 6.3X10-1 1.7X101
Pu-239 1.0X101 2.7X102 1.0X10-3 2.7X10-2 2.3X10-3 6.2X10-2
Pu-240 1.0X101 2.7X102 1.0X10-3 2.7X10-2 8.4X10-3 2.3X10-1
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

Table A - 1: A1 and A2 VALUES FOR RADIONUCLIDES (continued)

Specific activity
Symbol of Element and
A1 (TBq) A1 (Ci)b A2 (TBq) A2 (Ci)b (TBq/g) (Ci/g)
radionuclides atomic number
Pu-241 (a) 4.0X101 1.1X103 6.0X10-2 1.6X100 3.8X100 1.0X102
Pu-242 1.0X101 2.7X102 1.0X10-3 2.7X10-2 1.5X10-4 3.9X10-3
Pu-244 (a) 4.0X10-1 1.1X101 1.0X10-3 2.7X10-2 6.7X10-7 1.8X10-5
Ra-223 (a) Radium (88) 4.0X10-1 1.1X101 7.0X10-3 1.9X10-1 1.9X103 5.1X104
Ra-224 (a) 4.0X10-1 1.1X101 2.0X10-2 5.4X10-1 5.9X103 1.6X105
Ra-225 (a) 2.0X10-1 5.4X100 4.0X10-3 1.1X10-1 1.5X103 3.9X104
Ra-226 (a) 2.0X10-1 5.4X100 3.0X10-3 8.1X10-2 3.7X10-2 1.0X100
Ra-228 (a) 6.0X10-1 1.6X101 2.0X10-2 5.4X10-1 1.0X101 2.7X102
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

Table A - 1: A1 and A2 VALUES FOR RADIONUCLIDES (continued)

Specific activity
Symbol of Element and
A1 (TBq) A1 (Ci)b A2 (TBq) A2 (Ci)b (TBq/g) (Ci/g)
radionuclides atomic number
Rb-81 Rubidium (37) 2.0X100 5.4X101 8.0X10-1 2.2X101 3.1X105 8.4X106
Rb-83 (a) 2.0X100 5.4X101 2.0X100 5.4X101 6.8X102 1.8X104
Rb-84 1.0X100 2.7X101 1.0X100 2.7X101 1.8X103 4.7X104
Rb-86 5.0X10-1 1.4X101 5.0X10-1 1.4X101 3.0X103 8.1X104
Rb-87 Unlimited Unlimited Unlimited Unlimited 3.2X10-9 8.6X10-8
Rb(nat) Unlimited Unlimited Unlimited Unlimited 6.7X106 1.8X108
Re-184 Rhenium (75) 1.0X100 2.7X101 1.0X100 2.7X101 6.9X102 1.9X104
Re-184m 3.0X100 8.1X101 1.0X100 2.7X101 1.6X102 4.3X103
Re-186 2.0X100 5.4X101 6.0X10-1 1.6X101 6.9X103 1.9X105
Re-187 Unlimited Unlimited Unlimited Unlimited 1.4X10-9 3.8X10-8
Re-188 4.0X10-1 1.1X101 4.0X10-1 1.1X101 3.6X104 9.8X105
Re-189 (a) 3.0X100 8.1X101 6.0X10-1 1.6X101 2.5X104 6.8X105
Re(nat) Unlimited Unlimited Unlimited Unlimited 0.0X100 2.4X10-8
Rh-99 Rhodium (45) 2.0X100 5.4X101 2.0X100 5.4X101 3.0X103 8.2X104
Rh-101 4.0X100 1.1X102 3.0X100 8.1X101 4.1X101 1.1X103
Rh-102 5.0X10-1 1.4X101 5.0X10-1 1.4X101 4.5X101 1.2X103
Rh-102m 2.0X100 5.4X101 2.0X100 5.4X101 2.3X102 6.2X103
Rh-103m 4.0X101 1.1X103 4.0X101 1.1X103 1.2X106 3.3X107
Rh-105 1.0X101 2.7X102 8.0X10-1 2.2X101 3.1X104 8.4X105
Rn-222 (a) Radon (86) 3.0X10-1 8.1X100 4.0X10-3 1.1X10-1 5.7X103 1.5X105
Ru-97 Ruthenium (44) 5.0X100 1.4X102 5.0X100 1.4X102 1.7X104 4.6X105
Ru-103 (a) 2.0X100 5.4X101 2.0X100 5.4X101 1.2X103 3.2X104
Ru-105 1.0X100 2.7X101 6.0X10-1 1.6X101 2.5X105 6.7X106
Ru-106 (a) 2.0X10-1 5.4X100 2.0X10-1 5.4X100 1.2X102 3.3X103
S-35 Sulphur (16) 4.0X101 1.1X103 3.0X100 8.1X101 1.6X103 4.3X104
Sb-122 Antimony (51) 4.0X10-1 1.1X101 4.0X10-1 1.1X101 1.5X104 4.0X105
Sb-124 6.0X10-1 1.6X101 6.0X10-1 1.6X101 6.5X102 1.7X104
Sb-125 2.0X100 5.4X101 1.0X100 2.7X101 3.9X101 1.0X103
Sb-126 4.0X10-1 1.1X101 4.0X10-1 1.1X101 3.1X103 8.4X104
Sc-44 Scandium (21) 5.0X10-1 1.4X101 5.0X10-1 1.4X101 6.7X105 1.8X107
Sc-46 5.0X10-1 1.4X101 5.0X10-1 1.4X101 1.3X103 3.4X104
Sc-47 1.0X101 2.7X102 7.0X10-1 1.9X101 3.1X104 8.3X105
Sc-48 3.0X10-1 8.1X100 3.0X10-1 8.1X100 5.5X104 1.5X106
Se-75 Selenium (34) 3.0X100 8.1X101 3.0X100 8.1X101 5.4X102 1.5X104
Se-79 4.0X101 1.1X103 2.0X100 5.4X101 2.6X10-3 7.0X10-2
Si-31 Silicon (14) 6.0X10-1 1.6X101 6.0X10-1 1.6X101 1.4X106 3.9X107
Si-32 4.0X101 1.1X103 5.0X10-1 1.4X101 3.9X100 1.1X102
Sm-145 Samarium (62) 1.0X101 2.7X102 1.0X101 2.7X102 9.8X101 2.6X103
Sm-147 Unlimited Unlimited Unlimited Unlimited 8.5X10-1 2.3X10-8
Sm-151 4.0X101 1.1X103 1.0X101 2.7X102 9.7X10-1 2.6X101
Sm-153 9.0X100 2.4X102 6.0X10-1 1.6X101 1.6X104 4.4X105
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

Table A - 1: A1 and A2 VALUES FOR RADIONUCLIDES (continued)

Specific activity
Symbol of Element and
A1 (TBq) A1 (Ci)b A2 (TBq) A2 (Ci)b (TBq/g) (Ci/g)
radionuclides atomic number
Sn-113 (a) Tin (50) 4.0X100 1.1X102 2.0X100 5.4X101 3.7X102 1.0X104
Sn-117m 7.0X100 1.9X102 4.0X10-1 1.1X101 3.0X103 8.2X104
Sn-119m 4.0X101 1.1X103 3.0X101 8.1X102 1.4X102 3.7X103
Sn-121m (a) 4.0X101 1.1X103 9.0X10-1 2.4X101 2.0X100 5.4X101
Sn-123 8.0X10-1 2.2X101 6.0X10-1 1.6X101 3.0X102 8.2X103
Sn-125 4.0X10-1 1.1X101 4.0X10-1 1.1X101 4.0X103 1.1X105
Sn-126 (a) 6.0X10-1 1.6X101 4.0X10-1 1.1X101 1.0X10-3 2.8X10-2
Sr-82 (a) Strontium (38) 2.0X10-1 5.4X100 2.0X10-1 5.4X100 2.3X103 6.2X104
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

Table A - 1: A1 and A2 VALUES FOR RADIONUCLIDES (continued)

Specific activity
Symbol of Element and
A1 (TBq) A1 (Ci)b A2 (TBq) A2 (Ci)b (TBq/g) (Ci/g)
radionuclides atomic number
Sr-85 2.0X100 5.4X101 2.0X100 5.4X101 8.8X102 2.4X104
Sr-85m 5.0X100 1.4X102 5.0X100 1.4X102 1.2X106 3.3X107
Sr-87m 3.0X100 8.1X101 3.0X100 8.1X101 4.8X105 1.3X107
Sr-89 6.0X10-1 1.6X101 6.0X10-1 1.6X101 1.1X103 2.9X104
Sr-90 (a) 3.0X10-1 8.1X100 3.0X10-1 8.1X100 5.1X100 1.4X102
Sr-91 (a) 3.0X10-1 8.1X100 3.0X10-1 8.1X100 1.3X105 3.6X106
Sr-92 (a) 1.0X100 2.7X101 3.0X10-1 8.1X100 4.7X105 1.3X107
T(H-3) Tritium (1) 4.0X101 1.1X103 4.0X101 1.1X103 3.6X102 9.7X103
Ta-178 (long-lived) Tantalum (73) 1.0X100 2.7X101 8.0X10-1 2.2X101 4.2X106 1.1X108
Ta-179 3.0X101 8.1X102 3.0X101 8.1X102 4.1X101 1.1X103
Ta-182 9.0X10-1 2.4X101 5.0X10-1 1.4X101 2.3X102 6.2X103
Tb-157 Terbium (65) 4.0X101 1.1X103 4.0X101 1.1X103 5.6X10-1 1.5X101
Tb-158 1.0X100 2.7X101 1.0X100 2.7X101 5.6X10-1 1.5X101
Tb-160 1.0X100 2.7X101 6.0X10-1 1.6X101 4.2X102 1.1X104
Tc-95m (a) Technetium (43) 2.0X100 5.4X101 2.0X100 5.4X101 8.3X102 2.2X104
Tc-96 4.0X10-1 1.1X101 4.0X10-1 1.1X101 1.2X104 3.2X105
Tc-96m (a) 4.0X10-1 1.1X101 4.0X10-1 1.1X101 1.4X106 3.8X107
Tc-97 Unlimited Unlimited Unlimited Unlimited 5.2X10-5 1.4X10-3
Tc-97m 4.0X101 1.1X103 1.0X100 2.7X101 5.6X102 1.5X104
Tc-98 8.0X10-1 2.2X101 7.0X10-1 1.9X101 3.2X10-5 8.7X10-4
Tc-99 4.0X101 1.1X103 9.0X10-1 2.4X101 6.3X10-4 1.7X10-2
Tc-99m 1.0X101 2.7X102 4.0X100 1.1X102 1.9X105 5.3X106
Te-121 Tellurium (52) 2.0X100 5.4X101 2.0X100 5.4X101 2.4X103 6.4X104
Te-121m 5.0X100 1.4X102 3.0X100 8.1X101 2.6X102 7.0X103
Te-123m 8.0X100 2.2X102 1.0X100 2.7X101 3.3X102 8.9X103
Te-125m 2.0X101 5.4X102 9.0X10-1 2.4X101 6.7X102 1.8X104
Te-127 2.0X101 5.4X102 7.0X10-1 1.9X101 9.8X104 2.6X106
Te-127m (a) 2.0X101 5.4X102 5.0X10-1 1.4X101 3.5X102 9.4X103
Te-129 7.0X10-1 1.9X101 6.0X10-1 1.6X101 7.7X105 2.1X107
Te-129m (a) 8.0X10-1 2.2X101 4.0X10-1 1.1X101 1.1X103 3.0X104
Te-131m (a) 7.0X10-1 1.9X101 5.0X10-1 1.4X101 3.0X104 8.0X105
Te-132 (a) 5.0X10-1 1.4X101 4.0X10-1 1.1X101 1.1X104 3.0X105
Th-227 Thorium (90) 1.0X101 2.7X102 5.0X10-3 1.4X10-1 1.1X103 3.1X104
Th-228 (a) 5.0X10-1 1.4X101 1.0X10-3 2.7X10-2 3.0X101 8.2X102
Th-229 5.0X100 1.4X102 5.0X10-4 1.4X10-2 7.9X10-3 2.1X10-1
Th-230 1.0X101 2.7X102 1.0X10-3 2.7X10-2 7.6X10-4 2.1X10-2
Th-231 Thorium (90) 4.0X101 1.1X103 2.0X10-2 5.4X10-1 2.0X104 5.3X105
Th-232 Unlimited Unlimited Unlimited Unlimited 4.0X10-9 1.1X10-7
Th-234 (a) 3.0X10-1 8.1X100 3.0X10-1 8.1X100 8.6X102 2.3X104
Th(nat) Unlimited Unlimited Unlimited Unlimited 8.1X10-9 2.2X10-7
Ti-44 (a) Titanium (22) 5.0X10-1 1.4X101 4.0X10-1 1.1X101 6.4X100 1.7X102
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

Table A - 1: A1 and A2 VALUES FOR RADIONUCLIDES (continued)

Specific activity
Symbol of Element and
A1 (TBq) A1 (Ci)b A2 (TBq) A2 (Ci)b (TBq/g) (Ci/g)
radionuclides atomic number
Tl-200 Thallium (81) 9.0X10-1 2.4X101 9.0X10-1 2.4X101 2.2X104 6.0X105
Tl-201 1.0X101 2.7X102 4.0X100 1.1X102 7.9X103 2.1X105
Tl-202 2.0X100 5.4X101 2.0X100 5.4X101 2.0X103 5.3X104
Tl-204 1.0X101 2.7X102 7.0X10-1 1.9X101 1.7X101 4.6X102
Tm-167 Thulium (69) 7.0X100 1.9X102 8.0X10-1 2.2X101 3.1X103 8.5X104
Tm-170 3.0X100 8.1X101 6.0X10-1 1.6X101 2.2X102 6.0X103
Tm-171 4.0X101 1.1X103 4.0X101 1.1X103 4.0X101 1.1X103
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

Table A - 1: A1 and A2 VALUES FOR RADIONUCLIDES (continued)

Specific activity
Symbol of Element and
A1 (TBq) A1 (Ci)b A2 (TBq) A2 (Ci)b (TBq/g) (Ci/g)
radionuclides atomic number
U-230 (fast lung Uranium (92) 4.0X101 1.1X103 1.0X10-1 2.7X100 1.0X103 2.7X104
absorption) (a)(d)
U-230 (medium lung absorption) (a)(e) 4.0X101 1.1X103 4.0X10-3 1.1X10-1 1.0X103 2.7X104
U-230 (slow lung absorption) (a)(f) 3.0X101 8.1X102 3.0X10-3 8.1X10-2 1.0X103 2.7X104
U-232 (fast lung absorption) (d) 4.0X101 1.1X103 1.0X10-2 2.7X10-1 8.3X10-1 2.2X101
U-232 (medium lung absorption) (e) 4.0X101 1.1X103 7.0X10-3 1.9X10-1 8.3X10-1 2.2X101
U-232 (slow lung absorption) (f) 1.0X101 2.7X102 1.0X10-3 2.7X10-2 8.3X10-1 2.2X101
U-233 (fast lung Uranium (92) 4.0X101 1.1X103 9.0X10-2 2.4X100 3.6X10-4 9.7X10-3
absorption) (d)
U-233 (medium lung absorption) (e) 4.0X101 1.1X103 2.0X10-2 5.4X10-1 3.6X10-4 9.7X10-3
U-233 (slow lung absorption) (f) 4.0X101 1.1X103 6.0X10-3 1.6X10-1 3.6X10-4 9.7X10-3
U-234 (fast lung absorption) (d) 4.0X101 1.1X103 9.0X10-2 2.4X100 2.3X10-4 6.2X10-3
U-234 (medium lung absorption) (e) 4.0X101 1.1X103 2.0X10-2 5.4X10-1 2.3X10-4 6.2X10-3
U-234 (slow lung absorption) (f) 4.0X101 1.1X103 6.0X10-3 1.6X10-1 2.3X10-4 6.2X10-3
U-235 (all lung absorption types) (a), (d), Unlimited Unlimited Unlimited Unlimited 8.0X10-8 2.2X10-6
(e), (f)
U-236 (fast lung absorption) (d) Unlimited Unlimited Unlimited Unlimited 2.4X10-6 6.5X10-5
U-236 (medium lung absorption) (e) 4.0X101 1.1X103 2.0X10-2 5.4X10-1 2.4X10-6 6.5X10-5
U-236 (slow lung absorption) (f) 4.0X101 1.1X103 6.0X10-3 1.6X10-1 2.4X10-6 6.5X10-5
U-238 (all lung absorption types) (d), (e), Unlimited Unlimited Unlimited Unlimited 1.2X10-8 3.4X10-7
(f)
U (nat) Unlimited Unlimited Unlimited Unlimited 2.6X10-8 7.1X10-7
U (enriched to 20% or less)(g) Unlimited Unlimited Unlimited Unlimited N/A N/A
U (dep) Unlimited Unlimited Unlimited Unlimited 0.0X100 See Table
A-3
V-48 Vanadium (23) 4.0X10-1 1.1X101 4.0X10-1 1.1X101 6.3X103 1.7X105
V-49 4.0X101 1.1X103 4.0X101 1.1X103 3.0X102 8.1X103
W-178 (a) Tungsten (74) 9.0X100 2.4X102 5.0X100 1.4X102 1.3X103 3.4X104
W-181 3.0X101 8.1X102 3.0X101 8.1X102 2.2X102 6.0X103
W-185 4.0X101 1.1X103 8.0X10-1 2.2X101 3.5X102 9.4X103
W-187 2.0X100 5.4X101 6.0X10-1 1.6X101 2.6X104 7.0X105
W-188 (a) 4.0X10-1 1.1X101 3.0X10-1 8.1X100 3.7X102 1.0X104
Xe-122 (a) Xenon (54) 4.0X10-1 1.1X101 4.0X10-1 1.1X101 4.8X104 1.3X106
Xe-123 2.0X100 5.4X101 7.0X10-1 1.9X101 4.4X105 1.2X107
Xe-127 4.0X100 1.1X102 2.0X100 5.4X101 1.0X103 2.8X104
Xe-131m 4.0X101 1.1X103 4.0X101 1.1X103 3.1X103 8.4X104
Xe-133 2.0X101 5.4X102 1.0X101 2.7X102 6.9X103 1.9X105
Xe-135 3.0X100 8.1X101 2.0X100 5.4X101 9.5X104 2.6X106
Y-87 (a) Yttrium (39) 1.0X100 2.7X101 1.0X100 2.7X101 1.7X104 4.5X105
Y-88 4.0X10-1 1.1X101 4.0X10-1 1.1X101 5.2X102 1.4X104
Y-90 3.0X10-1 8.1X100 3.0X10-1 8.1X100 2.0X104 5.4X105
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

Table A - 1: A1 and A2 VALUES FOR RADIONUCLIDES (continued)

Specific activity
Symbol of Element and
A1 (TBq) A1 (Ci)b A2 (TBq) A2 (Ci)b (TBq/g) (Ci/g)
radionuclides atomic number
Y-91 6.0X10-1 1.6X101 6.0X10-1 1.6X101 9.1X102 2.5X104
Y-91m 2.0X100 5.4X101 2.0X100 5.4X101 1.5X106 4.2X107
Y-92 2.0X10-1 5.4X100 2.0X10-1 5.4X100 3.6X105 9.6X106
Y-93 3.0X10-1 8.1X100 3.0X10-1 8.1X100 1.2X105 3.3X106
Yb-169 Ytterbium (79) 4.0X100 1.1X102 1.0X100 2.7X101 8.9X102 2.4X104
Yb-175 3.0X101 8.1X102 9.0X10-1 2.4X101 6.6X103 1.8X105
Zn-65 Zinc (30) 2.0X100 5.4X101 2.0X100 5.4X101 3.0X102 8.2X103
Zn-69 3.0X100 8.1X101 6.0X10-1 1.6X101 1.8X106 4.9X107
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

Table A - 1: A1 and A2 VALUES FOR RADIONUCLIDES (continued)

Specific activity
Symbol of Element and
A1 (TBq) A1 (Ci)b A2 (TBq) A2 (Ci)b (TBq/g) (Ci/g)
radionuclides atomic number
Zn-69m (a) 3.0X100 8.1X101 6.0X10-1 1.6X101 1.2X105 3.3X106
Zr-88 Zirconium (40) 3.0X100 8.1X101 3.0X100 8.1X101 6.6X102 1.8X104
Zr-93 Unlimited Unlimited Unlimited Unlimited 9.3X10-5 2.5X10-3
Zr-95 (a) 2.0X100 5.4X101 8.0X10-1 2.2X101 7.9X102 2.1X104
Zr-97 (a) 4.0X10-1 1.1X101 4.0X10-1 1.1X101 7.1X104 1.9X106

a
A1 and/or A2 values include contributions from daughter nuclides with half-lives less than ten days, as listed in the
following:
Mg-28 Al-28
Ca-47 Sc-47
Ti-44 Sc-44
Fe-52 Mn-52m
Fe-60 Co-60m
Zn-69m Zn-69
Ge-68 Ga-68
Rb-83 Kr-83m
Sr-82 Rb-82
Sr-90 Y-90
Sr-91 Y-91m
Sr-92 Y-92
Y-87 Sr-87m
Zr-95 Nb-95m
Zr-97 Nb-97m, Nb-97
Mo-99 Tc-99m
Tc-95m Tc-95
Tc-96m Tc-96
Ru-103 Rh-103m
Ru-106 Rh-106
Pd-103 Rh-103m
Ag-108m Ag-108
Ag-110m Ag-110
Cd-115 In-115m
In-114m In-114
Sn-113 In-113m
Sn-121m Sn-121
Sn-126 Sb-126m
Te-127m Te-127
Te-129m Te-129
Te-131m Te-131
Te-132 I-132
I–135 Xe-135m
Xe-122 I-122
Cs-137 Ba-137m
Ba-131 Cs-131
Ba-140 La-140
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Ce-144 Pr-144m, Pr-144

Pm-148m Pm-148
Gd-146 Eu-146
Dy-166 Ho-166
Hf-172 Lu-172
W-178 Ta-178
W-188 Re-188
Re-189 Os-189m
Os-194 Ir-194
Ir-189 Os-189m
Pt-188 Ir-188
Appendix A: continued

Hg-194 Au-194
Hg-195m Hg-195
Pb-210 Bi-210
Pb-212 Bi-212, Tl-208, Po-212
Bi-210m Tl-206
Bi-212 Tl-208, Po-212
At-211 Po-211
Rn-222 Po-218, Pb-214, At-218, Bi-214, Po-214
Ra-223 Rn-219, Po-215, Pb-211, Bi-211, Po-211, Tl-207
Ra-224 Rn-220, Po-216, Pb-212, Bi-212, Tl-208, Po-212
Ra-225 Ac-225, Fr-221, At-217, Bi-213, Tl-209, Po-213, Pb-209
Ra-226 Rn-222, Po-218, Pb-214, At-218, Bi-214, Po-214
Ra-228 Ac-228
Ac-225 Fr-221, At-217, Bi-213, Tl-209, Po-213, Pb-209
Ac-227 Fr-223
Th-228 Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208, Po-212
Th-234 Pa-234m, Pa-234
Pa-230 Ac-226, Th-226, Fr-222, Ra-222, Rn-218, Po-214
U-230 Th-226, Ra-222, Rn-218, Po-214
U-235 Th-231
Pu-241 U-237
Pu-244 U-240, Np-240m
Am-242m Am-242, Np-238
Am-243 Np-239
Cm-247 Pu-243
Bk-249 Am-245
Cf-253 Cm-249

b
The values of A1 and A2 in Curies (Ci) are approximate and for information only; the regulatory standard units are
Terabecquerels (TBq) (see 105 CMR 120.798: Appendix A – Determination of A1 and A2 , subsection I).
c
The activity of Ir-192 in special form may be determined from a measurement of the rate of decay or a measurement
of the radiation level at a prescribed distance from the source.
d
These values apply only to compounds of uranium that take the chemical form of UF6 , UO2 F2 and UO2 (NO3 )2 in both
normal and accident conditions of transport.
e
These values apply only to compounds of uranium that take the chemical form of UO3 , UF4 , UCl4 and hexavalent
compounds in both normal and accident conditions of transport.
f
These values apply to all compounds of uranium other than those specified in notes (d) and (e) of this table.
g
These values apply to unirradiated uranium only.
h
A2 = 0.74 TBq (20 Ci) for Mo-99 for domestic use.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

Table A - 2: EXEMPT MATERIAL ACTIVITY CONCENTRATIONS AND EXEMPT

CONSIGNMENT ACTIVITY LIMITS FOR RADIONUCLIDES

Activity Activity Activity limit Activity limit

Symbol of Element and atomic concentration concentration for exempt for exempt
radionuclide number for exempt for exempt consignment consignment
material (Bq/g) material (Ci/g) (Bq) (Ci)
Ac-225 Actinium (89) 1.0X101 2.7X10-10 1.0X104 2.7X10-7
Ac-227 1.0X10-1 2.7X10-12 1.0X103 2.7X10-8
Ac-228 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Ag-105 Silver (47) 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Ag-108m (b) 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Ag-110m 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Ag-111 1.0X103 2.7X10-8 1.0X106 2.7X10-5
Al-26 Aluminum (13) 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Am-241 Americium (95) 1.0X100 2.7X10-11 1.0X104 2.7X10-7
Am-242m (b) 1.0X100 2.7X10-11 1.0X104 2.7X10-7
Am-243 (b) 1.0X100 2.7X10-11 1.0X103 2.7X10-8
Ar-37 Argon (18) 1.0X106 2.7X10-5 1.0X108 2.7X10-3
Ar-39 1.0X107 2.7X10-4 1.0X104 2.7X10-7
Ar-41 1.0X102 2.7X10-9 1.0X109 2.7X10-2
As-72 Arsenic (33) 1.0X101 2.7X10-10 1.0X105 2.7X10-6
As-73 1.0X103 2.7X10-8 1.0X107 2.7X10-4
As-74 1.0X101 2.7X10-10 1.0X106 2.7X10-5
As-76 1.0X102 2.7X10-9 1.0X105 2.7X10-6
As-77 1.0X103 2.7X10-8 1.0X106 2.7X10-5
At-211 Astatine (85) 1.0X103 2.7X10-8 1.0X107 2.7X10-4
Au-193 Gold (79) 1.0X102 2.7X10-9 1.0X107 2.7X10-4
Au-194 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Au-195 1.0X102 2.7X10-9 1.0X107 2.7X10-4
Au-198 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Au-199 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Ba-131 Barium (56) 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Ba-133 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Ba-133m 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Ba-140 (b) 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Be-7 Beryllium (4) 1.0X103 2.7X10-8 1.0X107 2.7X10-4
Be-10 1.0X104 2.7X10-7 1.0X106 2.7X10-5
Bi-205 Bismuth (83) 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Bi-206 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Bi-207 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Bi-210 1.0X103 2.7X10-8 1.0X106 2.7X10-5
Bi-210m 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Bi-212 (b) 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Bk-247 Berkelium (97) 1 2.7X10-11 1.0X104 2.7X10-7
Bk-249 1.0X103 2.7X10-8 1.0X106 2.7X10-5
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Activity Activity Activity limit Activity limit

Symbol of Element and atomic concentration concentration for exempt for exempt
radionuclide number for exempt for exempt consignment consignment
material (Bq/g) material (Ci/g) (Bq) (Ci)
Br-76 Bromine (35) 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Br-77 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Br-82 1.0X101 2.7X10-10 1.0X106 2.7X10-5
C-11 Carbon (6) 1.0X101 2.7X10-10 1.0X106 2.7X10-5
C-14 1.0X104 2.7X10-7 1.0X107 2.7X10-4
Ca-41 Calcium (20) 1.0X105 2.7X10-6 1.0X107 2.7X10-4
Ca-45 1.0X104 2.7X10-7 1.0X107 2.7X10-4
Ca-47 1.0X101 2.7X10-10 1.0X106 2.7X10-5
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

Table A - 2: EXEMPT MATERIAL ACTIVITY CONCENTRATIONS AND EXEMPT

CONSIGNMENT ACTIVITY LIMITS FOR RADIONUCLIDES (continued)

Activity Activity Activity limit Activity limit

Symbol of Element and atomic concentration concentration for exempt for exempt
radionuclide number for exempt for exempt consignment consignment
material (Bq/g) material (Ci/g) (Bq) (Ci)
Cd-109 Cadmium (48) 1.0X104 2.7X10-7 1.0X106 2.7X10-5
Cd-113m 1.0X103 2.7X10-8 1.0X106 2.7X10-5
Cd-115 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Cd-115m 1.0X103 2.7X10-8 1.0X106 2.7X10-5
Ce-139 Cerium (58) 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Ce-141 1.0X102 2.7X10-9 1.0X107 2.7X10-4
Ce-143 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Ce-144 (b) 1.0X102 2.7X10-9 1.0X105 2.7X10-6
Cf-248 Californium (98) 1.0X101 2.7X10-10 1.0X104 2.7X10-7
Cf-249 1 2.7X10-11 1.0X103 2.7X10-8
Cf-250 1.0X101 2.7X10-10 1.0X104 2.7X10-7
Cf-251 1 2.7X10-11 1.0X103 2.7X10-8
Cf-252 1.0X101 2.7X10-10 1.0X104 2.7X10-7
Cf-253 1.0X102 2.7X10-9 1.0X105 2.7X10-6
Cf-254 1 2.7X10-11 1.0X103 2.7X10-8
Cl-36 Chlorine (17) 1.0X104 2.7X10-7 1.0X106 2.7X10-5
Cl-38 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Cm-240 Curium (96) 1.0X102 2.7X10-9 1.0X105 2.7X10-6
Cm-241 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Cm-242 1.0X102 2.7X10-9 1.0X105 2.7X10-6
Cm-243 1.0X100 2.7X10-11 1.0X104 2.7X10-7
Cm-244 1.0X101 2.7X10-10 1.0X104 2.7X10-7
Cm-245 1 2.7X10-11 1.0X103 2.7X10-8
Cm-246 1 2.7X10-11 1.0X103 2.7X10-8
Cm-247 1 2.7X10-11 1.0X104 2.7X10-7
Cm-248 1 2.7X10-11 1.0X103 2.7X10-8
Co-55 Cobalt (27) 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Co-56 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Co-57 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Co-58 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Co-58m 1.0X104 2.7X10-7 1.0X107 2.7X10-4
Co-60 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Cr-51 Chromium (24) 1.0X103 2.7X10-8 1.0X107 2.7X10-4
Cs-129 Cesium (55) 1.0X102 2.7X10-9 1.0X105 2.7X10-6
Cs-131 1.0X103 2.7X10-8 1.0X106 2.7X10-5
Cs-132 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Cs-134 1.0X101 2.7X10-10 1.0X104 2.7X10-7
Cs-134m 1.0X103 2.7X10-8 1.0X105 2.7X10-6
Cs-135 1.0X104 2.7X10-7 1.0X107 2.7X10-4
Cs-136 1.0X101 2.7X10-10 1.0X105 2.7X10-6
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

Table A - 2: EXEMPT MATERIAL ACTIVITY CONCENTRATIONS AND EXEMPT

CONSIGNMENT ACTIVITY LIMITS FOR RADIONUCLIDES (continued)

Activity Activity Activity limit Activity limit

Symbol of Element and atomic concentration concentration for exempt for exempt
radionuclide number for exempt for exempt consignment consignment
material (Bq/g) material (Ci/g) (Bq) (Ci)
Cs-137 (b) 1.0X101 2.7X10-10 1.0X104 2.7X10-7
Cu-64 Copper (29) 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Cu-67 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Dy-159 Dysprosium (66) 1.0X103 2.7X10-8 1.0X107 2.7X10-4
Dy-165 1.0X103 2.7X10-8 1.0X106 2.7X10-5
Dy-166 (a) 1.0X103 2.7X10-8 1.0X106 2.7X10-5
Er-169 Erbium (68) 1.0X104 2.7X10-7 1.0X107 2.7X10-4
Er-171 1.0X102 2.7X10-9 1.0X106 2.7X10-5
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

Table A - 2: EXEMPT MATERIAL ACTIVITY CONCENTRATIONS AND EXEMPT

CONSIGNMENT ACTIVITY LIMITS FOR RADIONUCLIDES (continued)

Activity Activity Activity limit Activity limit

Symbol of Element and atomic concentration concentration for exempt for exempt
radionuclide number for exempt for exempt consignment consignment
material (Bq/g) material (Ci/g) (Bq) (Ci)
Eu-147 Europium (63) 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Eu-148 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Eu-149 1.0X102 2.7X10-9 1.0X107 2.7X10-4
Eu-150 (short-lived) 1.0X103 2.7X10-8 1.0X106 2.7X10-5
Eu-150 (long-lived) 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Eu-152 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Eu-152 m 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Eu-154 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Eu-155 1.0X102 2.7X10-9 1.0X107 2.7X10-4
Eu-156 1.0X101 2.7X10-10 1.0X106 2.7X10-5
F-18 Fluorine (9) 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Fe-52 Iron (26) 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Fe-55 1.0X104 2.7X10-7 1.0X106 2.7X10-5
Fe-59 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Fe-60 1.0X102 2.7X10-9 1.0X105 2.7X10-6
Ga-67 Gallium (31) 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Ga-68 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Ga-72 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Gd-146 Gadolinium (64) 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Gd-148 1.0X101 2.7X10-10 1.0X104 2.7X10-7
Gd-153 1.0X102 2.7X10-9 1.0X107 2.7X10-4
Gd-159 1.0X103 2.7X10-8 1.0X106 2.7X10-5
Ge-68 Germanium (32) 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Ge-71 1.0X104 2.7X10-7 1.0X108 2.7X10-3
Ge-77 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Hf-172 Hafnium (72) 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Hf-175 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Hf-181 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Hf-182 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Hg-194 Mercury (80) 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Hg-195m 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Hg-197 1.0X102 2.7X10-9 1.0X107 2.7X10-4
Hg-197m 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Hg-203 1.0X102 2.7X10-9 1.0X105 2.7X10-6
Ho-166 Holmium (67) 1.0X103 2.7X10-8 1.0X105 2.7X10-6
Ho-166m 1.0X101 2.7X10-10 1.0X106 2.7X10-5
I-123 Iodine (53) 1.0X102 2.7X10-9 1.0X107 2.7X10-4
I-124 1.0X101 2.7X10-10 1.0X106 2.7X10-5
I-125 1.0X103 2.7X10-8 1.0X106 2.7X10-5
I-126 1.0X102 2.7X10-9 1.0X106 2.7X10-5
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

Table A - 2: EXEMPT MATERIAL ACTIVITY CONCENTRATIONS AND EXEMPT

CONSIGNMENT ACTIVITY LIMITS FOR RADIONUCLIDES (continued)

Activity Activity Activity limit Activity limit

Symbol of Element and atomic concentration concentration for exempt for exempt
radionuclide number for exempt for exempt consignment consignment
material (Bq/g) material (Ci/g) (Bq) (Ci)
I-129 1.0X102 2.7X10-9 1.0X105 2.7X10-6
I-131 1.0X102 2.7X10-9 1.0X106 2.7X10-5
I-132 1.0X101 2.7X10-10 1.0X105 2.7X10-6
I-133 1.0X101 2.7X10-10 1.0X106 2.7X10-5
I-134 1.0X101 2.7X10-10 1.0X105 2.7X10-6
I-135 1.0X101 2.7X10-10 1.0X106 2.7X10-5
In-111 Indium (49) 1.0X102 2.7X10-9 1.0X106 2.7X10-5
In-113m 1.0X102 2.7X10-9 1.0X106 2.7X10-5
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

Table A - 2: EXEMPT MATERIAL ACTIVITY CONCENTRATIONS AND EXEMPT

CONSIGNMENT ACTIVITY LIMITS FOR RADIONUCLIDES (continued)

Activity Activity Activity limit Activity limit

Symbol of Element and atomic concentration concentration for exempt for exempt
radionuclide number for exempt for exempt consignment consignment
material (Bq/g) material (Ci/g) (Bq) (Ci)
In-114m 1.0X102 2.7X10-9 1.0X106 2.7X10-5
In-115m 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Ir-189 Iridium (77) 1.0X102 2.7X10-9 1.0X107 2.7X10-4
Ir-190 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Ir-192 1.0X101 2.7X10-10 1.0X104 2.7X10-7
Ir-194 1.0X102 2.7X10-9 1.0X105 2.7X10-6
K-40 Potassium (19) 1.0X102 2.7X10-9 1.0X106 2.7X10-5
K-42 1.0X102 2.7X10-9 1.0X106 2.7X10-5
K-43 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Kr-79 Krypton (36) 1.0X103 2.7X10-8 1.0X105 2.7X10-6
Kr-81 1.0X104 2.7X10-7 1.0X107 2.7X10-4
Kr-85 1.0X105 2.7X10-6 1.0X104 2.7X10-7
Kr-85m 1.0X103 2.7X10-8 1.0X1010 2.7X10-1
Kr-87 1.0X102 2.7X10-9 1.0X109 2.7X10-2
La-137 Lanthanum (57) 1.0X103 2.7X10-8 1.0X107 2.7X10-4
La-140 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Lu-172 Lutetium (71) 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Lu-173 1.0X102 2.7X10-9 1.0X107 2.7X10-4
Lu-174 1.0X102 2.7X10-9 1.0X107 2.7X10-4
Lu-174m 1.0X102 2.7X10-9 1.0X107 2.7X10-4
Lu-177 1.0X103 2.7X10-8 1.0X107 2.7X10-4
Mg-28 Magnesium (12) 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Mn-52 Manganese (25) 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Mn-53 1.0X104 2.7X10-7 1.0X109 2.7X10-2
Mn-54 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Mn-56 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Mo-93 Molybdenum (42) 1.0X103 2.7X10-8 1.0X108 2.7X10-3
Mo-99 1.0X102 2.7X10-9 1.0X106 2.7X10-5
N-13 Nitrogen (7) 1.0X102 2.7X10-9 1.0X109 2.7X10-2
Na-22 Sodium (11) 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Na-24 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Nb-93m Niobium (41) 1.0X104 2.7X10-7 1.0X107 2.7X10-4
Nb-94 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Nb-95 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Nb-97 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Nd-147 Neodymium (60) 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Nd-149 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Ni-59 Nickel (28) 1.0X104 2.7X10-7 1.0X108 2.7X10-3
Ni-63 1.0X105 2.7X10-6 1.0X108 2.7X10-3
Ni-65 1.0X101 2.7X10-10 1.0X106 2.7X10-5
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

Table A - 2: EXEMPT MATERIAL ACTIVITY CONCENTRATIONS AND EXEMPT

CONSIGNMENT ACTIVITY LIMITS FOR RADIONUCLIDES (continued)

Activity Activity Activity limit Activity limit

Symbol of Element and atomic concentration concentration for exempt for exempt
radionuclide number for exempt for exempt consignment consignment
material (Bq/g) material (Ci/g) (Bq) (Ci)
Np-235 Neptunium (93) 1.0X103 2.7X10-8 1.0X107 2.7X10-4
Np-236 (short-lived) 1.0X103 2.7X10-8 1.0X107 2.7X10-4
Np-236 (long-lived) 1.0X102 2.7X10-9 1.0X105 2.7X10-6
Np-237 (b) 1 2.7X10-11 1.0X103 2.7X10-8
Np-239 1.0X102 2.7X10-9 1.0X107 2.7X10-4
Os-185 Osmium (76) 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Os-191 1.0X102 2.7X10-9 1.0X107 2.7X10-4
Os-191m 1.0X103 2.7X10-8 1.0X107 2.7X10-4
Os-193 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Os-194 (a) 1.0X102 2.7X10-9 1.0X105 2.7X10-6
P-32 Phosphorus (15) 1.0X103 2.7X10-8 1.0X105 2.7X10-6
P-33 1.0X105 2.7X10-6 1.0X108 2.7X10-3
Pa-230 (a) Protactinium (91) 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Pa-231 1 2.7X10-11 1.0X103 2.7X10-8
Pa-233 1.0X102 2.7X10-9 1.0X107 2.7X10-4
Pb-201 Lead (82) 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Pb-202 1.0X103 2.7X10-8 1.0X106 2.7X10-5
Pb-203 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Pb-205 1.0X104 2.7X10-7 1.0X107 2.7X10-4
Pb-210 (b) 1.0X101 2.7X10-10 1.0X104 2.7X10-7
Pb-212 (b) 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Pd-103 Palladium (46) 1.0X103 2.7X10-8 1.0X108 2.7X10-3
Pd-107 1.0X105 2.7X10-6 1.0X108 2.7X10-3
Pd-109 1.0X103 2.7X10-8 1.0X106 2.7X10-5
Pm-143 Promethium (61) 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Pm-144 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Pm-145 1.0X103 2.7X10-8 1.0X107 2.7X10-4
Pm-147 1.0X104 2.7X10-7 1.0X107 2.7X10-4
Pm-148m 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Pm-149 1.0X103 2.7X10-8 1.0X106 2.7X10-5
Pm-151 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Po-210 Polonium (84) 1.0X101 2.7X10-10 1.0X104 2.7X10-7
Pr-142 Praseodymium (59) 1.0X102 2.7X10-9 1.0X105 2.7X10-6
Pr-143 1.0X104 2.7X10-7 1.0X106 2.7X10-5
Pt-188 Platinum (78) 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Pt-191 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Pt-193 1.0X104 2.7X10-7 1.0X107 2.7X10-4
Pt-193m 1.0X103 2.7X10-8 1.0X107 2.7X10-4
Pt-195m 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Pt-197 1.0X103 2.7X10-8 1.0X106 2.7X10-5
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

Table A - 2: EXEMPT MATERIAL ACTIVITY CONCENTRATIONS AND EXEMPT

CONSIGNMENT ACTIVITY LIMITS FOR RADIONUCLIDES (continued)

Activity Activity Activity limit Activity limit

Symbol of Element and atomic concentration concentration for exempt for exempt
radionuclide number for exempt for exempt consignment consignment
material (Bq/g) material (Ci/g) (Bq) (Ci)
Pt-197m 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Pu-236 Plutonium (94) 1.0X101 2.7X10-10 1.0X104 2.7X10-7
Pu-237 1.0X103 2.7X10-8 1.0X107 2.7X10-4
Pu-238 1 2.7X10-11 1.0X104 2.7X10-7
Pu-239 1 2.7X10-11 1.0X104 2.7X10-7
Pu-240 1 2.7X10-11 1.0X103 2.7X10-8
Pu-241) 1.0X102 2.7X10-9 1.0X105 2.7X10-6
Pu-242 1 2.7X10-11 1.0X104 2.7X10-7
Pu-244 1 2.7X10-11 1.0X104 2.7X10-7
Ra-223 (b) Radium (88) 1.0X102 2.7X10-9 1.0X105 2.7X10-6
Ra-224 (b) 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Ra-225 1.0X102 2.7X10-9 1.0X105 2.7X10-6
Ra-226 (b) 1.0X101 2.7X10-10 1.0X104 2.7X10-7
Ra-228 (b) 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Rb-81 Rubidium (37) 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Rb-83 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Rb-84 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Rb-86 1.0X102 2.7X10-9 1.0X105 2.7X10-6
Rb-87 1.0X104 2.7X10-7 1.0X107 2.7X10-4
Rb(nat) 1.0X104 2.7X10-7 1.0X107 2.7X10-4
Re-184 Rhenium (75) 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Re-184m 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Re-186 1.0X103 2.7X10-8 1.0X106 2.7X10-5
Re-187 1.0X106 2.7X10-5 1.0X109 2.7X10-2
Re-188 1.0X102 2.7X10-9 1.0X105 2.7X10-6
Re-189 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Re(nat) 1.0X106 2.7X10-5 1.0X109 2.7X10-2
Rh-99 Rhodium (45) 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Rh-101 1.0X102 2.7X10-9 1.0X107 2.7X10-4
Rh-102 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Rh-102m 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Rh-103m 1.0X104 2.7X10-7 1.0X108 2.7X10-3
Rh-105 1.0X102 2.7X10-9 1.0X107 2.7X10-4
Rn-222 (b) Radon (86) 1.0X101 2.7X10-10 1.0X108 2.7X10-3
Ru-97 Ruthenium (44) 1.0X102 2.7X10-9 1.0X107 2.7X10-4
Ru-103 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Ru-105 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Ru-106 (b) 1.0X102 2.7X10-9 1.0X105 2.7X10-6
S-35 Sulphur (16) 1.0X105 2.7X10-6 1.0X108 2.7X10-3
Sb-122 Antimony (51) 1.0X102 2.7X10-9 1.0X104 2.7X10-7
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

Table A - 2: EXEMPT MATERIAL ACTIVITY CONCENTRATIONS AND EXEMPT

CONSIGNMENT ACTIVITY LIMITS FOR RADIONUCLIDES (continued)

Activity Activity Activity limit Activity limit

Symbol of Element and atomic concentration concentration for exempt for exempt
radionuclide number for exempt for exempt consignment consignment
material (Bq/g) material (Ci/g) (Bq) (Ci)
Sb-124 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Sb-125 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Sb-126 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Sc-44 Scandium (21) 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Sc-46 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Sc-47 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Sc-48 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Se-75 Selenium (34) 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Se-79 1.0X104 2.7X10-7 1.0X107 2.7X10-4
Si-31 Silicon (14) 1.0X103 2.7X10-8 1.0X106 2.7X10-5
Si-32 1.0X103 2.7X10-8 1.0X106 2.7X10-5
Sm-145 Samarium (62) 1.0X102 2.7X10-9 1.0X107 2.7X10-4
Sm-147 1.0X101 2.7X10-10 1.0X104 2.7X10-7
Sm-151 1.0X104 2.7X10-7 1.0X108 2.7X10-3
Sm-153 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Sn-113 Tin (50) 1.0X103 2.7X10-8 1.0X107 2.7X10-4
Sn-117m 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Sn-119m 1.0X103 2.7X10-8 1.0X107 2.7X10-4
Sn-121m 1.0X103 2.7X10-8 1.0X107 2.7X10-4
Sn-123 1.0X103 2.7X10-8 1.0X106 2.7X10-5
Sn-125 1.0X102 2.7X10-9 1.0X105 2.7X10-6
Sn-126 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Sr-82 Strontium (38) 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Sr-85 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Sr-85m 1.0X102 2.7X10-9 1.0X107 2.7X10-4
Sr-87m 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Sr-89 1.0X103 2.7X10-8 1.0X106 2.7X10-5
Sr-90 (b) 1.0X102 2.7X10-9 1.0X104 2.7X10-7
Sr-91 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Sr-92 1.0X101 2.7X10-10 1.0X106 2.7X10-5
T(H-3) Tritium (1) 1.0X106 2.7X10-5 1.0X109 2.7X10-2
Ta-178 (long-lived) Tantalum (73) 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Ta-179 1.0X103 2.7X10-8 1.0X107 2.7X10-4
Ta-182 1.0X101 2.7X10-10 1.0X104 2.7X10-7
Tb-157 Terbium (65) 1.0X104 2.7X10-7 1.0X107 2.7X10-4
Tb-158 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Tb-160 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Tc-95m Technetium (43) 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Tc-96 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Tc-96m 1.0X103 2.7X10-8 1.0X107 2.7X10-4
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

Table A - 2: EXEMPT MATERIAL ACTIVITY CONCENTRATIONS AND EXEMPT

CONSIGNMENT ACTIVITY LIMITS FOR RADIONUCLIDES (continued)

Activity Activity Activity limit Activity limit

Symbol of Element and atomic concentration concentration for exempt for exempt
radionuclide number for exempt for exempt consignment consignment
material (Bq/g) material (Ci/g) (Bq) (Ci)
Tc-97 1.0X103 2.7X10-8 1.0X108 2.7X10-3
Tc-97m 1.0X103 2.7X10-8 1.0X107 2.7X10-4
Tc-98 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Tc-99 1.0X104 2.7X10-7 1.0X107 2.7X10-4
Tc-99m 1.0X102 2.7X10-9 1.0X107 2.7X10-4
Te-121 Tellurium (52) 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Te-121m 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Te-123m 1.0X102 2.7X10-9 1.0X107 2.7X10-4
Te-125m 1.0X103 2.7X10-8 1.0X107 2.7X10-4
Te-127 1.0X103 2.7X10-8 1.0X106 2.7X10-5
Te-127m 1.0X103 2.7X10-8 1.0X107 2.7X10-4
Te-129 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Te-129m 1.0X103 2.7X10-8 1.0X106 2.7X10-5
Te-131m 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Te-132 1.0X102 2.7X10-9 1.0X107 2.7X10-4
Th-227 Thorium (90) 1.0X101 2.7X10-10 1.0X104 2.7X10-7
Th-228 (b) 1 2.7X10-11 1.0X104 2.7X10-7
Th-229 (b) 1 2.7X10-11 1.0X103 2.7X10-8
Th-230 1 2.7X10-11 1.0X104 2.7X10-7
Th-231 1.0X103 2.7X10-8 1.0X107 2.7X10-4
Th-232 1.0X101 2.7X10-10 1.0X104 2.7X10-7
Th-234 (b) 1.0X103 2.7X10-8 1.0X105 2.7X10-6
Th (nat)(b) 1 2.7X10-11 1.0X103 2.7X10-8
Ti-44 Titanium (22) 1.0X101 2.7X10-10 1.0X105 2.7X10-6
Tl-200 Thallium (81) 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Tl-201 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Tl-202 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Tl-204 1.0X104 2.7X10-7 1.0X104 2.7X10-7
Tm-167 Thulium (69) 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Tm-170 1.0X103 2.7X10-8 1.0X106 2.7X10-5
Tm-171 1.0X104 2.7X10-7 1.0X108 2.7X10-3
U-230 (fast lung Uranium (92) 1.0X101 2.7X10-10 1.0X105 2.7X10-6
absorption) (b)(d)
U-230 (medium lung absorption) (e) 1.0X101 2.7X10-10 1.0X104 2.7X10-7
U-230 (slow lung absorption) (f) 1.0X101 2.7X10-10 1.0X104 2.7X10-7
U-232 (fast lung Uranium (92) 1.0X100 2.7X10-11 1.0X103 2.7X10-8
absorption) (b), (d)
U-232 (medium lung absorption) (e) 1.0X101 2.7X10-10 1.0X104 2.7X10-7
U-232 (slow lung absorption) (f) 1.0X101 2.7X10-10 1.0X104 2.7X10-7
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

Table A - 2: EXEMPT MATERIAL ACTIVITY CONCENTRATIONS AND EXEMPT

CONSIGNMENT ACTIVITY LIMITS FOR RADIONUCLIDES (continued)

Activity Activity Activity limit Activity limit

Symbol of Element and atomic concentration concentration for exempt for exempt
radionuclide number for exempt for exempt consignment consignment
material (Bq/g) material (Ci/g) (Bq) (Ci)
U-233 (fast lung absorption) (d) 1.0X101 2.7X10-10 1.0X104 2.7X10-7
U-233 (medium lung absorption) (e) 1.0X102 2.7X10-9 1.0X105 2.7X10-6
U-233 (slow lung absorption) (f) 1.0X101 2.7X10-10 1.0X105 2.7X10-6
U-234 (fast lung absorption) (d) 1.0X101 2.7X10-10 1.0X104 2.7X10-7
U-234 (medium lung absorption) (e) 1.0X102 2.7X10-9 1.0X105 2.7X10-6
U-234 (slow lung absorption) (f) 1.0X101 2.7X10-10 1.0X105 2.7X10-6
U-235 (all lung absorption types) (b), (d), (e), 1.0X101 2.7X10-10 1.0X104 2.7X10-7
(f)
U-236 (fast lung absorption) (d) 1.0X101 2.7X10-10 1.0X104 2.7X10-7
U-236 (medium lung Uranium (92) 1.0X102 2.7X10-9 1.0X105 2.7X10-6
absorption) (e)
U-236 (slow lung absorption) (f) 1.0X101 2.7X10-10 1.0X104 2.7X10-7
U-238 (all lung absorption types) (b), (d), (e), 1.0X101 2.7X10-10 1.0X104 2.7X10-7
(f)
U (nat) (b) 1.0X100 2.7X10-11 1.0X103 2.7X10-8
U (enriched to 20% or less)(g) 1.0X100 2.7X10-11 1.0X103 2.7X10-8
U (dep) 1.0X100 2.7X10-11 1.0X103 2.7X10-8
V-48 Vanadium (23) 1.0X101 2.7X10-10 1.0X105 2.7X10-6
V-49 1.0X104 2.7X10-7 1.0X107 2.7X10-4
W-178 Tungsten (74) 1.0X101 2.7X10-10 1.0X106 2.7X10-5
W-181 1.0X103 2.7X10-8 1.0X107 2.7X10-4
W-185 1.0X104 2.7X10-7 1.0X107 2.7X10-4
W-187 1.0X102 2.7X10-9 1.0X106 2.7X10-5
W-188 1.0X102 2.7X10-9 1.0X105 2.7X10-6
Xe-122 Xenon (54) 1.0X102 2.7X10-9 1.0X109 2.7X10-2
Xe-123 1.0X102 2.7X10-9 1.0X109 2.7X10-2
Xe-127 1.0X103 2.7X10-8 1.0X105 2.7X10-6
Xe-131m 1.0X104 2.7X10-7 1.0X104 2.7X10-7
Xe-133 1.0X103 2.7X10-8 1.0X104 2.7X10-7
Xe-135 1.0X103 2.7X10-8 1.0X1010 2.7X10-1
Y-87 Yttrium (39) 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Y-88 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Y-90 1.0X103 2.7X10-8 1.0X105 2.7X10-6
Y-91 1.0X103 2.7X10-8 1.0X106 2.7X10-5
Y-91m 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Y-92 1.0X102 2.7X10-9 1.0X105 2.7X10-6
Y-93 1.0X102 2.7X10-9 1.0X105 2.7X10-6
Yb-169 Ytterbium (79) 1.0X102 2.7X10-9 1.0X107 2.7X10-4
Yb-175 1.0X103 2.7X10-8 1.0X107 2.7X10-4
Zn-65 Zinc (30) 1.0X101 2.7X10-10 1.0X106 2.7X10-5
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

Table A - 2: EXEMPT MATERIAL ACTIVITY CONCENTRATIONS AND EXEMPT

CONSIGNMENT ACTIVITY LIMITS FOR RADIONUCLIDES (continued)

Activity Activity Activity limit Activity limit

Symbol of Element and atomic concentration concentration for exempt for exempt
radionuclide number for exempt for exempt consignment consignment
material (Bq/g) material (Ci/g) (Bq) (Ci)
Zn-69 1.0X104 2.7X10-7 1.0X106 2.7X10-5
Zn-69m 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Zr-88 Zirconium (40) 1.0X102 2.7X10-9 1.0X106 2.7X10-5
Zr-93 (b) 1.0X103 2.7X10-8 1.0X107 2.7X10-4
Zr-95 1.0X101 2.7X10-10 1.0X106 2.7X10-5
Zr-97 (b) 1.0X101 2.7X10-10 1.0X105 2.7X10-6

a
[Reserved]
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued
b
Parent nuclides and their progeny included in secular equilibrium are listed in the following:
Sr-90 Y-90
Zr-93 Nb-93m
Zr-97 Nb-97
Ru-106 Rh-106
Ag-108m Ag-108
Cs-137 Ba-137m
Ce-144 Pr-144
Ba-140 La-140
Bi-212 Tl-208 (0.36), Po-212 (0.64)
Pb-210 Bi-210, Po-210
Pb-212 Bi-212, Tl-208 (0.36), Po-212 (0.64)
Rn-220 Po-216
Rn-222 Po-218, Pb-214, Bi-214, Po-214
Ra-223 Rn-219, Po-215, Pb-211, Bi-211, Tl-207
Ra-224 Rn-220, Po-216, Pb-212, Bi-212, Tl-208(0.36), Po-212 (0.64)
Ra-226 Rn-222, Po-218, Pb-214, Bi-214, Po-214, Pb-210, Bi-210, Po-210
Ra-228 Ac-228
Th-228 Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64)
Th-229 Ra-225, Ac-225, Fr-221, At-217, Bi-213, Po-213, Pb-209
Th-nat Ra-228, Ac-228, Th-228, Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64)
Th-234 Pa-234m
U-230 Th-226, Ra-222, Rn-218, Po-214
U-232 Th-228, Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64)
U-235 Th-231
U-238 Th-234, Pa-234m
U-nat Th-234, Pa-234m, U-234, Th-230, Ra-226, Rn-222, Po-218, Pb-214, Bi-214, Po-214, Pb-210, Bi-210,
Po-210
Np-237 Pa-233
Am-242m Am-242
Am-243 Np-239

c
[Reserved]
d
These values apply only to compounds of uranium that take the chemical form of UF6 , UO2 F2 and UO2 (NO3 )2 in both
normal and accident conditions of transport.
e
These values apply only to compounds of uranium that take the chemical form of UO3 , UF4 , UCl4 and hexavalent
compounds in both normal and accident conditions of transport.
f
These values apply to all compounds of uranium other than those specified in notes (d) and (e) of this table.
g
These values apply to unirradiated uranium only.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

Appendix A: continued

Table A-3: General Values for A1 and A2 )

Activity Activity Activity Activity

concen- concen- limits for limits for
Contents A1 A2 tration for tration for exempt exempt
exempt exempt consign- consign-
material material ments ments
(TBq) (Ci) (TBq) (Ci) (Bq/g) (Ci/g) (Bq) (Ci)
Only beta or gamma
emitting radionuclides are 1 x 10-1 2.7 x 100 2 x 10-2 5.4 x 10-1 1 x 101 2.7 x10-10 1 x 104 2.7 x10-7
known to be present
Alpha emitting
radionuclides, but no
2 x 10-1 5.4 x 100 9 x 10-5 2.4 x10-3 1 x 10-1 2.7 x10-12 1 x 103 2.7 x10-8
neutron emitters, are
known to be present (a)
Neutron emitting
radio-nuclides are known
1 x 10-3 2.7 x 10-2 9 x 10-5 2.4 x 10-3 1 x 10-1 2.7 x 10-12 1 x 103 2.7 x 10-8
to be present or no
relevant data is available

a
If beta or gamma emitting radionuclides are known to be present, the A1 value of 0.1 TBq (2.7 Ci) should be used.

Table A-4: Activity-mass Relationships for Uranium

Uranium Enrichment1
Specific Activity
wt % U-235 present
TBq/g Ci/g
0.45 1.8 x 10-8 5.0 x 10-7
0.72 2.6 x 10-8 7.1 x 10-7
1 2.8 x 10-8 7.6 x 10-7
1.5 3.7 x 10-8 1.0 x 10-6
5 1.0 x 10-7 2.7 x 10-6
10 1.8 x 10-7 4.8 x 10-6
20 3.7 x 10-7 1.0 x 10-5
35 7.4 x 10-7 2.0 x 10-5
50 9.3 x 10-7 2.5 x 10-5
90 2.2 x 10-6 5.8 x 10-5
93 2.6 x 10-6 7.0 x 10-5
95 3.4 x 10-6 9.1 x 10-5

120.800: LICENSING AND OPERATIONAL REQUIREMENTS FOR LOW-LEVEL RADIOACTIVE

WASTE FACILITIES

120.801: Purpose and Scope

(A) 105 CMR 120.800 establishes procedures, performance objectives, criteria, terms and conditions
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

governing the issuance of licenses for the treatment, storage or disposal of low-level radioactive
wastes received from other persons, as well as the development, operation, closure, post-closure
observation and maintenance, and institutional control of a low-level radioactive waste treatment,
storage or disposal facility. The requirements of 105 CMR 120.800 are in addition to, and not in
substitution for, other applicable requirements of 105 CMR 120.000.

(B) 105 CMR 120.800 is applicable to any low-level radioactive waste facility for treatment, storage,
or disposal of all classes of waste, which are not exempt from regulation pursuant to 105 CMR
120.200 as well as any wastes that the Board has required to be treated, stored or disposed of at a
low-level radioactive waste facility.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.801: continued

(C) 105 CMR 120.800 is applicable to any method of treatment, storage or disposal except shallow
land burial, as defined in 105 CMR 120.803. Shallow land burial is prohibited.

(D) Class A, B, C, as defined in 105 CMR 120.200, and mixed waste may be accepted for storage,
treatment or disposal at a facility, if the Board so determines. Waste received at a facility shall be
handled in accordance with the operational requirements of 105 CMR 120.800.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.801: continued

(E) Any facility licensed pursuant to 105 CMR 120.800 may also accept NARM waste if the Board
so determines. The limits of the quantities and concentrations of such NARM waste that may be
accepted shall be specified as part of the waste acceptance criteria to be determined by the Board.

(F) No waste shall be acceptable for storage, treatment or disposal at a facility if either the Operator
or the Department has reason to believe that the waste, as originally generated, was not radioactive.
Acceptance of such waste shall be subject to penalty.

(G) No waste shall be accepted from an electric-power-generating facility if such waste requires
regulations more stringent than the most stringent management required for any waste that may be
accepted at the facility from another generator.

(H) In addition to the requirements of 105 CMR 120.800 all facility operations are subject to the
requirements of 105 CMR 120.001, 120.100, 120.200 and 120.750. If a conflict in 105 CMR 120.000
exists, the more stringent provision shall apply.

(I) 105 CMR 120.800 does not authorize the treatment, storage or disposal of byproduct material as
defined in 105 CMR 120.005: Byproduct Material in quantities greater than 10,000 kilograms
containing more than five millicuries of radium-226. Nor do they apply to the disposal of radioactive
material as provided for in 105 CMR 120.200.

120.802: Regulatory Authority

The authority for the Department of Public Health to promulgate 105 CMR 120.800 is found
in: M.G.L. c. 111, §§ 3, 5M, 5N, 5O and 5P; M.G.L. c. 111H, §§ 1, 7, 8, 11, 13, 16 and 31.

120.803: Definitions

As used in 105 CMR 120.800 the following definitions apply:

Accident means any event arising from the storage, treatment, recycling or disposal of waste that
causes a discharge or dispersal of waste or elements contained in the waste from its intended place
of confinement.

Active Maintenance means any significant activity needed during the period of institutional control
to maintain a reasonable assurance that the performance objectives in 105 CMR 120.811 and 120.812
are met. The term includes major remedial action such as replacement of disposal unit barrier. Active
maintenance does not include custodial activities such as repair of fencing, repair or replacement of
monitoring equipment, revegetation, minor additions to soil cover, minor repair of disposal unit
barriers, and general disposal site upkeep such as mowing grass.

Adverse Effect means an injurious impact which is significant in relation to the public health, safety,
or environmental interest being protected.

Affected Community means a community, other than a site community, which is identified in an
environmental impact report prepared pursuant to M.G.L. c. 111H, § 30, and can be expected to
experience significant impacts as a result of the location, development, operation, closure, post-
closure observation and maintenance or institutional control of a facility.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

ALARA [acronym for "as low as reasonably achievable"] means making every reasonable effort to
maintain exposures to radiation as far below the dose limits in 105 CMR 120.200 as is practical
consistent with the purpose for which the licensed activity is undertaken, taking into account the state
of technology, the economics of improvements in relation to state of technology, the economics of
improvements in relation to benefits to the public health and safety, and other societal and
socioeconomic considerations, and in relation to utilization of nuclear energy and licensed materials
in the public interest.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.803: continued

Board means the Low-Level Radioactive Waste Management Board established in M.G.L. c.
111H, § 2.

Buffer Zone means a parcel of land which is an integral part of a facility that is controlled by the
licensee and acts as a surrounding boundary to the facility.

Chelating Agent means certain organic compounds capable of forming (multiple) coordinate
bonds with metals through two or more atoms of the organic compound, typically resulting in
enhanced thermodynamic stability in solution and greatly altered behavior of the metal ions.
Examples include amine polycarboxylic acids (e.g., EDTA, DTPA), and polycarboxylic acids
(e.g., citric acid, carbolic acid, and gluconic acid).

Chief Executive Officer means the city manager in any city having a city manager, the mayor in
any other city, the town manager in any town having a town manager, the chairman of the Board
of Selectmen in any other town.

Closure means the permanent termination of low-level radioactive waste acceptance at a facility,
including closure prior to the scheduled closing date, and the implementation of a closure plan.

Closure Plan means the plan, required as a condition of a facility license, prepared pursuant to
regulations adopted under M.G.L. c. 111H, § 16, to assure safe facility closure after operation.

Commencement of Construction means initiation of site alteration or physical on-site

construction activities. The term does not mean site exploration, necessary roads for site
exploration, borings to determine foundation conditions, or other preconstruction monitoring or
testing to establish background information related to the suitability of the site or the protection
of environmental values.

Community means a city or town of the Commonwealth.

Community Supervisory Committee means a committee, established pursuant to M.G.L. c.

111H, § 21, to facilitate the participation of a community, in which a candidate site is located,
in the activities established by M.G.L. c. 111H.

Comprehensive Operating Contract means a contract entered into by an Operator and the Board
pursuant to M.G.L. c. 111H, § 33.

Container means the primary vessel, exclusive of other reusable shielding or other packaging
materials, in which waste is placed and received for treatment, storage or disposal; or the vessel
into which waste is repackaged for storage or disposal and potential retrieval.

Days means calendar days; provided that in computing time periods such periods shall exclude
the day of the event which starts the period running, and further provided that if the last day of
a period falls on a Sunday, legal holiday or declared state of emergency day, such period shall
be extended to the close of business on the next business day.

Department means Department of Public Health.

Department Environmental Monitoring Program means a monitoring program established by the

Department, after consultation with the department of environmental protection and the board
of health of each site community, for the purpose of collecting and analyzing environmental data
prior to construction and throughout the construction, operation, closure, post-closure
observation and maintenance and institutional control of a facility.

Detailed Site Characterization means the on-site investigatory and analytical step of site selection
established in M.G.L. c. 111H, § 23 and conducted prior to the selection of any superior site.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.803: continued

Development means all activities undertaken with respect to a low-level radioactive waste
facility during the period commencing with the selection of any superior site pursuant to M.G.L.
c. 111H, § 23 and continuing until the commencement of facility operation pursuant to M.G.L.
c. 111H, § 39.

Disposal means the isolation of low-level radioactive waste from the biosphere inhabited by
human beings and their food chains.

Disposal Unit means a discrete portion of a facility into which waste is emplaced for disposal.

Dose Modeling Program means a computational program for converting measured or expected
radioactivity to dose equivalent for the relevant critical organ(s) which employs a formula
selected by the facility operator and approved by the Department.

Emplacement of Waste means the placement of waste into a disposal unit for disposal.

Engineered Barrier means a manmade structure or device that is intended to improve a facility's
ability to meet the performance objectives set forth in 105 CMR 120.811 through 120.814.

Facility means a parcel of land, together with the structures, equipment and improvements
thereon or appurtenant thereto, which, pursuant to M.G.L. c. 111H, is being developed, is used,
or has been used for the treatment, storage or disposal of low-level radioactive waste; but does
not include any property used for temporary storage of low-level radioactive waste in sealed
containers by a broker.

Facility License means a license to operate a facility issued by the Department pursuant to
M.G.L. c. 111H, § 31.

Generator means a person, including a broker, who produces low-level radioactive waste.

Ground Water means water below the land surface in a saturated zone, including perched ground
water.

Inadvertent Intruder means a person who, without regulatory authorization, enters upon the site
of a facility after closure to engage in normal activities.

Institutional Control means the continued observation, monitoring and care of a facility
following transfer of the facility license from the Operator to the Board.

Institutional Control Account means an account within the Low-Level Radioactive Waste Trust
Fund established in M.G.L. c. 111H, § 41 for the purpose of paying institutional control costs
pursuant to M.G.L. c. 111H, §§ 9 and 47.

Intruder Barrier means a sufficient layer of material surrounding waste that inhibits contact with
the waste and helps to ensure that radiation exposures to an inadvertent intruder will meet the
performance objectives set forth in 105 CMR 120.800, or engineered structures that provide
equivalent protection to the inadvertent intruder.

Low-level Radioactive Waste means radioactive material that:

(1) is neither high-level waste, nor spent nuclear fuel, nor by-product material as defined
in Section 11(e)(2) of the Atomic Energy Act of 1954, as amended, 42 U.S.C. §2014(e); and
(2) is classified by the Federal Government as low-level radioactive waste, but not including
waste which remains a Federal responsibility, as designated in Section 3(b) of the Low-Level
Radioactive Waste Policy Act, as amended, 42 U.S.C. §2021c(b), as in effect as of
December 8, 1987.

Low-level Radioactive Waste Trust Fund means a trust fund established pursuant to M.G.L. c.
10, § 35H which shall consist of surcharges collected from users of the low-level radioactive
waste facility in an amount determined by the board on an annual basis, which shall be used to
meet the obligations set forth in M.G.L. c. 111H, §§ 9 and 47.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.803: continued

Manifest means a detailed record of the characteristics and quantities of packaged waste as
presented for transportation, treatment, storage, or disposal which usually accompanies waste
transfers for these purposes.

Mass Wasting means the movement of rock or soil material under the influence of gravity either
as the movement of the product of weathering down a slope or as mass movement of rock or soil
along joint planes or bedding planes. Mass wasting includes but is not limited to creep, mud
flows, earth flow, soil flow, rock avalanche, landslide, landslip and slumping.

Mixed Waste means low-level radioactive waste containing material that either:
(1) is listed in 310 CMR 30.131 through 30.136; or
(2) causes the waste to exhibit any of the characteristics identified in 310 CMR 30.120.

Monitoring means observing and making measurements to provide data on a facility, its site, its
surrounding environment, and its health safety and environmental impacts.

NARM means any naturally occurring or accelerator-produced radioactive material as defined

in 105 CMR 120.001. It does not include byproduct, source, or special nuclear material.

Neighboring Community means a community, other than a site community, which, according
to the most recent federal census, has at least 20% of its population residing within three miles
of any superior site.

Operation means the control, supervision or implementation of the actual physical activities
involved in the acceptance, storage, treatment, disposal or monitoring of low-level radioactive
waste at a facility and the maintenance of the facility and any other responsibilities of the
operation pertaining to the facility.

Operator means a person designated in accordance with the procedures established in

M.G.L. c. 111H, §§ 22 and 27 to develop and operate a low-level radioactive waste facility.

Operator Environmental Monitoring Program means a monitoring program conducted by the

Operator for the purpose of collecting and analyzing environmental data during the
preoperational, operational, closure, post-closure observation and maintenance, and institutional
control stages of a facility.

Person means any agency or political subdivision of the federal government or the
commonwealth or of any state, any public or private corporation or authority, individual, firm,
joint stock company, partnership, association, trust, estate, institution or other entity, and any
officer, employee or agent of such person, and any group of such persons.

Post-closure Observation and Maintenance means the active monitoring and maintenance of a
facility which has been closed in preparation for transfer of the facility's license from the
Operator to the Board.

Public Interest means the common welfare, convenience, benefit and necessity of the people of
the Commonwealth, including public health, safety and the environment.

Public Meeting means a public hearing, satisfying the requirements of M.G.L. c. 30A, § 2, in
which an agency presents information, responds to inquiries and hears testimony of interested
persons.

Radioactivity means the transformation of unstable atomic nuclei with the emission of radiation.

Radionuclide means an isotope that eventually undergoes spontaneous disintegration, with the
emission of radiation.

Radioactive Material means any solid, liquid, or gas which emits radiation spontaneously.

Retrieval means the recovery of waste in an intact container.

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.803: continued

Retrievability means the ability to recover waste in an intact container without substantial
destruction of the engineered barriers surrounding the waste containers.

Shallow Land Burial means a land disposal method that relies on the site's natural characteristics
as the primary barrier for isolation of the waste.

Site means a parcel of land which, pursuant to M.G.L. c. 111, §§ 3, 5M, 5N, 5O, and 5P is being
considered, developed or used or has been used as a location for a facility.

Site Community means the community in which is located all or any part of any superior site.

Source Minimization means minimizing the volume of radioactivity of low-level radioactive

waste prior to its generation by such methods as:
(1) avoiding unnecessary contamination of items during the use of radioactive materials;
(2) carefully segregating radioactive waste from non-radioactive trash; or
(3) substituting non-radioactive isotopes or radioisotopes with shorter half-lives where
practicable.

Stability means structural stability.

Storage means the holding of low-level radioactive waste for treatment or disposal.

Subsidence means the process by which the earth's surface sinks, either rapidly or slowly, with
little or no horizontal motion.

Superior Site means any site selected by the Board, after detailed site characterization, pursuant
to M.G.L. c. 111H, § 23.

Surveillance means observation of a facility for purposes of visual detection of the need for
maintenance or custodial care, evidence of intrusion, or compliance with other license or
regulatory requirements.

Temporary Closure means the nonpermanent termination of low-level waste acceptance at a

facility prior to its scheduled closing date.

Treatment means any method, technique, or process including source minimization, volume
minimization, and storage for decay, designed to change the physical, radioactive, chemical, or
biological characteristics or composition of low-level radioactive waste in order to render such
waste safer for management, amenable for recovery, convertible to another usable material or
reduced in volume.

Violation means any act or failure to act which constitutes or results in one or more of the
following:
(1) engaging in any business or other activity without a license or approval whenever
engaging in such business or activity requires such license or approval.
(2) engaging in any activity prohibited by, or not in compliance with, any statute, by-law,
ordinance or regulation.
(3) not fully doing, or not doing in timely fashion, anything required by any statute, by-law,
ordinance or regulation.

Volume Minimization means treatment of low-level radioactive waste after its generation in
order to minimize the physical dimensions of the waste and the. space required for disposal.

Waste means low-level radioactive waste.

Waste Form means those physical and chemical characteristics of waste of primary importance
in influencing its stability in a disposal environment.

Waste Management Area means that portion of a facility where low-level radioactive waste has
been, is being or will be treated, stored or disposed of.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.810: General Requirements

(A) No person may treat, store or dispose of waste received from other persons, unless
authorized by a license issued by the Department pursuant to 105 CMR 120.800 and 120.100.

(B) No license shall be issued to operate a disposal facility which does not permit monitoring
and retrieval of the waste.

(C) In order to obtain a facility license pursuant to 105 CMR 120.800, an applicant shall
provide full documentary evidence of having been designated an Operator, and shall demonstrate
that the facility site has been selected and the facility is designed and will be constructed,
operated, closed and controlled after closure so that the environmental and human exposure
performance objectives set forth in 105 CMR 120.811 through 120.814 are satisfied.

(D) Any facility so licensed shall be constructed, operated, closed and controlled after closure
so that environmental and human exposure performance objectives set forth in 105 CMR
120.811 through 120.814 are satisfied.

120.811: Protection of the General Population from Releases of Radioactivity

Concentrations of radioactive material which may be released to the general environment in

ground water, surface water, air, soil, plants, or animals shall not result in an annual dose
exceeding an equivalent of 25 millirems (0.25 mSv) to the whole body, 75 millirems (0.75 mSv)
to the thyroid, and 25 millirems (0.25 mSv) to any other organ of any member of the public. The
Operator shall assume initiatives which are necessary to maintain releases of radioactivity in
effluents to the general environment as low as is reasonably achievable.

120.812: Protection of Individuals from Inadvertent Intrusion

Design, operation, and closure of a facility shall ensure protection of any individual
inadvertently intruding into the facility and occupying the site or contacting the waste at any time
after active institutional controls over the facility are removed.

120.813: Protection of Individuals During Operations

Operations at a facility shall be conducted in compliance with the standards for radiation
protection set out in 105 CMR 120.200, except for releases of radioactivity in effluents from the
facility, which shall be governed by 105 CMR 120.811. The Operator shall assume initiatives
which are necessary to maintain radiation exposures as low as is reasonably achievable.

120.814: Stability of the Facility After Closure

The facility shall be sited, designed, used, operated, and closed to achieve long-term stability
of the facility and to eliminate, to the extent practicable, the need for long-term active
maintenance of the facility following closure so that only surveillance, monitoring, or minor
custodial care are required.

120.815: Facility Design

(A) Any disposal method utilized at a facility shall permit retrieval and monitoring of the waste.

(B) Retrieval of waste from disposal units must be feasible through the institutional control
period without adversely affecting the ability of the facility to meet the performance objectives
set forth in 105 CMR 120.811 through 120.814.

(C) The Operator shall provide extensive security for the facility during the development,
operation, closure, post-closure observation and maintenance, and institutional control of the
facility for a period of time that ensures the health and safety of the general public and the
environment. The Operator shall allow site community participation in this security planning
process.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.815: continued

(D) Any facility accepting waste for disposal shall, to the extent practicable, be designed,
operated, closed and controlled after closure so as to maintain the gross physical properties and
identity of such waste and containers for a minimum of 100 years for Class A waste, 300 years
for Class B waste, and 500 years for Class C waste.

(E) Any disposal facility shall have its engineered structures designed with the goal to totally
hold their waste content for the period of the hazardous life of the radioactive waste (zero release
design objective).

120.816: Facility Institutional Control

(A) The design of any facility accepting waste for disposal shall be based on the assumption
that the period of active institutional controls shall not exceed 100 years.

(B) The actual institutional control period shall not be less than the minimum time required for
any waste present at the site to decay to the maximum concentrations above natural background
levels permitted to be released into air or water in unrestricted areas under federal and state law.

120.820: License Required

(A) No person may treat, store or dispose of low-level radioactive waste received from other
persons unless authorized by a license issued by the Department pursuant to 105 CMR 120.800
and 120.100.

(B) The Department shall not license any facility pursuant to 105 CMR 120.800 unless the
Operator has provided a certification by the Board that the facility is proposed to be sited on a
superior site selected pursuant to M.G.L c. 111H, § 23(g). Such certification shall not be made
unless the time period set forth in M.G.L. c. 111H, § 24(a) for the filing of a petition for an
adjudicatory proceeding has expired without such a petition being filed or, if such petition has
been filed, until the Department of Environmental Protection has issued a final decision
approving the selection of the superior site pursuant to M.G.L. c. 111H, § 24(c).

(C) Except as provided in M.G.L. c. 111H, § 12(b)(10), the Department shall not issue a facility
license unless the person making application for such license has provided full documentation
of having been designated an Operator in accordance with the procedures established pursuant
to M.G.L. c. 111H, §§ 22 and 27.

(D) The Department shall not issue such a license unless the Operator has obtained all other
permits and licenses required by law in order to commence construction of a facility.

120.821: Licensing Process

The procedures for a license application shall include the following:

(A) An Operator shall file an application with the Department pursuant to 105 CMR 120.124
and obtain a license as provided in 105 CMR 120.800 before commencement of construction of
the facility. Failure to comply with this requirement may be grounds for denial of a license.

(B) After an Operator files, with the Secretary of the Executive Office of Environmental
Affairs (EOEA), its notification of intent to apply for a facility license, it may file a facility
license application with the Department.

(C) The license application shall be determined to be complete when the Department finds that
all information required by 105 CMR 120.800 has been submitted and any additional
requirements of 105 CMR 120.800 have been satisfied.

(D) The Department may deny a facility license if the Operator fails or refuses to correct
deficiencies in the application within 30 days after notification of such a deficiency by the
Department. Such summary denial shall be accompanied by an explanation of the reasons for
the denial.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.821: continued

(E) The Department shall set a decision schedule, for each complete application, setting forth
the date by which it intends to prepare a draft license or draft denial and to issue a final license
decision. The Department shall adhere to such decision schedule unless it finds that an extension
of the schedule, not to exceed 90 days, is necessary to protect public health or the environment,
in which case the Department must adhere to such decision schedule as extended.

(F) The Department shall give notice of the commencement of the public comment period by
mail to the Operator, the community supervisory committee of each site community and the
Board, and by publication in accordance with regulations adopted pursuant to M.G.L. c. 30, §
62A (MEPA), in a daily or weekly newspaper of general circulation within each site and
neighboring community and by broadcasting on radio stations serving each such community.

(G) The public comment period shall continue for 45 days after the issuance of a draft license
or draft denial. The Department shall extend the public comment period if it issues a modified
draft license until 45 days after the issuance of such a modified draft license.

(H) Anyone may submit comments to the Department during the comment period. The
Department shall make copies of all comments received available to persons upon request.

(I) The Department shall conduct at least one public meeting on the license application and the
draft license or draft denial within each site community and other public meetings in neighboring
communities upon request by the Chief Executive Officer of such community.

(J) The Department shall, after action by the Secretary of the Executive Office of Enviromental
Affairs on a draft environmental impact report pursuant to M.G.L. c. 111H, § 30 and M.G.L. c.
30, § 62C, prepare a draft license or draft denial. A draft license shall include facility design and
performance specifications and all conditions required to operate the facility.

(K) A copy of the draft license or draft denial shall be sent to the Operator, the community
supervisory committee of each site community, the Board and, upon request, to other interested
persons, and shall be accompanied by an explanation of the reasons therefor and a description
of the procedures to be followed in reaching a final license decision. Such description shall
include the date on which the public comment period is to end; the dates and locations of
scheduled public meetings on the draft license or draft denial, the procedures to be followed by
persons wishing to participate in the process leading to the final license decision, and the name,
address and telephone number of the person within the Department to contact for additional
information.

(L) The Department shall send a copy of the final facility license decision to the Operator, the
community supervisory committee of each site community, the Board, any person who submitted
written comments during the public comment period and, upon request, to other interested
persons. Such final decision shall be accompanied by a summary response to comments received
during the public comment period and an explanation of the reasons for any difference between
the draft license or denial and the final license decision.

120.822: Content of Application

(A) In addition to the requirements set forth in 105 CMR 120.100, an application for a facility
license shall include the general information, specific technical information, institutional
information, financial information, and the results of preoperational environmental monitoring
set forth in 105 CMR 120.823 through 120.828.

(B) The applicant shall prepare, and submit as part of the application, a Safety Analysis Report
(SAR). The Safety Analysis Report must follow the format described in the most current revision
of United States Nuclear Regulatory Commission's publication, Standard Format and Content
of a License Application for a Low-Level Radioactive Waste Disposal Facility, (NUREG-1199).
The SAR must include all of the applicable information required in NUREG-1199, in addition
to the information required in 105 CMR 120.823 through 120.828, and will be reviewed by the
Department following the guidance contained in the most current revisions of NUREG-1200 and
NUREG-1300.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.822: continued

Only certain general sections of NUREG-1199, which do not specifically address disposal
facilities, are of direct relevance to treatment and storage facilities.

120.823: General Information

The general information shall include each of the following:

(A) Identity of the Operator including:

(1) The full name address, telephone numbers and description of the business or occupation
of the Operator; and
(2) If the Operator is a partnership, the name and address of each partner and the principal
location where the partnership does business.
(3) If the Operator is a corporation or an unincorporated association:
(a) The state where it is incorporated or organized and the principal location where it
does business; and
(b) The names and addresses of its directors and principal officers.
(4) If the Operator is acting as an agent or representative of another person in filing the
application, all information required under 105 CMR 120.823(A) must be supplied with
respect to the other person.

(B) Qualifications of the Operator:

(1) The organizational structure of the Operator, both offsite and onsite, including a
description of lines of authority, key positions and assignments or responsibilities, whether
in the form of administrative directives, contract provisions, or otherwise. The Operator
shall, at any time during licensing, development, operation, closure, post-closure observation
and maintenance or institutional control of the facility, immediately notify the Department
of any significant change in its organizational structure information;
(2) The technical qualifications, including training and experience, of the Operator and
members of the Operator's staff to engage in the proposed activities. Minimum training and
experience requirements for personnel filling key positions described in 105 CMR
120.823(B)(1) must be provided. The Operator shall, at any time during licensing,
development, operation, closure, post-closure observation and maintenance or institutional
control of the facility, immediately notify the Department of any significant change in its
technical qualifications information;
(3) A description of the Operator's personnel training program; and,
(4) A plan to maintain an adequate complement of trained personnel to carry out waste
receipt, handling, treatment, storage, and disposal operations in a safe manner.

(C) A description of:

(1) The location of the proposed facility;
(2) The general character of the proposed activities;
(3) The types and quantities of waste to be treated, stored, and/or disposed of; and
(4) The proposed facility and equipment.

(D) Proposed schedules for construction, receipt of waste, treatment and storage of waste, and
first emplacement of waste at the proposed facility.

120.824: Specific Technical Information

The specific technical information shall include the following information needed for
demonstration that the performance objectives and applicable technical requirements of 105
CMR 120.800 will be met:

(A) A description of the natural characteristics of the site and demographic characteristics of
the surrounding areas and populations as determined by site selection and characterization
activities. The description shall include geologic, geochemical, geotechnical, hydrologic,
cultural, scenic, historical, ecologic, archaeologic, meteorologic, climatologic, and biotic features
of the facility and vicinity.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.824: continued

(B) An identification of any known natural resources, the exploitation of which could result in
inadvertent intrusion upon the site.

(C) A description of the design features of the facility, its waste management areas and any
disposal units including, in particular, design features or other provisions for normal and
abnormal or accident conditions. The description shall include those design features related to
the following:
(1) Prevention or minimization of infiltration by water, plants, and animals;
(2) Water management features for water that may enter any disposal units or other waste
management areas;
(3) Integrity and stability of engineered barriers;
(4) Stability of intruder barriers surrounding wastes;
(5) Facility drainage;
(6) Adequacy of the size of the buffer zone;
(7) Monitoring;
(8) Retrievability;
(9) Occupational exposures;
(10) Facility closure;
(11) Minimization to the extent practicable of long term active maintenance; and,
(12) Protection from inadvertent intrusion.

(D) A description of the relationship of the principal design features of the facility to the
performance objectives set forth in 105 CMR 120.811 through 120.814, and to natural site
characteristics and natural events or phenomena associated with the site.

(E) A description of codes and standards which the Operator has applied to the design and
which will apply to construction of waste management areas and any disposal units. Such
standards shall meet local, state and national building code standards.

(F) A description of the construction and operation of the facility, its waste management areas
and any disposal units. The description shall include as a minimum the following:
(1) Methods of constructing any disposal units;
(2) Types of intruder barriers and onsite traffic controls;
(3) Methods and areas of waste treatment and storage;
(4) Drainage systems to control surface water or groundwater access to the wastes;
(5) Operator's environmental monitoring and surveillance;
(6) Receipt and handling of waste and inspection of waste and package integrity;
(7) Procedures for and areas of waste segregation;
(8) Any waste emplacement;
(9) Worker monitoring and surveillance;
(10) Survey control program; and,
(11) Methods to be employed in the handling and any disposal of wastes containing
chelating agents or other non-radiological substances that might affect meeting the
performance objectives set forth in 105 CMR 120.811 through 120.814.

(G) A description of the kind, amount, classification and specifications of waste proposed to
be treated, stored or disposed of at the facility and a description of total facility design capacity
and facility expected operating life.

(H) A description of the quality assurance program for the determination of natural site
characteristics and for quality assurance during the design, construction, operation, and closure
of the facility including, in particular, the receipt, handling, and emplacement of waste. Audits
and managerial controls must be included.

(I) A description of the radiation safety program for control of radioactive effluents to ensure
compliance with the performance objective set forth in 105 CMR 120.811; for control of
occupational radiation exposure to ensure compliance with the requirements of 105 CMR
120.200 and for control of contamination of personnel, vehicles, equipment, buildings, and the
facility. Both routine operations and accidents shall be addressed. The program description must
include procedures, instrumentation, facilities, and equipment.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.824: continued

(J) A description of the Operator's environmental monitoring and the Operator's plans for taking
remedial measures when necessary.

(K) A description of the administrative procedures that the Operator will apply to control
activities at the facility.

(L) A description of the plan for facility closure and post closure observation and maintenance
including those design features intended to facilitate facility closure and to minimize the need
for long term active maintenance. Such plan shall include:
(1) A description of the relationship between individual waste containers (or disposal units,
in the case of a disposal facility) and final closure;
(2) Procedures to be implemented to ensure that any disposal units at a facility will not be
adversely affected by closure.

(M) A description of the waste containment within any disposal units as it applies to the design
objective to provide total containment of wastes within disposal units for 100 years for Class A
waste, 300 years for Class B waste, and 500 years for Class C waste.

(N) A description of the circumstances under which retrieval of waste would be necessary or
desirable and the plans and the procedures to be used to effect retrieval. The description shall
include an analysis of the impacts of waste retrieval on public and worker health and safety and
the environment.

(O) A description of the waste minimization program that would be instituted to reduce the
volume and activity of low-level radioactive waste generated at the facility pursuant to 105 CMR
120.890.

120.825: Technical Analyses

(A) The specific technical information shall also include the following analyses needed to
demonstrate that the performance objectives set forth in 105 CMR 120.811 through 120.814 will
be met:
(1) Pathways analyzed in demonstrating protection of the general population from releases
of radioactivity shall include air, soil, groundwater, surface water, plants and animals. The
analyses shall clearly identify and differentiate between the roles performed by the natural
site characteristics and facility design features in isolating and segregating the wastes. The
analyses shall demonstrate that there is assurance that the exposures to humans from the
release of radioactivity will not exceed the limits set forth in 105 CMR 120.811.
(2) Analyses of the protection of individuals from inadvertent intrusion shall demonstrate
that waste classification and segregation requirements will be met and that intruder barriers
will be provided.
(3) Analyses of the protection of individuals during operations shall include assessments
or expected exposures due to routine operations and potential accidents during handling,
treatment, storage, and disposal of waste. The analyses shall demonstrate that exposures will
be controlled to meet the requirements of 105 CMR 120.200.
(4) Analyses of the long term stability of the facility and the need for active long-term
maintenance after closure shall be based upon analyses of active natural processes (such as,
in the case of a disposal facility, erosion, mass wasting, slope failure, settlement of wastes,
infiltration through adjacent soils, and surface drainage of the facility). The analyses shall
demonstrate that there will not be a need for long term active maintenance of the facility
following closure.

(B) The Operator shall, at any time during licensing, development, operation, closure,
post-closure observation and maintenance or institutional control of the facility, immediately
notify the Department of any significant change in its technical analysis required to be submitted
pursuant to 105 CMR 120.800. Such notification shall include a substitute technical analysis,
satisfying the requirements of the Section and demonstrating that the performance objectives set
forth in 105 CMR 120.811 through 120.814 will be met by the facility.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.826: Institutional Information

The institutional information submitted by the Operator shall include:

(A) Certifications by the Board that the facility is proposed to be sited on land owned by the
Commonwealth in fee simple absolute and that the Board is prepared to accept transfer of the
license when the provisions of 105 CMR 120.870 are met and to assume responsibility for
institutional control of the facility after closure and post-closure observation and maintenance
are completed.

(B) All material submitted to, or substantially relied upon by the Board in support of its
certification of the operator pursuant to M.G.L. c. 111H, § 22(c).

120.827: Financial Information

(A) The Operator shall show that it either possesses the necessary funds or has reasonable
assurance of obtaining the necessary funds, or a combination of the two, to cover the estimated
costs of conducting all licensed activities over the planned operating life of the project, including
costs of facility development, construction, operation, and closure. The Operator shall
demonstrate that it is in compliance with all the financial criteria for operator certification set
forth in 345 CMR 3.12: Financial Criteria for Operator Certification.

(B) The Operator shall provide the Department with a certification issued by the Board that the
amount expected to be contained in the institutional control account of the Low-Level
Radioactive Waste Trust Fund will be adequate to pay the costs of institutional control of the
facility pursuant to M.G.L. c. 111H, §§ 9 and 47. At any time that the Board determines that
changes in inflation, technology of facility operations or other changes have significantly altered
the factual basis for the certification issued pursuant to 105 CMR 120.827(B), it shall
immediately notify the Department. Such notification shall include any proposal for changes in
the schedule of surcharges for the Low-Level Radioactive Waste Trust Fund, adopted pursuant
to M.G.L. c. 111H, § 38(c), deemed necessary by the Board.

120.828: Preoperational Environmental Monitoring

(A) At the time a license application is submitted, the Operator shall present the results of
preoperational environmental monitoring conducted to provide basic environmental data on the
facility and site characteristics. The preoperational environmental monitoring program shall
conform with that described in NUREG-1388 to the extent applicable to the type of facility,
M.G.L. c. 111H, and the requirements of 105 CMR 120.831. The Operator shall include
information about the ecology, meteorology, climate, hydrology, geology including geophysics
and geotechnical engineering, geochemistry, seismology, and radiologic characteristics of the site
and all other relevant information required in 105 CMR 120.824, 120.825 and 120.831 necessary
to demonstrate the suitability of the site for the intended use.

(B) For those characteristics that are subject to seasonal variation, any data collected by the
Operator, together with data from the detailed site characterization conducted by the Board, shall
cover a period of at least 12 consecutive months.

(C) The Operator shall continue the preoperational environmental monitoring program through
the Department's license review period.

120.829: Standards for Issuance of a License

A facility license may be issued by the Department, following action of the Secretary of
Environmental Affairs on a final environmental impact report pursuant to M.G.L. c. 111H, § 30
and M.G.L. c. 30, § 62C, if it finds that:

(A) The issuance of the license will not constitute an unreasonable risk to the health and safety
of the public;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.829: continued

(B) The Operator is qualified by reason of training and experience to carry out the proposed
treatment, storage, or disposal operations in a manner that protects health and minimizes danger
to life or property;

(C) The Operator's proposed facility design, environmental monitoring plan, equipment,
operations, procedures, facility closure, post-closure observation and maintenance and
institutional control are adequate to protect the public health and safety and demonstrate that the
performance objectives set forth in 105 CMR 120.811 through 120.814 will be satisfied;

(D) The Operator has demonstrated that the applicable technical requirements of 105 CMR
120.800 will be met;

(E) The Operator's proposal for institutional control demonstrates that such control will be
provided for a length of time not less than the minimum time required for any waste present at
the site to decay to the maximum concentrations above natural background levels permitted to
be released into air or water in unrestricted areas under federal and state law, and that the
institutional control meets the requirements of 105 CMR 120.871;

(F) The financial and surety arrangements comply with all the financial criteria for operator
certification set forth in 345 CMR 3.12; and

(G) The Operator has provided a written statement indicating that the Operator's proposed
facility design, equipment, operations procedures, closure, post-closure observation and
maintenance, and institutional control meet all applicable environmental, public health, labor,
occupational health and safety standards and regulations.

120.830: Conditions of Licenses

(A) Each person licensed by the Department pursuant to 105 CMR 120.800 shall confine
possession and use of materials to the locations and purposes authorized in the license.

(B) The Operator shall not treat, store or dispose of waste until the Operator has received
written notification from the Department that the Department has inspected the facility and has
found it to be in conformance with the design and construction described in the application for
a license.

(C) The Operator shall be subject to the provisions of M.G.L. c. 111H, and to all rules,
regulations, and orders of the Department. The terms and conditions of the license are subject
to amendment, revision, or modification, by reason of amendments to, or by reason of rules,
regulations, and orders issued in accordance with the terms of M.G.L. c. 111H.

(D) The Department may incorporate in any license at the time of issuance, or thereafter, by
appropriate rule, regulation or order, additional requirements and conditions with respect to the
Operator's receipt, possession, treatment, storage, or disposal of waste as it deems appropriate
or necessary in order to protect public health, safety or environment.

(E) The Department may require tests, reports and the keeping of records, and provide for such
inspections of activities under the license that may be necessary or appropriate to effectuate the
purposes of M.G.L. c. 111H and 105 CMR 120.800.

(F) The Department may issue orders to assure compliance with 105 CMR 120.800, or to cease
activity in violation of 105 CMR 120.800; it may revoke, suspend or modify licenses and impose
a civil penalty or have the Attorney General bring an action to restrain, prevent or enjoin any
conduct prohibited by 105 CMR 120.800 or compel action ordered by the Department as shall
be stated in 105 CMR 120.016: Enforcement.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.830: continued

(G) Each Operator shall notify the Department in writing immediately following the filing of
a voluntary or involuntary petition for bankruptcy under any Chapter of Title 11 (Bankruptcy)
of the United States Code by or against:
(1) The Operator;
(2) An entity (as that term is defined in 11 U.S.C. §101(14)) controlling the Operator or
listing the license of Operator as property of the estate; or,
(3) An affiliate (as that term is defined in 11 U.S.C. §101(2)) of the license.
Such notification shall indicate the bankruptcy court in which the petition for bankruptcy was
filed and the date of the filing of the petition.

(H) A license issued under 105 CMR 120.800, or any right thereunder, may not be transferred,
assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly,
through transfer of control of the license to any person, unless the Department finds, after
securing full information, that the transfer is in accordance with the provisions of M.G.L. c.
111H and 105 CMR 120.800 and the Department gives its consent in writing in the form of a
license amendment.

(I) The Operator shall submit written statements under oath upon request of the Department,
at any time before transferring of the license, to enable the Department to determine whether the
license should be modified, suspended, or revoked.

(J) The license may be transferred to the Board upon the full implementation of the facility
closure plan as approved by the Department, and completion of post-closure observation and
maintenance in accordance with 105 CMR 120.800.

(K) The authority to treat, store, and dispose of wastes expires on the date stated in the license.
Any expiration date on a license applies only to the site operations activities and to the authority
to treat, store, and dispose of waste. Failure to renew the license shall not relieve the Operator
of responsibility for implementing site closure, post-closure observation and maintenance, or
transfer of the license to the Board.

120.831: Environmental Monitoring

(A) The Operator must submit an environmental monitoring plan, of which the preoperational
environmental monitoring required in 105 CMR 120.828 is a component, as part of the complete
license application. The extent and duration of the Operator environmental monitoring program
shall take into account the nature of the licensed operation. In the case of a low-level radioactive
waste disposal facility, the Operator environmental monitoring program shall, at a minimum,
conform to the general guidance provided in U.S. Nuclear Regulatory Commission publication,
Environmental Monitoring of Low-Level Radioactive Waste Disposal Facility, NUREG-1388
(published in 1989).
The Operator shall submit with the license application a baseline health study of the site
community and any affected community. The study shall be paid for by the Operator and
conducted by the Department's Bureau of Environmental Health Assessment following the
design requirements for such a study that are currently being used by the Department. A
comparison health study shall be conducted every five years and paid for by the Operator.
The environmental monitoring programs for treatment and storage facilities shall be designed
for the specific needs of those facilities.

(B) During facility development, construction, operation, closure, post-closure observation and
maintenance, until the facility license is transferred to the Board, the Operator shall establish and
conduct the Operator environmental monitoring program as required by 105 CMR 120.831 and
in accordance with the environmental monitoring plan approved by the Department as a
condition of the final license.

(C) Within 30 days of the issuance of a facility license, the Department shall, after consultation
with the Department of Environmental Protection and the Board of Health of each site
community, establish and conduct a comprehensive environmental monitoring program at the
facility site which will compliment and validate the Operator environmental monitoring program.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.831: continued

(D) The Department environmental monitoring program and the Operator environmental
monitoring program shall each employ the best available monitoring technology to collect and
analyze data concerning standing and running surface water and drainage; groundwater samples
from offsite, site boundary and waste management area wells; soil and sedimentation samples,
air samples, vegetation and wildlife samples, and direct radiation measurements offsite, at the
site boundary and in the waste management area.

(E) Both the Department environmental monitoring program and the Operator environmental
monitoring program shall be designed to:
(1) Establish baseline environmental data on the site;
(2) Provide data to allow evaluation of facility impacts on public health, safety and the
environment, and evaluate the need for mitigative measures at the facility;
(3) Provide early warning of the magnitude and extent of any migration of radionuclides
and/or any hazardous chemicals;
(4) Determine compliance with applicable regulations, with conditions of the facility license
pursuant to 105 CMR 120.830, and with the terms of the comprehensive operating contract;
and
(5) Provide reliable environmental data throughout development, operation, closure,
post-closure observation and maintenance and institutional control at the facility.

(F) Both the Department environmental monitoring program and the Operator environmental
monitoring program shall be designed to detect:
(1) Any seepage through engineered barriers.
(2) The structural stability of engineered barriers.
(3) External or internal conditions that may cause physical changes leading to enhanced
water movement or compromises in stability.

(G) Both the Department environmental monitoring program and the Operator environmental
monitoring program shall include:
(1) Facility measurements.
(a) Soil sampling
(b) Pore water sampling
(c) Pore gas sampling
(d) In situ measurements
(e) Geophysical remote sensing
(f) Photogrammetric techniques
(g) Subsurface hydrological monitoring
(h) Subsurface physical monitoring
(i) Subsurface chemical monitoring
(2) Measurements at a representative test area.
(a) Use of a surrogate facility for area testing.
(b) Use of replaceable monitoring and nondestructive test systems.
(c) Undisturbed region not directly impacted by engineered facility or facility activity
(representative of natural or background conditions).

(H) Both the Department environmental monitoring program and the Operator environmental
monitoring program shall include a quality assurance program utilizing the best available
methods of monitoring plan formulation, data acquisition, database creation, data verification,
and data validation to minimize instances of false negative measurements. Data shall be
processed, synthesized and organized so as to be suitable for use to evaluate the performance of
the facility's engineered barriers and to ensure the protection of the public health, safety and the
environment.

(I) Both the Department environmental monitoring program and the Operator environmental
monitoring program shall be upgraded to provide the maximum protection of public health,
safety and the environment based on the results of the quality assurance program.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.831: continued

(J) A copy of all Department environmental monitoring program and Operator environmental
monitoring program records and analyses shall be kept at the Board field office in the site
community for public review.

(K) The Department environmental monitoring program shall provide, to the maximum extent
feasible, for the participation of officials and citizens of each site community and the training of
such persons to facilitate their participation.

(L) The Board of Health of each site community shall be entitled to obtain portions of the
samples collected pursuant to the environmental monitoring programs for independent analysis
by a laboratory certified to conduct such analysis by the U.S. Environmental Protection
Department.

(M) The Operator shall cooperate with the Department environmental monitoring program and
shall reimburse the Department and each site community annually for the costs thereof until the
facility license is transferred to the Board pursuant to 105 CMR 120.870.

(N) The Department shall:

(1) Issue an annual report describing and evaluating the findings of the environmental
monitoring program.
(2) Hold a public meeting within 60 days of the issuance of the report for public review and
comment on the report in:
(a) Each site community; and,
(b) Each affected and neighboring community, if the chief executive officer of such a
community so requests.
(3) Consider and evaluate all comments made at such public meetings or submitted in
writing within 60 days of the issuance of the report.

(O) The Operator shall have plans for taking corrective measures if either the Department
environmental monitoring program or the Operator environmental monitoring program detects,
or indicates the threat of, migration of radionuclides or hazardous chemicals or increased on-site
or off-site radiation levels which would indicate that the performance objectives set forth in 105
CMR 120.811 through 120.814 may not be met including:
(1) A restorative and protection action plan.
(2) A dose modeling program for site workers and the general public.
(3) A dose modeling program in the event of an accidental release to the environment.

(P) The Department, in consultation with the Board, may issue an order to temporarily close
the facility if it finds that there is a potential hazard to public health, safety or the environment
which justifies such temporary closure. A facility that is temporarily closed shall remain closed
as long as necessary for remedial action, and, in any event, through any period of facility
clean-up and stabilization. Prior to authorizing the reopening of a temporarily closed facility,
the Department shall:
(1) Conduct a minimum of one public meeting relative to the reopening in each site
community, and other public meetings in neighboring communities upon the request of the
chief executive officer of such community;
(2) Issue a summary response to all comments made at such public meetings or made in
writing during the time the facility is temporarily closed, and an explanation of the reasons
for authorizing the reopening.

120.832: Facility Design

(A) Facility design features shall be directed toward long-term isolation of waste and avoidance
of the need for continuing active maintenance after closure.

(B) The facility design and operation shall be compatible with the facility closure and closure
plan and lead to closure that ensures that the performance objectives set forth in 105 CMR
120.811 through 120.814 will be met.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.832: continued

(C) The facility shall be designed to complement and improve, where appropriate, the ability
of the facility's natural characteristics to assure that the performance objectives will be met.

(D) Engineered barriers shall be designed to minimize to the extent practicable, water
infiltration, to direct percolating of surface water away from waste, and to resist degradation by
surface geologic processes and biotic activity.

(E) Surface features shall direct surface water drainage away from disposal units at velocities
and gradients which will not result in erosion that will require ongoing active maintenance.

(F) The facility shall be designed to minimize to the extent practicable the contact of
percolating or surface water with waste.

(G) The facility design shall incorporate subsidence monitoring and minimization; long term
stability of any disposal units, storage and structural components; and facility safety systems to
ensure protection of facility workers, members of the general public, and the environment.

(H) The design of any disposal facility shall incorporate structural monitoring provisions for
a program which allows:
(1) Regular visual inspections of the exterior portions of any disposal units;
(2) Remote sensing of inaccessible areas, where applicable; and,
(3) Meters and gauges, as necessary.

(I) The Operator shall ensure that the facility design and operation plans allow for proper
inspection and receipt of all incoming waste shipments and packages.

(J) The buffer zone shall not be used for receipt or storage of waste.

NOTE: Short-term and long-term performance of a disposal facility may be achieved by a

combination of factors, including disposal method and engineered barriers, waste form and
packaging, facility operation, institutional controls, natural site features, and waste classification
and inventory limits.

120.833: Facility Construction

(A) The Operator shall present facility construction plans to be approved by the Department
prior to commencement of construction.

(B) The Operator may begin construction once the Department has determined that:
(1) The operator environmental monitoring program and Department environmental
monitoring program, together with the detailed site characterization of the site, has yielded
comprehensive baseline data.
(2) All required financial assurances have been accepted.
(3) All pre-construction conditions of the facility license have been satisfied.

(C) The Operator shall ensure that construction of the facility meets all the requirements of 105
CMR 120.800 and the license.

(D) The Board shall appoint a resident engineer who shall represent the Board daily at the site
during construction of the facility and who shall, in cooperation with officials at each site
community, check, inspect, and report to the Board as to events at the construction site.

(E) The Department will periodically inspect the construction process to ensure that the
requirements of 105 CMR 120.800 and the license are being met.

(F) The Operator shall construct, install, and make additions and improvements to such
structures and equipment as are determined by the Department to be necessary.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.834: Operating Budget Reimbursements

Once a license has been issued, and annually thereafter until the facility license is transferred
to the Board pursuant to 105 CMR 120.870, the Department shall establish a payment to be made
by the Operator. This payment shall equal the Department's expected annual operating budget
for the next fiscal year for its activities with respect to the facility, except that the payment shall
be adjusted by the amount of any operating deficit or surplus previously incurred by the
Department. The Operator shall make such payment to the Commonwealth prior to the
commencement of the fiscal year.

120.840: Facility Opening

(A) Prior to the acceptance of waste at a facility, the Operator shall notify the Department and
the Board that the construction of the facility is complete and in compliance with all
requirements of 105 CMR 120.800 and all license conditions, and that the facility is ready to
accept waste.

(B) Prior to the acceptance of waste at a facility, the Operator shall file with the Department the
waste acceptance criteria, approved by the Board, that will be utilized at the facility.

(C) Upon written notification from the Department that the Operator is in compliance with all
the regulations and conditions of the facility license, and upon a determination of compliance
with the comprehensive operating contract by the Board, commencement of operations may
begin. The Operator shall be required to begin accepting waste within 30 days after such
notification.

(D) No person may ship or transport any waste to a facility without the written consent of the
Operator.

120.841: Facility Operation

(A) Wastes designated as Class A pursuant to 105 CMR 120.247 shall be segregated from other
wastes by emplacing them in disposal units that are sufficiently separated from disposal units for
the other waste classes so that any interaction between Class A wastes and other wastes will not
result in the failure to meet the performance objectives of 105 CMR 120.800. This segregation
is not necessary for Class A wastes if they meet the stability requirements in 105 CMR
120.247(B).

(B) Wastes designated as Class C pursuant to 105 CMR 120.247 shall be disposed of with
intruder barriers that are designed to protect against an inadvertent intrusion for at least 500
years.

(C) Waste arriving at the facility shall comply with all other pertinent Sections of 105 CMR
120.000 with regard to waste classification, waste characteristics, labeling, manifests, the waste
acceptance criteria approved by the Board and any applicable provisions of the comprehensive
operating contract.

(D) The Operator shall have specific procedures to ensure compliance of waste with all
applicable waste acceptance criteria.

(E) The Operator of any disposal facility shall require evidence of a certificate signifying the
Department's approval of the waste minimization statement or plan of a generator, pursuant to
105 CMR 120.890 as a condition of access to the facility.

(F) Any facility accepting mixed waste shall provide an equivalent level of environmental
protection as that required by M.G.L. c. 21C and 310 CMR 30.000.

(G) The Operator shall provide adequate training for all site workers in the proper handling of
radioactive waste to ensure radiological controls. Such training shall include, but not be limited
to:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.841: continued

(1) Basic Radiation Principles

(2) Basic Radiation Protection
(3) Radiation Biology
(4) Decontamination Methods
(5) Personnel Safety Precautions/Work Habits
(6) Accident Response Actions/Notifications

120.842: Receipt, Handling, and Inspection of Waste

(A) The Operator shall submit a plan for the receipt, inspection, and handling of waste entering
the facility. The plan shall include, but not be limited to, the waste acceptance criteria approved
by the Board.

(B) The Operator shall ensure that special inspection and receiving plans are in place in case
of damaged transportation vehicles or packages, incorrect manifests or shipping documents, or
non-compliance with any Section of 105 CMR 120.000.

(C) The plans and procedures for moving the waste shall be implemented and equipment shall
be utilized so as to minimize contact or the possibility of contact with water.

(D) Upon arrival to the facility, all waste shall enter a waste inspection area and remain there
until the Department can inspect the manifests and the integrity of the waste being received.

(E) The Department shall inspect each shipment of waste before the shipment is accepted for
storage, treatment or disposal. Any shipment that is not found to be in compliance with
applicable regulations, license conditions, and waste acceptance criteria shall be held in a
controlled area within the facility until a representative from the generator is contacted, and the
generator or its agent remedies the deficiency; the operator shall notify the board of health of
each site community of any such failure of compliance.

(F) The generator shall be assessed a daily penalty until the deficiency is remedied and the
shipment complies with applicable regulations, license conditions and waste acceptance criteria.

(G) After a transport vehicle is unloaded and leaves the waste management area, it shall not
leave the facility until it is again inspected by the Department and decontaminated, if necessary.

(H) Once inspected, wastes accepted for disposal shall be emplaced in a manner to ensure that
container integrity is maintained during emplacement, and that the minimization of void spaces
between the containers permits the ability to fill the void spaces. Once inspected, wastes accepted
for storage shall be placed in storage in a manner to ensure that container integrity is maintained
throughout the period of storage.

(I) Void spaces between waste containers in disposal units shall be filled with material
appropriate to reducing future subsidence of the disposal units.

(J) Closure measures set forth in the approved facility closure plan shall be carried out as each
disposal unit is filled and sealed.

(K) Waste shall be emplaced and sealed in a manner that limits the radiation dose rate at the
surface of the engineered barrier to levels that at a minimum will permit the Operator to comply
with all provisions of 105 CMR 120.207 at the time of license transferral as provided in 105
CMR 120.800.

(L) Waste shall be handled in a manner to minimize workers exposure to radiation utilizing
ALARA (As Low As Reasonably Achievable) techniques.

(M) Waste shall be emplaced to ensure retrievability and the ability to monitor through the end
of the institutional control period.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.842: continued

(N) Following receipt and acceptance of a shipment of waste, the Operator shall record the date
of any emplacement of the waste, the waste's location in the facility, the condition of the waste
containers as received, any remedial measures taken pursuant to 105 CMR 120.842(E), any
discrepancies between materials listed on the manifest and those received, and any evidence of
leaking or damaged containers or radiation or contamination levels in excess of limits specified
in the regulations of the U.S. Department of Transportation (49 CFR 173.441 and 173.443,
revised as of November 1, 1984, as amended) and the Department. The Operator shall briefly
describe any repackaging operations of any of the waste containers included in the shipment, plus
any other information required by the Department as a license condition.

(O) Facility operations shall not have an adverse effect on the implementation of closure plan
measures.

(P) Only wastes containing or contaminated with radioactive material shall be accepted at the
facility.

(Q) Waste received at a disposal facility shall not be intentionally diluted by the Operator to
alter its classification as identified on the manifest.

120.843: Facility Boundaries and Markers

(A) The boundaries and locations of any disposal unit shall be accurately located, adequately
marked, and mapped.

(B) A buffer zone of land shall be maintained between the waste management area and the
facility boundary. The buffer zone shall be of adequate dimensions to carry out environmental
monitoring activities specified in 105 CMR 120.831 and satisfy the requirements of 310 CMR
41.27(b).

120.844: Contingency Plans for Facility Operations

(A) The Operator shall have contingency plans for unplanned occurrences, such as fires,
accidents, radiological contaminations or releases of radioactivity into the environment, severe
natural events, and any operational repair and waste recovery activities that may adversely affect
the health and safety of the facility workers or general public. Any retrieval of waste pursuant
to such contingency plans shall conform to the terms approved in the license.

(B) The plans shall identify the necessary minimal training, management, procedures,
equipment, communications and notification systems, and human resources needed and required
to provide emergency response to unplanned occurrences.

(C) The Operator shall include in the license application:

(1) Signed agreements with necessary emergency units that will respond to the requests
from the Operator.
(2) A demonstration of adequate emergency response capability as deemed appropriate by
the Department.

120.845: Facility Maintenance

The Operator shall maintain the facility so as to remain in compliance with all the terms and
conditions of the license and 105 CMR 120.000.

120.850: Funding for Facility Closure

(A) The Operator shall provide assurances prior to the commencement of operations, that
sufficient funds will be available to carry out facility closure. These assurances shall be based
on Department-approved cost estimates reflecting the Department-approved facility closure plan.
The Operator's cost estimates must take into account total costs that would be incurred if an
independent contractor were hired to perform the closure work. The assurances shall establish
that there will be sufficient funds for:
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.850: continued

(1) Decontamination, stabilization or dismantlement of facility components.

(2) Closure of the facility so that following transfer of the facility license to the Board, the
need for ongoing active maintenance is minimized to the extent practicable and only minor
custodial care, surveillance, and monitoring are required.

(B) In order to avoid unnecessary duplication and expense, the Department may accept financial
sureties that have been consolidated with earmarked financial or surety arrangements established
to meet requirements of Federal or other State agencies or local governmental bodies for such
closure. The Department may accept these arrangements only if they are considered adequate
to satisfy the requirements of 105 CMR 120.800 and that the portion of the surety which covers
the closure of the facility is clearly identified and committed for use in accomplishing these
activities.

(C) The Operator's financial or surety arrangement shall be submitted annually for review by
the Department to ensure that sufficient funds are available for completion of the closure plan
assuming that the work has to be performed by an independent contractor.

(D) The amount of the Operator's financial or surety arrangement shall change in accordance
with changes in the predicted costs of implementing the closure plan. Factors affecting closure
cost estimates include, but are not limited to inflation, increases in the amount of disturbed land,
changes in engineering plans, and closure that has already been accomplished. The financial or
surety arrangements shall be sufficient at all times to cover the costs of closure of any disposal
units that are expected to be used before the next license renewal.

(E) Financial or surety arrangements shall be written for a specified period of time and provide
for automatic renewal unless the person who issues the surety notifies the Department, the Board,
and the Operator not less than 90 days prior to the renewal date of its intention not to renew. In
such a situation, the Operator must submit a replacement surety within 30 days after notification
of cancellation. If the Operator fails to provide a replacement surety acceptable to the
Department, the Board may collect on the original surety.

(F) Proof of forfeiture shall not be necessary to collect the surety so that, in the event that the
Operator cannot provide an acceptable replacement surety within the required time, the surety
shall be automatically collected prior to its expiration. The conditions described above shall be
clearly stated on any surety instrument which is not open ended, and shall be agreed to by all
parties.

(G) Financial or surety arrangements generally acceptable to the Department include surety
bonds, cash deposits, certificates of deposit, deposits of government securities, escrow accounts,
irrevocable letters or lines of credit, trust funds, and combinations of the above or such other
types of arrangements as may be approved by the Department. Self-insurance, or any
arrangement which essentially constitutes pledging the assets of the Operator, will not satisfy the
surety requirement.

(H) The Operator's financial or surety arrangement shall remain in effect until closure has been
completed and approved by the Department, and the license has been transferred to the Board.

120.851: Application for Renewal or Closure

An application for renewal or an application for closure must be filed at least one year prior
to the date scheduled for facility closure in the facility closure plan. A final closure application
shall include a final revision and specific details of the facility closure plan included as part of
the license application submitted under 105 CMR 120.824(L) that includes each of the
following:

(A) Any additional geologic, hydrologic, or other data pertinent to the long-term containment
of any emplaced wastes obtained during the operational period.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.851: continued

(B) The results of tests, experiments, or any other analyses relating to treatment, storage or
disposal of waste, final closure and sealing, migration of radionuclides and interaction with
emplacement media, or any other tests, experiments, or analysis pertinent to the long-term
containment of any emplaced waste within the facility.

(C) Any proposed revision of plans for:

(1) Decontamination, stabilization and/or dismantlement of facility components; or,
(2) Post-closure observation and maintenance of the facility.

(D) Any significant new information regarding the environmental impact of final closure
activities and long-term performance of the facility.

120.852: Procedures for Review of Application for Facility Closure and Closure Plan

(A) The Department shall conduct a public meeting on the final closure plan at times to be
determined after consultation with the Board in each site community, and other public meetings
in neighboring communities upon request by the chief executive office of such community. The
Board shall participate in each such public meeting.

(B) The Department shall accept written comments on the submitted plan from any interested
person within 45 days of public notice of the availability of the plan. Prior to its acceptance of
the plan, the Department shall consider and evaluate all comments made at a public meeting or
submitted in writing.

(C) Upon review and consideration of an application for closure, the Department shall permit
closure of the facility if there is assurance that the long-term performance objectives set forth in
105 CMR 120.814 will be met during post closure observation and maintenance and institutional
control of the facility.

120.853: Facility Closure

(A) The Operator shall monitor the facility and carry out the closure plan until the facility
closure is complete. The Department shall, in cooperation with appropriate officials of each site
community, periodically inspect the Operator's implementation of the facility closure plan to
ensure that the requirements in 105 CMR 120.800 and the conditions of the facility license are
satisfied.

(B) Facility closure shall be conducted so as to ensure the stability of the facility until the
facility license is transferred to the Management Board pursuant to 105 CMR 120.870:
Post-closure Observation and Maintenance.

120.860: Post-closure Observation and Maintenance

The Operator shall observe, monitor, and carry out necessary maintenance and repairs at the
facility until a period of five years after the site closure is complete and the license is transferred
by the Department in accordance with 105 CMR 120.870. The Operator environmental
monitoring program of the facility shall continue as approved by the Department. Responsibility
for the facility must be maintained by the Operator for not less than five years. A longer time
period for post-closure observation and maintenance may be required as part of the site closure
plan, based on facility-specific conditions.

120.870: Transfer of License

Following the period of post-closure observation and maintenance, the Operator may apply
to transfer the facility license to the Board. The license shall be transferred under M.G.L. c.
111H, § 46 if the Department finds:

(A) That the closure of the facility has been completed in conformance with the Operator's
facility closure plan, as amended and approved as part of the license;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.870: continued

(B) That the performance objectives set forth in 105 CMR 120.811 through 120.814 are met;

(C) That all records of the Operator's development, operation, closure and post-closure
observations and maintenance of the facility have been transferred to the Board in compliance
with M.G.L. c. 111H, § 44, and that the Board has certified the adequacy of the amount
contained in the institutional control account of the Low-level Radioactive Waste Trust Fund to
pay the costs of institutional control of the facility pursuant to M.G.L. c.111H, §§ 9 and 47;

(D) That the Board has adopted a plan for institutional control of the facility and to accept
transfer of the license, and is prepared to continue the Operator environmental monitoring
program; and

(E) That the Management Board is prepared to assume responsibility for and satisfy the
institutional requirements as set forth in 105 CMR 120.800.

120.871: Institutional Control

The Board shall conduct an institutional control program which shall physically control
access to the facility following transfer of control of the facility from the facility Operator. The
institutional control program shall also include, but not be limited to, continuing the Operator
environmental monitoring, periodic surveillance, minor custodial care, and other requirements
as determined by the Department; and administration of funds to cover the costs for these
activities. The period of institutional controls shall be determined by the Department and shall
satisfy the requirements set forth in 105 CMR 120.816.

120.880: Maintenance of Records, Reports, and Transfers

(A) The Operator shall maintain any records and make any reports in connection with the
licensed activities as are required by the conditions of the license or by 105 CMR 120.800 or any
order of the Department.

(B) Records required by 105 CMR 120.800 or by license conditions shall be maintained for a
period specified by 105 CMR 120.800 or by license condition. If a retention period is not
otherwise specified, these records shall be maintained and transferred to the Board as a condition
of license transfer unless the Department authorizes their disposition because of inaccuracies or
obsolescence or that disposing of such records will not adversely affect the public health and
safety of the general public and the environment.

(C) Records which are required to be maintained pursuant to 105 CMR 120.800 may be the
original or a reproduced copy or microfilm if this reproduced copy or microfilm is capable of
producing copy that is clear and legible at the end of the required retention period. The record
may also be stored in electronic media with the capability for producing legible, accurate, and
complete records during the required retention period. Records such as letters, drawings,
specifications, must include all pertinent information such as stamps, initials, and signatures.
The licensee shall maintain adequate safeguards against tampering with and loss of records.

(D) Copies of all records of the location and the quantity of wastes contained in the facility shall
be transferred to the Board upon license transfer to the Board.

(E) Following receipt and acceptance of a shipment of radioactive waste, the licensee shall
record the date that the shipment is received at the disposal facility, the date of disposal of the
waste, a traceable shipment manifest number, a description of any engineered barrier or structural
overpack provided for disposal of the waste, the location of disposal at the disposal site, the
containment integrity of the waste disposal containers as received, any discrepancies between
materials listed on the manifest and those received, the volume of any pallets, bracing, or other
shipping or onsite generated materials that are contaminated, and are disposed of as contaminated
or suspect materials, and any evidence of leaking or damaged disposal containers or radiation
or contamination levels in excess of limits specified in Department of Transportation and Agency
regulations. The licensee shall briefly describe any repackaging operations of any of the disposal
containers included in the shipment, plus any other information required by the Agency as a
license condition. The licensee shall retain these records until the Agency transfers or terminates
the license that authorizes the activities described in 105 CMR 120.800.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.880: continued

(F) Annual reports:

(1) The Operator shall submit an annual report to the Department by the end of the first
calendar quarter of each year for the preceding year.
(2) The annual reports shall include:
(a) A copy of the Operator's financial report or a certified financial statement,
(b) Specification of the quantity of each of the principal contaminants released to
unrestricted areas in liquid and in airborne effluents during the preceding year,
(c) The data of the Operator environmental monitoring program,
(d) A summary of any disposal unit surveys and maintenance activities,
(e) A summary, by waste class, of activities and quantities of any radionuclides disposed
of,
(f) Any instances in which observed site characteristics were significantly different from
those described in the application for a license; and,
(g) Any other information the Department may require.
(3) The report shall identify and discuss any instance, during the reporting period, in which
monitoring results, maintenance performed or the quantities of waste released are
significantly different from those expected.

(G) The Operator shall comply with the recordkeeping requirements of 105 CMR 120.001.

(H) Any transfer of byproduct, source, and special nuclear materials by the Operator is subject
to the requirements in 105 CMR 120.140.

(I) In addition to the other requirements of 105 CMR 120.880, the licensee shall store, or have
stored, manifest and other information pertaining to receipt and disposal of radioactive waste in
an electronic recordkeeping system.
(1) The manifest information that must be electronically stored is:
(a) That required in 10 CFR part 20, Appendix G, with the exception of shipper and
carrier telephone numbers and shipper and consignee certifications; and,
(b) That information required 105 CMR 120.880(E).
(2) As specified in facility license conditions, the licensee shall report the stored
information, or subsets of this information, on a computer-readable medium.

120.881: Tests on Facilities

Each Operator shall perform, or permit the Department to perform, any tests the Department
deems appropriate or necessary for the administration of 105 CMR 120.800, including, but not
limited to, tests of:

(A) Wastes and facility components used for the receipt, storage, treatment, handling or
disposal of wastes;

(B) Radiation detection and monitoring instruments; or,

(C) Other equipment and devices used in connection with the receipt, possession, handling,
treatment, storage, or disposal of waste.

120.882: Department Inspection of Facilities

(A) Each Operator shall annually, and at such other times as requested by the Department,
provide detailed and accurate information, in a report, for the purpose of determining compliance
with 105 CMR 120.800, including, but not limited to:
(1) The type, volume, radioactivity, source and characteristics of the waste treated, stored,
or disposed of at the facility;
(2) The Operator's current and projected waste management activities, including source
minimization, volume minimization, on-site storage, treatment, packaging and transportation
practices.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.882: continued

(B) The Operator shall allow the duly authorized representatives of the Department, at all
reasonable times, without advance notice to enter and examine any property, facility, or activity
involving treatment, storage, and disposal of the waste. The Operator shall afford such
inspectors unfettered access, equivalent to access provided to persons regularly employed at the
facility, following proper identification and compliance with applicable access control measures
for security, radiological protection and personal safety. Such inspectors are authorized to make
such inspections, conduct such test, reviews, studies, monitoring, or sampling or examine books,
paper and records as the Department deems necessary for administration or enforcement of
M.G.L. c. 111H or 105 CMR 120.800. Such inspectors may copy and take away copies of, for
the Agency's use, any record required to be kept pursuant to 105 CMR 120.800.

(C) An annual summary of the Department's inspection and enforcement activities with respect
to the facility shall be transmitted to the Board and to the board of health of each site community.

120.885: Waivers

The Department may waive the application of any provision of 105 CMR 120.800 if it finds
that:

(A) The performance objectives set forth in 105 CMR 120.811 through 120.814 will be met;
and,

(B) Public health, safety and the environment will be protected; and,

(C) Strict application of the section to be waived would undermine the public interest; and,

(D) Specific substitute requirements can be adopted which will result in the substantial
protection of the process established in M.G.L. c. 111, §§ 3, 5M, 5N, 5O, and 5P and the rights
of persons affected by the action and the Operator; and,

(E) The action made possible by the waiver will not violate the provisions of M.G.L. c. 111H
or any other state or federal law.

120.890: LOW-LEVEL RADIOACTIVE WASTE MINIMIZATION REGULATIONS GENERAL

PROVISIONS

120.891: Purpose and Scope

(A) The purpose of 105 CMR 120.890 is to ensure that source and volume minimization and
storage for decay are integral parts of every radioactive material user's, as well as generator's,
waste management program. 105 CMR 120.890 has been made, after consultation with the
Board, as required in M.G.L. c. 111H, § 13.

(B) 105 CMR 120.890 apply to all radioactive material users, licensees and generators as
defined in 105 CMR 120.893.

(C) 105 CMR 120.890 do not apply to radioactive materials that are exempt from licensing as
specified in 105 CMR 120.100.

(D) The requirements of 105 CMR 120.890 are in addition to, and not in substitution for, 105
CMR 120.001, 120.100, 120.200 and 120.800.

120.892: Regulatory Authority

The authority for the Department of Public Health to promulgate 105 CMR 120.890 is found
in: M.G.L. c. 111, §§ 3, 5M, 5N, 5O, 5P; M.G.L. c. 111H, §§ 1, 7, 8, 11, 13, 16, 31.

120.893: Definitions

As used in 105 CMR 120.890, the following definitions apply:

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.893: continued

Board means the Low-level Radioactive Waste Management Board established in M.G.L. c.
111H, § 2.

Days means calendar days; provided that in computing time periods such periods shall exclude
the day of the, event which starts the period running, and further provided that if the last day of
a period falls on a Sunday, legal holiday or declared state of emergency day, such period shall
be extended to the close of business on the next business day.

Department means the Department of Public Health.

Development means all activities undertaken with respect to a low-level radioactive waste
facility during the period commencing with the selection of any superior site pursuant to M.G.L.
c. 111H, § 23 and continuing until the commencement of facility operation pursuant to M.G.L.
c. 111H, § 39.

Disposal means the isolation of low-level radioactive waste from the biosphere inhabited by
human beings and their food chains.

Generator means a person, including a broker, who produces low-level radioactive waste.

Generator Guidance means the document titled Low-level Radioactive Waste Minimization
Guidance compiled by the Department for the guidance of waste generators.

Half-life means the time in which half the atoms of a particular radioactive substance disintegrate
to another nuclear form.

Licensee means a person holding a license issued pursuant to 105 CMR 120.100 by the
Department of Public Health to transfer, acquire, own, possess or use quantities of, or devices
or equipment utilizing, radioactive material.

Low-level Radioactive Waste means radioactive material that"

(1) is neither high-level waste, nor spent nuclear fuel, nor by-product material as defined
in section 11(e)(2) of the Atomic Energy Act of 1954, as amended, 42 U.S.C. §2014(e); and
(2) is classified by the Federal Government as low-level radioactive waste, but not including
waste which remains a Federal responsibility, as designated in section 3(b) of the Low-Level
Radioactive Waste Policy Act, as amended, 42 U.S.C. §2021c(b), as in effect as of
December 8, 1987.

Management means the storage, packaging, treatment, transportation, or disposal, where

applicable, of low-level radioactive waste.

Management Plan means the low-level radioactive waste management plan adopted by the board
pursuant to M.G.L. c. 111H, § 12 to provide for the safe and efficient management of low-level
radioactive waste.

Manifest means a detailed record of the characteristics and quantities of packaged waste as
presented for transportation, treatment, storage, or disposal which usually accompanies waste
transfers for these purposes.

Minimization Plan means the plan required by each generator which identifies actions to allow
for "storage for decay" of short-lived radioisotopes, and actions to achieve source and volume
minimization.

Mixed Waste means low-level radioactive waste containing material that either:
(1) is listed in 310 CMR 30.131 through 30.136; or
(2) causes the waste to exhibit any of the characteristics identified in 310 CMR 30.120.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.893: continued

Person means any agency or political subdivision of the federal government or the
commonwealth, or of any state, any public or private corporation or authority, individual, firm,
joint stock company, partnership, association, trust, estate, institution or other entity, and any
officer, employee or agent of such person, and any group of such persons.

Radioactive Material means any solid, liquid, or gas which emits radiation spontaneously.

Radioactive Material User means any person who requires a license or registration with the
Department of Public Health pursuant to 105 CMR 120.000 to use radioactive materials for any
purpose.

Radioactivity means the transformation of unstable atomic nuclei with the emission of radiation.

Source Minimization means minimizing the volume of radioactivity of low-level radioactive

waste prior to its generation by such methods as:
(1) avoiding unnecessary contamination of items during the use of radioactive materials;
(2) carefully segregating radioactive waste from non-radioactive trash; or
(3) substituting non-radioactive isotopes or radioisotopes with shorter half-lives where
practicable.

Storage means the holding of low-level radioactive waste for treatment or disposal.

Storage for Decay means a procedure in which low-level radioactive waste with a relatively short
half-life is held for natural radioactive decay in compliance with applicable federal and state
regulations.

Treatment means any method, technique, or process including source minimization, volume
minimization, and storage for decay, designed to change the physical, radioactive, chemical, or
biological characteristics or composition of low-level radioactive waste in order to render such
waste safer for management, amenable for recovery, convertible to another usable material or
reduced in volume.

Volume Minimization means treatment of low-level radioactive waste after its generation in
order to minimize the physical dimensions of the waste and the space required for disposal.

Waste means low-level radioactive waste.

Waste Facility means a facility that is licensed in Massachusetts for the purposes of treating,
storing or disposing of low level radioactive waste.

120.895: Objectives

The following are the objectives of 105 CMR 120.890:

(A) To protect public health and safety and the environment by ensuring that radioactive
material users avail themselves of all the opportunities to produce less waste.

(B) To minimize the use of radioactive sources (this is a major objective of the Department's
minimization program).

(C) To reduce the amount of waste requiring treatment, storage and disposal. To this end all
radioactive materials users should strive to achieve "zero production" of low-level radioactive
waste and frivolous or unnecessary uses of radioactive materials should be avoided, especially
if non-radioactive alternatives are available.

(D) To ensure waste material is well characterized so as to reduce disposal liabilities and
conserve disposal capacity.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.895: continued

(E) To permit evaluation of the waste generation activity, allowing for optimal minimization
controls that are consistent with waste management policies and procedures authorized by federal
and state law and regulation as of December 8, 1987.

(F) To identify opportunities to achieve source minimization, volume minimization and storage
for decay. These opportunities shall include activities required in M.G.L. c. 111H, § 13,
including avoiding unnecessarily contaminating items while using radioactive materials;
segregating radioactive waste from non-radioactive trash; and identifying the objective of
substituting short-lived radionuclides or non-radioactive materials for long-lived radionuclides,
where possible.

(G) To be consistent with the promotion of responsible research and innovation.

120.896: Statement and Plan Requirements

All radioactive material users and generators of low-level radioactive waste are required to
examine their operations and institute waste minimization/reduction/elimination programs as
follows:

(A) All radioactive material users, as well as all generators, of low-level radioactive waste must
prepare a statement indicating the measures they have taken to minimize/ reduce/eliminate any
waste that may result from their operations. The statement should contain the rationale for the
use of a radioactive material, the quantities proposed, and the choice of radionuclide. The
statement should contain a consideration of the fate of any anticipated radioactive waste that
would be generated.

(B) Those persons whose operations result in 100 cubic feet or more of waste per annum, and
such waste requires disposal, must develop and institute waste minimization programs predicated
on detailed plans. The required elements of such a waste minimization program are described
in 105 CMR 120.897.

(C) A minimization statement or plan, as applicable, shall be submitted with each new
application for a license to manufacture, produce, transfer, receive, acquire, own, possess, or use
radioactive materials. Current licensees shall submit a minimization statement or plan within
90 days of the promulgation of 105 CMR 120.890. The minimization statement or plan shall be
updated yearly as part of the annual survey required by M.G.L. c. 111H, § 7.

(D) Persons who do not require a license from the Department for their operations but require
access to a waste facility licensed by the Department shall submit, pursuant to 105 CMR
120.890, a statement or plan regarding their waste which shall be updated yearly as part of the
annual survey required by M.G.L. c. 111H, § 7.

(E) The Department shall evaluate each minimization statement or plan submitted pursuant to
105 CMR 120.896(D) in accordance with 105 CMR 120.895, 120.896, 120.897, and upon
approval, shall issue a certificate.

(F) The approved minimization statement or plan shall be written into the license as a condition
of the license as required in 105 CMR 120.100.

120.897: Waste Minimization Plan Content

A waste minimization plan shall include:

(A) A waste minimization policy statement that presents the generator's goals for achieving
waste minimization/reduction/elimination, and assigns responsibility to an individual or group
to accomplish the objectives. The plan shall be approved by the highest official of the company
or institution or his/her designee, and include a statement committing to a defined
implementation schedule.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.897: continued

(B) A summary report which characterizes the generator's waste streams and assesses the
opportunities for waste minimization. The report shall include a systematic review of processes,
current applicable technologies, procedures and cost requirements. An operational assessment
of the generator's activities will be required in order to collect the necessary data and compile the
summary report. Sample assessment forms and a flow chart illustrating the assessment overview
can be found in the Department's Low-Level Radioactive Waste Minimization Guidance. The
following assessment activities are expected to be included in the waste minimization plan and
will be used to evaluate the plan:
(1) A description of the facility and the process or service that generates the waste. This
may be accomplished by reviewing design, operating and maintenance documentation.
(2) Identification and characterization of the waste streams which result from the process
or service. Potential sources of information include process flow diagrams, analytical test
data, waste shipment manifests, radioactive material purchase and inventory records.
(3) Prioritization of the radioactive sources and waste streams to select one or more for
minimization. Concerns which should be addressed when making this selection will include:
- minimization potential
- reclassification potential
- compliance with current and future regulations
- potential liability
- volume and activity of the waste
- cost/benefit relationship
(4) Analysis and selection of a technically-feasible minimization technique or technology.
The process or service that generates the waste will be analyzed relative to the candidate
techniques or technologies. If techniques or technologies have been developed, and
minimization is believed to have reached optimum levels, the summary report will indicate
what activities will allow minimization to continue.
(5) Analysis of the direct and indirect capital costs and operating costs associated with the
minimization activity as compared to on-site storage and increasing disposal costs.
(6) Evaluation of both tangible and intangible benefits and detriments of minimization.
(7) Evaluation of the progress or success of the minimization effort. This action should be
undertaken periodically after minimization plans are instituted.
(8) An operational assessment whenever a new product or substantial change in service is
being considered.
(9) Procedures which rely on reduction of the radioactivity of the waste through decay in
storage. These should include the following:
(a) Identification of the radioisotopes and waste which can be considered for decay in
storage, and development of a written set of procedures outlining handling and
processing steps necessary to isolate those wastes.
(b) Identification of an area where the storage for decay can occur, and evaluation of the
size of the area to ensure it is spacious enough to accommodate all wastes to be
accumulated through the entire decay cycle.
(c) Identification of adjacent unrestricted areas to ensure adequate shielding is available
to maintain radiation levels below specified limits.
(d) Establishment of adequate security measures for the storage for decay area.
(e) Establishment of a radiation survey procedure to measure radiation levels in adjacent
unrestricted areas at least weekly.
(f) Development of written procedures to monitor the waste in the storage for decay area
to ensure it has decayed to background levels prior to disposal.
(g) Maintenance of all records for all storage for decay and disposal activities, especially
radiation surveys.

(C) Specification of the considerations necessary to achieve the required goals. These
considerations shall include:
(1) The scope of work necessary to develop and implement the program;
(2) A best estimate of the schedule for implementing each identified task;
(3) Requirements for anticipated personnel, materials and equipment;
(4) A range of cost estimates of all program elements; and
(5) If a minimization program is already in place, the measures necessary to allow
minimization to continue at an optimum level should be indicated.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.897: continued

(D) A statement describing how future business plans will evaluate source and volume
minimization for the expected waste streams.

(E) A description of the strategies to be used to measure the success of the minimization
program.

(F) A summary of employee training activities which ensure that:

(1) All employees who work with radioactive materials have basic knowledge of common
waste problems;
(2) All workers involved directly with the minimization program have the necessary
technological skills.

[Note: Guidance for the preparation of a minimization plan may be found in the Generator
Guidance which is available from the Department.]

120.900: RADIATION SAFETY REQUIREMENTS FOR WIRELINE SERVICE OPERATIONS

AND SUBSURFACE TRACER STUDIES

120.901: Purpose and Scope

(A) 105 CMR 120.900 prescribes requirements for the issuance of a license or certificate of
registration authorizing the use of sources of radiation for well logging in a single well. 105
CMR 120.900 also establishes radiation safety requirements for persons using sources of
radiation for wireline service operations including mineral logging, radioactive markers, and
subsurface tracer studies. The requirements of 105 CMR 120.900 are in addition to, and not in
substitution for, the requirements of 105 CMR 120.001, 120.020, 120.750, 120.100 and 120.200.

(B) 105 CMR 120.900 applies to all licensees or registrants who use sources of radiation for
wireline service operations including mineral logging, radioactive markers, uranium sinker bars,
or subsurface tracer studies. 105 CMR 120.900 does not apply to the use of radioactive material
in tracer studies involving multiple wells, such as field flood studies, or to the use of sealed
sources auxiliary to well-logging but not lowered into wells.

120.902: Definitions

As used in 105 CMR 120.900, the following definitions apply:

Energy Compensated Source (ECS) means a small sealed source with an activity not exceeding
3.7 megabecquerel (100 :Ci), used within a logging tool or other tool components, to provide
a reference standard to maintain the tool’s calibration when in use.

Field Station means a facility where radioactive sources may be stored or used and from which
equipment is dispatched to temporary jobsites.

Fresh Water Aquifer for the purpose of this part, means a geologic formation that is capable of
yielding fresh water to a well or spring.

Injection Tool means a device used for controlled subsurface injection of radioactive tracer
material.

Irretrievable Well-logging Source means any sealed source containing radioactive material that
is pulled off or not connected to the wireline that suspends the source in the well and for which
all reasonable effort at recovery has been expended.

Logging Assistant means the individual who, under the personal supervision of a logging
supervisor, handles sealed sources or tracers that are not in logging tools or shipping containers
or who performs surveys required by 105 CMR 120.951.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.902: continued

Logging Supervisor means the individual who uses licensed material or provides personal
supervision of the utilization of sources of radiation at a temporary jobsite and who is responsible
to the licensee or registrant for assuring compliance with the requirements of the Agency's
regulations and the conditions of the license or registration.

Logging Tool means a device used subsurface to perform well-logging.

Mineral Logging means any logging performed for the purpose of mineral exploration other than
oil or gas.

Personal Supervision means guidance and instruction by the logging supervisor who is physically
present at a temporary jobsite and watching the performance of the operation in such proximity
that contact can be maintained and immediate assistance given as required.

Personnel Monitoring Badge means an individual personnel dosimeter that is processed and
evaluated by accredited National Voluntary Laboratory Accreditation Program (NVLAP)
processor.

Radioactive Marker means radioactive material placed subsurface or on a structure intended for
subsurface use for the purpose of depth determination or direction orientation.

Safety Review means a periodic review provided by the licensee for its employees on radiation
safety aspects of well logging. The review may include, as appropriate, the result of internal
inspections, new procedures or equipment, accidents or errors that have been observed, and
opportunities for employees to ask safety questions.

Source Holder means a housing or assembly into which a radioactive source is placed for the
purpose of facilitating the handling and use of the source in well-logging operations.

Subsurface Tracer Study means the release of unsealed radioactive material or a substance tagged
with radioactive material for the purpose of tracing the movement or position of the radioactive
material or tagged substance in the well-bore or adjacent formation.

Surface Casing for Protecting Fresh Water Aquifers means a pipe or tube used as a lining in a
well to isolate fresh water aquifers from the well.

Temporary Jobsite means a location to which radioactive materials have been dispatched to
perform wireline service operations or subsurface tracer studies.

Tritium Neutron Generator Target Source means a tritium source used within a neutron generator
tube to produce neutrons for use in well-logging applications.

Uranium Sinker Bar means a weight containing depleted uranium used to pull a logging tool
toward the bottom of well.

Well-bore means a drilled hole in which wireline service operations and subsurface tracer studies
are performed.

Well-logging means the lowering and raising of measuring devices or tools which may contain
sources of radiation into well-bores or cavities for the purpose of obtaining information about
the well and/or adjacent formations.

Wireline means a cable containing one or more electrical conductors which is used to lower and
raise logging tools in the well-bore.

Wireline Service Operation means any evaluation or mechanical service which is performed in
the well-bore using devices on a wireline.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.903: Licensing and Registration Requirements for Wireline Service Operations

The Agency will approve an application for a specific license for the use of licensed material
or a registration for use of radiation machines if the applicant meets the following requirements:

(A) The applicant satisfies the general requirements specified in 105 CMR 120.020 for
radiation machine facilities or 105 CMR 120.100 for radioactive material, as applicable, and any
special requirements contained in 105 CMR 120.900;

(B) The applicant submits an adequate program for training logging supervisors and logging
assistants that includes:
(1) Initial training;
(2) On-the-job training;
(3) Annual safety revies provided by the licensee;
(4) Means the applicant will use to demonstrate the logging supervisor's knowledge and
understanding of and ability to comply with 105 CMR 120.900 and licensing requirements
and the applicant's operating and emergency procedures; and
(5) Means the applicant will use to demonstrate the logging assistant's knowledge and
understanding of and ability to comply with the applicant's operating and emergency
procedures.

(C) The applicant shall submit to the Agency written operating and emergency procedures as
described in 105 CMR 120.932 or an outline or summary of the procedures that includes the
important radiation safety aspects of the procedures.

(D) The applicant shall establish and submit to the Agency its program for annual inspections
of the job performance of each logging supervisor to ensure that 105 CMR 120.000, license or
registration requirements, and the applicant's operating and emergency procedures are followed.
Inspection records must be retained for three years after each annual internal inspection.

(E) The applicant submits a description of the applicant's overall organizational structure as it
applies to the radiation safety responsibilities in industrial radiography, including specified
delegation of authority and responsibility;

(F) If an applicant intends to perform leak testing of sealed sources, the applicant shall identify
the manufacturers and model numbers of the leak test kits to be used. If the applicant wants to
analyze its own wipe samples, the applicant shall establish procedures to be followed and submit
a description of these to the Agency. The description must include the:
(1) Instruments to be used;
(2) Methods of analyzing the samples; and
(3) Pertinent experience of the person who will analyze the wipe samples.

120.904: Agreement with Well Owner or Operator

No licensee shall perform wireline service operations with a sealed source(s) unless, prior
to commencement of the operation, the licensee has a written agreement with the well operator,
well owner, drilling contractor, or land owner. The licensee shall retain a copy of the written
agreement for three years after the well logging operation has been completed. The written
agreement shall identify who will meet the following requirements:

(A) (1) In the event a sealed source is lodged downhole, a reasonable effort at recovery will be
made.
(2) A person may not attempt to recover a sealed source in a manner which, in the licensee's
opinion, could result in its rupture.
(3) The licensee shall conduct radiation monitoring to detect any contamination.
(a) If the licensee detects evidence of that a sealed source has ruptured or licensed
materials have caused contamination, the licensee shall initiate immediately the
emergency procedures required in 105 CMR 120.932.
(b) If contamination results from the use of licensed material in well logging, the
licensee shall decontaminate all work areas, equipment, and unrestricted areas.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.904: continued

(c) During efforts to recover a sealed source lodged in the well, the licensee shall
continuously monitor, with an appropriate radiation detection instrument or a logging
tool with a radiation detector, the circulating fluid from the well, if any, to check for
contamination resulting from damage to the sealed source.
(4) If the environment, any equipment, or personnel are contaminated with licensed
material, they must be decontaminated before release from the site or release for unrestricted
use.
(5) If the sealed source is classified as irretrievable after reasonable efforts at recovery have
been expended, the following requirements must be implemented within 30 days:
(a) Each irretrievable well logging source must be immobilized and sealed in place with
a cement plug.
(b) A means to prevent inadvertent intrusion on the source, unless the source is not
accessible to any subsequent drilling operations; and,
(c) A permanent identification plaque, constructed of long lasting material such as
stainless steel, brass, bronze, or monel, must be mounted at the surface of the well, unless
the mounting of the plaque is not practical. The size of the plaque must be at least 17 cm
(seven inches) square and three mm (c”) thick. The plaque must contain:
1. The word "CAUTION";
2. The radiation symbol (the conventional color requirement need not be met);
3. The date of abandonment;
4. The name of the well operator or well owner;
5. The well name and well identification number(s) or other designation;
6. The sealed source(s) by radionuclide and quantity of activity;
7. The source depth and the depth to the top of the plug; and,
8. An appropriate warning, depending on the specific circumstances of each
abandonment. (Appropriate warnings may include: (A) "Do not drill below plug
back depth"; (B) "Do not enlarge casing"; or (C) "Do not re-enter the hole", followed
by the words, "before contacting the Massachusetts Radiation Control Program".)

(B) In the event a decision is made to abandon the sealed source downhole, the requirements
of 105 CMR 120.904(A) and any other Commonwealth Agency having applicable regulations
shall be met.

(C) The licensee shall retain a copy of the written agreement for three years after the completion
of the well logging operation.

(D) A licensee may apply, pursuant to 105 CMR 120.904, for Agency approval, on a case-by-
case basis, of proposed procedures to abandon an irretrievable well logging source in a nanner
not otherwise authorized in 105 CMR 120.904(A)(5).

EQUIPMENT CONTROL

120.911: Labels, Security, and Transport Requirements

(A) Labels.
(1) The licensee may not use a source, source holder, or logging tool that contains licensed
material unless the smallest component that is transported as a separate piece of equipment
with the licensed material inside bears a durable, legible, and clearly visible marking or label.
The marking or label must contain the radiation symbol specified in 105 CMR 120.237(A)
without the conventional color requirements, and the wording "DANGER (or CAUTION)
RADIOACTIVE MATERIAL."
(2) The licensee may not use a container to store licensed material unless the container has
securely attached to it a durable, legible, and clearly visible label. The label must contain the
radiation symbol specified in 105 CMR 120.237(A) and the wording "CAUTION (or
DANGER), RADIOACTIVE MATERIAL, NOTIFY CIVIL AUTHORITIES (or NAME OF
COMPANY)."
(3) The licensee may not transport licensed material unless the material is packaged,
labeled, marked, and accompanied with appropriate shipping papers in accordance with 105
CMR 120.775.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.911: continued

(B) Security Precautions during Storage and Transportation.

(1) The licensee shall store each source containing licensed material in a storage container
or transportation package. The container or package must be locked and physically secured
to prevent tampering or removal of licensed or registered material from storage by
unauthorized personnel. The licensee shall store licensed or registered material in a manner
which will minimize danger from explosion or fire.
(2) The licensee shall lock and physically secure the transport package containing licensed
or registered material in the transporting vehicle to prevent accidental loss, tampering, or
unauthorized removal of the licensed or registered material from the vehicle.

120.914: Radiation Survey Instruments

(A) The licensee or registrant shall maintain sufficient calibrated and operable radiation survey
instruments capable of detecting beta and gamma radiation at each field station and temporary
jobsite to make physical radiation surveys as required by 105 CMR 120.900 and 120.221.
Instrumentation shall be capable of measuring 0.1 milliroentgen (2.58 x 10-8 C/kg) per hour
through at least 50 milliroentgens (1.29 x 10-5 C/kg) per hour.

(B) Each radiation survey instrument shall be calibrated:

(1) At intervals not to exceed six months and after each instrument servicing;
(2) For linear scale instruments, at two points located approximately a and b of full-scale
on each scale; for logarithmic scale instruments, at mid-range of each decade, and at two
points of at least one decade; and for digital instruments, at appropriate points; and,
(3) So that accuracy within plus or minus 20% of the true radiation level can be
demonstrated on each scale.

(C) Calibration records shall be maintained for a period of three years for inspection by the
Agency.

(D) The licensee shall have available additional calibrated and operable radiation detection
instruments sensitive enough to detect the low radiation and contamination levels that could be
encountered if a sealed source ruptured. The licensee may own the instruments or may have a
procedure to obtain them in a timely manner from a second party.

120.915: Leak Testing of Sealed Sources

(A) Requirements. Each licensee using sealed sources of radioactive material shall have the
sources tested for leakage. Records of leak test results shall be kept in units of becquerel
(m:Ci)and maintained for inspection by the Agency for three years after the leak test is
performed.

(B) Method of Testing. Tests for leakage shall be performed only by persons specifically
authorized to perform such tests by the Agency, the U.S. Nuclear Regulatory Commission, an
Agreement State, or a Licensing State. The wipe sample shall be taken from the nearest
accessible point to the sealed source where contamination might accumulate. The wipe sample
shall be analyzed for radioactive contamination, and the analysis shall be capable of detecting
the presence of (185 becquerel) (0.005 :Ci) of radioactive material on the wipe sample.

(C) Interval of Testing. Each sealed source of radioactive material shall be tested at intervals
not to exceed six months. Each ECS that is not exempt from testing in accordance with
105 CMR 120.915(A) shall be tested at intervals not to exceed three years. In the absence of a
certificate from a transferor indicating that a test has been made prior to the transfer, the sealed
source shall not be put into use until tested. If it is suspected that a sealed source may be leaking,
it shall be removed from service immediately and tested for leakage as soon as practical.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.915: continued

(D) Leaking or Contaminated Sources. If the test reveals the presence of 0.005 microcurie (185
Bq) or more of leakage or contamination, the licensee shall immediately withdraw the source
from use and shall cause it to be decontaminated, repaired, or disposed of in accordance with 105
CMR 120.200. The licensee shall check the equipment associated with the leaking or
contaminated source for radiation contamination and, if contaminated, have it decontaminated
or disposed of by an NRC or Agreement State licensee. A report describing the equipment
involved, the test results, and the corrective action taken shall be filed with the Agency within
five working days.

(E) Exemptions. The following sources are exempted from the periodic leak test requirements
of 105 CMR 120.915(A) through (D):
(1) Hydrogen-3 sources;
(2) Sources of radioactive material with a half-life of 30 days or less;
(3) Sealed sources of radioactive material in gaseous form;
(4) Sources of beta- and/or gamma-emitting radioactive material with an activity of 3.7
megabecquerel) (100 :Ci)) or less; and
(5) Sources of alpha-emitting radioactive material with an activity of 0.370 MB (10 :Ci)
or less.

120.916: Physical Inventory

Each licensee or registrant shall conduct a semi-annual physical inventory to account for all
sources of radiation. Records of inventories shall be maintained for three years from the date of
the inventory for inspection by the Agency and shall include the quantities and kinds of sources
of radiation, the location where sources of radiation are assigned, the date of the inventory, and
the name of the individual conducting the inventory. Physical inventory records may be
combined with leak test records.

120.917: Utilization Records

Each licensee or registrant shall maintain current records, which shall be kept available for
inspection by the Agency for three years from the date of the recorded event, showing the
following information for each source of radiation:

(A) Make, model number, and a serial number or a description of each source of radiation used;

(B) The identity of the well-logging supervisor or field unit to whom assigned and the identity
of the logging assistants present;

(C) Locations where used and dates of use; and,

(D) In the case of tracer materials and radioactive markers, the utilization record shall indicate
the radionuclide and activity used in a particular well and the disposition of any unused tracer
materials.

120.918: Design, Performance, and Certification Criteria for Sealed Sources Used in Downhole
Operations

(A) A licensee may use a sealed source for well logging applications if:
(1) The sealed source is doubly encapsulated;
(2) The sealed source contains licensed radioactive material whose chemical and physical
forms are as insoluble and non-dispersible as practical; and
(3) Meets the requirement of 105 CMR 120.918(B), (C),or (D).

(B) For a sealed source manufactured on or before July 14, 1989, a licensee may use the sealed
source for well logging applications, if it meets the requirements of USAI N5.10-1968,
“Classification of Sealed Radioactive Sources,” or the requirements of 105 CMR 120.918(C) or
(D).
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.918: continued

(C) For a sealed source manufactured after July 14, 1989, a licensee may use the sealed source
for well logging applications, if it meets the oil-well logging requirements of ANSI/HPS N.43.6-
1997, "Sealed Radioactive Sources-Classifications."

(D) For a sealed source manufactured after July 14, 1989, a licensee may use the sealed source
for well logging applications, if:
(1) The sealed source's prototype has been tested and found to maintain its integrity after
each of the following tests:
(a) Temperature. The test source must be held at -40°C for 20 minutes, 600°C for one
hour and then be subject to a thermal shock test with a temperature drop from 600°C to
20 C within 15 seconds.
(b) Impact Test. A five kg steel hammer, 2.5 cm in diameter, must be dropped from a
height of 1 m onto the test source.
(c) Vibration Test. The test source must be subjected to a vibration from 25 Hz to 500
Hz at five g amplitude for 30 minutes.
(d) Puncture Test. A one gram hammer and pin, 0.3 cm pin diameter, must be dropped
from a height of 1 m onto the test source.
(e) Pressure Test. The test source must be subject to an external pressure of 1.695 x 107
pascals (24,600 pounds per square inch absolute).

(E) The requirements of 105 CMR 120.918(A), (B), (C), and (D) do not apply to sealed sources
that contain radioactive material in gaseous form.

(F) The requirements in 105 CMR 120.918(A) through 105 CMR 120.918(D) do not apply to
energy compensated sources (ECS). ECSs must be registered with the Agency under
105 CMR 120.128(N) or with the U.S. Nuclear Regulatory Commission under 10 CFR 32.210
or with an Agreement State.

120.920: Inspection, Maintenance and Opening of a Source or Source Holder

(A) Each licensee shall visually check source holders, logging tools, and source handling tools,
for defects before each use to ensure that the equipment is in good working condition and that
required labeling is present. If defects are found, the equipment must be removed from service
until repaired, and a record must be made listing: the equipment involved, defects found, and
retained for three years after the defect is found.

(B) Each licensee or registrant shall have a program for semi-annual visual inspection and
routine maintenance of source holders, logging tools, injection tools, source handling tools,
storage containers, transport containers, and uraniun sinker bars to ensure that the required
labeling is legible and that no physical damage is visible. If defects are found, the equipment
must be removed from service until repaired, and a record must be made listing: date, equipment
involved, inspection and maintenance operations performed, any defects found, and any actions
taken to correct the defects. Records of inspection and maintenance shall be maintained for a
period of three years for inspection by the Agency.

(C) Removal of a sealed source from a source holder or logging tool, and maintenance on
sealed sources or holders in which sealed sources are contained may not be performed by the
licensee unless a written procedure developed pursuant to 105 CMR 120.932 has been approved
either by the Agency pursuant to 105 CMR 120.903(C), the NRC, an Agreement State or a
Licensing State.

(D) If a sealed source is struck in the source holder, the licensee shall not perform any
operation, such as drilling, cutting, or chiselling, on the source holder unless the licensee is
specifically approved by the Agency to perform such operation.

(E) The repair, opening, or modification of any sealed source shall be performed only by
persons specifically authorized to do so by the Agency, the U.S. Nuclear Regulatory
Commission, an Agreement State, or a Licensing State.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.922: Handling Tools

The licensee shall provide and require the use of tools that will assure remote handling of
sealed sources other than low activity calibration sources.

120.923: Subsurface Tracer Studies

(A) The licensee shall require all personnel handling radioactive tracer material to use
protective gloves and, if required by the license, other appropriate protective clothing and
equipment. The licensee shall take precautions to avoid ingestion or inhalation of radioactive
tracer material and to avoid contamination of the field stations and temporary jobsites.

(B) A licensee may not knowingly inject radioactive material into fresh water aquifers without
prior written authorization from the Agency.

120.924: Radioactive Markers

The licensee may use radioactive markers in wells only if the individual markers contain
quantities of radioactive material not exceeding the quantities specified in 105 CMR
120.196: Appendix B Table I. The use of radioactive markers is subject to the requirements of
105 CMR 120.916.

120.925: Uranium Sinker Bars

The licensee may use a uranium sinker bar in well logging after the effective date of
105 CMR 120.000 only if it is legibly impressed with the words "CAUTION -- RADIOACTIVE
-- DEPLETED URANIUM" and "NOTIFY CIVIL AUTHORITIES (or COMPANY NAME) IF
FOUND."

120.926: Use of a Sealed Source in a Well Without a Surface Casing

The license may use a sealed source in a well without casing for protecting fresh water
aquifers only if the licensee follows a procedure for reducing the probability of the source
becoming lodged in the well. The procedure must be approved by the Agency pursuant to 105
CMR 120.903(C).

120.927: Energy Compensated Sources

The licensee may use an energy compensated source (ECS) which is contained within a
logging tool, or other tool components, only if the ECS contains quantities of radioactive
material not exceeding 3.7 megabecquerel. (100 :Ci).

(A) For well-logging applications with a surface casing for protecting fresh water aquifers, use
of the ECS is only subject to the requirements of 105 CMR 120.915, 120.916 and 120.917.

(B) For well-logging applications without a surface casing for protecting fresh water aquifers,
use of the ECS is only subject to the requirements of 105 CMR 120.904, 120.915, 120.916,
120.917, 120.926 and 120.954.

120.928: Tritium Neutron Generator Target Source

Use of a tritium neutron generator target source, containing quantities not exceeding 1.110
terabecquerels (30 Ci) and in a well with a surface casing to protect fresh water aquifers, is
subject to the requirements of 105 CMR 120.900 except 105 CMR 120.904, 120.918 and
120.954.

(B) Use of a tritium neutron generator target source containing quantities exceeding 1.110
terabecquerels (30 Ci) or in a well without a surface casing to protect fresh water aquifers, is
subject to the requirements of 105 CMR 120.900 except 120.918.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.929: Particle Accelerators

No licensee or registrant shall permit above-ground testing of particle accelerators, designed

for use in well logging, which results in the production of radiation, except in areas or facilities
controlled or shielded so that the requirements of 105 CMR 120.200, as applicable, are met.

RADIATION SAFETY REQUIREMENTS

120.931: Training Requirements

(A) The licensee or registrant may not permit any individual to act as a logging supervisor as
defined in 105 CMR 120.900 until such individual has:
(1) Successfully completed a course recognized by the Agency, the U.S. Nuclear Regulatory
Commission, an Agreement State, or a Licensing State, at least 24 hours of formal training
in the subjects outlined in 105 CMR 20.960: Appendix A;
(2) Received copies of and instruction in the regulations contained in 105 CMR 120.900
and the applicable sections of 105 CMR 120.001, 120.200 and 120.750 or their equivalent,
conditions of appropriate license or certificate of registration, and the licensee's or registrant's
operating and emergency procedures;
(3) Demonstrated understanding of the requirements of 105 CMR 120.931(A)(1) and
120.931(A)(2) by successfully completing a written examination administered by the licensee
or registrant;
(4) Completed 320 hours of on-the-job training under the supervision of a logging
supervisor; and
(5) Demonstrated through a field evaluation, competence to use sources of radiation, related
handling tools, and survey instruments which will be used on the job.

(B) The licensee or registrant may not permit any individual to act as a logging assistant until
such individual has:
(1) Received copies of and instruction in the regulations contained in 105 CMR 120.900
and in the applicable sections of 105 CMR 120.001, 120.200 and 120.750 and the licensee's
or registrant's operating and emergency procedures and demonstrated an understanding
thereof;
(2) Demonstrated competence to use, under the personal supervision of the logging
supervisor, the sources of radiation, related handling tools, and radiation survey instruments
which will be used on the job.

(C) The licensee or registrant shall provide safety review for logging supervisors and logging
assistants at least once during each calendar year.

(D) The licensee or registrant shall maintain records documenting the training and reviews
required by 105 CMR 120.931(A), (B) and (C) for inspection by the Agency for three years
following termination of employment.

120.932: Operating and Emergency Procedures

The licensee's or registrant's operating and emergency procedures shall include instructions
in at least the following:

(A) Handling and use of sources of radiation, including the use of sealed sources in wells
without surface casing for protecting fresh water aquifers if appropriate;

(B) Methods and occasions for conducting radiation surveys, including surveys for detecting
contamination;

(C) Methods and occasions for locking and securing sources of radiation;

(D) Personnel monitoring and the use of personnel monitoring equipment;

(E) Transportation to temporary jobsites and field stations, including the packaging and placing
of sources of radiation in vehicles, placarding of vehicles, and securing sources of radiation
during transportation to prevent accidental loss, tampering or unauthorized removal;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.932: continued

(F) Minimizing exposure of individuals in the event of an accident;

(G) Procedure for notifying proper personnel in the event of an accident;

(H) Maintenance of records, including records generated by logging personnel at temporary

jobsites;

(I) Inspection and maintenance of sealed sources, source holders, logging tools, source handling
tools, storage containers, transport containers, injection tools and uranium sinker bars;

(J) Procedure to be followed in the event a sealed source is lodged downhole;

(K) Procedures to be used for picking up, receiving, and opening packages containing
radioactive material;

(L) For the use of tracers, decontamination of the environment, equipment, and personnel;

(M) Actions to be taken if a sealed source is ruptured, including actions to prevent the spread
of contamination and minimize inhalation and ingestion of radioactive material and actions to
obtain suitable radiation survey instruments as required by 105 CMR 120.914(B);

(O) The use of remote handling tools for handling sealed sources and radioactive tracer material
except low-activity calibration sources; and

(P) Identifying and reporting to the Agency defects and noncompliance as required by 10 CFR
Part 21 of the NRC regulations

120.933: Personnel Monitoring

(A) The licensee or registrant may not permit any individual to act as a logging supervisor or
to assist in the handling of sources of radiation unless each such individual wears, at all times
during the handling of licensed radioactive material and sources of radiation, a personnel
dosimeter that is processed and evaluated by an accredited National Voluntary Laboratory
Accreditation Program (NVLAP) processor. Each personnel monitoring badge shall be assigned
to and worn by only one individual. Film badges shall be replaced at least monthly and other
personnel monitoring badges replaced at least quarterly. After replacement, each personnel
dosimeter must be promptly processed. If a personnel monitoring badge is lost or damaged, the
worker shall cease work immediately until a replacement badge is provided and the exposure is
calculated by the RSO or the RSO’s designee for the time period from issuance to loss or damage
of the badge. The results of the calculated exposure and the time period for which the personnel
monitoring badge was lost or damaged shall be provided to the processor to adjust the
individual’s occupational exposure record.

(B) The licensee shall provide bioassay services to individuals using radioactive materials in
tracer studies if required by the license.

(C) Personnel monitoring records shall be maintained for inspection until the Agency authorizes
disposition.

120.941: Radiation Surveys

(A) Radiation surveys shall be made and recorded for each area where radioactive materials are
stored.

(B) Before transporting licensed material, radiation surveys and/or calculations shall be made
and recorded for the radiation levels in positions occupied by each individual in the vehicle and
on the exterior of each vehicle used to transport the licensed radioactive material. Such surveys
and/or calculations shall include each source of radiation or combination of sources to be
transported in the vehicle.
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.941: continued

(C) If the sealed source is removed from the logging tool before the departure from the
temporary jobsite, the logging tool detector shall be energized, or a survey meter used, to assure
that the logging tool is free of contamination.

(D) If the licensee has reason to believe that, as a result of any operation involving a sealed
source, the encapsulation of the sealed source could be damaged by the operation, the licensee
shall conduct a radiation survey, including a contamination survey, during and after the
operation.

(F) Records required pursuant to 105 CMR 120.951(A) through (E) shall include the dates, the
identification of individual(s) making the survey, the identification of survey instrument(s) used,
and an exact description of the location of the survey. Records of these surveys shall be
maintained for inspection by the Agency for three years after completion of the survey.

120.951: Security

(A) A logging supervisor must be physically present at a temporary jobsite whenever licensed
material are being handled or are not stored and locked in a vehicle or storage place. The logging
supervisor may leave the jobsite in order to obtain assistance if a source becomes lodged in the
well.

(B) During each logging or tracer application, the logging supervisor or other designated
employee shall maintain direct surveillance of the operation to protect against unauthorized
and/or unnecessary entry into a restricted area, as defined in 105 CMR 120.005.

120.952: Documents and Records Required at Field Stations

Each licensee or registrant shall maintain, for inspection by the Agency, the following
documents and records for the specific devices and sources used at the field station:

(A) Appropriate license, certificate of registration, or equivalent document;

(B) Operating and emergency procedures;

(C) Applicable regulations;

(D) Records of the latest survey instrument calibrations pursuant to 105 CMR 120.914;

(E) Records of the latest leak test results pursuant to 105 CMR 120.915;

(F) Quarterly inventories required pursuant to 105 CMR 120.916;

(G) Utilization records required pursuant to 105 CMR 120.917;

(H) Records of inspection and maintenance required pursuant to 105 CMR 120.920;

(I) Survey records required pursuant to 105 CMR 120.951; and,

(J) Training records required pursuant to 105 CMR 120.931.

120.953: Documents and Records Required at Temporary Jobsites

Each licensee or registrant conducting operations at a temporary jobsite shall have the
following documents and records available at that site for inspection by the Agency:

(A) Operating and emergency procedures;

(B) Survey records required pursuant to 105 CMR 120.951 for the period of operation at the
site;
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.953: continued

(C) Evidence of current calibration for the radiation survey instruments in use at the site;

(D) When operating in the Commonwealth under reciprocity, a copy of the appropriate license,
certificate of registration, or equivalent document(s); and,

(E) Shipping papers for transportation of radioactive material.

120.954: Notification of Incidents, Abandonment, and Lost Sources

(A) Notification of incidents and sources lost in other than downhole logging operations shall
be made in accordance with provisions of 105 CMR 120.281 and 120.282 and 120.142.

(B) Whenever a sealed source or device containing radioactive material is lodged downhole,
the licensee shall:
(1) Monitor at the surface for the presence of radioactive contamination with a radiation
survey instrument or logging tool during logging tool recovery operations; and,
(2) Notify the Agency immediately by telephone and subsequently, within 30 days, by
confirmatory letter if the licensee knows or has reason to believe that a sealed source has
been ruptured. This letter shall identify the well or other location, describe the magnitude
and extent of the escape of radioactive material, assess the consequences of the rupture, and
explain efforts planned or being taken to mitigate these consequences.

(C) When it becomes apparent that efforts to recover the radioactive source will not be
successful, the licensee shall:
(1) Advise the well-operator of an appropriate method of abandonment, which shall include:
(a) The immobilization and sealing in place of the radioactive source with a cement
plug;
(b) The setting of a whipstock or other deflection device; and,
(c) The mounting of a permanent identification plaque, at the surface of the well,
containing the appropriate information required by 105 CMR 120.954(D);
(2) Notify the Agency by telephone, giving the circumstances of the loss, and request
approval of the proposed abandonment procedures; and
(3) File a written report with the Agency within 30 days of the abandonment, setting forth
the following information:
(a) Date of occurrence and a brief description of attempts to recover the source;
(b) A description of the radioactive source involved, including radionuclide, quantity,
and chemical and physical form;
(c) Surface location and identification of well;
(d) Results of efforts to immobilize and set the source in place;
(e) Depth of the radioactive source;
(f) Depth of the top of the cement plug;
(g) Depth of the well; and,
(h) Information contained on the permanent identification plaque.

(D) Whenever a sealed source containing radioactive material is abandoned downhole, the
licensee shall provide a permanent plaque for posting the well or well-bore (an example of a
suggested plaque is shown in 105 CMR 120.900: Appendix 120.770(B). This plaque shall:
(1) Be constructed of long-lasting material, such as stainless steel or monel; and,
(2) Contain the following information engraved on its face:
(a) The word "CAUTION";
(b) The radiation symbol without the conventional color requirement;
(c) The date of abandonment;
(d) The name of the well operator or well owner;
(e) The well name and well identification number(s) or other designation;
(f) The sealed source(s) by radionuclide and quantity of activity;
(g) The source depth and the depth to the top of the plug; and,
(h) An appropriate warning, depending on the specific circumstances of each
abandonment. (Appropriate warnings may include: (A) "Do not drill below plug back
depth"; (B) "Do not enlarge casing"; or (C) "Do not re-enter the hole", followed by the
words, "before contacting the Massachusetts Radiation Control Program".)
 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.954: continued

(E) The licensee shall immediately notify the Agency by telephone and subsequently by
confirming letter if the licensee knows or has reason to believe that radioactive material has been
lost in or to an underground potable aquifer. Such notice shall designate the well location,
describe the magnitude and extent of loss of radioactive material, the consequences of such loss,
and explain efforts planned or being taken to mitigate these consequences.

120.960: Appendix A -- Subjects to be Included in Training Courses for Logging Supervisors

I. Fundamentals of Radiation Safety.

A. Characteristics of radiation
B. Units of radiation dose and quantity of radioactivity
C. Significance of radiation dose
1. Radiation protection standards
2. Biological effects of radiation dose
D. Levels of radiation from sources of radiation
E. Methods of minimizing radiation dose
1. Working time
2. Working distances
3. Shielding
F. Radiation safety practices including prevention of contamination and methods of
decontamination.

II. Radiation Detection Instrumentation to be Used.

A. Use of radiation survey instruments
1. Operation
2. Calibration
3. Limitations
B. Survey techniques
C. Use of personnel monitoring equipment

III. Equipment to be Used.

A. Handling equipment
B. Sources of radiation
C. Storage and control of equipment
D. Operation and control of equipment

IV. The Requirements of Pertinent Federal and Commonwealth Regulations

V. The Licensee's or Registrant's Written Operating and Emergency Procedures

VI. The Licensee's or Registrant's Record Keeping Procedures

 105 CMR: DEPARTMENT OF PUBLIC HEALTH

120.961: Appendix B -- Example of Plaque for Identifying Wells Containing Sealed Sources Containing
Radioactive Material Abandoned Downhole

The size of the plaque should be convenient for use on active or inactive wells, e.g., a
seven-inch square. Letter size of the word "CAUTION" should be approximately twice the letter
size of the rest of the information, e.g., ½-inch and ¼-inch letter size, respectively.

REGULATORY AUTHORITY

105 CMR 120.000: M.G.L. c. 111, §§ 3, 5, 5M, 5N, 5O and 5P.