The Role of Environmental Monitoring

for Controlling Pathogens in

Food Manufacturing Plants
A Presentation at the British Columbia
Food Protection Association’s Speakers’s Evening
February 24, 2004 Paul A. Hall, Ph.D.
Richmond, British Columbia Sr. Director
Microbiology and Food Safety
Kraft Foods N.A.
Glenview, IL
Producing Safe Food is our First
Priority

• Consumer Protection & Trust

– Consumer trust
– Food Safety is critical to that trust
• Business Survival
– Our brands are most important assets
• Industry Responsibility
– Committed to food safety across the
food chain
– Industry-wide agreement not to compete in
the area of food safety
 Methods to Reduce the Risk from
Pathogens in Food*

• Prevent inadvertent contamination

• Inhibit growth

• Remove contamination

* Adapted from Sofos, et al., 1998

Top Line Summary
Public health is best protected by control of
Pathogens via:
• Aggressive environmental monitoring
• Effective corrective actions
• Proper equipment design
• Adherence to GMPs and SSOPs
• Proper handling practice
– Refrigerate perishable RTE products at <40 F
(<4.40º C)
– Consume perishable RTE products quickly
• Appropriate intervention strategies
– Formulation (e.g. lactate salts/sodium diacetate)
– Post-packaging treatments
Pathogen Control Approaches/
Interventions
• HACCP and Prerequisite Programs
• Sanitation and GMP’s
– Environmental Monitoring Program
• Ingredient Specifications
• Product Formulation
• Vendor Qualification & Quality Expectations
• Auditing and Certification Programs
• New Processing Technologies
• Improved Detection Methods
• Good Agricultural Practices/On-Farm Controls
Pathogen Control - Listeria
monocytogenes as an Example

• Certain foods pose an increased risk of

being associated with listeriosis
• These foods have the following properties:
– Have the potential for contamination with LM
– Support the growth of LM to high numbers
– Are ready-to-eat foods
– Require refrigeration
– Stored for extended periods of time
Prevalence of Listeria monocytogenes** in
Sliced Lunchmeats and Franks

Sliced Lunchmeats
Franks
10
Percent Positive

8
6
4
2
0
1996 1997 1998 1999 2000 2001 2002
Year
* FSIS Results of ready-to-eat products analyzed for Listeria monocytogenes
 Incidence of Foodborne Illness
1996-2002: Listeria*
Incidence per 100,000 Population

0.6 National
Health
0.5 Objective:
.25
0.4

0.3

0.2

0.1

0
1996 1997 1998 1999 2000 2001 2002

*Preliminary FoodNet Data on the Incidence of Foodborne Illnesses --- Selected Sites, United
States, 2002
Environmental Monitoring

• Prerequisite controls are the foundation upon

which a solid HACCP program is built and include:
– GMP’s
– Sanitation Practices
– Employee Training
– Equipment Design and Maintenance
• An effective monitoring program is a critical
component to measuring the overall effectiveness
of the microbiological controls that are in place.
– Use of proper indicator organisms or specific target pathogens
depend upon the specific product/process/plant under
consideration.
Environmental Monitoring

Techniques
• Visual Inspection
• Direct Surface Testing
– Swab
– Sponge
– Contact Plate
– Rinse

• ATP Bioluminescence
• Air Sampling
Indicator Organisms

What They Measure

• Potential presence of pathogens
• Faulty production or handling practices
– Insufficient thermal kill
– Insufficient cleaning and sanitation
– Inappropriate equipment or facility design
– Improper human handling
– Product recontamination

• Quality of a food or ingredient

Indicators

Advantages
• Can identify microbial harborage points
• Are usually present more frequently that specific
pathogens
• Are cost effective
• Can be used for developing trend analysis and
statistical process control charts
Categories of Indicators

• Microbial numbers
– Aerobic Plate Count
– Direct Microscopic Count

• Metabolic products of microorganisms

– ATP
– pH
– Trimethylamine

• Specific microbial groups

– Total coliforms
– Total enterobacteriaceae
– Generic Escherichia coli
– Listeria species
Choice of Indicator

• The choice of a microbiological indicator depends on a

number of considerations
– Type of product/process (e.g. wet/dry)
– History of food product (association with known pathogens)
– History of the plant environment
– Points in the process to be monitored
– Expected background flora
– Pre-op vs. operational monitoring
– Safety vs. spoilage
– Others
Indicators vs. Specific Pathogens

• Under certain conditions it may be desirable to look for

specific pathogens in the environment. Examples:
– Dry powder operations
• Dairy powders
• Spices
• Dried vegetables/vegetable powders
• Cereal/grain products
– Troubleshooting
• Selection of the specific pathogen(s) depends on the
history of the product or process. Examples:
– Salmonella for dairy powders and spices
– E. coli O157:H7 for ground beef
Environmental Monitoring

Locations
• Where should sampling take place?
– Food contact surfaces
– Non-food contact surfaces
– Environment (air, water, personnel)

• It is often useful to use the zoning concept in order to

track environmental data.
Environmental Monitoring

Zone 1

Zone 2

Zone 3

Zone 4
 Environmental Monitoring
Zoning Concept

Zone 1 Zone 2
Direct and in-direct food Surfaces adjacent to
contact surfaces Zone 1 areas
Conveyors Slicers Equipment Guards
Pipes directly over open product zones Equipment Framework

Zone 3 Zone 4
Other surfaces within the Remote areas from the RTE
ready-to-eat room manufacturing locations
Floors Drains Walls Loading Dock Warehouse
Other Equipment Employee Cafeteria
Environmental Monitoring

Frequency
• The frequency of environmental monitoring will depend on a
number of factors
– Type of product/process
– Frequency of cleaning and sanitation (pre-op vs. operational)
– Maintenance (planned or unplanned)
– Other factors
• Generally, weekly is the minimum recommended frequency
depending on the situation
– Daily or multiple times throughout the day may be appropriate for
given situations
– Each plant should establish their own baseline of environmental data
Environmental Monitoring

Data Examples - Vegetable Processing Operation

Pre-Operational and Operational Swabs
Total Count Data
Time Total Count Per Square Cm.
0 <100
10 min 2,400
1 hour 1,100
2 hours 3,000
3 hours 4,700
4 hours 10,000
5 hours 300,000
6 hours 7,300,000
7 hours 75,000,000
8 hours 86,000,000
 Environmental Monitoring

Data Examples - Process Cheese Wet Mix

Location Timing Aerobic Plate Count Coliform Count

Whey Tank Su <10 <10

Mw 4.8x103 <10
Ew 3.1x103 1.0x102

WPC Tank Su <10 <10

Mw 1.5x103 4.2x103
Ew 2.2x104 3.6x104

Hold Tank Su <10 <10

Mw 1.1x104 2.3x103
Ew 8.5x107 4.2x106
 Project Forward - Listeria PROJECT
Control Program FORWARD

3-Stage Approach to Address Preventative & Corrective Actions

Sanitation /
Environmental Facility / Personnel
Practices Equipment Design Training
• Intensive • Facility layout • GMPs
Environmental • Floors • Maintenance
swabbing • Design for • Sanitation
• Footwear / Sanitation • Behavior based
clothing food safety
• Traffic patterns
• Sanitation
• Maintenance
 PROJECT
FORWARD
Listeria Equation

Dry,
Traffic Uncracked, Sanitary Sanitation
GMPs
Patterns + + Clean + Design + Procedures
Floors

= Listeria Control

Mismanagement of any of the components

may increase the risk of cross
contamination.
Logic Behind Environmental PROJECT
FORWARD
Control Program

• Listeria Control Equation is based on premise

that environmental monitoring is effective in
understanding the plant environment to control
Listeria
• Systematic, disciplined approach to seek out,
find and eliminate the undesirable conditions
which could support harborage or transference
of indicator organisms
• Focus improvement efforts (capital and
resources) as directed by results—
“follow the data”
Environmental Monitoring PROJECT
FORWARD
Approach

• Timely assessment of control of RTE environment

• Biased intensive sampling during production to
validate all components
• Large surface areas sampled for Listeria genus
• Sampling is randomized (by the day of the week
and shift)
• Every RTE processing line must be sampled
weekly
• Sampling plans need to be flexible and tailored
to each specific line and facility
Environmental Monitoring

Listeria Control as an Example

• Environmental monitoring requires a reasonably high
level of testing.
• Positive Listeria spp. findings will decline with
continued emphasis and focus on specific areas.
• Advise begin testing areas remote to the RTE areas as
well as floors of RTE areas before testing adjacent to
production or on product contact surfaces
– This helps to establish a better understanding of Listeria
sources in the plant
Logic Behind Environmental PROJECT
FORWARD
Control Program
• To verify effectiveness of the program, we
monitor all components in the Listeria equation
• Of ~100 RTE meat production lines
– 50% no positive contact surfaces
– 84% single occurrence
• These results indicate the level of Listeria is
very low in our environment
• Low levels in the environment are not likely
to result in product contamination
Low Levels in the Environment PROJECT
FORWARD
Enumeration Data

• Counts of >10 per area swabbed only seen on

floor after 2 shifts, or in niches
• Environmental samples of product contact
surfaces tested for Listeria have been
enumerated. Positive samples that were
enumerated contained less than the detection
limit of the methods (MOX and MPN)
• Data supports concept that random positive
product contact surfaces contain few Listeria
(<10) that can be transferred to product
 PROJECT
FORWARD
Corrective Actions
In the event of a positive Listeria species
environmental sample, Kraft requires follow-
up/ corrective actions. Typical corrective
actions include:
• Review of cleaning records
• Review of environmental data of the
area as well as adjacent areas
 PROJECT
FORWARD
Corrective Actions (cont’d)
(cont’d)

• Review of line records, for mechanical

downtime
• Audit and interview employees concerning
practices during sanitation, set-up, and
production
• Inspections of the area and equipment for
potential harborage points
• Complete a targeted clean
 Benefits of Aggressive Environmental PROJECT
FORWARD
Monitoring / Corrective Actions
Percent Positive
1.8%
1.48% Zone 1 Positive
1.6%
Percent Listeria spp. Positive Annual
1.4%
1.2% 1.05%
1.0%
0.8% 0.54%
0.6%
0.4% 0.23%
0.2%
0.16%
0.0%
1999 2000 2001 2002 2003

Year

Graph 1 values calculated with the formula

(total zone 1 composite + total follow up Results —
positive) / (total zone 1 composite samples * 5)
+ (total follow Reduced Zone 1 +’s
up samples) 85% since ‘99
Project Forward PROJECT
FORWARD
Validation Program
• To measure monitoring program effectiveness,
a validation program is in place to assure that
the samples taken represent the actual
conditions of the entire environment at a given
time.
• Includes multiple sampling points during:
– Pre-op
– Operation
– 2nd shift operation
• One day for two consecutive weeks
• Completed once every six months
Environmental Monitoring

Listeria Control as an Example

• Environmental monitoring of the entire manufacturing
area and adjacent areas is the best possible
mechanism to keep the level of risk as low as possible.
• Only environmental testing allows for systematic,
targeted and actionable information to significantly
reduce the risk of cross contamination.
• Essential to any microbiological control program is a
documented root cause analysis and
preventative/corrective
Environmental Monitoring

Root Cause Analysis

• The primary purpose of environmental monitoring is to
– Provide of a measure of microbiological control effectiveness (trend
analysis).
– Provide investigational data for root cause analysis.
• Programs will vary by company policy, but they must define what
action will be taken and be flexible enough to adapt to changes in
the operation and process or to changing regulatory requirements.
• There are numbers of follow-up actions that should be taken as
part of root cause investigational testing.
Environmental Monitoring

Root Cause Analysis

• If target organisms (e.g. Listeria spp.) are detected,
prompt corrective action steps must be taken and
documented
– Increased frequency of swabbing (e.g. daily from weekly).
– Increased number of sites (single site samples vs. composite
site samples).
– Conduct by-pass testing isolate potential sources of
contamination
Corrective and Preventative Actions

Traffic Patterns
• Plan traffic flow to segregate raw and ready to eat materials
• Establish and maintain separate areas for maintenance and
charging of electric carts
• Control carts, people and equipment that move bulk products
(forklifts, carts, hand trucks)
• Install footbaths and door foamers in plants that have wet
environments
• Require that contractors/visitors to RTE areas follow the same
procedures as the work force
• Install redundant hand washing and sanitation facilities at entry to
each RTE room; post proper washing and sanitation procedures at
the entry point
Corrective and Preventative Actions

GMPs
• Train and retrain all personnel in GMPs specifically for
cross-contamination especially for maintenance and
sanitation employees
• Assign tools and carts to RTE areas to avoid cross-
contamination
• Eliminate brooms from wet RTE areas and replace with
rubber-nubbed tools for moving product on the floor
Corrective and Preventative Actions

Dry, Uncracked, Clean Floors

• Keep the plant environment as dry as possible
• Keep floors clean and crack free
• Eliminate all leaks in equipment
• Pipe all water sources (condensates, cooling waters) to
a drain
Corrective and Preventative Actions

Sanitary Design and Sanitation Procedures

• Determine the efficacy of current periodic cleaning of floors, walls,
and ceilings
• Clean and maintain HVAC units
• Clean drains in RTE areas on the same schedule as the room
itself
• Work with suppliers to develop more cleanable processing
equipment and transportation equipment such as forklifts
• Color-code all cleaning supplies to differentiate equipment-
cleaning supplies from floor and drain cleaning supplies
• Minimize use of high pressure hoses
• Designate storage areas for clean housekeeping equipment
Environmental Monitoring

Choice of Test Method

• The choice of test method to be used for environmental
monitoring will vary by the type of monitoring being
conducted.
– However, the data being generated is only as good as the
method and technique used .
– Great care must be used to validate the methods to be used
for environmental monitoring.
– Also, the testing laboratory performing the analysis should be
validated and certified.
Environmental Monitoring

Choice of Test Method

• Listeria spp. Environmental Sponge Samples
USDA Cultural Method
+ ‘ve – ’ve
BAX®
PCR + ’ve 128 35
Method
– ’ve 1 113
• In this comparison the BAX® PCR screening method for Listeria spp. Was
significantly more sensitive over the USDA cultured method while offering
significant time to result savings.
Logic Behind Environmental PROJECT
FORWARD
Control Program
Finished product testing has significant
limitations.
Probability of Missing Contamination
% Contamination in Lot
Number of
Samples Tested 10% 2% 1% 0.5%
3 73% 94% 97% 99%
10 35% 82% 90% 95%
60 <0.5% 30% 55% 74%
120 <0.5% 8.5% 30% 55%
180 <0.5% 2.6% 16% 41%
240 <0.5% 0.8% 9% 30%
Environmental Monitoring

A Word About Error Rates

• Testing error rates are an important consideration
when conducting analysis.
• It is imperative to use the best methods, techniques,
and controls available to drive error rates down to
lowest level possible.
• Error rates are not only a measure of the testing
laboratory, but of the sampling and handling
techniques involved.
 Split Sample Comparison for
Qualitative Microbiology

August 1997 - July 1998

% Error % Error % Error
Salmonella Salmonella Salmonella Total
Pos. Sample Neg. Samples ‘97-’98 ‘95-’96

Benchmark
Laboratories 2.58 3.47 2.80 4.80

Total
Population 854 288 1,142

Source: Silliker, J., American Society for Microbiology, Food Microbiology Division Lecture,
1999, Chicago, IL.
Logic Behind Environmental PROJECT
FORWARD
Control Program
• Statistics demonstrate that finished product
testing has severe limitations
– Finished product sampling is not preventative and
does not help identify root cause of contamination
• Disciplined approach to monitoring promotes
knowledge and awareness of the
environmental conditions that could result in
product contamination
– If there is an effective kill step in the process, and if
there is no Listeria in the environment, there will be
no Listeria in the finished product
• Public health protection is better served with
an aggressive environmental program
Verifying the Effectiveness of a Practical
Microbiological Control Program

Conclusions
• In-process monitoring is the most effective means to measure the
success of a microbiological control program.
• Monitoring verifies that sanitation, GMP’s, and pre-requisite programs are
working as they should be.
• Environmental monitoring is an essential tool for measuring effectiveness
of microbiological control programs and as a root cause investigational
tool.
• It is essential that proper test methods and sampling procedures be
validated in order to ensure the lowest error rates possible.
• Proper follow-up actions must be documented to ensure that the process
is back within control.
Thank You!
Questions?