Dairy pathogen manual

May 2016
Contents
1. About this document 3
2. Pathogens and microbiological limits 4
3. Actions to take after a pathogen or toxin is detected 5
3.1 Identify and isolate affected products 6
3.2 Notify relevant authorities 6
3.3 Recall or withdraw contaminated products 6
3.4 Halt production and isolate affected process lines 6
3.5 Review records on affected product 7
3.6 Test raw materials, in-process materials and finished product 7
3.7 Enhanced environmental sampling 7
3.8 Clean and disinfect and verify effectiveness 8
3.9 Identify corrective action and rectify the cause of the incident 8
3.10 Product disposal 8
3.11 Clearance of products 8
3.12 Documentation, records and reporting 8
4. Undertaking a clearance program 9
5. Environmental monitoring of food processing zones 10
6. Food safety culture 13
7. Summary 13
8. Bibliography 14
9. Abbreviations 15
10. Glossary of terms 15

Dairy Food Safety Victoria

PO Box 8221
Camberwell North Victoria 3124
Tel: 61 3 9810 5900
Fax: 61 3 9882 6860
Email: info@dairysafe.vic.gov.au
May 2016

© Copyright Dairy Food Safety Victoria 2016

This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission
from Dairy Food Safety Victoria. Requests and inquiries concerning reproduction and rights should be addressed to the Communications Manager.
This document is intended to be used as a general guide only and is not a comprehensive statement of all the relevant considerations with respect to this food
safety topic or your particular circumstances, nor does it comprise, or substitute for, legal or professional advice. DFSV does not guarantee the accuracy, reliability,
currency or completeness of the information. Links to other websites are provided as a service to users and do not constitute endorsement, nor are we able to
give assurances of the accuracy of their content. DFSV accepts no legal liability arising from, or connected to, any reliance on this document.

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1. About this document
The Australian dairy industry has a reputation for the manufacture The Dairy pathogen manual supports businesses to meet
of safe, high quality products that are preferentially chosen around the requirements of Standard 4.2.4 (Primary production and
the world. Product safety is achieved by the implementation of processing standard for dairy products), Standard 1.6.1 and
through chain HACCP-based food safety programs, which are Schedule 27 (Microbiological limits in food) of the Australia
designed to ensure dairy foods meet the regulatory requirements New Zealand Food Standards Code (the Code). It should
of our domestic market and, where appropriate, international also be read in conjunction with relevant user guides and
markets. additional guideline criteria.
This document provides dairy manufacturers with guidance on This document:
how to respond when their products or their dairy processing • references current microbiological limits (Section 2)
environment are found to be contaminated with pathogens
• outlines actions to identify the cause of contamination and
(organisms that can cause disease). These pathogens may
manage the problem (Section 3)
be detected through routine product testing, environmental
surveillance or from regulatory surveillance programs. • describes product clearance programs (Section 4)
• discusses environmental monitoring (Section 5)
The presence of pathogens such as Listeria monocytogenes,
Salmonella spp., pathogenic Escherichia coli, Staphylococcus • discusses the importance of an organisation’s food safety
aureus or other pathogenic organisms in dairy products or culture (Section 6).
dairy processing environments requires rapid and effective The Dairy pathogen manual is published and maintained by
action to control and manage affected products, minimise the Dairy Food Safety Victoria (DFSV). It will be revised from time
risks to consumers and correct identified problems to prevent to time, to reflect ongoing changes to the Code and industry
recurrence. practices and the emergence of any newly identified pathogens.
The Dairy pathogen manual outlines the expected response to
detections of bacterial pathogens (and/or their toxins) associated
with dairy products and describes clearance procedures.
Strategies for the management of pathogens in the dairy
industry have evolved over the past 25 years. This document
describes current approaches and supersedes other pathogen
control publications, including:
• Australian Manual for Control of Listeria in the Dairy Industry,
ADASC (July 1999)
• Australian Manual for Control of Salmonella in the Dairy
Industry, ADASC (July 1999)
• National Guidelines-Pathogen Management, Dairy Authorities
Technical Advisory Committee (June 2011)

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2. Pathogens and microbiological limits
When certain bacterial pathogens and their toxins are present Table 1 lists pathogens that can be found in milk and
in dairy products, they can lead to foodborne illness. These dairy products. When evaluated in terms of probability
organisms may originate in the raw milk or they may be of occurrence and risk to consumers, a smaller group of
introduced via ingredients, people, environmental sources or dairy food and pathogen combinations are relevant to dairy
packaging materials. manufacturers. Further information on common agents of
foodborne illness may be obtained from a range of sources
To maximise the safety of a dairy product, manufacturers
(FSANZ, 2013 and FDA, 2012).
exercise control over incoming raw materials, ingredients,
processing operations (including pasteurisation, post-kill step Microbiological criteria are set when risk assessment has shown
hygiene, manufacturing, handling and storage practices) that the risk of foodborne illness is unacceptably high.
conditions in their facility and the physico-chemical properties Standard 1.6.1 and Schedule 27 of the Code establishes
of the product, that is, whether it will support the growth or microbiological criteria for finished dairy products. Dairy foods
survival of pathogens. that fail these limits may pose a threat to human health and
must not be offered for sale. When these limits are exceeded,
dairy manufacturers must take corrective action (see Section 3).

Table 1: Pathogens found in dairy products

Aeromonas hydrophila Bacillus cereus Campylobacter jejuni and C. coli

Clostridium botulinum Clostridium perfringens Coxiella burnetti
Cronobacter sakazakii Cryptosporidium parvum Mycobacterium bovis
Listeria monocytogenes E. coli (pathogenic) e.g. STEC Salmonella spp.
Shigella spp. Staphylococcus aureus Yersinia enterocolitica

Standard 1.6.1 and Schedule 27 do not list all potential only a subset of E. coli strains are pathogenic. Those of most
pathogens or all dairy foods. Furthermore, standards in the interest in Australia are the shiga toxin-producing E. coli (STEC).
Code are periodically reviewed and change over time so The most common STEC serotypes reported in Australia are
manufacturers should always check the current limits. E. coli O157, O111, and O26. The presence of E. coli in a processed
For example, recent changes have established limits for dairy product signals recent exposure of the product to faecal
L. Monocytogenes in ready-to-eat foods, which includes contamination and the potential presence of bona fide human
most dairy products as they are consumed without further pathogens.
preparation. Manufacturers should also refer to the DFSV document
The E. coli limits in the Code are also being examined. While Microbiological testing criteria which lists testing
E. coli is considered to be pathogenic, unless proven otherwise, requirements for finished products.

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3. Actions to take after a pathogen or toxin is detected
When harmful microorganisms such as Salmonella spp., • initiating a clearance program which involves high level
L. monocytogenes (including detections of Listeria spp.) and sampling and testing of subsequent batches of product on
E. coli are detected in dairy products above prescribed limits or the implicated production line
in a dairy manufacturing environment, the manufacturer must • putting into effect procedures that will prevent future
stop production and implement corrective action. occurrences.
Corrective action includes: The manufacturer must also notify DFSV.
• effectively dealing with the contaminated and at-risk
Table 2 provides a summary of the actions that need to be
product
considered and implemented. Note that some of these actions
• undertaking a root cause analysis to identify the cause will occur concurrently. The following sub-sections provide
• performing a major clean-up of the operation detail for each action.

Table 2: Actions required for pathogen (or toxin) detections in product

Actions Pathogen detected in product

Levels above limits in Code Levels below limits in Code
Immediate action
3.1 Identify and isolate affected products ✓ Consider†
3.2 Notify DFSV and other relevant authorities ✓ Consider†
3.3 Recall or withdraw contaminated productsπ Consider† Consider†
3.4 Halt production and isolate affected process linesφ ✓ Consider†
Investigative action to determine cause
3.5 Review records on affected product ✓ ✓
3.6 Test raw materials, in-process materials, ✓ ✓
and finished product
3.7 Enhanced environmental sampling (Zones A, B, C, and D) Ψ ✓ ✓
3.8 Clean and disinfect, and verify effectiveness ✓ ✓
3.9 Identify corrective action and rectify the cause of the ✓ ✓
incident
Follow-up
3.10 Disposal of product ✓ Consider†
3.11 Clearance of products ✓ Consider†
3.12 Documentation, records and reporting ✓ ✓

Key:
* Actions apply to dairy products containing pathogens exceeding limits in the Code.
It is recommended that these actions also apply for presumptive positive results for Salmonella spp. and Listeria spp.
✓ Action expected
π The decision to recall can be mandated by the relevant authority, but is usually voluntary (in consultation with the authority)
† When considering and assessing if action should be taken, assess trends, contaminant levels (cfu/gram), and the potential for a pathogen
(or toxin) to increase during product shelf-life. Seek guidance from DFSV. A risk assessment may be required.
φ Where manufacture has halted, production should not recommence until clearance by authorities
Ψ Enhanced monitoring should occur when pathogens (e.g. Salmonella spp., L. monocytogenes, pathogenic E. coli,
Cronobacter sakazakii) are detected in product (Zones are described in Section 5)

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3.1 Identify and isolate affected products 3.3 Recall or withdraw contaminated
Once a product is found to be contaminated, it is essential that products
steps are taken to identify, label, isolate and hold or withdraw The action taken will depend on where the contaminated
the product. This minimises the risk of affected units being product is.
mistaken for uncontaminated product and helps prevent the
• If contaminated product has not left the manufacturing site
product from being used, sold or further distributed.
it must be isolated and held (see 3.1).
• Clearly label the contaminated product to show its status
• If the product is at a storage facility or with wholesalers it
(for example, mark with Quarantine or Hold labels) or
should be identified and withdrawn (see 3.1).
otherwise manage the product to eliminate the risk of
accidental release or use. • If the product has entered the marketplace, a food recall
• Store contaminated product in a manner that minimises the may be required if there is a reasonable possibility that
potential for direct contact or cross-contamination with other consumption of the food would cause adverse health
products, packaging materials, equipment and surfaces. Where consequences or where the product has a serious defect
products are not packaged, the contaminated product should that poses a potential health risk.
be physically segregated from other uncontaminated products. The manufacturer responsible for the supply of a food normally
• Keep the affected product on hold to allow time for more initiates food recall action. Any decision to recall is usually
information to be gathered about the level of risk posed by made by the manufacturer in consultation with the State
the identified food safety hazard, so that appropriate decisions Department of Health. However, the Commonwealth Minister
and corrective actions can be implemented. responsible for consumer affairs and state and territory food
• Identify, label and hold for testing other products processed enforcement agencies have the legislative power to order a
on the same line or on lines in close proximity to the food recall when a serious public health and safety risk exists.
contaminated line. It is a legal requirement that food manufacturers have in place
a ‘food recall plan’ which must be followed in the event of a
3.2 Notify relevant authorities recall (Standard 3.2.2–Food Standards Code). FSANZ publishes
The manufacturer must notify DFSV at the earliest opportunity advice and guidance on how to develop a recall plan and
after learning of product contamination. conduct a recall (FSANZ, 2014). Depending on factors such as
Notification must be written confirmation (via email, letter, fax product composition, contamination levels and volume and
or any other written medium) and received by DFSV within 24 extent of distribution, the incident may result in either a trade
hours. Often a manufacturer will call their Food Safety Manager withdrawal or a consumer recall of the affected product.
to immediately inform them of a contamination incident. In addition to product known to be contaminated, consideration
Information that needs to be provided includes: should be given to recalling or withdrawing any other products
• product implicated that may be implicated, such as product processed on the same
• production codes (Lot or batch number) line or in close proximity to the contaminated line. This should
extend back to the last batch of product tested and found to be
• date of manufacture
free of the pathogen (the last clearance point).
• microbiological test results
• use by/best before date 3.4 Halt production and isolate affected
• unit size and quantity of product involved process lines
• location of product As soon as possible after notification of a pathogen in a dairy
• other products that may have been contaminated, such as product, the manufacturer should cease production and
dairy product(s) produced on the same line prior to or after isolate the affected process line.
the detection or product(s) produced in close proximity to
This allows for visual inspection of the line and equipment,
the contaminated batch.
which can help assess conditions and identify areas that may
If the contaminated product is made in an export registered be the source or harbourage point for pathogens. A critical
facility, the Australian Government Department of Agriculture part of this investigation is dismantling and thoroughly
and Water Resources must also be contacted and notified. inspecting equipment, looking for niches that are hard to
Before production recommences on the affected process access or not normally visible (see Section 3.7).
lines, DFSV must be consulted. DFSV may request additional
Halting production will help minimise the potential spread
information to verify the effectiveness of the corrective action
of the pathogen. Note that some days may have passed
and further testing.
between processing the contaminated batch and receipt of
the laboratory test results.

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At this point, enhanced environmental sampling should also 3.6 Test raw materials, in-process materials
be undertaken to identify the source of the contamination. and finished product
Associated process lines and areas may also need to be isolated
Pathogens may be introduced into the processing
and inspected and environmental sampling completed to
environment or finished products through raw ingredients,
determine additional sources of contamination.
in-process materials or the finished product.
When manufacture has been halted, production should not
To identify the extent of the contamination, it is essential to test:
recommence until clearance has been obtained from DFSV.
• raw materials, such as ingredients, additives and processing
aids
3.5 Review records on affected product
• in-process materials, including intermediate products post-
The manufacturer must review and trace-back production and
pasteurisation
processing records and microbiological test results to identify
the possible source, timing and extent of the contamination. • surrounding batches of finished product back to the
It is important to determine whether or not the process was last batch of product tested and found to be free of the
under control and that standard operating procedures were pathogen (see Section 4)
adequate and being followed. • packaging materials, including liners, inners, outers and
The identification of unusual or atypical conditions or data may pallet wrapping.
assist in determining possible causes or links to contamination.
3.7 Enhanced environmental sampling
The manufacturer should consider the following.
The processing environment is often the source of product
• Were there changes to product formulation or ingredient
contamination. Routine environmental sampling assists in
substitutions on that production line during the time of the
pinpointing sources of contamination and identifying niches
contamination?
where pathogens may potentially reside.
• Was there a loss of control at a critical control point? For
The level of monitoring should be enhanced when pathogens
example, review pasteurisation records to determine if the
such as L. monocytogenes, Salmonella spp., pathogenic E. coli,
target temperature was being met.
and Cronobacter sakazakii are detected in any environmental
• Was there equipment breakdown, plant modifications or
zones. For example, action should be considered when E. coli
maintenance work carried out on, or near, the process line
is detected in Zone A (food contact surfaces), as it reflects
prior to the contamination event?
poor hygiene control procedures. Similarly, the detection of
• Do records show cleaning and sanitation procedures were Listeria species in Zone A should also be investigated further,
followed correctly? Was the correct type and concentration as its presence suggests conditions may be suitable for survival
of detergent and sanitiser used? Was there a change in and/or growth of L. monocytogenes. For information on zones
methods or chemicals? within manufacturing plants see Section 5.
• Did environmental monitoring indicate any potential When an incident occurs, more intensive environmental
problems or lapses in hygiene? monitoring is recommended. The number of samples is
• Were there new or inexperienced staff on the affected increased and a wider range of sampling points surveyed.
process line at the time of the contamination? In this situation, pinpointing the contamination source is
• Were there frequent changes in the speed of the process essential, so the compositing of samples is not advisable.
line or changes in packaging films/containers during or A more extensive sampling program will include:
near the time of the contamination?
• hard-to-reach and clean surfaces and equipment (may
• Was there any unusual weather event, such as storms require equipment dismantling)
or dust?
• worn or damaged equipment or equipment that has
This information can help determine which product and recently been repaired
ingredients may be potentially contaminated and the need • a focus on equipment and surfaces suspected as
for additional microbiological testing to more accurately harbourage points for pathogens that are adjacent to food
determine the extent of the contamination. contact surfaces.
Identifying a possible cause of the contamination at this stage To identify potential sources of contamination, it is important
allows for specific actions to minimise the risk of the problem that environmental sampling takes place prior to any cleaning
recurring. and disinfection action, that is immediately after production
ceases.

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3.8 Clean and disinfect and verify • level of risks (food safety, occupational health and safety, and
effectiveness security) associated with the proposed disposal method and
how the risks will be managed
When a contaminated product has been identified, a
comprehensive cleaning and disinfection program should be • conditions and controls for the method of disposal.
initiated. This will involve all processing equipment, utensils and For reprocessed product, the following information should be
processing zones associated with the product, including the documented (where appropriate):
dismantling of equipment and conveyors. Any environmental • specifications
samples must be taken prior to this cleaning and disinfection
• location and storage details
process.
• quantity, identification and labelling information
At the completion of the cleaning and disinfection program,
• distribution, use and sale information
the cleaned and disinfected area, equipment and utensils
should be visually inspected to determine if they are clean and • microbiological sampling and testing.
environmental samples (swabs, ATP- adenosine triphosphate
measurements) taken to confirm the efficiency of the program. 3.11 Clearance of products
Manufacturers are encouraged to seek guidance and advice Clearance programs are designed to verify that corrective
from suppliers of cleaning and sanitising agents. actions undertaken in response to a pathogen detection have
been effective. These programs involve elevated levels of end-
3.9 Identify corrective action and rectify the product testing after an incident to demonstrate that a food
cause of the incident safety program is again under control. Clearance requirements
If the cause of the incident has been identified, corrective are described in detail in Section 4.
action may need to be implemented to minimise the Products under a clearance arrangement should be withheld
likelihood of recurrence and prevent future contamination. from distribution and sale until the test results for a batch
For example, if the cause of the contamination was ineffective satisfy microbiological limits in the Code. Manufacturers
cleaning, then the cleaning and disinfection program must ensure that there is an appropriate system for retaining
should be modified then validated to assess its efficacy. The products under a clearance program and for authorising
manufacturer’s food safety plan must reflect any modifications product release when each batch satisfies the criteria.
to operations and procedures, which may include the initiation
If product test results for any batches in the clearance program
and documentation of staff training.
fail to comply with the pathogen levels described in the Code,
the regulator will require the program to be recommenced.
3.10 Product disposal
Any alternative clearance arrangements to those described in
Dairy products found to contain pathogens may be
this manual must be submitted in writing to the relevant State
reprocessed or destroyed. For example, it may be possible to
regulator for approval.
reprocess contaminated product into animal feed or use in
non-food applications. Before reprocessing a contaminated
batch, the manufacturer will need written approval from DFSV.
3.12 Documentation, records and reporting
All records, actions, reports and relevant information relating
DFSV may also require proof of disposal when product has
to the contamination incident and investigation are to be
been dumped.
kept and made available upon request by the DFSV. This is a
The following information should be documented for each requirement under Standard 3.2.1 of the Food Standards Code
batch of product scheduled for disposal: [section 5(f )].
• location of the contaminated product
• quantity, identification and labelling information for the
contaminated product
• date and time of proposed disposal
• level of hazard associated with the contaminated product
• intended method of disposal, for example, destruction (by
burial in a controlled landfill, heat treatment or burning),
reprocessing or use as animal feed etc.
• records of location and method of disposal, for example,
photographic evidence, disposal receipt

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4. Undertaking a clearance program
The detection of pathogens (for example, Salmonella spp. or Once this is completed, a clearance program involving
L. monocytogenes and other selected microorganisms such as extensive sampling and product testing must commence on
Listeria spp.) during routine testing of a batch of dairy product subsequent production runs.
indicates a failure of a manufacturer’s food safety program
The clearance program protocol is based on sampling
and a potential threat to public health. All product of the
procedures suggested by the International Commission on
same batch/lot number and any product processed on the
Microbiological Specifications for Foods (ICMSF, 2002). The ICMSF
affected processing line should be considered to be potentially
recommend that where the hazard is severe and there is likely
contaminated.
to be no change before consumption, a sampling plan for lot
Further production on the affected processing line should only acceptance requires 30 samples to be tested. Testing must be
commence following a detailed inspection and analysis of the performed by an accredited laboratory.
cause, effective decontamination of the affected line, and the
identification and implementation of corrective action. The minimum clearance program arrangements are as follows:

30 samples are to be taken per batch from the affected production line at listed intervals.

Day Samples
Day 1 30 samples (immediately following comprehensive clean*)
Day 3 30 samples
Day 5 30 samples
Day 12 30 samples

* First batch after restart, not first batch after contamination event

The 30 samples representing the batch will need to be of Any product from the implicated processing line that was
sufficient size for the laboratory to take 25 grams (or 25 produced prior to the original contamination (day 0) and is
millilitres) from each. Each sample may be tested individually still available should also be tested at 30 samples per batch
or composited, for example, six lots of five samples. and withheld until cleared. This may include product within
For small scale manufacturers the requirement to take 30 the warehouse or retained samples. This will be particularly
samples for testing may be excessive when a small number of important where testing is done on a periodic basis rather
units are produced. In these circumstances, the regulator may than on every batch of product. Product should be tested back
consider alternative sampling protocols. to the last compliant test result.

A clearance program needs to be completed in full and is It is strongly recommended that all products from other
only considered to be complete when the results of all tests production lines in the same processing area be tested for the
meet regulatory requirements. If results from any of the contaminant detected on the day of, the day before and the
four batches fails to comply with the pathogen levels in the day after the original contamination. DFSV will provide advice
Code or indicate unacceptable levels of microorganisms, on interpreting the above requirements if necessary.
then DFSV will require the program be recommenced and
appropriate product control and incident investigation must
be undertaken.
It is recommended that products manufactured on day 1
are held and released when they test negative. Similarly,
product made on days 2 and 3, days 4 and 5, and days 6–12
are retained until the results from days 3, 5 and 12 have tested
negative, respectively. This may not be practical with short
shelf-life products which cannot be held pending release to
the market.

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5. Environmental monitoring of food processing zones
An important adjunct to product testing in the dairy industry is In dairy processing environments, sites for environmental
environmental monitoring. Environmental monitoring assesses monitoring must be selected in a logical and risk-based manner.
the efficacy of cleaning and sanitation programs and scrutinises This is done by dividing the manufacturing plant into four zones,
potential risks from pathogens such as L. monocytogenes and each based on the potential for product contamination if a
Salmonella spp. pathogen were to be present in that zone. This is referred to as
Detection of a pathogen in the processing environment the ‘zone concept’ and requires the manufacturer to define and
can be regarded as a warning of potential problems. identify production areas based upon pathways for product
When this happens, manufacturers need to implement contamination as described in Table 3 and as illustrated in Figure
further investigations and take corrective action to prevent 1. The zone of highest risk is classified as Zone A and the lower
contamination from environmental sources spreading to the level of risk is classified as Zone D.
product. The areas, surfaces, items and equipment in each zone will
An environmental sampling plan is implemented to assess vary between premises and will depend on of the history and
whether the hygienic status of the dairy processing environment experience of each individual manufacturer.
is effectively under control. The goal is to eliminate potential
contamination by pathogens.

Table 3: Descriptions and examples of environmental monitoring zones

Zone Description Risk to product Examples

A Product contact surfaces
Surfaces over or through which product High Conveyors, tables, racks, holding vats
passes during processing (product contact and tanks, utensils, pumps, valves, slicers,
surfaces/direct contact surfaces) freezers, packing/filling machines
B Non-product contact surfaces in close
proximity to product
Surfaces that are in close proximity to the High Conveyors, exterior of processing
flow of product and may indirectly lead equipment, refrigeration units, equipment
to product contamination (non-product control panels, service lines, equipment/
contact surfaces/in-direct contact surfaces building above exposed product. May also
that are close to product) include keypads and door handles
C Non-product contact surfaces located
further away from product
Surfaces located further away from the flow Low – provided good Drains, walls, floors, condensate, hoses,
of products. These surfaces are less likely manufacturing practice trolleys, pallets, conveyor belts, forklifts,
to lead to product contamination but may (GMP) establishes control computer keyboards and telephones,
hinder efforts to control pathogens (non- systems switches, etc.
product contact surfaces/in-direct contact
surfaces that are further away from product)
D Surfaces outside the processing area
Surfaces outside of the premises but Low Locker rooms, cafeterias, entry/access
includes areas through which people, ways, pallets and pallecons, loading bays,
equipment and ingredients may pass roofs, gutters, waste pits, garbage storage
areas

10
A properly designed environmental monitoring program When compositing environmental samples:
includes a diagram of the manufacturing site with markers • only composite samples within a single zone (do not mix
showing routine sampling sites. Selection of sampling sites samples from different zones)
should be based on the likelihood of revealing contamination
• do not composite wet with dry samples
by the target pathogen if it were present and the risk to the
product. This means looking for hard-to-reach and clean areas, • document the sample sites for all areas/points that make
and surfaces where biofilms are likely to form. The choice of sites up a composite.
should be justified and documented in the food safety program. In addition to swab and sponge samples, environmental
The results obtained from environmental monitoring (positive sampling may include residues from products, materials or
and negative) can be plotted on the diagram, and this can be surroundings in either dry or wet form, for example, shavings
used to identify patterns or trends. from slicing machines, rubbish or dust from the floor,
condensate and liquid residues.
Generally, the larger the number of samples taken the more
likely environmental contamination will be detected. When a pathogen is detected in a zone, the corrective action
To minimise testing costs, it is possible to composite swabs for varies depending upon the proximity of the zone to product.
routine environmental monitoring, although a positive result Table 4 describes recommended actions for pathogen
will implicate a number of sites and require further swabbing. detections in the different zones.
Compositing is not recommended during incident investigations.

Table 4: Specific actions recommended for environmental monitoring detections

ZONE A: Product contact surfaces ZONE B: Non-product contact surfaces in close proximity to
product
• Consider placing suspect product on hold • Increase sampling to pinpoint contamination sources
• Increase sampling to pinpoint contamination sources • Reassess access/entry restrictions to Zone B and review staff
• Reassess access/entry restrictions to Zone A and review staff hygiene training and knowledge
hygiene training and knowledge • Review Zone C results and trends to identify any areas that
• Review Zone B results and trends to identify any areas that may require control reassessment
may require control reassessment • Reassess cleaning and sanitising program
• Reassess cleaning and sanitising program • Reassess manufacturing and product handling procedures
• Reassess manufacturing and product handling procedures • Review sanitary design of equipment
• Review the sanitary design of equipment • Check receival of packaging material
• Clean and sanitise this zone and any suspect areas • Clean and sanitise this zone and any suspected areas
• Resample all sites to verify cleaning and sanitising efficacy • Resample all sites to verify cleaning and disinfection efficacy
• Sample and test any batches of product or retention
samples of short shelf-life products associated with the area
manufactured on the day of, day before, and day after the
positive environmental result. Corrective action is needed if
any batches are positive. If no product is available the next
available batch of product manufactured after the date of
the environmental positive should be tested
ZONE C: Non-product contact surfaces located further ZONE D: Surfaces outside of the processing area
away from product
• Increase sampling to pinpoint contamination sources • Reassess the cleaning and disinfection program for Zone C
• Reassess access/entry restrictions to Zone C and review staff • Undertake sampling in Zone C to ensure that access/entry
hygiene training and knowledge controls are intact and effective
• Review Zone D results and trends to identify any areas that • Review access/entry restrictions between Zones D and C
may require control reassessment and reinforce staff training and knowledge
• Check pallets and pallecons, trolleys and forklifts
• Reassess cleaning and disinfection program
• Reassess manufacturing and product handling procedures
• Clean and disinfect this zone and any suspect areas
• Resample all sites to verify cleaning and disinfection efficacy

11
Figure 1: Zones

Product contact surfaces ZONE A

(Vats, fillers, conveyors, racks, tables,
knives, hands, etc)

Non-product contact surfaces in close proximity ZONE B

(Cool rooms, under equipment, equipment housing,
computer screens, tools, etc)

Non-product contact surfaces further away ZONE C

(Drains, floors, wheels, fork lifts, cleaning equipment, etc)

Areas outside processing area ZONE D

(Loading dock, warehouse, maintenance areas, amenities, etc)

12
6. Food safety culture
The management of dairy food safety involves understanding • understanding the big picture – that is, food safety is not
and controlling a range of design and operational issues within negotiable
the processing facility. Manufacturers need to know how • understanding the goals of the company – striving to
identified contaminants may gain entry into raw materials, the produce safe food
plant and their products, and how processing operations are
managed to produce safe products. This is the basis of a food • understanding their own responsibility for food safety –
safety management program. where they fit in the picture.

Equally important is the conduct and behaviour of employees Manufacturers with a suitable food safety culture will have
within the food processing environment. Influencing and individuals who implement practices that represent the
changing human behaviour in the food processing environment company’s goals and can identify where they may be failing.
so there is a shared set of values that staff follow will enhance Such businesses can then demonstrate to their staff and
the production of safe dairy products. This is a critical part of customers that they are aware of food safety issues, that
managing dairy food safety, and is a demonstration of the they can learn from others’ mistakes and that food safety is
organisation’s food safety culture. important to them.

A strong food safety culture is evidenced by all staff (from An all-inclusive approach to management of food safety issues
senior management through to the operator on the involves an effective integration between the food safety
production line) understanding the risks associated with the culture and the food safety management program.
dairy foods they produce, knowing why managing these risks
is important and constantly striving to manage those risks in a
verifiable manner. It is based on all employees:

7. Summary
Maintaining a hygienic manufacturing environment is critical of product, root-cause analysis, effective decontamination and
to the production of safe and suitable dairy products. prevention measures, and the implementation of a product
Incursions of pathogens can occur from time to time. Dairy food clearance program.
manufacturers need to be vigilant and prepared to respond The combination of a suitable environmental monitoring
in a systematic manner when a problem occurs. This includes program and well trained, competent employees are the best
early notification to the regulator, identification and isolation defence for keeping pathogens out of dairy products.

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8. Bibliography
Australian Dairy Authorities Standards Committee 1999, Australian Manual for Control of Listeria. ADASC

Australian Dairy Authorities Standards Committee 1999, Australian Manual for Control of Salmonella. ADASC

Australian Dairy Authorities Standards Committee 2000, Minimum sampling guidelines for dairy products. ADASC

Australia New Zealand Food Standards Code 2016. Standard 1.6.1–Microbiological Limits for Food.
Viewed 29 March 2016 <http://www.comlaw.gov.au/Series/F2015L00411>

Australia New Zealand Food Standards Code 2015. Standard 4.2.4–Primary Production and Processing Standard for Dairy Products.
Viewed 29 March 2016 <http://www.comlaw.gov.au/Series/F2012L00294>

Codex Alimentarius Commission 1991. General Standard for Labelling of Prepackaged Foods. Codex Standard 1-1985, Revision 1

Codex Alimentarius Commission 2003. Recommended International Code of Practice–General Principles of Food Hygiene.
CAC/RCP 1-1969, Revision 4

Dairy Food Safety Victoria 2013. Microbiological testing of finished dairy products.
Viewed 29 March 2016 <http://www.dairysafe.vic.gov.au/publications-media/regulations-and-resources/technical-information-notes/
product/248-microbiological-testing-of-finished-dairy-products-updated-1>

Dairy Food Safety Victoria 2014. Cleaning in place (CIP).

Viewed 29 March 2016 <http://www.dairysafe.vic.gov.au/publications-media/technical-information-notes/premises/285-tin-cip-web/file>

Dairy Food Safety Victoria 2015. Microbiological testing criteria.

Viewed 29 March 2016 <http://www.dairysafe.vic.gov.au/publications-media/regulations-and-resources/guidelines/347-dfsv-micro-
testing-criteria2015web>

FSANZ 2013. Agents of foodborne illness. 2nd edition. Food Standards Australia New Zealand, Canberra.
Viewed 29 March 2016 <http://www.foodstandards.gov.au/publications/Documents/FSANZ_FoodborneIllness_2013_WEB.>

FSANZ 2014. Food Industry Recall Protocol–A guide to conducting a food recall and writing a food recall plan (7th ed).
Viewed 29 March 2016 <http://www.foodstandards.gov.au/publications/Documents/FSANZFoodRecallProtocol2014.pdf>

International Commission on Microbiological Specifications for Foods 2002. Microbiological testing in food safety management
(Microorganisms in foods 7). Kluwer Academic/Plenum Publishers, New York, USA.

US Food and Drug Administration 2012. Bad Bug Book. (2nd ed) USA.
Viewed 29 March 2016 <http://www.fda.gov/downloads/Food/FoodborneIllnessContaminants/UCM297627.pdf >

Yiannas, F. 2009. Food Safety Culture: Creating a Behavior-Based Food Safety Management System. Springer, NY

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9. Abbreviations
ADASC Australian Dairy Authorities Standards Committee
ATP Adenosine triphosphate
DFSV Dairy Food Safety Victoria
FSANZ Food Standards Australia New Zealand
FSC Australia New Zealand Food Standards Code
GMP Good manufacturing practice
HACCP Hazard analysis and critical control points
ICMSF International Commission on Microbiological
Specifications for Foods
STEC Shiga-toxin producing Escherichia coli

10. Glossary of terms

Animal feed – any single material (or multiple materials), Non-conforming – product that is suspected or known not to
whether processed, semi-processed or raw, which is intended meet regulatory requirements.
to be fed directly to food producing animals.
Pathogen – any microorganism capable of causing foodborne
Batch/Lot – a definitive quantity of a commodity produced illness.
essentially under the same conditions, for example, up to 24
Qualitative testing – laboratory analysis which establishes the
hours of continuous production of a product, or products from
presence or absence of a pathogen.
a specific line, or a lesser period of continuous production
between the completion of cleaning and disinfecting Quantitative testing – laboratory analysis which enables the
procedures; the term ‘batch’ has the same meaning as ‘lot’. level of pathogens present to be determined.

Cleaning – the removal of soil, food residue, dirt, grease or Routine pathogen sampling and testing programs – routine
other objectionable matter. A comprehensive clean would (regular and ongoing) sampling and testing that is conducted
generally indicate a requirement to disassemble, inspect and to detect pathogens in dairy products and the processing
clean individual manufacturing equipment components. environment. Routine sampling and testing is seen as an
essential element of a dairy manufacturer’s food safety program
Dairy product(s) – products defined by Standard 4.2.4 Primary to meet requirements in terms of monitoring and verification.
production and processing standard for dairy products of the
Australia New Zealand Food Standards Code, as well as dairy- Traceback – process of tracing back through various stages of
based dips and dairy-based desserts. production and processing to determine the cause of a problem.

Disinfection – the reduction, by means of chemical agents

and/or physical methods, of the number of microorganisms
in the environment to a level that does not compromise food
safety or suitability.

Disposal/Dispose – to change the purpose/intended use of

the product, such as to destroy, reprocess so that the risk is
reduced to a safe level, use as animal feed or use in a non-food
application.

Foodborne illness – any illness resulting from the

consumption of contaminated food.

Food recall – action to remove from distribution, sale and

consumption, food which may pose a health and safety risk
to consumers.

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 Dairy Food Safety Victoria
Level 2, 969 Burke Road, Camberwell, Victoria 3124
Postal address
PO Box 8221, Camberwell North, Victoria 3124
Phone: + 61 3 9810 5900 Fax: + 61 3 9882 6860
Email: info@dairysafe.vic.gov.au
www.dairysafe.vic.gov.au