BACKGROUND PAPER

Reviewing Standard 1.6.1 Microbiological Limits for Foods

1. Introduction

Standard 1.6.1 Microbiological Limits for Food was included in the joint Australia New
Zealand Food Standards Code (the Code) in December 2000. The process for developing
this standard (Proposal P178) took into account existing microbiological standards in the
Australian Food Standards Code and the New Zealand Food Regulations 1984, and applied
principles for the establishment and application of microbiological criteria for foods
developed by the Codex Alimentarius Commission (Codex) 1. These principles describe that
mandatory microbiological criteria shall apply to those products and/or points of the food
chain where no other more effective tools are available, and where they are expected to
improve the degree of protection offered to the consumer.

At the completion of Proposal P178, the Final Assessment stated:

Microbiological standards and guidelines proposed in the joint Australia and New Zealand
Food Standards Code are an interim measure, with food safety eventually being
managed by requirements set by food safety standards. It is proposed to review the
microbiological criteria in the joint Code once food safety requirements are implemented.

When the Food Safety Standards are being applied, there may be some use for
microbiological standards where the risk to consumers of foodborne illness is found to be
very high.

Since the development of this standard, food safety requirements have been included in the
Code that support a preventative approach to ensuring food safety:

Chapter 3 Food Safety Standards

Food safety programs for high risk businesses

Primary Production and Processing Standards

Additionally, work has progressed internationally through the Codex Committee on Food
Hygiene (CCFH) on the use of risk management metrics2, such as microbiological criterion,
in a food safety control system. CCFH has also recently established microbiological criteria
for Listeria monocytogenes in ready-to-eat foods and Cronobacter sakazakii and Salmonella
spp in powdered infant formula.

1
Codex Alimentarius Commission Principles for the Establishment and Application of Microbiological Criteria for
Foods (CAC/GL 21 1997)
2
Codex Alimentarius Commission Principles and Guidelines for the Conduct of Microbiological Risk Management
Annex II: Guidance on Microbiological Risk Management Metrics (CAC/GL 63 2007)
In light of the developments in food safety management that have progressed since the
development of Standard 1.6.1, a review of the current limits in the Code is needed. Further,
in reviewing Standard 1.6.1, the role that regulatory limits provide in protecting public health,
in conjunction with other regulatory and non-regulatory food safety measures, needs to be
elaborated.

2. Current requirements relating to microbiological food

safety

Standard 1.6.1 (Australia and New Zealand)

The limits set in Standard 1.6.1 are applied as direct control measures to determine the
maximum permissible levels of microorganisms that pose a risk to human health in a range
of nominated foods (i.e. determine when the lot of food is unacceptable).They are primarily a
tool for enforcement agencies to verify the safety of certain foods according to a defined
sampling plan. However, given the limitations in microbiological testing, the effectiveness of
testing against end point limits alone in order to assure safe food is limited.

Standard 1.6.1 applies to food for sale in Australia and New Zealand.

Chapter 3 and 4 requirements (Australia only)

The microbiological safety of foods is best ensured through the effective implementation of
validated control measures throughout the food chain to minimise contamination and
improve food safety.

Post 2000, FSANZ has developed Chapter 3 Food Safety Standards and sector specific
Primary Production and Processing Standards (Chapter 4 Standards). These standards
provide obligations on food businesses and food handlers to produce food that is safe to eat.

Food safety programs have also been mandated for a number of businesses in response to
policy guidelines3 that recommended the following food business sectors should develop and
implement mandatory food safety programs:
food service in which potentially hazardous food is served to vulnerable populations
businesses producing, harvesting, processing and distributing raw oysters and other
bivalves
businesses producing manufactured and fermented meat.

New Zealand requirements

New Zealand has its own food safety legislation for food businesses and primary producers,
which is developed and implemented by the Ministry of Agriculture and Forestry (MAF)4.

3
Ministerial Policy Guidelines on Food Safety Management in Australia: Food Safety Programs
4
Formally the New Zealand Food Safety Authority (NZFSA)

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There are four main Acts5 and associated regulations and standards that regulate the safety
of food produced and sold in New Zealand or intended for export. These Acts provide for a
risk management system that effectively and efficiently manages known biological, chemical
and physical hazards that might present a risk to humans and animals irrespective of where
in the production and processing chain they occur and requires that products are fit for their
intended purpose, wholesome and true to label.

The Food Act 1981 applies to all food available for domestic sale in New Zealand and allows
Standards to be issued in relation to the composition of food, including the microbiological
status. These Standards must be met by producers and processors in New Zealand.

The Animal Products Act 1999 is the main piece of legislation for managing the risks in the
animal products (e.g. seafood, meat, game, fish, shellfish, honey etc.). Generally any
microbiological standards issued under these Acts relate to the production and processing of
food, and/or the environment in which these occur. Food available for sale on the New
Zealand market or export must meet the microbiological limits in FSC Standard 1.6.1.

Summary

These more recent preventative approaches to food safety in Australia and New Zealand
rely on food businesses implementing control measures throughout their production process
and verifying that these measures are in place and working effectively. In this context,
microbiological criteria can be developed as a verification tool to check that a food control
system is functioning as intended, applied either to the finished product, the environment or
at specific points in production.

5
The New Zealand Acts for food safety are: Food Act 1981, Animal Products Act 1999, Agricultural
Compounds and Veterinary Medicines Act 1997 and the Wine Act 2003.

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 Chapters 3 and 4 of the Food Standards Code
(Australia only)

Through chain preventative measures requiring food businesses and food handlers
to produce safe food. Compliance checked through inspection, documentation,
verification testing and audit.

Primary Production and Food Safety Standards Food Safety Programs

Processing Standards
Set out food safety
requirements for businesses
that support the production
of safe and suitable food.
Current standards cover:
Standard 3.2.2 Food Safety
Practices and General
Requirements sets out
requirements for food
businesses and food
handlers:
Standard 3.2.1 Food Safety
Programs specifies
requirements on a food
business to develop a food
safety program that
documents:

Seafood business Food handling controls The food handling

Dairy primary production,
transport and processing
businesses
Poultry meat producers
and processors
Egg producers and
processors
Producers of ready to eat Premises and Equipment
meat
Health and hygiene operations of the
requirements business
Cleaning sanitising and Potential food safety
maintenance hazards
Skills and knowledge Control measures
Corrective actions
Standard 3.2.3 Food Review of the program
Record keeping
covers:
Design and construction
of food premises
Requirements for floors,
walls and ceilings
Fixtures, fittings and
equipment

Chapters 1 and 2 of the Food Standards Code

Standards apply to food products. Approach relies on end point testing to

check compliance.

Chapter 1 and 2 Food Standards Standard 1.6.1 Microbiological

Limits for Food
e.g.
Standard 1.3.1 Food Additives mandatory sampling plans
Standard 1.3.3 Processing Aids limits set for a number foods
Standard 1.4.1 Contaminants and Natural Toxicants used to determine pass or failure
Standard 1.4.2 Maximum Residue Limits* of a lot or consignment of food
Standard 1.6.2 Processing Requirements*

*Australia only
Figure 1.Overview of the requirements of the Food Standards Code relating to food safety

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3. Issues identified with Standard 1.6.1

Criteria for Listeria monocytogenes

CCFH recently completed work on microbiological criteria for L. monocytogenes in ready-to-
eat foods6. Microbiological criteria were proposed for two categories of food:

Ready-to-eat foods in which growth of L. monocytogenes will not occur

Ready-to-eat foods in which growth of L. monocytogenes can occur

The application of this approach requires the food business to be able to demonstrate
(validate) that the food product will or will not support growth if they wish to take advantage
of the flexibility that this approach offers.

A guideline document was developed by FSANZ in 2001 Recall guidelines for packaged
ready-to-eat foods found to contain Listeria monocytogenes at point of sale (Recall
Guidelines) which also provide two action levels for ready-to-eat foods based on whether or
not the food can support the growth of L. monocytogenes. This approach, however, is not
necessarily reflected in Standard 1.6.1. Currently, limits of not detected in 25 g are set for a
limited number of foods in the standard and do not allow for particular processing or product
characteristics to be taken into account.

The limits for L. monocytogenes in Standard 1.6.1 need to be reviewed to provide a

nationally consistent and internationally harmonised approach.

Status of guideline documents

In addition to the Recall Guidelines, there are other documents that have been developed
over time that provide microbiological guideline criteria for foods:

A number of guideline criteria were developed in conjunction with Standard 1.6.1. These
were provided in the User guide to Standard 1.6.1 Microbiological Limits for Food with
additional guideline criteria. These criteria were intended as advisory criteria for industry
and government where failure to meet guideline levels may indicate a failure in process
or hygiene procedures and would require corrective action.

Prior to the development of Standard 1.6.1, the Microbiological Reference Criteria for
Foods (1995) was prepared in New Zealand as a guide for regulators to assess when
foods can be considered unacceptable or unsafe. These reference criteria provided a
comprehensive set of limits for most food products and were intended to replace
standards and complement a HACCP based approach to food safety.

During the development of Standard 1.6.1, State and Territory food regulators raised the
need for microbiological criteria for ready-to-eat foods. FSANZ developed Guidelines for
the microbiological examination of ready-to-eat foods (RTE Guidelines) in 2001 to
provide assistance in the interpretation of microbiological analyses of foods. They assign
four categories of microbiological quality from satisfactory to potentially hazardous and
provide recommended actions such as investigation of food handling controls and recall.

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Guidelines on the Application of General Principals of Food Hygiene on the Control of Listeria monocytogenes in
Foods (CAC/GL 61 2007). Microbiological criteria provided in Annex II.

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Role of indicator and index microorganisms
Sampling for indicator and index (or model) microorganisms such as coliforms and
Escherichia coli can be used to:

indicate the effectiveness or otherwise of process hygiene and process controls, e.g.
poor handling practices or failure in a treatment process (indicator microorganisms)

indicate the presence of pathogenic microorganisms when direct and reliable analytical
methods are not available (index, or model microorganisms).

The use of indicator and index tests can provide a cost effective, simple and rapid means of
assessing the microbiological status of food. They are of particular value for monitoring and
verifying production processes and hygiene controls.

Standard 1.6.1 currently specifies some limits for indicator organisms in foods, including
Standard Plate Count (SPC) and E. coli, often in combination with pathogen limits. Where
pathogens can be detected directly and reliably, it is preferable to set limits for the pathogen
rather than testing for indicator/index organisms. The role of microbiological limits based on
indicator/index organisms as regulatory standards, particularly where the test does not
indicate a direct health hazard, needs to be assessed.

Infant formula products

The emergence of Cronobacter sakazakii (formerly Enterobacter sakazakii) as an

opportunistic pathogen resulted in joint FAO/WHO microbiological risk assessment work on
powdered infant formula in 2004 (Enterobacter sakazakii and other microorganisms in
powdered infant formula: Meeting report, MRA Series 6). This informed the development of
microbiological criteria by the CCFH, including limits for C. sakazakii in powdered infant
formula, formula for special medical purposes and human milk fortifiers as well as process
hygiene criteria (Codex Code of Hygienic Practice for Powdered Formulae for Infants and
Young Children CAC/RCP 66-2008)

There are currently a number of microbiological criteria specified in Standard 1.6.1 for
powdered infant formula products. These need to be reviewed with respect to emerged
pathogens (specifically C. sakazakii) and relevance of indicator tests.

3.5 Methods of analysis

When specifying microbiological criteria for food, it is generally necessary to know which
method of detection and/or quantification of the hazard is to be used. Currently, clause 4(1)
of Standard 1.6.1 makes reference to the Australian/New Zealand Standard Methods for
food Microbiology AS/NZS 1766 as of the date of commencement of this Standard.
Standards Australia has been progressively reviewing the food microbiology test
methodology series, aligning with International Standards Organization (ISO) standards, and
many of the AS/NZS 1766 standards have now been superseded and published as AS 5013
standards.

The necessity to specify methods of analysis in the Code, or use of other mechanisms to
ensure consistent application of microbiological criteria, needs to be considered.

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4. Principles for developing microbiological criteria
The Codex Principles for the Establishment and Application of Microbiological Criteria for
Foods (CAC/GL 21 1997) provide guidance on the establishment and application of
microbiological criteria for foods at any point in the food chain. They state that mandatory
microbiological criteria (i.e. standards) to be applied by regulatory authorities should only
apply to those products and/or points in the food chain where no other more effective tools
are available, and where they are expected to improve the degree of protection offered to
the consumer.

The Codex Committee on Food Hygiene is currently reviewing document CAC/GL 21 as well
as developing Guidelines for Establishment and Application of Microbiological Criteria to
supplement these principles following the development of microbiological risk management
metrics. Australia and New Zealand have participated in this process and provided input into
the working group to progress this work. These principles and guidelines will be used to
underpin the review work on Standard 1.6.1. As such, mandatory microbiological criteria
should only be established in the Code where they directly contribute to the protection of
public health and safety e.g. food safety criteria. Other criteria, including hygiene indicators,
can be developed as reference criteria against which the effectiveness of food safety
management systems in place can be verified e.g. process hygiene criteria and include
appropriate corrective actions.

5. Microbiological risk management metrics

The Codex Principles and Guidelines for the Conduct of Microbiological Risk Management
(CAC/GL 63 2007) include guidance on approaches to establishing traditional hazard-
based microbiological risk management metrics such as product criteria, process criteria and
microbiological criteria within a food safety control system. Emerging risk based metrics
have also been developed to relate directly to public health outcomes through a risk
assessment process. These include Food Safety Objectives (FSOs), Performance
Objectives (POs) and Performance Criteria (PCs). Of these, the PO (the maximum
frequency and/or concentration of a microbiological hazard in a food at the point in the food
chain which should not be exceeded) is the most likely to be used to derive other metrics
such as microbiological criterion.

Developing risk-based metrics such as POs can be a complex process and work is currently
being undertaken by CCFH to develop practical examples of how these can be applied.

6. Proposed approaches

A horizontal approach

The original development of Standard 1.6.1 involved undertaking numerous qualitative risk
assessments on a commodity-by-commodity basis (vertical assessments). While commodity
specific issues will need to be taken into account, it is proposed that a more horizontal
approach is undertaken for the review of Standard 1.6.1, for example looking at criteria for L.
monocytogenes across the entire category of ready to eat foods.

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Concurrent development of reference criteria

Mandatory microbiological standards do not exist for many foods. To assist enforcement
agencies, guideline criteria have been developed in the past (such as for ready to eat foods).
A comprehensive set of microbiological reference criteria (food safety and process hygiene
criteria) could be developed alongside the review of criteria included in Standard 1.6.1 to
assist food regulators and provide guidance to industry. Establishing appropriate indicator
tests would be part of this process and help inform whether existing regulatory indicator
limits should be retained.

Linking into other processes

FSANZ will be preparing to review aspects of Standard 2.9.1 Infant Formula Products in
2012. It is proposed that the scope of this work would consider microbiological limits for
powdered infant formula products, with a view to harmonising with internationally agreed
criteria.

FSANZ has also been assessing options for the production of raw milk products through
Proposal P1007. A new proposal for raw milk products will be raised in 2012 to progress the
risk management approach that has been outlined in P1007. A number of criteria for raw
milk products (e.g. cheese, butter) are already specified in Standard 1.6.1. Appropriate food
safety criteria for permitted products will be established as part of the new proposal, in line
with the overarching principles to be used for reviewing criteria in Standard 1.6.1.

Building on existing work

The development of Primary Production and Processing Standards in Australia has involved
risk assessments other scientific evaluations to be carried out for a number of sectors:
Seafood Eggs
Dairy Meat
Poultry meat Horticulture (seed sprouts)

These assessments have provided the basis for identifying through chain control measures
and it is proposed that any additional risk assessment required for this review will build on
this existing work, as well as taking into account assessments undertaken in New Zealand
and internationally (such as through JEMRA).