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08/03
19 March 2003
FIRST REVIEW REPORT
PROPOSAL P239
LISTERIA RISK ASSESSMENT & RISK
MANAGEMENT STRATEGY
1.
Background
The Australia and New Zealand Food Regulation Ministerial Council has requested a review
of the draft variation to Standard 1.6.1 (Volume 2) of the Australia New Zealand Food
Standards Code (the Code) as notified to the Ministerial Council on 13 November 2002. In
particular, the Ministerial Council has requested FSANZ to review the microbiological limit
for Listeria monocytogenes in cooked crustacea (deleted in the draft variation to Standard
1.6.1, resulting from Proposal P239) on the basis of concerns that:

it does not protect public health and safety;

it is difficult to enforce or comply with; and

a standard is necessary for the testing of imported products.
1.1
Review of the Australian Food Standards Code (formerly Volume 1)
The qualitative risk assessment for L. monocytogenes undertaken during the review of the
Australian Food Standards Code (the Review) concluded that there is a potential public
health risk posed by this pathogen/commodity combination. The findings of that risk
assessment were used as a basis for recommending that a standard for L. monocytogenes be
set for cooked crustacea in Standard 1.6.1 of the Code. Microbiological limits for
L. monocytogenes in cooked crustacea were included in Standard 1.6.1 in November 2000
and required that L. monocytogenes be ‘not detected’ in all five 25 g samples from a batch of
cooked crustacea at any stage during its stated shelf life. Prior to this recommendation, there
was no microbiological standard in the Code for L. monocytogenes in cooked crustacea.
The former Australia New Zealand Food Standards Council (ANZFSC) requested in
November 2000, as part of agreeing to the adoption of the Code, that ANZFA review the
microbiological criteria for L. monocytogenes in cooked crustacea in Standard 1.6.1. This
was because producers and importers of cooked crustacea did not support a zero limit for this
pathogen as they considered that insufficient scientific evidence had been presented to
support the requirement.
1.2
Proposal P239
The review of the microbiological criteria for L. monocytogenes in cooked crustacea (and
processed ready-to-eat finfish), as requested by ANZFSC, involved the raising of Proposal
P239. The risk assessment undertaken for this proposal sought to extend the previous work
that had been done by taking into consideration international data, further epidemiological
data and incidence data for L. monocytogenes in locally available product. Quantitative risk
modelling work was also incorporated to provide a measure of risk to the population posed
by L. monocytogenes in cooked crustacea.
As a result of the work undertaken for P239, FSANZ approved a draft variation to Standard
1.6.1 that deleted the existing standard for L. monocytogenes in cooked crustacea because the
existing measure could not be justified on public health grounds.
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2.
Issues Requested to be Reviewed by the Ministerial Council
2.1
Protection of public health and safety
2.1.1
Outcomes of the risk assessment
The risk assessment for L. monocytogenes in cooked crustacea presented in the Final
Assessment Report for P239 concluded that the risk of contracting Listeriosis from this
commodity is very low. This was based on the finding that L. monocytogenes in this
commodity is found infrequently (~ 3%) and at low levels (< 50 cfu per gram1); that the
production process includes a kill step (cooking), and that the shelf life of the product is
short, thereby limiting growth of the pathogen present in the food due to post processing
contamination.
FSANZ conducted a survey of the presence of L. monocytogenes in cooked prawns at the
retail level in Australia in July-August 2002. The aim of the survey was to gather sufficient
data that would permit an estimate of the actual risk to public health and safety posed by
L. monocytogenes in cooked crustacea (prawns representing, by far, the crustacea commodity
mostly consumed in Australia and New Zealand). The prawns surveyed included both peeled
and unpeeled product, produced domestically and imported.
The survey data analysed in August 2002 indicated that cooked crustacea sold at the retail
level in Australia is only infrequently contaminated with L. monocytogenes (only 3% of
samples [n=380] tested positive for this pathogen). None of the positive samples exceeded
levels of 50 cfu per gram. This survey data, in combination with other incidence and
epidemiological data, was used in a predictive modelling tool to estimate levels of Listeriosis
in vulnerable populations caused by cooked crustacea. The modelling indicated that,
assuming there was no growth of the organism during domestic storage, there would be one
case of Listeriosis every 1,600 years resulting from the consumption of contaminated
crustacea (a very low likelihood of illness). Modelling of a worst-case scenario which
assumed that the cooked prawns would be stored in a domestic refrigerator for a maximum of
3 days after purchase (allowing growth) indicated that there could be one case of Listeriosis
caused by cooked crustacea every 2.5 years. The modelling data indicated that L.
monocytogenes in cooked crustacea poses a low risk to the Australian and New Zealand
population.
Cooked crustacea has a short shelf life (10 days at -1C), giving limited time for microbial
growth to occur before spoilage of the product results. Temperature abuse that would allow
for the growth of L. monocytogenes would also result in an increase in the growth of spoilage
microorganisms and a decrease in the shelf life of the product.
It was concluded in the Final Assessment Report to P239 that the low risk to the population
posed by L. monocytogenes in cooked crustacea does not justify a mandatory risk
management measure on public health grounds. In requesting the review, the Ministerial
Council did not provide any new evidence that could be used to further refine the risk
assessment work previously undertaken. The outcomes of the risk assessment work at Final
Assessment, therefore, remain unchanged.
1
The limit of detection for the enumeration method used
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2.1.2
Limitations of microbiological standards
Microbiological standards in Australia and New Zealand provide legally enforceable limits
on the level of microorganisms that may be present in certain foods after processing, such as
the end of manufacture or at retail level. A limitation of microbiological standards is that
they do not specifically require any safety measures to be implemented during processing of
food.
End point testing against prescribed microbiological limits does not, in most cases, prevent
food-borne illness because the unsafe food would have been consumed and caused illness by
the time it was tested, or the results of the testing became available. Increasingly it is
recognised that preventive measures such as good hygienic practices and the use of food
safety programs are more effective measures in reducing the burden of food-borne illness in
the community than a reliance on end point testing. Microbiological limits may serve as
effective verification tools for a food safety approach to safe food production.
Pathogens such as L. monocytogenes are found infrequently in foods and testing a small
number of samples does not accurately predict the contamination of a consignment of food to
provide meaningful assurance of food safety or prevent food-borne disease. The usefulness
of testing for compliance against microbiological limits as an effective preventive public
health measure for pathogens, such as Listeria, in food with a short shelf life is questionable.
2.1.3
Additional microbiological limits for cooked crustacea
Standard 1.6.1 includes a number of microbiological standards for cooked crustacea
including limits for a standard plate count, coagulase-positive staphylococci and Salmonella.
Compliance with these existing limits ensures that crustacea are harvested and processed to
the standards expected under good hygienic practice. A good hygienic approach to the
storage and handling of cooked crustacea would also achieve the objective of minimising
post processing contamination and preventing the growth of all organisms, including
L. monocytogenes. These existing standards therefore serve to assure that hygienic practices
are used in the production and processing of cooked crustacea and can be applied
domestically and to imported crustacea.
2.1.4
Conclusion
L. monocytogenes in cooked crustacea, whether produced domestically or imported, presents
a low risk to public health and safety. Compliance with existing standards should ensure that
good hygienic practices are employed during production and handling of this product. A
microbiological limit for L. monocytogenes in cooked crustacea is therefore not justified on
the basis of the risk assessment work undertaken for P239. No further information has been
provided to change this finding. Deletion of the microbiological standards for
L. monocytogenes in cooked crustacea will therefore not adversely affect public health and
safety.
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2.2
Enforcement and compliance
After the Final Assessment of Proposal P263, FSANZ approved a draft variation to Standard
1.6.1 that deleted the standard for L. monocytogenes in cooked crustacea. The absence of a
standard for this pathogen should raise no enforcement and compliance issues in relation to
the microbiological safety of this commodity. Other microbiological standards for cooked
crustacea, relating to good manufacturing and handling, are specified in Standard 1.6.1, as are
the requirements in Chapter 3 - Food Safety Standards, relating to the production of safe and
suitable food. The risk assessment work has shown that there is a very low risk of listeriosis
associated with this commodity and as such no specific microbiological standard for this
pathogen is warranted.
2.2.1
Conclusion
The draft amendment to Standard 1.6.1 (Attachment 1) does not pose any difficulty in
relation to enforcement or compliance.
2.3
Imported foods testing
Australia and New Zealand are members of the WTO and are bound as parties to WTO
agreements. In Australia, an agreement developed by the Council of Australian Governments
(COAG) requires States and Territories to be bound as parties to those WTO agreements to
which the Commonwealth is a signatory. Under the agreement between the Governments of
Australia and New Zealand on Uniform Food Standards, FSANZ is required to ensure that
food standards are consistent with the obligations of both countries as members of the WTO.
Food standards within the Code generally apply equally to both imported and domestically
produced foods, without discrimination. This is consistent with Australia and New Zealand’s
obligations as members of the WTO. It is also consistent with FSANZ’s objectives under
section 10 of its Act, in particular the desirability of an efficient and internationally
competitive food industry and the promotion of consistency between domestic and
international food standards. Food standards can only be established on the basis of a risk
assessment and in this case the public health risk, as based on available evidence, was
estimated to be low.
The risk assessment work undertaken for P239 shows that the public health risk posed by
L. monocytogenes in cooked crustacea is very low and, based on that, it was concluded that a
microbiological limit for this pathogen in cooked crustacea is not justified. The data
supporting the risk assessment finding were for both domestically produced and imported
product. There is no justification, therefore, for the retention of this standard in the Code to
test either imported or domestic product for Listeria. The incidence of Listeria in cooked
prawns in Australia, for both domestic and imported product, has been shown to be very low.
Cooked crustacea are already categorised as a risk food by the Imported Foods Program and
100 % of consignments are referred to AQIS for inspection at a performance-based rate.
Microbiological tests currently include a standard plate count, staphylococcal enterotoxin
(SET), and Salmonella. Compliance with these existing microbiological standards ensures
that cooked crustacea has been produced and handled using good hygienic practices and
provides sufficient assurance of the protection of public health and safety.
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It should be noted that microbiological testing of imported cooked crustacea products
between 1995 and 1999 resulted in a low failure rate with less than 2% of samples failing
(4764 tests were conducted during this period).
2.3.1
Conclusion
There is no justification in retaining a L. monocytogenes standard for cooked crustacea in the
Code on the basis that this would allow AQIS to test this pathogen in imported crustacea.
3.
Regulatory Impact
FSANZ has undertaken a regulatory impact assessment process, which also fulfils the
requirement in New Zealand for an assessment of compliance costs. That process concluded
that an amendment to the Code to delete the microbiological limit for L. monocytogenes in
cooked crustacea was the preferred regulatory option, providing an overall benefit to all
parties.
4.
Conclusion and Statement of Reasons
After conducting a first review of P239, it is concluded that the recommendation made at
Final Assessment, to delete the microbiological limit for L. monocytogenes in cooked
crustacea, is justified.
4.1
Statement of Reasons
The draft variation to Standard 1.6.1, deleting the microbiological limit for L. monocytogenes
in cooked crustacea, is recommended for the following reasons:

the risk assessment work undertaken for P239 shows that L. monocytogenes in cooked
crustacea presents a low risk to public health and safety; and

a stringent microbiological standard requiring an absence of L. monocytogenes in
cooked crustacea cannot be justified on public health and safety grounds given the low
risk presented by this pathogen/commodity combination.
ATTACHMENT
1
Draft variation to Standard 1.6.1 – Microbiological Limits for Foods
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ATTACHMENT 1
DRAFT VARIATION TO THE
AUSTRALIA NEW ZEALAND FOOD STANDARDS CODE
[1]
Standard 1.6.1 of the Australia New Zealand Food Standards Code is varied by –
[1.1]
omitting from the Schedule, under the entry for Cooked crustacea, the entry and
associated microbiological limits for Listeria monocytogenes.
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