18 December 2002

PROPOSAL P251 - REVIEW OF PROCESSING REQUIREMENTS FOR UNCOOKED COMMINUTED FERMENTED MEAT (UCFM) PRODUCTS

DRAFT ASSESSMENT REPORT

                         Full Report [ pdf 533kb ]

Executive Summary and Statement of Reasons

Executive Summary

The consumption of uncooked comminuted fermented meat (UCFM) products, if contaminated by enterohaemorrhagic Escherichia coli (EHEC), poses a public health risk. The potential severity of such a public health risk is demonstrated by the 1995 Garibaldi outbreak of food poisoning where more than 35 people were hospitalised, 22 children developed haemolytic uraemic syndrome, one young child died, and a number of people suffered permanent adverse health effects.

A microbiological risk assessment, undertaken by FSANZ, concluded that a very low level of EHEC is likely to be present in a small proportion of UCFM products made in Australia. The risk of developing a clinical EHEC infection through consumption of UCFM products is very low for the general population. However, for vulnerable subpopulations, EHEC infection resulting from consumption of EHEC contaminated UCFM products can lead to very severe complications including death.  

A review of the existing standard (that was introduced as an emergency measure in 1996 as clause 9, Standard 1.6.2, Vol. 2 of the Food Standards Code and clause 60A, Standard C1, Vol. 1 of theFood Standards Code) found that:

• a key performance criterion in the existing standard, i.e. that the production process must reduce the number of Escherichia coli organisms by 99.9% or greater, could not be implemented effectively until recently because of the lack of an objective means to determine industry compliance;
• the key performance criterion in the existing standard is not food safety outcome based because it established neither a clear correlation with the initial E. coli load in the ingoing meat ingredients; nor a clear correlation with the end productE. coli specification; and
• the performance criterion is unnecessarily prescriptive.

Based on the findings of the risk assessment and the review of the current standard, an amendment to the existing standard is proposed. The implementation of HACCP based food safety programs for the production of UCFM products is the core component of the proposed regulatory measures.

The Draft Assessment also proposes a minor technical change to the minimum permitted level of E. coliin finished UCFM products specified in Standard 1.6.1 and Standard 1.6.2, Vol. 2 of the Food Standards Code, and clause 60, Standard C1, Vol. 1 of the Food Standards Code.

The Australia New Zealand Food Authority (ANZFA) to Food Standards Australia New Zealand (FSANZ) transitional requirements (1 July 2002) for a proposal at draft assessment stage have been followed and no additional submissions have been received.  

Statement of Reasons

FSANZ recommends a refinement to the existing standard for the following reasons:

• Regulation is required to protect public health and safety from the potentially severe consequences resulting from consumption of EHEC contaminated UCFM products. The proposed amendment to the Food Standards Code is consistent with the section 10 objectives of the Food Standards Australia New Zealand Act 1991.

The risk assessment found that:

• the EHEC infectious dose is low and ingestion of as little as 1 organism could result in severe adverse health outcomes to susceptible individuals;
• a very low level of EHEC (0.15 per 100 grams) is likely to be present in approximately 7.2% of UCFM products made in Australia; and
• young children, the frail elderly, and people suffering from chronic diseases, or with depressed immune system, are more susceptible to the development of complications resulting from EHEC infection than the rest of the population, and children under the age of 6 years are most susceptible.

The proposed regulatory measure is comprehensive and can be effectively implemented by industry, thus minimising the risk of EHEC infection from consumption of UCFM products.

The ANZFA to FSANZ transitional requirements for a proposal at preliminary (initial) stage provide that FSANZ is taken to have made an initial assessment of the Proposal. Any submissions received by ANZFA about a proposal in response to a notice given under section 22 of theAustralia New Zealand Food Authority Act 1991(ANZFA Act), are taken to be submissions made to FSANZ about a proposal in response to a notice under section 14A of the FSANZ Act.

                         Full Report [ pdf 533kb ]