PROPOSAL P251 - REVIEW OF PROCESSING REQUIREMENTS FOR UNCOOKED COMMINUTED FERMENTED MEAT (UCFM) PRODUCTS
10/03
16 July 2003
FINAL ASSESMENT REPORT
Full Report [ pdf 613kb ]
Executive Summary and Statement of Reasons
The consumption of uncooked comminuted fermented meat (UCFM), if contaminated by enterohaemorrhagic Escherichia coli (EHEC), poses a public health risk. The severity of such a health risk was 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 made in Australia. The risk of developing a clinical EHEC infection through consumption of UCFM was estimated to be very low for the general population. However, for the more susceptible subpopulations, EHEC infection resulting from consumption of EHEC contaminated UCFM can lead to very severe complications, including death.
A review of the existing standard (introduced as an emergency measure in 1996 as Clause 9, Standard 1.6.2 of the Australia New Zealand Food Standards Code) found that:
- a key performance criterion in the existing standard, that is the production process must reduce the number of Escherichia coliorganisms by 99.9% (i.e. a 3-log 10 reduction) or greater, could not be implemented effectively until recently because of the lack of an objective means to determine industry compliance;
- the requirement of a 3-log reduction is not consistent with the development of outcome based standards because it does not establish a clear correlation with the initial E. coli load in the ingoing raw meat ingredients; or a correlation with the end product E. coli specification; and
- the performance criterion is unnecessarily prescriptive.
Based on the findings of the risk assessment and the review of the current standard, the implementation of hazard analysis critical control point (HACCP) based food safety programs for UCFM production was proposed as an amendment to Standard 1.6.2.
The Draft Assessment also proposed a minor technical change to the minimum permitted level ofE. coliin finished UCFM specified in Standard 1.6.1 and Standard 1.6.2 of theFood Standards Code(Code). The change removed the confusion of twoE. colilimits being specified for UCFM in the Code.
All of the submissions received at Draft Assessment supported the introduction of HACCP based food safety programs for UCFM production, to replace the key performance criterion introduced previously, i.e. the 99.9% or greater reduction of E. coli organisms.
The proposed end product E. coli specification for UCFM was also supported.
A number of submissions opposed the “test and hold” measure proposed in the Draft Assessment as an alternative regulatory measure to HACCP based food safety programs. The “test and hold” refers to “microbiological end product testing for each production lot and holding the lots pending satisfactory compliance of the results with theE. colilimit specified in Standard 1.6.1 of the Code”. This measure was considered detrimental to the consistent uptake of preventative food safety measures embodied in the food safety program.
A number of submissions opposed a proposed maximumE. colilimit of 20 per gram in the ingoing raw meat ingredients, and considered this requirement as highly prescriptive and posing considerable uncertainty in implementation. It was argued that the ingoing raw meat would be monitored forE. colias a part of the food safety program and therefore the management of this potential hazard was covered elsewhere.
A number of submissions proposed mechanisms for effective implementation of the amended standard, more specifically:
- the need for an independent Expert Advisory Panel to assist the assessment of HACCP based food safety programs for their adequacy in meeting the food safety outcome required in the amended standard; and
- the need for a list of criteria that can be used to measure the competency of an individual’s skill and knowledge on food safety principles and UCFM production.
Resulting from the public consultation at Draft Assessment, a number of minor changes were made to the preferred regulatory option at the Draft Assessment including:
- a refined definition for UCFM which ensures that all heat-treated comminuted fermented meat will be categorised as UCFM;
- a refinement of the phrase associated with the “starter culture” which clarifies that “previously fermented meat or fermenting meat” can NOT be used in UCFM production;
- a whole of food chain approach which requires manufacturers to demonstrate through the food safety programs that their production processes can handle the variations ofE. colicontamination in the raw meat ingredients, so as to ensure the end products meet theE. colispecification;
- “E. coli” testing for raw meat ingredients and products in UCFM production is mandated as a part of the validation or verification process of the HACCP based food safety programs; and
- the use of direct-contact pH probes or meters is proposed as additional permissible methods for determining UCFM pH to reflect industry’s current practice.
FSANZ recommends a refinement to the existing standard for UCFM production 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 Code is consistent with the Section 10 objectives of the Food Standards Australia New Zealand Act 1991(the Act).
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 in susceptible individuals;
- a very low level of EHEC (0.15 per 100 grams) is likely to be present in approximately 7.2% of UCFM 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 amendments to Standard 1.6.1 and Standard 1.6.2 proposed in this report are justified by the objectives of the Act in that they provide the minimum effective measure to protect public health and safety. Effective implementation of the amended standard by industry and enforcement authorities will further reduce the risk of EHEC infection from consumption of UCFM.
Full Report [ pdf 613kb ]