Improving the Effectiveness of Food Safety Regulation to Minimise Shiga Toxin-Producing Escherichia coli Contamination in Fermented Meat Products.
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2011-10
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Abstract
Background: The consumption of uncooked comminuted fermented meat (UCFM)
contaminated with Shiga toxin-producing Escherichia coli (STEC) poses a public health
risk. The severity of such a health risk can be demonstrated by an outbreak that occurred
in South Australia in 1995, where the consumption of Mettwurst contaminated with E. coli
O111:NM resulted in the death of one child, haemolytic uraemic syndrome in twenty-two
children, and permanent adverse health effects in at least six children and one 60 years old
consumer. The Australian meat industry incurred an estimated loss of more than $A 400
million. In response to the outbreak, the Australian Government introduced an emergency
measure in 1996 to ensure the safety of UCFM products.
A key performance criterion prescribed in the emergency measure – that the UCFM
production process must reduce the number of E. coli organisms by 99.9% (a 3-log10
reduction) or greater – could not be effectively implemented by the industry or enforced by
the health authorities. This was largely due to a lack of an objective means to determine
compliance.
Food Standards Australia New Zealand (FSANZ) undertook a review of the emergency
measure between 2001 and 2003. This paper describes the risk analysis FSANZ
undertook to improve the effectiveness of food safety regulation in this area.
Aims: To develop a set of outcome-based regulatory measures to replace a prescriptive
requirement of a 3-log10 reduction of E. coli, designed to minimise STEC contamination in
UCFM.
Study design: Food safety risk analysis. Place and Duration of Study: FSANZ, Canberra, Australia, between November 2001 and
July 2003.
Methodology: The ability of Australian UCFM manufacturers to effectively implement the
processing requirement of a 3-log10 reduction in E. coli concentration was assessed using
an Excel® based predictive model developed by the University of Tasmania that estimates
the inactivation of generic E. coli during the UCFM manufacturing process. Temperature
and time parameters of fermentation and maturation applied to the production of UCFM for
sale in Australia were collected during 2002 and 2003 and applied to the predictive model.
Outcome-based regulatory measures to minimise STEC contamination in UCFM were
developed based on (1) the conclusions of a quantitative microbiological risk assessment
(based on point estimates), (2) close consultation with the Australian UCFM sector and
food regulation enforcement authorities, and (3) a regulatory impact assessment.
Tools to facilitate effective implementation of the outcome-based regulatory measures
were developed between 2004 and 2005 with the assistance of a national expert advisory
panel on UCFM safety. This panel was comprised of food safety and technical experts
from the Australian smallgoods sector and state enforcement authorities.
Results: Assessment of 96 production protocols used by Australian UCFM manufacturers
in April 2002 using the predictive E. coli inactivation model showed that only 19% of the
protocols were capable of achieving greater than or equal to a 3-log10 reduction of E. coli.
Up to 51% of the protocols assessed achieved less than 2-log10 reduction of E. coli. The
remaining protocols were capable of achieving a maximum reduction of E. coli between 2
and less than 3-log10. Among the 96 production protocols assessed, the highest level of
inactivation of E. coli potentially achievable was 9.08 log10 and the lowest was 0.13 log10. A
relatively long period of maturation and a relatively high temperature during the maturation
phase contributed to the bulk of E. coli inactivation achieved during the manufacture of
UCFM.
Production protocols resubmitted from UCFM manufacturers in the state of Victoria,
following the initial assessment, showed a steady improvement of capability in achieving
greater than or equal to a 3-log10 reduction of E. coli. This was achieved by making
adjustments to the time and temperature parameters of the production processes. Despite
these adjustments, 34% of the resubmitted protocols failed to meet the requirement of
reduction of E. coli by 3-log10.
Consultations with technical experts of the Australian smallgoods sector and enforcement
authorities identified several additional issues with the 3-log10 reduction requirement.
These included:
• the rationale behind of the need for a 3-log10 reduction of E. coli when safe UCFM
products can be produced using deep muscle meat and when subject to close
adherence to operational hygiene, knowing the fact that the extent of STEC
contamination in deep muscle meat is very low;
• doubts on the adequacy of a 3-log10 reduction of E. coli when raw ingredients used
to produce UCFM contain excessively high numbers of STEC;
• enforcement authorities did not have the tools to verify whether manufacturers of
UCFM had achieved a 3-log10 reduction of E. coli; and
• the science underpinning the mandatory requirement of a 3-log10 reduction of E.
coli in manufacturing UCFM was difficult to comprehend by members of the industry, let alone their ability to demonstrate compliance against the requirement.
A microbiological risk assessment was undertaken by FSANZ to provide a scientific basis
for the identification and development of effective outcome-based regulatory measures to
minimise STEC contamination in UCFM products. The main conclusions of the risk
assessment were that:
• the ingestion of as few as 1 STEC could lead to severe adverse health
consequences in susceptible individuals;
• children under the age of 6 are more likely to develop severe complications from
STEC infections;
• based on the available data at the time, it was estimated that a mean of 0.15
STEC/100 g was present in approximately 7.2% of the UCFM manufactured in
Australia; and
• under this level of STEC contamination, it was estimated that the likelihood of
encountering 1 STEC organism by UCFM consumers under the age of 6 years old
would be approximately 1 in 174 UCFM meals. If UCFM was produced under
minimum (time and temperature) processing conditions, this likelihood would shift
to approximately 1 in 3 UCFM meals.
The above findings of the risk assessment established the basis for further regulatory
interventions in UCFM production. The implementation of hazard analysis critical control
point (HACCP) based food safety programs, together with a number of specific
requirements, was identified as the preferred option to replace the prescriptive processing
requirement of a 3-log10 reduction of E. coli. This risk management decision took into
consideration of the issues identified during the consultations with the Australian
smallgoods sector and enforcement authorities, and the factors of:
• a mandatory requirement for having HACCP based food safety programs
developed and implemented by the UCFM sector would impose minimal
compliance costs because HACCP-based food safety systems have been
introduced into the Australian UCFM sector on a voluntary basis since 1998; and
• the policy of the Council of Australian Governments requires national food
standards to be outcome based.
Together with the requirement of having HACCP based food safety programs
implemented, the outcome-based regulatory measures specified validation and verification
procedures to ensure that the number of E. coli in the final product complies with limits
specified for UCFM in Standard 1.6.1 of the Australian and New Zealand Food Standards
Code (n=5, c=1, m=3.6, M=9.2). UCFM manufacturers were also required to provide
evidence to demonstrate that their production processes are capable of handling the
variations in the level of E. coli contamination in the ingredients. The latter requirement
puts UCFM manufacturers in charge of product safety by allowing the flexibility in raw
material selection. In addition, it requires that appropriate adjustments in manufacturing
parameters be made to cope with the extent of fluctuation of E. coli contamination in the
raw materials, to ensure UCFM safety.
To assist the UCFM sector to implement HACCP based food safety programs, a Protocol
for Assessing HACCP Based Food Safety Programs in the UCFM Sector (the protocol) has
been developed by FSANZ in association with experts in manufacturing smallgoods and
enforcing food safety regulations. The protocol has been adopted by the state enforcement
authorities for assessing UCFM manufacturers’ compliance against the requirement of implementation of HACCP based food safety programs. To raise the overall level of skills
and knowledge on food safety in the UCFM sector, a set of Competency Criteria for UCFM
Manufacturers on food safety skills and knowledge has been developed and incorporated
into an industry training package. The package was developed jointly by FSANZ, experts in
manufacturing smallgoods and enforcing food safety regulations, and the National Meat
Industry Training Advisory Council. It targets those who intend to enter the UCFM
manufacturing sector. This training package has been made available nationwide through
technical and further education institutes.
Conclusion: Careful considerations ought to be given to prescriptive requirements
developed for food safety regulation to ensure that they are practical and can be effectively
implemented by the food industry and verified by enforcement authorities.
Critical production parameters, such as time and temperature, applied in food production,
and appropriate tools such as predictive models for pathogen inactivation in food
production can facilitate an objective assessment of processing requirements to ensure
food safety.
Implementation of outcome based food safety requirements, if supported by appropriate
implementation tools, can lead to enhanced effectiveness in managing food safety.
Acknowledgements and additional information: The authors wish to acknowledge the
support and assistance provided to this study by the following organisations and
individuals: Ms. Amanda Hill and Dr. Marion Healy of FSANZ, the Australian Meat
Standards Committee, the Australian Meat Industry Council, Meat and Livestock Australia
Limited, Dr. Patricia Desmarchelier and Mr. Paul Vanderlinde of Food Science Australia,
members of the Australia New Zealand Food Authority’s UCFM Expert Advisory Panel, and
members of the Australian National Expert Advisory Panel on UCFM Safety.
The complete report of this risk analysis can be found on
https://www.foodstandards.gov.au/_srcfiles/P251%20UCFM%20FAR.pdf.
Two implementation tools developed as a follow up to this study were not published on the
web site of FSANZ, and are available upon request.
Description
Keywords
Uncooked comminuted fermented meat, Shiga-toxin producing Escherichia coli, log reduction of E. coli, HACCP
Citation
Hong Jin, Craig Duncan, Crerar Scott. Improving the Effectiveness of Food Safety Regulation to Minimise Shiga Toxin-Producing Escherichia coli Contamination in Fermented Meat Products. European Journal of Nutrition & Food Safety. 2011 Oct-Dec; 1(3): 145-148.