An Australian Process that Assesses Country BSE Food Safety Risk.

Background: Bovine spongiform encephalopathy (BSE) is a transmissible, fatal neurodegenerative disease of cattle. Recognised in 1986, the disease causes a spongiform degeneration of the neural network in the brain and spinal cord of infected cattle leading to incoordination, ataxia and ultimately death of the infected animal [1]. The agent causing BSE in cattle is a structurally modified prion protein. The BSE epidemic that started in the United Kingdom (UK) resulted in the destruction of more than 3.3 million cattle in the UK alone [2]. Variant Creutzfeldt-Jacob Disease (vCJD), a fatal neurodegenerative human disease described for the first time in 1996, is putatively linked to the consumption of specified tissues from the carcase of cattle infected with the BSE agent that causes BSE [3]. By June 2014, 184 people have died of vCJD infection and most of these lived in the UK http://www.cjd.ed.ac.uk/documents/worldfigs.pdf. As a result of the worldwide prohibition on processed animal proteins being fed to cattle, BSE is no longer a major threat to food and feed safety provided that appropriate control measures are effectively implemented. This paper discusses Australia’s approach to conducting country assessments to determine the food safety risk posed by the classical form of BSE but does not discuss the atypical forms of BSE, i.e. the H-type BSE and L-type BSE, identified more recently [4,5]. Australia has not recorded a case of BSE. In recognition of Australia’s effective BSE surveillance and control measures it has been assigned by its trading partners and the World Organisation for Animal Health (the OIE) the most favourable BSE risk status. In response to the identification of the linkage between BSE and vCJD in the BSE inquiry report [6], the Australian Government in 2001 introduced measures that prohibited the importation of beef and beef products from all countries that had reported cases of BSE. The Australia New Zealand Food Standards Code was amended in 2002 to ensure that beef and beef products sold in Australia were only derived from animals free of BSE. Some products were exempted from this requirement including: (a) collagen and gelatine sourced from bovine skins and hides; (b) bovine fat or bovine tallow at no more than 300 g/kg in a food product; and (c) dairy products sourced from bovines. Countries without BSE cases and wishing to export beef or beef products to Australia at the time were assessed by Food Standards Australia New Zealand (FSANZ) for country BSE risk status using a method based on the geographical BSE risk assessment methodology [7] between 2001 and 2003. As a result, retorted beef products were permitted for importation into Australia from 27 countries that included Argentina, Brazil, Chile, Croatia, Latvia, Lithuania, Mexico, New Zealand, Sweden, and Vanuatu. In view of the updated scientific information on BSE, the Australian Government announced a revised BSE food safety policy in 2009 that permitted the importation of beef and beef products from any country, providing that the country had been assessed by FSANZ as having appropriate and effective BSE controls in place. Countries wishing to export fresh beef (chilled or frozen) to Australia need to apply to the Australian Department of Agriculture for assessment of a broader range of animal health and quarantine risks. Since the announcement of the revised BSE food safety policy, FSANZ received submissions from 16 countries requesting country BSE food safety assessment and determination of their country’s BSE food safety risk status. This extended abstract describes an Australian process developed and applied by FSANZ for assessing country BSE food safety risk. Aims: To describe the features of a process developed and applied by FSANZ for assessing country BSE food safety risk. Study Design: The Australian process that assesses country BSE food safety risk is comprised of: 1) a food safety risk assessment across the beef supply chain; 2) a framework to assure the quality of the assessment outcomes; and 3) a set of arrangements to deliver transparent risk communication. Place and Duration of Study: FSANZ, Canberra, Australia, between April 2010 and December 2014. Methods: The Australian process to assess country BSE food safety risk was developed in accordance with the 2009 Australian Government’s BSE food safety policy http://www.foodstandards.gov.au/industry/bse/bseimports/documents/BSE%20Policy%2025%20Se ptember2009.pdf, and the principles described in the BSE chapter of the Terrestrial Animal Health Code published by the OIE. http://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_bse.htm. Results: The BSE food safety assessment: The food safety assessment across the beef supply chain for BSE risk is comprised of: (a) a desk-based assessment that evaluates information provided by the applicant country; and (b) an in-country verification assessment that verifies the effectiveness of the key BSE control measures implemented in the applicant country. The deskbased assessment evaluates the applicant country’s response to the Australian Questionnaire to Assess BSE Risk (the Questionnaire), http://www.foodstandards.gov.au/industry/bse/bsequestionnaire/pages/default.aspx, information provided as appendices to the applicant country’s response to the Questionnaire, and any relevant information that is publicly accessible. The latter may include data and information published by the applicant country, relevant statistics and audit reports published by the OIE, the European Commission, the United States of America and others, and articles in relevant scientific journals. In addition to undertaking a desk-based assessment for each applicant country, FSANZ risk assessors conducted in-country inspections of all applicant countries that have been assessed to date, to verify the effectiveness of BSE-related controls. The in-country verification inspection assesses the competent authority’s oversight of BSE control and prevention measures, verifies the effectiveness of BSE related control measures implemented on beef and/or dairy farms, in feed producing establishments, and at slaughtering and rendering establishments in the applicant country. The adequacy of the BSE-related food safety control measures developed by the applicant country and the effectiveness of their implementation are assessed against the following key areas: 1) The likelihood of the introduction and release of the BSE agent through importation of live cattle, bovine commodities and animal feed products; 2) The likely exposure of domestic cattle herds to the BSE agent via potential recycling of the BSE agent within the animal feed system; 3) The specific food safety controls around beef and beef products produced for human consumption; 4) The adequacy of BSE control and prevention related infrastructure including an animal identification and traceability system, and the competent authority’s oversight of BSE prevention and control measures; and 5) BSE notification, laboratory diagnostic and surveillance activities. A detailed BSE food safety assessment report is prepared to describe the BSE food safety controls established by the applicant country and the effectiveness of their implementation. The report recommends a BSE food safety risk category for the applicant country as part of the overall conclusion. This BSE food safety risk category then determines the trading conditions for beef products that may be exported from the applicant country to Australia. Governance and quality assurance: The FSANZ country BSE food safety assessment process is supervised by the Australian BSE Food Safety Assessment Committee comprised of experts in the fields of food safety and risk assessment, animal health, animal and agricultural production systems, international trade, and animal identification and traceability. The assessment report prepared by FSANZ is peer reviewed by food safety and veterinary experts, and comments are also invited from the competent authority of the applicant country. The assessment outcomes including the recommended BSE risk status are reviewed and endorsed by the Australian BSE Food Safety Assessment Committee and subsequently approved by the Chief Executive Officer of FSANZ prior to notification to the applicant country and the Australian Department of Agriculture. The Australian Department of Agriculture establishes the export certification required from the competent authority of the applicant country based on the BSE risk status assigned. Risk communication and transparency: Once a country’s status is finalised, FSANZ communicates the assessment outcome to the applicant country and relevant stakeholders including the OIE. The full country BSE food safety assessment report is subsequently published at http://www.foodstandards.gov.au/industry/bse/bsestatus/Pages/default.aspx. Consistency with established international risk assessment framework: The Australian process to assess country BSE food safety risk is consistent with the risk assessment framework applied by the OIE [8] in determining a country’s BSE risk status for animal health purposes. The OIE framework is comprised of: (1) release assessment; (2) exposure assessment; (3) BSE notification and investigation assessment; (4) BSE diagnosis assessment; and (5) BSE surveillance assessment. The Australian country BSE food safety assessment, based on the above OIE framework, addresses additional elements around food safety systems and controls in the applicant country aimed at preventing the contamination of beef and beef products for human consumption with the BSE agent and their tracing within the human food supply chain. Consequently, slaughterhouse operations, cattle identification and traceability, meat traceability and recall systems in the applicant country are examined for their effectiveness to ensure the safety and traceability of exported products of bovine ori

A Through-chain Analysis of Food Safety Hazards and Control Measures Associated with the Production and Supply of Seed Sprouts for Human Consumption.

Background: Seed sprouts contaminated with pathogenic microorganisms, such as Salmonella spp. and Shiga toxin-producing Escherichia coli (STEC) present an unacceptable health risk to consumers. An outbreak that occurred in Australia during 2005 and 2006 due to the consumption of alfalfa sprouts contaminated with Salmonella Oranienburg resulted in 141 infected cases, and cost an estimated $1.19 million to the Australian community. In Japan in 1996, consumption of radish sprouts contaminated with STEC O157:H7 affected more than 10,000 individuals. The outbreak of E. coli O104:H4 linked to the consumption of fenugreek sprouts that occurred in Europe in 2011 was an unprecedented foodborne outbreak. More than 4,000 individuals were infected by STEC O104:H4. Among them, 908 developed haemorrhagic uraemic syndrome (HUS), and 50 died of STEC infection. This demonstrates the potential food safety risk arising from seed sprouts and that the consequences can be devastating. Food Standards Australia New Zealand (FSANZ) initiated the development of a primary production and processing standard for seed sprouts in 2009 to enhance the safety of seed sprouts produced and sold in Australia. After extensive consultations with the State and Territory food safety regulators, and a thorough investigation of the Australian industry practices in producing seed sprouts for human consumption, a technical paper was prepared to inform the design of potential risk mitigation measures for a national food safety standard on seed sprout production. This technical paper described the Australian seed sprout industry, depicted the steps involved in the production of seed sprouts for human consumption, and provided an analysis of potential food safety hazards that could occur during seed sprout production and processing. A food safety standard for the production and sale of seed sprouts in Australia was finalised in November 2011. This extended abstract describes the key aspects of the technical paper. Aims: To provide technical and scientific information to support risk management decisions aimed at maximizing the safety of seed sprouts produced for human consumption in Australia. Study Design: A through-chain qualitative food safety risk analysis. Place and Duration of Study: FSANZ, Canberra, Australia, between July 2009 and January 2010. Methodology: This through-chain risk analysis was prepared upon a comprehensive review of literature available at the time on: investigations of foodborne outbreaks associated with consumption of seed sprouts; surveys of microbial contamination of seed sprouts; specific publications on crop production, seed harvest, post-harvest processing and storage of seeds; production of seed sprouts; risk assessments on seed sprouts; and regulatory guidelines published by Australian and international food safety regulatory authorities on seed sprouts. Members of the FSANZ project team conducted field studies of sprout production, lucerne crop production, lucerne seed processing, wholesale and retail sale of seed sprouts. A survey was conducted on the variety, volume and value of sprouts produced, source and quantity of seeds used to produce sprouts for human consumption, trend of consumption of seed sprouts in Australia, as well as the size and the location of sprout producers in Australia. Stakeholders were consulted through a FSANZ standard development committee with participants from State and Territory food safety regulators, peak sprout producer industry bodies, seed producers and seed processors, major food retailers, and consumer representatives. The through-chain analysis of food safety hazards associated with the production and processing of seed sprouts was prepared in line with the principles of hazard analysis critical control points (HACCP). Results: Key pathogens of concern: Among the range of biological, chemical and physical food safety hazards that were likely to be associated with seed sprouts produced for human consumption, pathogenic microorganisms represent the highest risk to consumers. Outbreaks associated with the consumption of seed sprouts contaminated with pathogenic microorganisms were seen to be frequent events in developed economies despite food regulatory interventions. The key pathogenic microorganisms of concern were Salmonella spp. and STEC. Salmonella spp. were found to be the causative pathogen almost five times more frequently than STEC. Main varieties of seed sprouts causing foodborne illness: Among the 41 reported outbreaks that occurred worldwide between 1988 and 2007 involving consumption of seed sprouts contaminated with pathogenic microorganisms, alfalfa sprouts represented 68% of the outbreaks, followed by mingbean sprouts (22%), clover sprouts (5%), radish sprouts (2%) and clover sprouts (2%). Source of pathogenic microorganisms: FSANZ divided the production and supply of seed sprouts for human consumption into eleven consecutive steps, starting with seed production in the field and ending with transportation and distribution of seed sprouts to retail establishments. This was to enable a systematic identification of the food safety hazards, sources of the hazards, specific controls that could be applied to control or eliminate food safety hazards, and the associated requirements of food safety management practices including food safety knowledge and food safety skills. Contamination of seeds by pathogenic microorganisms such as Salmonella spp. and STEC can occur during seed production, seed harvest, seed processing, seed storage and transportation. The origin of these pathogenic microorganisms is animal faeces and manure present in the field where the crop is grown. Soil for growing the seed crop, water used for irrigation, and machinery used for crop management including the harvest of seeds, can be contaminated with pathogenic microorganisms and can transfer the contamination to seeds during crop production and seed harvest. Seed processing as a post-harvest step may also contribute to seed contamination. For example, blending different harvest lots of seeds for seed cleaning can spread what was originally a localised contamination into a larger volume of seeds. Rodent, insect and bird activities in seed processing and seed storage establishments can introduce and spread pathogenic microorganisms to seeds. Provided that seeds delivered to sprout production sites are free of pathogenic microorganisms, activities of rodents, insects, and infected workers in seed receipt, storage, sprout production, sprout storage and transportation at sprouting establishment can lead to contamination of seed sprouts by pathogenic microorganisms. So is the use of contaminated water for sprouting. Much of these are also applicable to retail handling and storage of seed sprouts. Investigations into the source of sprout contamination for outbreaks that occurred between 1988 and 2007 found that in almost every case the pathogenic microorganisms causing the outbreaks were present in the seeds used for sprout production. In approximately 20% of the outbreaks, contamination in sprouting establishments was also identified as a likely source of contamination. Identified risk mitigation measures: Based on an analysis of a wide range of possible recommendations aimed at improving the safety of seed sprouts, the though-chain analysis recommended the following good agricultural practices to be implemented in the primary production phase of seeds: · Environment - soil and environment where seeds are grown for the production of seed sprouts as a human food should be suitable. · Inputs - manure, biosolids and other natural fertilisers should only be used for the growth of seed crops when a high level of pathogen reduction has been achieved; equipment (bins, containers, silos, vehicles) and machinery are maintained and used in a manner that minimises and/or avoids contamination of seeds with pathogenic microorganisms. · Protection - grazing animals and wild animals are prevented from entering the field where seeds are grown; and seed crops are protected from contamination by human, animal, domestic, industry and agricultural wastes. · Segregation - seeds produced for the production of sprouts for human consumption are segregated from seeds produced for the production of animal feed and are clearly labelled. The through-chain analysis also recommended the following components to be included in a Food Safety Program that must be effectively implemented in sprout production establishments: · Environment – the sprouting facility (including the seed storage area) should not allow access of rodents, insects, pests or animals; sprouting facility and equipment are effectively cleaned and sanitised to ensure the environment is suitable for producing ready-to-eat foods. · Input – each seed lot is tested for the presence of microbial pathogens of concern and seeds should not be used unless the testing results are negative; solid medium supporting sprout growth and water for sprouting are treated to eliminate pathogenic microorganisms; seeds are disinfected prior to sprouting to eliminate microbial pathogens. · Separation – seed rinsing and microbiological decontamination, seed germination/sprouting, and storage of seed sprouts are physically separated from each other to prevent cross contamination. · Monitoring – implement appropriate sampling/testing programs to regularly monitor microbial pathogens during and at the end of production of seed sprouts. Implementation of food safety controls on farm presents many challenges. One of the main obstacles is the inability to control environmental factors under conventional farming practices. The environment under which seeds are produced for the production of seed sprouts for human consumption should exclude animal grazing and minimise and avoid pest and wildlife interference. The cost involved in growing seeds under these conditions can be prohibitive unless s

Improving the Effectiveness of Food Safety Regulation to Minimise Shiga Toxin-Producing Escherichia coli Contamination in Fermented Meat Products.

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