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