Food Safety Risk Assessment of NSW Food Safety Schemes
Transcription
Food Safety Risk Assessment of NSW Food Safety Schemes
Food Safety Risk Assessment of NSW Food Safety Schemes March 2009 NSW/FA/FI039/1212 Note: Parts of this document were revised in December 2012 following peer review. Contents Executive summary ........................................................................................................... 6 Introduction.................................................................................................................... 12 Dairy food safety scheme ................................................................................................ 16 Meat food safety scheme ................................................................................................. 39 Plant products food safety scheme ................................................................................... 67 Seafood safety scheme .................................................................................................... 85 Vulnerable persons food safety scheme .......................................................................... 105 Egg food safety scheme ................................................................................................ 120 Risk assessment – Conclusion ........................................................................................ 137 Appendix 1: Microbiological and chemical hazards of concern .......................................... 138 Appendix 2: Australian food recalls (2004–2008) ........................................................... 161 Appendix 3: Australian foodborne illness outbreaks (1995–2008) ..................................... 164 Food Safety Scheme Risk Assessment Page 1 of 189 Tables Dairy food safety scheme Table 1 – Pathogenic microorganisms detected in raw milk................................................ 17 Table 2 – Microbiological hazards in dairy products ........................................................... 18 Table 3 – Consumption of dairy products .......................................................................... 21 Table 4 – Summary of foodborne illness outbreaks attributed to dairy products and foods including dairy as an ingredient........................................................................................ 23 Table 5 – NZFSA risk profile outcomes examining hazards in dairy products ....................... 28 Table 6 – Risk ranking for dairy products contaminated with Listeria monocytogenes .......... 29 Table 7 – Risk ranking of dairy products ........................................................................... 30 Table 8 – Microbiological hazards in livestock and poultry .................................................. 41 Table 9 – Consumption of meat and meat products in Australia ......................................... 45 Table 10 – Consumption of processed meats in Australia ................................................... 45 Table 11 – Summary of foodborne illness outbreaks attributed to all meat, meat products and meat included as an ingredient (1995–2008) (including poultry, game meat and processed meat products) ............................................................................................................... 46 Table 12 – Prevalence of microbiological hazards in Australian beef and sheep meat........... 48 Table 13 – Prevalence of microbiological hazards on retail chicken meat in NSW (2005–06) 50 Table 14 – Foodborne illness outbreaks of listeriosis from processed meats ........................ 52 Table 15 – Prevalence of Listeria monocytogenes in processed meats ................................ 52 Table 16 – NZFSA risk profile outcomes examining hazards in meat ................................... 54 Table 17 – Risk ranking for meat and meat products ......................................................... 55 Table 18 – Risk ranking for processed poultry meat products ............................................. 57 Table 19 – NZFSA risk profile outcomes examining hazards in poultry meat ........................ 57 Table 20 – NZFSA risk profile outcomes examining hazards in processed meats .................. 60 Table 21 – Risk ranking for processed meat products ........................................................ 61 Table 22 – Risk ranking for L. monocytogenes-contaminated processed meats ................... 62 Table 23 – Microbiological hazards associated with plant products ..................................... 67 Table 24 – Consumption of fruits and vegetables in Australia ............................................. 71 Table 25 – Summary of foodborne illness outbreaks attributed to plant products ................ 74 Table 26 – Risk ranking for plant products contaminated with Listeria monocytogenes ........ 78 Table 27 – Summary of international hazard identification studies for seafood .................... 85 Table 28 – Hazards in seafood and seafood products ........................................................ 86 Table 29 – Production volumes for seafood in Australia and NSW 2006–07 ......................... 88 Table 30 – Consumption of fish and seafood products in Australia ..................................... 90 Table 31 – Failure rate for imported seafood products (1998 – 2003) ................................. 90 Table 32 – Summary of Australian seafood testing results ................................................. 91 Table 33 – Summary of high mercury levels in NSW seafood ............................................. 91 Table 34 – Prevalence of L. monocytogenes in UK retail smoked fish ................................. 92 Table 35 – Summary of foodborne illness outbreaks attributed to seafood .......................... 94 Table 36 – Risk ranking for seafood products contaminated with Listeria monocytogenes .... 99 Table 37 – Seafood consumption required to reach reference doses for methylmercury .... 101 Table 38 – Summary of foodborne illness outbreaks attributed to food served to vulnerable persons ........................................................................................................................ 109 Food Safety Scheme Risk Assessment Page 2 of 189 Table 39 – Institutional foodborne illness outbreaks as a percentage of all outbreaks ........ 110 Table 40 – Relative susceptibility to listeriosis for different sub-groups ............................. 113 Table 41 – Estimated cases of listeriosis for vulnerable population sub-groups for each food category, based on US data ........................................................................................... 114 Table 42 – Hazards in the production of shell eggs and egg products ............................... 121 Table 43 – Prevalence of chemical residues in eggs ........................................................ 123 Table 44 – Prevalence of Salmonella in Australian eggs ................................................... 125 Table 45 – Consumption of eggs and egg products in Australia ........................................ 125 Table 46 – Summary of foodborne illness outbreaks attributed to eggs, egg products and eggs used as an ingredient ............................................................................................ 126 Table 47 – Risk ranking for type and use of eggs ............................................................ 129 Table 48 – Top Salmonella serovars from major sources ................................................. 140 Table 49 – Characteristics of Salmonella ......................................................................... 140 Table 50 – Characteristics of Campylobacter ................................................................... 141 Table 51 – Characteristics of Staphylococcus aureus ....................................................... 142 Table 52 – Characteristics of Clostridium perfringens ....................................................... 143 Table 53 – Characteristics of Bacillus cereus ................................................................... 144 Table 54 – Characteristics of Listeria monocytogenes ...................................................... 146 Table 55 – Characteristics of Vibrio parahaemolyticus...................................................... 148 Table 56 – Characteristics of Shigella spp. ...................................................................... 149 Table 57 – Characteristics of pathogenic Escherichia coli ................................................. 151 Table 58 – Characteristics of Clostridium botulinum......................................................... 152 Table 59 – Characteristics of Yersinia enterocolitica......................................................... 153 Table 60 – Important Aspergillus, Fusarium and Penicillium species and their mycotoxins . 158 Table 61 – Recalls of dairy products between 2004 and 2008 .......................................... 161 Table 62 – Recalls of meat products between 2004 and 2008 .......................................... 162 Table 63 – Recalls of plant products between 2004 and 2008 .......................................... 163 Table 64 – Recalls of seafood products between 2004 and 2008 ...................................... 163 Table 65 – Foodborne illness outbreaks attributed to milk, dairy products and dairy products used as an ingredient .................................................................................................... 165 Table 66 – Foodborne illness outbreaks attributed to meat, meat products and meat products used as an ingredient .................................................................................................... 166 Table 67 – Foodborne illness outbreaks attributed to plant products ................................ 174 Table 68 – Foodborne illness outbreaks attributed fish and seafood products ................... 175 Table 69 – Foodborne illness outbreaks attributed to foods served to vulnerable persons .. 182 Table 70 – Foodborne illness outbreaks attributed to eggs, egg products and eggs used as an ingredient ..................................................................................................................... 185 Food Safety Scheme Risk Assessment Page 3 of 189 Abbreviations aw Water activity ABARE Australian Bureau of Agricultural and Resource Economics ABS Australian Bureau of Statistics ACMF Australian Chicken Meat Federation ACMSF Advisory Committee on the Microbiological Safety of Food (UK) AECL Australian Egg Corporation Limited ANZDAC Australia New Zealand Dairy Authorities Committee (formerly ADASC) AMRA Australian Milk Residue Analysis Survey APL Australian Pork Limited APVMA Australian Pesticide and Veterinary Medicines Authority ASP Amnesic Shellfish Poisoning ASQAP Australian Shellfish Quality Assurance Program ATDS Australian Total Diet Survey/Study APVMA Australian Pesticides and Veterinary Medicines Authority AQIS Australian Quarantine and Inspection Service BSE Bovine Spongiform Encephalopathy BTEC Brucellosis and Tuberculosis Eradication Campaign CAC Codex Alimentarius Commission cfu Colony forming unit CFR Code of Federal Regulation (US) CJD Creutzfeldt-Jakob Disease DAFF Department of Agriculture Fisheries and Forestry (Australian Government) (formerly AFFA) DFSV Dairy Food Safety Victoria DSP Diarrhoetic Shellfish Poisoning EFSA European Food Safety Agency EHEC Enterohaemorrhagic E. coli ERL Extraneous Residue Limit EU European Union FAO Food and Agricultural Organization of the United Nations FDA Food and Drug Administration (US) FRDC Fisheries Research and Development Corporation FRSC Food Regulation Standing Committee FSA Food Science Australia FSAI Food Safety Authority of Ireland FSANZ Food Standards Australia New Zealand (formerly ANZFA) FSIS Food Safety and Inspection Service (US) GAP Good Agricultural Practices GBR Geographical BSE Risk GHP Good Hygienic Practices GMP Good Manufacturing Practices Food Safety Scheme Risk Assessment Page 4 of 189 HACCP Hazard Analysis Critical Control Point HAV Hepatitis A virus HTST High Temperature Short Time pasteurisation HUS Haemolytic Uremic Syndrome ICMSF International Commission on Microbiological Specifications for Foods JECFA Joint FAO/WHO Expert Committee on Food Additives KP Kanagawa phenomenon MAP Modified atmosphere packaging MeHg Methylmercury ML Maximum Level MLA Meat & Livestock Australia MMWR Morbidity and Mortality Weekly Report MRL Maximum Residue Limit NARM National Antibacterial Residue Minimisation program NEPSS National Enteric Pathogen Surveillance Scheme NGSP National Granuloma Submission Program NRS National Residue Survey NZFSA New Zealand Food Safety Authority OC Organochlorine OP Organophosphate PHLS Public Health Laboratory Service, UK PIRSA Primary Industries and Resources South Australia PISC Primary Industries Standing Committee PSP Paralytic Shellfish Poisoning PTWI Provisional Tolerable Weekly Intake REPFEDS Refrigerated processed foods of extended durability RIRDC Rural Industries Research and Development Corporation RIS Regulatory Impact Statement RTE Ready-to-eat SARDI South Australian Research and Development Institute SSOP Sanitation Standard Operating Procedures STEC Shiga toxigenic E. coli SWG Sector Working Groups TFAP Tuberculosis freedom assurance program TVC Total Viable Count UCFM Uncooked comminuted fermented meats UHT Ultra Heat Treated USDA US Department of Agriculture WHO World Health Organization YMT Yolk Mean Time Food Safety Scheme Risk Assessment Page 5 of 189 Executive summary The NSW Food Regulation 2004 contains food safety schemes that outline the regulatory requirements for dairy, meat, plant products, seafood businesses and businesses serving food to vulnerable persons in NSW. A draft egg food safety scheme is currently being finalised for inclusion in the Regulation. The regulatory requirements in the food safety schemes have been introduced over a number of years, either by the NSW Food Authority or its predecessor organisation SafeFood Production NSW. Dairy and meat food safety schemes were carried over from previous legislation. Individual risk assessments were carried out prior to the introduction of both the seafood and plant products food safety schemes. The development of the vulnerable persons food safety scheme occurred following the introduction of Standard 3.3.1 – Food Safety Programs for Food Service to Vulnerable Populations of the Australia New Zealand Food Standards Code (Food Standards Code). In respect to the egg food safety scheme, the NSW Food Authority conducted a risk assessment prior to developing requirements for the scheme. Within each sector covered by the food safety schemes there are a wide variety of hazards that may potentially be present and cause illness in the consumer. The degree of illnesses caused by these hazards can range from mild illness through to severe and life threatening disease. In general, it is the microbiological hazards associated with foods that are considered more significant, as chemical and physical hazards are rarely detected in food. This risk assessment document summarises the known information from previous risk assessments, risk profiles and hazard assessments, and includes new or updated information where it is available and applicable to food businesses in NSW. Dairy food safety scheme In 2006–2007 there were 684 million litres of milk sold in NSW and ACT, with the average person consuming in excess of 100 L of pasteurised milk each year. A wide variety of bacteria may be present in raw milk with the microbial status of milk being influenced by animal health, the farm environment and production methods. Pasteurisation was successfully introduced to eliminate tuberculosis and brucellosis from milk and nowadays the main microbiological hazards associated with milk and dairy products include Salmonella, Listeria monocytogenes, pathogenic Escherichia coli, Staphylococcus aureus, Campylobacter spp., Yersinia enterocolitica and Cronobacter sakazakii. Between 1995 and 2008 there were fourteen Australian outbreaks attributed to dairy products, none occurring in NSW. Nine of these outbreaks were associated with consumption of unpasteurised milk. Internationally, foodborne outbreaks associated with dairy products have been attributed to the use of unpasteurised milk, contaminated non-dairy ingredients, faulty pasteurisation process and poor hygiene. Controlling the safety of milk and dairy products relies on using raw materials (milk and non-dairy ingredients) of good quality, ensuring correct formulation, effective processing, prevention of recontamination and maintenance of temperature throughout the cold chain. Dairy products identified as high risk include unpasteurised milk, soft cheese, dairy desserts, fresh cheeses and dairy dips, as these products may support the growth of pathogenic microorganisms. Two critical steps in controlling pathogens in milk and dairy products are effective pasteurisation, followed by good manufacturing practices to ensure postFood Safety Scheme Risk Assessment Page 6 of 189 pasteurisation contamination does not occur. Food safety programs targeting these controls have been an effective mechanism for controlling microbial hazards in milk and dairy products. There are several potential sources of chemical contamination associated with milk production including agricultural and veterinary chemicals, environmental contaminants and chemicals from animal feed. The implementation of on-farm food safety programs has managed these risks, and the risk is considered low as surveys of dairy products have not detected significant levels of chemicals in Australian milk and dairy products. Meat food safety scheme It has been estimated that Australians each consume 38.2 kg of beef and veal, 11.4 kg of lamb, 2.7 kg of mutton and 14.4 kg of bacon and ham products each year. Various microbiological hazards are associated with different types of meats, with Salmonella, pathogenic E. coli, Clostridium perfringens, Campylobacter jejuni and the parasite Toxoplasma gondii associated with beef and sheepmeat, while the primary pathogen of concern in pigmeat is Yersinia enterocolitica. Livestock and poultry can serve as a reservoir for pathogenic microorganisms and within the abattoir environment these pathogens can be transferred from the gut to the external surfaces of the carcase and contaminate equipment and workers. Currently the risk associated with red meat is considered low, due to the control measures implemented by the meat industry, such as the Australian Standards for the hygienic production of meat and game meat. However, cross contamination of ready-to-eat (RTE) foods by raw meat is considered a potential issue of concern. It has been estimated that if the cross contamination rate of Salmonella increased from 1% to 10% there would be an extra 5000 cases of foodborne illness, while an increase to 50% would result in more than 29,000 cases of salmonellosis across Australia each year. Poultry is the most widely consumed meat in Australia, with each person consuming 39.5kg of poultry each year. The primary hazards of concern in poultry meat are Salmonella and Campylobacter spp. Contamination of poultry can occur on farm through breeding stock, contaminated water, litter, insects, rodents, wild birds and farm workers. Surveys have identified poultry meat as a significant source of foodborne illness, with 46 confirmed outbreaks and 1170 cases of illness between 1995 and 2002. Due to significant under-reporting, it is estimated that cases of foodborne illness due to processed chicken products may be as high as 79,000 cases per year. A through chain approach is the preferred option to reduce contamination of poultry meat, with estimates that this could reduce levels of poultry-related foodborne illnesses by between 74% and 93% each year. Processed meat products have also been identified as high risk, with the pathogens of concern including pathogenic E. coli, Salmonella and L. monocytogenes. There have been a large number of recalls of processed meats due to L. monocytogenes, and a significant number of foodborne illness outbreaks. Between 1991 and 2000, 323 cases of illness and one death were attributed to consumption of processed meats with a total cost to the community estimated to be $77 million. Controlling pathogens in processed meats include effective cooking, curing or fermentation with starter culture, and implementation of good hygienic practices (GHP) to limit the potential for post-processing contamination with L. monocytogenes. Food safety programs have been widely implemented in the Food Safety Scheme Risk Assessment Page 7 of 189 processed meat sector to ensure control measures are in place. However, it was estimated that if these programs are not complied with, and poorly controlled or unreliable processing was allowed to occur in the production of uncooked comminuted fermented meats, this could lead to a significant increase in risk, with estimates the number of foodborne illness cases in Australia due to pathogenic E. coli could be up to 604 cases per year. Plant products food safety scheme Previous risk assessment work conducted on the risk associated with plant products found that fresh cut fruit and vegetables, seed spouts, vegetables in oil and unpasteurised juice present a high risk. This was due to a history of foodborne illness outbreaks in Australia, mainly due to Salmonella, in addition to a number of outbreaks overseas. Annual NSW consumption of these products has been estimated as being 11,000 tonnes of fresh cut vegetables, 150 tonnes of fresh cut fruits, 2600 tonnes of seed sprouts, 1000 tonnes of vegetables in oil products, and 100,000 L of unpasteurised juice. Surveys of plant products have shown the potential for these high risk plant products to be contaminated with L. monocytogenes, Aeromonas spp., B. cereus and Salmonella. Contamination of fresh cut fruit and vegetables can occur during growth, harvest or processing with the main pathogens of concern being L. monocytogenes in general, and C. botulinum for modified atmosphere packaged product. These products are considered high risk when they are consumed raw. Seed sprouts can become contaminated with B. cereus, Salmonella and pathogenic E. coli during growth and harvest of the seeds and also during the sprouting process, which provides a near perfect environment for the growth of microorganisms. The oxygen reduced environment provided by vegetables immersed in oil allows for the growth of anaerobic microorganisms including C. botulinum, the cause of botulism. To reduce the risk, the vegetables or fruits are usually cooked and acidified prior to placement in oil. Unpasteurised fruit juices may become contaminated during the juicing process, either due to contamination on the exterior of the fruit or the use of damaged and mouldy fruit. Because the juice is not heat treated, any pathogenic microorganisms present are able to survive, and acid tolerant strains of pathogenic E. coli and Salmonella may grow. Seafood safety scheme Annual consumption of seafood has been estimated at approximately 15.1 kg per person. The hazards associated with seafood vary depending on the type of seafood and processing methods employed. Shellfish, particularly oysters, as filter feeders can accumulate contaminants from the growing environment. The hazards of concern for shellfish include pathogenic bacteria and viruses, algal toxins and chemical contaminant from the growing environment. Viral contamination of shellfish is recognised as the highest risk for all seafood and is effectively managed by the implementation of shellfish safety programs that manage the waterway and harvesting of the shellfish. Algal toxins in shellfish are generally considered low risk where harvest management programs manage the risk. Where no programs are in place, the risk associated with algal Food Safety Scheme Risk Assessment Page 8 of 189 toxins increases to medium. Severe illness has been associated with the consumption of oysters contaminated with V. vulnificus. Wild caught prawns particularly those caught in estuarine waters are susceptible to contamination from the environment, such as naturally occurring Vibrio spp. present in the waterway. Prawns treated with metabisulphite may present a problem to consumers who suffer from asthma-related conditions. The on-board cooking and cooling of prawns also has the potential to introduce bacterial contamination when water from the waterway is used to cool the prawns. Hazards associated with wild caught finfish include ciguatera and histamine, depending on the type of fish caught. Ciguatera poisoning is generally regarded as medium risk, with most illnesses occurring with fish caught near tropical reefs. Histamine poisoning is usually associated with certain fish such as tuna, swordfish, mahi mahi and blue grenadier and can be controlled by effective temperature control throughout the supply chain. If the fish are to be consumed raw, hazards such as parasites and Vibrio spp. become significant. Mercury in finfish presents a risk to pregnant women or women planning to become pregnant. Because mercury is naturally present in the marine environment, management strategies have relied on education of the consumer, in particular advising pregnant women to avoid consuming large predatory fish which are known to contain higher levels of mercury. Processed, RTE seafood products (including smoked seafood) can support the growth of L. monocytogenes, however contamination is thought to occur during the handling and packaging of the finished product. Strict hygiene and sanitation programs can reduce the likelihood of contamination. The packaging of smoked seafood under modified atmosphere packaging may allow the growth of C. botulinum. While botulism poisoning associated these products is rare, the illness is severe and is considered a medium risk. Vulnerable persons food safety scheme Certain population sub-groups are more at risk of foodborne illness or can develop more severe conditions due to foodborne illness when compared to the general population. The degree of vulnerability depends on the susceptibility of the individual and the pathogenicity of the pathogenic microorganism. In general terms, the vulnerable population group includes children under five years of age, people over 65 years old, pregnant women and persons with depressed immunity. It is estimated that the number of meals served to vulnerable persons in NSW facilities such as hospitals, aged-care facilities, hospices, day care establishments and childcare centres is approximately 133 million meals per year. It is estimated that up to one million meals per year served at these facilities may be contaminated with a foodborne pathogen. Since 1995 there have been 65 foodborne illness outbreaks in Australian aged-care facilities, childcare centres and hospitals with 758 illnesses and 75 fatalities. The pathogens implicated have included Salmonella, C. perfringens, L. monocytogenes and Campylobacter. The prevalence of foodborne-related illness and deaths in the elderly living in nursing homes is far greater than the baseline level of illness in general population, while children appear more at risk to Salmonella due high salmonellosis rate in children seen both in Australia and overseas. The major hazard of concern to vulnerable persons is L. monocytogenes, with some sub-groups within the vulnerable population being 100 times more susceptible to listeriosis than the general population. Other hazards of concern include infants Food Safety Scheme Risk Assessment Page 9 of 189 exposed to C. botulinum through consumption of contaminated honey, neonatal infants consuming Cronobacter sakazakii (formerly Enterobacter sakazakii) contaminated infant formula and individuals with liver dysfunction exposed to Vibrio vulnificus via raw oysters. Other organisms that may result in more severe illness in vulnerable sub-groups include pathogenic Enterohaemorragic E. coli, S. aureus and C. perfringens. When assessing the risk associated with foods, it is important to consider food preparation and hazardous scenarios. Businesses catering to vulnerable persons need to consider the susceptibility of their consumers when designing menus and sourcing, preparing and serving foods. Under the Food Standards Code, these establishments are required to implement a food safety program including, substitution of high risk foods with lower alternatives; effective cleaning and sanitation of fruits and vegetables to be consumed raw; limiting the storage of reconstituted infant formula; minimising storage times/temperatures for RTE foods; ensuring foods are cooked properly and effective cleaning and sanitation of equipment. Egg food safety scheme (draft) The average Australian consumes approximately 137 eggs per year, equating to over 800 million eggs being consumed in NSW each year. The primary hazard of concern is Salmonella, in particular Salmonella Typhimurium which may contaminate the egg shell through environmental contamination and through contact with bird faeces. Overseas foodborne illness outbreaks attributed to eggs have been predominantly due to Salmonella Enteritidis however, Australian layer flocks remain free of Salmonella Enteritidis. While Salmonella may be present in the farm environment, surveys have found the prevalence of Salmonella on shell eggs to be very low. However, eggs and egg products can also become contaminated during the grading and processing due to improper crack detection, incorrect washing of eggs and poor hygiene and sanitation during the processing of eggs into pulp and other products. Although egg products such as liquid pulp are pasteurised, the heat treatment is only mild and therefore it is important to limit the level of microbiological contamination. There is significant epidemiological evidence to suggest that a major contributing factor of salmonellosis in Australia is the use of dirty and cracked eggs, especially in products that receive minimal or no cook step. The Food Standards Code limits the sale of cracked eggs to businesses where the egg will be further processed and receive a heat treatment. Depending on the hygienic practices on farm and proper grading, processing and storage of eggs, the potential number of egg-related illnesses was estimated up to 1800 cases per year across Australia. Current industry practices to address these issues include strict biosecurity on farm, implementation of quality assurance systems during grading and processing and effective supply chain management. Potential sources of chemical contamination of eggs on farm include contaminated soil, insecticide spray, incorrect use of medication and inappropriate egg washing solutions and concentrations. However, in general, only low levels of chemicals have been detected in eggs and previous risk assessment has assessed the risk of chemicals in eggs as low. The exception to this are specialty eggs such as Balut, salted and century eggs, where surveys have detected the unauthorised use of lead as an additive, leading to chemical contamination of some products. These products Food Safety Scheme Risk Assessment Page 10 of 189 may also become contaminated with pathogens due to the extensive handling during processing. Conclusion This review has illustrated that across the food safety schemes there are many potential hazards that can impact on human health with microbiological hazards considered the most significant. It concludes that for food businesses within these schemes, mitigating food safety risks requires the development and implementation of reliable, systematic and preventative procedures. Such procedures are the core elements of food safety programs, introduced either due to regulatory requirements or through industry-sponsored codes of practice. The review acknowledges that mitigating food safety risk necessitates a multi-factorial approach extending beyond the controls implemented by a food business operating under a food safety scheme. Food Safety Scheme Risk Assessment Page 11 of 189 Introduction Purpose Under current legislation, the NSW Food Authority (the Authority) can establish food safety schemes in respect to different type or classes of foods, food businesses or food activity (Food Act 2003). The food safety schemes aims to assist in improving the safe production and handling food by outlining the regulatory requirements for the food, food businesses or food activity (or activities) covered by the scheme. Currently food safety schemes exist for dairy, meat, plant products and seafood businesses operating in NSW, as well as businesses serving food to vulnerable persons. In addition to these schemes that have already been implemented, an egg food safety scheme is currently being finalised. These commodities have been identified as containing high risk products that may potentially cause outbreaks of foodborne illness, and where the cost benefit analysis justified a regulatory presence, and the use of regulatory tools such as the implementation of food safety programs based on principles of Hazards Analysis Critical Control Point (HACCP). Current legislation also requires a risk assessment be undertaken when establishing a new food safety scheme. The risk assessment provides the science to underpin the food safety scheme and is required to be based on national or international standards. The Authority, or its predecessor SafeFood Production NSW, previously commissioned risk assessment prior to the introduction of food safety schemes relating to seafood and plant products. In addition, risk assessments were conducted on the proposed scheme for egg and egg products and during the review of the dairy food safety scheme. The requirements under the meat food safety scheme were carried over from a previous legislation which did not require a risk assessment to be conducted and as such the Authority has not previously conducted a risk assessment in relation to meat. The vulnerable persons food safety scheme was introduced following the gazettal of Standard 3.3.1 – Food Safety Programs for Food Service to Vulnerable Populations of the Australia New Zealand Food Standards Code. Food service to vulnerable populations were identified as high risk in the National Risk Validation Project (Food Science Australia and Minter Ellison, 2002) The purpose of this risk assessment document is to provide a scientific review of hazards and their associated risks for food businesses covered by the food safety schemes. This risk assessment summarises the known information from previous risk assessment and where new or updated information is available, this has been incorporated into the information. Scope This risk assessment will review the hazards associated with food businesses regulated under the food safety schemes of the NSW Food Regulation 2004 and includes: • Dairy • Meat • Plant products – fresh cut fruits and vegetables, unpasteurised juice and vegetables in oil Food Safety Scheme Risk Assessment Page 12 of 189 • Seafood • Food service to vulnerable persons • Eggs and egg products (draft food safety scheme currently being finalised) Overview of risk assessment Risk assessment forms part of an overall process, called risk analysis. Risk analysis is used by governments and industry to assess, manage and communicate the risk associated with particular food or food groups and in turn aims to reduce the potential for foodborne illness. The Codex Alimentarius Commission divides risk analysis into three components (CAC, 1999): • Risk assessment – a process by which the potential risk posed by food safety hazard(s) is determined • Risk management – the process of determining alternatives for control the hazards identified in the risk assessment and • Risk communication – the exchange of information on risk and risk management amongst interested parties. CAC (1999) has identified four components of risk assessment: • Hazard identification – the process of identifying potential hazards associated with the food • Exposure assessment – an estimation of the potential human exposure to the hazard and includes the use of data such as the occurrence in the food and/or potential consumption rates of the food • Hazard characterisation – the evaluation of the potential illness associated with the hazard • Risk characterisation – the process of determining the probability of occurrence and severity of the adverse health effects based on the information collected in the hazard identification, exposure assessment and hazard characterisation. Previous risk assessment work When developing a food safety scheme, the NSW Food Authority has previously commissioned hazard assessments, risk profiles and risk assessments or sourced information from risk assessments performed by other government and nongovernment organisations. These risk assessments have included: • Ross, T. & Sanderson, K. (1999). A risk assessment of selected seafoods in NSW • Food Science Australia (2000). Final report – Scoping study on the risk of plant products • Food Science Australia & Minter Ellison Consulting (2002). National risk validation project. Final report • Miles, D. (2004). Risk assessment of the NSW dairy industry (unpublished) • Miles, D. and Chan, C. (2007). Risk profile and risk management of eggs and egg products in NSW (unpublished) Food Safety Scheme Risk Assessment Page 13 of 189 In addition, risk assessments have been conducted in Australia by other government and non-government organisations. These include: • Sumner, J. (2002). Food safety risk profile for primary industries in South Australia. Department of Primary Industries and Resources SA, Adelaide • FSANZ [Food Standards Australia New Zealand] (2002). Final assessment report proposal P263. Safety assessment of raw milk very hard cooked-curd cheeses. Food Standards Australia New Zealand Report • FSANZ (2006). A risk profile of dairy products in Australia. Food Standards Australia New Zealand Report • MLA [Meat & Livestock Australia] (2003). Through chain risk profile for the Australian red meat industry Part 1: Risk Profile • FSANZ (2005). Scientific assessment of the public health and safety of poultry meat in Australia • FSANZ (2006). Public health and safety of poultry meat in Australia – Explanatory summary of the scientific assessment, Canberra • MLA (2006) Listeria monocytogenes in smallgoods: Risks and controls • Ross, T. Walsh, P. and Lewis, T. (2002). Risk assessment of fish cold smoking and marination processes used by Australian businesses. Biodevelopment Consulting Pty. Ltd for SafeFood Production NSW • FSANZ (2005). Final assessment report, P265, primary production and processing standard for seafood (Attachment 10) • Daughtry, B., Sumner, J. Hooper, G., Thomas, C. Grime, T., Horn, R., Moses, A. & Pointon, A. (2005). National food safety risk profile of egg and egg products. A report for the Australian Egg Corporation Limited (AECL) Publication No 05/06 Project SAR-47 • Thomas, C., Daughtry, B., Padula, D., Jordan, D., Arzey, G., Davey, K., Holds, G., Slade, J., & Pointon, A. (2006). An egg: Salmonella quantitative risk assessment model. AECL publication Current approach As there has been a considerable amount of risk assessment work already undertaken on industries covered by the food safety schemes, the approach taken in this document was to provide a review of previous work conducted. This information has been supplemented with other more recently published information where necessary (CAC, 2007). To minimise repetition, information common to the different food safety schemes has been placed in the appendices to the document: • Appendix 1 – Common microbiological and chemical food safety hazards • Appendix 2 – Food recalls in Australia • Appendix 3 – Foodborne illness outbreaks in Australia A number of methods have been used to estimate the level of exposure to hazards. The approaches used include production data, consumption data, imported foods testing failures, recalls, epidemiological data and results of food surveys. When considering exposure the fate of the hazard during processing and preparation must be taken into account. Food Safety Scheme Risk Assessment Page 14 of 189 References CAC [Codex Alimentarius Commission] (1999). Principles and guidelines for the conduct of microbiological risk assessment. CAC/GL-30. Retrieved 14 October 2008, from http://www.codexalimentarius.net/download/standards/357/CXG_030e.pdf. CAC [Codex Alimentarius Commission] (2007). Working principles for risk analysis for food safety for application by governments. CAC/GL 62/2007. Retrieved 22 December 2008, from http://www.codexalimentarius.net/download/standards/10751/CXG_062e.pdf. Food Act 2003, New South Wales Government (2008). Food Regulation 2004, New South Wales Government (2008). Food Science Australia & Minter Ellison Consulting (2002). National risk validation project. Final report 2002. Food Safety Scheme Risk Assessment Page 15 of 189 Dairy food safety scheme Hazard identification The safety of milk and milk products has been extensively reviewed by regulatory agencies in Australia and internationally. A large number of risk assessments and risk profiles have been undertaken, examining the risks across the entire dairy supply chain and conducting in-depth evaluations of specific pathogen-product combinations. This risk assessment will summarise the major body of relevant work undertaken to date. In 1999, the former NSW Dairy Corporation commissioned Food Science Australia to review the food safety systems that had been implemented in the NSW dairy industry (Jansson et al, 1999). The report included a brief risk assessment and endorsed the preventative approach to food safety through the implementation of HACCP-based food safety programs throughout the dairy supply chain. This was later updated in 2004, when the NSW Food Authority completed a qualitative risk assessment of the NSW dairy industry which examined the microbiological and chemical hazards along the dairy supply chain (Miles, 2004). This was developed as an internal document to provide scientific rigour to the updated dairy food safety scheme and provide a basis for determining the priority classification for segments of the industry. In 2002, Primary Industries and Resources South Australia (PIRSA) commissioned a food safety risk profile on primary production, including milk and dairy products (Sumner, 2002). This report highlighted consumption of raw (unpasteurised) milk as a high risk activity. In 2006, Food Standards Australia New Zealand (FSANZ) undertook a comprehensive risk profile of dairy products in Australia to inform the development of the Primary Production and Processing Standard for dairy products (FSANZ, 2006). The FSANZ risk profile examined both microbiological and chemical hazards. The findings of the FSANZ risk profile are reported here. Microbiological hazards A wide range of microbiological hazards may be introduced into milk during primary production and processing. Raw milk may have a diverse range of bacteria present in it, either shed directly into the milk from the udder as a result of illness or disease, or through contamination from the external surface of the cow and the milking environment. FSANZ (2006) highlighted the on-farm factors that most significantly impact on the microbiological quality of raw milk as: • animal-related factors (eg animal health, herd size, age and production status) • environmental factors (eg housing, faeces, feed, soil, and water) • method of milking, operation of milking and storage equipment (eg cleanliness of equipment and lines, appropriate storage temperature to limit pathogen growth) The initial levels of bacteria in raw milk can vary considerably, dependent on the level of control over these factors. Boor (1997) reviewed the different types of pathogenic microorganisms that have been detected in raw milk (Table 1). Food Safety Scheme Risk Assessment Page 16 of 189 Table 1 – Pathogenic microorganisms detected in raw milk Microorganism Enterobacteriaceae pathogenic Escherichia coli (eg EHEC, STEC) Disease Salmonella Shigella Yersinia enterocolitica Cronobacter sakazakii Gastroenteritis, other complications involve Haemolytic uraemic syndrome (HUS) and Thrombotic thrombocytopenic purpura (TTP) Gastroenteritis, typhoid fever Dysentery Gastroenteritis Meningitis in premature infants Campylobacter jejuni Aeromonas hydrophila Gastroenteritis Gastroenteritis Pseudomonas aeruginosa Brucella spp. Gastroenteritis Brucellosis (Bang’s Disease) Bacillus cereus Bacillus anthracis Clostridium perfringens Clostridium botulinum Gastroenteritis Anthrax Gastroenteritis Botulism Staphylococcus aureus Streptococcus agalactiae Streptococcus pyogenes Streptococcus zooepidemicus Emetic intoxication Sore throat Scarlet fever/sore throat Pharyngitis, nephritic sequelae Listeria monocytogenes Corynebacterium spp. Mycobacterium bovis Mycobacterium tuberculosis Mycobacterium paratuberculosis Listeriosis (various manifestations) Diphtheria Tuberculosis Tuberculosis Johne’s disease (ruminants) Crohn’s disease (unproven in humans) Vibrionaceae and Campylobacter Other Gram-negatives Gram-positive sporeformers Gram-positive cocci Miscellaneous Gram-positives Rickettsia Coxiella burnetii Viral Enteroviruses, including polioviruses and Coxsackie virus, Rotaviruses Foot and mouth disease virus Hepatitis virus Fungi Mould (and associated aflatoxins) Protozoan parasites Cryptosporidium parvum Entamoeba histolytica Giardia lamblia Toxoplasma gondii Q fever Enteric infection Foot-and-mouth disease (not a human disease) Infectious hepatitis Mycotoxicoses Cryptosporidiosis Amoebiasis Giardiasis Toxoplasmosis adapted from Boor (1997) Food Safety Scheme Risk Assessment Page 17 of 189 In the past, prior to the introduction of mandatory pasteurisation for milk in Australia, the most important human diseases disseminated by the consumption of raw milk were tuberculosis and brucellosis. These diseases have now been eradicated in Australian dairy cow herds. As a result, the FSANZ risk profile (FSANZ, 2006) went on to identify the most significant pathogenic microorganisms to public health and safety for the Australian dairy industry (Table 2). Further details on these microbiological hazards are available in Appendix 1. Table 2 – Microbiological hazards in dairy products Pathogens pathogenic Escherichia coli Significance in dairy products Pathogenic strains of E. coli can be found in cattle and may enter milk through faecal contamination. Is destroyed by pasteurisation Salmonella Salmonella is occasionally present in raw milk but is destroyed by Yersinia enterocolitica Campylobacter spp. Bacillus cereus Clostridium botulinum Staphylococcus aureus Listeria monocytogenes Cronobacter sakazakii (formerly Enterobacter sakazakii) pasteurisation. Can contaminate products after pasteurisation, with nondairy ingredients a source of contamination. Frequently isolated in milk powder Y. enterocolitica is destroyed by pasteurisation and its presence in heat treated milk products is due to environmental contamination after heat treatment. Y. enterocolitica is able to grow in dairy products held at refrigeration temperatures and therefore may be considered as a hazard in prolonged shelf life products Campylobacter spp. is destroyed by pasteurisation and its presence in milk products is due to environmental contamination after heat treatment. Not normally able to grow in foods Vegetative cells of B. cereus do not survive pasteurisation, however spores will survive. B. cereus is rapidly outgrown by psychrotrophic bacteria at refrigeration temperatures. However, in the absence of a competitive microflora, growth to levels of concern is possible Vegetative cells of C. botulinum do not survive pasteurisation, however spores will survive. Will only grow under anaerobic conditions May enter raw milk through udder infection. S. aureus is destroyed by pasteurisation, however toxins are heat stable. S. aureus does not grow well at refrigeration temperatures or compete with starter cultures L. monocytogenes is destroyed by pasteurisation. Its presence in dairy products is due to post-pasteurisation contamination. Can grow in milk products at refrigeration temperatures C. sakazakii will not survive pasteurisation. Recontamination of powdered infant formula during manufacture is a risk. C. sakazakii cannot grow in a dry substrate, but it can survive for long periods of time and is a potential hazard when the powder is reconstituted and held at favourable temperatures. Contamination and subsequent growth may occur during reconstitution and preparation adapted from FSANZ (2006) These hazards were considered significant due to either: • association with reported incidents of foodborne illness (including overseas outbreaks), or • the potential to contaminate dairy products after pasteurisation. This conclusion is supported by other work, such as that by Todd & Harwig (1996) in a risk analysis of Canadian food, who stated that although 21 microbial hazards have been reported to occur in Canadian milk, only eight of those presented a significant risk to the human population, with Campylobacter jejuni, Salmonella serovars and E. coli O157:H7 identified as the most important hazards. Johnson et al (1990) identified Salmonella, Listeria monocytogenes and pathogenic E. coli as the three Food Safety Scheme Risk Assessment Page 18 of 189 high risk organisms to the cheese industry in the USA. While, more recently, the presence of Cronobacter sakazakii in infant formula has presented a significant risk to premature infants (Lai, 2001; FDA, 2002; Himelright et al, 2002). Chemical hazards Chemicals are used by the dairy industry for a number of purposes, including pest and weed control on farm, animal health and sanitising equipment. As a result, milk may be susceptible to chemical contamination if proper controls are not in place. The FSANZ risk profile evaluated the following potential chemical hazards (FSANZ, 2006): • agricultural and veterinary chemical used in dairy primary production • environmental contaminants, including heavy metals, organic contaminants and micro nutrients • naturally-occurring chemicals found in plants or in fungi or bacteria associated with plants which may be ingested by grazing cattle • food processing by-products • food additives, processing aids, and those chemicals that may migrate from packaging into dairy products Dairy products must comply with Standard 1.4.1 – Contaminants and Natural Toxicants and Standard 1.4.2 – Maximum Residue Limits of the Food Standards Code. These Standards sets out the Maximum Levels (MLs) of specified metal, nonmetal contaminants and natural toxicants and the Maximum Residue Limits (MRLs) for agricultural and veterinary chemical residues present in food respectively. Agricultural and veterinary chemical hazards Without appropriate controls and the observance of appropriate withholding periods for treated dairy cattle, it is possible for residues of these chemicals to occur in raw milk. In Australia, the Australian Pesticide and Veterinary Medicines Authority (APVMA) is responsible for registering agricultural and veterinary chemical products, granting permits for use of chemical products and regulating the sale of agricultural and veterinary chemical products. Veterinary chemicals administered to dairy cattle are mainly antimicrobials and endo- and ectoparasiticides. Other veterinary chemical uses include reproductive therapy and use of anti-inflammatory drugs or anaesthetics. If the cow is lactating, then the product must specifically state that it can be used in lactating dairy cows, and a milk withholding period may be specified. The use of environmentally persistent pesticides, such as organochlorines, still poses a potential problem for grazing animals. Potential hazards include excessive levels of herbicides, pesticides or fungicides. Cereals and treated seeds used as animal feed supplement are the most likely source of these contaminants, with the most significant hazard to human health being those chemicals that can accumulate in animal tissues or are excreted in the milk. Aflatoxins Grain crops can become contaminated with biological toxins, such as aflatoxins, a group of extremely toxic metabolites produced by the fungi Aspergillus flavus and Aspergillus parasiticus. When these moulds are allowed to germinate and grow on harvested seed crops, the aflatoxins can be formed and ingested by dairy cattle during feeding, eventually contaminating the milk. Aflatoxin contamination of milk is more common in Europe where intensive supplementary feeding of dairy herds is Food Safety Scheme Risk Assessment Page 19 of 189 conducted. In Australia, where herds predominantly graze on pasture, aflatoxin contamination has not been reported (ANZFA, 2001). Cleaning chemicals Milking premises and equipment must be cleaned and sanitised to prevent the risk of contaminating the milk with microbiological pathogens. However, overuse of these chemicals can in itself create a hazard with the risk of chemical residues being left on equipment. All chemicals used in detergents and sanitisers have the potential to leave a residue on the dairy equipment surface if not used in the correct manner. Physical hazards The probability of introduction on farm of physical hazards which end up in the final product is thought to be minimal. Any physical hazard contamination that may be introduced on farm should be removed at the farm level. Most dairy farms include a filter ‘sock’ through which the milk passes prior to entering into the farm vat. This filter will remove most gross physical contaminants. The introduction of physical hazards at the processing level has occasionally happened in the past, with pieces of equipment ending up in a dairy product. The instances of this occurring are very rare, and the preventative maintenance of equipment means the risk is very low. Good manufacturing practices and staff training should also ensure that the risk of physical contaminants through the wearing of personal effects such as jewellery are minimal. Exposure assessment Consumption of pasteurised milk and dairy products Consumption of milk and milk products forms a significant part of the average Australian’s diet. Standard 4.2.4 – Primary Production and Processing Standard for Dairy Products of the Food Standards Code requires all milk for human consumption (including milk used to make dairy products) to be pasteurised at a minimum of 72°C for 15 seconds (or equivalent), unless an applicable law of a State or Territory provides an exemption 1. There is no such exemption for cows milk in NSW, therefore all dairy products for human consumption commercially sold in NSW are made from pasteurised milk. In 2006/07, 684 million litres of milk were sold in NSW/ACT, including modified and flavoured milk. Data from Dairy Australia shows the average consumption of dairy products in Australia each year is 103.6 L milk, 11.9 kg cheese, 6.8 kg yoghurt and 3.9 kg butter/blends per person (Dairy Australia, 2007). A closer analysis of consumption trends is shown in the Australian National Nutrition Survey (ABS, 1995), which showed that 84% of people surveyed consumed dairy products at a median amount of 347 g/day with the quantity ranging from 209–471 g/day (Table 3). Consumption of dairy products varies with age, declining from 98% for children aged 2–3 years to 90% for adults aged 19–24 years and then increasing again to 95% for persons aged 65 years and over. 1 Standard 4.2.4A – Primary Production and Processing Standard for Specific Cheeses of the Food Standards Code does allow imported Gruyere, Sbrinz, Emmental and Roquefort to be made from raw milk. Food Safety Scheme Risk Assessment Page 20 of 189 Table 3 – Consumption of dairy products Sex Age Male Male Male Male Male Male Male Male Male Female Female Female Female Female Female Female Female Female 2–3 4–7 8 – 11 12 – 15 16 – 18 19 – 24 25 – 44 45 – 64 65+ 2–3 4–7 8 – 11 12 – 15 16 – 18 19 – 24 25 – 44 45 – 64 65+ Proportion of persons consuming milk products and dishes 2 (%) 98.2 95.5 90.9 92.8 94.2 89.1 93.7 91.3 94.5 98.1 96.0 93.3 90.8 87.3 90.1 94.3 94.7 95.6 Median daily intake per consumer of milk products and dishes (g/day) 471.8 365.0 401.4 424.0 392.2 323.0 263.2 258.0 255.0 394.3 280.5 312.0 297.7 258.0 251.3 209.3 216.6 225.8 adapted from National Nutrition Survey (ABS, 1995) Liquid milk accounts for approximately 70% of the mean daily intake of dairy products for persons of all ages. However, the trend of milk consumption within Australia has been changing to more specialty types. Whole milk accounts for around 56% of milk sales, with lower fat lines increasing to 26%, long life or ultra high temperature (UHT) treated milk 8.5%, and the remainder as flavoured and specialty milks (Dairy Australia, 2007). Cheese consumption in Australia has jumped more than 20% in the past decade. The recent consumer trend has been away from cheddar cheeses to non-cheddar cheese types, and this is also being reflected in Australia’s cheese exports, where the non-cheddar share of total export sales has increased from 45% to 57% over the past seven years. Consumption of raw milk The current Dairy food safety scheme in the Food Regulation 2004 does not provide an exemption from the requirement to pasteurise cows milk sold for human consumption. However, no such limit exists on the private consumption of raw cows milk. This is believed to be limited to small communities in NSW, such as farm families. The amount of raw milk consumed on farm within NSW is difficult to estimate, but is considered to be extremely small when compared to the volume of pasteurised milk. The US Food and Drug Administration (FDA) and US Department of 2 Milk products and dishes are defined in the National Nutrition Survey (ABS, 1995) as including the following: - Dairy milk - Yoghurt - Cream - Cheese - Frozen milk products (eg ice -cream) - Other dishes where milk or a milk product is the major component - Milk substitutes (eg soy-based milk) - Flavoured milks Food Safety Scheme Risk Assessment Page 21 of 189 Agriculture (USDA) in its quantitative risk assessment on listeriosis estimated raw milk consumption to be less than 0.5% of total milk consumption in the USA (FDA/USDA, 2003). Todd & Harwig (1996) made the assumption that ‘farm families’ were the people most likely to consume unpasteurised dairy products and consequently be exposed to the microbiological hazards that may contaminate raw milk. The dairy food safety scheme does provide an exemption to allow the sale of unpasteurised goats milk in NSW. This was initially a continuation of the permit system implemented by NSW Health. The former SafeFood NSW commissioned a risk assessment (AgriQuality New Zealand, 2002), but the authors could not fully determine the risk from unpasteurised goats milk due to a lack of data. Recommendations from the risk assessment report included the implementation of HACCP-based food safety programs and a microbiological survey of unpasteurised goats milk to generate data to provide the basis for a risk assessment. The National Nutrition Survey (ABS, 1995) estimated that less than 1% of respondents consumed goats milk and there is no evidence to suggest this has increased in recent years. In fact the number of licensed goat milk producers in NSW has declined. Recently ‘cosmetic’ and ‘bathing’ raw milk products have become available for sale in NSW and other states. Although marketed for non-food use, it is believed these labelling terms are being used to bypass the Food Standards Code, and that these products are being consumed. While the volume consumed is considered to be very small, the products are potentially unsafe. As such, the NSW Food Authority has taken enforcement action when these products have been identified in the marketplace, as they do not comply with the Food Standards Code requirements for pasteurisation of cows milk for human consumption. FSANZ are currently considering Proposal P1007 – Primary Production & Processing Requirements for raw milk products. The outcome of that process could influence the volumes of unpasteurised dairy product offered for sale in Australia. Hazard characterisation Foodborne illness outbreaks from milk and dairy products Australian dairy products enjoy a reputation for high standards of quality and safety. There have been few reported failures leading to incidents of foodborne illness attributed to dairy products in the market place in recent years. FSANZ reviewed the foodborne illness data associated with milk and milk products in Australia (FSANZ, 2006). This data is summarised in Table 4, with more detailed information on each outbreak included in Table 65 (Appendix 3). Between 1995 and 2008 there were 14 reported outbreaks directly attributed to specific dairy products, affecting 284 people. Of these, nine were associated with consumption of unpasteurised milk and none occurred in NSW. In addition, there were 12 outbreaks identified involving a food product that contained dairy products as an ingredient. However, because dairy products are an ingredient in many foods, it is often difficult to determine whether they are the actual cause of an outbreak. There have been a number of reports of outbreaks associated with consumption of dairy products overseas. While unpasteurised dairy products have been a common cause of dairy-associated outbreaks of illness, pasteurised dairy products have also been implicated where there have been poor food safety control measures in place, including the use of contaminated non-dairy ingredients, faulty pasteurisation process, poor hygiene or contamination post pasteurisation. Food Safety Scheme Risk Assessment Page 22 of 189 Table 4 – Summary of foodborne illness outbreaks attributed to dairy products and foods including dairy as an ingredient Hazard Salmonella serovars Campylobacter Norovirus C. perfringens Chemical contamination Cryptosporidium S. aureus Unknown Total Australian outbreaks (1995–2008) 7 6 3 1 1 1 1 6 26 Cases 226 85 123 27 23 8 2 86 582 Hospitalisations Deaths 5 0 0 0 0 3 0 1 10 0 0 0 0 0 0 0 0 0 adapted from FSANZ (2006) While there is little corresponding evidence in Australia linking consumption of pasteurised dairy products to foodborne illness, the potential impact of a dairyrelated food poisoning outbreak due to the widespread consumption of dairy foods has been demonstrated by some large scale foodborne illness outbreaks overseas. In 2000, over 13,000 people were sick and 165 people hospitalised in Japan following consumption of dairy products made by the Snow Brand Milk Products Co. that were contaminated with S. aureus enterotoxin (Asao, 2003). In addition, the 2008 deliberate adulteration of Chinese milk with melamine resulted in worldwide recalls of dairy products and a wide range of other foods where milk powder was used as an ingredient. The broad distribution of Chinese milk powder graphically demonstrated that a food safety incident in one country can have international repercussions and encompass a broad spectrum of products. Shiga toxigenic Escherichia coli (STEC) in raw milk Cattle have been identified as an important reservoir for pathogenic E. coli, and although pasteurisation does eliminate E. coli, outbreaks of E. coli O157:H7 infections overseas have been attributed to contaminated raw milk and some pasteurised dairy products. A 1998 Australian study examined the incidence of STEC in dairy cattle on four farms, with evidence of STEC detected in the faeces of 39% of the 843 cattle tested (Desmarchelier, 1998). The prevalence rates varied between farms, although generally milking cows had a lower rate (24%) than younger animals (33–41%). The STEC isolated from dairy cattle included E. coli O157:H7 (0.9%) and E. coli O26 (0.16%), both known pathogenic serotypes. However, when the prevalence of STEC in Australian raw milk was assessed, it was found to be relatively low (Desmarchelier, 1998), with STEC isolated from 27 of 1,802 samples (1.5%). It was hypothesised that low level carriage may normally be present in the dairy herd and this is periodically stimulated by some host or environmental factor. It appears that during these episodes of increased faecal shedding, there is an increase in environmental contamination and associated increased risk of milk becoming contaminated. Salm onella in dairy products The first significant case of Salmonella in an Australian milk product occurred in 1943 in Victoria. A typhoid-carrying farm worker contaminated raw milk, which was then distributed for public consumption, resulting in over 400 cases of typhoid fever and Food Safety Scheme Risk Assessment Page 23 of 189 23 deaths (Merrilees, 1943). Since that time, there has been only one other major incident involving Salmonella in pasteurised dairy products. This occurred in Victoria in 1977 and was traced to milk powder becoming contaminated due to contaminated lining of the spray dryer (Forsyth et al, 2003). The former Australian Dairy Authorities’ Standards Committee (now ANZDAC) produced the Australian manual for control of Salmonella in the dairy industry (ADASC, 1999b) to specify control measures for limiting the risk of dried milk products becoming contaminated with Salmonella. Yersinia enterocolitica in milk Y. enterocolitica has been isolated from raw and pasteurised milk in various parts of the world. Although some strains occasionally associated with human disease have been isolated from raw milk, the main pathogenic types generally do not predominate. Milk has been associated with sporadic cases and outbreaks of Y. enterocolitica infections overseas where milk was contaminated postpasteurisation by contact with implements contaminated by milk crates used on piggeries (Barton & Robins-Brown, 2003). A suggested, though not proven, link between human yersiniosis and pasteurised milk in NSW has been reported (Butt et al, 1991). Cam pylobacter spp. in milk Both Campylobacter jejuni and Campylobacter coli are found in the faeces of cattle and can cause cases of subclinical mastitis. Hutchinson et al (1985) reported a milkborne outbreak resulting from the consumption of raw milk from cows exhibiting no outward evidence of illness. Healthy lactating cows can carry C. jejuni in the intestinal tract, providing an extrinsic source of contamination. In one US study of 193 healthy dairy cows at three dairies, 77 (40%) had positive rectal cultures (Martin et al, 1983). Overseas surveys of Campylobacter in raw milk have shown a prevalence of 1 to 6% (Wallace, 2003). Campylobacter is killed by pasteurisation. However, these organisms are unlikely to grow in milk or dairy products. Nevertheless, several outbreaks of Campylobacter food poisoning from consumption of raw milk in Australia have been reported among children who were taken on a class trip to a dairy and given raw milk to drink. Bacillus cereus in liquid milk Raw milk is frequently contaminated with Bacillus spp. spores, with the milk often contaminated at the farm. Sanitation of the teats prior to milking was able to reduce the incidence of B. cereus in raw milk (Christiansson et al, 1999). The presence of B. cereus in a processed dairy product is often associated with the ability of the spores to survive pasteurisation, after which the resulting vegetative cells may colonise pipes, tanks and filling machines (Lin et al, 1998). Notermans et al (1997) examined the risk from B. cereus in pasteurised liquid milk in the Netherlands. The study estimated that up to 7% of pasteurised milk may contain B. cereus, with levels ranging up to 105 cfu/mL. In Australia, pasteurised milk has not figured as a cause of B. cereus food poisoning. Clostridium botulinum in dairy products Dairy products have not traditionally been associated with outbreaks of botulism. Since 1912 fewer than 12 outbreaks associated with dairy products worldwide have been recorded (Szabo & Gibson, 2003). However, spores of C. botulinum survive the Food Safety Scheme Risk Assessment Page 24 of 189 normal milk pasteurisation process, and therefore control factors such as aw (water activity), redox potential, pH and temperature must be used in dairy products such as cheeses and dairy-based spreads and sauces to reduce the risk of botulism. In 2007, one case of botulism was reported in Victoria and was associated with the consumption of a nationally distributed ready-to-eat nachos meal. The neurotoxin was detected in discarded remains of that meal pathogen (OzFoodNet Working Group, 2007). One of the components was a cheese sauce and subsequent laboratory testing showed that the sauce provided an environment that would support growth of the organism. This case is not included in Appendix 3 data as it was not classed as an outbreak, affecting only one person. Botulism in dairy herds is caused by ingestion of preformed toxins produced by the growth of C. botulinum in decaying crops, vegetation or carcase material, or by the animal acquiring a gastrointestinal infection with the organism. The presence of neurotoxin in milk from animals diagnosed with botulism is periodically raised as a concern. When these incidents occasionally occur in dairy herds in Australia, farmers voluntarily remove affected animals from supplying milk. There is little evidence in the scientific literature to suggest the transfer of botulinum neurotoxins or the organism itself to milk occurs from either symptomatic or asymptomatic animals in affected herds. Staphylococcus aureus in milk S. aureus is a cause of mastitis in milk producing animals and can be frequently found in raw milk from cows with undetected mastitis. Even in subclinical cases of mastitis up to 105 cfu/mL of S. aureus can be shed into the milk. S. aureus is a poor competitor, and will not grow well in the presence of other bacteria commonly present in raw milk. However, it is believed that toxin can be produced under any conditions that permit growth (Stewart, 2003). The Snow Brand Milk Products Co. outbreak in Japan was suspected to be due to poor cleaning of distribution pipes in the production facility, leading to the opportunity for S. aureus to grow to high levels and produce toxin (Asao, 2003). Listeria m onocytogenes in dairy products L. monocytogenes has a history of causing large outbreaks from dairy products, with a 1985 outbreak in the USA from Mexican-style soft cheese affecting 142 people and causing 48 deaths and an outbreak in Switzerland from Vacherin Mont D'Or cheese affecting 122 people and causing 34 deaths (Ryser, 1999). The New Zealand Food Safety Authority (NZFSA) commissioned a series of risk profiles examining the risk of L. monocytogenes contamination in ice-cream, low moisture cheese and soft cheeses (see Table 5 for outcomes) while the FDA/USDA risk assessment on L. monocytogenes examined 11 categories of dairy products (FDA/USDA, 2003) (see Table 6 for outcomes extrapolated to the Australian population). The worldwide incidence rate for Listeria spp. in raw milk is estimated to be around 3–4% (Sutherland et al, 2003), while in Australian raw milk the incidence also appears low. A NSW Dairy Corporation survey of 600 raw milk samples failed to detect L. monocytogenes, however, 0.4% of samples were positive for Listeria spp. (Sutherland & Porritt, 1995). The organism is eliminated by pasteurisation, therefore the primary concern is postpasteurisation contamination with L. monocytogenes , as it is a common inhabitant of dairy processing facilities. In dairy factories, the major areas that have been Food Safety Scheme Risk Assessment Page 25 of 189 identified as sources of the organism are drains, floors, conveyors, refrigerated storage areas and crate wash lines (Sutherland et al, 2003). Cronobacter sakazakii in infant formula (formerly Enterobacter sakazakii) C. sakazakii is a rare, but life threatening cause of neonatal meningitis, sepsis, and necrotising enterocolitis. In general, the reported case-fatality rate varies from 33– 80% among newborns diagnosed with this type of severe infection (Lai, 2001). Premature infants and those with underlying medical conditions may be at highest risk for developing a C. sakazakii infection. However, it should be noted that healthy infants may not always be immune to C. sakazakii infections (Nazarowec-White & Farber, 1997). In 2002, the US FDA issued an alert to health care professionals regarding the risk associated with C. sakazakiiinfections among neonates fed milk-based, powdered infant formulas (FDA, 2002). There have been several C. sakazakiioutbreaks reported among infants fed milk-based powdered formula in neonatal intensive care units in England, Netherlands, Iceland, Belgium, Greece, U.S. and Canada (Biering et al, 1989; Lai, 2001; Van Acker et al, 2001; Himelright et al, 2002). These outbreaks have involved several deaths and were associated with temperature abuse of reconstituted powdered infant formula. In addition, there have been cases in premature babies in New Zealand (NZ Ministry of Health, 2005): • 1986 – a premature infant contracted C. sakazakii septicaemia. The infant survived, apparently without serious sequelae • 1991 – premature twins contracted C. sakazakii meningitis. One twin suffered serious permanent neurological effects and the other recovered fully • 2004 – a premature infant contracted C. sakazakii meningitis and died At the time of writing, there have been no reported cases of neonatal illnesses associated with C. sakazakiiin infant formula in Australia. However it must be noted that the organism is not a notifiable disease in Australia. Powdered infant formula is not a commercially sterile product, unlike liquid formula which is subjected to sufficient heat to render it commercially sterile. Powdered infant formula may be subject to contamination by opportunistic pathogens such as C. sakazakii through improper cleaning of production lines. While the pathogen does not grow in the powder it can survive for many months (Nazarowec-White & Farber, 1997) Chemicals The prevalence of chemical in dairy products is assessed by several surveys conducted each year in Australia to detect chemical residues. The Australian Milk Residue Analysis (AMRA) survey, the Australian Total Dietary Survey (ATDS), the National Antibacterial Residue Minimisation (NARM) program, and other targeted testing programs provide an indication of the potential for chemical contaminants ending up in dairy products. The AMRA survey from 1998 to 2005 showed the following: • 3,467 milk samples (89,121 analyses) for antimicrobials showed 99.997% compliance with the maximum residue limit (MRL) for veterinary chemicals residues in milk (there was one detection of Cloxacillin at a level at the MRL of 0.01 mg/kg in June 2002 in a bulk milk sample in NSW) Food Safety Scheme Risk Assessment Page 26 of 189 • 33,382 analyses for agricultural chemical residues, including organochlorines, organophosphates and synthetic pyrethroids, showed no detections Targeted testing of milk in areas subject to locust plagues has also shown very high compliance rates for organochlorines, organophosphates and Fipronil (a broad spectrum insecticide). In 2000–2001, 123 samples were tested in NSW, with no residues detected (DFSV, 2002). The NARM program conducts tests for antimicrobials on bobby calves and cull dairy cows that are presented to abattoirs. Testing on NSW cull dairy cows from 2000 to 2002 showed that 44 from 455 (9.7%) were positive. Of these positive trace results, eight were shown to be greater than MRL with Neomycin, and Sulphadiazine found in dairy cull cows, and Oxytetracycline and Sulphadiazine in the export calves. Chemical residues persist in meat much longer than milk, and this is reflected in recommended withholding periods. Traceback investigations where residues were detected showed that causes ranged from not obeying the withholding period, use of the wrong withholding period (milk rather than meat) and accidental feeding of medicated milk to calves (NSW Agriculture, 2001 NSW Agriculture, 2002). The ATDS detected no agricultural chemical residues in milk and milk products available on retail shelves. Naturally occurring aflatoxins are not considered a high risk, as a small survey of 40 dairy products by the NSW Food Authority in 2005 detected aflatoxin M1 in trace levels in only one sample, all others were below the limit of detection. Risk characterisation Risk ranking dairy products The outcomes of the NZFSA risk profiles examining L. monocytogenes and STEC in dairy products are summarised in Table 5. The FDA/USDA (2003) estimated the risk per serving and risk per annum of listeriosis for eleven RTE dairy products, based on the predicted number of illnesses associated with the consumption of these foods. The risk was calculated for each food on both a ‘per serving’ and ‘per annum’ basis. Predictions based on the FDA/USDA (2003) risk assessment with a population of 260 million people were extrapolated to the Australian population of approximately 21.6 million (ABS, 2009) by dividing by a factor of twelve. The predicted number of annual listeriosis cases are presented in Table 6 noting that these estimates are approximate, as it is acknowledged that there may be differences in the consumption levels of particular dairy products between American and Australian consumers. Food Safety Scheme Risk Assessment Page 27 of 189 Table 5 – NZFSA risk profile outcomes examining hazards in dairy products Hazard Listeria monocytogenes in ice- cream (Lake et al, 2003) Listeria monocytogenes in low moisture cheese (Lake et al, 2005a) Listeria monocytogenes in soft cheeses (Lake et al, 2005b) Shiga-toxin producing Escherichia coli in raw milk (Gilbert et al, 2007) Risk Found no evidence to link consumption of ice-cream with cases of L. monocytogenes infection in New Zealand Contamination with L. monocytogenes is unlikely unless introduced post-pasteurisation from environmental sources, added ingredients or further processing such as grating. Surveys of low moisture cheese suggest that contamination with L. monocytogenes is infrequent and that growth in product is unlikely. Even taking into account the high consumption of low moisture cheese, the available data indicates that L. monocytogenes in low moisture cheese does not represent a significant risk to human health Data on the prevalence of L. monocytogenes indicate that contamination rates are very low, most likely to occur postpasteurisation. Current risk to the general population is considered low, although susceptible populations will have a greater risk Approximately 10% of notified human cases of STEC infection (mostly E. coli O157:H7) in New Zealand reported consumption of raw milk. E. coli O157 has been reported, albeit rarely, in faecal samples from dairy and beef cattle. However, there is insufficient data on the prevalence and numbers of STEC in raw milk to robustly estimate the risk from consumption of raw milk in New Zealand Dairy products that are likely to support the growth and survival of pathogens and are prone to contamination after pasteurisation may be categorised as higher risk than other dairy products. Alternatively, dairy products that do not support the growth of pathogens, if correctly formulated, can be classified as low risk. However, it is also acknowledged that for some pathogens with a low infective dose, survival in the dairy product may become the issue more than the ability to grow. FSANZ ranked the degree of risk based on (FSANZ, 2006): • intrinsic properties of the product (ie the impact of aw, pH, salt concentration, and their effect on the growth of contaminating microorganisms) • extent to which food is exposed to factory environment or handling after heat treatment • hygiene and control during distribution and retail sale • degree of reheating or cooking before consumption (many dairy products are RTE, so this is rarely a factor) Food Safety Scheme Risk Assessment Page 28 of 189 Table 6 – Risk ranking for dairy products contaminated with Listeria m onocytogenes Dairy product Risk ranking (per serve) Unpasteurised fluid milk High fat and other dairy products (eg butter, cream, other miscellaneous milk products) Soft unripened cheese, >50% moisture (eg cottage cheese, cream cheese, ricotta) Pasteurised fluid milk Fresh soft cheese Semi-soft cheese, 39–50% moisture (blue, brick, monterey, muenster) Soft ripened cheese, >50% moisture (brie, camembert, feta) Ice-cream and other frozen dairy products Processed cheese (cheese foods, spreads, slices) Cultured milk products (yoghurt, sour cream, buttermilk Hard cheese, <39% moisture (cheddar, Colby, parmesan) High Moderate Median predicted cases of listeriosis per serve (in Australia) 3 7.1 x 10-9 2.7 x 10-9 Risk ranking (per annum) Moderate 1.8 x 10-9 Moderate 0.6 Moderate Low Low 1.0 x 10-9 1.7 x 10-10 6.5 x 10-12 High Low Low 7.5 0 0 Low 5.1 x 10-12 Low 0 Low Low Low 4.9 x 10-14 4.2 x 10-14 3.2 x 10-14 Low Low Low 0 0 0 Low 4.5 x 10-15 Low 0 Moderate High Median predicted annual number of listeriosis cases (in Australia) 4 0.25 4.7 adapted from FDA/USDA (2003) 3 4 The risk per serving is inherent to the particular food category, and is therefore assumed to be the same in Australia as that calculated for the USA (FDA/USDA, 2003). This is based on the assumption that consumption patterns for these foods are identical in Australia and the USA. The risk per annum has been adapted from USA population data contained in the FDA/USDA (2003) risk assessment of 260 million and extrapolated to Australian population data of approximately 21.6 million (ABS, 2009) by dividing by a factor of 12 Food Safety Scheme Risk Assessment Page 29 of 190 Table 7 provides a relative risk ranking for categories of dairy products (FSANZ, 2006), however the ranking can be quite variable. For example, once a shelf stable UHT product is opened, it may become contaminated via cross contamination and when subjected to temperature abuse it could become a high risk food. In contrast, the low pH and low water activity of extra hard cheese means it is unlikely to support the growth of any pathogen that contaminates the surface. Dried milk powders and infant formulae are inherently stable products due to their low water activity, however pathogens such as Salmonella are able to surive and upon reconstitution become higher risk, especially if improperly reconstituted and stored. Table 7 – Risk ranking of dairy products Risk ranking Higher risk Dairy product Risk characterisation Unpasteurised milk Soft cheeses No pathogen reduction step Mild pH, long shelf life allowing growth of Listeria monocytogenes (Bemrah et al, 1998) Mild pH, fermentable carbohydrate, long shelf-life Dependent on variety – some have low acid, high moisture Dependent on variety – some have low acid, high moisture, added ingredients Absence of salt, high moisture content Absence of salt, high moisture content Storage temperature only hurdle to control post-pasteurisation contamination Stored frozen, but soft serve may allow growth of Listeria Dairy desserts Fresh cheese Dairy dips Intermediate risk Unsalted butter Low fat spreads Pasteurised milk Ice-cream monocytogenes Low risk Yoghurt Salted butter Hard cheese Extra hard cheeses UHT milk Dried milk powder Low pH does not allow growth of pathogens High salt concentration Low water activity, low pH Low water activity, low pH Commercially sterile Low water activity, however prone to contamination adapted from FSANZ (2006) Consumption of raw milk The consumption of unpasteurised milk appears to represent a significant risk on a per serving basis, with the FDA/USDA risk assessment categorising unpasteurised milk as high risk for listeriosis (FDA/USDA, 2003), and the majority of foodborne illness attributed to dairy products worldwide due to the consumption of unpasteurised milk and dairy products made from unpasteurised milk. However, the predicted number of annual illnesses in the FDA/USDA risk assessment is very low because of the low levels of consumption of raw milk. From FSANZ consumption Food Safety Scheme Risk Assessment Page 30 of 189 data, it is estimated that the consumption of raw milk as less than 1% of overall milk consumption (FSANZ, 2006), while the FDA/USDA risk assessment estimated consumption to be less than 0.5% (FDA/USDA, 2003). PIRSA commissioned a food safety risk profile on primary production in South Australia, including milk and dairy products. This report highlighted consumption of raw milk as a high risk activity and predicted much higher rates of foodborne illness. It was predicted the risk of illness from all foodborne pathogens associated with raw milk to be in the order of 36 illnesses per annum among the 1000 consumers, compared with one illness in 20 years for pasteurised milk (Sumner, 2002). Control measures FSANZ found that the factors having the most significant impact on the safety of processed Australian dairy products are (FSANZ, 2006): • the quality of raw materials • correct formulation • effective processing • the prevention of recontamination of product • maintenance of temperature control through the dairy supply chain While pathogenic microorganisms may contaminate raw milk supplies and pasteurisation is a very effective Critical Control Point (CCP) in eliminating pathogens, good manufacturing practices must also be employed to ensure that post-pasteurisation contamination does not occur. Presence of pathogens in milk The effectiveness of pasteurisation is dependent upon the microbiological status of the incoming raw milk. Control measures at the primary production level involve minimising the likelihood of microbiological hazards contaminating the raw milk. This is achieved through the implementation of a food safety program incorporating good agricultural practices (GAP). These measures are effective in reducing the microbial load of milk being sent for processing. However, should microbial contamination of raw milk occur, it is critical that milk is stored at a temperature that minimises the opportunity for the bacteria to multiply. Temperature abuse of the milk may allow growth of pathogenic bacteria to the extent where the pasteurisation process may not eliminate all pathogenic bacteria and/or toxins. Chemical hazards Milk from multiple farms may be batched together, either within a milk tanker, or within a silo at a processing facility, therefore the potential exists for chemically tainted milk from a single farm to contaminate a large volume of milk within a tanker and silo at the processing factory. However, the implementation of on-farm food safety programs has minimised the presence of chemicals in milk. In addition to these testing programs, processing factories receiving milk from farms test incoming batches of milk for the presence of chemical hazards, such as antibiotics which can adversely affect starter cultures during cheese production. Food Safety Scheme Risk Assessment Page 31 of 189 Correct formulation Ingredients used in the manufacture of dairy products that are added post pasteurisation must be of a high microbiological standard. Many non-dairy ingredients added to ice-cream mix after heat treatment include fruits (canned, fresh, or frozen and usually in concentrated sugar syrups), nuts, chocolate, pieces of toffee and biscuit, colours and flavours. These ingredients and those added to other dairy products such as yoghurt, dairy desserts, dairy dips and cheese may introduce pathogens into the product (ICMSF, 1998). This is readily illustrated by a botulism outbreak involving a yoghurt product in the UK. In this outbreak it was not the yoghurt itself but hazelnut purée added to the yoghurt that was the source of the intoxication. The hazelnut purée was under processed, had a pH (between 5.0 and 5.5) and a high aw conducive to the growth of the pathogen. Previous batches were sweetened with sugar but the producer had recently switched to aspartame. The subsequent rise in aw was not compensated for by additional processing changes. A total of 27 people were affected and one died (Critchley et al, 1989). This addition of ingredients added after pasteurisation was identified as a high risk factor by Jansson et al (1999) who recommended that dairy products with these additions (eg ice-cream and cheeses) be moved into the high risk category and the finished product be subject to additional end product microbiological analysis. The microbial quality of dry-blended ingredients into infant formula was identified as a significant source of contamination by FSANZ, as there is no heat treatment to destroy bacteria in the final product (FSANZ, 2006). Effective processing (pasteurisation and equivalence) Dairy processing facilities primarily use High Temperature Short Time (HTST) pasteurisation (minimum 72°C for 15 seconds) or batch pasteurisation (minimum 65°C for 30 minutes) to eliminate the pathogens of concern in milk. The minimum times and temperatures for pasteurisation are stated in Standard 4.2.4 – Primary Production and Processing Standard for Dairy Products of the Food Standards Code. However, most factories actually heat the milk to higher temperatures and hold it for a longer time period as an in-built safety margin. Juffs & Deeth (2007) undertook an extensive evaluation of the effectiveness of pasteurisation in reducing pathogens in milk and milk products. They concluded that Australian consumers can be assured that pasteurisation does destroy the pathogens of concern in milk and dairy products with a reasonable margin of safety. They also observed that: • literature data indicate that the most significant milk-borne pathogens are destroyed by pasteurisation with a reasonable margin of safety • the pasteurisation times and temperatures used by Australian processors meets the minimum requirements prescribed in the Food Standards Code, and in many cases products are heated to a temperature and/or a time often well in excess of the prescribed minimums • lack of epidemiological data indicating that pasteurised milk products have been implicated in foodborne illness outbreaks in Australia in recent years, in contrast outbreaks have been associated with consumption of raw milk, in Australia and overseas Food Safety Scheme Risk Assessment Page 32 of 189 • in most cases, milk and dairy products are consumed as RTE foods and will readily support the growth and survival of any contaminating microorganisms. In the past, the dairy industry has been subjected to a high level of food safety regulation, ensuring high levels of hygiene and sanitation are maintained Pasteurisation destroys many pathogens with a reasonable margin of safety. It will not destroy C. botulinum spores, heat resistant tnerotoxins, some streptococci and destruction of some pathogens are debated an uncertain (Juffs & Deeth, 2007). The pasteurisation process eliminates all pathogenic bacteria likely to be present in raw milk, with the exception of the spore forming bacteria B. cereus and C. perfringens and heat resistant toxins. However, neither of these organisms has been identified in incidents of foodborne illness from dairy products. It is improbable that C. perfringens can germinate and multiply under the normal conditions of milk storage, while spoilage bacteria will outgrow B. cereus at refrigeration temperatures. Processes that are equivalent to pasteurisation are permitted under the Food Standards Code, including thermisation of milk for cheesemaking when combined with processing steps that achieve the regulatory food safety criteria. The prevention of recontamination of product Post-pasteurisation contamination can pose a major problem where good manufacturing practices are not employed (Zottola & Smith, 1991). Pathogenic microorganisms can be introduced into a dairy processing environment with raw milk. Once these organisms gain access to the processing plant, the presence of nutrients and moisture can allow not only for survival, but multiplication of these organisms. The application of food safety programs including elements of Good manufacturing practice (GMP) and Good hygienic practice (GHP) are critical to limit the potential for pathogens to contaminate dairy products after pasteurisation. The primary organisms of concern are L. monocytogenes for most dairy products and Salmonella in dried milk products. A large number of dairy products have been recalled due to contamination with L. monocytogenes, with nine recalls between 2004 and 2008 (Table 61 in Appendix 2). In 1999, the state dairy regulatory authorities introduced two manuals for the control of post-pasteurisation contamination with Listeria (ADASC, 1999a) and Salmonella (ADASC, 1999b). These manuals highlight steps to control entry of these organisms into dairy processing areas, as well as recommend frequencies for finished product and environmental testing, and clearance programs if the organisms are detected. Maintenance of temperature control through the dairy supply chain The intrinsic nature of many dairy products means they will support the growth and survival of pathogenic bacteria that may contaminate the product. This categorises these products as ‘potentially hazardous foods’ under the definition in Standard 3.2.2 – Food Safety Practices and General Requirements of the Food Standards Code. The exception to this are products such as yoghurt, hard cheeses (low pH) and frozen ice-cream (soft serve ice cream mix may allow growth of L. monocytogenes). As potentially hazardous foods, maintenance of temperature control through the dairy supply chain is critical to ensure these foods remain safe and suitable. Food Safety Scheme Risk Assessment Page 33 of 189 Conclusion The FSANZ risk profile concluded that (FSANZ, 2006): • a wide range of microbiological hazards may be associated with raw milk and dairy products, but these do not represent a significant problem under current management practices which: o control animal health o ensure adherence to good milking practices o require effective heat treatment (eg pasteurisation) and o have controls to prevent post-pasteurisation contamination in the dairy processing environment • current risk management measures ensure that pathogenic microorganisms are unlikely to be present in high numbers in raw milk • pasteurisation (or validated equivalent treatments) provides the kill step to effectively eliminate all but the spore-forming bacteria and heat resistant toxins • there are extensive regulatory and non-regulatory measures in place along the dairy industry primary production chain resulting in minimal public health and safety concerns regarding the use or presence of chemical in dairy products • extensive monitoring of chemical residues in milk over many years has demonstrated a high level of compliance with the regulations • Australian dairy products have an excellent reputation for food safety, and this is supported by the lack of evidence attributing foodborne illness to dairy products • continuation of the current management practices, particularly monitoring programs for chemicals along the primary production chain, will ensure that the dairy industry continues to maintain a high standard of public health and safety The NSW Food Authority and its predecessor organisations have taken a proactive role in implementing HACCP-based food safety programs along the dairy supply chain, a position that may well have contributed to the excellent safety record of dairy products in NSW. This, when combined with improvements in primary production practices that effectively manage animal health, adherence to good milking practices, and improvements in the hygiene of milking equipment and buildings, has been important in reducing the microbial load in raw milk entering NSW dairy processing facilities. The adoption of industry codes of practice and the extensive implementation of food safety programs in the dairy industry has helped to underpin these regulatory control measures. Food Safety Scheme Risk Assessment Page 34 of 189 References – Milk and dairy products ABS [Australian Bureau of Statistics] (1995). National Nutrition Survey: Foods Eaten, Australia, 1995. Australian Bureau of Statistics report. ABS Cat no 4804.0. Retrieved 13 January 2009, from http://www.ausstats.abs.gov.au/ausstats/subscriber.nsf/0/CA25687100069892CA256888001C D460/$File/48040_1995.pdf ABS [Australian Bureau of Statistics] (2009). Population clock. 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Food Safety Scheme Risk Assessment Page 38 of 189 Meat food safety scheme The meat food safety scheme under the Food Regulation 2004 regulates food safety practices across broad sections of the meat industry, from harvesting of game meat in the field, through to primary processing at the abattoir and further processing into ready-to-eat (RTE) meat products. In order to effectively assess the risks, and consider the different production systems and inherent hazards associated with different sectors of the meat industry, the following definitions have been used to categorise the data: Meat the dressed carcase and carcase parts of an animal (bovine, bubaline, camelidae, caprine, cervidae, ovine, porcine and soliped species) Poultry meat the edible part of any poultry (fowl, duck, geese, turkeys, pigeons, pheasants, quails, guinea fowls and other avian species) intended for human consumption. For the purposes of this report, this also includes processed poultry meat Game meat the edible part of any wild game animal (any vertebrate animal of a species that is not farmed, but is killed in the field and can be legally harvested, excluding fish) Processed meat meat that is further processed (such as curing, heat treated, dried, canned, fermented, rendered) to form a meat product with different characteristics and flavours Hazard identification Meat In Australia, the most comprehensive work has been funded by the meat industry itself, through Meat and Livestock Australia (MLA), who commissioned a risk profile of the red meat industry to identify (MLA, 2003a): • public health hazards that enter any point of the food chain for red meat products produced in Australia and rank them in terms of risks to the consumer • hazard:product combinations in which further risk analysis might be performed From a regulatory viewpoint, FSANZ will be undertaking a scientific assessment of the hazards that occur for meat, due to be completed in mid 2009. This work will be used to underpin broadening of the scope of Standard 4.2.3 – Primary Production and Processing Standard for Meat of the Food Standards Code to include requirements for primary production. The standard currently only contains requirements for producers of RTE meat products. Beef and sheepmeat The animal gut is a primary reservoir for a significant number of pathogens and, as such, may be associated with livestock (Table 8). Bacterial pathogens such as Salmonella serovars and pathogenic E. coli can persist for extended periods of time in the farm environment, where they may contaminate feed, water, pasture, farm equipment through to individual animals or entire herds. It is well established that cattle are a major reservoir for pathogenic organisms such as Clostridium Food Safety Scheme Risk Assessment Page 39 of 189 perfringens, Campylobacter jejuni, pathogenic Escherichia coli and Salmonella serovars in their gut including the rumen, caecum, colon and rectum (McEvoy et al, 2004). From these locations, pathogens are frequently transferred to the exterior, such as the hide and hooves and to the surrounding environment. In addition, sheep, cattle and pigs grazing on contaminated pastures can become infected with the encysted form of the parasite Toxoplasma gondii. Because livestock may serve as a reservoir for pathogens, it is not surprising that a number of these animals will carry pathogens into the abattoir environment. While the muscle tissue of healthy live animals is essentially sterile at the time of slaughter, the external surfaces of carcases may become contaminated during de-hiding and dressing, and if the intestinal tract is punctured and the gut contents escape. This can also lead to direct or indirect contamination of equipment and workers during dressing and processing, which may further contribute to carcase cross contamination. Internationally, the European Food Safety Authority (EFSA) has undertaken a risk assessment on Salmonella in meat (EFSA, 2008), while risk assessment work in the USA has tended to concentrate on specific hazards such as E. coli O157:H7 in hamburgers (Cassin et al, 1998) and in tenderised meat (FSIS, 2002). Although a hazard of concern in the USA, the prevalence of E. coli O157:H7 on Australian beef and sheep carcases appears to be very low (MLA, 2000; 2005). This organism does not appear to be a significant source of foodborne illness in Australia, with only two cases reported in a chiold care centre in Victoria in 1996 (See Table 69). In addition to the traditional bacterial pathogens, worldwide attention became acutely focussed on the possible acquisition of variant Creutzfeldt-Jakob Disease (CJD) from Bovine Spongiform Encephalopathy (BSE) infected animals. However, under the assessment of Geographical BSE Risk (GBR), Australian livestock are considered ‘highly unlikely’ as having BSE (EFSA, 2007). The potential risk factors for BSE have been addressed through the implementation of appropriate control measures within Australia.Therefore, BSE will not be further considered in this risk assessment. Pigmeat Pigs are often associated with the carriage of Yersinia enterocolitica, appearing to be the primary source of Yersinia infections in humans caused by bioserotype 4,O:3 (Barton & Robins-Browne, 2003). The pork tapeworm Taenia solium (larval stage Cysticercus cellulosae) and the nematode worm Trichinella spiralis are often associated with pork overseas. However these organisms are not present in Australian pigs (DAFF, 2004) and, therefore, are not further considered in this risk assessment. Food Safety Scheme Risk Assessment Page 40 of 189 Table 8 – Microbiological hazards in livestock and poultry Livestock Pathogenic bacteria pathogenic Escherichia coli Salmonella serovars Brucella Campylobacter jejuni Yersinia enterocolitica Coxiella burnetii Listeria monocytogenes Staphylococcus aureus Bacillus anthracis Clostridium spp. Mycobacterium bovis Streptococcus spp. Poultry Salmonella serovars Campylobacter jejuni Parasites Cysticercus bovis Cysticercus ovis Onchocerca spp. Taenia saginata Toxoplasma gondii Prions Bovine Spongiform Encephalopathy (BSE) adapted from Sumner (2002); FSANZ (2005) The rate of carriage of the pathogenic organisms in the gut by livestock may be affected by factors such as animal handling, husbandry techniques and other onfarm practices that can affect animal health. Practices such as co-mingling of animals, intensive rearing methods and stress (such as starvation and transport) have been shown to increase the shedding and transmission of pathogens in animals. Chemical hazards in the red meat industry were assessed as part of the risk profile conducted by the MLA. This work found that the current system for registering and monitoring the use of chemicals in the meat industry to be well managed. The incidence and levels of residue contamination reported by the National Residue Survey (NRS) and the Australian Total Diet Survey (ATDS) are very low. In instances where chemical residues have been detected in meat, the levels found have been too low to be considered a public health risk The MLA risk profile could find no data on physical hazards for the red meat industry. Poultry meat Internationally, a huge amount of resources have been employed to undertake risk assessment work on poultry. This work has concentrated on the pathogens considered to be most significant, namely Salmonella (FAO/WHO, 2001; WHO/FAO, 2002) and Campylobacter (FAO/WHO, 2003). In Australia FSANZ has undertaken a comprehensive scientific assessment of the poultry meat industry to underpin the development of Standard 4.2.2 – Primary Production and Processing Standard for poultry meat (FSANZ, 2005). This work considered: Food Safety Scheme Risk Assessment Page 41 of 189 • the extent of food safety risk associated with the consumption of poultry meat and poultry meat products in Australia • the factors along the poultry meat supply chain that have the greatest impact on public health and safety A range of microbiological hazards may be introduced to poultry meat during the primary production stages. These include bacterial pathogens that may contaminate breeding stock, feed, water and the environment. The FSANZ scientific assessment considered Salmonella serovars, Campylobacter spp., pathogenic E. coli, S. aureus, C. perfringens and L. monocytogenes as potential hazards in poultry meat. Poultry are exposed to Salmonella via sources such as feed or through environmental contamination. Once infected, a bird will excrete large numbers of salmonellae in its faeces which can lead to rapid spread throughout the flock. Salmonella positive birds at the time of slaughter have high numbers of organisms in their intestines as well as on external surfaces. Slaughtering and processing operations have the potential to contaminate the poultry carcase with faecal material and to facilitate cross contamination between pathogen-positive birds and pathogen-negative birds, leading to increased prevalence of Salmonella in finished products. This may occur at various stages of processing including unloading of birds, scalding, plucking, evisceration, washing and chilling. Care must be taken during evisceration to ensure the viscera is not damaged or ruptured as this can lead to significant contamination of the carcase. The means by which broiler chickens become exposed to contamination with Campylobacter during primary production is multi-factorial (FSANZ, 2005). Numerous factors in combination result in the introduction and spread of the organism within a flock. Campylobacter will colonise individual birds at two or three weeks of age, and usually within a week virtually all birds in the flock will become infected. Horizontal transmission is mainly through contaminated water, litter, insects, rodents, and wild birds and by farm workers via their boots (Wallace, 2003). The implication of this is that, unless a flock is Campylobacter free, virtually all birds in a positive flock will be carrying Campylobacter in their intestinal tract at the time of slaughter in high numbers. The FSANZ risk assessment concluded that although poultry meat may occasionally be contaminated with other pathogens, Salmonella and Campylobacter are the primary pathogens of concern and risk management strategies should be targeted to controlling these organisms (FSANZ, 2005). These two organisms are the leading causes of foodborne illness in Australia each year and are frequently isolated from raw poultry meat. They become associated with poultry during primary production and their prevalence and/or levels may be amplified during primary processing and further handling through to consumption. The FSANZ risk assessment found that the risk associated with the other pathogens was primarily a concern during the production of processed poultry meat products and temperature abuse of RTE poultry products (FSANZ, 2005). The hazards associated with further processing of poultry meat are outlined in the sections on processed meat. Game meat The main species harvested as game meat are kangaroo and pigs. Very little data exists for hazards in game meat, however kangaroo meat has been studied in some depth as the industry attempts to market the product to increase consumption rates Food Safety Scheme Risk Assessment Page 42 of 189 in the general population. Kangaroo meat is anecdotally stated as being a particular risk for toxoplasmosis and salmonellosis, however it appears as if there is little evidence to substantiate that kangaroo meat has Salmonella rates higher than other animals, and there is no known case of toxoplasmosis being transmitted by eating kangaroo meat in Australia. There is a risk of physical hazards in game meat, however strict guidelines exist for the harvesting of product. The animal must be head shot, not only to ensure a quick kill but also to prevent damage to the skin, carcase and internal organs which are required for inspection purposes, and to limit the potential for shot to contaminate the meat. Processed meats The risk posed by processed meats, such as manufactured and fermented meats was highlighted in the National Risk Validation Project (Food Science Australia & Minter Ellison Consulting, 2002), with these products classified as a high risk and earmarked for the introduction of food safety programs. The pathogens of significance for processed meats were identified as L. monocytogenes, Salmonella and pathogenic E. coli, as these had been previous causes of foodborne illness outbreaks in Australia. The primary sources of contamination for processed meats includes the contaminants associated with raw meat (eg pathogenic E. coli, Clostridium spp., Salmonella serovars), other ingredients such as spices (eg Salmonella serovars) and from the processing environment (eg L. monocytogenes), especially for products that are subject to further processing such as slicing (MLA, 2003a). Control of these organisms is normally through appropriate processing with Critical Control Points (CCPs) to inactivate these pathogens, such as cooking, fermentation with starter cultures and curing (MLA, 2003b). However, this does not eliminate any contamination that occurs post-processing, and as such L. monocytogenes has been the cause of many recalls of processed meats (Table 62 in Appendix 2) and responsible for several very large outbreaks overseas from RTE processed meat products (Doolittle, 2008). A potential chemical hazard with processed meat is the inclusion of preservatives such as sorbate and nitrate salts, particularly for cured products, in exceedance of limits in the Food Standards Code (MLA, 2003b). Exposure assessment Consumption of meat Daily consumption of meat and meat products was assessed during the National Nutrition Survey (ABS, 1995), which examined overall consumption of meat, including poultry and processed meats. The survey showed that approximately three quarters of the Australian population regularly consume meat and meat products, with males consuming slightly higher levels than females (Table 9). Consumption of specific types of meat was estimated in the ABARE report (ABARE, 2007) and by MLA through production statistics (MLA, 2008a; MLA 2008b). Food Safety Scheme Risk Assessment Page 43 of 189 Beef Consumption of beef and veal in 2006 was estimated by ABARE at 38.1 kg per person per year, while MLA estimates beef consumption alone at 35.6 kg beef per year (MLA, 2008a). Consumption of beef and veal has been steadily decreasing since the peak consumption period of the late 1970s. Sheepmeat Australians are among the highest consumers of lamb in the world, consuming 11.4kg of lamb and 2.7kg of mutton per person every year (MLA, 2008b). Pigmeat A considerable amount of the 23.5 kg of pork consumed by each person per year is eaten as processed product (see consumption of processed meats). Consumption of fresh pork in 2006 was estimated at 11.1 kg per person (APL, 2008). Consumption of poultry meat Annual per capita consumption of poultry meat in 2006 was estimated at 39.5 kg (ABARE, 2007). Chicken consumption accounts for approximately 95% of all poultry consumed, with the annual consumption of turkey and duck in Australia estimated at 1.6 kg and 0.5 kg per person respectively (FSANZ, 2005). FSANZ estimated the total number of poultry servings in Australia annually to be 2,880,000,000, with an average serving size of 250g. Consumption of game meat Very little consumption data specific to game meat is available and, when compared to the major meat categories, forms a very small part of the average persons diet. Ampt & Owen (2008) surveyed consumer attitudes towards the consumption of kangaroo meat and found that 58.5% of respondents had tried the meat, with 14.5% having eaten kangaroo meat at least four times in the past year (classed as ‘medium to high’ consumers). In NSW/ACT there were 549 respondents surveyed, with 14.2% were classified as medium to high consumers, 19.5% were nonconsumers, 43.9% were one-off or low consumers, and 22.4% objected to eating kangaroo meat. Men were marginally more likely to consume kangaroo than women. Ampt & Owen (2008) went on to report that although there had been considerable changes in the kangaroo industry over the past ten years, with the widespread availability of kangaroo in domestic supermarkets, the industry still remains reliant on export markets. Food Safety Scheme Risk Assessment Page 44 of 189 Table 9 – Consumption of meat and meat products in Australia Sex Age Male Male Male Male Male Male Male Male Male Female Female Female Female Female Female Female Female Female 2–3 4–7 8 – 11 12 – 15 16 – 18 19 – 24 25 – 44 45 – 64 65+ 2–3 4–7 8 – 11 12 – 15 16 – 18 19 – 24 25 – 44 45 – 64 65+ Proportion of persons consuming meat, poultry, game products and dishes 5 (%) 76.7 72.4 77.0 78.8 80.9 84.1 84.4 87.6 84.7 71.7 73.6 78.3 80.2 74.5 74.0 76.9 77.5 79.7 Median daily intake for consumers of meat, poultry, game products and dishes (g/day) 62.7 84.3 115.6 143.0 196.0 224.0 191.8 168.0 126.5 52.3 77.9 95.3 113.1 131.0 141.4 126.0 114.3 83.0 adapted from National Nutrition Survey (ABS, 1995) Table 10 – Consumption of processed meats in Australia Product category Processed meats (hams, whole muscle cooked meats) Cooked sausages (frankfurters, saveloys) Pâté and meat paste Daily serving size (grams per person) 28 – 58 63 – 108 40 – 56 adapted from MLA (2006) Consumption of processed meats The MLA (2006) reported consumption data for categories of processed meats. On any given day between 20 and 50% of the population consume processed meats. The amounts consumed are shown in Table 10. Consumption of processed pig meat, as bacon and ham, contributes approximately 14.4 kg per person per year (APL, 2008). 5 Meat, poultry and game meat products and dishes are defined in the National Nutrition Survey (ABS, 1995) as including the following: - muscle meat, - poultry and other feathered game, - organs meats and offal, products and dishes, - sausages, frankfurts and saveloys, - processed meat, - mixed dishes where beef or veal is the major component, - mixed dishes where lamb or pork, bacon or ham is the major component, - mixed dishes where poultry or game is the major component Food Safety Scheme Risk Assessment Page 45 of 189 Hazard characterisation Foodborne illness outbreaks from meat and meat products Table 11 summarises the foodborne illness outbreaks attributed to all meat and meat products, including poultry, game and processed meats. This data also includes outbreaks where meat was an ingredient in an implicated food (more detailed information on each outbreak is included in Table 66 in Appendix 3). Table 11 – Summary of foodborne illness outbreaks attributed to all meat, meat products and meat included as an ingredient (1995–2008) (including poultry, game meat and processed meat products) Hazard Salmonella serovars C. perfringens Campylobacter spp Toxin Norovirus Viral S. aureus B. cereus L. monocytogenes Pathogenic E. coli Shigella spp. Unknown Total Australian outbreaks (1995–2008) 74 27 14 6 5 5 4 2 1 1 1 63 203 Cases 1829 804 106 520 201 175 51 20 32 173 13 766 4690 Hospitalisations 97 0 2 0 5 0 5 0 0 0 0 5 114 Deaths 2 0 0 0 0 0 0 0 0 1 0 0 3 Meat The European Food Safety Agency (EFSA, 2008) evaluated the relative contribution of different meat categories to cases of foodborne salmonellosis infections in humans and found that poultry was more often implicated than beef, pork and lamb. Adak et al (2005) used data from foodborne illness outbreaks in England and Wales to attribute the source of various types of implicated meats. In this study the most important cause of foodborne illness was chicken (398,420 cases, 141 deaths) while red meat was also a very significant source (287,485 cases, 164 deaths). Three major microbiological baseline surveys have been undertaken by MLA of red meat processed in Australian abattoirs (MLA, 2000; MLA, 2005). These surveys provide a useful indication of the prevalence and levels of hygiene indicators such as Total Viable Count (TVC), as well as pathogens such as Escherichia coli O157:H7 and Salmonella serovars on carcases and in boneless meat (see Table 12). The surveys have shown an improvement in both the prevalence and levels of microbiological contamination every 5–6 years that the surveys have been conducted. This has been attributed to significant improvements in hygiene and sanitation during primary processing and efficient cooling of carcases. A baseline survey of NSW abattoirs by the NSW Food Authority (Bass et al, 2008) found a strong commitment to food safety and that facilities were managing food safety issues well. Surveys of carcase and meat portion load-out temperatures found that 96% of product complied with temperature requirements. However, only 38% of offal samples complied. The microbiological hygiene of beef carcases sampled were Food Safety Scheme Risk Assessment Page 46 of 189 categorised as excellent 6 or good, with TVC counts ranging from 0.48 log cfu/cm2 to 3.95 log cfu/cm2. One quarter of the beef carcases sampled tested positive for E. coli. This prevalence is higher than that found in the national MLA surveys, but the levels detected were quite low, with counts ranging from -0.89 log cfu/cm2 to 0.69 log cfu/cm2. Almost all sheep carcases (lamb/hogget/mutton) were rated as excellent or good for TVC and E. coli respectively. The sheep TVC counts ranged from 0.30 log cfu/cm2 to 5.47 log cfu/cm2. Just over half (53%) of the sheep carcases tested were positive for E. coli, counts ranging from -0.48 log cfu/cm2 to 2.24 log cfu/cm2. The hygiene results for pig carcases showed that 80% were rated as excellent or good for TVC, and 91% rated as excellent or good for E. coli. The pig TVC counts ranged from 0.85 log cfu/cm2 to 5.03 log cfu/cm2. The percentage of carcases testing positive for E. coli was 63%, with counts ranging from -1.10 log cfu/cm2 to 1.30 log cfu/cm2. European surveillance schemes have found the proportion of fresh beef positive for Salmonella serovars to be below 0.6% at slaughter, with higher levels at retail (8.3%) (EFSA, 2008). Despite worldwide consumption of lamb and mutton, these products have rarely been associated with salmonellosis in humans. There has been a two-pronged approach to controlling hazards in the meat industry. Hazards related to zoonotic diseases have been controlled through the application of preventative programs, such as the Brucellosis and Tuberculosis eradication campaign (BTEC), which was aimed at eradicating brucellosis and tuberculosis from all Australian cattle. As a result, Australia has been free of brucellosis caused by Brucella abortus since 1989, and bovine tuberculosis-free status was achieved in 1997, which is now assessed through the Tuberculosis Freedom Assurance Program (TFAP) and National Granuloma Submission Program (NGSP). The second prong has been the implementation of the Australian Standard for the hygienic production and transportation of meat and meat products for human consumption (FRSC, 2007c) and previous versions of this standard. 6 Meat Standards Committee (2002) – Microbiological testing for process control in the meat industry - guidelines defined the following categories: - Total Viable Count (TVC) Excellent (<103 cfu/cm2) Good (103-104cfu/cm2) Acceptable (104–105cfu/cm2) Marginal (105-106cfu/cm2) - E. coli Excellent (not detected) Good (>0-10 cfu/cm2) Acceptable (10-100cfu/cm2) Marginal (100-103cfu/cm2). Food Safety Scheme Risk Assessment Page 47 of 189 Table 12 – Prevalence of microbiological hazards in Australian beef and sheep meat Beef carcases Number of samples TVC (mean log cfu/g) E. coli (%) S. aureus (%) Salmonella (%) E. coli O157:H7 (%) Listeria Campylobacter Boneless beef Number of samples TVC (mean log cfu/g) E. coli (%) S. aureus (%) Salmonella (%) E. coli O157:H7 (%) Boneless sheepmeat Number of samples TVC (mean log cfu/g) E. coli (%) S. aureus (%) Salmonella (%) E. coli O157:H7 (%) 1993 survey 1998 survey 2004 survey 1043 3.02 19 128/465 (27.5%) 4/1043 (0.38%) 4/1036 (0.38%) 4/190 (2.1%) 2/753 (0.26%) 1268 2.43 11 3.9 0.6 not detected 1155 1.33 4.9 20.1 0 0.1 929 2.77 16.7 n/a 6/921 (0.65%) 0/804 (not detected) 987 3.52 5.1 17.5 0.1 not detected 1082 1.19 1.1 2.6 0.1 0 415 3.47 47.7 n/a 27/415 (6.5%) 1/342 (0.3%) 467 3.29 24.5 38.6 1.3 1.3 560 1.81 4.3 14.1 0.5 0.2 0 adapted from MLA (2000); MLA (2005) NSW legislation requires that any abattoir processing meat must comply with the AS4696:2007. As part of compliance with this standard, all abattoirs must have qualified meat safety inspectors (meat safety officer) to conduct ante-mortem inspections of livestock prior to slaughter. This is used to identify any stock suspected of carrying infectious zoonotic diseases, which may then be culled to prevent spread to healthy stock. Online post-mortem inspection in abattoirs is used to identify and excise diseased tissues and organs and/or to exclude diseased carcases from human consumption. Many studies have been undertaken to assess the influence of different processing practices in contributing to microbial contamination of carcases. Widders et al (1995) showed that the level of microbial contamination of meat was influenced by the level of carcase contamination at boning, and by the boning process itself. If carcases were heavily contaminated, the contamination of processing surfaces was irrelevant in determining eventual microbial loads on meat. However, where carcase contamination was at low to moderate levels, cutting boards were a major source for microbial dissemination during the boning process. It was shown that improved sanitation of cutting surfaces in the boning room could result in a significant reduction in microbial contamination on the surface of meat. Special control measures have also been implemented to target specific hazards of concern in pigs. In order to minimise pig carcase contamination with Y. enterocolitica during slaughter, the tongue and pharynx are removed early in the slaughter process to reduce the leakage of saliva and contaminated material from the tongue and tonsils onto the carcase (Barton & Robins-Browne, 2003). Food Safety Scheme Risk Assessment Page 48 of 189 The NRS and Australian Total Diet survey results show that misuse of agricultural and veterinary chemicals within the meat industry is low, with most analyses returning either no detectable residues or residues well below established legal limits. As a result, the Australian dietary exposure to pesticides and contaminants falls well within acceptable health standards (MLA, 2003a). Poultry meat The FSANZ poultry risk assessment summarised OzFoodNet data for foodborne illness outbreaks in Australia from poultry meat products (FSANZ, 2005). Between 1995 and 2002 they reported 46 outbreaks involving 1170 cases. The data in Table 66 of Appendix 3 includes and updates the outbreaks from the FSANZ report. From 1995–2008, 94 outbreaks were attributed to products containing chicken, affecting 1815 people and 54 requiring hospitalisation. In addition to these outbreaks, another six outbreaks were observed in institutional settings serving vulnerable persons. Details on these outbreaks are included in Table 69 of Appendix 3. A case control study conducted on foodborne illness outbreaks in New Zealand concluded that consumption of raw and undercooked chicken was the most important source of human campylobacteriosis (Eberhart–Phillips et al, 1997). The EFSA (2008) reported prevalence of Salmonella in EU member countries at slaughter ranging from 5.7% to 21.5%, while prevalence in fresh turkey meat varied from 0 to 11%, fresh duck meat from 15 to 39% and 10% in fresh geese meat. Although data is not readily available for contamination rates at slaughter for Australian birds, a survey of retail chicken in NSW from 2005 to 2006 found 47.7% of poultry samples contained low levels of Salmonella. However, of the Salmonella serovars isolated approximately 65% were the serovar S. Sofia, considered of very low virulence to humans. In addition, 87.8% of poultry samples were found to be contaminated with Campylobacter (Pointon et al, 2008, summarised in Table 13). All facilities slaughtering and processing poultry in NSW are required to comply with AS 4465:2005, the Australian Standard for the construction of premises and hygienic production of poultry meat for human consumption (FRSC, 2007a). This requires ante-mortem inspection of poultry presented for slaughter to reject any moribund, unhealthy or diseased birds and post-mortem inspection to identify and apply a disposition to any carcase and parts that are not considered wholesome for human consumption. In addition to the regulatory requirements, there are various industry codes of practice and guidelines, such as the National Biosecurity Manual Contract Meat Chicken Farming (ACMF, 2003) and Model Code of Practice for the Welfare of Animals – Land Transport of Poultry (PISC, 2006). These codes of practice concentrate on prevention of animal disease and welfare aspects, with potential implications for food safety. The extent of compliance with these control measures varies within the poultry industry, depending on whether it is a legislative requirement or a voluntary scheme. Food Safety Scheme Risk Assessment Page 49 of 189 Table 13 – Prevalence of microbiological hazards on retail chicken meat in NSW (2005–06) Retailer Product Butcher Skin off Skin on Supermarket Specialty store Whole bird Skin off, bulk Skin off, tray Skin on, bulk Skin on, tray Whole bird Skin off Skin on Whole bird TOTAL Number positives / total samples (%) 18/28 (64.3) 29/47 (61.7) 7/9 (77.8) 21/37 (56.8) 39/106 (36.8) 28/50 (56.0) 63/150 (42.0) 11/37 (29.7) 14/28 (50.0) 28/47 (59.6) 4/10 (40.0) 262/549 (47.7) Salm onella Mean concentration ± SD NonSofia (%) -1.31 ± 0.58 7.1 -1.18 ± 0.70 44.7 -1.70 ± 0.95 0.0 -1.41 ± 0.33 13.5 -1.38 ± 0.41 16.0 -1.43 ± 0.47 18.0 -1.48 ± 0.67 9.3 -1.75 ± 0.76 5.4 -1.33 ± 0.58 21.4 -1.38 ± 0.60 21.3 -2.05 ± 0.04 10 -1.42 ± 0.60 15.8 Cam pylobacter Number positives / total samples (%) 27/28 (96.4) 40/47 (85.1) 8/9 (88.9) 35/37 (94.6) 95/106 (89.6) 42/50 (84) 124/150 (82.7) 34/37 (91.9) 25/28 (89.3) 44/47 (93.6) 8/10 (80) Mean concentration ± SD 482/549 (87.8) 0.87 ± 0.45 1.14 ± 0.57 1.24 ± 0.64 1.11 ± 1.00 1.06 ± 0.35 0.90 ± 0.27 0.82 ± 0.23 0.66 ± 0.36 0.61 ± 0.53 1.04 ± 0.35 0.90 ± 0.35 0.77 ± 0.37 adapted from Pointon et al (2008) The high risk factors for poultry becoming contaminated with Salmonella or Campylobacter were identified in the FSANZ scientific assessment (FSANZ, 2005). The development of Standard 4.2.2 – Primary Production and Processing Standard for poultry meat in the Food Standards Code aims to reduce the contamination of poultry, poultry carcases and poultry meat by pathogenic Salmonella and Campylobacter through the implementation of control measures on-farm, as well as maintain existing control measures during processing at abattoirs. Game meat NSW legislation requires that harvesting facilities, primary processing and storage facilities and vehicles comply with AS4464:2007, the Australian Standard for the hygienic production of wild game meat for human consumption (FRSC, 2007b). This requires that all carcases are subject to inspection by a qualified meat safety inspector and temperature control of the carcase is maintained. There is no data to indicate that game meat has been the subject of any foodborne illness outbreaks or recalls. There is also no recent data to indicate prevalence of microorganisms on game meat carcases, although it is assumed that with similar control measures in place to the broader meat industry, that the prevalence of pathogens may be similar. Food Safety Scheme Risk Assessment Page 50 of 189 The incidence of zoonoses and other public health risks from kangaroo meat was investigated and summarised by Andrew (1988), quoted in Pople & Grigg (1999). The work summarised the records of inspections between 1980 and 1987 made of carcases by AQIS officers at export game meat establishments. Of the 204,052 kangaroo carcases harvested, 196,104 were passed as fit for human consumption and 7948 were rejected. Of those rejected, 81% were rejected for reasons not associated with parasites or pathology, mainly poor handling, particularly inadequate refrigeration. Of the rest, 1452 were rejected because of a nematode parasite, Pelicitus roemeri, which is harmless to humans but is considered unsuitable for human consumption. Processed meat products Processed meat products have been implicated in several large scale food poisoning outbreaks, both overseas and within Australia (see Table 14 and Table 66 of Appendix 3). For the period 1991–2000, the National Risk Validation Project identified greater than 323 cases of foodborne illness and one death attributed to the consumption of fermented meats, with a further 97 cases and two deaths attributed to other manufactured meat products. The pathogens implicated in these outbreaks were pathogenic E. coli, L. monocytogenes and Salmonella and the total cost of foodborne illness associated with fermented and manufactured meats was calculated to $77 million per year (Food Science Australia & Minter Ellison Consulting, 2002) The most significant outbreak from a processed meat product occurred in 1995 in South Australia from Garibaldi-brand Mettwurst, with over 150 people ill and the death of a young child from E. coli O111. Well controlled fermentation and maturation should achieve a low pH and water activity to eliminate any pathogens present in the raw meat ingredient. However, uncontrolled fermentation, as was the case with the Garibaldi product, can lead to survival of pathogens. This outbreak led to changes to the Food Standards Code and regulations regarding the manufacture of uncooked comminuted fermented meats. An outbreak of listeriosis from Conroy’s smallgoods occurred in South Australia in 2005, resulting in three deaths of hospital patients. Listeria was isolated from the slicing machines in the factory used to slice the deli meats. Details are included in Table 69 in Appendix 3, as the food was served to vulnerable persons. The cost of the subsequent recall by Conroy’s was in the order of $2 million. A Canadian outbreak in 2008 from Maple Leaf Foods Inc. resulted in 20 deaths, and the resultant recall of more than 220 product lines and settlements from class action lawsuits was in the order of $27 million (AUS$ 33 million) (Doolittle, 2008). The manual handling associated with preparing and packaging processed meat products tend to lend themselves to contamination with L. monocytogenes. Surveys have shown a significant number of RTE processed meat products are contaminated with this organism (Table 15). Sliced meats in particular tend to have higher contamination rates with L. monocytogenes, although actual numbers of organisms are quite low. The long shelf life associated with these products (~ six weeks) can allow growth of the organism to occur. Advice provided to susceptible persons, such as pregnant women, is to avoid consuming pre-packaged sliced meats. Table 62 of Appendix 2 shows the number of recalls from RTE processed meats from 2004-08, during which time there have been 33 recalls, mostly due to contamination with L. monocytogenes. Food Safety Scheme Risk Assessment Page 51 of 189 NSW legislation requires that any facility producing processed meat must comply with AS4696:2007 the Australia Standard for the hygienic production and transportation of meat and meat products for human consumption (FRSC, 2007c). In addition to this, there are industry produced documents such as Guidelines for the safe manufacture of smallgoods (MLA, 2003b) and Listeria monocytogenes in smallgoods: Risks and controls (MLA, 2006), which provide information on hygiene and sanitation and CCPs for controlling hazards. Table 14 – Foodborne illness outbreaks of listeriosis from processed meats Year 1987–89 1990 1992 1993 1996 1998–99 1999 1999 1999 2000 2000–01 2002 2005 2008 Country United Kingdom WA France France SA USA France USA France New Zealand USA USA SA Canada Processed meat Pâté Pâté Jellied pork tongue Pork rillettes, pâté Diced chicken Hot dogs and deli meats Ham rillettes Pâté Jellied pork tongue Corned beef Turkey franks Deli meats (poultry) Corned beef Deli meats Cases 366 11 279 39 5 101 >6 11 23 2 >29 >50 5 50 Deaths 94 6 85 11 1 21 2 3 7 >7 11 3 20 adapted from MLA (2006); Doolittle (2008) Table 15 – Prevalence of Listeria m onocytogenes in processed meats Product category Processed meats (hams, whole muscle cooked meats) Cooked sausages (Frankfurters, saveloys) Pâté and meat paste Contamination rate (%) 4.8 2.8 1.2 adapted from MLA (2006) Risk characterisation Red meat The MLA risk profile examined the risk of fresh meats consumed in the home and found that meat consumed as cuts, roasts, chops, steak are low risk (MLA, 2003a). These products normally receive a cooking step by the end consumer that will reliably eliminate most pathogenic bacteria. However, the importance of cross contamination from pathogens in raw and undercooked meat across to RTE foods was highlighted by Lake et al (2004) as a potential source of infection from Yersinia in pork (Table 16), and as a potential source for large numbers of Salmonella food poisoning cases (Table 17). It was predicted that if the cross contamination rate of Salmonella from raw meat to RTE foods increased from 1% to 10% it would result in almost an extra 4800 cases, while an increase to a 50% cross contamination rate would result in more than 26,000 cases of foodborne illness in Australia each year, where fresh meat was the cause (MLA, 2003a). Another hazard categorised as high risk by the MLA risk profile was undercooked sheep meat or liver contaminated with Toxoplasma gondii, particularly when Food Safety Scheme Risk Assessment Page 52 of 189 consumed by pregnant women (MLA, 2003a). This area was identified as a data gap in work undertaken on the New Zealand meat industry by Lake et al (2002b). While it was predicted there may be more than 600 cases of illness due to infection withToxoplasma gondii per annum (200 in pregnant women), further work was required to fully understand the risk factors involved. Undercooking of meat and hamburgers is associated with survival of pathogenic E. coli and the ranking of this pathogen as a medium hazard. However, a study by the FSIS (2002) in the USA calculated the probability of illness occurring as extremely low. This work estimated that the probability of E. coli O157:H7 surviving in a piece of cooked steak was 0.000026% (2.6 of every 10 million servings), given normal cooking practices. It was shown that even inadequate cooking of meat would still reduce the numbers of pathogenic E. coli present on the meat, albeit to a lesser degree than proper cooking. The predicted number of food poisoning cases from E. coli O157:H7 in cooked steaks was calculated to be one case for every 15.9 million servings (FSIS, 2002). The risk of illness from pathogenic E. coli in New Zealand meat was considered low by Lake et al (2002a), as there was no data to link illness to pathogenic E. coli in that country. The risk from comminuted meat such as hamburgers is considered greater, as the contamination may be spread throughout the product, as opposed to just the surface on an intact steak. The MLA risk profile estimated that if all hamburgers were appropriately cooked, there would be no illness. However, if 20% of hamburgers were undercooked, there would be six illnesses per annum in Australia (MLA, 2003a). The NZFSA also commissioned risk profile work on tuberculosis (Cressey et al, 2006) and Campylobacter (Lake et al, 2007c) from red meat, and both were considered low risk (Table 16). These were not examined in the MLA risk profile, as Australia has been declared tuberculosis free and a definitive association of Campylobacter with red meat could not be established (MLA, 2003a). The risk from C. perfringens from meat consumed in the home was considered medium (Table 17), with poor cooling and reheating the main contributing factors. Problems with C. perfringens have arisen more in large-scale, catering-type operations than in the home, where the spore forming bacteria have been allowed to germinate and grow due to poor cooling of meat-based dishes. Food Safety Scheme Risk Assessment Page 53 of 189 Table 16 – NZFSA risk profile outcomes examining hazards in meat Hazard Risk Shiga toxin-producing Escherichia coli in red meat and meat products Overseas studies have consistently linked human cases of STEC infection and particularly E. coli O157:H7 to consumption of red meat in the form of undercooked hamburgers, not one case in New Zealand has been associated with regulated foods. (Lake et al, 2002a) Toxoplasma gondii in red meat and meat products (Lake et al, 2002b) Yersinia enterocolitica in pork (Lake et al, 2004) Mycobacterium bovis in red meat (Cressey et al, 2006) Campylobacter jejuni/coli in red meat (Lake et al, 2007c) Food Safety Scheme Risk Assessment Toxoplasma gondii is a protozoan parasite that causes disease in humans with a range of outcomes including, at worst, miscarriages. Cysts in the muscle tissue of meat animals may result in infection when eaten. The significance of human infections, especially congenital toxoplasmosis, in New Zealand is unknown and has been identified as a knowledge gap Pigs are known to be frequently contaminated with Y. enterocolitica, but effective cooking or pasteurisation will eliminate Y. enterocolitica from foods. Pork consumption has consistently been associated with yersiniosis in studies in New Zealand and overseas, with cross contamination from uncooked meats to RTE foods a potential source of infection. A proportion of human tuberculosis cases have been caused by Mycobacterium bovis. While transmission of tuberculosis to humans through consumption of M. bovisinfected meat is possible, no cases of this have been confirmed in New Zealand and it is considered low risk. Seventeen outbreaks of campylobacteriosis in New Zealand from 1999 to 2004 have been associated (weakly) with red meat consumption. Data in New Zealand indicates there is low but consistent contamination across pork, beef, and sheep meat. On this basis it is identified as a minor risk factor for exposure to Campylobacter in New Zealand. Page 54 of 189 Table 17 – Risk ranking for meat and meat products Meat product Severity 7 Effect of production, processing, handling on the hazard ↓↑→ Retail meats consumed in the home (steak, mince, chops, roast, fresh sausages) Consumed Toxoplasma IB Medium No ↓freezing, → undercooked/raw gondii Consumed undercooked Reheated roasts Reheated roasts Potential pathogen Poor cooling 7 8 Hazard Probability Growth required to cause illness Consumer does pathogen reduction step Epidemiological link Risk rating Predicted annual number of illnesses (in Australia) 8 Yes/No Yes High EHEC IB Low Yes ↓→ Yes Yes Medium 715 (242 in pregnant women) No estimate C. perfringens S. aureus Aeromonas Mycobacterium paratuberculosis Bacillus Yersinia enterocolitica III III III III/IB Low Medium Low Low Yes Yes Yes N/A ↓↑ ↓↑ ↓↑ ?? No No Yes ?? Yes Yes No ?? Medium Low Low Low No No No No III III Low? Low?? Yes Yes ↓↑ ↓↑ Yes Yes ??No ? Low Low No estimate No estimate estimate estimate estimate estimate ICMSF (2002) defines the level of severity as follows: − IA – Severe hazard for general population, life threatening or substantial chronic sequelae or long duration − IB – Severe hazard for restricted populations, life threatening or substantial chronic sequelae or long duration − II – High hazard incapacitating but not life threatening sequelae rare moderate duration. − III – Moderate, not usually life threatening no sequelae normally short duration symptoms are self limiting can be severe discomfort. Data from Sumner (2002) predicted annual numbers of illness per annum for the South Australia population (1.5 million), the MLA Risk Profile (MLA, 2003a) used an Australian population figure of 19.7 million. These estimates have been extrapolated to the current population of Australia estimated by ABS (2009) as approximately 21.6 million, by multiplying by a factor of 14.4 and 1.1 respectively. Food Safety Scheme Risk Assessment Page 55 of 189 Retail meats consumed in the home (steak, mince, chops, roast, fresh sausages) ↓↑ Assume 1% cross Salmonella II/IB Low Yes contamination rate ↓↑ Assume 10% Salmonella II/IB Low Yes cross contamination rate ↓↑ Assume 50% Salmonella II/IB Low Yes cross contamination rate Enterohaemorrhagic E. coli in hamburger ↓→ Hamburgers EHEC IA/IB Low No ↓→ Hamburgers EHEC IA/IB Low No assume 50% undercooked ↓→ Hamburgers Salmonella II/IB Low Yes Yes Yes Medium 583 Yes Yes High 5,830 Yes Yes High 29,370 Yes Yes Yes Yes Low Low 0 7 Yes Yes Low 0 adapted from Sumner (2002); MLA (2003a) Food Safety Scheme Risk Assessment Page 56 of 189 Table 18 – Risk ranking for processed poultry meat products Processed meat product Hazard Severity Probability Growth required to cause illness Consumer does pathogen reduction step Epidemiological link Risk rating Predicted annual number of illnesses (in Australia) 9 Yes Effect of production, processing, handling on the hazard ↓↑→ ↓ Processed chicken Processed chicken Salmonella II/IB Low No Yes High 864 Campylobacter IB Low Yes ↓↑ No Yes High 86,400 adapted from Sumner (2002) Table 19 – NZFSA risk profile outcomes examining hazards in poultry meat Hazard Risk Salmonella (non-typhoid) in poultry (whole and pieces) (Lake et al, 2004) Campylobacter jejuni/coli in poultry (Lake et al, 2007a) Salmonellosis is the second most frequently notified enteric disease in New Zealand. Poultry meat is regarded as an important source of infection Campylobacter jejuni/coli in mammalian and poultry offals (Lake et al, 2007b) 9 Campylobacter is the most frequently notified cause of enteric disease in New Zealand. Consumption of chicken was linked with Campylobacter infection and several outbreaks of campylobacteriosis identified undercooked chicken as the transmission vehicle The consumption of poultry and mammalian offal is low in comparison to other meat types. However the high prevalence of Campylobacter in raw sheep and chicken livers is of concern, especially when some advice to consumers is to cook chicken livers "until they're pink in the middle" or "lightly sautéed". Offal for pet food is frequently contaminated and handling may provide a risk of infection Data from Sumner (2002) predicted annual numbers of illness per annum for the South Australia population (1.5 million). These estimates have been extrapolated to the current population of Australia estimated by ABS (2009) as approximately 21.6 million, by multiplying by a factor of 14.4. Food Safety Scheme Risk Assessment Page 57 of 189 Poultry meat In the FSANZ scientific assessment of poultry meat, it was found there was reasonable evidence to indicate poultry is the vehicle for a significant proportion of campylobacteriosis and salmonellosis cases in Australia (FSANZ, 2006). This conclusion was made on the basis of epidemiological data, results from microbiological surveys of raw poultry carcase and outputs from a probabilistic model. Sumner (2002) estimated large numbers of foodborne illness cases to be due to processed chicken products, greater than 80,000 cases per annum from Salmonella and Campylobacter in Australia (Table 21). Work commissioned by the New Zealand Food Safety Authority has also found the presence of these organisms on poultry to be a significant source of infection (Table 19). Management of both Salmonella and Campylobacter requires an approach across both primary production and processing. Good hygienic practices and good agricultural practices are necessary prerequisites for the management of Salmonella and Campylobacter, and appropriate hygiene and sanitation is required during processing to minimise cross contamination between birds. Surveys of poultry pieces available for retail sale show that a large proportion of poultry carries these organisms, creating a risk of foodborne illness from consuming undercooked chicken, but also the risk of cross contamination occurring in food preparation areas. FSANZ (2005) found that the implementation of control measures to reduce the prevalence and levels of Salmonella and Campylobacter by ten-fold at the end of processing could result in a 74% and 93% reduction in the number of predicted cases of illness respectively. FSANZ identified the following significant factors contributing to contamination of poultry meat with Salmonella and Campylobacter : • On-farm contamination with Salmonella is mainly due to contaminated feed and water, environmental sources and transmission from contaminated eggs • Important on-farm risk factors for Campylobacter are the age of the birds and environmental factors • The presence and amount of Salmonella on a chicken after processing largely determines the likelihood of salmonellosis • Inadequate hand washing and food handling practices determine the likelihood of human illness from Campylobacter • Adequate cooking is the main means of minimising the risk to human health from both pathogens The FSANZ scientific assessment found little evidence of public health risks associated with chemical hazards from Australian poultry meat. The report concluded that the current regulatory measures appear to adequately protect public health and safety with respect to chemical hazards (FSANZ, 2006). Game meat Evidence suggests that the consumption of kangaroo meat and other game meat present little risk as a source of foodborne illness when compared to other forms of meat. Food Safety Scheme Risk Assessment Page 58 of 189 Processed meats Sumner (2002) stated that the highest risk products in the meat industry in South Australia are smallgoods, predominantly due to pathogenic E. coli, Salmonella and L. monocytogenes. The risk of L. monocytogenes from processed RTE meats in New Zealand was examined by Lake et al (2002), who found that these products were a significant route of infection in that country. The FDA/USDA risk assessment for L. monocytogenes identified processed meats products or ‘deli meats’ as the highest risk food from the 23 RTE foods examined in the USA (FDA/USDA, 2003). Deli meats were the only food to be ranked as very high risk and when extrapolated to the Australian population are predicted to be responsible for 133 cases of listeriosis per annum (see Table 22). In addition, frankfurters that were not reheated were ranked as high risk by the FDA/USDA in their risk assessment. However it is not believed that this practice is as common in Australia as in the US. Pâté and meat spreads were ranked as high risk on a per serving basis, predominantly due to the probability of contamination with L. monocytogenes post cooking, but this did not correlate with a high number of predicted illnesses due to low consumption rates. The MLA risk profile examined different scenarios for processed meat products and provided risk rankings and predicted numbers of illness (MLA, 2003a, summarised in Table 21). It was predicted that processed deli meats were responsible for 43 cases of listeriosis in Australia per annum. Although there are 50-60 cases of listeriosis reported each year in Australia, it is estimated that due to under-reporting, the true number is closer to 120 per year. Therefore, processed meats were considered to be the source of approximately one third of listeriosis cases in any one year (MLA, 2006). The MLA guideline Listeria monocytogenes in smallgoods: risks and controls (MLA, 2006) proposes measures to control post processing contamination with L. monocytogenes in processed meat: • install effective GMPs and sanitation standard operating procedures (SSOPs), particularly in post-cooking operations such as slicing/portioning and packing • incorporate antimicrobials into formulations of products which are intended for slicing and packing as long shelf-life products • employ technologies for in-pack pasteurisation In late 2008, the NSW Food Authority implemented national testing requirements for sliced pre-packaged RTE meat products (Meat Standards Committee, 2008). This Listeria management program involved the introduction of minimum finished product and environmental testing to any facilities manufacturing these products (NSW Food Authority, 2008). The MLA risk profile (MLA, 2003a) and the work of Gilbert et al (2007) considered the risk of pathogenic E. coli (STEC and EHEC) from UCFM products such as salami. Both studies found that well controlled processes, including efficient fermentation and a maturation producing a low pH and water activity, effectively controlled the hazard (Table 20 and Table 21), with a 2-3 log reduction in E. coli. As a result, with a well controlled process, it was predicted that no illnesses would result from these products. However, if contaminated meat was used, and an unreliable process was not able to reduce the hazard, then there may be up to 604 illnesses in a year (see Food Safety Scheme Risk Assessment Page 59 of 189 Table 21). In addition, if susceptible members of the population consumed product with high levels of pathogenic E. coli present there may be up to 125 cases per annum. It was predicted that Salmonella may cause 11 illnesses per year from UCFM products, while green runners used for casings of sausages and salami would not cause any illness. Given the level of specialist skills and knowledge required to safely make these products, specific requirements for the production of UCFM products are included in Standard 4.2.3 – Primary Production and Processing Standard for Meat of the Food Standards Code. Salmonella was considered a medium risk, while the risk from L. monocytogenes in UCFM products was considered low, as it will not grow in the product, however it may survive for extended periods. The risk from Toxoplasma in UCFM products was also considered low, as the risk can be considerably reduced if the meat is frozen before use, as this will kill the organism. Kebabs were predicted to be a significant source of illness if allowed to be recontaminated in the drip tray after cooking, with approximately 25,000 illnesses per annum. Under normal conditions for cooking kebabs, or even when an extra cook step was added, it was modelled that in 1% of cases, there may still be an element of undercooking or some other mishandling to allow survival of Salmonella. In this scenario, there were still 25 illnesses per annum predicted with kebabs as the cause. A survey of NSW kebab retail outlets (Jansson et al, 2008) showed that 92% of outlets undertook an extra cooking step after slicing the meat from the kebab. Table 20 – NZFSA risk profile outcomes examining hazards in processed meats Hazard Listeria monocytogenes in processed ready-to-eat meats (Lake et al, 2002) Shiga-like toxin producing Escherichia coli in uncooked comminuted fermented meat products (Gilbert et al, 2007) Food Safety Scheme Risk Assessment Risk Several notified cases in New Zealand and an outbreak of non-invasive listeriosis in February/March 2000 associated with corned silverside and ham indicate that processed RTE meats are a route of infection for listeriosis in New Zealand. While uncooked comminuted fermented meat (UCFM) products might appear to be a higher risk, well controlled processing to lower the pH and water activity control STECs. Page 60 of 189 Table 21 – Risk ranking for processed meat products Processed meat product Hazard Severity Probability Growth required to cause illness Consumer does pathogen reduction step Epidemiological link Risk rating Predicted annual number of illnesses (in Australia) 10; Yes Yes Yes Yes Yes Effect of production, processing, handling on the hazard ↓↑→ ↓↑ ↓↑ ↓→ ↓ ↓ Deli meats Terrines Fresh sausage Cooked sausages Green runners Kebabs L. monocytogenes L. monocytogenes L. monocytogenes L. monocytogenes Salmonella IB IB IB IB II/IB Low Low Low Low N/A No No Yes No Yes Yes Yes No No No High Medium Low Low Low 43 0.8 >0.01 0.04 0 Kebabs – Salmonella II/IB Low contaminated in drip tray Kebabs – normal Salmonella II/IB Low Kebabs – finished Salmonella II/IB Low with extra cook step Uncooked comminuted fermented meat (UCFM) products Yes ↓→ Yes Yes High 27,500 Yes Yes ↓→ ↓→ Yes Yes Yes Yes Medium Medium 28 28 Salami – general population Salami – vulnerable population Salami – unreliable process EHEC IA/IB II/IB IB IB Low Low Low Low No Yes Yes No ↓ ↓ ↓ ↓freezing No No No No Yes Yes No No Medium Medium Low Low 1 12 >0.01 0 EHEC IA/IB Low No ↓ No Medium 125 EHEC IA/IB Low No ↓ No Yes – high level contamination Yes High 604 Salmonella L. monocytogenes Toxoplasma gondii adapted from Sumner (2002); MLA (2003a) 10 Data from Sumner (2002) predicted annual numbers of illness per annum for the South Australia population (1.5 million), the MLA Risk Profile (MLA, 2003a) used an Australian population figure of 19.7 million. These estimates have been extrapolated to the current population of Australia estimated by ABS (2009) as approximately 21.6 million, by multiplying by a factor of 14.3 and 1.1 respectively. Food Safety Scheme Risk Assessment Page 61 of 189 Table 22 – Risk ranking for L. m onocytogenes- contaminated processed meats Processed meat product Deli meats Frankfurters, not reheated Pâté and meat spreads Frankfurters reheated Dry / semi-dry fermented sausage Risk ranking (per serve) High High High Low Low Predicted cases of listeriosis per serve (in Australia) 11 7.7 x 10-8 6.5 x 10-8 Risk ranking (per annum) Very high High Predicted annual number listeriosis cases (in Australia) 12 133 2.5 3.2 x 10-8 6.3 x 10-11 1.7 x 10-11 Moderate Low Low 0.3 0.03 0 adapted from FDA/USDA (2003) Conclusion The production and processing of meat has a long history of successful regulation. The preventative programs implemented by government and industry have improved animal health to the point that many diseases are no longer present in Australian animals. The meat food safety scheme under the Food Regulation 2004 requires compliance with national meat standards, leading to ante-mortem and post mortem inspections at abattoirs that have been effective in ensuring that meat produced in NSW is safe and suitable for human consumption. The microbiological surveys of meat production have shown a steady increase in the quality of meat produced. However, epidemiological data suggests that the prevalence of Salmonella and Campylobacter on raw poultry significantly contributes to the burden of foodborne illness within the community, not only from the consumption of contaminated poultry itself but the added potential for the introduction of these pathogens from poultry into food preparation areas where they may be a source of cross contamination onto RTE foods. Currently the food safety scheme requires compliance with the national poultry meat standard, however this only provides control measures for the processing sector. A whole chain approach is considered necessary, with control measures introduced at the primary production level to reduce the prevalence of these foodborne pathogens. With this aim in mind, FSANZ are currently finalising the development of Standard 4.2.2 – Primary Production and Processing Standard for poultry meat into Chapter 4 of the Food Standards Code. When finalised, this will be adopted into NSW legislation. The contamination of processed meats with L. monocytogenes continues to cause issues for meat processors, including a substantial number of product recalls. Additional hygiene and sanitation measures, including mandating the testing of finished product and food contact surfaces in high risk processing facilities, such as those packaging sliced RTE meats, aims to minimise contamination of this organism in product. 11 12 The risk per serving is inherent to the particular food category, and is therefore assumed to be the same in Australia as that calculated for the USA (FDA/USDA, 2003). This is based on the assumption that consumption patterns for these foods are identical in Australia and the USA. One significant difference would be that frankfurters are not commonly eaten without reheating in Australia, with MLA (2003b) estimating that only 5% are eaten without further cooking The risk per annum has been adapted from USA population data contained in the FDA/USDA (2003) risk assessment of 260 million and extrapolated to Australian population data of approximately 21.6 million (ABS, 2009) by dividing by a factor of 12 Food Safety Scheme Risk Assessment Page 62 of 189 References – Meat and meat products ABARE [Australian Bureau of Agricultural and Resource Economics] (2007). Australian Commodity Statistics 2007. Canberra. Retrieved 27 November 2008, from http://www.abareconomics.com/publications_html/acs/acs_07/acs_07.pdf. ABS [Australian Bureau of Statistics] (1995). National Nutrition Survey: Foods Eaten, Australia, 1995. Australian Bureau of Statistics report. ABS Cat no 4804.0. 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Retrieved 14 January 2009 from, http://www.mla.com.au/NR/rdonlyres/3EF73ECB-4FBB4455-A561-14CC636D7ADB/0/BeefFastFacts2008.pdf MLA [Meat & Livestock Australia] (2008b). Fast facts 2008. Australia’s sheepmeat industry. Retrieved 14 January 2009, from http://www.mla.com.au/NR/rdonlyres/70C05D4D-5D3E425D-96F7-4B973E5BFF55/0/SheepmeatFastFacts2008.pdf NSW Food Authority (2008). Listeria management program. Retrieved 19 February 2009, from http://www.foodauthority.nsw.gov.au/_Documents/industry_pdf/listeria-managementprogram.pdf PISC [Primary Industries Standing Committee] (2006). Model Code of Practice for the Welfare of Animals - Land Transport of Poultry. PISC Report 91. Pointon, A., Sexton, M., Dowsett, P., Saputra, T., Kiermeier, A., Lorimer, M., Holds, G., Arnold, G., Davos, D., Combs, B., Fabiansson, S., Raven, G., McKenzie, H., Chapman, A. & Sumner, J. (2008). A baseline survey of the microbiological quality of chicken portions and carcasses at retail in two Australian states (2005 to 2006). Journal of Food Protection, 71, 1123-1134. Pople, T. & Grigg, G. (1999). Commercial harvesting of kangaroos in Australia – background paper. Retrieved 10 November 2008, from http://www.environment.gov.au/biodiversity/trade-use/wildharvest/kangaroo/harvesting/index.html Ross, T. & Shadbolt, C.T. (2001). Predicting pathogen inactivation in uncooked comminuted fermented meat products. Report for Meat & Livestock Australia. Sumner, J. (2002). Food Safety Risk Profile for Primary Industries in South Australia (Final Report). Department of Primary Resources SA, Adelaide. Retrieved 30 September 2008, from http://www.pir.sa.gov.au/__data/assets/pdf_file/0003/25068/SA_PI_Risk_profile.pdf Wallace. R.B. (2003). Campylobacter in. In Hocking A.D. (Ed.) Foodborne Microorganisms of Public Health Significance (pp. 311-331). Australian Institute of Food Science and Technology, Waterloo. Widders, P.R., Coates, K.J., Warner, S., Beattie, J.C., Morgan, I.R. & Hickey, M.W. (1995). Controlling microbial contamination on beef and lamb during processing. Australian Veterinary Journal, 72(6), 208-211. WHO/FAO [World Health Organization/Food and Agriculture Organization of the United Nations] (2002). Risk assessment of Salmonella in eggs and broiler chickens: Interpretive summary. Retrieved 14 January 2009, from www.who.int/foodsafety/publications/micro/salmonella/en/index/html Food Safety Scheme Risk Assessment Page 66 of 189 Plant products food safety scheme Hazard identification In 2000, the former SafeFood Production NSW commissioned Food Science Australia to determine the relative food safety risks for various plant products produced and/or marketed in NSW (FSA, 2000a). This work resulted in six products being ranked as high risk due to microbiological hazards (Table 23), and formed the scientific basis for the introduction of the Plant products food safety scheme into the Food Regulation 2004. The scheme was developed to introduce minimum regulatory requirements for businesses producing high risk plant products, and to implement control measures to minimise the risks from the microbiological hazards associated with these products. Table 23 – Microbiological hazards associated with plant products Plant product Fresh cut vegetables – may be consumed raw Fresh cut vegetables – chilled, MAP or extended shelf life Vegetables in oil Seed sprouts Fresh cut fruit Fruit juice / drink (unpasteurised) High risk ranking Pathogenic E. coli Salmonella serovars L. monocytogenes L. monocytogenes C. botulinum C. botulinum Pathogenic E. coli Salmonella serovars Pathogenic E. coli Salmonella serovars L. monocytogenes Salmonella serovars Pathogenic E. coli Medium risk ranking B. cereus L. monocytogenes Cryptosporidium parvum Enteric viruses adapted from FSA (2000a) Fresh cut vegetables Fresh cut fruits and vegetables are raw agricultural products that have been processed by means of washing, trimming, cutting or slicing to make them ready for consumption. Contamination of vegetables may occur during growth, harvest, or processing. Under certain conditions microorganisms can also become internalised within the vegetables. Conditions that promote internalisation of microorganisms include damage to the natural structure (eg punctures, stem scars, cuts, splits) and placing warm produce into cooler, contaminated wash water. The actual process of cutting and/or removing the protective outer surfaces of the plants may increase the potential for pathogenic bacteria to survive and/or grow. Many vegetable products do not undergo a kill step that will completely eliminate pathogens, however measures such as sanitising washes may be used to reduce microbial contamination of pathogens. Many fresh cut vegetables are packaged under modified atmosphere packaging (MAP) and refrigerated to extend the shelf life. This form of processing may lead to an increased risk with pathogens such as L. monocytogenes and psychrotrophic strains of C. botulinum by enhancing the conditions for their survival and allowing additional time for growth. MAP products may become fully anaerobic if the plant tissue is actively respiring and uses up all the oxygen. As any competition from aerobic spoilage organisms is inhibited, this may increase the opportunity for anaerobic or facultative anaerobic pathogens to grow. Food Safety Scheme Risk Assessment Page 67 of 189 Fresh cut fruit Fresh fruit are normally perceived as low risk foods, as they tend to have a thicker protective skin than most vegetables and most are harvested from trees or bushes. The notable exceptions are melons and strawberries, which are considered higher risk because they grow close to the ground and their surfaces may become contaminated with soil. Contamination of fruit may occur at any point from growing (soil, fertilisation, irrigation water, animal/bird waste), through to harvesting, processing (including washing), distribution, marketing and consumption. Many microbial pathogens cannot survive or grow on most fruit due to the low pH environment. However, melons and strawberries have relatively high pH which makes them more likely to be a food safety hazard. In addition, the skin of rockmelon tends to be porous which may allow the penetration of pathogens and agricultural chemicals into the fruit. Melons are often dipped in a sanitising solution after harvest (FSA, 2000a). Fresh cut fruits may be value added by peeling, chopping, slicing and packaging (FSA, 2000a). Many fresh cut fruit are packaged under MAP and refrigerated to extend the shelf life. With additional time, this can lead to an increased risk from pathogens that are adapted to the acidic environment of fruit and are able to survive and grow in these foods. A range of bacterial and viral pathogens and enteric parasites have been identified as being of concern in fresh cut fruit. The actual process of cutting and/or removing protective outer surfaces of the fruit may increase the potential for pathogens to survive and/or grow. Fruit pickers and handlers with infections are also an important source of contamination. Vegetables in oil This product category includes a diverse range of vegetables and mixtures of vegetables and herbs that may be used fresh, dried, roasted or acidified. Oil is added to exclude air, which prevents discolouration of the vegetable. Although immersion of vegetables in oil reduces the available oxygen in the container, contrary to popular belief, it does not preserve the food. Some pathogenic bacteria are able to survive and grow in reduced levels of oxygen and even under anaerobic conditions in the absence of oxygen. C. botulinum is the main pathogen of concern because of its ability to grow anaerobically and it has been linked to outbreaks of illness from the consumption of vegetables in oil. Vegetables may be contaminated by C. botulinum spores, which are frequently associated with soil and processes such as cooking and acidification may be insufficient to inactivate the spores or prevent their germination and growth. Acidification to below pH 4.6 should prevent outgrowth, however more than one hurdle is recommended as a safeguard. Seed sprouts Seed sprouts are usually consumed raw and include alfalfa, mung bean, chickpeas, cress, fenugreek, soy, lentils, sunflower, onion and radish. Seeds for sprouting generally do not receive any special treatment during harvesting and transport and so may become contaminated with pathogenic organisms in the field or during harvesting, handling, processing and distribution. While some bean sprouts may be cooked prior to consumption, many others are consumed raw, for instance with salads. Food Safety Scheme Risk Assessment Page 68 of 189 The microbiological pathogens frequently found associated with seeds for sprouting include B. cereus, Salmonella serovars, and E. coli and these organisms have also been implicated in foodborne illness outbreaks. The rough surfaces and cracks in the seed may protect the pathogens from microbiocidal treatments and may make detection during routine analysis difficult. High levels of organic matter also reduce the effectiveness of chlorine treatments during seed washing and seed sprouting. Bacterial populations of 102-107 cfu/g have been observed on seeds for sprouting and this natural population can rapidly increase under the high moisture and moderate temperature conditions used in sprouting facilities. Microorganisms may also become internalised in the sprout during growth so sanitising wash treatments of sprouted seeds are not likely to be effective (FSA, 2000a). Unpasteurised fruit juice Fruit juices are made by extracting fruit (citrus juices) or by macerating fruit (grape, cherry, berry, apple juice, etc). This may be followed by clarification, filtration, pasteurisation, and/or other processes to reduce the microbial load. In recent years there has been a trend to produce ‘natural’ fruit juices containing no preservatives and receiving little or no heat treatment. Any microorganisms present on the surface of fruit may potentially contaminate the juice made from it. Bacterial pathogens are unlikely to grow due to the low pH but some bacteria, viruses or protozoa may be able to survive for extended periods. The length of time the microorganism may survive is dependent on the pH of the juice, storage temperature and the physiological state of the microorganism. Some Salmonella serovars and strains of pathogenic E. coli are known to be particularly acid tolerant, with this response thought to be activated by previous exposure to sub-lethal pH values. Apple and pear juice are can become contaminated by the mycotoxin patulin which is produced by several Penicillium and Aspergillus species. P. expansum appears to be the main patulin producer in apples and apple products. Since patulin is concentrated in the rotting tissue of fruit, it is a good indicator of the quality of fruit used to make the juice. The acidic nature of fruit juices makes them corrosive to metals. To avoid potential chemical contamination, only stainless steel or corrosion resistant vessels should be used to store these products. Other metals such as copper can leach into the beverage during storage. Exposure assessment Production data Leafy salad vegetables, such as lettuce, rocket and baby spinach are the most common products in the fresh cut category, contributing towards an estimated national production value of $44 million for the year 1997–98 (Szabo & Coventry, 2001). The Regulatory Impact Statement (RIS) prepared for the Food Regulation 2004, based on limited industry information, estimated annual NSW consumption of the fresh cut fruit and vegetables (NSW Food Authority, 2004) as: • 11,000 tonnes fresh cut vegetables, with a high proportion imported from Victoria and Queensland • 150 tonnes of fresh cut fruit Food Safety Scheme Risk Assessment Page 69 of 189 • Approximately 1000 tonnes of vegetables in oil, with the vast majority imported from overseas and interstate and • Between 2100 and 2600 tonnes of seed sprouts Subsequent recent surveys by the NSW Food Authority of the NSW sprout industry suggest that 2007/08 production was in the order of 3630 tonnes, with some of this product being sold interstate. NSW fruit juice suppliers suggest that manufacture of unpasteurised fruit juices occurs at relatively low volume, about 100,000 L/year, not including juices prepared in retail premises (NSW Food Authority, unpublished). Consumption of plant products Consumption data for fruits and vegetables from the National Nutrition Survey are summarised in Table 24 (ABS, 1995). During the period 1997-98 and 1998-99, fruit and fruit products (including fruit juices) consumption increased by 8.3% from 124.7 kg per capita to 135.0 kg. In the same period, imports for oranges and other citrus fruit rose by more than 62% (ABS, 2000). Consumption of vegetables has shown a steady 9.4% increase over the last decade. Per capita consumption of tomatoes showed a significant increase from 20.9 kg in 1997-98 to 24.9 kg in 1998-99, a rise of 19%. The category of other vegetables showed an increase in consumption in 1998-99 of 4.6% to 25.1 kg per person. Data from the Australian 1995 National Nutrition Survey (ABS, 1995) indicates that fruit juices and drinks are consumed in significant amounts by a large proportion of the population. Approximately 35% of all respondents consumed fruit juices and drinks with the mean consumption being 250mL per day. Food Safety Scheme Risk Assessment Page 70 of 189 Table 24 – Consumption of fruits and vegetables in Australia Sex Age Male Male Male Male 2-3 4-7 8 - 11 12 15 16 18 19 24 25 44 45 64 65+ 2-3 4-7 8 - 11 12 15 16 – 18 19 24 25 44 45 64 65+ Male Male Male Male Male Female Female Female Female Female Female Female Female Female Proportion of persons consuming fruit products and dishes 13 (%) 77.6 65.6 56.4 49.9 Median daily intake for consumers of fruit products and dishes (g/day) 153.6 168.0 166.0 167.2 Proportion of persons consuming vegetable products and dishes 14 (%) 68.1 72.7 77.0 78.8 Median daily intake for consumers of vegetable products and dishes (g/day) 92.1 118.0 165.0 223.0 39.9 172.0 83.1 253.6 31.9 179.2 84.7 271.3 45.8 210.0 86.6 263.0 59.5 229.0 91.0 297.8 69.6 75.4 72.8 62.5 58.0 202.0 140.0 166.0 150.8 172.0 91.7 79.2 79.7 77.0 85.9 280.4 95.2 122.5 158.0 180.8 41.1 191.0 85.8 185.0 41.4 166.0 86.5 220.5 55.0 188.4 88.0 216.1 69.8 192.0 91.0 258.5 75.6 196.0 91.5 239.3 adapted from National Nutrition Survey (ABS, 1995) The consumption data does not provide information on how much unpasteurised juice is consumed, however the Australian Fruit Juice Association believes that approximately 95% of juice sold has undergone some form of pasteurisation process. 13 Fruit products and dishes are defined in the National Nutrition Survey (ABS, 1995) as including the following: - Pome fruit, berry fruit, citrus fruit, stone fruit, tropical fruit, other fruit - Mixtures of two or more groups of fruit - Dried fruit, preserved fruit - Mixed dishes where fruit is the major component 14 Vegetable products and dishes are defined in the National Nutrition Survey (ABS, 1995) as including the following: - Potatoes, cabbage, cauliflower and similar brassica vegetables, carrot and similar root vegetables, leaf and stalk vegetables, peas and beans, tomato and tomato product, other fruiting vegetables - Other vegetable and vegetable combinations - Dishes where vegetable is the major component Food Safety Scheme Risk Assessment Page 71 of 189 Prevalence of hazards in plant products There have been a small number of surveys of Australian plant products. Arnold & Coble (1995) in a broad survey of NSW food found 1/54 samples (1.9%) of RTE salads and vegetables positive for L. monocytogenes. Szabo et al (2000) tested 120 minimally processed, cut and packaged lettuce samples. Three samples (2.5%) were positive for L. monocytogenes, 66 samples (55%) were positive for Aeromonas hydrophila or A. caviae and 71 samples (59%) were positive for Y. enterocolitica. The Victorian Department of Human Services (DHS) surveyed the microbiological quality of freshly squeezed juices from retail businesses across the state (Victorian DHS, 2005). L. monocytogenes was detected in 1/291 samples (0.3%), but the level was sufficient to classify the sample as potentially hazardous. E. coli was detected in 7/291 samples (2.4%). Salmonella and coagulase positive S. aureus were not detected. The Western Australian Department of Health (WA Health, 2006) tested 261 samples of sprouted seeds from retail stores. E. coli was detected in 7 samples (2.7%), while Listeria and Salmonella were not detected in any samples. The NSW Food Authority undertook a small survey in 2006 to determine the safety of fresh cut vegetables sold in NSW. E. coli was detected in 1/119 samples (0.8%), while Salmonella, L. monocytogenes and verotoxigenic E. coli (VTEC) were not detected in any samples (NSW Food Authority, unpublished). The Authority has also undertaken several surveys of seed sprouts. In 2005, all 30 samples were found to be microbiologically acceptable. In 2006, 1/36 samples (2.7%) was found to be potentially hazardous due to the presence of VTEC and a further two samples were categorised as unsatisfactory due to elevated levels of E. coli. A more extensive survey in 2008 of 122 samples found 99.2% of samples were microbiologically acceptable, with a single sample categorised as unsatisfactory due to B. cereus at a level of 5500 cfu/g (NSW Food Authority, 2008). There has been considerable international interest in the safety of plant products. O’Brien et al (2000) prepared a discussion paper on the microbiological status of RTE fruit and vegetables for the UK Advisory Committee on the Microbiological Safety of Food (ACMSF). The report provided a summary of foodborne illness outbreaks and surveys of plant products. The report concluded that while contamination of raw vegetables usually occurs at low prevalence, it is pervasive. The Food Safety Authority of Ireland (FSAI) surveyed the bacteriological safety of a range of plant products as part of a European Commission coordinated program (FSAI, 2003). Pre-cut fruit and vegetables had samples classed as unacceptable/potentially hazardous due to the presence of Salmonella in 1/529 samples (0.2%) and L. monocytogenes in 1/344 samples (0.3%). Qualitative tests found 21/513 samples (4.1%) positive for L. monocytogenes. No sprouted seeds samples were classed as unacceptable or potentially hazardous. L. monocytogenes was detected in 1/26 samples (3.8%). No problems were detected with unpasteurised fruit and vegetable juices. A similar European Commission program surveyed pre-packed mixed salads from retail premises in the UK for L. monocytogenes (Little et al, undated). L. monocytogenes was detected in 4.8% of samples collected. A parallel survey by the FSAI included Salmonella testing in the survey design (FSAI, undated). Qualitative analysis showed L. monocytogenes was present in 19/714 samples Food Safety Scheme Risk Assessment Page 72 of 189 (2.7%). Quantitative analysis detected two samples with L. monocytogenes at levels exceeding 100 cfu/g, however Salmonella was not detected in any sample. Little & Gillespie (2008) summarised microbiological results of surveys of prepared salads and fruit examined in the UK. No isolations of E. coli O157 or Campylobacter were reported. Five of 3852 samples (0.1%) of bagged salad vegetables were positive for Salmonella but other commodities were negative. L. monocytogenes and E. coli were detected in most commodities surveyed, usually at low incidence. Crepet et al (2007) used statistical techniques on 165 prevalence studies and concentration data from 15 studies of L. monocytogenes in fresh vegetables to estimate an overall probability of significant counts being found in the products. Their mathematical method required a minimum of one positive sample in each survey. However, as some survey sets had no actual detections, this change was made to data sets to accommodate the statistical analysis. Acknowledging this deliberate overestimation, the authors calculated the probability of sample contamination with L. monocytogenes exceeding 10 cfu/g as 1.4%, exceeding 100 cfu/g as 0.6% and exceeding 1000 cfu/g as 0.2%. Hazard characterisation Foodborne illness outbreaks from plant products An indication of the exposure to hazards in plant products is provided by an examination of the Australian foodborne illness outbreaks between 1995 and 2008 attributed to fresh produce and plant products, summarised in Table 25 (details of each outbreak are included in Table 67 of Appendix 3). Prior to this, two other Australian outbreaks of significance brought plant products into the spotlight as a significant source of foodborne illness. In NSW in 1989 there were three separate outbreaks from fruit salad due to Salmonella Bovismorbificans traced to a single NSW salad manufacturer (Biffin & McCarthy, pers comm), while in 1991 a nationwide outbreak from Norovirus was attributed to the consumption of unpasteurised orange juice. The juice was served on airline flights and was responsible for more than 3000 cases of illness (Foodlink, 2002). In addition, the risk of listeriosis from plant products was highlighted by an outbreak of listeriosis from contaminated fruit salad in NSW aged care facilities and hospitals in the Hunter Valley area. Through 19981999, six deaths of elderly patients occurred and nine were affected (this outbreak is included in outbreak data for the section on the Vulnerable persons food safety scheme). Internationally, there have been many examples of outbreaks that have been attributed to plant products. Sivapalasingham et al (2004) summarised the outbreaks attributed to fresh produce in the USA from 1993 to 1997. The authors identified 190 produce-associated outbreaks, resulting in 16,058 illnesses, 598 hospitalisations and eight deaths. They report that produce-associated outbreaks were an increasing proportion of all reported foodborne outbreaks with a known food cause, rising from 0.7% in the 1970s to 6% in the 1990s. Salad, lettuce, juice, melon, sprouts, and berries were the fresh produce most frequently implicated. Sivapalasingham et al (2004) also recognised Cyclospora and E. coli O157:H7 as novel causes of foodborne illness from plant products. Food Safety Scheme Risk Assessment Page 73 of 189 Table 25 – Summary of foodborne illness outbreaks attributed to plant products Hazard Salmonella serovars Campylobacter spp. Norovirus Shigella spp. Viral Unknown Total Australian outbreaks (1995–2008) 11 2 1 1 1 10 26 Cases 941 128 18 55 61 192 1395 Hospitalisations Deaths 33 0 0 0 0 2 35 1 0 0 0 0 0 1 DeWaal et al (2009) also reviewed outbreaks in the USA from fruit and vegetables for the period 1990 to 2005. They reported greens-based salads contaminated with norovirus as the most common cause of outbreaks, followed by lettuce with norovirus, sprouts with Salmonella, fruit with norovirus, greens-based salads with Salmonella and melon with Salmonella. Produce-related outbreaks resulted in an average of 47.8 cases, which is higher than reported for outbreaks from poultry, beef and seafood. Doyle & Erickson (2008) presented an overview of the problems associated with fresh produce. Four further outbreaks that occurred in 2006 were discussed; an outbreak traced to fresh spinach contaminated with E. coli O157; salmonellosis traced to tomatoes and two outbreaks linked to lettuce contaminated with E. coli O157:H7. Little & Gillespie (2008) reviewed outbreaks related to prepared salads in England and Wales in the period 1992 to 2006. The authors reported 82 outbreaks from prepared salads with 3434 people affected, 66 hospitalisations and one death. Peck et al (2008) reviewed the potential for growth and neurotoxin formation by – non-proteolytic C. botulinum in short shelf-life foods designed to be chilled. Their foodborne illness examples included seven outbreaks of botulism in products of plant origin. The implicated products were commercial garlic-in-oil, hazelnut yoghurt (attributable to the hazelnut conserve, see the section on the Dairy food safety), restaurant potato dip, restaurant aubergine dip, commercial black bean dip, commercial hummus and commercial refrigerated carrot juice. Temperature abuse was suspected to be contributing factor in four of the outbreaks. The following international outbreaks warrant individual mention because of either their size or novel cause: • In 1996 an outbreak of E. coli O157:H7 infection occurred among schoolchildren in Sakai City, Osaka, Japan. The outbreak was attributed to white radish sprouts served in a centralised luncheon program servicing 56 schools. Over 8000 children developed symptoms and 398 children were hospitalised. Two further incidents of E. coli O157:H7 in neighbouring areas were also related to white radish sprouts. All the implicated sprouts were traced back to one farm (Michino et al, 1999). This illustrates the size of an outbreak that can result when a hazard becomes a reality in a centrally processed and is a widely distributed product. • In 1998 an outbreak of cyclosporiasis (a gastrointestinal illness caused by the parasite Cyclospora) occurred in Ontario, Canada. A further 12 clusters of cyclosporiasis were identified with a total of 192 cases. The investigation linked the clusters to raspberries imported from Guatemala. Outbreaks of Food Safety Scheme Risk Assessment Page 74 of 189 cyclosporiasis in North America during the spring of 1996 and 1997 were also linked to Guatemalan raspberries. This is an example of repeated outbreaks attributable to parasites due to failures in hygiene and sanitation during the growing and handling of raspberries (MMWR, 1998). • In 2003 an outbreak of Hepatitis A was traced to a restaurant in Pennsylvania, USA and linked to the consumption of green onions (similar to shallots). Early in the outbreak 555 cases had been identified and three people died. The report noted that green onions require extensive handling during harvesting and preparation for packing. Contamination by Hepatitis A virus (HAV) could occur by contact with infected workers or contaminated workers (MMWR, 2003). This is a large outbreak of viral illness attributable to fresh produce. • In 2006 a multi-state outbreak of E. coli O157:H7 attributed to consumption of fresh bagged spinach occurred in the USA. By January 2007, 205 cases had been reported with 103 hospitalisations and 31 cases of haemolytic uraemic syndrome (HUS) and 3 deaths confirmed. Contamination was traced back to one farm. While no definitive determination of how the pathogens contaminated the spinach could be made, the presence of wild pigs near the growing fields and the irrigation wells were determined to be environmental risk factors. Processing of the spinach included washing, did not eliminate the problem and may have facilitated the spread of pathogens from contaminated to uncontaminated spinach (California Food Emergency Response Team, 2007). This is an example of a widespread outbreak of severe bacterial illness attributable to hygiene failures in the growing and processing of spinach. • In 2007, 55 cases of Salmonella Senftenberg infection in England and Wales were linked to fresh basil. Scotland, Denmark, the Netherlands and the USA reported 19 further cases with the outbreak strain. Eight samples of fresh packed basil from Israel tested positive with the same strain. Microbiological evidence suggested an association between contamination of fresh basil and the cases of Salmonella Senftenberg infection, leading to withdrawal of basil from all potentially affected batches from the UK market (Pezzoli, 2008). • In 2008 a large outbreak of Salmonella Saintpaul in the USA and Canada was associated with multiple raw produce items. As at August 2008, 1442 people had been affected, with at least 286 hospitalisations and the outbreak might have contributed to 2 deaths. The epidemiological data suggested the major vehicle for the spread of the pathogen was jalapeno peppers. However, serrano peppers were also considered to be a vehicle, and early in the outbreak tomatoes were considered a source. Contamination of produce may have occurred on the farm or during processing or distribution. The outbreak strain of Salmonella has been found in one growing area and an associated packing facility in Mexico (MMWR, 2008). This is the largest culture confirmed outbreak in the USA in the last decade. As many persons with Salmonella illness do not seek care or have stool specimens tested, many more unreported illnesses may have occurred. Food Safety Scheme Risk Assessment Page 75 of 189 As previously discussed, the Food Science Australia plant products scoping study ranked five specific plant product as high risk due to specific pathogens (FSA, 2000a), these are discussed as follows: Fresh-cut vegetables and fresh cut fruit Listeria monocytogenes Survey data shows that L. monocytogenes occurs in cut vegetables at low prevalence and usually at low levels. Lake et al (2005) presented data showing that L. monocytogenes can grow in a range of vegetables, however growth is typically slow at refrigeration temperatures but numbers can increase by several logs in some commodities stored at 10°-15°C for 7-10 days. The potential for growth in refrigerated short shelf-life products would seem to be low. These products have no final cooking process to eliminate contamination. Where product is packaged in MAP, the potential longer shelf life increases the potential for pathogen growth. Pathogenic Escherichia coli The potential exists for pathogenic E. coli to be present on vegetables via direct or indirect contamination with ruminant faeces or from food handlers that carry the organism in their gut. However, surveys of pre-cut vegetables and salads, other than in Mexico, rarely, if ever, detect pathogenic E. coli. Gilbert et al (2006) reviewed the dose response estimates for E. coli O157:H7 and original estimates of infectious dose were less than a few hundred cells. Later work estimated the probability of infection from exposure to differing numbers of cells. One model predicted a dose of 5.9 x 105 organisms would result in infection in 50% of consumers, while the probability of illness from 100 organisms was 2.6 x 10-4. A second study calculated a median dose (50% of people exposed become symptomatic) of 1.9 x 105 and a probability of 6 x 10-2 of infection when exposed to 100 cells. An analysis of data from the Sakai City elementary school outbreak with E. coli O157:H7 indicates much higher probabilities of infection at lower doses than previous models. Gilbert et al (2006) also reported dose-response for E. coli O111 and O55. The dose for infection of 50% of the exposed population was 2.6 x 106 organisms. The probability of illness when exposed to 100 cells was 3.5 x 10-4. Gilbert et al (2006) state that the organism will grow on leafy vegetables at temperatures above 7°C. However, due to the low infectious dose of the organism in food, growth may not be required to cause illness. Salmonellae Jay et al (2003) included data on the incidence of salmonellae in fruit, vegetables and spices with the prevalence shown to be below 10%. They note that numbers of salmonellae on raw vegetables are usually <1 cfu/g, but numbers as high as 240 cfu/g have been found on Dutch endive. Jay et al (2003) also includes information about an outbreak in Germany traced to paprika and paprika powdered potato chips which resulted in an estimated 1000 cases of salmonellosis. The numbers of salmonellae detected in the food were very low, around 2.5 Salmonella cfu/g in the paprika and 0.04-0.45 Salmonella cfu/g of chips. Clostridium botulinum The risk of botulism is increased for products packaged in MAP, with the longer shelf life increasing the potential for spore germination and pathogen growth. Food Science Australia rated the risk of this pathogen / product pair as high (FSA, 2000a). The contributing factors were the low dose required to cause illness, the severity of the illness, the fact that processing increases the risk and the existence of an Food Safety Scheme Risk Assessment Page 76 of 189 epidemiological link. That rating remains appropriate, particularly as longer shelf life vegetable products are becoming more available. Vegetables in oil The US Food and Drug Administration (FDA, undated) lists a history of botulism attributed to inadequately acidified foods and notes that products processed by 29 firms were found to be inadequately acidified. The FDA concluded that the evidence demonstrated that certain manufacturers of acidified foods did not realise the importance of adequate pH control. This resulted in the development of a specialised regulation for acidified foods in Title 21 of the Code of Federal Regulation (21 CFR 114). Despite the acidified foods regulation being published in 1979, two serious outbreaks of botulism were reported in the 1980s in Canada and the USA. Chopped garlic in oil was clearly identified as the source of botulism toxin (St Louis et al, 1988). The concern about vegetables in oil and botulism remains current. The products are popular and home production is common. According to Food Science Australia (FSA, 2000b), two false assumptions persist about vegetables in oil: • That the addition of oil has a preservative effect o • Incorrect. The only function of the oil is to prevent oxidation from air in the container which can lead to discolouration of some foods. By excluding air from the surface, this establishes anaerobic conditions which actually favour the growth of some types of bacteria, including C. botulinum. That some herbs and spices, and especially garlic, have significant antimicrobial properties o Incorrect. The preservative effect of these materials is slight and inconsistent as outbreaks of botulism in Canada and the USA have demonstrated. While acidification to a pH less than 4.6 would adequately control the outgrowth of C. botulinum, refrigeration is also used in some cases as an additional hurdle. Seed sprouts Outbreak investigations have identified several factors that affect the microbiological safety of sprouted seeds. To date, contaminated seeds have been the likely source for most outbreaks. Seed contamination could have occurred at the farm, seed processor, or sprouting facility. The hydrophobic surface of seeds makes sanitation and removal of contaminating microorganisms difficult. Conditions during sprouting (time, temperature, aw, pH and nutrients) are ideal for growth of pathogenic bacteria leading to an increased risk. Unpasteurised fruit juice The majority of outbreaks caused by consumption of juice have been attributed to the use of fruit that has been contaminated by animal faeces. Orchards are often located near livestock or wildlife with the potential for microbial contamination. Contamination of juice is more likely to occur where the skin or peel of the fruit is in contact with the juice during processing. Food Safety Scheme Risk Assessment Page 77 of 189 Risk characterisation Fresh-cut vegetables and fresh cut fruit Listeria monocytogenes To date, there has been no epidemiological evidence to link cases of L. monocytogenes infection in Australia with fresh cut vegetables. As such, there is sparse outbreak data to support the high risk rating allocated by Food Science Australia (FSA, 2000a). The FDA/USDA (2003) quantitative risk assessment on L. monocytogenes assigned low relative risk rankings to fruits, vegetables and delitype salads (Table 26). The report acknowledged the diversity of the product group and supported further study. While it appears the probability of infection is low, even for persons vulnerable to listeriosis, the consequences of the illness remain severe. This was graphically demonstrated by the Hunter Valley outbreak where six persons died from consumption of Listeria-contaminated fruit salad. The high risk rating is also applied to modified atmosphere products (MAP) that are stored for extended periods. The potential for growth in storage increases the ranking for MAP vegetables and salads. Pathogenic Escherichia coli There have been a number of E. coli outbreaks attributed to this group of products around the world. Consequences of illness are potentially severe with high rates of hospitalisation and long terms effects such as HUS and kidney problems. Food Science Australia (FSA, 2000a) rated the risk as high, while Gilbert et al (2006) placed pathogenic E. coli in the highest severity category but lowest incidence category for New Zealand foods. It was concluded that it is essential that efforts continue to prevent the likelihood of foodborne transmission from this group of organisms. Table 26 – Risk ranking for plant products contaminated with Listeria m onocytogenes Plant product Vegetables Fruits Deli-type salads Risk ranking (per serve) Low Low Low Predicted cases of listeriosis per serve (in Australia) 15 2.8 x 10-12 1.9 x 10-11 5.6 x 10-13 Risk ranking (per annum) Low Low Low Predicted annual number of listeriosis cases (in Australia) 16 0.02 0.08 0 adapted from FDA/USDA (2003) Salmonella serovars Food Science Australia rated the risk of Salmonella in these products as high risk, based on the severity of the illness and no consumer cooking step to eliminate the hazard (FSA, 2000a). Basset & McClure (2008) rated Salmonella serovars as a significant hazard for both fruit and vegetables based on similar criteria to Food Science Australia, but note that growth in the product is not required for illness to 15 16 The risk per serving is inherent to the particular food category, and is therefore assumed to be the same in Australia as that calculated for the USA (FDA/USDA, 2003). This is based on the assumption that consumption patterns for these foods are identical in Australia and the USA. The risk per annum has been adapted from USA population data contained in the FDA/USDA (2003) risk assessment of 260 million and extrapolated to Australian population data of approximately 21.6 million (ABS, 2009) by dividing by a factor of 12 Food Safety Scheme Risk Assessment Page 78 of 189 eventuate. This appears consistent with the many outbreaks attributed to products in which Salmonella might survive but not grow. Clostridium botulinum Food Science Australia (FSA, 2000a) rated the risk of C. botulinum in these products as high. The contributing factors were the severity of the illness, the fact that processing and packaging in MAP may increase the risk and the existence of an epidemiological link. There is no domestic epidemiological evidence to support the high risk ranking but, to date, longer shelf life vegetable products have had limited availability. Vegetables in oil There appears clear potential for products prepared without appropriate control measures to result in a poorly acidified product, with potential to cause severe illness from pathogens such as C. botulinum. These products are sometimes prepared by small and medium enterprises, which is considered to increase the risk if knowledge of food safety controls is not adequate. Seed sprouts The conditions during sprouting (time, temperature, water activity, pH and nutrients) are ideal for growth of pathogenic bacteria such as Salmonella and pathogenic E. coli leading to seed sprouts being considered a high risk product (FSA, 2000a). The potential for growth of pathogenic organisms during sprouting increases the risk substantially, and there is epidemiological evidence to demonstrate that contamination does occur. The implementation of control measures, such as sanitation of seeds prior to sprouting, may lower the prevalence of pathogens. Unpasteurised fruit juice The high risk ranking of unpasteurised juice by Food Science Australia is appropriate (FSA, 2000a). The potential sources of contamination are virtually identical as for fresh cut fruit, and there is strong epidemiological evidence to justify the risk. The two large scale outbreaks in Australia in 1991 and 1999, due to contamination of unpasteurised juice with Salmonella serovars have clearly demonstrated the potential for unpasteurised juice to cause illness. Conclusion The introduction of a plant products food safety scheme into the Food Regulation 2004 targeted the five plant products categorised as high risk by the Food Science Australia scoping study (FSA, 2000a). Minimum food safety control measures were introduced with the aim of avoiding outbreaks of foodborne illness from these products. While plant products such as fresh cut fruit and vegetables generally have an image as healthy foods and form an important part of a healthy nutritious diet, the occurrence of several large scale outbreaks of foodborne illness in the US affecting thousands of consumers highlights the potential risks associated with these products. Due to the increasing demand for convenience foods from consumers, the market share of pre-packed fresh cut fruits and vegetables on supermarket shelves has increased dramatically in the last several years, therefore it is important that food safety control measures are in place to ensure that the consuming public is protected. In addition to pre-packaged salads, there has been a history of unpasteurised juice causing two large outbreaks in Australia, while seed sprouts have a history of Food Safety Scheme Risk Assessment Page 79 of 189 causing foodborne illness outbreaks overseas and within Australia. While the history associated with vegetable in oil products does not involved large outbreaks, there exists the potential for severe illness, from pathogens such as C. botulinum, if these products are not produced in a controlled manner. The food safety schemes requirement for businesses producing plant products to implement a food safety program means that appropriate control measures are applied, and that verification of those controls occurs at regular intervals through testing of finished product. While the Authority has a regulation in place covering the high risk plant products, increasingly overseas there have been a number of large scale foodborne illness outbreaks associated to intact fruit and vegetables, such as leafy greens, spinach and rockmelon. While this has not occurred to date in Australia, the Authority will continue to work with the Department of Primary Industries and the horticulture industry to ensure food safety controls, such as control over the use of biosolids, continue to be employed across the entire horticulture sector. Food Safety Scheme Risk Assessment Page 80 of 189 References – Plant products ABS [Australian Bureau of Statistics] (1995). 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Sivapalasingham, S., Friedman, C.R., Cohen, L. and Tauxe, R.V. (2004). Fresh produce: A growing cause of outbreaks of foodborne illness in the United States, 1973 through 1997. Journal of Food Protection 67, 2342-2353. St. Louis, M., Peck, S., Bowering, D., Morgan, G., Blatherwick, J., Satyen Banerjee, et al (1988) Botulism from chopped garlic: delayed recognition of a major outbreak. Annals of Internal Medicine 108, 363-368. Stafford, R., lMcCall, B., Neill, A., Leon, D., Dorricot, G., Towner, C. & Micalizzi, G. (2002), A statewide outbreak of Salmonella Bovismorbificans phage type 32 infection in Queensland. Communicable Diseases Intelligence 26(4) Retrieved 15 December 2008, from http://www.health.gov.au/internet/main/publishing.nsf/Content/cda-2002-cdi2604-pdfcnt.htm/$FILE/cdi2604k.pdf Szabo, E., Scurrah, K. & Burrows, J. (2000). Survey for psychrotrophic bacterial pathogens in minimally processed lettuce. Letters in Applied Microbiology 30, 456-460. 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Retrieved 4 December 2008, from http://www.health.wa.gov.au/envirohealth/food/docs/Doubts_About_Sprouts.pdf Food Safety Scheme Risk Assessment Page 84 of 189 Seafood safety scheme Hazard identification The food safety hazards of seafood have been extensively studied. Huss, Ababouch & Gram (2004) considered the management of seafood safety and quality from an international viewpoint. The risks they identified were based on cases of foodborne illness traced to seafood and rejections of seafood imports (Table 27). Table 27 – Summary of international hazard identification studies for seafood Data analysed USA, fish, foodborne illness Hazard Scombroid Ciguatera C. botulinum USA, molluscan shellfish, foodborne illness UK, seafood, foodborne illness USA, seafood, import refusals EU, seafood, import rejection/detention Bacterial pathogens Norovirus (formerly Norwalk-like viruses) Poisonous fish (puffer fish) Chemical contaminants Vibrio spp. Norovirus Algal toxin Bacterial pathogens Scombroid Ciguatera Parasite Scombroid Algal toxin Virus Bacterial pathogens Unknown Bacterial pathogens Scombroid Poison Other Vibrio spp. Bacterial pathogens Hepatitis virus Algal toxins Pesticides Metal contaminants Antibiotics Other chemical contaminants Parasites adapted from Huss, Ababouch & Gram (2004) The former SafeFood Production NSW (predecessor organisation of the NSW Food Authority) commissioned several studies in preparation for the introduction of the Food Production (Seafood safety scheme regulation) 2001. Subsequent studies have been undertaken by NSW, South Australian and Australian Governments and by international agencies. Walsh & Grant (1999) identified hazards as shown in Table 28. Food Safety Scheme Risk Assessment Page 85 of 189 Table 28 – Hazards in seafood and seafood products Sector Hazard Priority Wild caught finfish Histamine/Scombroid High Ciguatera Mercury Bivalve molluscs Pathogenic bacteria Viruses Algal toxins: Paralytic shellfish poisoning (PSP), Diarrhoetic shellfish poisoning (DSP), Amnesic shellfish poisoning (ASP), Neurotoxic shellfish poisoning (NSP) Cold smoked fish RTE Hot smoked fish RTE Smoked fish vacuum packed or modified atmosphere packaged (MAP) Listeria monocytogenes L. monocytogenes Clostridium botulinum Bivalve molluscs Vibrio spp. Medium High Wild caught finfish (raw) Parasites Medium Bivalve molluscs Agrichemicals Aquaculture crustaceans Vibrio spp. C. botulinum Raw fish – vacuum packaged or MAP Surimi RTE L. monocytogenes Cooked whole prawns Post-cooking contamination by pathogenic bacteria Cooked peeled prawns or crabmeat L. monocytogenes, Staphylococcus aureus, general Salted seafood S. aureus pathogens adapted from Walsh & Grant (1999) Those marked were subsequently evaluated by Ross & Sanderson (2000). Ross & Sanderson (2000) prepared a risk assessment of selected seafood in NSW. The seafood selected for their study were extracted from the lists developed by Walsh & Grant (1999). The report noted that the incidence of foodborne illness due to most hazards was low, but recognised that oysters and other shellfish have repeatedly been involved in outbreaks. Ciguatera and histamine poisonings are also relatively common, but are generally less severe in their outcomes (Ross & Sanderson, 2000). On behalf of SafeFood Production NSW, Woods & Ruello (2000) facilitated five industry Sector Working Groups (SWG) to examine the food safety hazards associated with the five high priority seafood sectors shown in Table 28, and to recommend practical risk mitigation measures. Food Safety Scheme Risk Assessment Page 86 of 189 Ross, Walsh & Lewis (2002) studied the food safety risks associated with cold smoking and marination processes used by Australian businesses. This report identified and ranked hazards with L. monocytogenes, C. botulinum, scombroid and parasites identified as most significant. Sumner (2002) undertook a risk profile on seafood and aquaculture products in South Australia, and based on outbreak data and recalls the report identified ciguatera, scombroid, viruses, bacterial pathogens and algal toxins as the hazards of concern. During development of Standard 4.2.1 – Primary Production and Processing Standard for Seafood, to underpin the standard A Risk Ranking of Seafood in Australia was prepared (FSANZ, 2005). The report identifies hazards along the seafood supply chain and also includes details on imported food testing failures and epidemiological data. The identified hazards were consistent with those mentioned in other risk assessment work. Some detailed description on the nature of the hazards is included below: Bivalve molluscs (oysters, pipis, mussels) Bivalve molluscan shellfish are filter feeders, extracting marine algae, bacteria and nutrients from surrounding waters. Because of this they are prone to contamination from the growing environment. Some pathogenic bacteria, especially Vibrio spp. are endogenous to aquatic environments and can survive and grow in oysters, presenting a risk to health if ingested. Bacterial pathogens may also be introduced into shellfish growing areas through pollution from sewage and animal waste. These organisms can multiply quickly, particularly at higher temperatures, potentially rendering oysters unsafe. Pathogenic viruses, such as norovirus may be introduced into shellfish growing waters through sewage pollution and can survive for long periods in shellfish. Oysters can extract chemical contaminants from their growing waters and bioaccumulate them to hazardous concentrations in their flesh. Certain species of toxin-producing algae present a food safety risk from shellfish consumption. Toxins can accumulate to high levels in shellfish especially, particularly during periods of an algal bloom. Prawns – wild caught Prawns are also potentially exposed to a range of indigenous microbial contaminants from the water environment. Vibrios are known to utilise the chitinous exoskeleton of crustacea as points of attachment and to metabolise it as a carbon/energy source (Karunasagar et al, 1986). V. parahaemolyticus, V. vulnificus and V. cholerae are considered part of the indigenous microflora of estuarine prawns. V. cholera may be introduced by human excreta or from aquatic environments where it is autochthonous. Enteric pathogens derived from faecal contamination may become established as environmental contaminants in water from which prawns are harvested and have the potential to contaminate free-living prawns prior to catch. During on-board processing, dipping of prawns in metabisulphite to inhibit formation of blackspot can present a risk to asthmatics. Prawns may also be exposed to chemical hazards from the environment, including the metals arsenic and mercury. Other chemical residues may be present in wild-catch crustacea due to industrial pollution and agricultural run-off. This will be a greater risk in estuarine prawns than those caught in open marine waters (Ross & Sanderson, 2000). Food Safety Scheme Risk Assessment Page 87 of 189 Processing of prawns can lead to the potential for contamination with marine pathogenic bacteria, other pathogenic bacteria or chemical contaminants. Cooked prawns can be subject to cross contamination between raw and cooked prawns. Finfish At the point of harvest, hazards potentially present in finfish include metals (eg arsenic and mercury) and indigenous pathogens from the marine or estuarine environment which are naturally present in live fish. Marine toxins such as ciguatoxin may be a significant hazard in tropical reef fish. Ciguatoxin is heat stable, and is not inactivated by normal cooking. Histamine/scombroid is a hazard in certain species of fish, particularly if the fish are harvested from warmer waters, die before landing or are subject to time/temperature abuse after landing. Histamine is heat stable. A number of parasites may be associated with fish species harvested from particular locations. This is particularly significant for finfish sourced from overseas locations and that have been associated with illness in humans after ingestion of raw or undercooked fish. C. botulinum (type E non-proteolytic strains), which causes botulism, is commonly associated with the marine environment. As spores tend to be associated with the gut of the fish, evisceration will reduce the risk of exposure. Other strains may also be present in the processing environment. Cold smoked fish have a number of significant hazards. Processing temperatures are too low to ensure freedom from pathogens or parasites. L. monocytogenes may occur post-harvest and during processing and prolonged storage may allow numbers to increase. With sushi, the primary concern is related to product prepared in advance and stored without refrigeration. Hazards include vibrios, other bacterial pathogens and viruses. Sashimi hazards of concern are parasites and V. parahaemolyticus. Exposure assessment Consumption of seafood Production data for seafood in Australia is summarised in Table 29. From these figures, the estimated annual consumption of seafood in Australia is about 396,000 tonnes or 18–19 kg per person. This equates to about 10kg of edible weight when the conversion factor used by Walsh & Grant (1999) is applied. The Fisheries Research and Development Corporation (FRDC, 2002) estimated the yearly per capita seafood consumption, expressed as edible weight, to be 15.1 kg in Sydney and 14.7 kg in Perth. Data on the consumption of fish and seafood products by sex and age from the National Nutrition Survey (ABS, 1995) is shown in Table 30. This data showed that seafood was consumed by approximately 20% of the population, with consumption levels varying between different age groups. Table 29 – Production volumes for seafood in Australia and NSW 2006–07 Sector Australia Tonnes (gross) NSW Value ($000) Tonnes (gross) Value ($000) Wild caught 185,925 1,429,328 15,462 80,657 Aquaculture 59,663 793,039 5200 45,975 Seafood imports 198,602 1,184,394 Seafood exports 48,010 1,157,909 adapted from Australian Fisheries Statistics 2007 (ABARE, 2008) Food Safety Scheme Risk Assessment Page 88 of 189 Prevalence of hazards in seafood The FSANZ (2005) risk ranking report includes statistics on failed tests for seafood tested upon entry to Australia. These are summarised in Table 31. In addition, information from FSANZ (2005) on Australian and international surveys of seafood used to rank risk is included in Table 32. A sampling program undertaken by the NSW Food Authority from 2004 to 2007 tested 658 samples spanning 60 species to gauge the extent of exposure to mercury from NSW retail seafood (NSW Food Authority, unpublished). The higher level results summarised in Table 33 do not necessarily imply noncompliance with Standard 1.4.1 – Contaminants and Natural toxicants of the Food Standards Code. The Maximum level (ML) is applicable to the mean of results for a prescribed number of sampling units (determined by the size of the sample lot). Overall 85% of individual samples were below the appropriate ML but the results suggest that limiting intake of some fish types remains a valid risk management strategy. Listeria m onocytogenes in smoked fish The UK Food Standards Agency recently surveyed L. monocytogenes in smoked fish (UKFSA, 2008) and the results are summarised in Table 34. Detection of Listeria and L. monocytogenes were relatively common in cold smoked fish. Detections were less common in hot smoked fish but L. monocytogenes at levels greater than 100 cfu/g were only found in hot smoked fish. These results are consistent with Ross & Sanderson (2000) who reported that cold smoked fish were more prone to contamination by L. monocytogenes but, due to lower levels of background flora, there is potential for growth to higher numbers in hot smoked fish. Food Safety Scheme Risk Assessment Page 89 of 189 Table 30 – Consumption of fish and seafood products in Australia Sex Age Male Male Male Male Male Male Male Male Male Female Female Female Female Female Female Female Female Female 2–3 4–7 8–11 12–15 16–18 19–24 25–44 45–64 65+ 2–3 4–7 8–11 12–-15 16–18 19–24 25–44 45–64 65+ Proportion of persons consuming fish and seafood products and dishes 17 (%) 9.6* 18 10.6 11.8 12.8 8.8 16.0 16.6 20.8 20.3 13.3 16.8 11.5 11.2 16.7 15.8 17.2 20.5 18.8 Median daily intake for consumers of fish and seafood products and dishes (g/day) 63.3* 71.0 100.5 148.0 114.8* 134.6 120.0 120.0 95.2 47.5* 48.0 90.4 105.0 95.0 99.0 86.3 96.0 74.5 adapted from National Nutrition Survey (ABS, 1995) Table 31 – Failure rate for imported seafood products (1998 – 2003) Commodity Molluscs Hazard Mercury Crustacea Standard plate count Sulphur dioxide Finfish Staphylococcal enterotoxins Standard plate count Chloramphenicol Antibiotics Mercury Salmonella V. cholerae E. coli L. monocytogenes Salmonella V. cholerae E. coli L. monocytogenes Scombroid/Histamine E. coli Standard Plate Count Failure rate (%) 1.0 0.5 0.2 (Oysters 1.0) 2.4 (Oysters 4.8) 0.8 3.5 1.9 0.8 1.3 0.9 0.3 5.4 5.3 5.9 1.3 15.1 1.6 6.5 1.7 adapted from Imported Foods Inspection Scheme data (FSANZ, 2005) 17 Fish and - seafood products and dishes are defined in the National Nutrition Survey (ABS, 1995) as including: Fin fish (excluding canned) Crustacea and molluscs (excluding canned) Other sea and freshwater foods Packed (canned and bottled) fish and seafood Fish and seafood products - Mixed dishes with fish or seafood as the major component 18 Results marked with * had a relative standard error of 25 – 50% due to small sample size Food Safety Scheme Risk Assessment Page 90 of 189 Table 32 – Summary of Australian seafood testing results Hazard V. parahaemolyticus V. vulnificus L. monocytogenes Commodity Marine fish at market Unopened oysters Opened oysters Pacific oysters Scallops, mussels, oysters, fish Oysters Smoked salmon fillets & slices Salmon pâté Smoked fish and mussels Marina mix Smoked fish Seafood salad Flake Smoked salmon* 19 Other smoked fish* Salmon cheese* Salmon dip* Salmon mousse/ pâté* Cooked prawns Retail seafood Smoked fish Dried fish Detected/Sampled 39/66 (59%) 16/16 (100%) 13/14 (93%) (69-74%) 20/80 (25%) Detected at low numbers 1/285 (0.4%) 2/433 (0.4%) 8/61 (29.5%) sic 2/49 (4.1%) (31%) (10%) (3%) (1.5%) 10/56 (17.9%) 0/11 3/5 (60%) 10/21 (47.6%) 2/8 (25%) 12/380 (3.2%) 1/11 (9%) <100mg/kg 0/13 3/5 (60%) <100mg/kg 1/5 (20%) 653 mg/kg Canned fish 1/7 (15%) <100mg/kg Canned tuna 3/107 (2%) 50-100mg/kg Several species exceed the regulatory limit – see Table 33 Histamine Mercury adapted from (FSANZ, 2005) Table 33 – Summary of high mercury levels in NSW seafood Fish type Angel fish Flake Ling Marlin Shark Swordfish Number of samples 5 41 5 22 23 37 Maximum (mg/kg) 20 1.002 3.35 1.03 1.682 3.47 4.092 Mean (mg/kg) 21 0.712* 0.880 0.503 0.851 0.690 1.454* adapted from NSW Food Authority (unpublished) 19 Results marked with * is data is from a NSW retail survey. The report includes international information on Hepatitis A virus and the parasite Anisakis simplex 20 Results for individual samples exceed the maximum level (ML) specified in Standard 1.4.1 – Contaminants and Natural toxicants of the Food Standards Code 21 Results marked with *, the mean exceeds the ML specified by Standard 1.4.1 – Contaminants and Natural toxicants of the Food Standards Code, which is generally 0.5 mg/kg for most fish and 1mg/kg for some fish, rays and sharks Food Safety Scheme Risk Assessment Page 91 of 189 Table 34 – Prevalence of L. m onocytogenes in UK retail smoked fish Number of samples Listeria spp. detected L. monocytogenes detected L. monocytogenes > 100cfu/g Cold smoked fish 1,344 282 (20.5%) 236 (17.4%) 0 Hot smoked fish 1,878 96 (5.2%) 66 (3.4%) 3 (0.06%) adapted from UKFSA (2008) Algal biotoxins The Shellfish program of the NSW Food Authority averaged 15–16 oyster harvest areas closures each year attributable to biotoxin issues from July 2004 to June 2008 (unpublished data). The closures were based on either very high levels of potentially toxic phytoplankton or positive results from screening tests for algal biotoxins. The NSW pipi industry also experiences closures due to potential biotoxin issues, typically in summer or early autumn. Six biotoxin closures were recorded for the period July 2007 to June 2008. Pipi biotoxin management plans were introduced following the 1997 and 1998 diarrhoetic shellfish poisoning (DSP) outbreaks and there have been no subsequent reports of DSP attributed to NSW pipis. Fate of hazards A number of hazards are of additional concern because they are not eradicated by further processing or cooking. These include: • Histamine / scombroid • Ciguatera • Mercury contamination • Algal toxins • Clostridium botulinum spores • Agrichemicals • S. aureus toxin Certain commodities are of additional concern because they may be consumed without adequate cooking and bacterial pathogens or viruses, if present, are not eliminated. • Oysters • RTE cold smoked and hot smoked fish • Fish intended for consumption raw (eg in sushi and sashimi) • Cooked prawns and other crustaceans Food Safety Scheme Risk Assessment Page 92 of 189 Hazard characterisation Foodborne illness outbreaks from seafood OzFoodNet annual reports for 2002–2006 tabulated 85 foodborne illness outbreaks attributed to seafood, with 558 people affected and 77 hospitalisations. Table 35 includes an updated summary of Australian foodborne illness outbreaks attributed to fish and seafood products from 1995 to 2008, while more details of these outbreaks are provided in Table 68 of Appendix 3. Several large food poisoning outbreaks related to consumption of oysters occurred in NSW: • in the mid 1980s there were a series of outbreaks of Norovirus from oysters harvested from the Georges River, the largest outbreak affected over 2000 people and • in 1997, an outbreak of Hepatitis A virus (HAV) from Wallis Lake oysters affected around 467 people with one death. It is estimated the cost to the industry from the Wallis Lake outbreak was around $30 million and this was the catalyst for the introduction of the NSW Shellfish Quality Assurance Program, the forerunner to the current NSW Shellfish Program operated by the NSW Food Authority. Prior to 1997, there was some voluntary monitoring by shellfish farmers, but no consistent testing of water quality in harvest areas. The implementation of harvest area management plans has gone a long way to minimising the risk from shellfish (Food Science Australia & Minter Ellison Consulting, 2002). The National Risk Validation Project highlighted producers, harvesters, processors and vendors of raw ready-to-eat seafood (including shellfish) as one of five high risk foods (Food Science Australia & Minter Ellison Consulting, 2002). FSANZ (2005) reports that 3 outbreaks (with 102 people affected) of shellfish poisoning occurred in Australia in the period 1990–2000. Mussels with levels of paralytic shellfish poisoning (PSP) toxin exceeding regulatory limits were detected in Victoria in 1988 and every year between 1990 and 1995. PSP toxins exceeding regulatory limits have been reported in Tasmanian mussels, oysters and scallops. Outbreaks of DSP were caused by NSW pipis in 1997 and 1998. There has been a detection of amnesic shellfish poisoning (ASP) toxin (domoic acid) above regulatory limits in scallop viscera from Victoria. Food Safety Scheme Risk Assessment Page 93 of 189 Table 35 – Summary of foodborne illness outbreaks attributed to seafood Hazard Ciguatoxin Scombroid Norovirus Salmonella serovars Wax ester Hepatitis A Vibrio spp. B. cereus C. perfringens DSP Toxin Unknown Total Australian outbreaks (1995–2008) 85 32 9 9 6 5 3 2 2 2 2 23 180 Cases 449 126 303 64 72 517 15 41 58 115 11 208 1979 Hospitalisations Deaths 83 17 1 29 0 64 3 0 1 0 0 9 207 0 0 0 0 0 1 0 0 0 0 0 0 0 Ross & Sanderson (2000) prepared detailed risk assessments on 10 hazard/product pairs. Current national and international data suggests that their selections remain appropriate. The extracts below are from their report and the FSANZ risk ranking. Viral contamination of shellfish Enteric viruses can be introduced into aquatic environments through contamination with sewage. They may persist longer than enteric bacteria in marine environments and can be accumulated in bivalve molluscs. As a consequence, their presence in shellfish does not always correlate with bacterial indicators of faecal pollution in marine environments. Viruses may also take longer to depurate from contaminated shellfish than enteric bacteria and viruses are more resistant to inactivation during cooking than bacteria. Outbreaks of viral food poisoning associated with shellfish continue to occur in Australia and worldwide. In general, the incidence of seafoodborne viral food poisoning is low, suggesting that existing control strategies are effective. Australian outbreaks have been associated with failures or nonimplementation of control strategies. Noroviruses cause human gastrointestinal illness. Symptoms in children are generally mild and self-limiting. A more severe gastroenteritis with dehydration as the result of vomiting or diarrhoea may occur. Mortality in the absence of other compromising factors is extremely rare. Infections in adults typically manifest as explosive projectile vomiting and/or diarrhoea. Incubation times are dose dependant, typically 15–50 hours with a mean of 24–48 hours (Ross & Sanderson, 2000). Hepatitis A (HAV) is usually a mild illness characterised by sudden onset of fever, malaise, nausea, anorexia and abdominal discomfort followed in several days by jaundice. The incubation period for HAV varies from 10 to 50 days (mean 30 days), and is dependent upon the number of infectious particles consumed. Many infections with HAV do not result in clinical illness, especially in children. When illness does occur, it is usually mild and recovery is complete in one or two weeks. Occasionally the symptoms are severe and convalescence can take several months. Patients suffer from chronic tiredness during convalescence, and their inability to work can cause financial loss. Less than 0.4% of the reported cases in the U.S. are fatal. These rare deaths are usually in the elderly (Ross & Sanderson, 2000). Food Safety Scheme Risk Assessment Page 94 of 189 Algal toxins in shellfish Shellfish poisoning is caused by a group of toxins elaborated by planktonic algae upon which the shellfish feed. The toxins are accumulated and sometimes metabolised by the shellfish. Since shellfish toxins are heat stable, the form in which shellfish are consumed does not affect the level of the hazard. All individuals are susceptible to shellfish toxins, although the elderly may be more severely affected, particularly by amnesic shellfish poisoning (ASP). There are about 20 toxins responsible for PSP, and all are chemical derivatives of saxitoxin, but differ in the type and localisation of the derivation. PSP toxins are also produced by species of cyanobacteria found in Australian freshwater rivers and lakes (Hallegraeff, 2003). PSP toxins block the sodium channels of excitable membranes of the nervous system and associated muscles. The extreme potency of PSP toxins has, in the past, resulted in an unusually high mortality rate. In humans, 120–180 µg of PSP toxin can produce moderate symptoms; 400–1060 µg can cause death, but 2000–10,000 µg is more likely to constitute a fatal dose. DSP is caused by a group of high molecular weight polyethers, including okadaic acid, the pectenotoxins and yessotoxin produced by the armoured dinoflagellate algae including Dinophysis spp. and Prorocentrum spp. These species are omnipresent but their toxicity is variable and unpredictable. Dense blooms can sometimes be completely non-toxic, but at other times shellfish can become toxic even when only sparse dinoflagellate populations are present. No human fatalities have been reported due to DSP and patients usually recover within three days. Recovery is generally complete with no after effects and the poisoning is generally not life threatening. In extreme cases chronic exposure may promote tumour formation in the digestive system. ASP is caused by the unusual amino acid, domoic acid, produced by chain-forming diatoms of the Pseudonitzschia spp. The toxicosis is particularly serious in elderly patients. All fatalities (up to a report date of 2003) had involved elderly patients. During an outbreak in Canada, the affected people had consumed mussels containing 300–1200 µg/g of domoic acid. Vibrio parahaem olyticus in molluscs and crustaceans Illness is caused when the ingested organism attaches itself to an individual’s small intestines and secrets a toxin. Not all strains of the organism are pathogenic. There appears to be a lack of correlation between pathogenicity and serotype of V. parahaemolyticus isolates. Virulence correlates with the ability to produce a thermostable direct haemolysin termed the Kanagawa Phenomenon (KP) haemolysin. KP negative strains appear to be non-pathogenic (Sanyal & Sen, 1974). Human volunteer studies have established an infectious dose for KP positive strains between 2 x 105 and 3 x 107 cfu. V. parahaemolyticus can multiply rapidly in seafood at permissive temperatures. In a study numbers of V. parahaemolyticus on octopus stored at 30°C increased from 102/g to 108/g in six hours. Listeria m onocytogenes in RTE smoked fish products. Indications of the nature of foodborne listeriosis have emerged from outbreak data, animal studies and mathematical modelling of illness. Knowledge is incomplete because of difficulties such as: some strains of L. monocytogenes are pathogenic but others are not; the determinants of pathogenicity are not well understood and so the distribution of pathogenic strains in food is not known. Food Safety Scheme Risk Assessment Page 95 of 189 However, there is general acceptance of some elements of the disease process (Ross & Sanderson, 2000): • The infectious dose of L. monocytogenes cannot be stated with precision but it appears that human listeriosis does not usually occur in the absence of a predisposing risk factor (such as compromised immunity) • Most commentators consider doses of <1000 organisms are highly unlikely to cause illness in normal individuals, and this has been reflected in food safety regulations • Attempts to link exposure to the organism to observed levels of illness suggest the infective dose is much higher than 1000 organisms, but it appears in some cases fewer than 1000 organism may cause illness • This difference between observed and predicted cases of illness suggests that the human population susceptible to listeriosis is actually a much smaller subgroup of the immunocompromised population. However, it could also be an artefact of under-reporting of listeriosis cases, due to some cases only developing mild flu-like symptoms. Clostridium botulinum in vacuum-packed RTE fish products Foodborne botulism results from eating food contaminated with preformed botulinum toxin due to the presence and growth of Clostridium botulinum bacteria. Botulism varies from a mild illness to an acute disease which can be fatal. With treatment, death due to respiratory failure or airway obstruction is rare. The case fatality rate in North America has fallen from 60% to 20% due to the availability and prompt administration of antitoxin. Provision of artificial respiration greatly increases the chances of recovery from intoxication. Nonetheless, recovery may take many months. Internationally, the aquatic environment of fish is frequently contaminated with C. botulinum spores and so fish will often be contaminated also. The organism only grows in the absence of air, and represents a risk only in those products which exclude oxygen by virtue of their packaging (eg vacuum packaged, MAP) or contain anaerobic regions (eg gut left intact). The toxin is heat labile, so the hazard is primarily limited to RTE seafoods that are stored in vacuum or anaerobic packaging. For seafoods, botulism is most commonly associated with C. botulinum type E. This type is capable of growth and toxin production at refrigeration temperatures but generally needs weeks of growth to produce amounts of toxin to cause foodborne illness. This is significantly greater than the shelf life generally observed for seafood and seafood products. Botulism is a concern in extended shelf life products and thus the concern with vacuum packaging and canning. Ciguatera poisoning Ciguatera is a form of human poisoning caused by the consumption of subtropical and tropical marine finfish which have accumulated naturally occurring toxins through their diet. In the US, ciguatera intoxication is considered to be one of the two most common sources of seafood-borne food poisoning associated with finfish. Human populations of tropical and subtropical marine regions have a much higher incidence of ciguatera intoxication. A relatively high incidence of ciguatera poisoning has been reported in Queensland. Only a small volume of reef fish from Queensland or other problem areas is on sale in NSW. There have been several large scale outbreaks in NSW involving scores of victims. The true incidence of ciguatera poisoning in NSW is unknown. The illness Food Safety Scheme Risk Assessment Page 96 of 189 has only recently become known to the general medical community and there is a concern that the incidence is largely under-reported because of the general non-fatal nature and short duration. The ciguatoxins are lipid-soluble toxins that are relatively inert molecules and remain toxic after cooking and exposure to mild acidic and basic conditions. The minimum toxic dose is estimated to be about 1ng/kg body weight. In one incident, six US soldiers became ill after eating fish containing approximately 20ng ciguatoxin/g flesh. Scombroid / Histamine poisoning Scombroid poisoning (histamine poisoning) is associated with the ingestion of foods that contain high concentrations of histamine and possibly other vasoactive amines and compounds. Histamine is the physiological amine involved in allergic reactions and is the main toxin involved in histamine fish poisoning. A ‘missing factor’ might be required to produce illness. Due to uncertainty about its aetiology, it is difficult to determine the susceptible population for scombroid poisoning. A wide range of histamine concentrations in implicated foods, particularly the increasing number of incidents associated with low histamine concentrations, suggests that some individuals are more susceptible to the toxin than others. Symptoms can be severe for the elderly and for those taking medications such as isoniazid, a potent histamine inhibitor. Mercury in seafood The commentary provided by Ross & Sanderson (2000) on mercury in NSW seafood has not lost currency. “Based on acute mercury food poisonings in Japan and Iraq, it is known that high levels of dietary mercury may cause measurable deficits in mental and physical development of young children exposed during gestation. Low levels of mercury are naturally present in the environment and in all foods. Inorganic mercury is poorly absorbed via the diet, however, in aquatic environments bacteria can convert inorganic mercury to methylmercury (MeHg) which is readily absorbed by the human body. MeHg is bioaccumulated in aquatic food chains, so all fish contain small amounts of mercury in their muscle tissue. Predatory fish or mammals such as whales at the top of the food web have the highest amounts. Mercury levels in most commercially harvested oceanic fish in the US and Australia are <0.5 mg/kg MeHg, but some large predators such as sharks, marlin and swordfish may have higher levels. Numerous studies have shown that nearly all the human exposure to MeHg occurs via seafood (predominately finfish) consumption. Therefore individuals who regularly consume large amounts of fish (particularly those fish with high mercury levels) could be exposed to dangerous levels of mercury.” Corbett & Poon (2008) reported on cases in NSW where elevated mercury levels were found in three infants, who had eaten fish congee (a rice and fish porridge) as a weaning food and ate fish regularly as toddlers. The parents had sought medical advice as a result of the children displaying either developmental delay or neurological symptoms. Fish congee is a common weaning food in coastal regions of southern China and South-East Asia. The authors recommended the development of multilingual information about fish and mercury be made available to pregnant women and mothers, especially targeting groups who are likely to be frequent consumers of fish and who use fish in weaning and infant foods. Food Safety Scheme Risk Assessment Page 97 of 189 Risk characterisation Viral contamination of shellfish There is very little information on levels of enteric viruses in shellfish available on which to base a risk characterisation. The greatest uncertainties in assessing the risk are the levels of the viruses of concern (HAV and norovirus) in contaminated shellfish, the frequency of shellfish contamination and the rate of loss of infectivity of the viruses in the environment and the oyster (Ross & Sanderson, 2000). FSANZ concluded that the overall public health risk for bivalve molluscs is relatively high for products harvested in polluted waters and/or waters not subject to a monitoring scheme such as the Australian Shellfish Quality Assurance Program (ASQAP). The relative risk ranking is not significantly reduced where these products are lightly cooked or steamed prior to consumption (FSANZ, 2005). Where the implementation of shellfish safety management schemes, such as ASQAP, is taken into account, the relative risk ranking for oysters and other bivalves is reduced to medium. The Seafood safety scheme requires shellfish harvesters to comply with the harvest area management plans developed by the NSW Food Authority. These plans are established to ensure compliance with ASQAP requirements. Algal toxins in shellfish Ross & Sanderson (2000) assessed the risk of algal biotoxins as low from commercial harvest areas and medium from recreational harvest areas. The difference was due to the algal monitoring and area management that occurs in commercial harvest areas. FSANZ found the relative risk is medium for waters that are subject to pollution, but where harvesting of shellfish is controlled under an effective management system. The risk rating is elevated to high if there is no effective management system in place (FSANZ, 2005). Vibrio parahaem olyticus in molluscs and crustaceans Levels of V. parahaemolyticus in Australian seafood are similar to that found in other parts of the world. It has been estimated that a meal of raw shellfish would contain no more than 104 cfu KP positive cells, based on typical numbers of V. parahaemolyticus present in fish and shellfish and the low incidence of KP positive isolates in the marine environment. For an infectious dose to be reached, mishandling of food at temperatures allowing the growth of the bacterium would be required. As Vibrio spp. are sensitive to heat, it is raw or inadequately cooked product that poses the greatest risk of vibriosis. However, several documented cases have involved post processing contamination. The rapid growth rate of the organism at ambient temperatures exacerbates the consequences of post-processing contamination. Although pathogenic Vibrio spp. are often found in bivalve molluscs and on crustaceans, the incidence of illness is low. For healthy individuals, doses of organisms higher than those normally found on food are required. The risk of contamination is seasonal, corresponding to the increased levels of Vibrio spp. in growing areas as water temperatures rise. The risk of thermal abuse also increases during summer. Food Safety Scheme Risk Assessment Page 98 of 189 The FSANZ relative risk ranking for V. parahaemolyticus is low but V. vulnificus and V. cholerae are rated medium based on severity of illness. Foodborne V. vulnificus infection is clearly associated with underlying medical conditions. Liver disease is a prominent risk factor for V. vulnificus infection, including cirrhosis due to alcohol consumption. Additional risk factors include diabetes, gastrointestinal disorders (surgery, ulcers), haematological conditions, and immunodeficiency due to underlying conditions such as cancer (WHO/FAO, 2005). The ranking for V. parahaemolyticus might change if the pandemic O3:K6 strain naturalises in Australian waters. Listeria m onocytogenes in RTE smoked fish products Based on models developed overseas Ross & Sanderson (2000) estimated that 6–7 cases of listeriosis in NSW per annum would be attributable to smoked salmon. This estimate is about the same order of magnitude as the overall level of incidence observed from all potential avenues of exposure. The estimate was noted to be conservative because Australian regulations are tighter than those countries on which the models were based. Their revised estimate was, at most, a few cases of listeriosis from smoked vacuum packed seafood per annum in NSW. The outcome of the FDA/USDA (2003) risk assessment for L. monocytogenes predicted cases of listeriosis from RTE seafood products to occur very rarely (Table 36). However, the risk per serving for cooked RTE crustaceans was considered high. Table 36 – Risk ranking for seafood products contaminated with Listeria m onocytogenes Plant product Cooked RTE crustaceans Smoked seafood Raw seafood Preserved fish Risk ranking (per serve) High Predicted cases of listeriosis per serve (in Australia) 22 5.1 x 10-9 Risk ranking (per annum) Moderate Predicted annual number of listeriosis cases (in Australia) 23 0.2 High 6.2 x 10-9 Moderate 0.1 Low Low 2.0 x 10-11 2.3 x 10-11 Low Low 0 0 adapted from FDA/USDA (2003) Ross & Sanderson (2000) then estimated the likely affect of a single, high contamination event. Depending on the assumptions used for different scenarios, a single batch of contaminated product was predicted to impact <1, about 20 or 65 immunocompromised consumers. FSANZ found that contamination of cold smoked products with L. monocytogenes at levels representing a health risk to the general population is considered unlikely. This rose to ‘likely’ where there is insufficient management of risk through the food chain and for susceptible sub-populations. This rises further to ‘very likely’ when both conditions apply. 22 23 The risk per serving is inherent to the particular food category, and is therefore assumed to be the same in Australia as that calculated for the USA (FDA/USDA, 2003). This is based on the assumption that consumption patterns for these foods are identical in Australia and the USA The risk per annum has been adapted from USA population data contained in the FDA/USDA (2003) risk assessment of 260 million and extrapolated to Australian population data of approximately 21.6 million (ABS, 2009) by dividing by a factor of 12 Food Safety Scheme Risk Assessment Page 99 of 189 Other than scrupulous factory hygiene, there is no CCP available to prevent contamination of RTE cold smoked seafood products. Hot smoking can reduce the levels of L. monocytogenes on the product, but post-processing contamination can occur. It appears that some factories are able to achieve very low levels of contamination relatively consistently, but others are not and rapidly become recolonised. Clostridium botulinum in vacuum-packed RTE fish products On the basis of the low incidence of spores in products likely to be available in the Australian market, and in particular the typical salt levels in these products, type E botulism risk from these products is considered to be negligible. Product shelf lives also mitigate against the risk of sufficient growth of C. botulinum potentially present to reach toxic doses. Ross & Sanderson (2000) note that other products (including those with the gut intact) and products from other regions (where C. botulinum spores could be more frequent) may represent a greater risk. FSANZ (2005) ascribes a medium relative risk rating for C. botulinum in smoked fish products. This reflects the balance between severity (severe) and likelihood (unlikely). Ciguatera poisoning Ciguatoxins are responsible for many outbreaks of foodborne illnesses due to fish consumption in Australia. In the period 1995 to June 2002, outbreaks were recorded in all states except South Australia and Tasmania. Queensland and NSW accounted for the great majority of outbreaks, reflecting both the linkage of the illness with fish caught near tropical reefs in Queensland and the role of Sydney as the hub for marketing seafood on the east coast of Australia. A number of fish species were involved, with coral trout, queenfish, Spanish mackerel and cod species predominant. FSANZ (2005) rates the relative risk as medium for tropical fish species (in particular larger members of particular species from certain fishing areas). Scombroid / Histamine poisoning Time-temperature abuse during transport, processing, storage or display will potentially allow formation of histamine. Scombroid species of fish, which have high levels of histadine, are more likely to accumulate high concentrations of histamine under conditions of temperature abuse, but many non-scombroid species have also been involved in outbreaks of histamine fish poisoning. Data from testing samples at retail and results from testing imported fish products indicate a low level of histamine in whole fish and fish fillets available in Australia. However, epidemiological data shows a significant number of outbreaks in commercial and restaurant settings, indicating potential problems in the cold chain and resultant time-temperature abuse. Tuna, blue grenadier and mahi mahi have been identified as species involved in these outbreaks. FSANZ allocated a relative risk rating of low, due to a moderate severity of disease and the probability of occurring as ‘likely’ (FSANZ, 2005). Mercury in seafood Ross & Sanderson (2000) approached a risk assessment for mercury in seafood by calculating the weight of fish required to equal the provisional tolerable weekly intake (PTWI) of methylmercury for consumers of varying body weights and various mercury levels. Their tables are reproduced in Table 37, except that the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Provisional tolerable weekly intake (PTWI) estimate has been reduced following a review (JECFA, 2004). Food Safety Scheme Risk Assessment Page 100 of 189 Estimates in Table 37 are based on the JECFA PTWI and US EPA reference dose, for comparison. Table 37 – Seafood consumption required to reach reference doses for methylmercury Mercury level mg/kg Body weight 13 kg 40 kg 60 kg 70 kg Weekly consumption (g) required to reach JECFA PTWI of 1.6ug/kg body weight/week 0.15 0.5 1.0 1.5 146 44 22 15 449 135 67 45 674 202 101 67 786 236 118 79 13 kg 40 kg 60 kg 70 kg Weekly consumption (g) required to reach to USEPA reference dose of 0.7ug/kg body weight/week 63 19 10 6 196 59 29 20 295 88 44 29 344 103 52 34 adapted from Ross & Sanderson (2000); JECFA (2004) Table 37 shows that for non-predatory fish (average mercury level 0.15 mg/kg – Ross & Sanderson 2000) significant consumption is required to exceed the PTWI. Average consumption figures quoted above equate to 200–300g of seafood per week. Consumers who predominately consume predatory fish or those consuming above average levels of fish are at risk. JECFA noted the existing PTWI of 1.6 µg/kg body weight was set in 2003 based on the most sensitive toxicological end-point (developmental neurotoxicity) in the most susceptible species (humans). However, life-stages other than the embryo and foetus may be less sensitive to the adverse effects of methylmercury (JECFA, 2006). In the case of adults, intakes of up to about two times higher than the existing PTWI of 1.6 µg/kg body weight would not pose any risk of neurotoxicity. Although in the case of women of childbearing age, the intake should not exceed the PTWI, in order to protect the embryo and foetus. JECFA’s data did not allow firm conclusions to be drawn regarding the sensitivity of infants and children compared to that of adults. While it is clear that they are not more sensitive than the embryo or foetus, they may be more sensitive than adults because significant development of the brain continues in infancy and childhood. The joint committee could not identify a level of intake higher than the existing PTWI that would not pose a risk of developmental neurotoxicity for infants and children (JECFA, 2006). Conclusion The Wallis Lake Hepatitis outbreak in 1997 graphically demonstrated the need for tighter food safety controls on commercial harvesting of shellfish for human consumption. Since that time, the implementation of a seafood safety scheme and the NSW Shellfish Program has significantly improved the safety of shellfish through the classification of harvest areas and the implementation of harvest area management plans which identify high risk events such as heavy rainfall and holiday periods which may contribute to pollution of the waterways and compromise shellfish safety. As coastal populations continue to increase and place additional pressure on local infrastructure such as sewage treatment plants, it is considered that the future role of the NSW Shellfish Program in ensuring the continued safety of shellfish is vital. This was acknowledged by FSANZ when it ranked shellfish harvested from managed areas as a medium risk, as opposed to high risk when these controls were not in place. Food Safety Scheme Risk Assessment Page 101 of 189 The management of other food safety hazards associated with seafood, such as minimising the risk of histamine poisoning, requires general food safety control measures such as hygiene and sanitation and the application of appropriate storage temperatures. The seafood safety scheme requires businesses processing seafood to implement a food safety program, to ensure appropriate control measures are implemented for hazards such as L. monocytogenes and C. botulinum. Because it naturally occurs in seafood, the issue of mercury is addressed through consumer education campaigns, particularly targeting high risk consumers such as pregnant women. Food Safety Scheme Risk Assessment Page 102 of 189 References – Seafood ABARE [Australian Bureau of Agricultural Resource] (2008). Australian Fisheries Statistics 2007. Australian Bureau of Agricultural Resources. Retrieved 30 September 2008, from http://www.abare.gov.au/publications_html/fisheries/fisheries_08/08_fishstats.pdf ABS [Australian Bureau of Statistics] (1995). National Nutrition Survey: Foods Eaten, Australia, 1995. Australian Bureau of Statistics report. ABS Cat no 4804.0. Retrieved 13 January 2009, from http://www.ausstats.abs.gov.au/ausstats/subscriber.nsf/0/CA25687100069892CA256888001C D460/$File/48040_1995.pdf Corbett, S.J. & Poon, C.C.S. (2008). Toxic levels of mercury in Chinese infants eating fish congee. Medical Journal of Australia. 188(1), 59-60. Food Science Australia & Minter Ellison Consulting (2002). National Risk Validation Project. Final Report. FRDC (Fisheries Research and Development Corporation] (2002). Retail Sale and Consumption of Seafood (Revised Edition). Ruello and Associates for the Fisheries Research and Development Corporation. Retrieved 14 January 2009, from http://www.frdc.com.au/bookshop/Seafood_report.pdf FSANZ (2005). Final Assessment Report, P265, Primary Production and Processing Standard for Seafood (Attachment 10). Retrieved 3 September 2008, from http://www.foodstandards.gov.au/_srcfiles/P265_Seafood_PPPS_FAR.pdf#search=%22risk% 20ranking%20seafood%22 Hallegraeff, G.M. (2003). AIFST (2008). Algal toxins in Australian shellfish. In Hocking, A.D. (Ed.). Foodborne Microorganisms of Public Health Significance (pp. 675-688). Australian Institute of Food Science and Technology, Waterloo. Huss, H.H., Ababouch, L. & Gram, L. Assessment and management of seafood safety and quality. FAP Fisheries technical Paper 444. Retrieved 30 September 2008, from ftp://ftp.fao.org/docrep/fao/006/y4743e/y4743e00.pdf JECFA [Joint FAO/WHO Expert Committee on Food Additives] (2004), WHO Food Additives Series 52, Safety Evaluation of Certain Additives and Contaminants. Retrieved 21 November 2008, from http://whqlibdoc.who.int/publications/2004/924166052X.pdf JECFA [Joint FAO/WHO Expert Committee on Food Additives] (2006), Joint FAO/WHO Expert Committee on Food Additives Summary and Conclusions of the 67th Meeting. Retrieved 21 November 2006, from http://www.who.int/ipcs/food/jecfa/summaries/summary67.pdf Karunasagar, I, Venugopal, M.N., Karunasagar, I. & Segar, K. (1986). Role of chitin in the survival of Vibrio parahaemolyticus at different temperatures. Canadian Journal of Microbiology 32, 889-891. OzFoodNet (2002 to 2006). Annual Report of the OzFoodNet Network (5 individual annual reports). Retrieved 30 September 2008, from http://www.ozfoodnet.org.au/internet/ozfoodnet/publishing.nsf/Content/reports-1 Ross, T. & Sanderson, K. (2000). A Risk Assessment of Selected Seafoods in NSW (Final report December 2000). SafeFood Production NSW. Ross, T. Walsh, P. & Lewis, T. (2002). Risk Assessment of Fish Cold Smoking and marination Processes Used by Australian Businesses. Biodevelopment Consulting Pty. Ltd for SafeFood Production NSW. Sanyal, S.C. & Sen, P.C. (1974). Human volunteer study on the pathogenicity of Vibrio parahaemolyticus. In T. Fujino, G. Sakaguchi, R. Sakazaki, Y. Takeda (Eds) International Symposium on Vibrio paramhaemoylticus (pp. 227-230) Saikon Publishing Co. Tokyo. Food Safety Scheme Risk Assessment Page 103 of 189 Sumner, J. (2002). Food Safety Risk Profile for Primary Industries in South Australia (Final Report). Department of Primary Resources SA, Adelaide. Retrieved 30 September 2008, from http://www.pir.sa.gov.au/__data/assets/pdf_file/0003/25068/SA_PI_Risk_profile.pdf UK Food Standards Agency (2008). A microbiological survey of retail smoked fish with particular reference to the presence of Listeria monocytogenes, Food Survey Information sheet 05/08. Retrieved 30 September 2008, from http://www.food.gov.uk/multimedia/pdfs/fsis0508.pdf Walsh, P. & Grant, N. (1999). Consultancy for Researching the Business Profile of the NSW Seafood Industry & Food Safety Hazards of Seafood in NSW (Final Report). Food Factotum. WHO/FAO [World Health Organization/Food and Agriculture Organization of the United Nations] (2005). Risk assessment of Vibrio vulnificus in raw oysters. Interpretive summary and technical report. Microbiological risk assessment series 8. Retrieved from http://www.who.int/foodsafety/publications/micro/mra8.pdf Woods, J. & Ruello, N. (2000). Report of Seafood Sector Working Groups’ Development of Model Food Safety Programs. Ruello and Associates Pty. Ltd. For SafeFood Production NSW. Food Safety Scheme Risk Assessment Page 104 of 189 Vulnerable persons food safety scheme From time to time certain population subsets within the community are more at risk to foodborne illness or can develop more serious complications from foodborne illness than the general population (Acheson & Lubin, 2008). Exactly defining who is vulnerable can be problematic. This is predominately due to the differing degree of vulnerability from one person to the next and the varying degrees of virulence of some pathogenic microorganisms to different vulnerable sub-populations (Acheson & Lubin, 2008). Acheson & Lubin (2008) provides an overview of the different factors that influence vulnerability and in general terms vulnerability is due to a suppressed immune system, either due to age, pregnancy, disease or pharmacologic therapy (ie chemotherapy or immunosuppressive drug use after an organ transplant). As such it is common to include the following sub-groups within the vulnerable population group: • Children under 5 years old • People over 65 years of age • Pregnant women • Persons with depressed immunity due to either some underlying condition, therapy treatment or medication The increased risk posed by the vulnerable populations requires businesses that cater specifically to these groups to consider the risk when deciding on the types of foods and how they prepare, store and serve these foods. In developing Standard 3.3.1 – Food Safety Program for Food Service to Vulnerable Populations of the Food Standards Code, Food Standards Australia New Zealand (FSANZ) defined the vulnerable population by considering the types of businesses likely to serve food to these people (FSANZ, 2006). Standard 3.3.1 of the Food Standards Code (FSANZ, 2008) includes a list of these businesses to which the standard applies, these include: • Hospitals • Nursing homes • Hospices • Certain daycare establishments and • Childcare centres In performing a risk assessment on businesses catering to vulnerable populations, it is acknowledged that the businesses can supply a variety foods to these groups and the methods for preparation will vary from complete preparation and assembly within the business through to purchase of ready-to-eat (RTE) foods. To avoid duplication this section should be read in conjunction with other sections within this risk assessment in respect to the risk posed by different foods. Information will be provided to illustrate areas of concerns and elaborate on other foods not covered in other sections of this document. This section will focus on microbiological hazards, only as the risks posed by chemical and physical hazards are not known to be influenced by a decreased immunity. It should be noted that most of the risk assessments conducted do not specifically address establishments serving to vulnerable populations. Where they do examine specific hazards that affect the vulnerable population (eg L. monocytogenes ) the context is usually within that of the general population and includes both those Food Safety Scheme Risk Assessment Page 105 of 189 situated in care-type establishments and those living outside these establishments. Wherever possible, this risk assessment will attempt to focus on the risks associated with those people within care-type establishments, although due to the lack of information specific to these establishments this may not always be possible. Hazard identification When considering the food safety hazard presented to vulnerable populations, the hazards can be separated into two groups: • Specific hazards – those hazards that present a unique risk to vulnerable populations and • General hazards – those hazards that, due to a decrease in immunity of an individual, can result in a greater prevalence in illness when compared to the general population or result in more serious illnesses. General information concerning the hazards included in this section can be found in Appendix 1. Specific hazards Listeria monocytogenes It is well documented the importance of controlling L. monocytogenes in foods consumed by the vulnerable population. While the exact dose needed to cause illness in the vulnerable populations is ill-defined and open for much debate, it is generally agreed that lower infective doses are needed for illness to occur within the vulnerable population. However, the type and severity of illness may be dependent on virulence of the pathogen, host susceptibility and the food matrix (FDA/USDA, 2003). Sutherland et al. (2003) notes that while the infective dose is not clearly defined, some studies suggest infective doses as low as 102 to 103 cfu/g may cause illness. L. monocytogenes is of concern in any RTE food or foods not likely to receive a heat treatment prior to consumption. This is predominately due to the organism being ubiquitous in nature, the potential for cross contamination after cooking and the ability of the organism to grow at refrigeration temperatures. In their risk assessment, the FDA/USDA (2003) ranks the potential risk posed by some RTE foods. Those of very high to high risk include: • Deli meats and uncooked frankfurters • Pâté and meat spread • Unpasteurised milk • Smoked seafood • High fat and other dairy milk • Pasteurised milk • Soft unripened cheese Others which present a low risk include cooked crustacean, salads, fermented smallgoods, other soft cheese and fruits and vegetables. In general terms, any foods that can support the growth of L. monocytogenes and does not include a cook step prior to consumption can potentially present some level of risk to the vulnerable populations. Food Safety Scheme Risk Assessment Page 106 of 189 Clostridium botulinum Infant botulism has been reported in many countries including Australia. It is caused by the ingestion of C. botulinum spores which subsequently germinate, multiply and produce toxin in the infant’s gastrointestinal tract. It usually occurs in infants aged one year or less. Symptoms include constipation followed by weak sucking and crying ability. The illness affects the nervous system and while death can occur, mortality rates are generally low due to good intensive care facilities. In cases of infant botulism, the cause is often unknown, however the presence of C. botulinum in honey is thought to be one cause of infant botulism (Szabo & Gibson, 2003). Cronobacter sakazakii Cronoobacter. sakazakii, recently reclassified from the genus Enterobacter, is a pathogenic microorganism that has been linked to foodborne illness outbreaks predominately affecting infants (Lenhner & Stephan, 2004). While there is limited surveillance data, FAO (2008) reports at least 120 cases worldwide with 27 deaths. Powdered infant and follow-on formula have been identified as the main food vehicle, with practices such as reconstitution with warm water and holding bottles at room temperature increasing the risk of foodborne illness (FAO, 2007 FAO, 2008). Other factors thought to increase the risk of illness include: age of the infant, nutritional status, HIV status, other clinical conditions, pharmaceutical treatment, low birth weight and premature birth (FAO, 2008). C sakazakii isolates are thought to have a high rate of antibiotic resistance (Lehner & Stephan, 2004). Vibrio vulnificus A specific sub-group within the vulnerable population are at risk from infection by V. vulnificus that is found in the marine environment and can contaminate seafood. V. vulnificus infections normally affect people with liver dysfunctions (eg cirrhosis, hepatitis) and also patients with malignancies or those who have undergone gastrectomy (ICMSF, 1996). Symptoms of infection from V. vulnificus include fever, chills and nausea (Desmarchelier, 2003). While infections are rare, mortality rates are high. Most illnesses have been linked to consumption of raw seafood, predominately raw oysters (Desmarchelier, 2003). General hazards When vulnerable populations are exposed to other pathogenic microorganisms the resulting illnesses are like to be more prevalent and more severe than in the general population. Buzby (2002) attributed this in elderly people to age related factors (eg decreased immune function and stomach acid production, digestive orders, medication and altered sense of smell and taste) and a decrease in stomach and intestinal contractions resulting in a longer time required to eliminate pathogens and allowing a greater time for toxin formation and damage. Buzby (2002) also reports that in the US, rates of foodborne illness can be 10 to 100 times greater for elderly people within nursing homes when compared to the general population and that the elderly are more vulnerable to gastroenteritis-induced deaths. Other sub-groups within the vulnerable population exhibit increased sensitivity to foodborne illnesses due to decreased immunity. Acheson & Lubin (2008) contribute this increased risk due to many factors including the use of antibiotics that, while they aim to treat illnesses caused by certain pathogens, they can also eliminate from the intestinal tract certain microorganisms that inhibit or suppress the growth of pathogenic microorganisms. Cancer and transplant patients also have greater susceptibility to foodborne illness due to their treatments lowering the immune Food Safety Scheme Risk Assessment Page 107 of 189 system, with mortality rates from foodborne illness higher than the general population (Acheson & Lubin, 2008). Jay et al (2003) also suggests that the immunocompromised or those with underlying disease are at a greater risk of infection from Salmonella and the infection is likely to result in more serious illness. It is thought that the lower gastric acidity and immature immune response may influence the sensitivity of children to salmonellosis (Jay et al, 2003). This appears to be supported by a higher number of reported salmonellosis infections in children aged four or under, at least three times higher than other age groups (NSW Health, 2008). Other pathogens where increased prevalence or severity has been observed in the vulnerable population include: • Enteropathogenic E. coli – strains of shiga toxigenic E. coli (STEC) are known to cause severe illness in infants and the elderly and can result in death (Desmarchelier & Fegan, 2003) • Staphylococcus aureus – while for the healthy populations staphylococcal food poisoning is rarely fatal, fatalities have been reported in infants and the elderly (Stewart, 2003) • Clostridium perfringens – fatal cases of C. perfringens food poisoning are • generally associated with the elderly in institutionalised settings (Bates & Bodnaruk, 2003) in the general population fatalities are rare and Bacillus cereus – fatal cases are very rare, when reported they have been linked to children with liver failure (Dierick et al, 2005) Exposure assessment Estimating the exact portion of the vulnerable population who are in care-type establishment that provide food, and the number of meals served by these facilities is difficult, although there is some information that may be used to estimate potential numbers of both. Population figures from the Australian Bureau of Statistics surveys (ABS, 2005; ABS, 2008) indicate that in NSW: • In June 2008 there were 225,945 children aged 4 years old or younger • In 2005 there were 17.5% and 35.8% of children aged 0 to 2 years old and 3 to 4 years old respectively in long daycare Using these figures it could be assumed that approximately 26.6% of children aged less than 5 years old are in long daycare, which would correlate to 60,214 children in long daycare facilities. It should be noted that not all these children would be served meals prepared by the facility and the number of meals each facility serves may differ. A survey conducted by the NSW Food Authority (2008a) indicates that: • 1,856 childcare centres in NSW provide food for approximately 79,808 children each day • Approximately 26,815,488 meals are served in childcare centres each year ABS data (ABS, 2008) also indicate that in June 2007, there were 422,656 people aged 65 or older. The NSW Food Authority (2008b) surveyed other businesses included in the definition of Standard 3.3.1 – Food Safety Program for Food Service to Vulnerable Populations of the Food Standards Code and found that: Food Safety Scheme Risk Assessment Page 108 of 189 • there are 1867 facilities in NSW as defined by Standard 3.3.1 (excluding childcare facilities) • these facilities serve approximately 106,824,172 meals each year Therefore, in total, ’food service to vulnerable populations‘ facilities would serve approximately 133 million meals per year in NSW. It would be expected that some of the components of these meals may present a risk to sub-groups within the vulnerable population. Hazard characterisation Foodborne illness outbreaks involving food service establishments for vulnerable populations Table 38 provides a summary of foodborne illness outbreaks attributed to food served to vulnerable persons in Australian institutions (Table 69 of Appendix 3 provides more detailed information on each outbreak). Since 1995 there have been 67 foodborne illness outbreaks across Australia involving establishments that serve food to vulnerable populations, with 1138 illnesses, 64 hospitalisations and 12 fatalities. These outbreaks occurred in aged-care facilities, childcare centres and hospitals and the most common organism implicated was Salmonella, others organisms involved include C. perfringens, L. monocytogenes and Campylobacter. An outbreak in 1998–99 in aged-care facilities and hospitals in the Hunter Valley, NSW highlighted the risks of listeriosis from foods served in these establishments. The implicated food was fruit salad and the outbreak affected 9 patients, with 6 deaths resulting. All patients were elderly, and some had underlying conditions making them more susceptible to infection with L. monocytogenes. All the establishments served food prepared in a central catering facility (Food Science Australia & Minter Ellison Consulting, 2002). One sample of fruit salad subsequently tested positive for low levels (<50 cfu/g) of L. monocytogenes, a level considered unlikely to cause illness, even in immunosuppressed individuals. Table 38 – Summary of foodborne illness outbreaks attributed to food served to vulnerable persons Hazard Salmonella serovars C. perfringens Campylobacter spp. L. monocytogenes Norovirus Toxin Viral B. cereus St. aureus Cryptosporidium Pathogenic E. coli Unknown Total Food Safety Scheme Risk Assessment Australian outbreaks (1995–2008) 23 10 7 5 4 3 3 1 1 1 1 8 67 Cases 395 267 101 24 111 44 38 19 7 4 2 126 1138 Hospitalisations Deaths 43 1 6 5 0 1 0 0 0 0 0 8 64 4 1 0 7 0 0 0 0 0 0 0 0 12 Page 109 of 189 Table 39 – Institutional foodborne illness outbreaks as a percentage of all outbreaks 24 Year Outbreaks Cases Hospitalisation Deaths (% of total) (% of total) (% of total) (% of total) 2001 5.8% 2.9% 1.4% NR 25 2002 8.7% 5.6% 4.8% 50% 2003 15.1% 16.2% 32.4% 66.7% 2004 9.3% 8.1% 24.1% NR 2005 12.7% 10.3% 6.0% NR 2006 6.1% 6.4% 24.6% NR adapted from outbreak data from OzFoodNet 2002-2006 (OzFoodNet Working Group, 2003; 2004; 2005; 2006; 2007) Vulnerability to foodborne illness Previous sections of this chapter provide some insight into the factors why some groups within the population are more vulnerable to foodborne illness than others. This can be further illustrated by reviewing foodborne illness surveillance data. Table 39 provides a breakdown on the percentage of outbreaks reported to have occurred in facilities serving food to the vulnerable populations. Based on NSW Food Authority research (2008) and ABS data (ABS 2005 ABS 2008a ABS, 2000b), the percentage of the NSW population within facilities catering to vulnerable populations is approximately 2.5%. When this is compared to the figures in Table 39, it can be seen that foodborne illness affecting individuals in facilities catering to vulnerable populations are over-represented compared to the entire population which may be an indication of their increased vulnerability. Prevalence of pathogens Very little information is available on the prevalence of pathogens or other microorganisms in foods served to vulnerable populations. Other chapters within this document provide some general information on the prevalence of microorganisms in certain commodities some of which would be served to vulnerable populations. A study conducted by Gillespie et al (2001) in the UK looked at the microbiological quality of sliced cold RTE meats from catering establishments. They found that 26% of samples were categorised as unsatisfactory when compared to UK Public Health Laboratory Services microbiological guidelines, with 0.4% of samples categorised as unacceptable or potentially hazardous. Gillespie et al (2001) also compared the results of various food handling practices and found: • A higher level of unsatisfactory or unacceptable results with product made external to the kitchen when compared to product made in-house • A higher level of unsatisfactory or unacceptable results with product purchased pre-sliced when compared to product sliced in-house. A review of ready-to-use vegetables from health-care facilities found L. monocytogenes in 5/135 samples (3.7%) and also found total bacterial levels similar to samples that had been subjected to temperature abuse scenarios (Odumeru et al, 1997). 24 25 Institutions include aged-care facilities, childcare, hospitals and institutions NR – not reported Food Safety Scheme Risk Assessment Page 110 of 189 During 2005 and 2006, Little et al (2008) undertook a study on the microbiological safety of sandwiches served in hospitals and other health care establishments in the UK. In this study they found L. monocytogenes in 2.7% of 88 samples which included samples collected from wards. They also found a higher frequency of L. monocytogenes in sandwiches prepared outside the establishment, where the filling included poultry meat or contained salad ingredients, soft cheese and/or mayonnaise. Food service operations Food service operations by establishments preparing foods for vulnerable populations can undertake a variety of methods to prepare these foods. The types of operations can include: • Preparation and plating of raw or RTE foods • Preparation and plating of previously cooked foods without further heating • Preparation and plating of freshly cooked foods • Reheating and plating of foods previously cooked using: o Cook chill for short shelf life or o Cook chill for extended shelf life There are also some other specific operations for certain sub-groups that present specific hazards and will influence the risk to the vulnerable populations. Examples of these include: Visitors to some establishments (eg hospitals, aged-care facilities) bringing food to patients or residents, some of which can present a risk to the subpopulation (Wall, 2008) • Texture-modified or puréed foods provide the opportunity for recontamination of cooked foods due to improperly cleaned and sanitised equipment (Tallis et al, 1999) • Extended storage and handling of reconstituted infant formula can increase the risk of foodborne illness in infants due to C. sakazakii (Lehner & Stephan, 2004) In addition to these operations, food establishments may also purchase some foods or meals ready cooked, which then require little or minimal handling by the establishment. • The hazard and subsequent risks associated with the foods served to the vulnerable populations will be influenced by the type of operations they undertake. For example: • • • • Inadequate control of the cook chill process (eg poor cooling rates, improper storage temperatures and inadequate reheating) can result in the growth and survival of pathogenic microorganisms (Cox & Bauler, 2008) Improper storage time and temperature of RTE foods that require no further heat treatment can result in the growth of L. monocytogenes (ILSI, 2005) Inadequate cooking and poor post-cooking temperature growth can result in the survival and subsequent growth of pathogenic microorganisms (Cox & Bauler, 2008) For foods served raw, inadequate control steps to minimise the presence of pathogenic microorganisms and inhibit their growth during storage (Desmarchelier & Fegan, 2003; Sutherland et al, 2003) Food Safety Scheme Risk Assessment Page 111 of 189 Risk characterisation Risk of listeriosis The high risk associated with listeriosis in establishments serving foods to the vulnerable population has also been noted in the National Risk Validation Project (Food Science Australia & Minter Ellison Consulting, 2002). In this report the authors ranked L. monocytogenes and foodservice operations for sensitive populations as the highest risk rating due to the ability of the pathogen to grow at refrigeration temperatures and the high mortality and hospitalisation rates associated with the listeriosis infection. The main hazard affecting the vulnerable population that has been studied is L. monocytogenes. FAO (2004) published a risk assessment on L. monocytogenes in RTE foods that assessed the relative susceptibility of different groups within the population to listeriosis (Table 40). From this table it can be seen that the subgroups within the vulnerable population are more susceptible to listeriosis and in turn the food served to them presents a greater risk of foodborne illness than the food consumed by the general population. In their risk assessment on L. monocytogenes in RTE foods, the FDA/USDA (2003) estimated the number of cases of listeriosis per serving and per annum for different food categories for certain sub-groups of the vulnerable population. Assuming similar consumption rates in Australia and using Australian population figures, the potential number of listeriosis cases per year within Australia for each food category can be estimated (Table 41). It can be seen from this data that the risk of contracting listeriosis from any single serving of food is extremely rare, even for the highest risk foods (eg deli meats, estimated cases are 3.0 x 10-7 per serve for the elderly, therefore 30 million serves of deli meats would result in one case of listeriosis each year). Taking this estimation of risk, and extrapolating from the FDA/USDA (2003) data for all elderly consumers (not only those residing in aged care facilities), the number of serves of deli meats in Australia each year may actually result in up to 70 cases of listeriosis (Table 41). However, the number of elderly actually exposed to L. monocytogenes is likely to be much lower in aged care facilities. Even if deli meats were served at every meal in aged care facilities, the number of meals (estimated at 106 million per year) means that the estimated number of cases of listeriosis is likely to be less than 3.5 per annum. Risk of foodborne illness associated with C. perfringens A risk profile published by Meat and Livestock Australia (2003) examined the risk posed by C. perfringens in institutional meals for the aged where food safety programs have been implemented. In determining the risk, factors such as severity, probability, and the effect of processing and handling were considered. From this information it was concluded that the risk rating of C. perfringens in institutional meals for the aged was high with an estimated of 250 cases of C. perfringens foodborne illness in Australia per year. The ABS (2008) estimates that 33.8% of the population aged over 65 reside in NSW. Assuming the proportion of elderly within aged-care facilities is similar, it can be estimated that the number of cases of foodborne illness due to C. perfringens in facilities in NSW would be 84.5 per annum. Food Safety Scheme Risk Assessment Page 112 of 189 Table 40 – Relative susceptibility to listeriosis for different sub-groups Condition Transplant Cancer – blood AIDS Dialysis Cancer – pulmonary Cancer – gastrointestinal and liver Non-cancer liver disease Cancer – bladder and prostate Cancer – gynaecological Diabetes, insulin dependant Diabetes, non-insulin dependant Alcoholism Over 65 years old Less than 65 years, no other condition (reference or general population) Relative susceptibility 2584 1364 865 476 229 211 143 112 66 30 25 18 7.5 1 adapted from FAO (2004) Risk based on meals served and prevalence rates The potential risk can also be calculated using the information collected on the number of meals served within establishments catering to the vulnerable population and studies undertaken on the prevalence of pathogens in foods from these establishments. As reported by Gillespie et al (2001) in the UK, 15/3494 (0.4%) of cold sliced RTE meats where found to be of unacceptable / potentially hazardous, due to the presence of high levels of E. coli, S. aureus, Listeria and C. perfringens 26. Using the information collected by the NSW Food Authority on meals served and assuming one meal per day consists of sliced cold meat and also assuming the contamination rates in the UK and Australia are comparable, then it could be expected that: 26 • 35,753 meals per annum served in childcare facilities that include sliced cold meats could be potentially hazardous • 142,432 meals per annum served in other establishments catering to the vulnerable population could be potentially hazardous Unacceptable / potentially hazardous was defined from categories in the Public Health Laboratory Service (PHLS) Guidelines for the microbiological quality of some ready-to-eat foods at the point of sale (PHLS, 2000) Food Safety Scheme Risk Assessment Page 113 of 189 Table 41 – Estimated cases of listeriosis for vulnerable population sub-groups for each food category, based on US data Product Dairy Pasteurised fluid milk High fat and other dairy products Soft unripened cheese Unpasteurised fluid milk Fresh soft cheese Ice-cream/frozen dairy products Processed cheese Hard cheese Cultured milk products Soft ripened cheese Semi-soft cheese Meat Deli meats Pâté and meat spreads Frankfurters (reheated) Dry/Semi-dry fermented sausages Plant products Fruit Vegetables Deli type salads Seafood Cooked RTE crustacean Smoked seafood Raw seafood Preserved seafood Intermediate age 27 Per serve 29 Per annum 30 Elderly 28 Per serve Per annum Perinatal Per serve Per annum 4.4 x 10-10 1.0 x 10-9 5.8 x 10-10 2.9 x 10-9 1.2 x 10-10 1.3 x 10-14 1.4 x 10-14 3.4 x 10-15 9.5 x 10-15 2.1 x 10-12 2.9x 10-12 2.6 1.4 0.2 0.09 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 3.4 8.3 4.9 2.2 1.0 9.2 9.3 9.2 5.6 2.2 3.0 x x x x x x x x x x x 10-9 10-9 10-9 10-8 10-9 10-14 10-14 10-15 10-14 10-11 10-11 4.2 2.9 0.4 0.1 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 1.5 3.2 2.0 9.9 4.2 6.5 6.7 8.1 4.7 1.3 1.6 x x x x x x x x x x x 10-7 10-7 10-7 10-7 10-8 10-12 10-12 10-13 10-12 10-9 10-9 0.7 0.3 0.04 0.03 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 10-8 10-8 10-11 10-12 49.1 0.1 <0.01 <0.01 3.0 1.1 2.7 6.2 x x x x 10-7 10-7 10-10 10-11 70.8 0.2 0.02 <0.01 1.2 4.5 1.6 3.7 x x x x 10-5 10-6 10-8 10-9 13.4 0.03 <0.01 <0.01 5.0 x 10-12 8.4 x 10-13 1.7 x 10-13 0.02 <0.01 <0.01 5.1 x 10-11 8.2 x 10-12 1.4 x 10-12 0.05 <0.01 <0.01 2.8 x 10-9 4.8 x 10-10 8.8 x 10-11 <0.01 <0.01 <0.01 7.4 x 10-7 8.4 x 10-7 6.7 x 10-9 4.1x 10-9 0.03 <0.01 <0.01 <0.01 3.3 1.2 2.7 6.0 2.2 2.1 1.3 6.4 x x x x x 10-9 x 10-9 x 10-11 x 10-12 0.08 0.03 <0.01 <0.01 1.9 1.9 1.3 6.7 x 10-8 x 10-8 x 10-10 x 10-11 0.1 0.07 <0.01 <0.01 adapted from FDA/USDA (2003) 27 28 29 30 Intermediate age includes susceptible populations not captured in other groups (eg cancer, AIDS and transplant patients) Elderly includes all elderly consumers in the population, not just those in aged care facilties The risk per serving is inherent to the particular food category, and is therefore assumed to be the same in Australia as that calculated for the USA (FDA/USDA, 2003). This is based on the assumption that consumption patterns for these foods are identical in Australia and the USA The risk per annum has been adapted from USA population data contained in the FDA/USDA (2003) risk assessment of 260 million and extrapolated to Australian population data of approximately 21.6 million (ABS, 2009) by dividing by a factor of 12 Food Safety Scheme Risk Assessment Page 114 of 189 As mentioned previously, the contamination rate of L. monocytogenes in RTE vegetables and sandwiches from health care facilities in the Canada and UK were found to be 3.7% and 2.5% respectively (Odumeru et al, 1997; Little et al, 2008). Again, assuming these foods were served at one meal per day, the number of meals potentially contaminated with L. monocytogenes would be: • 330,724 meals per annum containing RTE vegetables at childcare facilities • 1,137,498 meals per annum containing RTE vegetables at other facilities serving to vulnerable populations • 223,462 sandwiches served per annum at childcare facilities • 890,201 sandwiches served per annum at other facilities catering to vulnerable populations These figures are likely to be an over estimation as exact information on meal types is not known and it is likely that establishments will have risk managements strategies in place to minimise the risks associated with food service to vulnerable populations. It is also noted that the contamination rates for pathogens are extrapolated from data from other countries. Characterising the risk associated with other hazards within food service for vulnerable populations is problematic due to the lack of information on the types of meals served within these establishments. Other chapters within this document provide an estimation of the risk for certain potentially hazardous foods and the risk posed is likely to be similar for establishments serving food to the vulnerable population. Control measures in food service for vulnerable populations The risk characterisation and predicted number of listeriosis cases stated previously are generally not observed due to the risk management strategies or control measures implemented by establishments serving food to vulnerable populations. The main strategy to assist in reducing the risk of foodborne illness at these establishments is the effective development and implementation of a food safety program. Woody & Benjamin (2008) provide an overview of the practicalities of implementing a food safety program in healthcare settings. In addition, in implementing the requirements of Standard 3.3.1 – Food Safety Program for Food Service to Vulnerable Populations of the Food Standards Code, the NSW Food Authority developed guidance material to assist industry meet the requirements (NSW Food Authority, 2008c). These documents provide some potential control measures for establishments serving vulnerable populations including: • Substitution of high risk foods with lower risk alternatives • Effective cleaning and sanitation of fruits and vegetables to be consumed raw • Limited storage of pre-prepared infant formula • Minimise storage times of foods to be consumed without further heat treatment • Proper cooking of foods • Effective cleaning and sanitation of equipment, in particular those used for foods that will not receive a further heat treatment Food Safety Scheme Risk Assessment Page 115 of 189 Conclusion A small sub-group within the population are known to be more susceptible to foodborne illness. This group is generally referred to as the vulnerable population and includes children under five years of age, the elderly over 65 and those with underlying immune suppressant conditions. The hazards affecting the vulnerable population can be unique to certain groups such as L. monocytogenes and C. sakazakii or may involve well known foodborne pathogens such as Salmonella resulting in more severe illness in the vulnerable persons. This tends to be reflected in epidemiological data, where institutional outbreaks are overrepresented in the number of foodborne illness outbreaks, cases of illness and deaths from food sources. Based on prevalence data for bacterial pathogens, it is estimated that over one million of the 133 million meals served at institutions catering to vulnerable populations in NSW each year may be potentially contaminated with a food pathogen. This emphasises the importance in implementing control measures such as food safety programs at establishments catering to the vulnerable populations, to ensure the safety of their consumers. Food Safety Scheme Risk Assessment Page 116 of 189 References – Food service to vulnerable populations Acheson, D. & Lubin, L. (2008). Vulnerable populations and their susceptibility to foodborne disease. In B. M. Lund & P. R. Hunter (Eds), The microbiological safety of food in healthcare settings (pp. 290-319). Oxford: Blackwell Publishing Ltd. Ashbolt, R. et. al (2002) Enhancing foodborne disease surveillance across Australia in 2001: the OzFoodNet Working Group. Communicable Diseases Intelligence, 26(3), 375-406. ABS [Australian Bureau of Statistics] (2005). 4402.0 Child care survey. Retrieved 30 November2008, from http://www.ausstats.abs.gov.au/ausstats/subscriber.nsf/0/4FB69C9AE4BBC0EBCA257186007BAA 38/$File/44020_nsw.xls. ABS [Australian Bureau of Statistics] (2008). 3101.0. Australian demographic statistics. Retrieved 22 October 2008, from http://www.ausstats.abs.gov.au/ausstats/subscriber.nsf/0/B6C3FC4377C676B9CA2574CD001250C 1/$File/31010_mar%202008.pdf. Bates, J.R. & Bodnaruk, P.W. (2003). Clostridium perfringens. In Hocking, A.D. (Ed.) Foodborne Microorganisms of Public Health Significance (pp 479-504). Australian Institute of Food Science and Technology, Waterloo. Buzby, J. C. (2002). Older adults at risk of complications from microbial foodborne illness. Food Review, 25(2), 30-35. Cox, B. & Bauler, M. (2008). Cook chill for food service and manufacturing: guidelines for safe production, storage and distribution. Alexandria: Australian Institute of Food Science and Technology. Desmarchelier, P.M. (2003). Pathogenic vibrios. In Hocking, A.D. (Ed.) Foodborne Microorganisms of Public Health Significance (pp. 333-358). Australian Institute of Food Science and Technology, Waterloo. Desmarchelier, P.M. & Fegan, N. (2003) Enteropathogenic Escherichia coli. In Hocking, A.D. (Ed.) Foodborne Microorganisms of Public Health Significance (pp. 267-310). Australian Institute of Food Science and Technology, Waterloo. Dierick, K., Van Coillie, E., Swiecicka, I., Meyfroidt, G., Devlieger, H., Meulemans, A., Hoedemaekers, G., Fourie, L., Heyndrickx, M., & Mahillon, J. (2005). Fatal Family Outbreak of Bacillus cereus-associated Food Poisoning. Journal of Clinical Microbiology, 43(8), 4277-4279. FAO [Food and Agricultural Organization of the United Nations] (2004). Risk assessment of Listeria monocytogenes in ready-to-eat foods. Retrieved 17 October 2008, from ftp://ftp.fao.org/es/esn/jemra/mra4_en.pdf FAO [Food and Agricultural Organization of the United Nations] (2007). Enterobacter sakazakii and Salmonella in powdered infant formula: meeting report, MRA series 10. Retrieved 19 November 2008, from http://www.who.int/foodsafety/publications/micro/es.pdf. FAO [Food and Agricultural Organization of the United Nations] (2008). Microbiological risk assessment series: Enterobacter sakazakii (Cronobacter spp.) in powdered follow-up formulae. Retrieved 17 October 2008, from http://www.fao.org/ag/agn/agns/jemra/Sakazaki_FUF_report.pdf. FDA/USDA [Food and Drug Administration/ United States Department of Agriculture] (2003). Quantitative assessment of relative risk to public health from foodborne Listeria monocytogenes among selected categories of ready-to-eat foods. Retrieved 30 October 2008, from http://www.foodsafety.gov/~dms/lmr2-toc.html. Food Science Australia & Minter Ellison Consulting (2002). National Risk Validation Project. Final Report. FSANZ [Food Standards Australia New Zealand] (2006). Final assessment report. Proposal P288. Food safety program for food service to vulnerable populations. Canberra, ACT: Author. Food Safety Scheme Risk Assessment Page 117 of 189 FSANZ [Food Standards Australia New Zealand] (2008). Australia New Zealand Food Standards Code. Standard 3.3.1 – Food safety programs for food service to vulnerable populations. Retrieved October 30, 2008, from http://www.foodstandards.gov.au/_srcfiles/Standard_3_3_1_FSPs_%20Vulnerable_pops_v95.pdf. Gillespie, I., Little, C. & Mitchell, R. (2001). Microbiological examination of cold ready-to-eat sliced meats from catering establishments in the United Kingdom. Journal of Applied Microbiology, 88(3), 467-474. Goulet, V., Hedberg, C., Le Monnnier, A. & de Valk, H. (2008). Increasing incidence of listeriosis in France and other European countries. Emerging Infectious Disease, 14(5), 734-740. ILSI Research Foundation/Risk Science Institute (2005). Achieving continuous improvement in reductions in foodborne listeriosis – a risk-based approach. Journal of Food Protection. 68(9), 1932-1994. ICMSF [International Commission on Microbiological Specifications for Foods] (1996). Microorganisms in Foods 5: Microbiological specifications of food pathogens. Roberts, T.A., BairdParker, A.C. & Tompkin, R.B. (Eds.). Blackie Academic & Professional, London. Jay, S., Davos, D., Dundas, M., Frankish, E. & Lightfoot, D. (2003). Salmonella. In Hocking, A.D. (Ed.) Foodborne Microorganisms of Public Health Significance (pp. 207-266). Australian Institute of Food Science and Technology, Waterloo. Lehner, A. & Stephan, R. (2004). Microbiological, epidemiological and food safety aspects of Enterobacter sakazakii. Journal of Food Protection, 67(12), 2850-2857. Little, C.L., Barrett, N.J., Grant, K. & McLauchlin, J. (2008). Microbiological safety of sandwiches from hospitals and other health care establishments in the United Kingdom with a focus on Listeria monocytogenes and other Listeria species. Journal of Food Protection, 71(2), 309-318. MLA [Meat & Livestock Australia] (2003). Through chain risk profile for the Australian red meat industry, PRMS.038c, part 1: risk profile. North Sydney: Meat & Livestock Australia. NSW Food Authority (2008a). Regulatory impact statement: food amendment (child care centres) regulation 2008. Sydney: NSW Food Authority. NSW Food Authority (2008b). Regulatory impact statement: food amendment (vulnerable persons food safety scheme) regulation 2008. Sydney: NSW Food Authority. NSW Food Authority (2008c). Vulnerable persons food safety scheme manual: policy and information to help businesses comply with the food service to vulnerable populations food safety scheme under the Food Regulation 2004. Retrieved 11 December 2008, from http://www.foodauthority.nsw.gov.au/_Documents/industry_vp_pdf/vulnerable_persons_food_saf ety_scheme_manual_compl.pdf. NSW Health (2008). Salmonellosis notification in NSW residents. Retrieved 15 October 2008, from http://www.health.nsw.gov/data/diseases/salmonellosis.html. O’ Brien, S.J. (2008). Foodborne Disease Outbreaks in Healthcare Setting. In Lund, B.M. & Hunter, P.R. (Eds.), The microbiological safety of food in healthcare settings (pp. 251-289). Oxford: Blackwell Publishing Ltd. Odumeru, J.A, Mitchell, S.J., Alves, D.M., Lynch, J.A., Yee, A.J., Wang, S.L., Styliadis, S. and Farber, J.M. (1997). Assessment of the microbiological quality of ready-to-use vegetables from health-care food services. Journal of Food Protection, 60(8), 954-960. OzFoodNet Working Group (2003). Foodborne disease in Australia incidence, notifications and outbreaks. Annual report of the OzFoodNet network, 2002. Communicable Diseases Intelligence, 27(20), 209-243 OzFoodNet Working Group (2004). Foodborne disease investigation across Australia: Annual report of the OzFoodNet network, 2003. Communicable Diseases Intelligence, 28(3), 359-389. OzFoodNet Working Group (2005). Reported foodborne illness and gastroenteritis in Australia: Annual report of the OzFoodNet network, 2004. Communicable Diseases Intelligence, 29(2), 164190. Food Safety Scheme Risk Assessment Page 118 of 189 OzFoodNet Working Group (2006). Burden and causes of foodborne disease in Australia: annual report of the OzFoodNet network, 2005. Communicable Diseases Intelligence, 30(3), 278-300. OzFoodNet Working Group (2007). Monitoring the incidence and causes of disease potentially transmitted by food in Australia: Annual report of the OzFoodNet, 2006. Communicable Disease Intelligence, 31(4), 345-365. PHLS [Public Health Laboratory Service, UK). (2000). Guidelines for the microbiological quality of some ready-to-eat foods samples at the point of sale. Communicable Disease and Public Health 3(3), 163-167. Stewart, C. (2003). Staphylococcus aureus and staphylococcal enterotoxins. In Hocking, A.D. (Ed.) Foodborne Microorganisms of Public Health Significance (pp. 359-379). Australian Institute of Food Science and Technology, Waterloo. Sutherland, P., Miles, D. & Laboyrie, D. (2003). Listeria monocytogenes. In Hocking, A.D. (Ed.) Foodborne Microorganisms of Public Health Significance (pp. 381-443). Australian Institute of Food Science and Technology, Waterloo. Szabo, E. A. & Gibson, A. M. (2003). Clostridium botulinum. In Hocking, A.D. (Ed.) Foodborne Microorganisms of Public Health Significance (pp. 505-542). Australian Institute of Food Science and Technology, Waterloo. Tallis, G., et al. (1999). A nursing home outbreak of Clostridium perfringens associated with pureed food. Australian and New Zealand Journal of Public Health. 23(40), 421-423. Wall, P. (2008). Overview. In Lund, B.M. & Hunter, P.R. (Eds.), The microbiological safety of food in healthcare settings (pp. 1-11). Oxford: Blackwell Publishing Ltd. Woody, J-M. & Benjamin, D.L. (2008). Practical implementation of food safety management systems in healthcare setting. In Lund, B.M. & Hunter, P.R (Eds.), The microbiological safety of food in healthcare settings (pp. 351-380). Oxford: Blackwell Publishing Ltd. Food Safety Scheme Risk Assessment Page 119 of 189 Egg food safety scheme Hazard identification The NSW Food Authority previously undertook a risk profile on the NSW egg industry (Miles & Chan, unpublished) and proposed several risk management strategies to underpin the incorporation of an Egg food safety scheme into the Food Regulation 2004. As SafeFood NSW, the Authority commissioned Food Science Australia to provide a scoping study on plant products, which also examined eggs (FSA, 2000). This report identified potential hazards associated with the production of eggs and egg products, shown in Table 42. In addition the egg industry’s peak body, the Australian Egg Corporation Ltd (AECL) commissioned the South Australian Research and Development Institute (SARDI) to complete two sections of work, a risk profile on eggs and egg products to examine all potential hazards (Daughtry et al, 2005), and a quantitative risk assessment concentrating on evaluating the risks from Salmonella serovars (Thomas et al, 2006) All bodies of work include comprehensive assessments of both microbiological and chemical hazards in eggs and egg products. Risk assessment work on the Australian egg industry is currently being undertaken by FSANZ to underpin the development of the Primary Production and Processing Standard for Eggs, Proposal P301 (FSANZ, 2006). Microbiological hazards In an assessment of microbiological standards for eggs and egg products, the former Australia New Zealand Food Authority (now FSANZ) identified the following microorganisms of concern in relation to the commercial production, processing and distribution of eggs (ANZFA, 1999): • Salmonella serovars • Bacillus cereus • Listeria monocytogenes • Staphylococcus aureus It is recognised that pathogenic organisms may contaminate the shell of the egg, through environmental and faecal contamination. B. cereus (van Netten et al, 1990), L. monocytogenes (McKellar, 1993) and S. aureus (Papadopoulou et al, 1997) have all been detected during analysis of eggs and/or egg products. However, an analysis of foodborne illness attributed to eggs in Australia shows that virtually all outbreaks have been due to Salmonella serovars, with S. Typhimurium the dominant serovar responsible for illness associated with egg consumption. A risk profile undertaken by the NZFSA concentrated on non typhoidal Salmonella in and on eggs as the main hazard (Lake et al, 2004) and the AECL quantitative risk assessment work focused on Salmonella as the primary hazard of concern. Food Safety Scheme Risk Assessment Page 120 of 189 Table 42 – Hazards in the production of shell eggs and egg products Product Shell eggs Egg products Hazard / contributing factors Contamination with Salmonella serovars Growth of Salmonella serovars Contamination with other pathogens Penetration of pathogens during egg production and handling Pathogen survival due to undercooking Development of antibiotic resistant pathogens Mycotoxins Pyrrolizidine alkaloids from feed transferred to eggs Heavy Metals Agricultural and veterinary chemicals Pesticide residues (eg organochlorine residues) in free range and ‘backyard’ eggs Polychlorinated biphenyls Potential contamination of eggs or egg products from packaging Contamination with Salmonella serovars or other pathogens Pathogen survival due to inadequate process treatment Contamination of raw and processed product with heavy metals, chemicals (including agricultural compounds and veterinary medicines) or other toxicants adapted from FSA (2000) Overseas, the focus of egg safety assessment has been slightly different, as Salmonella Enteritidis has become endemic in overseas laying flocks since the 1980s. This has provided a major problem for the overseas egg industry as Salmonella Enteritidis has the unusual ability to colonise the ovarian tissue of hens and this causes Salmonella cells to be present within the contents of newly laid intact shell eggs. Contamination of eggs and of egg products with Salmonella Enteritidis is believed to be the cause of the large increase in human infections in Europe and North America. The Centre for Disease Control in the USA attributed 77-82% of Salmonella Enteritidis-related foodborne outbreaks to eggs and egg products. In many of these cases the outbreaks were associated with the consumption of ‘Grade A’ shell eggs (WHO, 2002). Currently Australian layer flocks remains free of Salmonella Enteritidis, and it has been estimated that this is worth around $48 million per annum to the Australian egg industry (Sergeant et al, 2003). Given this, there is a strong push from the industry peak body, the AECL, for the implementation of quality assurance programs and codes of practice in the industry, including biosecurity measures on farm to ensure the maintenance of the Salmonella Enteritidis-free status (AECL, 2005a, AECL, 2005b). However, other Salmonella serotypes are intrinsic in the Australia poultry industry and form part of the microbiota in the intestinal tract of chickens. The external surfaces of eggs may become contaminated with faecal material, including Salmonella bacteria between when the egg is laid and when it is collected. However, if the egg is kept dry it is likely that the bacteria will die on the outside of the shell. In a survey of Australian farms that included testing of faecal samples and egg pulp, Cox et al (2002) found that S. Singapore was the dominant organism. This was thought to be related to the high numbers of Salmonella found in the feed intended for the chickens, which in turn showed in the numbers found in the faecal specimens. Survival of Salmonella on the egg surface may be enhanced by high relative humidity and the organism may penetrate the egg shell if it is wet, as the shell becomes more porous. Cox et al (2002) showed that S. Infantis, S. Typhimurium, S. Heidelberg and S. Singapore were all capable of migrating into the egg under favourable conditions. Food Safety Scheme Risk Assessment Page 121 of 189 Normally the contents of an intact shell egg are essentially sterile when laid and the intrinsic structure of an egg, with the cuticle, shell and shell membranes combining to form a protective barrier against bacteria penetrating into the egg. However, if the egg is cracked (the shell is cracked but the shell membrane is intact) or broken (shell is cracked and shell membrane is also broken), this can facilitate access of pathogenic bacteria into the egg contents, where they may be able to increase in numbers in the nutrient-rich yolk. Standard 2.2.2 – Egg and Egg Products of the Food Standards Code prohibits cracked eggs being made available for retail sale or for catering purposes, due to the increased risk of bacterial contamination. However, there is anecdotal evidence to suggest that cracked eggs are being sold at a substantially reduced price for use in restaurants and for catering purposes. A Canadian risk assessment on the use of cracked eggs stated that any country producing eggs has to recognise that, despite regulations controlling the use of cracked eggs, economics will dictate that some of these will be consumed as whole eggs and a management plan is desirable to limit hazardous practices associated with these eggs (Todd, 1996). Chemical hazards Dawson et al (2001) listed the possible sources of chemical contamination of eggs including: • free range birds feeding on contaminated soil • insecticide sprays used while birds are present • water medication at incorrect rate • eggs washed in inappropriate solutions • egg washing compound mixed at wrong concentrations • systemic pesticides used in grower sheds • shed fumigation while birds are present • chemical feed additives included at wrong rate • use of antibiotics or other veterinary medicines Survey results from the National Residue Survey (NRS) and Market Basket Survey have shown occasional detections of heavy metals. Dieldrin residues have also been found in free range eggs (FSA, 2000). Free range hens are considered a higher risk for coming into contact with environmental chemical contaminants because they have the opportunity to source their own food outside, thus increasing the potential for eating contaminated vegetation or soil. However, all detections have been at levels well below the Maximum Residue Level (MRL), and the health risk to humans was concluded to be low. There have been detections of veterinary chemical residues in eggs above the MRL, in the past several years (Table 43). The use of antiprotozoals is common to control coccidiosis in the hens, and is mainly used as a feed additive. The traceback investigations of positive detections on farm have tended to indicate mix ups with feed. The use of cages has reduced the need for veterinary chemical usage because the hens are housed off the floor and parasitic infections are less of a problem (FSA, 2000). The AECL risk profile concluded that there was no evidence that pesticides, veterinary medicines or other chemical contaminants, present a food safety or public health risk (Daughtry et al, 2005). Despite occasional low level detections, in general eggs are residue free and no egg samples have been found to contain chemical residues which would present an immediate health risk. Food Safety Scheme Risk Assessment Page 122 of 189 Table 43 – Prevalence of chemical residues in eggs National Number of Number with Number of residues above MRL Residue analyses residues Survey 1991 617 21 (3.4%) 1 (0.16%) 1992 564 30 (5.3%) 2 (0.35%) 1997 228 1 (0.44%) 0 National Number of Number of Residues above Residues Residue samples analyses MRL/ERL above ML Survey 1998 248 703 0 0 31 1999 83 1190 0 0 32 1999–2000 158 3242 0 1 33 2000–2001 122 1683 0 0 2001–2002 92 1387 0 0 No testing of eggs was conducted in 2002–2003 or 2003–2004 2004–2005 75 1000 2 34 0 2005–2006 75 1000 2 35 0 2006–2007 75 1025 2 36 0 adapted from BRS (1996); BRS (1998); AFFA (1999); AFFA (2000); AFFA, (2001); AFFA (2002); DAFF (2003); DAFF (2005); DAFF (2006); DAFF (2008) Physical hazards Due to the protection offered by the shell of the egg, there is a very small likelihood of physical contaminants affecting eggs. The main physical hazards present on farm are blood spots, rodent droppings and insects. Blood spots may be present in eggs when they are laid and may reach the consumer if the eggs are not carefully checked during grading. The candling process used for crack detection of commercial eggs should prevent eggs containing physical contaminants from entering the market. FSANZ concluded that physical hazards are not a significant issue for eggs and egg products (FSANZ, 2006). Other eggs The Australian egg industry is primarily based on eggs and egg products produced from hens. Other egg-producing avian species, such as ducks, quails, pheasants, pigeon, geese, turkey and guinea fowl form a very minor part of the egg market. There is little detailed information available about the national production of eggs and egg products from these species (FSANZ, 2006), or on the microbiological and chemical status of these products. There is some evidence to suggest that duck eggs may be more highly contaminated with Salmonella serovars than chicken eggs. Overseas studies have shown up to 14% of duck eggs contaminated with Salmonella serovars This is possibly due to the added potential for external contamination of the eggs from less on-farm controls, but also through an increased probability of vertical transmission, particularly of Salmonella with ducks (Jay et al, 2003). 31 32 33 34 1998 – two Dieldrin residues detected in free-range eggs, at concentrations of less than 20% MRL 1999 – one residue of Dieldrin in free-range eggs, at concentrations of less than 20% MRL 1999–2000 – one residue of copper above the ML was detected 2004 –2005 – both residues were due to anticoccidials. One sample containing Lasalocid was thought to be the result of a mix-up with feed. The traceback for sample containing Nicarbazin was not complete when the NRS report was published. 35 2005–2006–two samples showed residue levels of Nicarbazin (anticoccidial) above the Australian Standard and were found to be the result of a mix-up with feed. 36 2006–2007 – two samples showed residue levels of Nicarbazin (anticoccidial) above the Australian Standard and were found to be the result of a mix-up with feed. Food Safety Scheme Risk Assessment Page 123 of 189 Most duck eggs are processed into specialty products, such as salted eggs, century eggs and Balut egg. While the primary microbiological hazard of concern remains Salmonella serovars, the manual handling associated with specialty egg production could possibly lead to contamination with other pathogens such as S. aureus and E. coli. The NSW Food Authority has detected high level of lead in century eggs made from duck eggs (McCreadie et al, 2007). Traditional practices involved the use of lead oxide in the pickling solution, believed to modify the porosity of the egg shell, and thus influence the rate of ingress of the alkaline pickling solution into the egg. This was thought essential to produce century eggs with the desirable semi-solid yolk texture. The Authority survey found a single NSW processor adding lead oxide to the brine the eggs were soaked in. Lead oxide can be extremely poisonous and is not permitted as a food additive in Australia. Given the traditional use of lead salts in specialty egg products, there may be a need to monitor the lead content of these products periodically in case of processors go back to a ‘proven’ traditional technique. Exposure assessment Consumption of shell eggs (‘table eggs’) In NSW, it is estimated there are 139 egg producers with annual production of almost 58 million dozen eggs worth an estimated $90 million per annum (ABS, 2006). While egg consumption has been steadily declining, consumption data from 1998–99 indicates that the Australian population consumes an average 137 eggs per person each year (ABS, 2000). The National Nutrition Survey (ABS, 1995) reported that 16.1% of the NSW population consumed eggs and egg products (see Table 45). Overall results showed that rates of consumption ranged from 8.5% (females aged 16 to 18) to 20.5% (males aged 45 to 64). Of those males consuming eggs and egg products, average daily consumption varied from 27.8 g/day (2 to 3 years) to 74.0 g/day (12 to 24 years), while for females average daily consumption varied from 43.0 g/day (2 to 3 years) to 50.0 g/day (25 to 44 years). The consumption data only recorded the consumption levels of eggs (eg fried egg, poached egg) and dishes where egg was the major ingredient (eg omelette, soufflé, scrambled eggs). It did not record consumption of foods where egg may be included as one of many ingredients (eg mayonnaise, desserts). The national consumption data reveals that between 12–13% of infants (2–3 yrs) and 14–17% of the elderly (65+ yrs) regularly consume eggs. No distinction was made in what form the eggs were consumed, whether they were served lightly or thoroughly cooked. This demonstrates that a significant proportion of the vulnerable population are regular consumers of eggs. Food Safety Scheme Risk Assessment Page 124 of 189 Prevalence of Salm onella in Australian eggs Survey data included in the AECL risk assessment provides the best prevalence data of Salmonella serovars on and within Australian eggs (Thomas et al, 2006). The external surface of 11,036 eggs from various sources (caged, free range and barn-laid) and the internal contents of 20,000 caged egg samples were sampled (see Table 44). Table 44 – Prevalence of Salm onella in Australian eggs Egg type Shell eggs – ungraded Caged (shell) Free range (shell) Barn laid (shell) Shell eggs – graded Caged (shell) Caged (internal contents) Number of samples tested Salm onella detected (estimated prevalence) 2160 1200 1200 0 (0 – 0.2%) 0 (0 – 0.3%) 0 (0 – 0.3%) 6476 20,000 0 (0 – 0.06%) 0 (0 – 0.02%) adapted from Daughtry et al (2004) Based on comparable prevalence of external contamination to overseas data (0.21%), Thomas et al. (2006) concluded that the prevalence of internal contamination by Salmonella in Australian eggs is likely to be close to the overseas reported rate of 0.004%, roughly equivalent to one egg every 25,000 being contaminated with Salmonella. This prevalence must be considered in the context that there are over 800 million eggs consumed in NSW each year, both as shell eggs and as an ingredient in food. At this prevalence, there may be 32,000 eggs contaminated with Salmonella consumed each year in NSW. Table 45 – Consumption of eggs and egg products in Australia Sex Age Male Male Male Male Male Male Male Male Male Female Female Female Female Female Female Female Female Female 2–3 4–7 8 – 11 12 – 15 16 – 18 19 – 24 25 – 44 45 – 64 65+ 2–3 4–7 8 – 11 12 – 15 16 – 18 19 – 24 25 – 44 45 – 64 65+ Proportion of persons consuming egg products and dishes 37 (%) 12.6 11.1 14.0 12.3 18.1 15.7 17.9 20.5 17.6 13.9 12.2 10.7 8.7 8.5 12.8 15.2 16.8 14.2 Median daily intake for consumers of egg products and dishes (g/day) 27.8 50.0 58.0 74.0 74.0 74.0 62.5 57.0 72.0 43.0 50.0 50.0 50.0 49.0 50.0 50.0 50.0 50.0 adapted from National Nutrition Survey (ABS, 1995) 37 Egg products and dishes are defined in the National Nutrition Survey (ABS, 1995) as including the following: - Eggs - Dishes where egg is the major ingredient - Egg substitutes and dishes Food Safety Scheme Risk Assessment Page 125 of 189 Use of shell eggs It is estimated that 87% of all egg production is sold at retail as shell eggs, with the remaining 13% being further processed into egg products such as pasteurised liquid egg (ABS, 2000). Where egg products are processed, they must meet prescribed microbiological criteria under Standard 1.6.1 – Microbiological Limits for Food of the Food Standards Code. Of those eggs sold at retail, it is estimated that 30% are used as an ingredient in a food where it will be thoroughly cooked. There is little data on the consumption patterns of eggs by Australian consumers, but an American survey estimated that 27% of all egg dishes consumed in the US are lightly cooked (Lin et al, 1997), translating to each person on average consuming lightly cooked eggs 20 times a year. Lightly cooked eggs are described as ‘runny’, ‘runny yolk’ or ‘runny white’ and may allow the survival of any pathogenic bacteria that are present within the egg. Eggs fried ‘over easy’ and ‘sunny side up’ accounted for almost half (49%) of the lightly cooked eggs eaten. Of instances where raw eggs were consumed as an ingredient in an uncooked or very lightly cooked food, 52% was in frosting, salad dressing (18.5%), blended milk beverages (16%), homemade ice-cream (6%), and hollandaise sauce. Although Australian consumption patterns may be different to the American data cited here, this does provide an indication of the potential exposure to pathogens from undercooked eggs. Consumption of specialty duck egg products and quail eggs Production data on specialty egg products is limited, and it is assumed that the level of consumption forms a very small portion of overall egg consumption. Moreover, they are likely to be consumed by specific minority groups and/or as delicacies only occasionally rather than as part of routine diet. A per capita consumption figure is not available for these products. Hazard characterisation Foodborne illness outbreaks from eggs A summary of foodborne illness outbreaks attributed to eggs, or where egg was used as an ingredient in the implicated food is shown in Table 46 (more detailed information on these outbreaks is included in Table 70 of Appendix 3). It is clear from epidemiological data and the literature that Salmonella serovars is the primary pathogen of concern in relation to foodborne illness associated with eggs. Table 46 – Summary of foodborne illness outbreaks attributed to eggs, egg products and eggs used as an ingredient Hazard Salmonella serovars Streptococcus pyogenes Toxin Norovirus Campylobacter Unknown Total Food Safety Scheme Risk Assessment Australian outbreaks (1995–2008) 103 1 1 1 1 3 110 Cases Hospitalisations 3808 72 16 11 2 32 3941 265 0 0 0 1 0 266 Deaths 0 0 0 0 0 0 0 Page 126 of 189 Effect of yolk mean time (YMT) on exposure to Salm onella While it appears inevitable that Salmonella will penetrate into a small proportion of eggs, the bacteria will not begin to increase in numbers immediately. Studies have shown that Salmonella will not grow in the iron restricted environment of the albumen (egg white), and is only able to grow after a considerable period of time. As the egg ages, the vitelline membrane surrounding the yolk breaks and allows the Salmonella to enter the yolk and utilise the rich iron supply within the yolk to grow and rapidly increase in numbers. This length of time for the membrane to break down is determined by the yolk mean time (YMT) and is affected by the temperature the egg is stored at. Humphrey (1994) observed large numbers of Salmonella in both the yolk and albumen after the resolution of YMT. Thomas et al. (2006) estimated that 75% of eggs in Australia are consumed before resolution of YMT, based on average industry practices and storage temperatures throughout the production, distribution and retail chain. In effect, this minimises the opportunity for Salmonella to proliferate to high numbers within the egg and results in eggs being a low risk food. However, where eggs are stored at elevated temperatures for extended periods of time, this can allow the YMT to resolve and provide the conditions for any Salmonella which may be present in the egg to grow. Under these conditions, the risk of foodborne illness is increased unless the egg is fully cooked prior to consumption to eliminate the Salmonella. Grading and processing of eggs Several processes used in the grading and processing of eggs may lead to cross contamination of eggs and egg products if sufficient food safety controls are not in place. Efficient crack detection is required when the eggs are graded to ensure that cracked eggs are identified and are re-directed for further processing where they will be pasteurised or an equivalent treatment. To ensure the efficacy of the crack detection method, it should be validated and verified. Washing of eggs is sometimes undertaken by graders and processors to remove any gross faecal or environmental contamination from the shell of the eggs prior to sale. However, if not carefully controlled, the washing process has the potential to damage the shell cuticle and actually increase the risk of microbial penetration into the egg. Inadequate control of temperature, pH and insufficient changes in wash water can result in a build up of microorganisms and lead to cross contamination of eggs. In addition, the incorrect use of chemicals has the potential to cause unacceptable levels of chemical residues in the egg. Eggs must be dried after washing as inadequately dried eggs can allow microbial growth and any remaining bacteria may be aspirated into the egg. The design and hygiene of equipment used in the processing of eggs is of considerable importance to avoid niches for bacterial growth (Jones et al, 2003). The method used to separate the egg contents from the shell for further processing into liquid pulp can have a major impact on the microbiological content of the resulting pulp. The risk of bacterial contamination is markedly worsened by the use of dirty eggs. Liquid egg pulp made from cracked or broken eggs is more likely to be associated with pathogens or increased pathogen numbers than pulp prepared from intact shell eggs. Industry practice is to discard broken eggs, as they are considered a microbiological risk for both safety and quality. The exception to this appears to be where eggs may be broken just prior to when they are pulped. The production of egg products must involve pasteurisation, with the minimum times and temperatures defined in Standard 1.6.2 – Processing Requirements of the Food Standards Code, or an equivalent treatment may be used. Pasteurisation of egg pulp must deliver a sufficient heat treatment to ensure the finished product complies with the microbiological standards specified in Standard Food Safety Scheme Risk Assessment Page 127 of 189 1.6.1 – Microbiological Limits for Food of the Food Standards Code. The pasteurisation process for egg pulp is relatively mild as coagulation of the egg protein needs to be avoided (ICMSF, 1998). The effectiveness of the pasteurisation process is influenced by the microbial load, so the higher the bacterial load prior to pasteurisation, the higher the bacterial population remaining after processing. Thomas et al. (2006) demonstrated that the pasteurisation parameters set by the Food Standards Code delivers a relatively small log reduction of Salmonella for liquid egg yolk and albumen and the presence of viable Salmonella in processed products has been demonstrated (NEPSS, 2003). To ensure the effectiveness of the pasteurisation process, the process must be monitored and verified through end product testing and additional control measures implemented to limit the extent of contamination, and the opportunity for growth of contaminating organisms in the raw material. Hygienic handling of pasteurised product must be undertaken to ensure pasteurised product is not recontaminated. Egg pulp remains vulnerable to further contamination post pasteurisation if GMP and GHP are not implemented. Salmonella serovars are able to grow rapidly in egg yolk under both aerobic and anaerobic conditions (ICMSF, 1998), unless the product is stored under appropriate temperature control or kept in a frozen state. Specialty duck egg products Production of processed duck eggs exposes the eggs to greater risks of invasion by pathogens likely to be found in the prevailing environment (eg Salmonella serovars). The extensive manual handling these products receive may also introduce pathogens such as S. aureus and E. coli. However, reported cases of illness implicating these pathogens in processed duck eggs are rare. Salted duck eggs and Balut eggs are intended to be eaten cooked. The one documented case of Salmonella poisoning implicating salted eggs was probably an example of uninformed use of that product (Campbell, pers comm.). There is a high risk of chemical contamination with the use of non-food grade chemicals such as lead oxide, if processors resort to traditional methods for making century eggs. Risk characterisation The primary hazard to human health from eggs and egg products are Salmonella serovars. This is evident from the epidemiological data, with Salmonella serovars determined as the cause for the majority of foodborne illness cases attributed to eggs in Australia. While it is possible that other pathogens may also contaminate the shell of the egg through faecal and environmental contamination, this is not reflected in foodborne illness data across Australia. In the AECL-funded risk profile, Daughtry et al (2005) examined 33 different scenarios of egg production and storage and final usage. An estimate was made of how many eggs were captured by each scenario, and an estimate made of the risk per serving and predicted annual number of illnesses attributable to each (see Table 47). It is acknowledged that there are a number of assumptions made in generating such predictions, however this information can provide a useful indication of the highest risk practices and be used to focus risk management strategies. Food Safety Scheme Risk Assessment Page 128 of 189 Table 47 – Risk ranking for type and use of eggs growth (YMT resolved) Eggs subjected to pathogen reduction step (eg cooking) 1. Commercial eggs Intact None Salm onella Risk ranking Predicted cases of Salmonellosis per serve (in Australia) Predicted annual number of Salmonellosis cases (in Australia) 42 MR Low 4 x 10-11 3.34 x 10-2 2. Commercial eggs Intact None SR Low 4 x 10-14 3.34 x 10-5 3. Commercial eggs Intact None RE Low 0 0 Scenario Cracked/Intact Salm onella kill step MR 38, SR 39, RE 40, NE 41 -6 4. 5. Commercial eggs Commercial eggs Intact Intact 5-log 5-log MR SR Medium Low 4 x 10 4 x 10-9 772 7.72 x 10-1 6. Commercial eggs Intact 5-log RE Low 0 0 -11 7. Non-commercial eggs Intact None MR Low 4 x 10 3.43 x 10-3 8. 9. Non-commercial eggs Non-commercial eggs Intact Intact None None SR RE Low Low 4 x 10-14 0 3.43 x 10-6 0 10. Non-commercial eggs Intact 5-log MR Medium 4 x 10-6 79 -9 11. Non-commercial eggs Intact 5-log SR Low 4 x 10 7.92 x 10-2 12. Non-commercial eggs 13. Non-commercial eggs Intact Cracked 5-log None RE MR Low Low 0 4 x 10-9 0 1.32 x 10-3 14. Non-commercial eggs Cracked None SR Low 4 x 10-12 1.32 x 10-6 15. Non-commercial eggs Cracked None RE Low 0 0 -4 16. Non-commercial eggs 17. Non-commercial eggs Cracked Cracked 5-log 5-log MR SR Medium Low 4 x 10 4 x 10-7 66 6.60 x 10-2 18. Non-commercial eggs Cracked 5-log RE Low 0 0 38 39 40 41 42 MR – moderate reduction – 100-fold decimal reduction in Salmonella (eg light cooking, fried ‘sunny side up’, microwave, boiled where liquid yolk remains) SR – substantial reduction – 10,000 fold decimal reduction in Salmonella (eg fried ‘easy over’, lightly scrambled or omelette, pasta) RE – reliably eliminates – 1,000,000,000 fold decimal reduction in Salmonella (eg hard boiled or scrambled, cakes, biscuits) NE - no effect – no reduction in Salmonella (eg raw egg drinks, some desserts) Data from Daughtry et al (2005) used an Australian population figure of 19.5 million. These estimates have been extrapolated to the current population of Australia estimated by ABS (2009) as approximately 21.6 million, by multiplying by a factor of 1.1, for consistency with other sections of this risk assessment. Food Safety Scheme Risk Assessment Page 129 of 189 Consumed without pathogen reduction step in raw egg drinks and cold desserts 19. Commercial eggs Intact None NE Low 4.0 x 10-9 2.57 x 10-1 20. Commercial eggs Intact 5-log NE Medium 4 x 10-5 643 21. Non-commercial eggs 22. Non-commercial eggs Intact Intact None 5-log NE NE Low Medium 4.0 x 10 4 x 10-5 7.92 x 10-2 198 23. Non-commercial eggs Cracked None NE Low 4 x 10-7 1.32 x 10-2 24. Non-commercial eggs Cracked 5-log NE Medium 4 x 10-4 13 -6 10 25. Non-commercial eggs Cracked eggs in egg butter -9 3-log NE High 4 x 10 1-log NE Medium 2.5 x 10-4 -6 Commercial liquid egg pulp 26. Commercial eggs Unpasteurised pulp 11 27. Commercial eggs 28. Commercial eggs Unpasteurised pulp Unpasteurised pulp 1-log 1-log SR RE Medium Low 2.5 x 10 2.50 x 10-9 2.15 x 10-1 2.68 x 10-4 29. Commercial eggs Unpasteurised pulp 1-log MR Low 0 0 30. Commercial eggs Pasteurised pulp None NE Low 2 x 10-7 10 -9 31. Commercial eggs 32. Commercial eggs Pasteurised pulp Pasteurised pulp None None SR RE Low Low 2.00 x 10 2.00 x 10-12 1.29 x 10-1 1.29 x 10-4 33. Commercial eggs Pasteurised pulp None MR Low 0 0 adapted from Daughtry et al (2005) Food Safety Scheme Risk Assessment Page 130 of 189 The highest risk per serving was for scenarios where the storage conditions of the eggs allowed the YMT to be resolved and therefore allowed the numbers of Salmonella to significantly increase (scenario 16, 24 from Table 47), resulting in a risk per serving of 400 predicted illnesses per million servings. However, this did not necessarily translate to a large number of predicted illnesses, as the number of eggs actually captured by the particular scenario may not be that large. These two particular scenarios looked at non-commercially produced eggs, which account for a very small portion of overall egg production. The largest number of actual predicted illnesses was from scenario 4, where the storage conditions for the eggs allowed the resolution of the YMT, and final use only involved a moderate kill step. Thomas et al (2006) estimated that as many as 25% of shell eggs in Australia are consumed after resolution of YMT, and although the risk per serving was predicted to be 4 illnesses per million servings, because of the large number of eggs captured by this scenario, it results in a prediction of 772 illnesses each year when extrapolated to the current Australian population. Total numbers of predicted illnesses from all scenarios was greater than 1800 cases per annum. The final estimate for the level of illness was shown to be dependent on a number of factors, namely: • the quality of hygienic practices on-farm (ie level and prevalence of contamination with Salmonella) • hygienic practices during processing • time and temperature of egg storage (ie whether this allowed the resolution of YMT and subsequent increase in levels of Salmonella in the egg) • end use of the eggs (level of cooking and subsequent reduction in Salmonella) The risk profile undertaken previously by the NSW Food Authority (Miles & Chan, unpublished) identified that the significant control measures to manage microbiological and chemical hazards were as follows: Biosecurity measures on farm Continued strict biosecurity measure will be necessary on commercial farms to maintain the S. Enteritidis-free status. Because of the small number of breeder flocks in Australia, and the already high level of biosecurity on these flocks, it is concluded that the probability of a breeding flock becoming infected with S. Enteritidis is low. However, should a breeding flock become infected and remain undetected, there would be significant spread to a large number of layer flocks throughout Australia (Arzey, 2002). If this should happen it is believed there would be significant increase in the number of human cases of S. Enteritidis-related illness from eggs (Sergeant et al, 2003), as has been observed in other countries where S. Enteritidis has become endemic. To ensure laying hens and breeding stock remain free from S. Enteritidis the Australian egg industry has proactively initiated and developed various generic egg quality Codes of Practice and food safety programs to manage relevant food safety and quality risks at specific stages of the supply chain for both eggs and egg products (AECL, 2005a; AECL, 2005b). However the uptake of these by industry is voluntary. Through-chain regulatory control and implementation of food safety controls and traceability on farm may aid in maintaining the S. Enteritidis-free status. Food Safety Scheme Risk Assessment Page 131 of 189 Control measures for grading and processing of eggs and egg products Higher risk operations, including grading and washing of eggs, handling and processing of egg pulp, and processing of specialty duck eggs, should be carried out with adequate control through the implementation of HACCP-based food safety program. The revised Codex Code of Hygienic Practice for Eggs and Egg products emphasises the use of the HACCP approach wherever appropriate to minimise food safety hazards (Codex, 2006). Pasteurisation of all liquid egg preparations should be monitored, recorded and periodically verified. Monitoring should include evidence of the effectiveness of the process. Thomas et al (2006) stated that the epidemiological data shows that few foodborne outbreaks in Australia can be attributed to the ingestion of clean intact shell eggs that are produced under a quality control system, graded and retailed commercially. Effective management of the supply chain The time and temperature that eggs are stored at determines the length of time to resolve the YMT. Resolution of the YMT can allow significant growth of Salmonella within the egg, with Daughtry et al (2005) demonstrating that this was a significant factor in increasing the risk of illness from egg consumption. While Thomas et al (2006) estimated that 75% of eggs are consumed before the YMT is resolved, management of the supply chain should ensure that a realistic shelf life is applied to shell eggs, according to the expected storage conditions through the distribution, wholesale and retail supply chain. Prohibition on sale of cracked eggs The Food Standards Code prohibits the sale of eggs with cracked shells unless those eggs are sold for further processing. Crack detection forms a significant food safety control for eggs, and as stated previously this should be undertaken with an implemented food safety program in place. There is epidemiological evidence pointing to the use of ungraded eggs and dirty, cracked/seconds eggs being sold direct off-farm leading to outbreaks of salmonellosis. A requirement for egg farms to notify of their operation to the NSW Food Authority would ensure greater ability to trace back to the potential sources of foodborne illness. Use of unpasteurised liquid egg preparations Risk assessment work demonstrates that consumption of uncooked, or lightly cooked foods containing raw eggs represent an increased risk for foodborne illness. Use of unpasteurised liquid egg preparations, where sold, should be clearly identified as an ingredient only for foods that will receive adequate heat treatment to destroy Salmonella. Due to the potential for survival and growth of Salmonella serovars in unpasteurised egg pulps, these are unsuitable for use in processed foods unless the foods receives a sufficient heat treatment to ensure any Salmonella that may be present are inactivated. Food service to vulnerable populations Epidemiological data from foodborne outbreaks consistently points to the use of raw eggs in foods where it will not be well cooked, and/or the use of cracked and/or dirty eggs in catering situations. Education of food service to vulnerable populations should be undertaken on the risks of using raw eggs in foods or drinks that will not be cooked. As an alternative, these institutions should look to use pasteurised egg pulp that has been tested and certified as pathogen free. Food Safety Scheme Risk Assessment Page 132 of 189 Conclusions The risk assessment work undertaken on eggs and egg products consistently demonstrates that Salmonella is the primary hazard of concern. This is clearly evident from the epidemiological evidence from outbreaks around Australia where eggs have been implicated as the vehicle. However, prevalence data indicate that the use of clean intact eggs before the resolution of YMT, and/or consumed either well cooked or used as an ingredient where the egg will be well cooked should present very little risk to the consuming public. But with the number of outbreaks attributable to eggs appearing to increase in the past few years, there continues to be issues with the management of hazards throughout the egg supply chain. This risk assessment has identified a number of areas that may, if not addressed through the implementation of appropriate control measures, potentially contribute to the contamination of eggs and egg products with Salmonella and lead to further increases in the outbreaks of foodborne illness attributable to eggs. The development of a draft egg food safety scheme aims to implement control measures across the egg supply chain to minimise further foodborne illness attributable to eggs. Food Safety Scheme Risk Assessment Page 133 of 189 References – Egg and egg products ABS [Australian Bureau of Statistics] (1995). National Nutrition Survey: Foods Eaten, Australia, 1995. Australian Bureau of Statistics report. ABS Cat no 4804.0. Retrieved 13 January 2009, from http://www.ausstats.abs.gov.au/ausstats/subscriber.nsf/0/CA25687100069892CA256888001C D460/$File/48040_1995.pdf ABS [Australian Bureau of Statistics] (2000). Apparent Consumption of Foodstuffs, Australia, 1997-98 and 1998-99. ABS Cat no 4306.0. Retrieved 23 September 2011, from http://www.abs.gov.au/AUSSTATS/[email protected]/0/123FCDBF086C4DAACA2568A90013939A?Ope nDocument ABS [Australian Bureau of Statistics] (2006). Value of Agricultural Commodities produced 2004-05. ABS Cat no 7503.0. Retrieved 13 January 2009, from http://www.ausstats.abs.gov.au/ausstats/subscriber.nsf/0/758410C5AB68DCA9CA2571E6001 C8F0F/$File/75030_2004-05.pdf AECL [Australian Egg Corporation Limited] (2005a). Code of Practice for shell egg, production, grading, packing and distribution. Australian Egg Corporation Limited. AECL [Australian Egg Corporation Limited] (2005b). Code of Practice for the manufacture of Egg Products. Australian Egg Corporation Limited. AFFA [Agriculture, Fisheries and Forestry Australia] (1999). Report on the National Residue Survey 1998 Results, National Office of Food Safety, Department of Agriculture, Fisheries and Forestry Australia, Canberra AFFA [Agriculture, Fisheries and Forestry Australia] (2000). Report on the Australian National Residue Survey Results 1999-2000. Agriculture, Fisheries and Forestry – Australia, Canberra. AFFA [Agriculture, Fisheries and Forestry Australia] (2001). Report on the Australian National Residue Survey Results 2000-2001. Agriculture, Fisheries and Forestry – Australia, Canberra. AFFA [Agriculture, Fisheries and Forestry Australia] (2002). Report on the Australian National Residue Survey Results 2001-2002. Agriculture, Fisheries and Forestry – Australia, Canberra. ANZFA [Australia New Zealand Food Authority] (1999). Review of Microbiological Standards Egg and Egg Products. Australia New Zealand Food Authority, Canberra. Arzey, G. (2002). Salmonella Enteritidis in Australia – Facts and fiction. Proceedings of Poultry Information Exchange (PIX) 2002 pp 165-170 BRS [Bureau of Resource Science] (1996). Report on the National Residue Survey Results 1991-92 Results. Bureau of Resource Sciences, Canberra. BRS [Bureau of Resource Science] (1998). Report on the National Residue Survey Results 1997 Results. Bureau of Resource Sciences, Canberra. Codex (2006). Code of Hygienic Practice for Eggs and Egg Products. CAC/RCP 15. Codex Alimentarius Commission. Cox, J.M., Woolcock, J.B. & Sator, A.L. (2002). The significance of Salmonella, particularly S. Infantis, to the Australian egg industry. Rural Industries Research and Development Corporation (RIRDC) Web Publication W02/028. Retrieved 21 January 2009, from http://www.aecl.org/Images/03-b%20The%20significance%20of%20Salmonella.pdf Daughtry, B., Sumner, J., Hooper, G., Thomas, C., Grimes, T., Horn, R., Moses, A. & Pointon, A. (2005). National food safety risk profile of eggs and egg products. A report for the Australian Egg Corporation Limited (AECL) Publication No 05/06 Project SAR-47. DAFF [Department of Agriculture, Fisheries and Forestry] (2003). National Residue Survey Annual Report 2002-2003. Australian Government Department of Agriculture, Fisheries and Forestry, Canberra. DAFF [Department of Agriculture, Fisheries and Forestry] (2005). National Residue Survey Annual Report 2004-2005. Australian Government Department of Agriculture, Fisheries and Forestry, Canberra. Food Safety Scheme Risk Assessment Page 134 of 189 DAFF [Department of Agriculture, Fisheries and Forestry] (2006). National Residue Survey Annual Report 2005-2006. Australian Government Department of Agriculture, Fisheries and Forestry, Canberra. DAFF [Department of Agriculture, Fisheries and Forestry] (2007). National Residue Survey Annual Report 2006-2007. Australian Government Department of Agriculture, Fisheries and Forestry, Canberra. Dawson, R.C., Cox, J.M., Almond, A. & Moses, A. (2001). Food Safety Risk Management in Different Egg Production Systems. RIRDC Publication No 01/111. Lin, C.-T.J., Morales, R.A. & Ralston, K. (1997). Raw and undercooked eggs: A danger of salmonellosis. Food Review, January-April 1997, pp. 27-32. Retrieved 20 January 2009, from http://www.ers.usda.gov/publications/foodreview/jan1997/jan97d.pdf FSA [Food Science Australia] (2000). Final report – scoping study on the risk of plant products. Food Science Australia prepared for SafeFood NSW. FSANZ (2006). Initial Assessment Report – Proposal P301. Primary Production and Processing Standard for Eggs and Egg Products. Food Standards Australia New Zealand, Canberra. Humphrey, T.J. (1994). Contamination of egg shell and contents with Salmonella enteritidis: a review. International Journal of Food Microbiology, 21, 31-40. ICMSF [International Commission on Microbiological Specifications for Foods] (1998). Eggs and egg products in Microorganisms in Foods 6. Microbial ecology of food commodities. (p. 475-520). Blackie Academic and Professional, London. Jay, S., Davos, D., Dundas, M., Frankish, E. & Lightfoot, D. (2003). Salmonella. In Hocking, A.D. (Ed.) Foodborne Microorganisms of Public Health Significance (pp. 207-266). Australian Institute of Food Science and Technology, Waterloo. Jones, D.R., Northcutt, J.K., Musgrove, M.T., Curtis, P.A., Anderson, K.E., Fletcher, D.L. & Cox, N.A. (2003). Survey of Shell Egg Processing Plant Sanitation Programs: Effects on Egg Contact Surfaces. Journal of Food Protection, 66,1486-1489 Lake, R. Hudson, A., Cressey, P. & Gilbert, S. (2004). Risk Profile: Salmonella (non-typhoidal) in and on eggs. Institute of Environmental Science and Research Limited report prepared for the New Zealand Food Safety Authority. Retrieved 14 January 2009, from http://www.nzfsa.govt.nz/science/data-sheets/Salmonella-eggs.pdf Lin, C.-T.J., Morales, R.A., & Ralston, K. 1997. Raw and undercooked eggs: The dangers of Salmonellosis. Food Review, 20, 27-32. McCreadie, K., Rizzo, J. & Keygan, M. (2007). Survey of specialty egg products in NSW. Poster presented at Australian Institute of Food Science and Technology Convention – Melbourne 2007. McKellar, R.C. (1993). Effect of preservative and growth factors on secretion of listeriolysin O by Listeria monocytogenes. Journal of Food Protection, 56, 380-384. Miles, D. and Chan, C. (unpublished). Risk Profile and Risk Management of eggs and egg products in NSW. NSW Food Authority report. NEPSS [National Enteric Pathogen Surveillance Scheme] (2003). Non-human Annual Report 2002. Microbiological Diagnostic Unit, The University of Melbourne. National Enteric Pathogen Surveillance Scheme report. Papadopoulou, C., Dimitiou, D., Levidiotou, S., Gessouli, H., Panagiou, A., Golegou, S. & Antoniades, G. (1997). Bacterial strains isolated from eggs and their resistance currently used antibiotics: is there a health hazard for consumer? Comparative Immunology, Microbiology and Infectious Diseases, 20:35-40 Sergeant, E.S.G., Grimes, T.M., Jackson, C.A.W., Baldock, F.C. & Whan, I.F. (2003). Salmonella Enteritidis surveillance and response options for the Australian egg industry. RIRDC Publication No 03/006. Food Safety Scheme Risk Assessment Page 135 of 189 Thomas, C., Daughtry, B., Padula, D., Jordan, D., Arzey, G., Davey, K., Holds, G., Slade, J., & Pointon, A.. (2006). An Egg: Salmonella Quantitative Risk Assessment Model. AECL Publication Todd, E. (1996). Risk Assessment of use of cracked eggs in Canada. International Journal of Food Microbiology, 30, 125-143. van Netten, P., van de Moosdijk, A., van Hoensel, P., Mossel, D.A.A. & Perales, I. (1990). Psychrotrophic strains of Bacillus cereus producing enterotoxin. Journal of Applied Bacteriology, 69, 73-79 WHO/FAO [World Health Organization/Food and Agriculture Organization of the United Nations] (2002). Risk assessment of Salmonella in eggs and broiler chickens: Interpretive summary. Retrieved 14 January 2009, from www.who.int/foodsafety/publications/micro/salmonella/en/index/html Food Safety Scheme Risk Assessment Page 136 of 189 Risk assessment – Conclusion Risk is a function of the probability of a hazard occurring, multiplied by the severity of the outcome. It is dependent on the food, the potential sources of contamination, the hazard of concern, the type of processing, eventual use of the food product, and the resulting illness. The latter can range from mild illness through to severe and life threatening illnesses. This risk assessment document provides a scientific review of the hazards and their associated risks for food businesses covered by the food safety schemes of NSW Food Regulation 2004. The document summarises the information from previous risk assessments or risk profiles and supplements it with new and updated information as available. The review has illustrated that across the food safety schemes there are many potential hazards that can impact on human health. In general, microbiological hazards were considered the most significant, as chemical and physical hazards were rarely detected in foods, or where chemical hazards were detected, they were at levels that do not cause adverse health effects. The review notes that mitigating the risk presented by such hazards involves a multifactorial approach that often extends beyond the controls implemented by a food business operating under a food safety scheme of NSW Food Regulation 2004. The implementation of control measures along the entire food chain, from on-farm controls through to retail, is seen as being the most effective strategy for mitigating risks. It is concluded that for food businesses covered by the food safety schemes of NSW Food Regulation 2004 mitigating food safety risks requires the development and implementation of reliable, systematic and preventative procedures. Such procedures are the core elements of food safety programs, which are either introduced due to regulatory requirements or through industry sponsored Codes of Practice. Food Safety Scheme Risk Assessment Page 137 of 189 Appendix 1: Microbiological and chemical hazards of concern This appendix provides additional information on selected microbiological and chemical hazards, as a supplement to the information included the main part of this risk assessment. The information included in this appendix is limited to key points that have particular relevance to the food commodities covered by the food safety schemes discussed in previous chapters. In-depth descriptions of the microbiological hazards and extensive reference lists are available in the reference documents listed at the end of this appendix. Food Safety Scheme Risk Assessment Page 138 of 189 Salm onella Nature of the illness Salmonellosis is one of the most important public and animal health disease problems, causing worldwide morbidity and mortality of humans and animals. Salmonellosis is a communicable disease readily transmissible from animals to man, either directly or through contaminated products of plant or animal origin (Jay et al, 2003). Gastroenteritis is caused by the penetration and passage of Salmonella cells from the gut lumen into the epithelium of the small intestine where inflammation occurs. Acute symptoms include nausea, vomiting, abdominal cramps, diarrhoea, fever and headache. The onset time varies between 6–48 hours after consumption of contaminated food. In some cases, chronic arthritis follows 3–4 weeks after the onset of acute symptoms (FDA, 1992). Salmonella serovars are important causes of gastrointestinal illness in humans. Salmonella Enteritidis and S. Typhimurium are the most frequently reported non- typhoidal serotypes in many countries and outbreaks have been associated with a diverse range of food. However, a wide variety of serotypes have been associated with outbreaks involving fresh produce. Although most Salmonella infections are selflimiting, in a small proportion of cases these may lead to bacteraemia. The case fatality rate in industrialised countries is less than 1% (EU SCF, 2002). The infective dose for causing foodborne salmonellosis in humans was, for decades, believed to be high, that is 100,000 to one million cells. However, a number of outbreaks have now occurred where the infective dose was found to be much lower, for example <10–100 cells. This is particularly the case where products containing a high fat level are involved, such as chocolate, cheese and salami (Bell & Kyriakides, 2002). Associated foods Salmonellosis has been associated with many foods including raw meats, poultry, eggs, dairy products, fish, yeast, coconut, salad dressings, cake mixes, dried gelatine, peanut butter, cocoa and chocolate (FDA, 1992). Salmonella reside in the intestinal tract of infected animals. They are shed in the faeces and can be readily transmitted to other animals or man. Most colonised individuals become healthy excreters, resulting in contamination of the environment. Contamination is spread amongst animals during transport, holding in confined quarters and slaughter. Foods of animal origin become contaminated following faecal contamination of the environment and equipment (ICMSF, 1996). Table 48 is a recent history of common isolates of Salmonella from major animal sources. Cross contamination is produced by contaminated raw foods during further processing and preparation. Salmonella can also become established and multiply in the environment and equipment of a variety of food-processing facilities (ICMSF, 1996). Contamination of eggs, and particularly of egg contents, is believed to be a cause of the large increase in human infections with S. Enteritidis in Europe and North America since the 1980s. Contamination of intact eggs with S. Enteritidis is mainly the result of infection of the hen’s reproductive system. Australia has been an exception to the S. Enteritidis problem. Poultry and eggs in Australia have remained free of S. Enteritidis (Jay et al, 2003). Food Safety Scheme Risk Assessment Page 139 of 189 Table 48 – Top Salm onella serovars from major sources Source Human Bovine Porcine Raw meats Ovine Chicken – broilers Chicken – layers Eggs 2007 Number of isolates Serovar & incidence 2185 Typhimurium 34.3% Enteritidis 6.7% 313 Bovismorbificans 33.5% Typhimurium 23.6% Dublin 13.7% 118 Derby 27.1% Johannesburg 16.9% Typhimurium 10.2% 236 London 24.4% Derby 22.9% Stanley 13.6% 131 Bovismorbificans 48.9% Typhimurium 44.3% 3842 II Sofia 33.8% Typhimurium 14.8% Infantis 10.2% 631 Typhimurium 17.3% Virchow 13.3% Mbandaka 10.5% 102 Typhimurium 30.4% Agona 12.7% Anatum 10.8% 2006 Number of isolates Serovar & incidence 1792 Typhimurium 34.3% Bovismorbificans 15.0% 280 Bovismorbificans 43.9% Typhimurium 30.4% Dublin 10.0% 226 Derby 51.3% London 11.9% Johannesburg 10.2% 98 Heidelberg 29.6% Bovismorbificans 7.1% Chester 7.1% 297 Bovismorbificans 52.2% Typhimurium 39.4% 4386 II Sofia 43.3% Typhimurium 16.2% Infantis 6.6% 791 Mbandaka 20.9% Typhimurium 15.8% Agona 10.7% 63 Anatum 36.5% Montevideo 19.0% Ohio 19.0% 2005 Number of isolates Serovar & incidence 1713 Typhimurium 34.3% Enteritidis 8.8% 293 Bovismorbificans 48.8% Typhimurium 23.9% Dublin 10.9% 208 Infantis 34.1% Derby 23.6% Anatum 13.0% 501 Johannesburg 29.1% London 15.2% Derby 13.4% 66 Bovismorbificans 54.5% Typhimurium 31.8% 6011 II Sofia 49.8% Infantis 11.1% Typhimurium 7.8% 364 Typhimurium 13.5% Kiambu 11.8% Mbandaka 10.4% 84 Typhimurium 38.1% Anatum 22.6% Singapore 10.7% adapted from Australian Salmonella Reference Centre 2007 Annual Report (Davos, 2007) Table 49 – Characteristics of Salm onella Minimum Optimum Maximum Temperature (°C) 5.2* 35–43 46.2 pH 3.8 7–7.5 9.5 aw 0.94 0.99 >0.99 Limits for growth of Salmonellae when other conditions are near optimum * Most serotypes fail to grow at <7°C Survival in food Survive for long periods in foods — 10 weeks in butter, 28 days in refrigerated vegetables and very stable in chocolate Survival in Survive well on ceramic, glass and stainless steel surfaces. Survive on environment human skin. Can become established and multiply in a food processing environment, where they become a source of contamination Controls • A kill step, such as cooking, to assure destruction of Salmonellae in contaminated foods, especially raw meats • Prevention of contamination (cross contamination) of RTE foods, including good personal hygiene and exclusion of ill food handlers • Low or high temperature storage of foods to prevent growth • Control of contamination in food processing areas adapted from ICMSF (1996) Food Safety Scheme Risk Assessment Page 140 of 189 Campylobacter Nature of the illness Campylobacter is now recognised as an important enteric pathogen with OzFoodNet data showing that campylobacteriosis is the major cause of notified food poisononing in Australia (despite the fact it is not a notifiable infection in NSW). Surveys have also shown that Campylobacter jejuni is the leading cause of bacterial diarrhoea in the USA. It causes more illness than Shigella spp. and Salmonella serovars combined (FDA, 1992). Symptoms of campylobacteriosis (also known as campylobacter enteritis or gastroenteritis) often include fever abdominal pain, nausea, headache, and muscle pain as well as diarrhoea. The illness usually occurs 2–5 days after ingestion of the contaminated food or water. Illness generally lasts 7–10 days but relapses are not uncommon, occurring in about 25% of cases (FDA, 1992). Complications are relatively rare, but infections have been associated with reactive arthritis, haemolytic uraemic syndrome, and following septicaemia, infections of nearly any organ. Meningitis, recurrent colitis, acute cholecystitis and Guillain-Barré syndrome are very rare complications (FDA, 1992). Associated foods Campylobacter frequently contaminates raw chicken, with surveys showing that 20– 100% of raw retail chickens are contaminated. Raw milk is also a source of infections. The bacteria are often carried by healthy cattle and by flies on farm. Nonchlorinated drinking water may also be a source of infections. Campylobacter from raw meat may contaminate work areas and the hands of kitchen staff before being transferred to RTE foods or causing self-infection. Raw milk was the most frequently reported vehicle in food related outbreaks of Campylobacter (Wallace, 2003; ICMSF, 1996). Those references also noted evidence that sporadic (as opposed to outbreak) illness was linked to poultry consumption. A more recent case-control study of Campylobacter infection found that consumption of chicken at restaurant was the largest attributable factor, followed by consumption of non-poultry meat at a restaurant (Friedman et al, 2004). Table 50 – Characteristics of Cam pylobacter Minimum Optimum Maximum Temperature (°C) 32 42–43 45 pH 4.9 6.5–7.5 ~9 aw >0.987 0.997 Limits for growth of Campylobacter when other conditions are near optimum The organisms are do not tolerate high levels of oxygen and grow best with 5-6% oxygen and 10% carbon dioxide Survival in food Growth usually does not occur in foods due to the minimum temperature requirement not being met. The organism is relatively fragile and is inactivated by oxygen, drying, heating, disinfectant and acid conditions. Despite declining numbers, the organism does survive in moist foods for variable lengths of time Survival in Survival on surfaces is prolonged by blood and the fluid obtained environment from the thawing of frozen meat Controls • A kill step, such as cooking, to assure destruction of Campylobacter in contaminated foods, especially raw meats and raw milk • Prevention of contamination (cross contamination) of RTE foods • Prevention of infection of flocks has been proposed as a control measure adapted from ICMSF (1996) Food Safety Scheme Risk Assessment Page 141 of 189 Staphylococcus aureus Nature of the illness Some strains of Staphylococcus aureus are capable of producing a highly heat stable protein toxin that causes illness in humans. Onset of symptoms of food poisoning occurs between 1 and 7 (usually 2–4) hours after the ingestion of food containing staphylococcal enterotoxins. The most common symptoms are nausea, vomiting, retching, abdominal cramps and diarrhoea. In severe cases, headache and collapse may occur. Recovery is rapid, usually within two days (ICMSF, 1996). A toxin dose of less than 1.0 microgram in contaminated food will produce symptoms of staphylococcal intoxication. This toxin level is reached when S. aureus populations exceed 100,000 per gram (FDA, 1992). Associated foods Foods that require considerable handling during preparation and that are kept at slightly elevated temperatures after preparation are frequently involved in staphylococcal food poisoning. Frequently implicated foods include meat and meat products; poultry and egg products; salads such as egg, tuna, chicken, potato and macaroni; bakery products such as cream-filled pastries, cream pies and chocolate éclairs; sandwich fillings; and milk and dairy products. Staphylococci are wide-spread in the environment. Humans and animals are the primary reservoir. Staphylococci are present in the nasal passages and throats and on the hair, and skin of 50% or more of healthy individuals. Although food handlers are the main source of food contamination in food poisoning outbreaks, equipment and environmental surfaces can also be sources of contamination with S. aureus (FDA, 1992). Table 51 – Characteristics of Staphylococcus aureus Growth Growth Toxin Toxin Range Optimum Range Optimum Temperature (°C) 37 7–48 40–45 10–48 pH 6–7 4–10 7–8 4.5–9.6 aw 0.98 0.83->0.99 0.98 0.87->0.99 Limits for growth and toxin production for S. aureus when other conditions are near optimum and aerobic Survival in food Bacteria are easily killed by heat but are salt tolerant and resistant to drying and can survive for extended periods in food. The toxins are very resistant to heat and will survive cooking Survival in environment Bacteria survive well under most environmental conditions and can persist for some time in food-production areas Controls • Protect foods from contamination • Avoid conditions (mainly temperatures) where S. aureus growth can occur • For products such as salami and cheese that are held at temperatures where S. aureus can grow, it is very important to exercise control over the raw materials as well as the fermentation and maturation stages adapted from ICMSF (1996) Food Safety Scheme Risk Assessment Page 142 of 189 Clostridium perfringens Nature of the illness Food poisoning caused by Clostridium perfringens continues to be an important cause of morbidity in the community. Large outbreaks are still common in Australia (Bates & Bodnaruk, 2003). Spores of the organism persist in soil, sediments, and areas subject to human or animal faecal pollution. From the natural environment it is easily spread to foods. All foods are considered potential sources of the organism, however according to Bates & Bodnaruk (2003) only about 2–5% of C. perfringens isolated from food and animals produce C. perfringens enterotoxin (CPE). The common form of perfringens food poisoning is characterised by intense abdominal cramps and diarrhoea which begins 8–22 hours after consumption of foods containing large numbers of C. perfringens. More than 108 vegetative cells are required and the strain of C. perfringens must be capable of producing the food poisoning toxin. This illness is a food infection or toxicoinfection only one episode has ever implied the possibility of intoxication (ie illness from preformed toxin). Toxin production occurs in the digestive tract and is associated with sporulation (FDA, 1992). Associated foods Diarrhoea due to C. perfringens is most commonly associated with the consumption of cooked, uncured meat products that have been cooled slowly or stored under inadequate refrigeration and then consumed without thorough reheating. C. perfringens is commonly found on all meats, but in relatively low numbers. It is largely derived from the intestines of the animal. C. perfringens produces a spore which helps it survive harsh environmental conditions. The spores of food poisoning strains are more heat resistant and can survive cooking. Table 52 – Characteristics of Clostridium perfringens Minimum Optimum Maximum Temperature (°C) 12 43–47 50 pH 5.5–5.8 7.2 8.0–9.0 aw 0.93* 0.95-0.96 Limits for growth of C. perfringens when other conditions are near optimum * Reports vary depending on the humectant Survival in food The bacterial spore survives well in food Survival in C. perfringens is widely distributed in the environment where it environment survives well. It frequently occurs in the intestines of humans and many domestic and feral animals Controls • Control relies almost entirely on cooking and cooling procedures. An effective control measure is to cool the product rapidly, particularly through the temperature range 55 to 15°C • Vegetative cells are readily killed by heat and an effective reheating process will ensure that large numbers of vegetative cells are not consumed adapted from ICMSF (1996) Food Safety Scheme Risk Assessment Page 143 of 189 Bacillus cereus Nature of the illness Foodborne illnesses associated with Bacillus cereus may occur as two distinct syndromes: diarrhoeal and emetic. The diarrhoeal illness has a typical incubation period of 10–13 hours. The gastroenteritis is usually mild with abdominal cramps, profuse watery diarrhoea, rectal spasms and moderate nausea, usually without vomiting. Evidence indicates that diarrhoeal illness is caused by the consumption of moderate to high numbers of organisms and production of toxin in the gut. The emetic illness usually has an onset from 1–5 hours after consuming the implicated food. Acute nausea and vomiting are the major symptoms with diarrhoea being uncommon. The symptoms of the emetic syndrome are toxin mediated. The emetic toxin is a heat stable peptide that appears to be produced when B. cereus grows on particular substrates such as those containing starch or other farinaceous materials (Jenson & Moir, 2003). Associated foods A wide variety of foods including meats, milk, vegetables and fish have been associated with the diarrhoeal type food poisoning. The vomiting type outbreaks have generally been associated with rice products, however other starchy foods such as potato, pasta and cheese products have also been implicated. Food mixtures such as sauces, puddings, soups, casseroles, pastries, and salads have frequently been incriminated in food poisoning outbreaks (FDA, 1992). Every well-documented report of B. cereus intoxication has described time and temperature abuse that allowed relatively low (innocuous) levels of B. cereus in foods to greatly increase. Table 53 – Characteristics of Bacillus cereus Minimum Optimum Maximum Temperature (°C) 4 30–40 55 pH 5.0 6.0–7.0 8.8 aw 0.93 Limits for growth of B. cereus when other conditions are near optimum Survival in food The bacterial spore survives well in food including cooked foods Survival in B. cereus is widely distributed in nature. It is readily isolated from environment soil, dust, cereal crops, vegetation, animal hair, fresh water and sediments. Consequently, it is not surprising to find the organism on virtually every raw agricultural commodity Controls • Prevention of illness requires the control of spore germination and the growth of vegetative cells in cooked RTE food. Cell multiplication during inadequate cooling of cooked cereal-based or protein-containing foods is a major concern • Food to be stored should be cooled rapidly to a temperature that prevents the growth of B. cereus • Food that is to be held warm should be maintained above 60°C • Once formed in a food the emetic toxin is heat stable and can withstand normal cooking or reheating temperatures adapted from ICMSF (1996) Food Safety Scheme Risk Assessment Page 144 of 189 Listeria m onocytogenes Nature of the illness Foodborne listeriosis presents in three ways (Sutherland et al, 2003): • Infection during pregnancy acquired following the consumption of food contaminated with Listeria monocytogenes. This is a mild flu-like illness or asymptomatic in the mother but with serious implications for unborn infants including spontaneous abortion, foetal death, stillbirth and meningitis. Infection is more common in the third trimester. • Infection of non-pregnant adults acquired following the consumption of contaminated food. Asymptomatic or mild illness which might progress to central nervous system infection such as meningitis. Most common in the immunocompromised or elderly. • Listeria food poisoning following consumption of food with exceptionally high levels of L. monocytogenes (>107/g). Vomiting and diarrhoea, sometimes progressing to bacteraemia but usually self resolving. The onset time to serious forms of listeriosis is unknown but may range from a few days to three weeks. The onset time to gastrointestinal symptoms is unknown but is probably greater than 12 hours. When listeric meningitis occurs, the overall mortality may be as high as 70% from septicaemia 50% from perinatal/neonatal infections greater than 80%. The mother usually survives infections during pregnancy (FDA, 1992). Lake et al (2005) comments that it is becoming increasingly realised that the only completely safe dose of L. monocytogenes is zero, even in healthy people. However, the probability of invasive disease following exposure to even moderate levels of cells is very low. The probability of illness for a given dose is about 100 times higher for ‘at risk’ populations (the elderly, the immunocompromised and the perinatal). The dose response model used by Lake et al (2005) for a significant L. monocytogenes dose of 106 cells generates probabilities of illness of about 10-6 for the ‘more at risk’ and approaching 10-8 for the general population. When compared with probabilities of illness in generated in the FDA/USDA (2003) risk assessment on RTE foods, this appears to be a conservative. Associated foods L. monocytogenes has been associated with such foods as raw milk, supposedly pasteurised milk, cheese (particularly soft-ripened varieties), ice-cream, raw vegetables, fermented raw meat sausages, raw and cooked poultry, raw meats and raw and smoked fish. Its ability to grow at low temperatures permits multiplication in refrigerated foods. The vast majority of cases are sporadic, making epidemiological links to food very difficult. Food Safety Scheme Risk Assessment Page 145 of 189 Table 54 – Characteristics of Listeria m onocytogenes Minimum Optimum Maximum Temperature (°C) -0.4* 37 45 pH 4.39 7.0 9.4 aw 0.92 Limits for growth of L. monocytogenes when other conditions are near optimum * Growth can occur in a variety of foods at normally encountered refrigeration temperatures Survival in food L. monocytogenes is quite hardy and resists the deleterious effects of Survival in environment Listeria have been isolated from a wide variety of habitats, including soil, Controls freezing, drying and heat remarkably well for a bacterium that does not form spores silage, sewage, and food-processing environments. Wet surfaces in foodprocessing plants often harbour listeriae and this, combined with the ability of listeriae to grow at low temperatures, is reflected in their occurrence in refrigerators and on chilling units. Owing to the prevalence of L. monocytogenes in raw materials and its ability to multiply in the environment of many food-processing, traditional cleaning and disinfection methods, equipment design and management practices may be inadequate or even impair the control of L. monocytogenes The prevention of human listeriosis begins at the farm and continues through processing to the selection and handling of food by the consumer. A complete diet that is free of L. monocytogenes is impossible to obtain. However, the application of farm-to-consumer controls can reduce the risk of foodborne listeriosis On farm: Silage should be rapidly acidified to pH <4.0 to prevent the development of high numbers of L. monocytogenes. This is particularly important for use on dairy farms where milk could be used for raw milk cheeses In processing: • Minimise the growth of L. monocytogenes in raw materials, particularly before and during the processing of raw foods • Where possible use listericidal processes to assure the destruction of • L. monocytogenes Minimise the risk of recontamination of RTE foods that are further processed after receiving a listericidal treatment through environmental controls and GMP Storage: • Storage at 5°C or below will retard, but not prevent, multiplication in many food products Retail: • Separate raw food of animal origin from RTE foods • Use an effective method, at appropriate intervals, of disinfecting slicing equipment and display cases • Maintain proper storage and display temperatures and monitor ‘useby’ and ‘best before’ dates Consumers: The risk of foodborne listeriosis is much greater among persons with reduced immunity (eg pregnant women, persons with malignant disease or AIDS) and patients with certain underlying illnesses (eg heart disease, diabetes, renal disease). These groups should follow published advice on the selection and handling of foods to reduce the risk of listeriosis adapted from ICMSF (1996) Food Safety Scheme Risk Assessment Page 146 of 189 Vibrio parahaem olyticus Nature of the illness Pathogenic and non-pathogenic forms of Vibrio parahaemolyticus can be isolated from marine and estuarine environments and from fish and shellfish dwelling in these environments. Gastroenteritis is the most common clinical syndrome caused by V. parahaemolyticus. The infectious dose for healthy individuals, recorded in outbreaks, is about 105 to 109 viable cells and results in an acute illness, following a short incubation period of between 4–30 hours. The major symptoms include diarrhoea which can be bloody, abdominal pain, nausea, and vomiting. Usually gastroenteric infections remain in the gut and are self-limiting however, a death due to V. parahaemolyticus following the consumption of oysters was reported in NSW in 1992 (Desmarchelier, 2003). The infectious dose may be markedly lowered by the coincident consumption of antacids (FDA, 1992). Associated foods Infections with this organism have been associated with the consumption of raw, improperly cooked, or cooked and recontaminated fish and shellfish. A correlation exists between the probability of infection and the warmer months of the year. Improper refrigeration of seafood contaminated with this organism will allow its proliferation, which increases the probability of infection. A pandemic strain of V. parahaemolyticus O3:K6 has caused epidemics in South-east Asia and North America since 1995. In Australia, sporadic cases occasionally occur and these often have a recent history of overseas travel (Desmarchelier, 2003). Serotype O3:K6 and its serovariants are undergoing global spread (Balakrish Nair et al, 2007). The organism could arrive in Australia in ballast water, imported seafood or carried by a traveller. International evidence suggests that domestic foodborne illness could result. Other Vibrio spp. of concern include Vibrio cholerae and Vibrio vulnificus. There is a risk associated with imported seafood and travellers arriving from countries where cholera is endemic. V. vulnificus is found in Australia and there have been rare episodes of foodborne illness. The controls listed above for V. parahaemolyticus are effective against V. vulnificus. There is a strong association between V. vulnificus infection and patients with underlying chronic conditions including liver disease, malignancy and increased serum iron levels. Avoidance of raw seafood is recommended in these cases. Food Safety Scheme Risk Assessment Page 147 of 189 Table 55 – Characteristics of Vibrio parahaem olyticus Optimum Range Temperature (°C) 37 5–43 pH 7.8–8.6 4.8–11 aw 0.981 0.940–0.996 Salt (%) 3 0.5-10 Limits for growth of V. parahaemolyticus when other conditions are near optimum Survival in food V. parahaemolyticus die when exposed to temperatures below 5–7°C the rate of mortality is highest between 0–5°C. The organisms are only moderately sensitive to freezing and will persist in frozen seafoods for long periods Survival in environment The number of culturable V. parahaemolyticus in water is directly related to temperature and the organisms are rarely isolated when water temperatures are <15°C. The apparent disappearance of vibrios in the aquatic environment when conditions are suboptimal may be explained in part by the ability of the organisms to enter a dormant or viable but non-culturable state. Associations between vibrios and higher organisms and animals play a significant environmental role for vibrios and may be protective during adverse conditions Controls • The primary control measure is to prevent multiplication of the organism after harvesting and this is most readily achieved by chilling seafoods to <5°C and holding them under refrigeration. Since temperatures are maintained in the range 0–5°C in fish storage and distribution systems this may considerably reduce the risk. (Note that live bivalve molluscs have differing storage requirements) • Cooking to an internal temperature of >65°C will effectively destroy V. parahaemolyticus • Cross contamination of cooked foods, such as crabs or prawns, should be avoided by strict separation of raw and cooked products and by preventing transfer via containers or shared surfaces or by employees preparing both raw and cooked products adapted from ICMSF (1996) Food Safety Scheme Risk Assessment Page 148 of 189 Shigella species Nature of the illness Shigellosis is principally a disease of humans and rarely occurs in animals. Most cases of shigellosis result from the ingestion of faecally contaminated food or water. The major contribution to contamination of food is poor personal hygiene of food handlers. The illness is caused when virulent Shigella organisms attach to, and penetrate, epithelial cells of the intestinal mucosa. Some strains produce endotoxin and Shiga toxin (very much like the verotoxin of E. coli O175:H7). After invasion, they multiply intracellularly and spread to contiguous cells resulting in tissue destruction. Symptoms include abdominal pain cramps diarrhoea fever vomiting blood, pus or mucous in stools and tenesmus. The onset time is from 12 to 50 hours. Infections are associated with mucosal ulceration, rectal bleeding and drastic dehydration. The fatality rate may be as high as 10–15% with some strains. Reiter’s disease, reactive arthritis and haemolytic uremic syndrome are possible sequelae that have been reported following shigellosis. Associated foods A variety of foods have been associated with shigellosis. Faecal contamination of water and unsanitary handling by food handlers are the most common cause. Table 56 – Characteristics of Shigella spp. Minimum Maximum Temperature (°C) 6.1 47.1 pH 4.9 9.34 S. sonnei Salt (%) 5.18 S. flexneri Temperature (°C) 7.9 45.2 pH 5.0 9.19 Salt (%) 3.78 Limits for growth of Shigella when other conditions are near optimum Survival in food Shigellae survive in a wide range of foods Survival in environment On inanimate surfaces shigellae survive well between -20°C and 37°C Controls • Contamination can be prevented or minimised by using clean utensils instead of hands. Control is achieved by good personal hygiene and hand washing prior to working with food is most important • Cooked foods should not be touched with the hands • Persons who are ill should be excluded from areas where food is prepared adapted from ICMSF (1996) Food Safety Scheme Risk Assessment Page 149 of 189 Escherichia coli Nature of the illness Escherichia coli is a normal non-pathogenic and useful inhabitant of the bowel. There are a minority of enterovirulent strains within the species that cause illness ranging from travellers’ diarrhoea through to a destructive and, not uncommonly, fatal illness. Enterohaemorrhagic E. coli (EHEC) are associated with ‘hamburger disease’ in the USA and the Garibaldi outbreak in Australia. EHEC produce potent toxins known as Shiga toxins which are toxic to cultured Vero cells (thus the abbreviations STEC and VTEC) and other toxic factors. The illness caused by EHEC is called haemorrhagic colitis. It is characterised by severe cramping and diarrhoea which is initially watery but becomes grossly bloody. Occasionally vomiting occurs. Fever is usually low grade or absent. The illness is usually self limiting and lasts for an average of eight days. Some victims, particularly the very young, have developed haemolytic uraemic syndrome (HUS), which is characterised by renal failure and haemolytic anaemia. From 0–15% of haemorrhagic colitis victims may develop HUS. The illness can lead to permanent loss of kidney function. In the elderly, HUS with fever and neurologic symptoms constitute thrombotic thrombocytopenic purpura. This illness can have a mortality rate in the elderly as high as 50% (FDA, 1992). Associated foods Undercooked or raw hamburger mince has been implicated in many of the documented US EHEC outbreaks. However, E. coli O157:H7 outbreaks have implicated alfalfa sprouts, unpasteurised fruit juices, dry-cured salami, lettuce, game meat and cheese curds. Raw milk was the vehicle in a school outbreak in Canada (FDA, 1992). Other EHEC strains include O26, O111, O103, O121, O45 and O145. Humans are believed to be the major, if not the only, source for most of the enterovirulent E. coli that cause human illness. Infected food handlers can contaminate food. Humans may also be carriers of EHEC strains. However, the major reservoirs of a number of important STEC strains that infect humans are the intestinal tract of ruminants such as cattle and sheep (Desmarchelier & Fegan, 2003). Food Safety Scheme Risk Assessment Page 150 of 189 Table 57 – Characteristics of pathogenic Escherichia coli Minimum Optimum Maximum Temperature (°C) ~ 7-8 35-40 ~ 44–46 pH 4.4 6–7 9.0 aw 0.95 0.995 Limits for growth of E. coli when other conditions are near optimum Survival in food Pathogenic E. coli generally survive well in refrigerated foods and in frozen ground beef. EHEC may survive for long periods in fermented or acid foods Survival in E. coli is capable of growth in food and on inadequately cleaned environment surfaces associated with food processing. It can also become established in food processing plants (Desmarchelier & Fegan, 2003). Pathogenic E. coli have no unique resistance to chlorine Controls • Hygienic practices during slaughter • Protect vegetable crops from manures and untreated sewage effluent • Rapidly cool carcases after slaughtering and processing • Use safe food handling techniques and proper personal hygiene to avoid contamination of RTE foods • Properly heat foods to kill pathogens and hold food at appropriate temperatures • Do not use un-chlorinated water for cleaning food-processing equipment or food contact surfaces • Avoid raw and partially cooked meats and unpasteurised milk adapted from ICMSF (1996) Clostridium botulinum Nature of the illness Foodborne botulism is a severe type of food poisoning caused by ingestion of foods containing the potent neurotoxin formed during the growth of the organism. As little as 30 ng of neurotoxin is sufficient to cause illness and even death. The toxin is heat labile and can be destroyed if heated at 80°C for 10 minutes or longer. The incidence of illness is low but is of considerable concern because of its high mortality rate if not treated immediately and properly. Limiting the pathogen’s growth in foods is important for public health. Onset of symptoms in foodborne botulism is usually 18 to 36 hours after ingestion of food containing the toxin, although cases have varied from four hours to eight days. Early signs of intoxication consist of marked lassitude, weakness and vertigo followed by double vision and progressive difficulty in speaking and swallowing. Difficulty in breathing, weakness in other muscles, abdominal distension and constipation may also be common symptoms. Foodborne botulism is primarily associated with two physiologically and genetically distinct anaerobic bacteria, proteolytic C. botulinum and non-proteolytic C. botulinum. Proteolytic C. botulinum is a mesophile, while non-proteolytic C. botulinum is a psychrotroph that grows and forms toxin at 3°C. With an ability to grow at chill temperatures, non-proteolytic C. botulinum is the principal microbiological safety concern, in relation to spore-forming bacteria, in the manufacture of chilled foods (Peck et al, 2008). Associated foods Any food that is conducive to outgrowth and toxin production, that when processed allows spore survival and is not subsequently heated before consumption can be Food Safety Scheme Risk Assessment Page 151 of 189 associated with botulism. Almost any type of food that is above pH 4.6 can support the growth and toxin production by C. botulinum. Botulism toxin has been isolated in a considerable variety of foods such as canned corn, peppers/capsicum, green beans, soups, beets, asparagus, mushrooms, ripe olives, spinach, tuna, chicken and chicken livers and liver pâté, luncheon meats, ham, sausage, stuffed eggplant, lobster, smoked and salted fish and chopped garlicin-oil (FDA, 1992). Refrigerated processed foods of extended durability (REPFEDS) are of concern as some strains of C. botulinum grow and form toxin at refrigeration temperatures (Szabo & Gibson, 2003). Peck et al (2008) reviewed data from 1307 independent challenge tests. The results from some of those tests demonstrate that non-proteolytic C. botulinum, if present, is able to form toxin in certain foods and materials at <10°C within 10 days. At 8°C, 100/514 (19.5%) independent challenge tests were positive for toxin by day 10, while at 4–7°C only 5/387 (1.3%) tests were positive. The products that were positive for toxin by day 10 were mainly fish and meat products. One cooked vegetable food was also positive. Peck et al (2008) noted that 1010 prepared chilled meals have been produced in the UK over the last two decades. In that time no reports could be identified of foodborne botulism associated with correctly stored commercial chilled food. They attribute the lack of botulism to one or more ‘unquantified controlling factors’ (eg raw material quality, heats process that damage spores, high hygiene during manufacture, good chill chain) and note the need for better understanding of the controlling factors. Table 58 – Characteristics of Clostridium botulinum Proteolytic C. botulinum Minimum Optimum Maximum Temperature (°C) 10 45-50 pH 4.6 aw ~ 0.94 Non-proteolytic C. botulinum Minimum Optimum Maximum Temperature (°C) 3.3 40-45 pH 5.0 aw ~ 0.97 Limits for growth of C. botulinumwhen other conditions are near optimum C. botulinum produces heat resistant spores and grows in the absence of oxygen Survival in food Spores survive well in foods. Also survive normal cooking temperatures Survival in C. botulinum is ubiquitous and survives well in a wide variety of environment environmental conditions Controls • Retort low acid canned food correctly. Outbreaks are mostly reported with home canned products and rarely with commercial products following a formulation change • Ensure all components of high acid foods and acidified foods are below pH 4.6 • Include additional hurdles to Clostridial growth or limit shelf life of products on RTE chilled foods adapted from ICMSF (1996); Szabo & Gibson (2003) Food Safety Scheme Risk Assessment Page 152 of 189 Yersinia enterocolitica Nature of the illness Yersiniosis is frequently characterised by such symptoms as gastroenteritis with diarrhoea and/or vomiting however, fever and abdominal pain are the hallmark symptoms. Yersinia infections mimic appendicitis and mesenteric lymphadenitis, but the bacteria may also cause infections of other sites such as wounds, joints and the urinary tract. Illness onset is usually 24–48 hours after the ingestion of food or drink. The major ‘complication’ is the performance of unnecessary appendectomies, since one of the main symptoms of infections is abdominal pain in the lower right quadrant. Reactive arthritis occurs in 2–3% of cases bacteraemia and diffuse disease occur rarely (FDA, 1992). Associated foods Strains of Yersinia enterocolitica can be found in pork, beef, lamb, oysters, fish and raw milk, however not all serotypes carry the plasmid encoding the virulence factors for pathogenicity (Barton & Robins-Brown, 2003). The exact cause of food contamination is unknown. However, the prevalence of this organism in soil, water and in animals offers ample opportunities for it to enter the food supply. Pigs are believed to be the principal reservoir of bioserotypes pathogenic to humans (ICMSF, 1996). Table 59 – Characteristics of Yersinia enterocolitica Maximum 42 Growth at 9.6 No Growth at 10 NaCl (%) Growth at 5 No Growth at 7 Limits for growth of Y. enterocolitica when other conditions are near optimum Survival in food Y. enterocolitica is quite resistant to adverse storage conditions. Since it capable of multiplying at very low temperatures, refrigerated storage may not be a reliable means of preventing foodborne illness Survival in The organism survives well in water and soil. The major reservoir is environment the live pig Controls • Reduction in contamination of pig carcases can be achieved by changes in pig slaughtering procedures (Barton & RobinsBrowne, 2003) • Proper handling of raw pork when preparing food in foodservice establishments and the home. Especially separating raw pork from RTE foods Temperature (°C) pH Minimum -1.3 4.2 Optimum 25–37 7.2 adapted from ICMSF (1996) Food Safety Scheme Risk Assessment Page 153 of 189 Cronobacter sakazakii Cronobacter sakazakii (formerly classified as Enterobacter sakazakii) has been associated with neonatal meningitis, necrotising enterocolitis, bacteraemia and necrotising meningoencephalitis. Reported mortality rates are high 10–55% for necrotising enterocolitis and 40-80% for meningitis in neonates. Invasive C. sakazakii illness is not a common occurrence in infants. Approximately 60 cases were reported between 1958 and 2008. However, there is concern that it has been underreported. Studies estimate the annual rate of invasive C. sakazakii to be 1 per 100,000 children under 12 months old and 9.4 per 100,000 in very low birth weight infants. Meningitis tends to be associated with near-term infants of normal birth weight where infection occurred soon after birth. Bacteraemia tends to be associated with pre-term infants of very low birth weight where infection occurs in the first two months of life (FSAI, 2007). C. sakazakii has been isolated from many foods and environmental sources and can be considered to be ubiquitous. The role of these sources in neonatal infection has not been determined. However, infection studies provide evidence of the role of powdered infant formula: • Eight cases cite infant formula as the suspected cause with the source unknown or not specified in the other 19 cases • In 26 cases where feeding patterns were specified 24 were fed on powdered infant formula 15 of the formula samples yielded C. sakazakiiin 13 of the cases the clinical and formula strains were indistinguishable (Bowen & Braden, 2006) C. sakazakiihas been isolated from infant formula milk powder on many occasions, although contamination can be considered as low and sporadic. A number of control measures are emerging (FSAI, 2007): • Tight microbiological specifications on powdered infant formula • The use of recommended procedures for the preparation of formula • Limitations on ‘hang times’ for prepared formula • The use of commercially sterilised ready-to-feed formula in some circumstances Food Safety Scheme Risk Assessment Page 154 of 189 Parasitic protozoa and worms Foodborne infections due to parasites have been known since ancient times, and continue to be of great importance in many regions of the world (ICMSF, 1996). Some may be confined to tropical regions for climatic reasons. Others are world-wide in distribution, although they are more often found at a higher level of prevalence, in such areas as Third World countries, being associated with conditions of poor sanitation and hygiene. While some parasitic diseases may be a significant cause of human mortality, most cause chronic illness and are associated with high levels of morbidity, especially in the developing countries of the world. Parasites may be involved with food in a number of ways: • They may directly contaminate food or water, mainly through direct or indirect faecal contamination of the soil or via infected food handlers • They may contaminate invertebrates which are eaten as food or accidently ingested on salads • They may infect food animals comprising a direct part of their life cycle as an intermediate host (or as a transfer or transport host where no development occurs) and which infects the human host when the meat is eaten (Goldsmid et al, 2003) Many of the strategies used to control foodborne parasites are commonplace in Australia. General sanitation levels are high, water quality is good, community infection rates are low and meat inspection is required. Manure control and effluent reuse are possible issues. Viruses Hepatitis A and viral gastroenteritis are the only viral diseases that have been regularly shown in recent years to be foodborne. Foodborne viral gastroenteritis is commonly caused by members of the small, round, structured viruses group, the best known being Norovirus (formerly classified as Norwalk and Norwalk-like viruses). The human body is the only ultimate source of the contamination by the human enteric viruses discussed here. The viruses are shed in large quantities in the faeces of infected persons for a period varying from a few days to several weeks. Contamination of food occurs only through direct (eg food handlers) or indirect (eg environmental) faecal contamination. Two general types of food have been dominant amongst reports of viral contamination: bivalve molluscs harvested from polluted waters and foods prepared by infected food handlers and not subsequently cooked. Contamination of food by infected food handlers is attributed to poor personal hygiene. Bivalve molluscs feed by filtering large volumes of surrounding water in order to trap suspended particles. Bivalves can contain human enteric viruses and increase their concentration to a higher level than that in water. Viruses are introduced into watercourses and coastal waters by the routine discharge of treated and untreated domestic sewage and by runoff from land during rain. Bivalves are generally eaten raw or after light cooking that does not inactivate viruses. Prevention of contamination by food handlers relies on the adoption of appropriate work practices. Food handlers must not work while suffering from intestinal illness. Food handlers must practise good personal hygiene and should use food-handling Food Safety Scheme Risk Assessment Page 155 of 189 techniques that prevent the contact between the hands and foods that will not receive a virucidal treatment. Control of shellfish-borne viral illness is difficult. The main measure is ensuring that shellfish growing areas are sufficiently remote from sources of pollution with human waste to be considered safe. This has reduced the incidence of shellfish-borne illness but failed to eliminate the transmission of viruses (ICMSF, 1996). Survival of noroviruses Based on infectivity in human dose response research studies norovirus is stable and resistant to heat, acid and solvents. The virus retained infectivity after incubation at 60°C for 30 min. Pasteurisation is not sufficient to eliminate viruses. Resistance is reported to be greater in foods and shellfish. Steaming of oysters might not inactivate norovirus (Greening et al, 2003). Under refrigeration and freezing conditions the virus remains intact (and presumably viable) for several months, possibly years. Freezing generally does not inactivate viruses. Norovirus resists gastric acids at pH 3–4. The virus retained infectivity after exposure to pH 2.7 for 3 hours at room temperature. It is believed to be sensitive to pH >9.0 but this is unproven. Norovirus is resistant to drying. Infectious norovirus were detected on environmental surfaces, including carpets, for up to 12 days after outbreaks in institutions. Survival of Hepatitis A Hepatitis A is caused by a nonenveloped RNA picornavirus that infects only primates. Lack of a lipid envelope confers resistance to bile lysis. The virus is hardy, surviving on human hands and fomites and requiring temperatures higher than 85°C for inactivation. Hepatitis A virus survives for extended periods in seawater, fresh water, wastewater, and soil. The virus is resistant to freezing, detergents, and acids, but it is inactivated by formalin and chlorine (Brundage & Fitzpatrick, 2006). Scombroid poisoning Scombroid poisoning or ‘histamine fish poisoning’ is the most common form of toxicity caused by the ingestion of fish (Hahn & Capra, 2003). It is caused by the ingestion of food that contains high levels of histamine and possibly other vasoactive amines and compounds. Histamine and other amines are formed by the growth of certain bacteria and the subsequent action of their decarboxylase enzymes on histadine and other amino acids (FDA, 1992). Fishery products that have been implicated in Scombroid poisoning include tuna, mackerel and other fish with dark flesh. However, any food that contains the appropriate amino acids and is subject to certain bacterial contamination and growth may lead to scombroid poisoning. For example, Swiss cheese has been implicated with intoxication. Neither cooking, canning nor freezing reduces the toxic effect. Common sensory examination by the consumer cannot ensure the absence or presence of the toxin (FDA, 1992). Prevention of scombroid poisoning in fish can be achieved by appropriate post harvest practice. Handle fish hygienically to reduce bacterial contamination and ice fish to control decomposition. Food Safety Scheme Risk Assessment Page 156 of 189 Ciguatera Ciguatera poisoning is caused by the consumption of toxic fish from tropical and subtropical marine environments. Ciguatera has a circumtropical distribution, usually in close association with coral reefs. It is caused by ingestion of small quantities of a group of closely related, very powerful toxins that occur in the tissues of offending fish. The toxins are bioaccumulated by fish through dietary exposure prior to capture. Toxin and toxin precursors are produced by a dinoflagellate alga named Gambierdiscus toxicus. Ciguatoxins enter the human food chain by grazing fish and then move through the various trophic levels. In Australia ciguatera poisoning in humans usually occurs after consumption of high level carnivorous fish such as Spanish mackerel and coral trout. After ingestion the illness often follows a reasonably predictable pattern. Initial symptoms usually occur about 6 hours after ingestion and include vomiting, diarrhoea and abdominal cramps. Neurological symptoms usually begin to appear 12–18 hours after consumption of toxic fish. Symptoms can include tingling of the lips and extremities, bone pain, muscle pain, dental pain, convulsions, muscular paralysis, vertigo, severe headache, short term memory loss, temperature perceptions reversals, sweating and itching. The neurological symptoms are prominent and account for the major discomfort of most victims. In some cases symptoms are evident for months or years (Hahn & Capra, 2003). Shellfish poisoning Microscopic unicellular algae form an important component of the plankton diet of shellfish such as oysters, mussels and scallops. Some species of dinoflagellates and diatoms produce potent neurological toxins which can find their way though shellfish to humans. When humans eat seafood contaminated by these microalgae, they may suffer gastrointestinal and neurological illnesses. These include paralytic shellfish poisoning (PSP) which in extreme cases can lead to death through respiratory paralysis diarrhoetic shellfish poisoning (DSP) which causes severe gastrointestinal problems and may promote stomach cancers and amnesic shellfish poisoning (ASP) which can lead to permanent brain damage including short-term memory loss (FDA, 1992). Poisonous seafood neither looks or tastes different from uncontaminated seafood. Cooking and other treatments do not destroy the toxins. If precautions are not taken with shellfish harvest then public health problems can be considerable. Control measures include routine monitoring of shellfish harvest areas for levels of toxic algae and testing shellfish for toxin presence (Hallegraeff, 2003). Mycotoxins / Aflatoxins Toxic fungal metabolites, mycotoxins, have been responsible for a number of major epidemics in man and animals during recent historical times. Historically, the most important epidemics have been ergotism, which have killed hundreds of thousands of people in the last millennium; alimentary toxic aleukia, which was responsible for the death of at least 100,000 Russian people between 1942 and 1948; stachybotryotoxicosis, which killed tens of thousands of horses in the USSR in the 1930s; and aflatoxicosis, which came to attention when it killed 100,00 young turkeys in the United Kingdom in 1960 and has caused death and illness in many other animals, including man (Hocking & Pitt, 2003). Food Safety Scheme Risk Assessment Page 157 of 189 Table 60 – Important Aspergillus , Fusarium and P enicillium species and their mycotoxins Toxigenic species Mycotoxins Aspergillus flavus Aflatoxins B1, B2 Aspergillus parasiticus Aflatoxins B1, B2, G1, G2 Aflatoxin M1 Hydroxylated metabolites of aflatoxin B Affected commodities Maize, peanuts, cottonseed, oilseed, tree nuts, spices Maize, peanuts, cottonseed, oilseed, tree nuts Milk Toxic effects Maize Nuts, barley, processed meats, and many others Maize, wheat Carcinogenic Kidney damage, teratogenic, immunosuppressive Gastrointestinal symptoms Deoxynivale nol Maize, wheat Gastrointestinal symptoms Patulin Apple, pears Kidney damage, chromosomal aberration Fusarium verticillioides Aspergillus ochraceus, Penicillium verrucosum Fumonisin B1 Ochratoxin A Fusarium graminearum, Fusarium culmorum, Fusarium crookwellense Fusarium graminearum, Fusarium culmorum, Fusarium crookwellense Penicillium expansum Zearalenone Acute liver damage, carcinogenic, teratogenic, immunosuppressive Acute liver damage, carcinogenic, teratogenic, immunosuppressive Carcinogenic adapted from Hocking & Pitt (2003) Aflatoxicosis is poisoning that results from ingestion of aflatoxins in contaminated food or feed. Aflatoxins are toxic compounds produced by certain strains of the fungi Aspergillus flavus and Aspergillus parasiticus. Under favourable conditions of temperature and humidity, these fungi grow on certain foods and feeds, resulting in the production of aflatoxins. The most pronounced contamination has been encountered in tree nuts, peanuts and other oilseeds, including corn and cottonseed. The major aflatoxins of concern are designated B1, B2, G1 and G2. Aflatoxin B1 is usually prominent and is the most toxic. Aflatoxin M is a major metabolic product of aflatoxin B1 in animals and is usually secreted in the milk and urine of dairy cattle. Aflatoxins produce acute necrosis, cirrhosis and carcinoma of the liver in a number of animal species. In well-developed countries contamination rarely occurs in foods at levels that cause acute aflatoxicosis in humans. Studies on human toxicity from ingestion of aflatoxins have focussed on their carcinogenic potential (FDA, 1992). While it will never be possible to eliminate mycotoxins completely from the food supply, better cropping, harvesting, storage and processing techniques can minimise the opportunities for fungi to produce toxic metabolites in food (Hocking & Pitt, 2003). Gempylotoxin Purgative properties are reported for fish of the marketing groups escolar (Lepidocybium flavobrunneum, Ruvettus pretiosus) and rudderfish (Centrolophus niger and Tubia species). Escolar are commonly sold in the domestic market mislabelled as 'rudderfish' or 'butterfish'. Studies have found that both escolar and rudderfish have higher oil composition than most seafood, but it is the high wax ester content in escolar oil that explains the purgative property. In humans, indigestible wax esters accumulate in the rectum causing oily diarrhoea (Yohannes et al, 2002). Food Safety Scheme Risk Assessment Page 158 of 189 References – Appendix 1 AIFST (2003). Hocking, A.D. (Ed.). Foodborne Microorganisms of Public Health Significance. Australian Institute of Food Science and Technology, Waterloo. − Barton, M.D. & Robins-Brown, R.M. (2003). Yersinia enterocolitica. (pp. 577-596). − Bates, J.R. & Bodnaruk, P.W. (2003). Clostridium perfringens. (pp. 479-504). − Desmarchelier, P.M. (2003). Pathogenic vibrio. (pp. 333-358). − Desmarchelier, P.M. & Fegan, N. (2003). Enteropathogenic Escherichia coli. (pp. 267310). − Goldsmid, J.M., Speare, R. & Bettiol, S. (2003). The parasitology of foods. (pp. 703-722). − Hahn, S. & Capra, M.F. (2003). Fishborne illnesses: Scombroid and ciguatera poisoning. (pp. 689-702). − Hallegraeff, G.M. (2003). Algal toxins in Australian shellfish. (pp. 675-688). − Hocking, A.D. & Pitt, J.I. (2003). Mycotoxigenic fungi. (pp. 641-674). − Jay, S., Davos, D., Dundas, M., Frankish, E., & Lightfoot, D. (2003). Salmonella (pp. 207266). − Jenson, I. & Moir, C.J. (2003). Bacillus cereus and other Bacillus species. (pp. 445–478). − Sutherland, P.S., Miles, D.W. & Laboyrie, D.S. (2003). Listeria monocytogenes. (pp. 381– 443). − Szabo, E.A. & Gibson, A.M. (2003). Clostridium botulinum. (pp. 479-504). − Wallace, R.B. (2003). Campylobacter. (pp. 311-331). Balakrish Nair, G. et al. (2007). Global Dissemination of Vibrio parahaemolyticus Serotype O3:K6 and its Serovariants. Clinical Microbiology Reviews, Jan 2007, 39-48. Retrieved 1 September 2008, from http://cmr.asm.org/cgi/content/abstract/20/1/39 Bell, C. & Kyriakides, A. (2002). Salmonella, a practical approach to the organism and its control in foods. Blackwell Science. Bowen, A.B. and Braden, C.R. (2006). Invasive Enterobacter sakazakii disease in infants. Emerging Infectious Diseases 12, August 2006 1185-1189. Retrieved from http://wwwnc.cdc.gov/eid/article/12/8/05-1509_article.htm Brundage, S. & Fitzpatrick, A. (2006). Hepatitis A. American Family Physician 73 (12) (web version). Retrieved 19 December 2008, from http://www.aafp.org/afp/AFPprinter/20060615/2162.pdf Davos, D. (2007). Australian Salmonella Reference Centre 2007 Annual Report, Institute of Medical and Veterinary Science. EC SCF [European Commission, Scientific Committee on Food] (2002). Risk profile on the microbiological contamination of fruits and vegetable eaten raw, 29 April 2002. European Commission Health & Consumer Protection Directorate-General, Scientific Committee on Food. Retrieved 8 December 2008, from http://ec.europa.eu/food/fs/sc/scf/out125_en.pdf FDA (1992). The “Bad Bug Book” - Foodborne Pathogenic Microorganisms and Natural Toxins Handbook US Food and Drug Administration, Center for Food Safety and Nutrition. Originally published 1992, with periodic updates. Retrieved 25 August 2008 from http://www.cfsan.fda.gov/~mow/intro.html Friedman C. R. et al. (2004). Risk Factors for Sporadic Campylobacter Infection in the United States: A Case-Control Study in FoodNet Sites. Clinical Infectious Diseases 38(3), S285-96. Retrieved 25 August 2008, from http://origin.cdc.gov/enterics/publications/70_friedmanc.pdf Food Safety Scheme Risk Assessment Page 159 of 189 FSAI [Food Safety Authority of Ireland] (2007). Guidance Note 22: Information Relevant to the Development of Guidance Material for the Safe Feeding of Reconstituted Powdered Infant Formula. Retrieved 12 September 2008, from http://www.fsai.ie/publications/guidance_notes/gn22.pdf Greening, G., et al (2003) Risk Profile: Norwalk-like Virus in Mollusca (Raw). Institute of Environmental Science and research Ltd, Christchurch, NZ. ICMSF [International Commission on Microbiological Specifications for Foods] (1996). Microorganisms in Foods 5: Microbiological specifications of food pathogens. Roberts, T.A., Baird-Parker, A.C. & Tompkin, R.B. (Eds.). Blackie Academic & Professional. Lake, R. Hudson, A., Cressey, P. & Gilbert, S. (2005). Risk Profile: Listeria monocytogenes in soft cheeses. Institute of Environmental Science and Research Limited report prepared for the New Zealand Food Safety Authority. Retrieved 13 January 2009, from http://www.nzfsa.govt.nz/science/riskprofiles/FW0440_L_mono_in_low_moisture_cheese_Final_Mar_2007.pdf Peck, M.W., Goodburne, K.E., Betts, R.P. & Stringer, S.C. (2008). Assessment of the potential for growth and neurotoxin formation by non-proteolytic Clostridium botulinum in short shelflife commercial foods designed to be stored chilled. Trends in Food Science & Technology 19(4), 207-216. Yohannes, K. et al. (2002). An outbreak of gastrointestinal illness associated with the consumption of escolar fish. Communicable Diseases Intelligence, Volume 26(3). Retrieved 11 September 2008, from http://www6.health.gov.au/internet/main/publishing.nsf/Content/cdapubs-cdi-2002-cdi2603-htm-cdi2603l.htm Food Safety Scheme Risk Assessment Page 160 of 189 Appendix 2: Australian food recalls (2004–2008) Table 61 – Recalls of dairy products between 2004 and 2008 Product Reason for recall 1. Ice-cream cake 2. Custard Escherichia coli 3. Haloumi 4. 5. 6. 7. Yoghurt Custard Cream Milk, UHT, flavoured (variety) 8. Cheese, soft 9. Cheese, soft 10. Bocconcini, soft 11. Cheese, hard 12. Cream 13. Cream 14. Goats cheese 15. 16. 17. 18. Milk Infant formula Ricotta Cheese, hard + ingredients 19. Dairy dessert 20. Cheese, hard + ingredients 21. Mozzarella, shredded 22. Milk, goats, frozen unpasteurised, 23. Cheese, hard 24. Feta 25. Ice-cream + ingredients qq Was the recall instigated due to illness? Not reported Not reported Distribution Year WA National qq 2004 2004 Not reported VIC 2004 Not reported Not reported Not reported n/a NSW National WA National 2004 2004 2004 2005 No National 2005 No No WA NSW, ACT 2005 2005 No National 2006 No No No NSW NSW National 2006 2006 2006 No No No No NSW, ACT National QLD National 2006 2007 2007 2007 Listeria monocytogenes Escherichia coli No NSW 2007 No NSW 2007 Listeria monocytogenes Salmonella Zanzibar No VIC 2008 No QLD 2008 No National 2008 No National 2008 No NSW 2008 Possibility of spoilage before expiry date Coagulase positive staphylococcus Escherichia coli Microbial spoilage Escherichia coli may spoil before expiry date. Listeria monocytogenes Escherichia coli Listeria monocytogenes Listeria monocytogenes Escherichia coli Escherichia coli Listeria monocytogenes Escherichia coli mould mould (Salmonella) Salmonella Listeria monocytogenes Listeria monocytogenes Listeria monocytogenes National includes distribution to three or more states and territories Food Safety Scheme Risk Assessment Page 161 of 189 Table 62 – Recalls of meat products between 2004 and 2008 Product Reason for recall 1. 2. 3. 4. 5. 6. 7. 8. Chicken, BBQ, shaved Ham, sliced Pork, pickled Beef, roast, sliced Ham, sliced Brawn Frankfurts Salami Distribution Year Listeria monocytogenes Was the recall instigated due to illness? Not reported WA 2004 Listeria monocytogenes Listeria monocytogenes Listeria monocytogenes Not reported Not reported Not reported NSW NSW NSW 2004 2004 2004 Listeria monocytogenes Listeria monocytogenes Listeria monocytogenes Not Not Not Not reported reported reported reported NSW NSW National National 2004 2004 2004 2004 Insufficient salt added during processing that may result in microbial growth 9. Meat, roast 10. Chicken, breast, sliced 11. Pork pies 12. Devon Listeria monocytogenes Listeria monocytogenes Not reported No National VIC 2004 2005 Escherichia coli No No WA National 2005 2005 13. Smallgoods (variety), sliced 14. Smallgoods (variety), sliced 15. Silverside 16. Chicken, whole, smoked 17. Smallgoods 18. Lamb, sliced 19. Cacciatore 20. Chicken breast, shaved 21. Prosciutto Ham, slices & whole legs 22. Smallgoods 23. Silverside 24. Beef, cooked, sliced 25. Ham Silverside, sliced 26. Pastrami 27. Cabanossi 28. Chicken breast, smoked 29. Ham, sliced 30. Bacon 31. Ham 32. Beef, cooked, sliced Pastrami, sliced 33. Chicken breast, sliced Listeria monocytogenes No QLD 2005 Listeria monocytogenes No National 2005 Listeria monocytogenes Listeria monocytogenes No No VIC, NSW NSW, ACT 2006 2006 Salmonella Listeria monocytogenes Listeria monocytogenes Listeria monocytogenes Not reported No No No National National NSW National 2006 2006 2007 2007 Listeria monocytogenes No NSW 2007 Salmonella Listeria monocytogenes Listeria monocytogenes No No No National National SA, NT 2007 2007 2007 Listeria monocytogenes No QLD 2007 Listeria monocytogenes Listeria monocytogenes Listeria monocytogenes No No No National National National 2007 2008 2008 Listeria Listeria Listeria Listeria monocytogenes monocytogenes monocytogenes monocytogenes No No No No National QLD National National 2008 2008 2008 2008 Listeria monocytogenes No National 2008 Some product not thoroughly cooked. Food Safety Scheme Risk Assessment Page 162 of 189 Table 63 – Recalls of plant products between 2004 and 2008 Product Reason for recall 1. Peppercorns 2. Mushrooms, in brine Salmonella 3. Parsley, fresh 4. Alfalfa Listeria monocytogenes, Salmonella Salmonella 5. Alfalfa 6. Sprouts 7. Orange juice Escherichia coli Salmonella Not commercially sterile – suspected under processing Oranienburg Salmonella, Listeria Was the recall instigated due to illness? Not reported No Distribution Year National National 2004 2005 No National 2006 No WA 2006 No No No VIC, TAS National NSW, VIC 2006 2007 2007 Table 64 – Recalls of seafood products between 2004 and 2008 Product 1. 2. 3. 4. 5. 6. 7. Prawns, cooked & peeled Mackerel, in oil Salmon, smoked, sliced Prawns, frozen, cooked & peeled Clams, frozen Tuna, steaks Tuna, canned Reason for recall Was the recall instigated due to illness? not reported Distribution Year National 2004 Histamine not reported Not reported National NSW 2004 2004 Microbial contamination Potential No SA, QLD 2005 No National 2005 Yes No SA National 2008 2008 Salmonella Infantis Listeria monocytogenes Salmonella contamination Histamine Potential pathogenic contamination Food Safety Scheme Risk Assessment Page 163 of 189 Appendix 3: Australian foodborne illness outbreaks (1995–2008) The tables on the following pages list foodborne illness outbreaks affecting two or more people from 1995 to 2008 and attributed to foods that are regulated by the food safety schemes contained in the Food Regulation 2004, or where those foods were included as an ingredient in the food implicated in the outbreak. These tables use the epidemiological data from the following sources: • Food Science Australia & Minter Ellison Consulting (2002). National Risk Validation Project. Final Report. • OzFoodNet Working Group (2002). Enhancing foodborne disease surveillance across Australia in 2001: the OzFoodNet Working Group. Communicable Diseases Intelligence, 26(3), 375–406. • OzFoodNet Working Group (2003). Foodborne disease in Australia: incidence, notifications and outbreaks. Annual report of the OzFoodNet network, 2002. Communicable Diseases Intelligence, 27(2), 209–243. • OzFoodNet Working Group (2004). Foodborne disease investigation across Australia: Annual report of the OzFoodNet network, 2003. Communicable Diseases Intelligence, 28(3), 359–389. • OzFoodNet Working Group (2005). Reported foodborne illness and gastroenteritis in Australia: Annual report of the OzFoodNet network, 2004. Communicable Diseases Intelligence, 29(2), 164–190. • OzFoodNet Working Group (2006). Burden and causes of foodborne disease in Australia: Annual report of the OzFoodNet network, 2005. Communicable Diseases Intelligence, 30(3), 278–300. • OzFoodNet Working Group (2007). Monitoring the Incidence and Causes of Diseases Potentially Transmitted by Food In Australia: Annual Report of the OzFoodNet network, 2006 Communicable Diseases Intelligence, 31(4), 345–365. Key for contributing factors Temperature misuse T1 T2 T3 T4 T5 Inadequate handling C1 C2 Inadequate environment E1 E2 Raw material R1 R2 R3 Process P a (CF) Improper heating Improper reheat Inadequate storage Preparation far in advance Inadequate thawing Food handler contamination Cross contamination Insufficient hygiene Inadequate facilities Contaminated raw ingredient Infected animals Food from unsafe source Inadequate process Assumption made on the basis of information available, eg implicated microorganism, normal mode of transmission Food Safety Scheme Risk Assessment Page 164 of 189 Table 65 – Foodborne illness outbreaks attributed to milk, dairy products and dairy products used as an ingredient State Year Food vehicle Agent SA SA WA SA VIC SA VIC ACT QLD VIC VIC WA NSW VIC VIC NSW QLD QLD SA VIC SA QLD 1997 1998 1998 1999 1999 2000 2000 2001 2001 2001 2001 2001 2002 2002 2002 2003 2003 2003 2003 2003 2004 2005 Cheese sauce Gelato Unpasteurised milk 44 Unpasteurised milk Continental custard cake Unpasteurised milk Unpasteurised milk Cheese sticks Unpasteurised pets milk (cow) Unpasteurised milk Unpasteurised milk (suspected) Cranachan (dessert) Cream filled cake Cream filled cakes/pastries Cheesecake (suspected) Apple strudel Cheese Trifle Unpasteurised milk Unpasteurised milk/animal contact Creamed cakes Custard filled dumplings C. perfringens S. Oranienburg Campylobacter S. Typhimurium 44 S. Typhimurium 9 Campylobacter Campylobacter SA NSW VIC SA 2006 2007 2007 2008 Sweet potato and feta cheese salad Fruit, meringue and custard tart Fetta cheese (suspected) Milk (suspected) S. Typhimurium 9 Unknown Unknown Unknown 44 unknown Cryptosporidiosis Unknown Campylobacter Contributing factors (CF) C2 C2 R3 R3 T3a R3 R3 T3 R3 Unknown S. Typhimurium 135 S. Typhimurium U290 Norovirus Norovirus Sorbic acid Norovirus Campylobacter Campylobacter S. Typhimurium 108 S. aureus R3 Number affected 27 102 9 12 54 12 25 2 8 12 12 50 29 10 25 67 23 31 14 13 13 2 Hospitalised (deaths) 6 9 10 5 0 3 0 0 1 0 1 0 0 0 5 - Setting prepared Commercial caterer Manufacturer Camp Farm Bakery Retail dairy Camp Restaurant Community Camp Camp Function Bakery Bakery Commercial caterer Restaurant Childcare Restaurant Camp Camp/excursion Bakery Grocery store/delicatessen Restaurant Unknown Restaurant Camp Unpasteurised cows milk is not currently regulated under the dairy food safety scheme or the Food Standards Code, however FSANZ is reviewing the regulatory requirements relating to unpasteurised milk as part of Proposal P1007 - Primary Production & Processing Requirements For Raw Milk Products Food Safety Scheme Risk Assessment Page 165 of 189 Table 66 – Foodborne illness outbreaks attributed to meat, meat products and meat products used as an ingredient State Year Food vehicle Agent ACT NSW NSW NSW NSW, ACT, QLD, VIC SA ACT 1995 1995 1995 1995 1995 Roast chicken Deboned roast pork Sandwiches BBQ chicken Meat or chicken S. Bredeney S. Typhimurium pt 9 1995 1995 E. coli O:111 S. Bredeney QLD NSW NSW VIC NSW 1996 1996 1996 1996 1996 NSW 1997 NSW NSW NSW SA VIC VIC VIC, SA WA NSW 1997 1997 1997 1997 1997 1997 1997 1997 1998 Mettwurst (uncooked) Cold chicken, salad, prawns, custard Anglaise sauce Ham sandwiches (suspected) Chicken soup Beef & pork cooked on spit Beef, chinese cabbage & sprouts Chicken or thai-style beef salad Cold chicken pieces Meat loaf & gravy Turkey/pork Bread rolls with meat filling Beef/lamb curry with rice Ham & corned beef Sliced corned beef / ham Roast lamb Ham & potato bake SA SA 1998 1998 Ham Spatchcock S. sonnei biotype g S. Typhimurium rdnc SA SA 1998 1998 Chicken nuggets Steak roll S. Typhimurium 12 Food Safety Scheme Risk Assessment Suspected viral Unknown S. Bredeney S. Heidelberg pt 16 Norwalk-like virus Suspected viral C. perfringens S. Typhimurium 135 C. perfringens S. Typhimurium pt 9 Unknown S. Typhimurium 135 S. Typhimurium 135 C. perfringens S. Anatum S. Muenchen C. perfringens L. monocytogenes (non-invasive) ao45 Unknown Contributing factors (CF) T1a T1 C2 T3 C1 T3 C2 Number affected 3 22 17 19 157 Hospitalised (deaths) E1 P U 173 14 unknown (1) R1 R3 C2a C1 T3 C1 C2 E1 >500 20 67 33 17 T3 C2 171 T3 C2 E2 U T1 T3 T1a T3a C2a E2a T3a C2a Pa T3 C2 T3a T1 T3 78 8 85 71 9 25 32 12 32 C1 T1 T2 13 38 T1 U 18 200 1 23 4 5 Setting prepared Takeaway Camp Commercial caterer Private residence Takeaway Manufacturer Commercial caterer Commercial Commercial Commercial Commercial Restaurant caterer caterer caterer caterer Commercial caterer 3 2 unknown (2) Function Institution Institution Manufacturer Commercial caterer Manufacturer Manufacturer Commercial caterer Commercial caterer Commercial caterer Commercial caterer Private residence Takeaway Page 166 of 189 State Year Food vehicle Agent Suspected viral S. Typhimurium 64 S. Typhimurium 64 Unknown S. Typhimurium TAS VIC VIC NSW NSW QLD QLD QLD QLD VIC VIC VIC VIC 1998 1998 1998 1999 1999 1999 1999 1999 1999 1999 1999 1999 1999 VIC VIC ACT ACT ACT NSW 1999 1999 2000 2000 2000 2000 NSW NSW NSW NSW NT QLD 2000 2000 2000 2000 2000 2000 Chicken Chicken meal Cooked chicken Salami (suspected) Chicken kebab Spit roast pork Roast lamb Meat pie Curried chicken Chicken vol au vents Pancake with meat filling Chicken briyani Stir-fry chicken & vegetable (or sweet and sour pork) Chicken vietnamese dish Chicken/beef satay, beef dish Chicken breast Lamb curry Venison stew Range of foods especially sliced smallgoods and antipasto Thai beef salad Beef enchiladas/nachos Roast beef & roast pork Meat pie & gravy Chicken-a-la-king Burger (suspected) QLD QLD QLD QLD VIC 2000 2000 2000 2000 2000 Steak salad & chip meal Chicken meal Lemon chicken Chicken Frankfurters Food Safety Scheme Risk Assessment C. perfringens Viral C. perfringens C. perfringens C. perfringens S. Hessarek S. aureus C. perfringens Unknown S. Virchow 34 Unknown C. perfringens Unknown Norwalk-like virus Salmonella spp Unknown C. perfringens Unknown C. perfringens Unknown Unknown S. aureus Suspected viral Unknown S. Typhimurium 9 Contributing factors (CF) C1a T1 T1a T3a C2a E1 T3 T1 T3 C1 T3 T3 T3 T1 T3 C2 T3a T3 Number affected 15 32 46 92 4 29 74 >2 3 >34 >11 35 16 T3 T1 C2 T3 T3 T3 C1 >14 32 3 14 2 35 T3 C1 T3 E1 U T3 U 21 3 5 3 56 2 C2 T3 C2 C1a U T1 5 3 2 4 5 Hospitalised (deaths) Setting prepared Commercial caterer Restaurant Takeaway Function Takeaway Commercial caterer Commercial caterer Manufacturer Takeaway Commercial caterer Commercial caterer Private residence Private residence 1 1 1 Restaurant Wholesaler Restaurant Restaurant Restaurant Commercial caterer Restaurant Restaurant Restaurant Bakery Commercial caterer National franchised fast food Restaurant Takeaway Takeaway Takeaway Private residence Page 167 of 189 State Year Food vehicle Agent S. Typhimurium 170 S. Virchow pt 34 Campylobacter S. Typhimurium pt64 VIC VIC 2000 2000 Sucuk Chicken kebabs ACT ACT ACT ACT ACT ACT NSW NSW NSW NSW NSW 2001 2001 2001 2001 2001 2001 2001 2001 2001 2001 2001 NSW NSW NSW, VIC QLD QLD QLD QLD QLD QLD QLD QLD SA SA SA VIC 2001 2001 2001 2001 2001 2001 2001 2001 2001 2001 2001 2001 2001 2001 2001 VIC 2001 Spit roast meal (suspected) Spit roast meal (suspected) Spit roast meal (suspected) Spit roast meal (suspected) Spit roast Chicken burger Prawn stuffed chicken breast Honey chicken (suspected) Roast beef with gravy Chicken pizza Takeaway chicken (suspected) Chicken kebab (suspected) BBQ chicken (suspected) Chicken kebab Cajun chicken Chicken salad in pita bread Chicken Duck liver Beef curry Beef curry Chicken kebabs Chicken kebabs Chicken Chicken Homemade italian sausages Soup or roast beef (suspected) Lamb's fry Food Safety Scheme Risk Assessment Suspected Suspected Suspected Suspected Unknown Unknown Unknown Unknown Contributing factors (CF) T1 R3 P T1 toxin toxin toxin toxin C. perfringens S. Typhimurium 126 U U C2 T3 Unknown Unknown Unknown S. Virchow pt 36 var 1 B. cereus S. Bovismorbificans 32 S. Virchow pt 8 Campylobacter C. perfringens C. perfringens C. jejuni C. jejuni S. Typhimurium 126 Salmonella serovars S. Typhimurium 135a Suspected toxin S. Typhimurium 99 T1 C2 T3a T3 T1 R1 Number affected 8 3 Hospitalised (deaths) Private residence Takeaway 22 110 68 31 9 3 9 10 27 2 2 0 0 0 0 2 3 38 6 36 2 2 8 15 3 3 88 50 2 269 0 0 22 Setting prepared 0 1 0 Function Function Function Function Restaurant Takeaway Commercial caterer Restaurant Restaurant Takeaway Takeaway 0 0 Takeaway Takeaway Takeaway Commercial caterer Community Function Restaurant Restaurant Restaurant Takeaway Takeaway Community Farm Private residence Function 2 Hotel 6 0 0 0 0 unknown Page 168 of 189 State Year Food vehicle Agent C. perfringens C. perfringens S. Typhimurium 43 S. Typhimurium 135 S. Typhimurium 135 VIC 2001 VIC VIC VIC VIC WA WA 2001 2001 2001 2001 2001 2001 NSW NSW NSW NSW NSW NSW NSW NSW NSW NSW NSW NSW NSW QLD QLD 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 Potato and bacon soup (suspected) BBQ chicken/meat Eye fillet meal Sausages (suspected) Kebabs (suspected) Chicken (suspected) Undercooked turkey (suspected) Spit roast beef/and or pork Chicken casserole Chicken Beef dish (suspected) Beef curry Lamb curry Bbq chicken Pasta (suspected) Thai salad Baked beans/chilli con carne Kebabs (suspected) Pizza Pizza Chicken Pizza SA SA VIC VIC VIC VIC NSW NSW NSW 2002 2002 2002 2002 2002 2002 2003 2003 2003 Potato and meat pie Sliced ham Roast chicken Home bbq chicken Pea and ham soup Steak or sauce Chicken Chicken / eggs (suspected) Soccerball ham Food Safety Scheme Risk Assessment Contributing factors (CF) S. Virchow 34 S. Typhimurium 99 Norwalk virus Unknown (1 positive Salmonella) Norwalk virus Unknown C. perfringens Unknown S. Virchow Unknown Unknown C. perfringens Unknown Unknown S. Typhimurium 126 S. Typhimurium 9 Unknown Unknown Unknown C. jejuni S. aureus Unknown Unknown Campylobacter S. Typhimurium Unknown Number affected 9 11 95 65 3 56 6 Hospitalised (deaths) 0 Hotel 2 1 0 1 0 0 Private residence Restaurant Restaurant Takeaway Function Restaurant 0 2 0 Commercial caterer Commercial caterer Fast food outlet Restaurant Restaurant Restaurant Takeaway Private residence Restaurant School Takeaway Takeaway Takeaway Community National franchised fast food Private residence Community Private residence Private residence Restaurant Restaurant Camp/excursion Community Private residence 16 3 3 4 2 70 2 20 21 132 2 4 5 24 8 8 5 19 6 10 5 19 20 1 Setting prepared Page 169 of 189 State Year Food vehicle Agent Salmonella S. Typhimurium S. Typhimurium S. Typhimurium S. Typhimurium S. aureus NSW NSW NSW NSW NSW NT 2003 2003 2003 2003 2003 2003 NT NT NT QLD QLD VIC VIC VIC NSW 2003 2003 2003 2003 2003 2003 2003 2003 2004 Pork dish Chicken Pigeon meat Chicken Pigs ear salad, ducks gizzard Rice, beef and black bean sauce Quail (suspected) Pizza Roast turkey (suspected) Beef burgundy Roast pork Roast pork Roast pork Club sandwiches BBQ meat pizza (suspected) NSW 2004 Roast pork NSW NSW NSW NSW NSW NSW NSW QLD 2004 2004 2004 2004 2004 2004 2004 2004 Chicken Cold chicken sandwiches chicken (suspected) Bacon and ham (suspected) Chicken (suspected) Takeaway chicken Chicken Meat pizza QLD VIC ACT ACT NSW NSW 2004 2004 2005 2005 2005 2005 Chicken kebab Chicken vol au vents Pork bruschetta & duck tart Chicken salad & chicken pasta Beef casserole Lambs liver Food Safety Scheme Risk Assessment Unknown Unknown S. Typhimurium Unknown Contributing factors (CF) Number affected 4 3 61 12 20 5 Hospitalised (deaths) 1 0 5 0 0 4 Unknown Unknown 10 18 7 7 21 20 12 17 5 0 0 0 0 2 0 0 0 1 S. Typhimurium 170, 27 1 Salmonella S. Typhimurium S. Typhimurium Rdnc S. Typhimurium 170 Unknown Campylobacter Unknown S. Typhimurium 170 Unknown S. Typhimurium 12 C. perfringens Campylobacter Suspected toxin Norovirus Campylobacter Unknown S. Typhimurium 197 13 7 21 12 3 5 141 6 2 20 25 11 13 43 3 0 1 0 1 0 unknown 0 0 0 1 1 0 13 Setting prepared Restaurant Restaurant Restaurant Takeaway Takeaway Camp/excursion Commercial caterer Private residence Takeaway Restaurant Restaurant Commercial caterer Commercial caterer Commercial caterer National franchised fast food Other Restaurant Restaurant Restaurant Restaurant Takeaway Takeaway Unknown National franchised fast food Takeaway Commercial caterer Commercial caterer Restaurant Commercial caterer Private residence Page 170 of 189 State Year NSW NSW NSW NSW NSW NSW 2005 2005 2005 2005 2005 2005 QLD 2005 QLD QLD QLD SA VIC VIC VIC VIC NSW NSW NSW 2005 2005 2005 2005 2005 2005 2005 2005 2006 2006 2006 NSW NSW NSW 2006 2006 2006 NSW NT 2006 2006 QLD QLD QLD QLD 2006 2006 2006 2006 QLD 2006 Food vehicle Agent Chicken caesar salad burger Lamb & beef Chicken Chicken Ham pizza Chicken, rice, coleslaw, potatoes Chicken kebabs Unknown Unknown Unknown Unknown Unknown S. Typhimurium 9 Beef rendang Chicken and lamb guvec Chicken meat Marinated chicken roll Veal rolls & red curry Chicken vol-au-vents Gravy & pork Pork (suspected) Chicken curry Cooked chicken Pork dish or fried ice-cream (suspected) Chicken pizza Chicken schnitzel in gravy Chicken/beef burgers with eggs (suspected) Roast pork Sticky rice balls with chicken (suspected) Chow mien Chicken teriyaki sushi roll Chicken and lamb guvec Chicken teriyaki sushi rolls (suspected) Lamb korma C. perfringens C. perfringens S. Typhimurium 170/108 S. Typhimurium 170/108 Food Safety Scheme Risk Assessment Contributing factors (CF) Campylobacter Number affected 3 5 2 2 9 4 Hospitalised (deaths) 2 0 0 0 0 3 Setting prepared Restaurant Restaurant Restaurant Restaurant Restaurant Takeaway 4 0 C. perfringens B. cereus S. Typhimurium 170 3 14 2 9 40 29 17 20 70 14 2 0 0 1 0 0 0 1 0 0 2 Grocery store/delicatessen Restaurant Restaurant Takeaway Restaurant Commercial caterer Commercial caterer Commercial caterer Restaurant Commercial caterer Commercial caterer Restaurant Unknown Unknown S. Typhimurium 170 2 3 4 0 0 2 Restaurant Takeaway Takeaway C. perfringens S. Oslo 80 2 0 0 Takeaway Private residence S. Singapore 2 2 13 6 1 0 0 1 Restaurant Restaurant Restaurant Restaurant 6 0 Restaurant Unknown Unknown Unknown S. Typhimurium 170/108 Unknown C. perfringens S. Typhimurium 135 C. perfringens Page 171 of 189 State Year Food vehicle Agent Contributing factors (CF) Number affected 4 5 23 4 5 15 Hospitalised (deaths) 0 0 7 0 0 4 Setting prepared QLD SA SA SA VIC WA 2006 2006 2006 2006 2006 2006 Beef/lamb kebab (suspected) Chicken dish Ravioli Silverside Salami (non commercial) Capocollo Unknown NSW 2007 Unknown 9 NSW 2007 S. Typhimurium 12 7 Restaurant NSW NSW NSW NSW 2007 2007 2007 2007 Unknown Unknown Unknown Unknown 5 4 5 4 Restaurant Takeaway Takeaway Takeaway NSW NT QLD QLD VIC 2007 2007 2007 2007 2007 Campylobacter S. Oslo 2 3 7 8 5 Takeaway Commercial caterer Private residence Restaurant Restaurant VIC VIC NSW 2007 2007 2008 Unknown Unknown 17 20 75 Takeaway Commercial caterer Commercial caterer NSW NSW NSW QLD QLD SA VIC 2008 2008 2008 2008 2008 2008 2008 Chicken stir-fry / beef massaman Marinated chicken dish, noodle dish, fried rice (suspected) Chicken schnitzel (suspected) Fried chicken (suspected) Hot dogs Beef & chicken kebabs (suspected) Meat kebab Roast pork (suspected) Wurst Duck pâté Chicken massaman curry (suspected) Meat curry (suspected) Roast chicken and/or stuffing Chicken curry, curry pumpkin, rice with lamb, plain rice Chicken rissoles (suspected) Chilli beef dish Stir-fry beef Chicken Chicken liver pâté Chicken (suspected) Chicken and pasta salad and ham Takeaway Commercial caterer Other Private residence Unknown Commercial manufactured food Restaurant S. Typhimurium 135 S. Typhimurium U290 5 7 2 2 4 3 18 Commercial caterer Restaurant Restaurant Restaurant Restaurant Private residence Commercial caterer Food Safety Scheme Risk Assessment Campylobacter S. Typhimurium 108 S. Typhimurium 135 S. London S. Bovismorbificans 11 Unknown S. Typhimurium 135a S. Typhimurium 9 C. perfringens / B. cereus Unknown Campylobacter Campylobacter S. Typhimurium 9 S. Typhimurium 170 Page 172 of 189 State Year VIC 2008 VIC VIC 2008 2008 Food vehicle Agent Chicken and pasta salad and ham Chicken curry Roast pork Campylobacter Food Safety Scheme Risk Assessment Unknown S. Johannesburg Contributing factors (CF) Number affected 4 21 14 Hospitalised (deaths) Setting prepared Commercial caterer Commercial caterer Restaurant Page 173 of 189 Table 67 – Foodborne illness outbreaks attributed to plant products State Year Food vehicle SA 1995 NSW 1998 NSW 1998 NSW, VIC, QLD, SA 1998 SA, VIC 1999 QLD 2000 ACT 2001 QLD 2001 VIC 2001 NSW 2003 VIC 2003 VIC 2004 NSW 2005 TAS 2005 WA 2005 VIC 2006 VIC WA 2006 2006 WA 2006 NSW NSW NSW QLD 2007 2007 2007 2007 VIC VIC NSW 2007 2007 2008 Contributing Number Hospitalised Setting prepared factors (CF) affected (deaths) Cucumber Campylobacter C2 78 Commercial caterer Cold salad Unknown U 26 1 Commercial caterer Pasta salad or coleslaw, tossed salad Unknown T3 C1 E1 E2 29 Commercial caterer Semi-dried tomatoes with garlic in oil S. Virchow 8 R1 P 85 unknown (1) Manufacturer Orange juice, unpasteurised S. Typhimurium 135a E1 R1 533 Manufacturer Vegetables & dips Unknown C2 3 Restaurant Salad at BBQ (suspected) Suspected viral 61 0 Function Lettuce S. Bovismorbificans 32 C2 E1 36 Takeaway Tomato and cucumber salad Campylobacter 50 0 Function Salad (suspected) Unknown 24 0 Restaurant Cucumbers (suspected) Salmonella 6 0 Community Gourmet rolls/red onion S. Typhimurium 12a 28 3 Commercial caterer Self-serve salad bar Unknown 37 1 Institution Salad rolls/sandwiches S. Typhimurium 135 6 0 Bakery Alfalfa sprouts S. Oranienburg 125 11 Contaminated primary produce Alfalfa sprouts S. Oranienburg 15 2 Contaminated primary produce Bean shoots (suspected) S. Saintpaul 11 1 Restaurant Rockmelon S. Saintpaul 79 12 Contaminated primary produce Paw paw S. Litchfield 17 4 Contaminated primary produce Watermelon (suspected) Unknown 7 Private residence Mushroom & cos lettuce (suspected) Unknown 6 Restaurant Fresh fruit juice (suspected) Unknown 6 Takeaway Baby corn S. sonnei biotype g 55 Contaminated primary produce Passionfruit coulis (suspected) Unknown 37 Commercial caterer Fruit salad Norovirus 18 Commercial caterer Fattouch salad Unknown 17 Restaurant Food Safety Scheme Risk Assessment Agent Page 174 of 189 Table 68 – Foodborne illness outbreaks attributed fish and seafood products State Year Food vehicle NSW 1995 Chargrilled tuna NSW 1995/1996 Prawns QLD 1995 Coral trout QLD 1995 Spanish mackerel steak WA 1995 Coral trout WA 1995 Pilchards NSW 1996 Rock cod NSW, QLD 1996 Oysters NSW 1997 Prawns NSW 1997 Coral trout NSW 1997 Coral trout NSW 1997 Pipis NSW 1997 Marlin NSW 1997 Coral trout NSW 1997 Prawns NSW 1997 Fish NSW 1997 Pipis NSW, QLD, 1997 Oysters, raw WA NT 1997 Coral cod VIC 1997 Maori wrasse fish NSW 1998 Spotted cod NSW 1998 Cod NSW 1998 Spotted cod NT 1998 Barracuda SA 1998 Scampi VIC 1998 Thai fish cakes VIC 1998 Fish head soup VIC 1998 Fish head soup VIC 1998 Fish VIC 1998 Seafood risotto VIC 1998 Tuna steaks Food Safety Scheme Risk Assessment Agent Scombroid poisoning S. Typhimurium Ciguatoxin Ciguatoxin Ciguatoxin Scombroid poisoning Ciguatoxin Norwalk-like virus Hepatitis A Ciguatoxin Ciguatoxin Diarrhoetic shellfish toxin Scombroid poisoning Ciguatoxin Hepatitis A Ciguatoxin Diarrhoetic shellfish toxin Hepatitis A Ciguatoxin Ciguatoxin Ciguatoxin Ciguatoxin Ciguatoxin Ciguatoxin Unknown Scombroid poisoning Ciguatoxin Ciguatoxin B. cereus Scombroid poisoning Scombroid poisoning Contributing Number Hospitalised factors (CF) affected (deaths) T3 4 R3 4 R1 4 R1 15 1 R1 4 T3 >6 R1 2 R3 97 T1 R3 23 R1 6 R1 10 R1 59 T3 2 R1 6 C1a R3 17 R1 8 3 R1 56 R3 467 64 (1) R1 R1 R1 R1 R1 R1 T1 T5 R1 T3 R1 R1 T3a T3 T3 20 18 12 3 10 7 38 9 3 5 9 3 6 4 17 4 3 6 Setting prepared Restaurant Restaurant Private residence Retail Private residence Restaurant Private residence Community Restaurant Community Community Community Private residence Private residence Restaurant Retail Unknown Community Community Restaurant Private residence Private residence Private residence Private residence Commercial caterer Function Private residence Private residence Restaurant Restaurant Restaurant Page 175 of 189 State Year Food vehicle Agent Scombroid poisoning NSW NSW NT QLD QLD QLD 1999 1999 1999 1999 1999 1999 Tuna Curried prawns Grenadier fish fillets Mackerel Leatherskin/queenfish Red claw crayfish VIC VIC VIC 1999 1999 1999 Spanish mackerel Pasta with tuna and chilli sauce Rudderfish (butterfish) QLD 1999 NSW QLD QLD QLD QLD QLD QLD QLD QLD VIC ACT NSW NSW 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2001 2001 2001 Scallops or trout & ham dish, mildly cooked prawn dumplings Black trevally Coronation trout Spotted mackerel Queenfish Black kingfish Coral trout Cod Crab cakes & sweetlip Flake Coral trout / coral cod Prawns Escolar Fish curry made using rudderfish QLD QLD QLD QLD QLD QLD QLD 2001 2001 2001 2001 2001 2001 2001 Spanish mackerel steak Spanish mackerel Spotted mackerel Barracuda Coral trout Spanish mackerel Spotted mackerel Food Safety Scheme Risk Assessment C. perfringens Scombroid poisoning Ciguatoxin Ciguatoxin V. cholerae non 01, non 139 Ciguatoxin Scombroid poisoning Wax ester (butterfish diarrhoea) Norwalk-like virus Ciguatoxin Ciguatoxin Ciguatoxin Ciguatoxin Ciguatoxin Ciguatoxin Ciguatoxin Ciguatoxin Marine toxin Ciguatoxin Unknown Escolar wax esters Scombroid poisoning & wax ester Ciguatoxin Ciguatoxin Ciguatoxin Ciguatoxin Ciguatoxin Ciguatoxin Ciguatoxin Contributing Number Hospitalised factors (CF) affected (deaths) T3 4 T3 E2 39 1 T3 5 1 R1 2 R1 7 C2 10 1 R1 T3 R1 4 unknown >14 T1a C1a 14 R1 R1 R1 R1 R1 R1 R1 R1 R1 R1 U R1 T3 R1 unknown 9 unknown unknown unknown 4 3 2 2 unknown 3 20 9 R1 R1 R1 R1 R1 R1 R1 14 14 2 3 4 9 2 Setting prepared Private residence Restaurant Restaurant Private residence Private residence Restaurant Private residence Restaurant Restaurant Commercial caterer 2 0 7 11 11 0 3 0 0 Private residence Private residence Private residence Private residence Private residence Private residence Restaurant Restaurant Takeaway Private residence Restaurant Function Takeaway Commercial caterer Private residence Private residence Private residence Private residence Private residence Private residence Page 176 of 189 State Year Food vehicle Agent Scombroid poisoning Scombroid poisoning S. Mississippi Ciguatoxin Ciguatoxin Wax ester (butterfish diarrhoea) Unknown Unknown Ciguatoxin Unknown Unknown Unknown Hepatitis A Ciguatoxin Ciguatoxin Ciguatoxin Suspected wax ester Unknown Norovirus Unknown Scombroid poisoning Hepatitis A Norovirus Ciguatoxin Ciguatoxin Ciguatoxin Scombroid poisoning Ciguatoxin QLD QLD VIC VIC VIC VIC 2001 2001 2001 2001 2001 2001 Mahi mahi Mahi mahi Suspect oysters Coral trout Coral trout Butterfish NSW NSW NSW NSW NSW NSW NSW QLD QLD QLD VIC WA WA ACT NSW NSW NT QLD QLD QLD QLD QLD QLD QLD QLD QLD QLD 2001 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2002 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 2003 Seafood sauce (suspected) Seafood vehicle (suspected) Spanish mackerel Seafood (suspected) Seafood (suspected) Fish Yum cha Striped perch Brunter bream Spanish mackerel Suspect rudderfish Oyster shooters Seafood salad Fish Sardines Prawns Japanese IQF oysters Coral trout Mackerel steaks Coral trout Tuna patties Fish (Mooloolaba bay) Curried prawn dish Cod fish heads Giant trevally fish Barracuda Fish head soup - red emperor Food Safety Scheme Risk Assessment C. perfringens Ciguatoxin Ciguatoxin Ciguatoxin Ciguatoxin Contributing Number Hospitalised factors (CF) affected (deaths) T3 4 0 T3 4 6 0 R1 16 0 R1 17 R1 5 0 R1 R1 R1 R1 R1 T3 R1 R1 R1 R1 T3 R1 R1 R1 R1 R1 6 5 7 3 4 2 8 2 3 2 10 unknown 60 3 2 2 48 2 3 7 2 3 19 2 3 5 3 0 0 2 0 0 0 0 0 0 0 0 0 0 5 0 Setting prepared Restaurant Restaurant Community Private residence Private residence Restaurant Restaurant Fast food outlet Private residence Restaurant Restaurant Takeaway Restaurant Private residence Private residence Takeaway Restaurant Commercial caterer Restaurant Private residence Private residence Restaurant Restaurant Private residence Private residence Private residence Private residence Private residence Private residence Private residence Private residence Private residence Private residence Page 177 of 189 State Year Food vehicle Agent Contributing Number Hospitalised factors (CF) affected (deaths) R1 4 0 T3 3 0 R1 15 0 R1 20 0 Setting prepared T3 R1 R1 17 22 35 3 0 0 0 0 Commercial caterer Restaurant Restaurant Restaurant R1 16 12 24 0 2 1 Restaurant Restaurant Contaminated primary produce National franchised fast food Private residence Restaurant Restaurant Contaminated primary produce Contaminated primary produce Contaminated primary produce Contaminated primary produce Private residence Private residence Private residence Private residence Restaurant Takeaway Commercial caterer QLD QLD QLD QLD 2003 2003 2003 2003 Fish species unknown Dolphin fish Spanish mackerel Escolar fish VIC VIC VIC VIC 2003 2003 2003 2003 Japanese IQF oysters Escolar fish Japanese IQF oysters Escolar fish ACT ACT NSW 2004 2004 2004 Calamari Seafood (suspected) Ling fish Oysters Ciguatoxin Scombroid poisoning Ciguatoxin Wax ester (butterfish diarrhoea) Unknown Scombroid poisoning Norovirus Wax ester (butterfish diarrhoea) Unknown S. Typhimurium 197 Norovirus NSW 2004 Fish cakes S. Typhimurium u290 3 0 NSW NSW NSW NT 2004 2004 2004 2004 Chinese style minced fish balls Fried rice, pipis Crab Oysters (frozen) S. Typhimurium u290 3 7 3 5 2 6 2 0 QLD 2004 Oysters (frozen) Norovirus R1 4 0 QLD 2004 Spanish mackerel/trevally Ciguatoxin R1 5 unknown QLD 2004 Oysters (frozen) Norovirus R1 2 unknown QLD QLD QLD QLD QLD QLD VIC 2004 2004 2004 2004 2004 2004 2004 Golden spotted trevally fish Fish species unknown Trevally Grey mackerel Coral trout Grey mackerel Butter fish (rudderfish) Ciguatoxin Ciguatoxin Ciguatoxin Ciguatoxin Ciguatoxin Ciguatoxin Suspected toxin R1 R1 R1 R1 R1 R1 R1 2 2 3 4 4 4 9 2 0 0 0 1 0 0 Food Safety Scheme Risk Assessment Unknown S. Typhimurium 135 Unknown Private residence Restaurant Restaurant Restaurant Page 178 of 189 State Year Food vehicle Agent VIC 2004 Redfin Unknown NSW NT QLD 2005 2005 2005 Tuna steak Vietnamese rice paper rolls Mackerel steaks Scombroid poisoning S. Typhimurium rdnc Ciguatoxin QLD 2005 Black trevally Ciguatoxin QLD 2005 Yellowtail kingfish Ciguatoxin QLD 2005 Spanish mackerel Ciguatoxin QLD 2005 Black king fish Ciguatoxin QLD 2005 Spanish mackerel Ciguatoxin QLD 2005 Trevally Ciguatoxin QLD 2005 Barracuda Ciguatoxin QLD 2005 Yellowtail king fish Ciguatoxin QLD QLD QLD TAS TAS VIC 2005 2005 2005 2005 2005 2005 Prawn soup Yellow fin tuna Seafood mornay & rice Seafood (suspected) Yellow fin tuna Fijian snapper S. Typhimurium 44 VIC 2005 Fish Scombroid poisoning VIC VIC VIC 2005 2005 2005 Seafood platter, baked fish, octopus Tuna Spanish mackerel seafood (suspected) Unknown Scombroid poisoning Unknown Food Safety Scheme Risk Assessment Scombroid poisoning Unknown Vibrio Scombroid poisoning Ciguatoxin Contributing Number Hospitalised Setting prepared factors (CF) affected (deaths) 7 3 Contaminated primary produce T3 4 0 Private residence 4 1 Private residence R1 4 0 Contaminated primary produce R1 2 0 Contaminated primary produce R1 2 0 Contaminated primary produce R1 17 2 Contaminated primary produce R1 5 0 Contaminated primary produce R1 2 0 Contaminated primary produce R1 2 0 Contaminated primary produce R1 10 0 Contaminated primary produce R1 8 0 Contaminated primary produce 23 22 Private residence T3 2 0 Restaurant 18 0 Restaurant 2 0 Private residence T3 2 0 Restaurant R1 5 0 Contaminated primary produce T3 2 0 Contaminated primary produce 16 0 Restaurant T3 2 0 Restaurant 11 0 Restaurant Page 179 of 189 State Year Food vehicle Agent NSW 2006 Tuna and salmon sushi rolls S. Typhimurium 170 NSW NSW NSW NSW NSW NT 2006 2006 2006 2006 2006 2006 Nile perch seafood (suspected) Oysters seafood (suspected) White bait Tuna steaks Yellowtail kingfish fillets Slate sweetlips fish Unknown Unknown QLD 2006 Cod fish heads Ciguatoxin QLD 2006 Blue fin tuna Scombroid poisoning QLD 2006 Trevally Ciguatoxin QLD 2006 Spanish mackerel Ciguatoxin QLD 2006 Spanish mackerel Ciguatoxin QLD 2006 Black kingfish Ciguatoxin VIC 2006 Coral perch or coral trout Ciguatoxin VIC NSW NSW NSW NSW NSW NT 2006 2007 2007 2007 2007 2007 2007 Kingfish Fish balls Tuna kebab steaks Seafood platter Tuna steaks Oysters Tinned tuna NT 2007 Reef cod Scombroid poisoning Unknown Scombroid poisoning Norovirus Suspect scombroid poisoning Ciguatoxin QLD 2007 Mackerel Ciguatoxin Food Safety Scheme Risk Assessment V. cholerae Scombroid poisoning Scombroid poisoning Ciguatoxin Scombroid poisoning B. cereus Contributing Number Hospitalised Setting prepared factors (CF) affected (deaths) 6 0 Commercial manufactured food 4 0 Private residence 6 0 Private residence 3 2 Private residence T3 2 1 Restaurant T3 6 6 Restaurant R1 14 4 Contaminated primary produce R1 2 0 Contaminated primary produce T3 2 0 Contaminated primary produce R1 2 0 Contaminated primary produce R1 4 4 Contaminated primary produce R1 2 0 Contaminated primary produce R1 4 0 Contaminated primary produce R1 2 0 Contaminated primary produce T3 2 0 Restaurant 32 Commercial caterer T3 3 Delicatessen 4 Restaurant T3 2 Restaurant R1 19 Restaurant T3 2 Commercial manufactured food R1 2 Contaminated primary produce R1 2 Contaminated primary produce Page 180 of 189 State Year Food vehicle Agent QLD 2007 Mackerel Ciguatoxin QLD 2007 Coral trout Ciguatoxin QLD 2007 Mackerel Ciguatoxin QLD 2007 Coral trout Ciguatoxin QLD 2007 Coral trout Ciguatoxin QLD 2007 Spanish mackerel Ciguatoxin QLD QLD TAS 2007 2007 2007 Tuna Tuna kebabs Oysters (suspected) Scombroid poisoning Scombroid poisoning Unknown VIC VIC NSW NSW QLD 2007 2007 2008 2008 2008 Tuna Mahi mahi Marinated mussels (suspected) Rice or salt & pepper prawn Black kingfish Scombroid poisoning Scombroid poisoning Unknown Unknown Ciguatoxin QLD 2008 Yellowtail kingsfish Ciguatoxin Food Safety Scheme Risk Assessment Contributing Number Hospitalised Setting prepared factors (CF) affected (deaths) R1 6 Contaminated primary produce R1 3 Contaminated primary produce R1 2 Contaminated primary produce R1 5 Contaminated primary produce R1 2 Contaminated primary produce R1 2 Contaminated primary produce T3 2 Private residence T3 4 Private residence 19 Contaminated primary produce T3 2 Restaurant T3 2 Restaurant 7 Restaurant 7 Restaurant R1 6 Contaminated primary produce R1 2 Private residence Page 181 of 189 Table 69 – Foodborne illness outbreaks attributed to foods served to vulnerable persons State Year Food vehicle Agent Contributing Number Hospitalised factors (CF) affected (deaths) T3 C2 39 Setting prepared NSW 1995 Unknown Suspect S. Infantis NSW 1995 Unknown Unknown U 64 NSW 1996 Eggs flip R3 13 QLD 1996 Sandwiches U 52 TAS 1996 Chicken with gravy T3 32 VIC 1996 Unknown U 2 Childcare NSW 1996 Sandwiches & meat salad U 5 Hospital SA 1996 Chicken (cooked) Salmonella serovars S. Typhimurium C. perfringens E. coli O157 L. monocytogenes L. monocytogenes o1 L. monocytogenes C2 5 unknown (1) Hospital C2 R1 9 unknown (6) Aged-care facility & hospital T3 T4 E1 36 T3 25 U 13 Hospital & MOW 20 Childcare 12 Aged-care facility C1 25 Aged-care facility 8 Childcare 29 Childcare NSW 1997–1999 Fruit salad NSW 1997 Beef casserole VIC 1997 Unknown C. perfringens C. perfringens NSW 1998 Chicken soup Suspect viral NSW 1998 Unknown Norwalk-like virus U S. Virchow PT 34 a VIC 1998 Eggs T1 R1 a NSW 1999 Unknown Norwalk virus QLD 1999 Unknown Unknown U R3 unknown (3) Aged-care facility Aged-care facility 1 unknown (1) Aged-care facility Hospital Aged-care facility Aged-care facility unknown (1) Aged-care facility QLD 1999 Unknown VIC 1999 Oranges Salmonella serovars S. Typhimurium 135a QLD 2000 Egg flip S. Heidelberg pt 1 QLD 2000 Chicken nuggets (suspected) Norwalk virus geno 2 T1 24 Childcare SA 2000 Unknown Cryptosporidiosis U 4 Childcare SA 2000 Unknown Rotavirus U 12 Childcare U (4cx+) SA 2000 Unknown Rotavirus QLD 2001 Unknown Unknown QLD 2001 Unknown S. Muenchen Food Safety Scheme Risk Assessment U unknown 12 Childcare 6 13 Aged-care facility Childcare 19 0 Aged-care facility 3 0 Aged-care facility Page 182 of 189 State Year Food vehicle Agent Contributing factors (CF) QLD 2001 Unknown QLD 2001 QLD 2001 SA 2001 SA 2001 VIC 2001 QLD 2002 Suspect B. cereus QLD 2002 QLD 2002 VIC 2002 VIC 2002 VIC 2002 S. Heidelberg PT 1 S. Heidelberg PT 1 Raw eggs S. Typhimurium 135 Rice pudding, potato pie S. Typhimurium 135 Unknown Campylobacter Eggs white dish (suspected) S. Typhimurium 102 Eggs sandwiches (suspected) S. Typhimurium 135a Eggs sandwiches (suspected S. Typhimurium 135a Rice S. aureus Gravy (suspected) C. perfringens Gravy (suspected) C. perfringens NSW 2003 Chicken schnitzel Unknown a a QLD 2003 Raw eggs (suspected) VIC 2003 Gravy (suspected) S. Typhimurium C. perfringens NSW 2004 Beef curry (suspected) Unknown SA 2004 Unknown SA 2004 Unknown VIC 2004 Unknown S. Typhimurium 126 var Listeria C. perfringens VIC 2004 Unknown Suspected toxin VIC 2004 BBQ (suspected) VIC 2004 VIC Hospitalised affected (deaths) Setting prepared T3 C2 E1 19 12 6 Aged-care facility E1 R3 12 6 Aged-care facility 17 3 Aged-care facility 18 3 Aged-care facility 49 1 Aged-care facility Eggs (suspected) Eggs flip a Number Aged-care facility 12 Aged-care facility 12 0 Childcare 16 0 Childcare 7 Childcare 15 Aged-care facility 23 Aged-care facility 3 3 Hospital 47 16 Aged-care facility 42 DK Aged-care facility 5 5 Hospital 13 0 Aged-care facility 2 2 Hospital 22 1 Aged-care facility 9 1 Aged-care facility 24 2 Aged-care facility Drinking water (suspected) Campylobacter Campylobacter 7 0 Aged-care facility 2004 Unknown Suspected toxin 14 unknown Hospital VIC 2004 Unknown Suspected toxin 21 unknown Hospital QLD 2005 Braised steak and gravy 0 Aged-care facility 2005 Cold meats 3 3 Hospital VIC 2005 Eggs (suspected) 7 2 Aged-care facility NSW 2006 Undercooked chicken C. perfringens Listeria S. Enteritidis 26 var C. jejuni 36 SA 3 3 Aged-care facility Food Safety Scheme Risk Assessment Page 183 of 189 State Year Food vehicle Agent Contributing Number Hospitalised factors (CF) affected (deaths) Setting prepared NSW 2007 Beef sausages (suspected) Unknown 4 Aged-care facility NSW 2007 Tiramisu & cream, fruit salad, Unknown strudel & custard (suspected) 6 Aged-care facility QLD 2007 Unknown 2 Aged-care facility SA 2007 Unknown VIC 2007 VIC 6 Aged-care facility Unknown S. Kiambu Campylobacter S. Typhimurium 44 22 Aged-care facility 2007 Unknown Unknown 17 Aged-care facility VIC 2007 Unknown 6 Aged-care facility VIC 2007 30 Aged-care facility VIC 2007 6 Aged-care facility VIC 2007 3 Aged-care facility VIC 2007 4 Hospital SA 2008 VIC 2008 Campylobacter Several foods were suspected C. perfringens Unknown Campylobacter Unknown S. Saintpaul Unknown S. Typhimurium 9 Vitamised foods S. Typhimurium 135 Unknown C. perfringens WA 2008 Unknown Food Safety Scheme Risk Assessment Norovirus 38 Aged-care facility 6 Aged-care facility 42 Aged-care facility Page 184 of 189 Table 70 – Foodborne illness outbreaks attributed to eggs, egg products and eggs used as an ingredient State Year Food vehicle Agent Contributing Number Hospitalised factors (CF) affected (deaths) Setting prepared VIC 1996 Mayonnaise S. Typhimurium RDNC R1 36 VIC 1997 Pork rolls T1 T3 C2 150 8 Bakery VIC 1997 Pork rolls T1 T3 C2 E1 808 79 Bakery NSW 1998 Curried eggs (suspected) R1 11 NSW 1999 Fish & eggs sauce R1 16 NSW 1999 Curried eggs rolls S. Typhimurium 9 S. Typhimurium 1 S. Typhimurium 135 S. Typhimurium Streptococcus pyogenes Group A B- C1 72 Institution A015 Café Commercial caterer 2 Commercial caterer haemolytic QLD 1999 Tiramisu QLD 1999 Eggs-based dessert S. Typhimurium S. Typhimurium S. Typhimurium S. Typhimurium PT 8 T3 R1 51 Restaurant PT 8 R1 60 Restaurant a 17 Restaurant 22 Takeaway QLD 1999 Hollandaise sauce ACT 2000 Curried eggs or home-made mayonnaise NSW 2000 2000 WA 2000 NSW 2000 SA 2001 SA 2001 S. Typhimurium S. Mbandaka Ice-cream dessert S. Typhimurium Mango mousse S. Typhimurium Custard tarts S. Typhimurium Custard tart with strawberries S. Typhimurium PT 9 QLD 126 9 3 Takeaway NSW 2001 17 11 Restaurant 2001 8 0 Hotel SA 2001 11 4 Private residence TAS 2001 9 6 1 Private residence WA 2001 64 36 4 Restaurant SA 2001 S. Typhimurium S. Montevideo Tiramisu dessert S. Typhimurium Duck eggs whites (suspected) S. Typhimurium Fried ice-cream S. Typhimurium Mango pudding S. Typhimurium 126 QLD 64 var 28 0 Restaurant Fried ice-cream 135 T1 PT 9 T3 R1 C2 E1 41 T3 C2 27 Manufacturer 135 R1 53 Unknown PT 9 C1 40 126 T3 C2 E1 9 Eggs sandwich and a jelly glaze Chicken, mayonnaise Eggs Food Safety Scheme Risk Assessment 135a 2 1 Restaurant Restaurant Bakery Page 185 of 189 State SA Year 2002 Food vehicle Agent S. Typhimurium 99 Deep fried ice-cream S. Typhimurium 9 Vietnamese pork/chicken rolls S. Typhimurium 126 Eggs based dressing S. Potsdam Caesar salad dressing, S. Potsdam Custard and cream cakes Contributing Number Hospitalised factors (CF) affected (deaths) 22 NSW 2002 NSW 2002 NSW 2002 NSW 2002 QLD 2002 Salmon/eggs/onion/rice patties S. Typhimurium 135a 10 QLD 2002 Asparagus egg surprise dish S. Hadar 22 S. Typhimurium 8 S. Typhimurium 135 S. Typhimurium 170 S. Hessarek 3 mayonnaise Setting prepared Bakery 8 Restaurant 32 Bakery 17 Restaurant 12 0 Restaurant Private residence 0 Restaurant SA 2002 Caesar salad VIC 2002 Vietnamese pork rolls VIC 2002 Hedgehog - possibly eggs VIC 2002 Raw egg mayonnaise (suspected) VIC 2002 Caesar salad with raw egg mayonnaise (suspected) S. Typhimurium 135 NSW 2003 Mayonnaise S. Typhimurium NT 2003 Curried eggs sandwiches Norovirus 11 0 Commercial caterer QLD 2003 Sauces based on raw eggs (suspected) S. Typhimurium 18 3 Restaurant QLD 2003 Mousse (suspected) 6 1 Private residence VIC 2003 Pork rolls 213 22 VIC 2003 Raw eggs dishes 52 4 Restaurant NSW 2003 Caesar salad 2 1 Restaurant SA 2003 Cold set cheesecake NSW 2004 Custard NSW 2004 Tiramisu QLD 2004 Custard fruit tarts S. Typhimurium S. Typhimurium S. Typhimurium Campylobacter S. Typhimurium S. Typhimurium S. Typhimurium S. Typhimurium Food Safety Scheme Risk Assessment 4 78 Restaurant 20 Bakery 6 Private residence 3 1 Restaurant 4 0 Restaurant 41 0 Restaurant Bakery 6 1 Community 135 43 17 Institution 126 11 3 Private residence 135a 5 5 Bakery Page 186 of 189 State Year Food vehicle Agent QLD 2004 Japanese rice balls, omelette, Mixed toxins chicken, fish SA 2004 SA 2004 SA Contributing Number Hospitalised factors (CF) affected (deaths) Setting prepared 16 0 Restaurant Home made ice-cream 0 Private residence 4 0 Private residence 2004 S. Typhimurium 9 S. Saintpaul Potato bake, lemon meringue, S. Typhimurium 108 4 Boiled eggs 8 0 Private residence VIC 2004 Sauce - raw eggs (suspected) S. Typhimurium 9 8 1 Café VIC 2004 Eggs (suspected) 11 5 Contaminated primary produce ACT 2005 Hollandaise sauce 5 2 Restaurant NSW 2005 NSW 2005 NSW 2005 NSW 2005 S. Hessarek Raw eggs dishes (suspected) S. Typhimurium Caesar salad dressing S. Typhimurium Pork rolls S. Typhimurium Tiramisu S. Typhimurium NT 2005 Vietnamese pork rolls Unknown QLD 2005 Eggs based filled dumplings S. Typhimurium S. Typhimurium S. Typhimurium S. Typhimurium chicken patty QLD 2005 Eggs and bacon roll TAS 2005 Bakery products TAS 2005 Sauces/dressing containing raw eggs TAS 2005 VIC S. Typhimurium 126 9 16 - Restaurant 44 8 2 Restaurant 9 21 1 Retail 44 7 0 Private residence 5 0 Private residence 13 7 Bakery 197 3 0 Private residence 135 107 6 Bakery 135 11 2 Restaurant Mayonnaise & tartare sauce S. Typhimurium 135 77 2 Restaurant 2005 Pork rolls (suspected) Unknown 6 0 Bakery VIC 2005 Chocolate mousse 14 5 Commercial caterer VIC 2005 Eggs (suspected) VIC 2005 Hollandaise sauce ACT 2006 Free range eggs S. Typhimurium S. Typhimurium S. Typhimurium S. Typhimurium ACT 2006 Free range eggs S. Typhimurium 170 Food Safety Scheme Risk Assessment 44 9 126 var 4 5 0 Private residence 9 13 5 Restaurant 44 4 1 Contaminated primary produce 13 0 Contaminated primary produce Page 187 of 189 State Year Food vehicle Agent NSW 2006 Pikelets made from whole eggs (suspected) S. Potsdam NSW 2006 White chocolate mousse NSW 2006 Plain hamburger cross contaminated with eggs S. Typhimurium 170 S. Montevideo NSW 2006 NSW 2006 NSW 2006 S. Typhimurium 135a Eggs S. Typhimurium 170 Chicken/beef hamburger cross S. Typhimurium 170 SA 2006 SA 2006 SA 2006 Beef burger with bacon & eggs VIC 2006 Eggs (suspected) VIC 2006 VIC 2006 VIC 2007 NSW NSW Contributing Number Hospitalised factors (CF) affected (deaths) Setting prepared 4 0 Childcare 47 32 Institution 3 2 Takeaway 2 1 Takeaway 4 3 Takeaway 3 1 Camp/excursion 15 1 Bakery 7 0 Private residence 5 0 Restaurant S. Typhimurium 44 Milkshake containing raw eggs S. Typhimurium 44 Hazelnut gateau cake made S. Typhimurium 44 43 9 Community 4 4 Private residence 10 1 Private residence Chicken foccacia/raw eggs aioli S. Typhimurium 44 16 2007 Eggnog 2007 Fried ice-cream 12 Restaurant NSW 2007 Vietnamese pork & chicken rolls S. Typhimurium 29 S. Typhimurium 9 S. Typhimurium 9 294 Takeaway QLD 2007 Eggs (suspected) 197 21 Community QLD 2007 Eggs (suspected) 197 3 Restaurant QLD 2007 Eggs (suspected) 197 12 Restaurant QLD 2007 Eggs (suspected) 197 6 Restaurant Eggs (suspected) contaminated with eggs (suspected) S. Typhimurium 9 Homemade ice-cream and ice- S. Typhimurium 108 Eggs through a bakery cream topping S. Anatum with raw eggs mousse filling Food Safety Scheme Risk Assessment S. Typhimurium S. Typhimurium S. Typhimurium S. Typhimurium 3 Restaurant Private residence Page 188 of 189 State Year QLD 2007 TAS 2007 VIC 2007 VIC 2007 VIC 2007 VIC 2007 VIC 2007 VIC 2007 VIC 2007 WA Food vehicle Agent S. Typhimurium Eggs (suspected) S. Typhimurium Pork rolls S. Typhimurium Milkshake includes raw eggs S. Typhimurium Trifle - includes raw eggs S. Typhimurium Tiramisu - include raw eggs S. Typhimurium Chocolate mousse S. Typhimurium Caesar salad dressing includes S. Typhimurium Eggs (suspected) Contributing Number Hospitalised factors (CF) affected (deaths) Setting prepared 197 2 135a 20 Bakery 44 45 Bakery 44 4 Private residence 44 11 Private residence 44 10 Private residence 9 8 Private residence 44 15 Restaurant Eggs used in a undercooked food (risottini) S. Typhimurium 44 13 Restaurant 2007 Caesar salad 75 Restaurant QLD 2007 Cheesecake NSW 2008 Custard cake S. Typhimurium U307 S. Typhimurium 135a S. Typhimurium 170 17 Private residence VIC 2008 Continental custard cake Unknown 21 Commercial caterer S. Typhimurium S. Typhimurium S. Typhimurium S. Typhimurium S. Typhimurium S. Typhimurium S. Typhimurium raw eggs NSW 2008 Eggs NSW 2008 Suspect eggs NSW 2008 Raw eggs dressing TAS 2008 Eggs (suspected) TAS 2008 Eggs (suspected) VIC 2008 Lemon dessert VIC 2008 Eggs (suspected)/custard dessert VIC 2008 Suspect dessert Food Safety Scheme Risk Assessment 126/126 var 1 7 Restaurant Bakery 41 Private residence 135 4 Private residence 126/126 var 1 3 Restaurant 135a 3 Private residence 135a 78 Restaurant 44 12 Private residence 4 Private residence 4 Restaurant 135a S. Typhimurium 44 Page 189 of 189 NSW Food Authority 6 Avenue of the Americas Newington NSW 2127 PO Box 6682 Silverwater NSW 1811 Phone 1300 552 406 Fax 02 9647 0026 www.foodauthority.nsw.gov.au