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The dilemma of regulatory testing of dairy foods in Australia: minimising risk to the public while avoiding unnecessary regulatory burden
26 The dilemma of regulatory testing of dairy foods in Australia: minimising risk to the public while avoiding unnecessary regulatory burden D. W. Eddy and I. N. Haynes, Dairy Food Safety Victoria, Australia
Abstract: For food safety regulators, ensuring that that the public are protected from unsafe food products is a given expectation. But what constitutes being ‘unsafe’? The presence of a microbial pathogen alone does not determine that the product is unsafe. The level of a microbial pathogen and the characteristics of the dairy food in which it is contained will determine whether the microbe will die, survive or be able to grow and reach numbers that could constitute an infectious dose at the point of consumption. Susceptibility of the consumer also plays a significant role in determining whether the product could be determined unsafe. Understanding the circumstances of each case and determining the relative associated risk is an approach that the regulator can take to ensure that risk to the public is minimised, and to avoid unnecessary regulatory burden on industry. Key words: dairy products, risk assessment, strain typing.
26.1
Introduction to the cases
Australia’s dairy industry produces about 9 billion litres of milk each year, of which around 65% comes from the southern state of Victoria (Dairy Australia, 2011). The dairy industry businesses in this state (farms, milk carriers, manufacturers and distributors) are required to be licensed by the statutory authority, Dairy Food Safety Victoria (DFSV). This authority is responsible for ensuring that standards which safeguard public health are maintained in the Victorian dairy industry, whilst ensuring that it performs its functions and exercises its powers efficiently and effectively.
© Woodhead Publishing Limited, 2012
238
Case studies in food safety and authenticity
Within the authority, an Operations team deals with the aspects of licensing the dairy businesses and verifying licensees’ compliance with approved hazard analysis and critical control point (HACCP)-based food safety programs. Uncharacteristic, however, of similar regulatory organisations, DFSV also has a separate Technical team, which provides assistance to the industry through standards interpretation and guidance as well as technical information on industry queries and problems. Over recent years, DFSV has endeavoured to move toward the adoption of a partnership role with the industry. This has been facilitated by the Technical team through providing a broadening of industry knowledge and understanding wherever possible. The compliance and enforcement activities of the Operations team remain a separate stream within DFSV. Regulators will at times come across circumstances where the results of the microbiological testing indicate a failure of the defined Standards for a particular food type. Sometimes, the action to be taken, as required by the regulator, may not be a good reflection of the true level of risk involved. In such circumstances, the manufacturers, especially the smaller artisanal cheese makers, can lose a significant proportion of their income through the costs incurred in having to dispose of the implicated product.
26.2
Significance of the cases
The cases presented in this chapter address some significant questions. Can a boundary be drawn, as distinct from the prescribed Standards, to effectively determine what constitutes an unsafe product? Is it possible to have a pathogenic microbe present and yet still have a safe product? Can strict adherence to prescriptive standards, in circumstances where the actual outcome sought is protection of public health, be moderated so as not to cause small manufacturers excessive financial hardship whilst ensuring public safety? It was considered that, with the advent of cost-effective and reliable molecular identification techniques, it should be possible for regulators to be reassured that any deviations from the prescriptive nature of the regulations are balanced by scientific validation of the effectiveness of food safety programs. This approach also aligns with the concepts used in microbial risk management strategies, whereby food safety objectives (FSO) set at the point of product consumption are more informative than public health standards. 26.2.1 Regulatory aspects Of particular interest to our dairy industry are the pathogens Listeria monocytogenes and Escherichia coli. In Australia, the only stipulated requirement for L. monocytogenes in cheeses is for soft cheese (>39% moisture and >5.0 pH), where the organism must be absent in 25 g of the product (Food Standards Australia New Zealand, 2011a). A user guide document suggests, however, that L. monocytogenes should also be absent in 25 g (or 25 ml) of pasteurised milk and cream, dried milk powder, ice cream and ice cream mixes, and infant formulae
© Woodhead Publishing Limited, 2012
The dilemma of regulatory testing of dairy foods in Australia
239
(Food Standards Australia New Zealand, 2011b). In the state of Victoria, an industry Code of Practice for Dairy Food Safety mandates that all pathogen levels specified in this Guide must be met (Dairy Food Safety Victoria, 2002). It also requires that manufacturers of all dairy products comply with the Australian Manual for Control of Listeria in the Dairy Industry (Australian Dairy Authorities’ Standards Committee, 1999), which involves advising the regulator of detections, and initiating clearance and corrective action procedures. The Food Standards Code Standard 1.6.1 clause 5 also requires that all cheese products be tested for E. coli, which may be present (at a level above 10, but less than 100/g) in no more than one of the mandatory five samples tested. Most E. coli organisms appear to exist as harmless commensals, and of no threat to human health (Donnenberg and Whittam, 2001). However, we contend that the emergence of particularly pathogenic strains of E. coli causing major outbreaks of illness throughout the food industry in recent years clearly indicate that the need to test for E. coli is still warranted. 26.2.2 Utilising technology to identify bacterial strains Hazards exist in all aspects of life. The level of those hazards in the specific circumstances will determine what degree of risk is present. Determining the boundary between the point where the public is exposed to undue risk and the point where the level of risk is so low that the chance should be permitted remains problematic. The victorian dairy industry has progressed from a quality control system to a quality assurance system over the last 25 years. However, when verification testing of a quality assurance process indicates that contamination has occurred, the prescriptive basis of a quality control system seems to take over. The nature of quality assurance means that each unit process and step within the production system has controls applied to it in order to prevent any problems from occurring. If end-product testing indicates that contamination is present, it is highly unlikely that every step of the process has failed. It is most likely that only one step has an issue that allowed the contamination to occur. The resulting contamination is most likely to be confined to a small range of unwanted organisms. If tests can be undertaken to demonstrate that they are limited in diversity and not pathogenic, then consideration should be given to including a risk analysis of this in the overall assessment for accepting or rejecting the product.
26.3 The case histories continue 26.3.1 L. monocytogenes in cheese for the pizza market In 2009, DFSV commenced working with the official public health microbiological laboratory, the Microbiological Diagnostic Unit (MDU) at the University of Melbourne, to apply genetic typing to all strains of L. monocytogenes isolated from dairy product samples. This same laboratory performs the typing of isolates detected in human cases of illness. The tests being applied included pulsed-field
© Woodhead Publishing Limited, 2012
240
Case studies in food safety and authenticity
gel electrophoresis (PFGE), ribotyping, binary typing, molecular serotyping and multi-locus sequence typing (MLST). The combination of these methods is providing a basis for determining if more rapid methods can match the PFGE method for reliable differentiation between strains. Around the same time, a manufacturer licensed with DFSV was experiencing intermittent detections (present in 25 g) of L. monocytogenes in shredded semihard to hard cheese varieties that were destined for the pizza market. Efforts to quantify the level of contamination repeatedly came back with a result of ‘not detected’ (<10/g). Given that this product was to undergo further heat treatment in a pizza oven at around 180 °C for some minutes and the compositional parameters (pH and Aw) of the product, risk analysis by DFSV in this case indicated that the likelihood of survival of any L. monocytogenes present would be remote. The possibility of the bacteria surviving at levels which could constitute an infectious dose if the product was consumed would be unlikely. The health department, ultimately responsible for taking the regulatory decision with respect to this food product, responded to this situation strictly in the only way possible according to the prescribed legislative requirements, and required that the product not be released for sale. This resulted in many tonnes of product being destroyed. The specific L. monocytogenes strain isolated in this case by the testing laboratory was submitted for molecular typing by the range of tests being applied at that time. The subsequent result indicated that this particular dairy isolated strain had not been linked with human illness (personal communication). Since that time in 2009, other closely related strain isolations from this same manufacturing facility have occurred. All occurrences have been responded to, but the particular strain(s) involved have not yet been linked to cases of human illness. In almost 3 years, since the molecular fingerprinting project was initiated, there have been approximately 150 samples of dairy product, mainly further processed (cut, shredded or grated) hard cheese, that have tested positive for the presence of L. monocytogenes. Interestingly, in these types of product, L. monocytogenes is not expected to grow due to pH and water activity hurdles, and will most probably die out slowly. The effectiveness of the HACCP-based food safety programs implemented by manufacturers has indicated that the overall production and processing systems in place are able to produce safe product. Whilst the possibility of L. monocytogenes contaminating a product is low, the capability of it being detected in qualitative testing (presence in 25 g of product) remains relatively good. The results of industry contaminations, however, indicate that the possibility of being able to quantify the level of L. monocytogenes contamination from a qualitative positive sample is very low given that the vast majority of quantitative testing yields a negative result. 26.3.2 The application of qualitative risk assessment Whether these low-level contaminations constitute sufficient risk still needs to be determined. None of the molecular fingerprints from these ‘dairy’ isolates match
© Woodhead Publishing Limited, 2012
The dilemma of regulatory testing of dairy foods in Australia
241
any strain of L. monocytogenes that has been responsible for human illness cases over that period of time. This suggests that, whilst a product may contain very low levels of pathogenic microbes, this is not necessarily an indication of the likelihood of the product to cause illness in the consumer. In order to support this understanding, DFSV has recently undertaken to develop an approach to enable the application of a qualitative risk assessment to each case where a dairy product test result indicates contamination with a pathogen that contravenes the prescriptive requirements of the Australian Food Standards Code. The specific circumstances of the detection, the product composition and batch details, units produced and likely use of the product are all considered in this assessment. In each case, the results of this qualitative risk assessment, and the recommended actions, have then been passed on to the state Department of Health, which is ultimately responsible for declaring whether the product may be released for sale or must be withdrawn or recalled if already on the market. This process has resulted in closer communications and an increasing level of trust developing between the dairy authority and the health department, which has proven to be a very good means for knowledge sharing. 26.3.3 E. coli in cheese In another incident, a small cheese-maker received results of E. coli testing that indicated that the product was over the limit set by the product standard. In this instance, the product was required to be destroyed and not offered for sale. Subsequent testing that our Authority commissioned with a university indicated that only one E. coli strain was identical throughout the product and that it was not a pathogenic type. In this instance, knowledge of this additional information would have offered the potential for a manufacturer to understand that corrective action needs to be undertaken, but that the product does not constitute a health risk to the consumer. The potential for additional information to be used to confirm or refute a claim as to whether a product is unsafe should be more fully investigated.
26.4
Resolutions and outcomes
Food safety standards are written to provide levels for microbial pathogens that producers and processors need to confirm products comply with in order to ensure the products are safe to consume. Our work indicates that a prescriptive approach can sometimes place an unfair burden on a manufacturer. Our focus is always to ensure public health and safety, but, where the application of reliable new technology enables greater understanding of the actual risk, we should consider being more flexible in our overall approach. All dairy businesses in Australia are required to have HACCP-based food safety programs (FSP) in place. These FSP ensure that safety and quality parameters that are required for the protection of consumers are managed within the production and processing environment. Regulators protect the consumer by
© Woodhead Publishing Limited, 2012
242
Case studies in food safety and authenticity
ensuring that the approved food safety system will result in safe product and that no unsafe product reaches the market. There is also a role for the regulator in assisting in the education of manufacturers to reduce the likelihood of adverse food safety incidents. It is clearly recognised that the detection of potential pathogens in dairy products indicates that there has been a breakdown in the food safety system of the manufacturer concerned. Immediate remedial action is required to establish the facts, identify the reason for the contamination, and implement corrective actions to prevent a possible recurrence. When regulators can apply a flexible approach using appropriate tools and work cooperatively with the manufacturer, problems are often resolved more efficiently than would otherwise have been the case. Such an approach also increases overall knowledge which can be applied more broadly. This helps management focus on the causes, rather than just eliminating the immediate problem.
26.5
Commentary
Whilst standards exist to protect public health and safety, they tend to be general in scope and not always applicable to each and every product in the category for which they are written. They should be flexible enough in their application to recognise the benefit of additional information and the specific circumstances that may influence whether a food product is indeed unsafe. Large manufacturers may have the resources and time to conduct further testing to show that, under a given set of circumstances, a product that may contravene the standard does not represent a risk to the consumer. The application of additional testing and research may greatly assist the industry and the regulator to better understand where to draw the ‘line in the sand’ between safe and unsafe product. But small to medium food businesses are highly unlikely to have this resource capability. Whilst there is clearly a need to ensure that products do not have pathogenic E. coli present, it is somewhat detrimental to industry if the presence of non-pathogenic E. coli demands removal of that product. The role of the regulator is to apply controls where risks exist, not necessarily to apply a simple approach that makes regulatory decisions easier to implement. Modern genetic testing methods are becoming more reliable, rapid and costeffective; making greater use of these tools in regulatory decision-making would appear to be warranted. Regulators and standards authorities should consider whether access to additional testing might provide greater clarity in their decision-making process.
26.6
Critical questions for discussion
1. Should set standard criteria apply equally to all products without consideration of product variation or degrees of safety to individuals?
© Woodhead Publishing Limited, 2012
The dilemma of regulatory testing of dairy foods in Australia
243
2. What types of microbiological or genetic testing could be applied to provide greater definition to regulators between which products are safe or unsafe to the consumer when investigating qualitative product contaminations? 3. Should any additional testing process be able to benefit the business if results indicate that contamination is not from a pathogenic strain? 4. Should a manufacturer be able to claim losses against a regulator for the ordered destruction of product that may ultimately prove not to have been unsafe? 5. The question has been raised as to whether E. coli, as an indicator organism, should be removed from standards or regulations. Does having to test for E. coli within industry any longer serve a purpose?
26.7
References
(1999). Australian Manual for the Control of Listeria in the Dairy Industry (Listeria Manual). Available at http://www. dairysafe.vic.gov.au/. DAIRY AUSTRALIA (2011). Latest Production and Sales Statistics. Available at http://www. dairyaustralia.com.au/Statistics-and-markets/Production-and-sales/Latest-Statistics. aspx. DAIRY FOOD SAFETY VICTORIA (2002). Code of Practice for Dairy Food Safety. Section 5.3: Standards. Available at www.dairysafe.vic.gov.au/pdf/DFSV_CodeOfPractice2002.pdf. DONNENBERG M.S., and WHITTAM T.S. (2001). Pathogenesis and evolution of virulence in enteropathogenic and enterohemorrhagic Escherichia coli. Journal of Clinical Investigation, 107(5), 539–48. FOOD STANDARDS AUSTRALIA NEW ZEALAND (2011a). Food Standards Code (2011) Standard 1.6.1, Clause 5 – Microbiological Limits for Food. Available at www.foodstandards.gov. au/thecode/foodstandardscode.cfm. FOOD STANDARDS AUSTRALIA NEW ZEALAND (2011b). User Guides to the New Food Standards Code (2011) User Guide to Standard 1.6.1 – Microbiological Limits for Food. Available at www.foodstandards.gov.au/thecode/assistanceforindustry/userguides/index.cfm. AUSTRALIAN DAIRY AUTHORITIES’ STANDARDS COMMITTEE
© Woodhead Publishing Limited, 2012
Abstract: For food safety regulators, ensuring that that the public are protected from unsafe food products is a given expectation. But what constitutes being ‘unsafe’? The presence of a microbial pathogen alone does not determine that the product is unsafe. The level of a microbial pathogen and the characteristics of the dairy food in which it is contained will determine whether the microbe will die, survive or be able to grow and reach numbers that could constitute an infectious dose at the point of consumption. Susceptibility of the consumer also plays a significant role in determining whether the product could be determined unsafe. Understanding the circumstances of each case and determining the relative associated risk is an approach that the regulator can take to ensure that risk to the public is minimised, and to avoid unnecessary regulatory burden on industry. Key words: dairy products, risk assessment, strain typing.
26.1
Introduction to the cases
Australia’s dairy industry produces about 9 billion litres of milk each year, of which around 65% comes from the southern state of Victoria (Dairy Australia, 2011). The dairy industry businesses in this state (farms, milk carriers, manufacturers and distributors) are required to be licensed by the statutory authority, Dairy Food Safety Victoria (DFSV). This authority is responsible for ensuring that standards which safeguard public health are maintained in the Victorian dairy industry, whilst ensuring that it performs its functions and exercises its powers efficiently and effectively.
© Woodhead Publishing Limited, 2012
238
Case studies in food safety and authenticity
Within the authority, an Operations team deals with the aspects of licensing the dairy businesses and verifying licensees’ compliance with approved hazard analysis and critical control point (HACCP)-based food safety programs. Uncharacteristic, however, of similar regulatory organisations, DFSV also has a separate Technical team, which provides assistance to the industry through standards interpretation and guidance as well as technical information on industry queries and problems. Over recent years, DFSV has endeavoured to move toward the adoption of a partnership role with the industry. This has been facilitated by the Technical team through providing a broadening of industry knowledge and understanding wherever possible. The compliance and enforcement activities of the Operations team remain a separate stream within DFSV. Regulators will at times come across circumstances where the results of the microbiological testing indicate a failure of the defined Standards for a particular food type. Sometimes, the action to be taken, as required by the regulator, may not be a good reflection of the true level of risk involved. In such circumstances, the manufacturers, especially the smaller artisanal cheese makers, can lose a significant proportion of their income through the costs incurred in having to dispose of the implicated product.
26.2
Significance of the cases
The cases presented in this chapter address some significant questions. Can a boundary be drawn, as distinct from the prescribed Standards, to effectively determine what constitutes an unsafe product? Is it possible to have a pathogenic microbe present and yet still have a safe product? Can strict adherence to prescriptive standards, in circumstances where the actual outcome sought is protection of public health, be moderated so as not to cause small manufacturers excessive financial hardship whilst ensuring public safety? It was considered that, with the advent of cost-effective and reliable molecular identification techniques, it should be possible for regulators to be reassured that any deviations from the prescriptive nature of the regulations are balanced by scientific validation of the effectiveness of food safety programs. This approach also aligns with the concepts used in microbial risk management strategies, whereby food safety objectives (FSO) set at the point of product consumption are more informative than public health standards. 26.2.1 Regulatory aspects Of particular interest to our dairy industry are the pathogens Listeria monocytogenes and Escherichia coli. In Australia, the only stipulated requirement for L. monocytogenes in cheeses is for soft cheese (>39% moisture and >5.0 pH), where the organism must be absent in 25 g of the product (Food Standards Australia New Zealand, 2011a). A user guide document suggests, however, that L. monocytogenes should also be absent in 25 g (or 25 ml) of pasteurised milk and cream, dried milk powder, ice cream and ice cream mixes, and infant formulae
© Woodhead Publishing Limited, 2012
The dilemma of regulatory testing of dairy foods in Australia
239
(Food Standards Australia New Zealand, 2011b). In the state of Victoria, an industry Code of Practice for Dairy Food Safety mandates that all pathogen levels specified in this Guide must be met (Dairy Food Safety Victoria, 2002). It also requires that manufacturers of all dairy products comply with the Australian Manual for Control of Listeria in the Dairy Industry (Australian Dairy Authorities’ Standards Committee, 1999), which involves advising the regulator of detections, and initiating clearance and corrective action procedures. The Food Standards Code Standard 1.6.1 clause 5 also requires that all cheese products be tested for E. coli, which may be present (at a level above 10, but less than 100/g) in no more than one of the mandatory five samples tested. Most E. coli organisms appear to exist as harmless commensals, and of no threat to human health (Donnenberg and Whittam, 2001). However, we contend that the emergence of particularly pathogenic strains of E. coli causing major outbreaks of illness throughout the food industry in recent years clearly indicate that the need to test for E. coli is still warranted. 26.2.2 Utilising technology to identify bacterial strains Hazards exist in all aspects of life. The level of those hazards in the specific circumstances will determine what degree of risk is present. Determining the boundary between the point where the public is exposed to undue risk and the point where the level of risk is so low that the chance should be permitted remains problematic. The victorian dairy industry has progressed from a quality control system to a quality assurance system over the last 25 years. However, when verification testing of a quality assurance process indicates that contamination has occurred, the prescriptive basis of a quality control system seems to take over. The nature of quality assurance means that each unit process and step within the production system has controls applied to it in order to prevent any problems from occurring. If end-product testing indicates that contamination is present, it is highly unlikely that every step of the process has failed. It is most likely that only one step has an issue that allowed the contamination to occur. The resulting contamination is most likely to be confined to a small range of unwanted organisms. If tests can be undertaken to demonstrate that they are limited in diversity and not pathogenic, then consideration should be given to including a risk analysis of this in the overall assessment for accepting or rejecting the product.
26.3 The case histories continue 26.3.1 L. monocytogenes in cheese for the pizza market In 2009, DFSV commenced working with the official public health microbiological laboratory, the Microbiological Diagnostic Unit (MDU) at the University of Melbourne, to apply genetic typing to all strains of L. monocytogenes isolated from dairy product samples. This same laboratory performs the typing of isolates detected in human cases of illness. The tests being applied included pulsed-field
© Woodhead Publishing Limited, 2012
240
Case studies in food safety and authenticity
gel electrophoresis (PFGE), ribotyping, binary typing, molecular serotyping and multi-locus sequence typing (MLST). The combination of these methods is providing a basis for determining if more rapid methods can match the PFGE method for reliable differentiation between strains. Around the same time, a manufacturer licensed with DFSV was experiencing intermittent detections (present in 25 g) of L. monocytogenes in shredded semihard to hard cheese varieties that were destined for the pizza market. Efforts to quantify the level of contamination repeatedly came back with a result of ‘not detected’ (<10/g). Given that this product was to undergo further heat treatment in a pizza oven at around 180 °C for some minutes and the compositional parameters (pH and Aw) of the product, risk analysis by DFSV in this case indicated that the likelihood of survival of any L. monocytogenes present would be remote. The possibility of the bacteria surviving at levels which could constitute an infectious dose if the product was consumed would be unlikely. The health department, ultimately responsible for taking the regulatory decision with respect to this food product, responded to this situation strictly in the only way possible according to the prescribed legislative requirements, and required that the product not be released for sale. This resulted in many tonnes of product being destroyed. The specific L. monocytogenes strain isolated in this case by the testing laboratory was submitted for molecular typing by the range of tests being applied at that time. The subsequent result indicated that this particular dairy isolated strain had not been linked with human illness (personal communication). Since that time in 2009, other closely related strain isolations from this same manufacturing facility have occurred. All occurrences have been responded to, but the particular strain(s) involved have not yet been linked to cases of human illness. In almost 3 years, since the molecular fingerprinting project was initiated, there have been approximately 150 samples of dairy product, mainly further processed (cut, shredded or grated) hard cheese, that have tested positive for the presence of L. monocytogenes. Interestingly, in these types of product, L. monocytogenes is not expected to grow due to pH and water activity hurdles, and will most probably die out slowly. The effectiveness of the HACCP-based food safety programs implemented by manufacturers has indicated that the overall production and processing systems in place are able to produce safe product. Whilst the possibility of L. monocytogenes contaminating a product is low, the capability of it being detected in qualitative testing (presence in 25 g of product) remains relatively good. The results of industry contaminations, however, indicate that the possibility of being able to quantify the level of L. monocytogenes contamination from a qualitative positive sample is very low given that the vast majority of quantitative testing yields a negative result. 26.3.2 The application of qualitative risk assessment Whether these low-level contaminations constitute sufficient risk still needs to be determined. None of the molecular fingerprints from these ‘dairy’ isolates match
© Woodhead Publishing Limited, 2012
The dilemma of regulatory testing of dairy foods in Australia
241
any strain of L. monocytogenes that has been responsible for human illness cases over that period of time. This suggests that, whilst a product may contain very low levels of pathogenic microbes, this is not necessarily an indication of the likelihood of the product to cause illness in the consumer. In order to support this understanding, DFSV has recently undertaken to develop an approach to enable the application of a qualitative risk assessment to each case where a dairy product test result indicates contamination with a pathogen that contravenes the prescriptive requirements of the Australian Food Standards Code. The specific circumstances of the detection, the product composition and batch details, units produced and likely use of the product are all considered in this assessment. In each case, the results of this qualitative risk assessment, and the recommended actions, have then been passed on to the state Department of Health, which is ultimately responsible for declaring whether the product may be released for sale or must be withdrawn or recalled if already on the market. This process has resulted in closer communications and an increasing level of trust developing between the dairy authority and the health department, which has proven to be a very good means for knowledge sharing. 26.3.3 E. coli in cheese In another incident, a small cheese-maker received results of E. coli testing that indicated that the product was over the limit set by the product standard. In this instance, the product was required to be destroyed and not offered for sale. Subsequent testing that our Authority commissioned with a university indicated that only one E. coli strain was identical throughout the product and that it was not a pathogenic type. In this instance, knowledge of this additional information would have offered the potential for a manufacturer to understand that corrective action needs to be undertaken, but that the product does not constitute a health risk to the consumer. The potential for additional information to be used to confirm or refute a claim as to whether a product is unsafe should be more fully investigated.
26.4
Resolutions and outcomes
Food safety standards are written to provide levels for microbial pathogens that producers and processors need to confirm products comply with in order to ensure the products are safe to consume. Our work indicates that a prescriptive approach can sometimes place an unfair burden on a manufacturer. Our focus is always to ensure public health and safety, but, where the application of reliable new technology enables greater understanding of the actual risk, we should consider being more flexible in our overall approach. All dairy businesses in Australia are required to have HACCP-based food safety programs (FSP) in place. These FSP ensure that safety and quality parameters that are required for the protection of consumers are managed within the production and processing environment. Regulators protect the consumer by
© Woodhead Publishing Limited, 2012
242
Case studies in food safety and authenticity
ensuring that the approved food safety system will result in safe product and that no unsafe product reaches the market. There is also a role for the regulator in assisting in the education of manufacturers to reduce the likelihood of adverse food safety incidents. It is clearly recognised that the detection of potential pathogens in dairy products indicates that there has been a breakdown in the food safety system of the manufacturer concerned. Immediate remedial action is required to establish the facts, identify the reason for the contamination, and implement corrective actions to prevent a possible recurrence. When regulators can apply a flexible approach using appropriate tools and work cooperatively with the manufacturer, problems are often resolved more efficiently than would otherwise have been the case. Such an approach also increases overall knowledge which can be applied more broadly. This helps management focus on the causes, rather than just eliminating the immediate problem.
26.5
Commentary
Whilst standards exist to protect public health and safety, they tend to be general in scope and not always applicable to each and every product in the category for which they are written. They should be flexible enough in their application to recognise the benefit of additional information and the specific circumstances that may influence whether a food product is indeed unsafe. Large manufacturers may have the resources and time to conduct further testing to show that, under a given set of circumstances, a product that may contravene the standard does not represent a risk to the consumer. The application of additional testing and research may greatly assist the industry and the regulator to better understand where to draw the ‘line in the sand’ between safe and unsafe product. But small to medium food businesses are highly unlikely to have this resource capability. Whilst there is clearly a need to ensure that products do not have pathogenic E. coli present, it is somewhat detrimental to industry if the presence of non-pathogenic E. coli demands removal of that product. The role of the regulator is to apply controls where risks exist, not necessarily to apply a simple approach that makes regulatory decisions easier to implement. Modern genetic testing methods are becoming more reliable, rapid and costeffective; making greater use of these tools in regulatory decision-making would appear to be warranted. Regulators and standards authorities should consider whether access to additional testing might provide greater clarity in their decision-making process.
26.6
Critical questions for discussion
1. Should set standard criteria apply equally to all products without consideration of product variation or degrees of safety to individuals?
© Woodhead Publishing Limited, 2012
The dilemma of regulatory testing of dairy foods in Australia
243
2. What types of microbiological or genetic testing could be applied to provide greater definition to regulators between which products are safe or unsafe to the consumer when investigating qualitative product contaminations? 3. Should any additional testing process be able to benefit the business if results indicate that contamination is not from a pathogenic strain? 4. Should a manufacturer be able to claim losses against a regulator for the ordered destruction of product that may ultimately prove not to have been unsafe? 5. The question has been raised as to whether E. coli, as an indicator organism, should be removed from standards or regulations. Does having to test for E. coli within industry any longer serve a purpose?
26.7
References
(1999). Australian Manual for the Control of Listeria in the Dairy Industry (Listeria Manual). Available at http://www. dairysafe.vic.gov.au/. DAIRY AUSTRALIA (2011). Latest Production and Sales Statistics. Available at http://www. dairyaustralia.com.au/Statistics-and-markets/Production-and-sales/Latest-Statistics. aspx. DAIRY FOOD SAFETY VICTORIA (2002). Code of Practice for Dairy Food Safety. Section 5.3: Standards. Available at www.dairysafe.vic.gov.au/pdf/DFSV_CodeOfPractice2002.pdf. DONNENBERG M.S., and WHITTAM T.S. (2001). Pathogenesis and evolution of virulence in enteropathogenic and enterohemorrhagic Escherichia coli. Journal of Clinical Investigation, 107(5), 539–48. FOOD STANDARDS AUSTRALIA NEW ZEALAND (2011a). Food Standards Code (2011) Standard 1.6.1, Clause 5 – Microbiological Limits for Food. Available at www.foodstandards.gov. au/thecode/foodstandardscode.cfm. FOOD STANDARDS AUSTRALIA NEW ZEALAND (2011b). User Guides to the New Food Standards Code (2011) User Guide to Standard 1.6.1 – Microbiological Limits for Food. Available at www.foodstandards.gov.au/thecode/assistanceforindustry/userguides/index.cfm. AUSTRALIAN DAIRY AUTHORITIES’ STANDARDS COMMITTEE
© Woodhead Publishing Limited, 2012