apter PO BOX A 2613 Dr Ir Taco Wijtzes Sydney South Wijtzes Food Consultancy Australia Dr Schoyerstraat 52 4205 KZ Gorinchem The Netherlands Tel:+61(0)292955777 Fax:+61(0)292612434 Tel:+3l(0183614334 E-mail Fax:+31(0)183617414 chris. chan @safefood. nsw.gov.au E-mail: Wijtzes( @ foodconsult nl apter Chapter 11 R Gaze.R. Betts and dr mike Dr Tom ross chool of Agricultural Science Campden Chorleywood Food University of Tasmania Research Association Group GPO Box 252-54 Chipping Campden GL55 6LD Gloucestershire Tasmania 7001 England Tel:+44(0)1386842000 Tel:+61(0362261831l Fax:+44(0)1386842100 Fax:+61(0)362262642 E-mail: rgaze(@campden. co uk E-mail: tom ross autas. edu. au r.betts@campden. co uk m.stringer@campden. co uk Mr chris chan Safe Food Production NSw
Chapter 10 Dr Ir Taco Wijtzes Wijtzes Food Consultancy Dr Scho¨yerstraat 52 4205 KZ Gorinchem The Netherlands Tel: +31 (0)183 614334 Fax: +31 (0)183 617414 E-mail: Wijtzes@foodconsult.nl Chapter 11 Dr Tom Ross School of Agricultural Science University of Tasmania GPO Box 252-54 Hobart Tasmania 7001 Australia Tel: +61 (0) 3 62 26 1831 Fax: +61 (0) 3 62 26 2642 E-mail: tom.ross@utas.edu.au Mr Chris Chan Safe Food Production NSW PO Box A 2613 Sydney South NSW 1235 Australia Tel: +61 (0) 2 9295 5777 Fax: +61 (0) 2 9261 2434 E-mail: chris.chan@safefood.nsw.gov.au Chapter 12 R. Gaze, R. Betts and Dr Mike Stringer Campden & Chorleywood Food Research Association Group Chipping Campden GL55 6LD Gloucestershire England Tel: +44 (0) 1386 842000 Fax: +44 (0) 1386 842100 E-mail: r.gaze@campden.co.uk r.betts@campden.co.uk m.stringer@campden.co.uk Contributors xiii
reface Complete elimination of risk from food manufacture and consumption is an impossible goal, but risk reduction is an essential part of every food producers responsibility to protect both its customers and its business. Risk reduction is necessary because the term risk is never applied to good events. This book presents microbiological risk analysis (MRA)concepts, principles and techniques to help the reader understand and use them for managing food safety Theoretical studies and research work in the area of risk have provided powerful analytical tools for dealing with microbiological and epidemiological information, reaching and communicating decisions and then taking preventa- tive actions that are appropriate to the hazard, consumers and the intended use of the product. The use of a range of indirect assessment tools as explained in the chapters of this book is necessary because risk cannot be directly measured; it can only be calculated, based on data indicating probability and type of hazard Many of the techniques available have their roots in risk assessment in other fields, the chapter authors have refined their application to microbiological risk assessment. Similarly many international organisations(e.g. World Health Organisation, Codex Alimentarius, International Life Sciences Institute and the International Commission on Microbiological Specifications for Foods)are also cussing these tools on microbiological hazards, whilst also trying to maintain niformity in risk-based approaches to protecting all aspects of public health, so that it is evident to consumers that chemical and microbiological hazards are assessed in the same way The performance of MRA will always be limited by the availability of data In spite of this, informal risk assessments leading to management actions are taken every day based on expert opinion and assumptions that cannot be validated. Part of the function of this book is to highlight the benefits of formal
Complete elimination of risk from food manufacture and consumption is an impossible goal, but risk reduction is an essential part of every food producer’s responsibility to protect both its customers and its business. Risk reduction is necessary because the term risk is never applied to good events. This book presents microbiological risk analysis (MRA) concepts, principles and techniques to help the reader understand and use them for managing food safety. Theoretical studies and research work in the area of risk have provided powerful analytical tools for dealing with microbiological and epidemiological information, reaching and communicating decisions and then taking preventative actions that are appropriate to the hazard, consumers and the intended use of the product. The use of a range of indirect assessment tools as explained in the chapters of this book is necessary because risk cannot be directly measured; it can only be calculated, based on data indicating probability and type of hazard. Many of the techniques available have their roots in risk assessment in other fields; the chapter authors have refined their application to microbiological risk assessment. Similarly many international organisations (e.g. World Health Organisation, Codex Alimentarius, International Life Sciences Institute and the International Commission on Microbiological Specifications for Foods) are also focussing these tools on microbiological hazards, whilst also trying to maintain uniformity in risk-based approaches to protecting all aspects of public health, so that it is evident to consumers that chemical and microbiological hazards are assessed in the same way. The performance of MRA will always be limited by the availability of data. In spite of this, informal risk assessments leading to management actions are taken every day based on expert opinion and assumptions that cannot be validated. Part of the function of this book is to highlight the benefits of formal Preface
xvi Preface risk analysis systems and encourage risk managers to ensure that transparent and unbiased risk assessment processes and the best available data are used for decision making. As part of this process, uncertainties and variability or imperfections in data should be clearly identified and taken into account by decisions. Methods for doing this are explained. Potential users of MRa rightly xpect the technique to produce results that they can use to suggest controls and improvements at costs that their products can bear and their consumers accept Use of formal MRA systems will increase the chances of achieving this; but performance will always be limited by the availability of information for the risk assessment. It should be within the capabilities of anyone undertaking a risk assessment to identify hazards and generate reliable supply chain data for the exposure assessment, the weak link may lie in providing hazard characteris- tions appropriate to consumers. As foods and drinks are increasingly tailored for specific consumer groups it is important that we have a better knowledge of the relationship between exposure to a particular hazard and the severity of associated adverse health effects Governmental management of food safety is changing on a global basis to meet the challenge of changing patterns in the food trade, such as globalisation of the food supply. In the near future, there is the challenge of how MRa will lead to the establishment of food safety objectives, providing an appropriate level of protection and how this will impinge on industrial food safety management practices such as HACCP. Independent, consumer focussed national(e.g. UK Food Standards Agency) and regional authorities(e.g European Food Safety Authority) have been established and they are seeking common ways of working. Never before has the requirement for absolute transparency in the decision-making process behind food safety management policy been so necessary. The three components of risk analysis suggested by Codex Alimentarius - assessment. communication and management are now accepted tools for reaching supportable decisions on public health policy, risk anagement strategies and preventative measures. To be credible, such decision making has to be based on the available science and take account of political economic and other factors that may alter local perception of a risk. Additionally the techniques have far wider application at the food production level. For communicating and managing risks at the plant level by providing material for improved hazard analyses and providing information to help trading partners and consumers make informed choices The topic of risk is frequently examined by the media, who often dwell or knowledge of a new hazard or a change in risk to the extent that many consumers feel that they face more risks from food today than in the past and producers feel that changes in the trading environment and consumer preference introduce new hazards and increased levels of risk. This book only deals with the technical analysis of risk; the topics of risk perception and acceptable risk are not covered because expertise in mra does not yet exist to address these issues. The best that can be produced by risk assessors is a technically justifiable evaluation of real(rather than perceived)risks, with uncertainty and variability
risk analysis systems and encourage risk managers to ensure that transparent and unbiased risk assessment processes and the best available data are used for decision making. As part of this process, uncertainties and variability or imperfections in data should be clearly identified and taken into account by decisions. Methods for doing this are explained. Potential users of MRA rightly expect the technique to produce results that they can use to suggest controls and improvements at costs that their products can bear and their consumers accept. Use of formal MRA systems will increase the chances of achieving this; but performance will always be limited by the availability of information for the risk assessment. It should be within the capabilities of anyone undertaking a risk assessment to identify hazards and generate reliable supply chain data for the exposure assessment, the weak link may lie in providing hazard characterisations appropriate to consumers. As foods and drinks are increasingly ‘tailored’ for specific consumer groups it is important that we have a better knowledge of the relationship between exposure to a particular hazard and the severity of any associated adverse health effects. Governmental management of food safety is changing on a global basis to meet the challenge of changing patterns in the food trade, such as globalisation of the food supply. In the near future, there is the challenge of how MRA will lead to the establishment of food safety objectives, providing an appropriate level of protection and how this will impinge on industrial food safety management practices such as HACCP. Independent, consumer focussed national (e.g. UK Food Standards Agency) and regional authorities (e.g. European Food Safety Authority) have been established and they are seeking common ways of working. Never before has the requirement for absolute transparency in the decision-making process behind food safety management policy been so necessary. The three components of risk analysis suggested by Codex Alimentarius – assessment, communication and management are now accepted tools for reaching supportable decisions on public health policy, risk management strategies and preventative measures. To be credible, such decision making has to be based on the available science and take account of political, economic and other factors that may alter local perception of a risk. Additionally the techniques have far wider application at the food production level. For communicating and managing risks at the plant level by providing material for improved hazard analyses and providing information to help trading partners and consumers make informed choices. The topic of risk is frequently examined by the media, who often dwell on knowledge of a new hazard or a change in risk to the extent that many consumers feel that they face more risks from food today than in the past and producers feel that changes in the trading environment and consumer preference introduce new hazards and increased levels of risk. This book only deals with the technical analysis of risk; the topics of risk perception and acceptable risk are not covered because expertise in MRA does not yet exist to address these issues. The best that can be produced by risk assessors is a technically justifiable evaluation of real (rather than perceived) risks, with uncertainty and variability xvi Preface
Preface xvii clearly explained. Microbiologists cannot handle perceived risks because every consumer is different and each one perceives hazards and risks differently making it difficult to reach valid conclusions. Risk assessment can however improve the performance of risk management tools, such as HACCP, and this is well illustrated by the chapters Risk analysis is focused on microbiological safety because injuries and deaths d by food have the most serious implications possible for a country or business(e.g. BSE), it is very difficult to fully quantify the costs of consumer compensation or liability in defining the implications of safety management failures. Often these costs are borne centrally, whereas risk management decisions are made at the local level. Closer commercial links between suppliers and retailers and users of products has resulted in a need for much closer control and management of food hygiene and safety. This book is aimed at helping risk managers take a wider view of systems and techniques, so that they can directly contribute to the success of their business or agency. Different products have different hazards and different consumers different sensitivities and this must be considered by risk assessor and risk manager in developing risk cost effectiv management procedures The most serious long-term consequence of a safety failure for a food business is a decision by consumers to change their eating habits, risk modification is an action everybody takes to some extent. An unpredictable change in eating habits, because of unidentified or uncontrolled hazards can destroy the value of a business. Therefore decisions between course of action available to a risk manager, including providing information to consumers must be guided by the best information(risk assessment)and the most transparent procedures available - risk management and communication. A comprehensive MRa provides a framework from which the potential effectiveness of different intervention or mitigation strategies for risk management can be assessed thus enabling more scientifically robust decision making. Users of this book need to remember that risk analysis deals with real events and real consequences and that people(e.g. consumers and plant staff and management)are an integral part of the process of assessment and management. Mra should be used for decision making or trade-offs, limited by acceptable risk on one hand and consumer preference on the other. No magic words or infallible techniques exist in this rea,this book only provides access to the existing tools and sources of information Martyn Brown and Mike Stringer
clearly explained. Microbiologists cannot handle perceived risks because every consumer is different and each one perceives hazards and risks differently, making it difficult to reach valid conclusions. Risk assessment can however improve the performance of risk management tools, such as HACCP, and this is well illustrated by the chapters. Risk analysis is focused on microbiological safety because injuries and deaths caused by food have the most serious implications possible for a country or business (e.g. BSE), it is very difficult to fully quantify the costs of consumer compensation or liability in defining the implications of safety management failures. Often these costs are borne centrally, whereas risk management decisions are made at the local level. Closer commercial links between suppliers and retailers and users of products has resulted in a need for much closer control and management of food hygiene and safety. This book is aimed at helping risk managers take a wider view of systems and techniques, so that they can directly contribute to the success of their business or agency. Different products have different hazards and different consumers different sensitivities and this must be considered by risk assessor and risk manager in developing risk cost effective management procedures. The most serious long-term consequence of a safety failure for a food business is a decision by consumers to change their eating habits; risk modification is an action everybody takes to some extent. An unpredictable change in eating habits, because of unidentified or uncontrolled hazards can destroy the value of a business. Therefore decisions between course of action available to a risk manager, including providing information to consumers must be guided by the best information (risk assessment) and the most transparent procedures available – risk management and communication. A comprehensive MRA provides a framework from which the potential effectiveness of different intervention or mitigation strategies for risk management can be assessed, thus enabling more scientifically robust decision making. Users of this book need to remember that risk analysis deals with real events and real consequences and that people (e.g. consumers and plant staff and management) are an integral part of the process of assessment and management. MRA should be used for decision making or trade-offs, limited by acceptable risk on one hand and consumer preference on the other. No magic words or infallible techniques exist in this area, this book only provides access to the existing tools and sources of information. Martyn Brown and Mike Stringer Preface xvii
Introduction M. Brown, Unilever Research, Sharnbrook and M. stringer, Campden and Chorleywood Food Research Association, Chipping Campden Attempts to assess the nature of the risks posed by foodborne pathogens to consumers have long been undertaken by the food industry as a means of ensuring safe food. However, the 1990s in particular have seen growing government and industry commitment towards developing an internationally accepted methodology for assessing the importance of microbiological risks. A number of factors have driven this process. Serious and well-publicised outbreaks of foodborne disease in the US and Europe have highlighted the need to improve the identification of new hazards, the assessment and management of existing microbiological food safety risks, and the need for dialogue with consumers about microbiological safety(Pennington, 1997, Tuttle et al, 1999) At the same time, developments in risk assessment methodology, better microbiological data and greater computing power have made it possible to develop more sophisticated and meaningful risk assessments(Tennant, 1997; Benford, 2001; Morgan, 1993) Further impetus has been provided by the continued globalisation of the food supply, and renewed attempts to harmonise food safety principles and practice in nternational trade. In 1993 the Uruguay Round of the General Agreement on Tariffs and Trade(GaTt) resolved that barriers to international trade in food, including those designed to protect public health, could only be science-based In response, member countries of the World Trade Organisation (WTO) concluded the sanitary and phytosanitary(SPS)agreement(Anon, 1995a and b) The SPS agreement proposed the key requirements necessary to demonstrate equivalent levels of safety in foods originating in different nations, produced by different manufacturing systems and complying differing regulator requirements. The agreement requires that food measures taken by individual countries are
Attempts to assess the nature of the risks posed by foodborne pathogens to consumers have long been undertaken by the food industry as a means of ensuring safe food. However, the 1990s in particular have seen growing government and industry commitment towards developing an internationallyaccepted methodology for assessing the importance of microbiological risks. A number of factors have driven this process. Serious and well-publicised outbreaks of foodborne disease in the US and Europe have highlighted the need to improve the identification of new hazards, the assessment and management of existing microbiological food safety risks, and the need for dialogue with consumers about microbiological safety (Pennington, 1997; Tuttle et al., 1999). At the same time, developments in risk assessment methodology, better microbiological data and greater computing power have made it possible to develop more sophisticated and meaningful risk assessments (Tennant, 1997; Benford, 2001; Morgan, 1993). Further impetus has been provided by the continued globalisation of the food supply, and renewed attempts to harmonise food safety principles and practice in international trade. In 1993 the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) resolved that barriers to international trade in food, including those designed to protect public health, could only be science-based. In response, member countries of the World Trade Organisation (WTO) concluded the sanitary and phytosanitary (SPS) agreement (Anon, 1995a and b). The SPS agreement proposed the key requirements necessary to demonstrate equivalent levels of safety in foods originating in different nations, produced by different manufacturing systems and complying with differing regulatory requirements. The agreement requires that food safety measures taken by individual countries are: 1 Introduction M. Brown, Unilever Research, Sharnbrook and M. Stringer, Campden and Chorleywood Food Research Association, Chipping Campden