22 Microbiological risk assessment in food processing were the principles of risk communication and barriers to, and strategies for making the process effective. It is generally accepted that risk communication is essential throughout the risk analysis process. For successful risk communication, it is important that (1) all interested parties are involved, (ii)use is made of individuals trained in risk communication, (iii) risk communication is received and understood, and(iv) transparency is fostered during the whole process. The nature of the risk and the benefits and uncertainty in risk assessment and assessment of risk management options are regarded as the main elements for effective risk communication. The main barriers in risk communication include differences in perception and receptivity, lack of understanding of the scientific process, and media and social characteristics The fourth expert consultation, convened in 1999, was directed specifically at risk assessment of microbiological hazards in foods. The main outcome of this consultation was an outline strategy and mechanism for addressing mra at the international level. The expert consultation made recommendations regarding the activities required to support MRA and how to improve the necessary capabilities. In addition, it recommended that outcomes of risk assessments should be immediately integrated into HACCP plans, that additional expert meetings should be held and that collaborative studies should be conducted between developing and developed countries In 2000, a second specific expert consultation was organised, dealing with the interaction between assessors and managers of microbiological hazards in foods At this consultation, the linkage between risk assessment and risk management was discussed in more detail, with the aim of providing guidance on how both processes could be improved. Issues addressed ranged from the identification of a food safety problem and the establishment of risk profiles to assessment of the effectiveness of management decisions. The former is of interest in relation to collecting as much information as possible for both risk assessment purposes and effective risk management Current microbiological risk assessment activities In 1999, following the request of the Cac and in order to address the needs of their member countries, the FAO and WHO initiated a series of joint expert consultations to assess risks associated with specific microbiological contaminants in foods. This followed the adoption by the CAc of the Principles and Guidelines for the Conduct of Microbiological Risk Assessment(MRA) elaborated by the Codex Commission for Food Hygiene(CCFH)(CAC/GL 30 1999) The aims of these joint expert consultations were to provic review of scientific data on the state of the art of mrA, and to develop the means of achieving sound quantitative risk assessments for specific pathogen- ommodity associations. The work included an evaluation of existing risk assessments. a review of the available data and risk assessment methodologies highlighting their strengths and weaknesses and how they might be applied
were the principles of risk communication and barriers to, and strategies for, making the process effective. It is generally accepted that risk communication is essential throughout the risk analysis process. For successful risk communication, it is important that (i) all interested parties are involved, (ii) use is made of individuals trained in risk communication, (iii) risk communication is received and understood, and (iv) transparency is fostered during the whole process. The nature of the risk and the benefits and uncertainty in risk assessment and assessment of risk management options are regarded as the main elements for effective risk communication. The main barriers in risk communication include differences in perception and receptivity, lack of understanding of the scientific process, and media and social characteristics. The fourth expert consultation, convened in 1999, was directed specifically at risk assessment of microbiological hazards in foods. The main outcome of this consultation was an outline strategy and mechanism for addressing MRA at the international level. The expert consultation made recommendations regarding the activities required to support MRA and how to improve the necessary capabilities. In addition, it recommended that outcomes of risk assessments should be immediately integrated into HACCP plans, that additional expert meetings should be held and that collaborative studies should be conducted between developing and developed countries. In 2000, a second specific expert consultation was organised, dealing with the interaction between assessors and managers of microbiological hazards in foods. At this consultation, the linkage between risk assessment and risk management was discussed in more detail, with the aim of providing guidance on how both processes could be improved. Issues addressed ranged from the identification of a food safety problem and the establishment of risk profiles to assessment of the effectiveness of management decisions. The former is of interest in relation to collecting as much information as possible for both risk assessment purposes and effective risk management. Current microbiological risk assessment activities In 1999, following the request of the CAC and in order to address the needs of their member countries, the FAO and WHO initiated a series of joint expert consultations to assess risks associated with specific microbiological contaminants in foods. This followed the adoption by the CAC of the Principles and Guidelines for the Conduct of Microbiological Risk Assessment (MRA), elaborated by the Codex Commission for Food Hygiene (CCFH) (CAC/GL 30, 1999). The aims of these joint expert consultations were to provide a transparent review of scientific data on the state of the art of MRA, and to develop the means of achieving sound quantitative risk assessments for specific pathogen– commodity associations. The work included an evaluation of existing risk assessments, a review of the available data and risk assessment methodologies, highlighting their strengths and weaknesses and how they might be applied, 22 Microbiological risk assessment in food processing
The evolution of microbiological risk assessment 23 provision of examples and identification of information needs/gaps. A further im of these consultations was the development of guidelines relating to the different steps in risk assessment, such as hazard characterisation and exposure assessment. The purpose of such guidelines would be to help the risk assessor, the risk manager and other interested parties to understand the principles and science behind the risk assessment steps Three such consultations have already been convened. Two of these, one in ly 2000 and one in May 2001 have dealt with the risk assessment of Salmonella spp. in broilers, Salmonella enteriditis in eggs and listeria nocytogenes in ready-to-eat foods. These assessments are currently near completion. In July 2001 another expert consultation addressed risk assessment of Campylobacter spp. in broiler chickens, and vibrio spp in seafood. Work these will continue for another year. The work plan and priorities programme for work on MRA are established by FAO and WHO, taking into consideration the needs of the ccfh. as well as the member countries 2.4 International food safety standards 2. 4.1 Setting of current international standards Based on the SPS Agreement, food safety standards need to be based on sound science and risk assessment. Figure 2.2 shows how these standards are set. The starting point is the relevant food safety policy. By using risk analysis, this policy is transformed into food safety objectives, which equate with an agreed level of consumer protection Food safety policy Risk Risk assessment management Risk communication Agreed level of consumer Fig. 2.2 The use of risk analysis to convert a food safety policy into food safety
provision of examples and identification of information needs/gaps. A further aim of these consultations was the development of guidelines relating to the different steps in risk assessment, such as hazard characterisation and exposure assessment. The purpose of such guidelines would be to help the risk assessor, the risk manager and other interested parties to understand the principles and science behind the risk assessment steps. Three such consultations have already been convened. Two of these, one in July 2000 and one in May 2001 have dealt with the risk assessment of Salmonella spp. in broilers, Salmonella enteriditis in eggs and Listeria monocytogenes in ready-to-eat foods. These assessments are currently near completion. In July 2001 another expert consultation addressed risk assessment of Campylobacter spp. in broiler chickens, and Vibrio spp. in seafood. Work on these will continue for another year. The work plan and priorities programme for work on MRA are established by FAO and WHO, taking into consideration the needs of the CCFH, as well as the member countries. 2.4 International food safety standards 2.4.1 Setting of current international standards Based on the SPS Agreement, food safety standards need to be based on sound science and risk assessment. Figure 2.2 shows how these standards are set. The starting point is the relevant food safety policy. By using risk analysis, this policy is transformed into food safety objectives, which equate with an agreed level of consumer protection. Fig. 2.2 The use of risk analysis to convert a food safety policy into food safety objectives. The evolution of microbiological risk assessment 23
24 Microbiological risk assessment in food processing Currently, the FAO and WHO are the organisations concerned with food safety at the international level. As far as international food safety standards are concerned. these are established under the Joint FAO/ho Food Standards Programme by the CAC. This organisation has delegated the development of standards, guidelines and other recommendations to its subsidiary bodies, which are guided by the CAC. Normally, the general subject Codex committee (described as horizontal Codex committees) are more routinely involved risk management. These include the codex committees on food additives and Contaminants, Pesticide Residues, Residues of Veterinary Drugs in Food, Food Hygiene, General Principles, Food Labelling, and Nutrition and Food for Special Dietary Uses. The tasks of these intergovernmental bodies are to prepare draft standards, guidelines and recommendations for consideration by the CAC. The process of setting international food safety standards is expressed in Fig Initiating the process of standard setting The risk analysis procedure is usually initiated by one of the respective Codex committees,when it proposes setting standards for additives, contaminants, microbiological agents, etc. This process may also be triggered by direct requests to FAO/HO from member countries. The initiation of the evaluation procedure serves as the hazard identification step Risk assessment The first step in the process of risk analysis is risk assessment, which is carried out by independent expert committees or groups that advise the respective Codex committees. At present, there are two long-standing expert groups that provide advice to Codex, governments and industry. They are the JECFA and the Joint FAO/WHO Meeting on Pesticide Residues (JMPR). In addition, FAO and WHO convene ad hoc expert consultations, as required, to address specific sues not covered by JECFA or JMPR. In recent years, several expert consultations have been held on microbiological hazards in food, the risk assessment of foods derived from biotechnology and on animal feeding and food safety. Recently, the CAC, at its Twenty-fourth Session, held in Geneva, Switzerland from 2 to 7 July 2001, requested the FAO and WHO to further trengthen scientific support for science-based decision making. The FAO and WHO, conscious of the importance of this issue, are currently studying the possibility of harmonising the risk assessment procedures used by the various scientific advisory groups and are looking for ways to improve the quality quantity and time-lines of scientific advice The work of the JECFa now includes the evaluation of contaminants naturally occurring toxicants and residues of veterinary drugs in food. For food additives, the JECFA normally establishes so-called acceptable daily intakes ADIs)on the basis of available toxicological and other relevant information pecifications for identity and purity are also developed for food additives which help to ensure that the product in commerce is of appropriate quality, can
Currently, the FAO and WHO are the organisations concerned with food safety at the international level. As far as international food safety standards are concerned, these are established under the Joint FAO/WHO Food Standards Programme by the CAC. This organisation has delegated the development of standards, guidelines and other recommendations to its subsidiary bodies, which are guided by the CAC. Normally, the general subject Codex committees (described as ‘horizontal’ Codex committees) are more routinely involved in risk management. These include the Codex committees on Food Additives and Contaminants, Pesticide Residues, Residues of Veterinary Drugs in Food, Food Hygiene, General Principles, Food Labelling, and Nutrition and Food for Special Dietary Uses. The tasks of these intergovernmental bodies are to prepare draft standards, guidelines and recommendations for consideration by the CAC. The process of setting international food safety standards is expressed in Fig. 2.3. Initiating the process of standard setting The risk analysis procedure is usually initiated by one of the respective Codex committees, when it proposes setting standards for additives, contaminants, microbiological agents, etc. This process may also be triggered by direct requests to FAO/WHO from member countries. The initiation of the evaluation procedure serves as the hazard identification step. Risk assessment The first step in the process of risk analysis is risk assessment, which is carried out by independent expert committees or groups that advise the respective Codex committees. At present, there are two long-standing expert groups that provide advice to Codex, governments and industry. They are the JECFA and the Joint FAO/WHO Meeting on Pesticide Residues (JMPR). In addition, FAO and WHO convene ad hoc expert consultations, as required, to address specific issues not covered by JECFA or JMPR. In recent years, several expert consultations have been held on microbiological hazards in food, the risk assessment of foods derived from biotechnology and on animal feeding and food safety. Recently, the CAC, at its Twenty-fourth Session, held in Geneva, Switzerland from 2 to 7 July 2001, requested the FAO and WHO to further strengthen scientific support for science-based decision making. The FAO and WHO, conscious of the importance of this issue, are currently studying the possibility of harmonising the risk assessment procedures used by the various scientific advisory groups and are looking for ways to improve the quality, quantity and time-lines of scientific advice. The work of the JECFA now includes the evaluation of contaminants, naturally occurring toxicants and residues of veterinary drugs in food. For food additives, the JECFA normally establishes so-called acceptable daily intakes (ADIs) on the basis of available toxicological and other relevant information. Specifications for identity and purity are also developed for food additives, which help to ensure that the product in commerce is of appropriate quality, can 24 Microbiological risk assessment in food processing
The evolution of microbiological risk assessment 25 Member‖ Member Member Membet Member countriescountries countries countries countries Final FAONHO Draft Standards Standards Recommendations Codex alimentarius Codex Committ or groups dealing CCFAC(Food additives) JECFA (Joint FAO/HO Expert Committee on Food Additives CCRVDR (Veterinary drug JMPR (Joint FAO/HO Meeting on[ CCPR(Pesticide residues Pesticide Residues Joint FAO/HO CCFH (Food Hygiene consultations on microbial hazards, etc CCGP(General Principl CCFL (Food Labelin CCFICS(Import/Export CCNFSDU(Nutrition 「如m t FAO/HO ad hoc expert Ad hoc intergovernme ultations on biotechnology taskforce on biotechnology Fig. 2.3 Visualisation of the process of setting intemational food safety standards be manufactured consistently, and is equivalent to the material that was subjected to toxicological testing. For contaminants and naturally occurring toxicants, levels corresponding to tolerable intakes, such as the provisional maximum tolerable daily intake(PMTDi)or provisional tolerable weekly intake TWT)are normally established when there is an identifiable no-observed effect level. If such a level cannot be identified, the Committee may provide other advice depending on the circumstances. In the case of veterinary drugs
be manufactured consistently, and is equivalent to the material that was subjected to toxicological testing. For contaminants and naturally occurring toxicants, levels corresponding to ‘tolerable’ intakes, such as the provisional maximum tolerable daily intake (PMTDI) or provisional tolerable weekly intake (PTWI) are normally established when there is an identifiable no-observed effect level. If such a level cannot be identified, the Committee may provide other advice depending on the circumstances. In the case of veterinary drugs, Fig. 2.3 Visualisation of the process of setting international food safety standards. The evolution of microbiological risk assessment 25
26 Microbiological risk assessment in food processing data on good practice are evaluated and corresponding maximal residue levels (MRLs)in animal tissues, milk or eggs are recommended. Such MRLs are ntended to provide assurance that when the drug has been used properly, the intake of any residues of the drug in food is unlikely to exceed the AD The JMPR comprises the Joint Meeting of the FAO Panel of Experts Pesticide Residues in Food and in the environment and the who Core Assessment Group. The JMPR carries out toxicological evaluation of pesticide residues, normally resulting in an estimate of the ADI. In addition, the JMPR proposes MRLs for individual pesticides in or on specific commodities. These MRLs are primarily based on the residue levels estimated in supervised field trials, when the pesticide is used according to good agricultural practices(GAP) In cases where initial estimates indicate that the ADI may be exceeded, more refined intake calculations are performed, using national food consumption data and information from pesticide residue monitoring programmes Both the JECFA and JMPR establish chemical safety standards that are based n a review of toxicological studies in the most sensitive test-animal species They allow for an adequate level of safety, use risk assessment procedures, consider use and consumption patterns and define specifications for the identity and purity of food grade chemicals to be used For microbiological hazards, there is currently no JECFA or JMPR-like body For food safety risk assessment activities, ad hoc expert consultations are set up and independent and appropriately qualified experts are invited. A procedure for this process, adopted and in use since 2000, enhances the principles of transparency, equal opportunity, excellence and independence, and seeks to harmonise the working procedures between different expert bodies and between FAO and WHO. Briefly, the procedure involves the following steps An open call for experts is made 6 months prior to each expert meeting Review of candidates by a four-member selection panel Completion of a Declaration of Interests'form, indicating institutional affiliation by candidates Secretariat selects appropriate individuals Secretariat notifies governments of the selected experts to obtain their consent Secretariat invites the experts Risk management The risk management activities are carried out by the respective Codex ommittees, comprising participants from all member countries, including presentatives of industry, consumers and governmental bodies. These representatives carry out the risk management part of the standard-setting procedure. Draft standards, guidelines and recommendations are elaborated via an eight-step process(or in some cases a five-step, accelerated process)by the committees. The final decision regarding their adoption is made by the CAc
data on good practice are evaluated and corresponding maximal residue levels (MRLs) in animal tissues, milk or eggs are recommended. Such MRLs are intended to provide assurance that when the drug has been used properly, the intake of any residues of the drug in food is unlikely to exceed the ADI. The JMPR comprises the Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and in the Environment and the WHO Core Assessment Group. The JMPR carries out toxicological evaluation of pesticide residues, normally resulting in an estimate of the ADI. In addition, the JMPR proposes MRLs for individual pesticides in or on specific commodities. These MRLs are primarily based on the residue levels estimated in supervised field trials, when the pesticide is used according to good agricultural practices (GAP). In cases where initial estimates indicate that the ADI may be exceeded, more refined intake calculations are performed, using national food consumption data and information from pesticide residue monitoring programmes. Both the JECFA and JMPR establish chemical safety standards that are based on a review of toxicological studies in the most sensitive test-animal species. They allow for an adequate level of safety, use risk assessment procedures, consider use and consumption patterns and define specifications for the identity and purity of food grade chemicals to be used. For microbiological hazards, there is currently no JECFA or JMPR-like body. For food safety risk assessment activities, ad hoc expert consultations are set up and independent and appropriately qualified experts are invited. A procedure for this process, adopted and in use since 2000, enhances the principles of transparency, equal opportunity, excellence and independence, and seeks to harmonise the working procedures between different expert bodies and between FAO and WHO. Briefly, the procedure involves the following steps: • An open call for experts is made 6 months prior to each expert meeting. • Review of candidates by a four-member selection panel. • Completion of a ‘Declaration of Interests’ form, indicating institutional affiliation by candidates. • Secretariat selects appropriate individuals. • Secretariat notifies governments of the selected experts to obtain their consent. • Secretariat invites the experts. Risk management The risk management activities are carried out by the respective Codex committees, comprising participants from all member countries, including representatives of industry, consumers and governmental bodies. These representatives carry out the risk management part of the standard-setting procedure. Draft standards, guidelines and recommendations are elaborated via an eight-step process (or in some cases a five-step, accelerated process) by the committees. The final decision regarding their adoption is made by the CAC. 26 Microbiological risk assessment in food processing