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1 FAO
2 FAO WHO FAO WHO FAO Chief, Publishing and Multimedia Service, Information Division, FAO, Viale delle Terme di Caracalla, Rome, Italy E copyright@fao.org 2005 FAO WHO Food Quality and Standards Service Food and Agriculture Organization of the United Nations (FAO) Viale delle Terme di Caracalla Rome, Italy Fax: (39) food-quality@fao.org Web site:
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7 College of Notre Dame Charles Yoe Leon Gorris International Life Sciences Institute ILSI International Council for Development (ICD) University of Campinas Maria Cecilia Toledo Centre for Food Safety and Applied Nutrition Marianne D. Miliotis John C. Bowers Sherri B. Dennis Mark O. Walderhaug RB Toxicology and Mycotoxin Research Unit Carleton University Ronald T. Riley J. David Miller vii
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15 Codex 13 1 HACCP 2.5 FAO/WHO Application of risk analysis to food standards issues. Report of the Joint FAO/WHO Expert Consultation. Geneva, March 1995 ftp://ftp.fao.org/es/esn/food/risk_analysis.pdf FAO/WHO Assuring food safety and quality: Guidelines for strengthening national food control systems. Food and Nutrition Paper No Institute of Medicine, National Research Council of the National Academies Scientific criteria to ensure safe food. National Academies Press, Washington DC 1 CAC Procedural Manual. 13 th Edition. Joint FAO/WHO Food Standards Programme. 7
16 : Codex
17 2: Codex 13 Procedural Manual 13 th Edition i) ii) iii) iv)
18 5: : CAC Working principles for risk analysis for application in the framework of the Codex Alimentarius alimentarius.net/reports.asp
19
20 3.4 - CAC. Procedural Manual. 14 th Edition. Joint FAO/WHO Food Standards Programme. Codex Alimentarius Commission, Rome - FAO/WHO The interaction between assessors and managers of microbiological hazards in food. Report of a WHO Expert Consultation in collaboration with the Institute for Hygiene and Food Safety of the Federal Dairy Research Centre, Germany and the Food and Agriculture Organization of the United Nations (FAO). Kiel, Germany, March 2000 ftp://ftp.fao.org/es/esn/food/interaction%20report.pdf - Granger Morgan, M. & Henrion, M. eds Uncertainty: A guide to dealing with uncertainty in quantitative risk and policy analysis. Cambridge University Press, New York. - Slovic, P The perception of risk. Earthscan, London. 12
21 : Codex integrity (risk assessment policy)
22 4.2 Codex Codex 2 3: 2 CAC. January Draft principles and guidelines for the conduct of microbiological risk management (at step 3 of the procedure). Agenda Item 6 at the 36 th Session, Washington DC, March 29 to April 3, Joint FAO/WHO Food Standards Programme, Codex Committee on Food Hygiene. ftp://ftp.fao.org/codex/ccfh36/fh04_06e.pdf 14
23 : 3 (risk evaluation)codex 13 (risk assessment) (preliminary risk management activity) 15
24 2: 7 16
25 17 8 7:
26 8: 3:
27 4: Codex safety factors 5 (3 23 ) 5: 5 FAO Expert Consultation on Food Safety: Science and Ethics. Rome, Italy, 3-5 September
28 6: ALOP 6 ALOP SPS ALOP 7 ALOP ALOP ALOP ALOP ALOP 9 TDI 6 FAO Food and Nutrition Paper No. 76: Assuring food safety and quality "Introducing the WTO SPS and TBT Agreements" 7 FAO/WHO The Interaction between assessors and managers of microbiological hazards in food. Report of a WHO Expert Consultation in collaboration with the Institute for Hygiene and Food Safety of the Federal Dairy Research Centre, Germany and the Food and Agriculture Organization of the United Nations (FAO). Kiel, Germany, March
29 ADI ADI MRL (limitation) 21
30 9: Salmonella Enteritidis 10 1 S. Enteritidis 1,000 ALOP ALOP S.Enteritidis 500 ALOP Codex 8 1: 8 CAC. January Draft principles and guidelines for the conduct of microbiological risk management (at step 3 of the procedure). Agenda Item 6 at the 36 th Session, Washington DC, March 29 to April 3, Joint FAO/WHO Food Standards Programme, Codex Committee on Food Hygiene ftp://ftp.fao.org/codex/ccfh36/fh04_06e.pdf 22
31 : ph : FAO/WHO Principles and guidelines for incorporating microbiological risk assessment in the development of food safety standards, guidelines and related texts. Kiel 2 Report 23
32 11: FAO/WHO JECFA Codex CCFAC JECFA * *WHO : ( ) 12 24
33 12: FSO 27 Codex FSO ALOP Codex ALINORM 04/27/41 * FSO FSO TLR ALOP FSO FSO Y S.Enteritidis Z 10 x FSO TLR ALOP S.Enteritidis 10 1 Codex ALIMORM 04/27/
34 13: ALARA : 26
35 2: HACCP HACCP review 1: 2: i)2)3) 27
36 4.4 CAC Report of the thirty-sixth session of the Codex Committee on Food Hygiene, Washington DC, 29 March to 3 April ALINORM 04/27/13 FAO/WHO Risk management and food safety. FAO Food and Nutrition Paper No. 65. Report of a Joint FAO/WHO Consultation in Rome, Italy, January FAO/WHO Principles and guidelines for incorporating microbiological risk assessment in the development of food safety standards, guidelines and related texts. Report of a Joint FAO/WHO Consultation. Kiel, Germany, March 2002 ftp://ftp.fao.org/docrep/fao/006/y4302e/y4302e00.pdf 28
37 : 5.2 Codex 29
38 5.3 Codex 4 30
39 4 Codex Codex Codex Codex 31
40 15 15: 32
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49 resource resource 41
50 42
51 5.7 Byrd, D.M. & Cothern, C.R Introduction to risk analysis. ABS Consulting, Government Institutes Division, Rockville, Maryland. Clemen, R.T. & Reilly, T Making hard decisions with decision tools. Duxbury Thomson Learning, Pacific Grove, California. Derman, C., Gleser, L.J. & Olkin, I A guide to probability theory and applications. Holt, Rinehart and Winston, Inc., New York. Out of print. Evans, J.R. & Olson, D.L Introduction to simulation and risk analysis. Prentice Hall, New Jersey. FAO/WHO Food consumption and exposure assessment of chemicals. Report of a FAO/WHO Consultation. Switzerland, Geneva, February FAO/WHO Risk assessments of Salmonella in eggs and broiler chickens: Interpretative summary. Microbiological Risk Assessment Series, No. 1 FAO/WHO Risk assessments of Salmonella in eggs and broiler chickens. Microbiological Risk Assessment Series, No. 2 FAO/WHO Hazard characterization for pathogens in food and water. Guidelines. Microbiological Risk Assessment Series, No. 3 ftp://ftp.fao.org/docrep/fao/006/y4666e/y4666e00.pdf 43
52 FAO/WHO Risk assessment of Listeria monocytogenes in ready-to-eat foods: Interpretative summary. Microbiological Risk Assessment Series, No. 4 FAO/WHO Risk assessment of Listeria monocytogenes in ready-to-eat foods. Technical Report. Microbiological Risk Assessment Series, No. 5 FAO/WHO Enterobacter sakazakii and microorganisms in powdered infant formula, Meeting Report. Microbiological Risk Assessment Series, No. 6 FAO/WHO. In press. Exposure assessment of microbiological hazards in foods: Guidelines. Microbiological Risk Assessment Series, No. 7. Haas, C.N., Rose, J.B. & Gerba, C.P Quantitative microbial risk assessment. John Wiley and Sons. Paustenbach, D.J. ed The risk assessment of environmental and human health hazards: a textbook of case studies. John Wiley and Sons, New York. Vose, D Risk analysis: a quantitative guide. Second edition. John Wiley and Sons, New York. 44
53 : 6.2 Codex 45
54
55 21: : FAO/WHO The application of risk communication to food standards and safety matters. Report of a Joint FAO/WHO Expert Consultation, Rome, 2-6 February Food and Nutrition Paper No
56 The Presidential / Congressional Commission on risk assessment and risk management Final report, Volume 2. 48
57 22:
58 23 23:
59 24 51
60 24: : : : : : : : : : : Harvard Center for Risk Analysis. Risk in Perspective. June Volume
61
62 4. 54
63 25: FAO/WHO The application of risk communication to food standards and safety matters. Report of a Joint FAO/WHO Expert Consultation, Rome, 2-6 February Food and Nutrition Paper No
64
65
66 6.9 FAO/WHO The application of risk communication to food standards and safety matters. Report of a Joint FAO/WHO Expert Consultation in Rome, Italy, 2 6 February FAO Food and Nutrition Paper No Fischoff, B Risk perception and communication unplugged: twenty years of process. Risk Analysis, 15: Harvard Center for Risk Analysis. Risk in Perspective. June Volume 11, Issue 2 Joint Institute for Food Safety and Applied Nutrition. Food safety risk communication resources. A joint project between the University of Maryland and the United States Food and Drug Administration Sandman, P.M Risk communication. In: Encyclopaedia of the Environment, Eblen, R.A. & Eblen, W.R. (eds.) Boston, MA: Houghton Mifflin, pp University of Maryland. Food safety risk communication primer. 58
67 1: 11 ADI FAO/WHO (Codex ) 60 FAO/WHO JECFA FAO/WHO ADI ADI 11 FAO/WHO 13 13th Edition of the Procedural Manual of the Codex Alimentarius Commission. Joint FAO/WHO Food Standards ProgrammeFAO/WHO
68 JECFA Codex GL Codex GL30 Codex GL30 12 CAC Principles and guidelines for the conduct of microbiological risk assessment. CAC/GL
69 61
70 2: I
71 6: NOAEL ADI ADI ADI II. FAO/WHO JECFA 50 JECFA 1, JECFA 7 JECFA 63
72 JECFA Compendium of food additive specifications JECFA FAO Food and Nutrition Paper 52 JECFA JECFA 7: JECFA JECFA CD-ROM 64
73 JECFA The Toxicology and Environmental Health Information Programme WHO WHO GEMS/Food III. ADI ADI (Codex) ADI 1 ADI 26 NOAEL ADI JECFA ADI 65
74 NOAEL JECFA CSAP CSAP NOAEL 1kg 5mg/ / 100 ADI 1kg 0.05 mg/ / ADI = NOAEL/ ADI = 100 ADI 5/100 = ADI (mg/kg/ /) 5 NOAEL IV Codex
75 WHO 67
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77 Codex 1999 Principles and guidelines for the conduct of microbiological risk assessmentcac/gl 30 FAO/WHO 2003 Hazard characterization for pathogens in food and water. Guidelines. Microbiological Risk Assessment Series, No. 3 ftp://ftp.fao.org/docrep/fao/006/y4666e/y4666e00.pdf FAO/WHO Exposure assessment of microbiological hazards in foods: Guidelines. Microbiological Risk 69
78 Assessment Series, No. 7 ILSI 2000 Revised framework for microbial risk assessment Codex ILSI Codex Codex
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85 TMDI TMDI 60 ADI 1 ADI TMDI TMDI ADI MRL EDI IEDI NEDIEDI ADI EDI 1 ARfD ADI NOAEL 77
86 5: Codex 13 CAC Principles for the Risk Analysis of Foods Derived from Modern Biotechnology Codex Alimentarius Commission (CAC). CAC/GL CAC Guideline for the conduct of food safety assessment of foods derived from recombinant-dna plants. Codex Alimentarius Commission (CAC). CAC/GL
87 CAC Guideline for the conduct of food safety assessment of foods produced using recombinant-dna microorganisms. Codex Alimentarius Commission (CAC). CAC/GL GMO GMO DNA DNA 79
88 DNA i. ii. iii. 80
89 6 SPS IPPC 100 SPS IPPC SPS IPPC IPPC 10 Codex 81
90 11 IPPC 1 : 2 : 3 : 2 11 PRA 1 82
91 1 83
92 3 IPPC 84
93 7 OIE SPS OIE OIE OIE i) ii) iii) iv) 85
94 14 OIE 14 OIE Guidelines for import risk analysis. In Chapter of the International Animal Health Code 86
95 Byrd, D.M. & Cothern, C.R Introduction to risk analysis. ABS Consulting, Government Institutes Division, Rockville, Maryland. Clemen, R.T. & Reilly, T Making hard decisions with decision tools. Duxbury Thomson Learning, Pacific Grove, California. CAC Procedural Manual. 13 th Edition. Joint FAO/WHO Food Standards Programme CAC Draft working principles for risk analysis for application in the framework of the Codex Alimentarius. Appendix IV. ALINORM 03/33a CAC. January Draft principles and guidelines for the conduct of microbiological risk management (at step 3 of the procedure). Agenda Item 6 at the 36 th Session, Washington DC, March 29 to April 3, Joint FAO/WHO Food Standards Programme, Codex Committee on Food Hygiene ftp://ftp.fao.org/codex/ccfh36/fh04_06e.pdf CAC Report of the thirty-sixth session of the Codex Committee on Food Hygiene, Washington DC, 29 March to 3 April ALINORM 04/27/13 CAC Report of the twenty-seventh session of the Joint FAO/WHO Food Standards Programme. Codex Alimentarius Commission. Geneva, 28 June to 3 July ALINORM 04/27/41 Derman, C., Gleser, L.J. & Olkin, I A guide to probability theory and applications. Holt, Rinehart and Winston, Inc., New York. Out of print. 87
96 Evans, J.R. & Olson, D.L Introduction to simulation and risk analysis. Prentice Hall, New Jersey. Fischoff, B Risk perception and communication unplugged: twenty years of process. Risk Analysis, 15: FAO/WHO Application of risk analysis to food standards issues. Report of the Joint FAO/WHO Expert Consultation. Geneva, March 1995 ftp://ftp.fao.org/es/esn/food/risk_analysis.pdf FAO/WHO Risk management and food safety. FAO Food and Nutrition Paper No. 65. Report of a Joint FAO/WHO Consultation in Rome, Italy, January FAO/WHO Food consumption and exposure assessment of chemicals. Report of a FAO/WHO Consultation. Switzerland, Geneva, February FAO/WHO The application of risk communication to food standards and safety matters. Report of a Joint FAO/WHO Expert Consultation, Rome, 2-6 February Food and Nutrition Paper No FAO/WHO The interaction between assessors and managers of microbiological hazards in food. Report of a WHO Expert Consultation in collaboration with the Institute for Hygiene and Food Safety of the Federal Dairy Research Centre, Germany and the Food and Agriculture Organization of the United Nations (FAO). Kiel, Germany, March 2000 ftp://ftp.fao.org/es/esn/food/interaction%20report.pdf FAO/WHO Principles and guidelines for incorporating microbiological risk assessment in the development of food safety standards, guidelines and related texts. Report of a Joint FAO/WHO Consultation. Kiel, Germany, March 2002 ftp://ftp.fao.org/docrep/fao/006/y4302e/y4302e00.pdf FAO/WHO Risk assessments of Salmonella in eggs and broiler chickens: 88
97 Interpretative summary. Microbiological Risk Assessment Series, No. 1 FAO/WHO Risk assessments of Salmonella in eggs and broiler chickens. Microbiological Risk Assessment Series, No. 2 FAO/WHO Assuring food safety and quality: Guidelines for strengthening national food control systems. Food and Nutrition Paper No FAO/WHO Hazard characterization for pathogens in food and water. Guidelines. Microbiological Risk Assessment Series, No. 3 ftp://ftp.fao.org/docrep/fao/006/y4666e/y4666e00.pdf FAO/WHO Risk assessment of Listeria monocytogenes in ready-to-eat foods: Interpretative summary. Microbiological Risk Assessment Series, No. 4 FAO/WHO Risk assessment of Listeria monocytogenes in ready-to-eat foods. Technical Report. Microbiological Risk Assessment Series, No. 5 FAO/WHO Enterobacter sakazakii and microorganisms in powdered infant formula, Meeting Report. Microbiological Risk Assessment Series, No. 6 FAO/WHO. In press. Exposure assessment of microbiological hazards in foods: Guidelines. Microbiological Risk Assessment Series, No. 7. Granger Morgan, M. & Henrion, M. eds Uncertainty: A guide to dealing with uncertainty in quantitative risk and policy analysis. Cambridge University Press, New York. Haas, C.N., Rose, J.B. & Gerba, C.P Quantitative microbial risk assessment. John Wiley and Sons. 89
98 Harvard Center for Risk Analysis. Risk in Perspective. June Volume 11, Issue 2 Institute of Medicine, National Research Council of the National Academies Scientific criteria to ensure safe food. National Academies Press, Washington DC Joint Institute for Food Safety and Applied Nutrition. Food safety risk communication resources. A joint project between the University of Maryland and the United States Food and Drug Administration OIE Guidelines for import risk analysis. In The International Animal Health Code (Chapter 1.3.2). World Organisation for Animal Health Paustenbach, D.J. ed The risk assessment of environmental and human health hazards: a textbook of case studies. John Wiley and Sons, New York. Slovic, P The perception of risk. Earthscan, London. The Presidential / Congressional Commission on risk assessment and risk management Final report, Volume 2. Vose, D Risk analysis: a quantitative guide. Second edition. John Wiley and Sons, New York. 90
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