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General introduction to Food Safety Risk Analyses

Acronyms and abbreviations

ADI	Acceptable Daily Intake
ARfD	Acute Reference Dose
ALOP	Appropriate Level of Protection
ALARA	As Low As Reasonably Achievable
BSE	Bovine Spongiform Encephalopathy
CAC	Codex Alimentarius Commission
CCFAC	Codex Committee on Food Additives and Contaminants
CCFH	Codex Committee on Food Hygiene
CCMH	Codex Committee on Meat Hygiene
CCPR	Codex Committee on Pesticide Residues
CCRVDF	Codex Committee on Residues of Veterinary Drugs in Foods
FAO	Food and Agriculture Organization of the United Nations
FSO	Food Safety Objective
GEMS	Global Environment Monitoring System
GAP	Good Agricultural Practice
GHP	Good Hygienic Practice
GMP	Good Manufacturing Practice
HACCP	Hazard Analysis and Critical Control Point
JECFA	Joint FAO/WHO Expert Committee on Food Additives
JEMRA	Joint FAO/WHO Expert Meetings on Microbiological Risk Assessment
JMPR	Joint FAO/WHO Meeting on Pesticide Residues
MC	Microbiological Criteria
ML	Maximum Level
MRL	Maximum Residue Level
NOAEL	No Observed Adverse Effect Level
OIE	Office international des épizooties (World Organisation for Animal Health
PTWI	Provisional Tolerable Weekly Intake
RfD	Reference Dose
RMF	Risk Management Framework
SPS Agreement	WTO Agreement on the Application of Sanitary and Phytosanitary Measures
TDI	Tolerable Daily Intake
WHO	World Health Organization
WTO	World Trade Organization

Foreword

Ensuring food safety to protect public health and promote economic development remains a significant challenge in both developing and developed countries. Considerable progress to strengthen food safety systems has been achieved in many countries, highlighting the opportunities to reduce and prevent food-borne disease. However, unacceptable rates of food-borne illness still remain and new hazards continue to enter the food supply.

Food-borne risks to human health can arise from hazards that are biological, chemical or physical in nature. A key discipline for further reducing food-borne illness and strengthening food safety systems is risk analysis. During the last several decades, risk assessment, risk management and risk communication have been formalized and incorporated into the specific discipline known as food safety risk analysis. This approach has now gained wide acceptance as the preferred way to assess possible links between hazards in the food chain and actual risks to human health, and takes into account a wide range of inputs to decision-making on appropriate control measures. When used to establish food standards and other food control measures, risk analysis fosters comprehensive scientific evaluation, wide stakeholder participation, transparency of process, consistent treatment of different hazards and systematic decision-making by risk managers. Application of harmonized risk analysis principles and methodologies in different countries also facilitates trade in foods.

The Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) have played a leading role in the development of food safety risk analysis. In 1991, the Joint FAO/WHO Conference on Food Standards, Chemicals in Food, and Food Trade recommended that the Codex Alimentarius Commission (CAC) incorporate risk assessment principles into its decision-making process. The 19 and 20 sessions of the CAC, in 1991 and 1993, endorsed the recommendation of the Conference to base its food safety decisions and standards on risk assessment and encouraged the relevant Codex Committees to harmonize their standard-setting methodologies.

At the request of the CAC, FAO and WHO have convened a number of expert consultations to provide advice to Codex and member countries on practical approaches for the application of risk analysis to food standard issues. These have included expert meetings on risk assessment (1995), risk management (1997) and risk communication (1998). The initial consultations focused on the overall risk analysis paradigm, producing a number of definitions and broad principles for risk assessment, risk management and risk communication.¹ Subsequent consultations have addressed in greater detail some specific aspects of the risk analysis paradigm.²

The CAC adopted in 2003 the working principles for risk analysis for application in the framework of the Codex Alimentarius,³ developed by the Codex Committee on General Principles (CCGP). The CAC asked relevant Codex committees to develop specific principles and guidelines on risk analysis in their specific areas. In this perspective, CCGP has initiated work to develop general risk analysis principles as guidance for national governments. Several subsidiary bodies of the Commission have developed specific guidance on risk analysis or are in the process of doing so, especially as regards food additives and (chemical) contaminants, food hygiene (microbial contaminants), pesticide residues, residues of veterinary drugs, and biotechnology.

As part of the body of work being carried out by FAO/WHO and the CAC, considerable progress has been made in developing a systematic framework for applying principles and guidelines for food safety risk analysis. Governments have moved quickly to incorporate much of this international work in national legislation and further developments in food safety risk analysis at the national level are ongoing.

FAO and WHO have developed this Guide to improve food safety regulators’ understanding and use of risk analysis in national food safety frameworks. The primary audience is food safety officials at the national government level. The Guide provides essential background information, guidance and practical examples of ways to apply food safety risk analysis. It presents internationally agreed principles, a generic framework for application of the different components of risk analysis, and wide-ranging examples rather than prescriptive instructions on how to implement risk analysis. It complements and is aligned with other documents that have been, or are being, produced by FAO/WHO and the CAC, and can be revised and improved as new experiences and knowledge in the field of risk analysis become available.

Following an initial chapter that explains how risk analysis offers an essential framework for effective food safety management, the Guide introduces the three basic components of risk analysis in some detail. Principles and mechanisms for risk management, risk assessment and risk communication are explained in succeeding chapters. The emphasis throughout is on what food safety officials need to know in order to oversee and manage the risk analysis process. Current information and knowledge, including materials developed by FAO and WHO, are incorporated or referenced throughout the Guide as applicable. Case studies that provide practical examples of how risk analysis has been applied for methylmercury in fish and Listeria monocytogenes in ready-to-eat foods are attached as annexes.

The Guide is the first part of a two-part set, all of which is available on CD-ROM. The second part comprises a number of educational elements for capacity building, including a slide presentation for use in training, a collection of up-to-date FAO and WHO tools and training materials related to food safety risk analysis, and case studies of risk analysis for aspartame, Vibrio parahaemolyticus and fumonisins.

Introduction risk analysis

Risk management

Risk assessment

Risk communication

Glossary risk analyses

Case methylmercury in fish

Case L monocytogenes

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notes:
¹
For information, see: i) FAO/WHO. 1995. Application of Risk Analysis to Food Standards Issues. Report of the Joint FAO/WHO Expert Consultation. Geneva, 13-17 March 1995 (available at: ftp://ftp.fao.org/es/esn/food/Risk_Analysis.pdf); ii) FAO/WHO. 1997. Risk Management and Food Safety. FAO Food and Nutrition Paper No. 65 (available at: ftp://ftp.fao.org/docrep/fao/w4982e/w4982e00.pdf); iii) FAO/WHO. 1998. The application of risk communication to food standards and safety matters. FAO Food and Nutrition Paper No. 70. (available at: http://www.fao.org/docrep/005/x1271e/x1271e00.htm).

²
For information, see: i) FAO/WHO. 1999. Risk Assessment of Microbiological Hazards in Foods. Report of the Joint FAO/WHO Expert Consultation. Geneva, Switzerland, 15-19 March 1999 (available at: http://www.who.int/foodsafety/publications/micro/en/march1999_en.pdf); ii) FAO/WHO. 2000. The interaction between assessors and managers of microbiological hazards in food. Report of a WHO Expert Consultation in collaboration with the Federal Ministry of Health, Germany and FAO. Kiel, Germany, 21-23 March 2000 (available at: ftp://ftp.fao.org/docrep/nonfao/ae586e/ae586e00.pdf); iii) FAO/WHO. 2002. 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, 18-22 March 2002 (available at: ftp://ftp.fao.org/docrep/fao/006/y4302e/y4302e00.pdf); and iv) FAO/WHO. 2006. The Use of Microbiological Risk Assessment Outputs to Develop Practical Risk Management Strategies: Metrics to improve food safety. Report of a Joint FAO/WHO Expert Meeting in collaboration with the Federal Ministry of Food, Agriculture and Consumer Protection, Germany. Kiel, Germany, 3-7 April 2006 (available at: http://www.fao.org/ag/agn/jemra/riskmanagement_en.stm).

³
FAO/WHO. 2005. Working principles for risk analysis for application in the framework of the Codex Alimentarius. In Codex Alimentarius Commission. Procedural Manual. 15th Edition, pp 101-107 (available at: ftp://ftp.fao.org/codex/Publications/ProcManuals/Manual_15e.pdf)

Source: FAO

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