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1 An introduction to risk analysis
In addition to improving public health, effective food safety systems maintain consumer confidence in the food supply and provide a sound regulatory foundation for domestic and international trade in food, which supports economic development. International trade agreements developed under the World Trade Organization (WTO) emphasize the need for regulations governing international trade in foods to be based on science and risk assessment. The Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) permits countries to take legitimate measures to protect the life and health of consumers provided such measures can be justified scientifically and do not unnecessarily impede trade.
Article 5 of the SPS Agreement directs countries to ensure that their sanitary and phytosanitary measures are based on an assessment of the risk to human, animal or plant life or health, taking into account risk assessment techniques developed by relevant international organizations and bodies. Article 9 of the SPS Agreement defines the obligation of developed countries to provide technical assistance to less developed countries with the goal of improving their food safety systems.
|Box 1.1. Elements of food safety systems at the national level
Regardless of the level of sophistication of national food control systems, a wide range of factors are placing generally increasing demands on national authorities responsible for food safety. Box 1.2 and Figure 1.1 describe rapidly changing dimensions of the global food system. Some of these changing factors contribute directly to increasing food-borne risks to human health, while others demand more rigorous evaluation and sometimes modification of existing food safety standards and approaches.
|Box 1.2. Changing global factors that affect national food safety systems
Figure 1.1. Factors driving changes in food safety systems
|Box 1.3. Examples of hazards that may occur in foods
|Biological hazards||Chemical hazards||Physical hazards|
There are important differences among hazards of different classes, which require somewhat different approaches to risk analysis. Certain chemical hazards, especially those that can be tightly controlled in the food supply such as food additives, residues of crop pesticides and veterinary drugs, have historically been subject to a “notional zero-risk approach” (discussed in more detail in Chapters 2, Risk management and 3, Risk assessment ). In contrast, microbiological hazards are usually living organisms that can reproduce in foods and are ubiquitous in the environment; they require a different risk assessment approach and management strategies that seek to keep risks within tolerable limits, rather than to eliminate them entirely. These differences are discussed in greater depth in Chapter 2 Risk management.
|Box 1.4. Food control principles that increase demands on national authorities
For instance, risk analysis can be used to obtain information and evidence on the level of risk of a certain contaminant in the food supply helping governments to decide which, if any, actions should be taken in response (e.g. setting or revising a maximum limit for that contaminant, increasing testing frequency, review of labelling requirements, provision of advice to a specific population subgroup, issuing a product recall and/or a ban on imports of the product in question). Furthermore, the process of conducting a risk analysis enables authorities to identify the various points of control along the food chain at which measures could be applied, to weigh up the costs and benefits of these different options, and to determine the most effective one(s). As such, it offers a framework to consider the likely impact of the possible measures (including on particular groups such as a food industry subsector) and contributes towards enhanced utilization of public resources by focusing on the highest food safety risks.
Risk analysis is comprised of three components: risk management, risk assessment and risk communication. Each of these components has been applied in essentially all countries for a long time, even before they came to be called by these names (see Box 1.5). During the past two decades or so, the three components have been formalized, refined and integrated into a unified discipline, developed at both the national and international levels, and now known as “risk analysis.” This section provides a broad introduction to food safety risk analysis, advantages of applying it, and conditions necessary for its successful implementation.
|Box 1.5. Welcome to the role of “risk managers”
In risk analysis terminology, food safety officials working for national governments generally play the role of “risk managers.” They have overall responsibility for ensuring that a risk analysis is carried out, as well as the ultimate responsibility for choosing and implementing food safety control measures. National risk managers do not need to understand in detail how to carry out a risk assessment, but they do need to know how to commission one when that is required and see the task through to completion. They also need to understand the outcome of risk assessment in order to make appropriate risk management decisions. Similarly, national risk managers do not need to be experts at risk communication, but they need to know how risk communication supports successful risk analysis, and how to ensure that proper kinds and amounts of communication occur at all the appropriate steps in risk assessment and risk management.
The terminology used in risk analysis may seem daunting at first, but as readers come to understand the concepts it will become clear that risk analysis often applies recently developed, internationally agreed terms to familiar activities. By explaining these activities and providing practical examples, this Guide aims to help national food safety officials gain the advantages of applying risk analysis to their own food control activities.
Figure 1.2. Generic components of risk analysis
The three main components of risk analysis have been defined by Codex as follows:
- Risk assessment: A scientifically based process consisting of the following steps: i) hazard identification; ii) hazard characterization; iii) exposure assessment; and iv) risk characterization.
- Risk management: The process, distinct from risk assessment, of weighing policy alternatives in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options.
- Risk communication: The interactive exchange of information and opinions throughout the risk analysis process concerning risk, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions.
Codex Committees act as risk managers in the sense that they organize and direct the decision-making process, weigh the results of the risk assessments and other legitimate factors such as the feasibility of risk management options and the interests of Codex members, and recommend standards to protect public health and ensure fair practices in the food trade. Their activities may include developing risk management tools referred to as related texts, such as guidelines, codes of practice and sampling plans, and standards for specific food-hazard combinations. Draft standards and related texts prepared by these committees are forwarded to the CAC for final adoption and publication in the Codex Alimentarius. Codex standards and related texts are voluntary in nature and have no direct binding effect to CAC members unless they are adopted in national legislation. Codex does not implement risk-mitigating measures. Implementation, enforcement and monitoring activities are within the responsibilities of Codex members, governments and institutions.
National food safety authorities, in contrast, generally are responsible for carrying out risk analysis in its entirety. Some governments have their own institutions and infrastructure for conducting risk assessments, choosing among risk management options, implementing and enforcing decisions, and monitoring and reviewing the impacts of decisions. Other countries may have fewer resources available to carry out risk analysis tasks. In such cases, and even where governments have their own capacities, components of risk analysis carried out at the international level can be very usefully applied in the national context.
International risk assessments done by JECFA, JMPR or JEMRA, for instance, can be partially or fully applied at the national level depending on particular circumstances (see Chapter 3, Risk assessment ). Similarly, international guidance on risk management for a particular hazard can identify an array of potential control options for national risk managers to consider in their own food control setting. Examples of both international and national risk analyses, and of some links between the two, are provided in subsequent chapters and in case studies presented in the Annexes to this Guide.
In its Working Principles for Risk Analysis for Application in the Framework of the Codex Alimentarius, the CAC has stated that risk analysis should: i) follow a structured approach comprised of the three distinct components illustrated in Figure 1.2; ii) be based on the best available scientific evidence; iii) be applied consistently, for instance, to hazards of different types and from country to country; iv) be carried out in an open, transparent and well-documented process; v) be clear in its treatment of uncertainty and variability; and vi) be evaluated and reviewed as appropriate on the basis of new information.
Risk analysis is also a systematic discipline that fosters broad perspectives (such as “production to consumption” approaches), wide-ranging collection of data (for instance, on risks and on risk management options), and comprehensive analysis of alternatives. It is based on a philosophy of transparent, fully documented decision-making and open processes in which participation by all parties affected by the risk or by measures to manage it is solicited.
The successful use of the risk analysis framework requires countries to have the essential foundations of a food safety system in place. As discussed in section 1.1.2 above, this includes enabling food laws, policies, regulations and standards, efficient food safety and public health institutions and mechanisms for coordination between them, operational food inspection and laboratory services, information, education, communication and training, infrastructure and equipment, and human resource capacity, among other elements. Other essential conditions necessary for a government to implement successful risk analysis include: having government officials and decision-makers at policy levels, as well as those at operational levels, who understand risk analysis and the value it adds to the public health perspective; having enough scientific capability to carry out needed risk assessments in the national context; and having the support and participation of key interested parties such as consumers, industry and academia (generally called “stakeholders” in this Guide). When these conditions are met, national food safety authorities have much to gain by adopting risk analysis as a discipline for their food control activities.
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:
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).
FAO/WHO. 1999. The application of risk communication to food standards and safety matters. Report of a Joint FAO/WHO Expert Consultation. Rome, 2-6 February 1998.
FAO Food and Nutrition Paper No. 70 (available at: http://www.fao.org/DOCREP/005/X1271E/X1271E00.htm#TOC).
FAO/WHO. 2000. 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, 21-23 March 2000 (available at: ftp://ftp.fao.org/docrep/nonfao/ae586e/ae586e00.pdf).
FAO/WHO. 2002. Improving efficiency and transparency in food safety systems - sharing experiences. Proceedings of the Global Forum of Food Safety Regulators. Marrakesh, Morocco, 28-30 January 2002 (available at: ftp://ftp.fao.org/docrep/fao/meeting/004/Y3680E/Y3680E00.pdf).
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 in collaboration with the Federal Institute for Health Protection of Consumers and Veterinary Medicine, Germany and the Federal Ministry for Consumer Protection, Food and Agriculture, Germany. Kiel, Germany, 18-22 March 2002 (available at: ftp://ftp.fao.org/docrep/fao/006/y4302e/y4302e00.pdf).
FAO/WHO. 2003. Assuring food safety and quality: Guidelines for strengthening national food control systems. FAO Food and Nutrition Paper No. 76 (available at: http://www.fao.org/DOCREP/006/Y8705E/Y8705E00.HTM).
FAO/WHO. 2004. The application of risk analysis in food control – challenges and benefits. Paper prepared by Food Standards Australia New Zealand (FSANZ) for the FAO/WHO Regional Conference on Food Safety for Asia and the Pacific. Seremban, Malaysia, 24-27 May 2004 (available at: ftp://ftp.fao.org/docrep/fao/meeting/006/j1985e/j1985e00.pdf).
FAO/WHO. 2005. Codex Alimentarius Commission. Procedural Manual. 15th Edition. Joint FAO/WHO Food Standards Programme, Rome (available at: ftp://ftp.fao.org/codex/Publications/ProcManuals/Manual_15e.pdf).
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. Joint FAO/WHO Food Standards Programme, Rome. Pp 101-107 (available at: ftp://ftp.fao.org/codex/Publications/ProcManuals/Manual_15e.pdf).
FAO/WHO. 2005. Building effective food safety systems. Proceedings of the 2nd FAO/WHO Global Forum of Food Safety Regulators. Bangkok, Thailand, 12-14 October 2004 (available at: http://www.fao.org/docrep/meeting/008/y5871e/y5871e00.htm).
Information on FAO/WHO food safety activities is available at http://www.fao.org/ag/agn/index_en.stm# and http://www.who.int/foodsafety/en/. The first Global Forum of Food Safety Regulators was convened in Marrakesh, Morocco in January 2002. The second Global Forum took place in Bangkok, Thailand in 2004. The proceedings, conference room documents and other information related to these global fora are available at http://www.foodsafetyforum.org/index.asp.