1 An introduction to risk analysis

Summary

Food safety is a fundamental public health concern, and achieving a safe food supply poses major challenges for national food safety officials. Changing global patterns of food production, international trade, technology, public expectations for health protection and many other factors have created an increasingly demanding environment in which food safety systems operate. An array of food-borne hazards, both familiar and new, pose risks to health and obstacles to international trade in foods. These risks must be assessed and managed to meet growing and increasingly complex sets of national objectives. Risk analysis, a systematic, disciplined approach for making food safety decisions developed primarily in the last two decades, includes three major components: risk management, risk assessment and risk communication. Risk analysis is a powerful tool for carrying out science-based analysis and for reaching sound, consistent solutions to food safety problems. The use of risk analysis can promote ongoing improvements in public health and provide a basis for expanding international trade in foods.

1.1. Background

Food-borne disease remains a real and formidable problem in both developed and developing countries, causing great human suffering and significant economic losses. Up to one third of the population of developed countries may be affected by food-borne diseases each year, and the problem is likely to be even more widespread in developing countries, where food and water-borne diarrhoeal diseases kill an estimated 2.2 million people each year, most of them children. Chemical hazards in foods occasionally cause acute illnesses, and some food additives, residues of pesticides and veterinary drugs, and environmental contaminants may pose risks of long-term adverse effects on public health. New technologies such as genetic modification of agricultural crops have raised additional food safety concerns that require assessment and management, and proper risk communication.

1.1.1. The changing food safety environment

Better scientific knowledge of the hazards that cause food-borne disease and the risks these hazards pose to consumers, combined with the capacity to take appropriate interventions, should enable governments and industry to significantly reduce food-related risks. However, the links between hazards in foods and illness in humans have sometimes been difficult to establish, let alone quantify and, where they have been identified, interventions have not always been technically, economically or administratively feasible. Serious challenges therefore continue to face food safety regulators in many countries.
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.

1.1.2. Evolving food safety systems

Responsibility for food safety is shared by everyone involved with food from production to consumption, including growers, processors, regulators, distributors, retailers and consumers. However, governments have to provide an enabling institutional and regulatory environment for food control. Most countries have a food control system in place that incorporates a number of essential elements (see Box 1.1); these elements are in place to varying degrees in different countries. FAO and WHO have been working for several decades, in collaboration with national governments, scientific institutions, the food industry, consumers and others, to improve the safety and quality of food. More information about these activities, as well as recently convened FAO/WHO global fora of food safety regulators that have focused on mechanisms and strategies for building effective national food safety systems, including the use of risk analysis, is available on the Internet.⁴

Box 1.1. Elements of food safety systems at the national level Food laws, policies, regulations and standards. Institutions with clearly defined responsibilities for food control management and public health. Scientific capacity. Integrated management approach. Inspection and certification. Diagnostic and analytical laboratories. Standard-setting. Infrastructure and equipment. Monitoring structures and capabilities. Surveillance of human health problems related to food intake. Capacity for emergency response. Training. Public information, education and communication

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 Increasing volume of international trade. Expanding international and regional bodies and resulting legal obligations. Increasing complexity of food types and geographical sources. Intensification and industrialization of agriculture and animal production. Increasing travel and tourism. Changing food handling patterns. Changing dietary patterns and food preparation preferences. New food processing methods. New food and agricultural technologies. Increasing resistance of bacteria to antibiotics. Changing human/animal interactions with potential for disease transmission.

Figure 1.1. Factors driving changes in food safety systems

1.1.3. An abundant array of hazards

A food-borne hazard is defined by Codex as “a biological, chemical or physical agent in, or condition of, food, with the potential to cause an adverse health effect.” Box 1.3 lists a variety of food-borne hazards of current concern. Many of these hazards have long been recognized and addressed by food safety controls, however, some of the changing global conditions described in Box 1.2 may have exacerbated the problems they pose. A number of new and emerging hazards are also of growing concern. Some previously unidentified hazards have gained worldwide importance, such as the mutant protein (technically called a prion) that causes “mad cow disease” or bovine spongiform encephalitis (BSE). Some familiar hazards are regaining prominence, for example acrylamide residues in baked and fried starchy foods, methylmercury in fish, and Campylobacter in poultry. Some new food hazards arise indirectly from other trends, such as the increasing presence in foods of bacteria that are resistant to antimicrobial agents, while certain food production methods, such as the use of antimicrobials as animal feed additives, may in turn contribute to those broader trends.

Box 1.3. Examples of hazards that may occur in foods
Biological hazards	Chemical hazards	Physical hazards
Infectious bacteria Toxin-producing organisms Moulds Parasites Viruses Prions	Naturally occurring toxins Food additives Pesticide residues Veterinary drug residues Environmental contaminants Chemical contaminants from packaging Allergens	Metal, machine filings Glass Jewellery Stones Bone chips

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.

1.1.4. Increasing demands on national food safety authorities

Today, governments and other parties involved in food control are developing new methods and applying and enhancing a wide variety of existing administrative systems, infrastructures and approaches to ensuring food safety. While the main focus of these efforts remains improving food safety, national food control programmes must increasingly take other goals into account as well (see Box 1.4). For example, many national official bodies, sometimes called “Competent Authorities”, now have to review the cost-effectiveness of their structure and operations so that they do not impose unjustified compliance costs on industry. Also, such authorities must keep in mind the fair trading requirements of international agreements and establish mechanisms to ensure that domestic and import standards are consistent in intent and application.

Box 1.4. Food control principles that increase demands on national authorities Increasing reliance on science as the basic principle governing development of food safety standards. Shifting the primary responsibility for food safety to industry. Adopting a “production-to-consumption” approach to food control. Giving industry more flexibility in implementation of controls. Ensuring the cost-effectiveness and efficiency of government control functions. Increasing the role of consumers in decision making. Recognizing the need for expanded food monitoring. Epidemiologically-based food source attribution. Adopting a more “integrated” approach to working with related sectors (such as animal and plant health). Adopting risk analysis as an essential discipline to improve food safety.

1.2. Risk analysis

Risk analysis is used to develop an estimate of the risks to human health and safety, to identify and implement appropriate measures to control the risks, and to communicate with stakeholders about the risks and measures applied. It can be used to support and improve the development of standards, as well as to address food safety issues that result from emerging hazards or breakdowns in food control systems. It provides food safety regulators with the information and evidence they need for effective decision-making, contributing to better food safety outcomes and improvements in public health. Regardless of the institutional context, the discipline of risk analysis offers a tool that all food safety authorities can use to make significant gains in food safety.

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.

1.2.1. Components of risk analysis

Risk analysis represents a structured decision-making process with three distinct but closely connected components: risk management, risk assessment and risk communication (see Figure 1.2). The three components are essential, complementary parts of the overall discipline. Although the figure shows them as separate entities, in reality they are highly integrated. In the course of a typical food safety risk analysis, almost constant interactions occur between risk managers and risk assessors within an environment characterized by risk communication. Risk analysis is most effective when all three components are successfully integrated by the risk managers directing the process.

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.

Risk assessment is considered to be the “science-based” component of risk analysis, while risk management is the component in which scientific information and other factors, such as economic, social, cultural and ethical considerations, are integrated and weighed in choosing the preferred risk management options. In fact, risk assessment may also involve judgments and choices that are not entirely scientific, and risk managers need a sound understanding of scientific approaches used by risk assessors. The interactions and overlaps of science and non-scientific values at various stages in risk analysis will be explored in more detail in subsequent chapters concerned with risk management and risk assessment.

1.2.2. Carrying out risk analysis

The risk analysis process normally begins with a risk management step, to define the problem, articulate the goals of the risk analysis and identify questions to be answered by the risk assessment, if and when one is required (see Chapter 2 Risk management, section on preliminary risk management activities). The science-based tasks of “measuring” and “describing” the nature of the risk being analysed are performed during the risk assessment phase (see Chapter 3, Risk assessment ). Risk management and risk assessment are performed within an open and transparent environment involving extensive communication and dialogue, in which a variety of interested parties may participate at appropriate points. The risk analysis process often culminates with the implementation of risk-reducing measures and continuous monitoring of their effectiveness by government, the private sector and other stakeholders.

1.2.3. Risk analysis at the international and national levels

Food safety risk analysis is carried out by national, regional and international food safety authorities. There are some important differences between these processes at the different levels. Internationally, Codex committees that recommend food safety standards (for example, the Committees on Food Hygiene, Meat Hygiene, Food Additives, Contaminants, Pesticide Residues, and Residues of Veterinary Drugs in Foods) act as risk managers. Risk assessments to support the development of Codex food safety standards are provided by the three Joint FAO/WHO Expert Bodies: the Joint Expert Committee on Food Additives (JECFA); the Joint Meeting on Pesticide Residues (JMPR); and the Joint Expert Meeting on Microbiological Risk Assessment (JEMRA). Additional risk assessments may be provided, on occasion, by ad hoc expert consultations, and by member governments that have conducted their own assessments.

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.

1.2.4. Essential characteristics of risk analysis

Although figures depicting risk management (see Figure 2.1) and risk assessment (see Figure 3.1) may suggest a linear process that moves from one step to the next in a sequence, in reality risk analysis is highly iterative and ongoing, with many feedback loops and steps that are repeated as needed, or as better information is developed. A unifying overall characteristic is repeated interaction between and among risk managers, risk assessors and other participants. Risk analysis also does not end once a decision is reached and implemented. Members of the risk analysis team and others (e.g. industry) regularly monitor the success and impact of their decision, and may make modifications to control measures that have been implemented if that is indicated from new information being incorporated in the risk analysis.

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.

1.3. Benefits for national governments of using food safety risk analysis

Applying risk analysis to food safety problems offers many advantages to all parties with a stake in these matters. Risk analysis supports taking decisions that are in proportion to the public health risks involved, and systematic evaluation of likely impacts of specific measures chosen to manage those risks. Risk analysis allows likely costs of compliance to be compared with expected benefits, and supports setting priorities among different food safety problems. By using risk analysis where practical and feasible, governments meet their obligations under the SPS Agreement and strengthen their basis for trading foods internationally. For instance, by helping to objectively demonstrate the absence of hazards or the effective control of hazards to produce safe food, risk analysis provides a solid basis to increase trade access to new markets. In addition, risk analysis identifies gaps and uncertainties in scientific knowledge on risks, which can help set research priorities and contribute in the long term toward improved understanding of food-related impacts on public health. For all of these reasons, risk analysis is the preferred approach for establishing food safety control measures.

1.4. Suggestions for further reading

FAO. 2003. Food Safety: Science and Ethics. Report of an FAO Expert Consultation. Rome, 3-5 September 2002. FAO Readings in Ethics 1 (available at ftp://ftp.fao.org/docrep/fao/006/j0776e/j0776e00.pdf).

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).

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. 15^th 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. 15^th 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 2^nd 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).

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Notes:
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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.

Source: FAO

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