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| Agenda Item 4.2 | GF 01/4 |
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FAO/WHO Global Forum of Food Safety Regulators Sharing information on national experiences in the general field of risk managementPaper submitted by the Delegation of France
II. How can food safety regulators manage a known or future risk to protect the health of consumers? III. What is the role of food chain professionals in risk management? It must now be acknowledged that food safety is a priority for consumers. They want safe, healthy food which will keep them healthy. It is the responsibility of food safety authorities to meet consumers' expectations and to guarantee them a high level of health protection, by adopting the necessary measures. Risk management is one of the essential tools for setting up food safety systems and it seems appropriate to share experiences in this field so that all the countries have access to information which will allow them to adopt the necessary measures to protect the health of consumers. The subject of risk management is a broad one; the discussion group on "Sharing information on national experiences in the general field of risk management" is to discuss two specific topics in detail: "Reduction in foodborne hazards, including microbiological and others, with emphasis on emerging hazards" and "Integrated approaches to the management of food safety throughout the food chain". I would like to go beyond that in introducing the discussion group debates by touching on the various aspects of this subject and the ways in which risk managers and policy makers can approach it. I. FIRSTLY, WHAT IS RISK MANAGEMENT?It is primarily one of the three aspects of risk analysis, the others being risk evaluation and risk communication. The Codex Alimentarius has adopted the following definition: risk management is the process of weighing up the various possible policies, taking account of the evaluation of risks and other factors involved in the health protection of consumers and the promotion of fair trade practices, and taking decisions accordingly, i.e. choosing and implementing the appropriate prevention and monitoring measures. The management of food-related risk is therefore a political prerogative which involves balancing the recommendations formulated by the experts commissioned to scientifically evaluate the risks, and the resources of all types that social and commercial groups and manufacturers can set aside for dealing with these risks. II. HOW CAN FOOD SAFETY REGULATORS MANAGE A KNOWN OR FUTURE RISK TO PROTECT THE HEALTH OF CONSUMERS?1. By basing policies and measures adopted on an evaluation of the risks This is not merely a recommendation but a duty for member countries of the World Trade Organization (WTO). The WTO Agreement on the Application of Sanitary and Phytosanitary measures (SPS Agreement) states, in fact, that WTO members should base their sanitary and phytosanitary measures on risk evaluation. It should be noted, in this respect, that risk evaluation is a scientific process consisting of stages of identifying and characterizing the dangers, then evaluating exposure to these dangers in order to characterize the risk (probability that the danger will be expressed in real terms). Risk evaluation is a particularly important process in the case of new or emerging risks. Example: 2-3 years ago import controls in France frequently detected germs of the genus Vibrio parahaemolyticus on shrimps. Up to that time the discovery of those microbes led to the implementation of protective measures (destruction of batches) owing to the pathogenic nature of V. parahaemolyticus (one of the major causes of gastroenteritis from seafood). The discovery of an increase in the appearance of this germ led the risk manager to order a risk evaluation of this specific problem. This evaluation enabled the risk manager to define his position as follows: only strains of V. parahaemolyticus producing a toxin, haemolysin, are pathogenic; V. parahaemolyticus microbes producing haemolysins can be detected by molecular techniques. In the light of these conclusions, the risk manager altered his approach to the risk represented by V. parahaemolyticus as follows: destruction of any batch contaminated by a strain of V. parahaemolyticus with a gene for haemolysin; market distribution of other batches (on which non-haemolysin-producing strains of V. parahaemolyticus have been detected). Risk evaluation should also help to achieve a high level of consumer health protection. It is therefore important for risk evaluation which, it should be remembered, is used to draw up food safety regulations, to meet several criteria: excellence, i.e. a very high level of scientific expertise; independence, i.e. the greatest possible objectivity, and in particular no interaction with economic lobbies; transparency; useful, available scientific and technical information as a basis. In order to guarantee the independence and transparency of this high-quality scientific and technical information, some countries or regional interest groups have decided to separate risk evaluation from risk management, while considering interaction to be essential only from a pragmatic point of view. This strategy has, moreover, been recognized internationally since according to the Codex Alimentarius, there should be a functional separation between risk evaluation and management. Example: In France, a scientific body, the "Agence française de sécurité sanitaire des aliments"- the French agency for food safety - (Afssa) was set up by law in 1998, with responsibility for evaluating the health and nutritional risks which could affect food intended for humans and animals, including possible risks from water intended for human consumption. It had the further task of providing the scientific and technical support necessary for drafting regulations. This body has broad scientific powers applied to food safety, ranging from the production of raw materials (animal and plant products) to distribution to the end consumer. It is organized around committees of experts specializing in nutrition, microbiology, biotechnology, transmissible subacute spongiform encephalopathies, physical and chemical contaminants and residues, animal feed, contact materials, additives, technological auxiliary substances and flavours, animal health, and water supplies. The Afssa comes under the supervision of three ministries (agriculture and fishery; economy, finances and industry; and solidarity and employment); it issues independent scientific opinions. In order to guarantee its independence, the members of its specialized expert committees were appointed after a public call for candidates. Furthermore, along with 13 national specialized laboratories the Afssa constitutes a centre for research and technical support for French risk managers working in the field of food safety. Risk managers work closely with the agency. It is compulsory to consult the Afssa on any change in regulations related to food safety, and the Afssa can propose any measure it considers appropriate to protect public health. The Afssa is also a watchdog body which must be informative and transparent. Its opinions and recommendations are published. It has no powers of inspection. 2. The principle of precautionary measures, in the absence of sufficient scientific proof There is, however, an exception to the obligation to base sanitary and phytosanitary measures on a risk evaluation. This allows governments to adopt sanitary and phytosanitary measures even when the risk evaluation is incomplete and to use precautionary measures to protect their citizens. The SPS agreement (article 5.7) states that in cases where relevant scientific proof is insufficient, a WTO member country may provisionally adopt sanitary and phytosanitary measures based on the relevant information available. Under such circumstances, the countries should then strive to obtain the additional information necessary for a more objective evaluation of the risk and should re-examine the sanitary and phytosanitary measure accordingly, within a reasonable time-frame. Scientific uncertainty cannot, therefore, serve as an excuse for a decision-maker to fail to act in response to a food-related risk. Thus when a potentially dangerous and irreversible situation begins to emerge, but the scientific evidence is lacking for a full scientific evaluation, risk managers are legally and politically justified in adopting precautionary measures without waiting for scientific confirmation. It is, in fact, the responsibility of decision-makers to adopt the necessary measures to protect consumers. It should be noted once again in this respect that citizens are more demanding today than formerly as regards food safety. They give priority to health safety over other criteria which might have prevailed in the past, in a context in which the food supply is large enough to offer replacements. In order to explain the concept of the precautionary approach, I am going to give an example of its use in the risk management of the dioxin crisis in Europe in 1999. Example: This crisis began in late May 1999, when the Belgian authorities alerted the European Commission and other Member States to serious dioxin contamination of certain products of animal origin. The affair had begun in Belgium a few months earlier, in February, with the appearance of unusual clinical signs in poultry stock. The investigations conducted by the Belgian services found that these symptoms were related to poisoning of the stock by dioxin probably present in feed, and identified the animal feed manufacturer concerned as well as the company which prepared the fat used in the feed, which was the cause of the problem. The Belgian authorities then carried out traceability tests to determine the extent of the damage, informed the European Commission and other Member States, and decided to destroy all contaminated eggs and poultry. Bearing in mind the recognized carcinogenic effect of dioxin and the absence of specific information on the extent of the contamination (dioxin concentrations 700 times the limits set by the World Health Organization had been detected by the Belgian authorities in some foods), it was necessary to adopt emergency measures even though the risk evaluation was incomplete in various aspects. Although the danger, namely dioxin contamination, was known,
The following precautionary measures were consequently adopted:
In accordance with the SPS agreement, the community decision to ban the distribution within the community of products containing milk, eggs, meat and fat from Belgium and the protective measures adopted with regard to French production were amended, then progressively lifted as more precise information became available on the identification of the risk and exposure to the risk (analytical results, scientific opinions). To conclude, although the cost of this crisis was economically very great (384 flocks subject to restrictive measures, more than 9 million tonnes of animals and products of animal origin destroyed), it should be noted that the objective of the measures adopted, namely consumer protection, was understood and accepted by all parties involved. Consumers themselves were constantly kept up to date by decision-makers and did not lose confidence in the policy followed: they did not turn away permanently from the products affected by the crisis. Finally, no harmful effects of this contamination on human health have been identified to date, which tends to prove the effectiveness of the measures implemented. The example described shows that the principle of precautionary measures is used in very specific cases in the field of food safety. The risk manager, i.e. the decision-maker, applies this principle when there is a major risk to human health and if all the data necessary to evaluate the risk are not available. This approach, which is part of risk management, is not static, but evolves as additional scientific data become available within the framework of risk evaluation, in accordance with the provisions of the WTO SPS agreement. Although the application of a precautionary measure can temporarily cause commercial restrictions or hindrances, it cannot be described as protectionism since it is a tool which allows risk managers to implement temporary measures which can evolve as the availability of scientific data evolves, and which have as their sole aim the protection of the health of consumers, animals, or plants, a right recognized by the same agreement. This is indeed the intention of the resolution adopted by the European Council at Nice. Member States of the European Union focused on setting out in this resolution the guidelines for the use of precautionary measures and management of their application by the relevant State authorities. They recognized that when a multi-disciplinary, adversarial, independent, transparent evaluation, based on the available data, has failed to yield a definite conclusion regarding the risk level, risk management measures must be taken based on a political assessment of the level of protection sought. They also stated that these measures must, where a choice is possible, represent the solutions that are least restrictive for trade, respect the principle of proportionality while taking into account the long- and short-term risks, and be re-examined in the light of evolving scientific knowledge. The Council then emphasized the importance of consultation and adequately informing the general public. It should also be noted that when dealing with a public generally reacting emotionally given the lack of scientific data concerning a risk or the uncertainty of the extent of the risk, the precautionary principle also aims to manage expectations as regards additional scientific information. It should moreover be emphasized that health risks exist all over the world, they are amplified by the globalization of trade and can pose a serious threat to developed as well as developing countries which may be particularly vulnerable in this respect. The implementation of the precautionary principle should not therefore be confined to the most highly developed countries, but should also be perceived as a factor of development allowing the destructive consequences of potential major health incidents to be avoided. 3. The "farm to table" approach To be sure of the safety of foodstuffs, all aspects of the food production chain in continuity must henceforth be considered, from primary production (including animal protection and health aspects) and the production of animal feed, to the distribution of foodstuffs to the end consumer. Each component may have an impact on food safety. Examples: In the 1999 dioxin crisis in Belgium, the high levels of dioxin contamination in some products of animal origin were shown to be due to animals ingesting dioxin in their feed. Elsewhere, the detection of salmonella in food can be caused not only by poor hygiene in agri-food companies, but also by salmonella contamination of the animals from which the foodstuffs are made. Socio-economic changes over the last 30 years make for an integrated approach to food safety. The following are of particular relevance:
This integrated approach to risk management has a number of advantages. The following lessons can be learned from the French experience of the subject. This approach facilitates the circulation of information, the implementation of decisions and the application of checks. It allows better coherence and greater effectiveness not only of epidemiosurveillance networks, i.e. the gathering of information on human and animal diseases, but also of measures to control zoonotic diseases (salmonellosis for example) and food contaminant surveillance plans. This process monitoring approach has proved to be essential in the management of risks related to bovine spongiform encephalopathy: coherent monitoring from the farm (epidemiological surveillance) to distribution (traceability of meat), via the abattoir (withdrawal of specified hazardous material, for example). Finally, this approach is one way of guaranteeing the traceability of foodstuffs and also of reassuring the consumer, at a time when consumer demands as regards food safety are increasing and confidence is falling (emerging diseases, extensive industrialization of the process, innovations and new technologies). I will not dwell on this subject; it will be covered in the discussion group. 4. Traceability Traceability is an essential requirement in guaranteeing food safety. When a danger threatens (for example food poisoning), the risk manager should be able to determine the food responsible, rapidly carry out a precise, targeted withdrawal of dangerous products, inform consumers or agents in charge of monitoring foodstuffs, go back along the whole length of the food chain if necessary to identify the source of the problem, and put it right. Traceability studies thus allow risk managers to limit exposure of consumers to the risk and thus the economic impact of the measures by targeting products at risk. For it to be effective, the traceability system must involve all stages in the pathway, from the live animal or raw material to the product undergoing final processing, from stock-rearing to food sector companies via companies in the animal feed sector. Example: All cattle in the European Union are identified. Animal movements within the EU can be followed on a computerized system called the ANIMO network. When the animals are slaughtered, the abattoir keeps a record of the animal's details and has a traceability system which allows it to trace the resulting carcasses to an animal. The carcasses are stamped to identify the abattoir from which they come. Furthermore, when meat is put on the market, it is accompanied by a document stating in particular the source establishment and the destination establishment. This type of system is present at each subsequent level of product processing. 5. Management of health risks in an emergency and in emerging risks Despite the checks carried out by risk managers, incidents are always possible. To ensure consumer safety, it is important that risk managers are informed as soon as possible of an incident and have access to the most precise possible evaluation of the risk in order to be able to implement the necessary measures and avert the danger. Health surveillance is thus vital, and within this framework the circulation of information is essential. Sources of alarms can be varied. I could mention monitoring services at departmental* or central level, production or distribution companies, the embassy of another country, or an international organization, or in the particular case of the European Union, the rapid warning network. A Member State which learns of a serious anomaly in the field of food safety can use the rapid warning network to warn all the other Member States and the European Commission so that they can rapidly assess any danger to which they may be exposed. Scientists, the media, and consumer associations are also sources of warnings. Furthermore, managing health risks in an emergency or emerging risks requires good cooperation between the monitoring services in charge of food safety and effective procedures for withdrawing suspect products from the market. Example: In France, a health surveillance provision was set up by law in 1998. It involved creating the Institute of Health Surveillance (IVS) which relies on interregional epidemiology cells and departmental* directorates of health and social affairs. The IVS has 3 tasks:
This is the provision whereby, for example, groups of cases of human listeriosis can be identified and action coordinated as rapidly as possible between all the authorities responsible for risk management (the Ministry of social affairs and employment, the Ministry of agriculture and fishery, the Ministry of the economy, finances and industry) to identify the food responsible for the infection. 6. Taking account of socio-economic concerns The implementation of regulations aimed at protecting consumer health can be effective only if the risk manager is aware of the resources that companies and manufacturers can set aside for managing risks. One recommendation is thus to bring together professionals involved in drafting regulatory texts to hear their opinions. This is what happens in France. Various bodies are involved, from the purely professional (national association for agri-food industries, trade unions, health defence groups) to the multi-disciplinary (National Food Council and National Consumer Council, for example). It is recognized, in this respect, that in some cases risk evaluation cannot on its own provide all the information on which to base a risk management decision. In response to the expectations of the general public and consumers, other relevant factors should legitimately also be taken into consideration, notably social and economic factors (technical feasibility, economic impact), traditional and ethical factors (animal well-being) and environmental factors, as well as the feasibility of inspections. III. WHAT IS THE ROLE OF FOOD CHAIN PROFESSIONALS IN RISK MANAGEMENT?The first responsibility of professionals is the marketing of their products. They can participate in the policy to improve food safety in various ways. 1. Self-monitoring and company laboratory accreditation Agri-food companies can monitor the health quality of the foodstuffs they produce by carrying out, on their own initiative, laboratory analyses of their products and by appropriate monitoring of the production processes: this is called self-monitoring. They can thus act immediately, where necessary, in advance of official checks, to remedy a health problem (for example, when a hygiene problem is identified). These companies can use an external laboratory, or have their own analytical laboratory. To give their analyses the necessary credibility, companies can seek accreditation of their own analytical laboratory. They can thus give guarantees of reliability and transparency recognized by the regulatory authority and by their clients. 2. Guides to good hygiene practice In France, several production processes have guides to good hygiene practice recommended by the risk manager (French and Community regulations). These guides, produced by professional organizations and validated by the relevant authority on the scientific advice of the Higher Council of public hygiene of France, are based on the implementation of the HACCP system which defines methods for the monitoring and surveillance of specific identified risks. 3. The development of company certification This is a voluntary system which involves having the quality management strategy of a company certified. Certification is carried out in France by an independent and accredited organization, such as the French Association for Quality Assurance (AFAQ). More than 1000 French industrial agri-food sites already have a quality assurance certificate resulting from the implementation of ISO 9000 standards. The association suggested by consumers between protecting the environment and the health of the general public has recently led companies to move towards environmental management systems (the ISOI 14000 procedure). 4. Product standardization Standards signal the will to accept a number of commitments. Many companies are thus setting up technical reference systems which describe the characteristics of products, the manufacturing process or analytical and control methods, as a result of a voluntary strategy. This practice is well established in France; the French Standardization Agency (AFNOR) is coordinating the drafting of these standards. 5. Contribution to product traceability This involves setting up and keeping up-to-date written procedures concerning information recorded and product or product batch identification, using appropriate methods, in order to trace the origin and determine the production and distribution conditions of these products or product batches. Traceability is an essential component of product certification or quality assurance certification systems, and increasing numbers of French agri-food sector companies are putting it into practice. 6. Distribution Self-monitoring and quality management systems can be set up at the distribution stage. This is not an exhaustive presentation of the subject of risk management. It provides a number of pointers as regards the risk management tools available to food safety regulatory heads and professionals, with a view to meeting consumer concerns and expectations.
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