Classification of food hazards
Process of risk analysis
Harmonization of risk analysis
A.J. Whitehead and C.G. Field
Anthony Whitehead is a Senior Officer (Food Quality Liaison Group) and Colin Field is a Food Control Officer for the Food Quality and Standards Service, Food and Nutrition Division, FAO.
Every day, all people face many dangers or hazards, including hazards related to they food the consume, Hazards associated with food can and do result in injury and harm to human health. Millions of people worldwide suffer from some sort of food poisoning each year. Uncontrolled and abusive application of agricultural chemicals, environmental contamination, use of unauthorized additives, improper food quality control and handling practices during food processing and other abuses of food along the food chain can all contribute to the introduction of hazards or the failure to reduce hazards related to food. The effects on human health of hazards associated with food, the increasing importance and rapid growth of world food trade and the demand by consumers for a safe food supply make the analysis of the risks associated with food more important today than ever before.
Consumers have expressed concern about the safety of food additives, agricultural and veterinary chemical residues, biological, chemical and physical contaminants, radionuclide contamination and uncontrolled and unacceptable food handling practices and processing which can result in the introduction of hazards to food at all stages along the food chain, from primary production to the consumer, These concerns have been voiced most often by consumers in developed countries, but improvements in global communication have heightened the interest of consumers throughout the world regarding these matters.
Food hazards can be classified into three categories: physical, chemical and biological. Physical hazards (e.g. stones in rice or beans; bone pieces in meat) are most likely to be understood by people. Far more complex and less understood is the nature of the impact of chemical and biological hazards oh human health because of the complexities of the interaction between the hazard and human biochemistry and the absence of empirical data to confirm the theories. Human responses to disease or agents that cause adverse reactions are dependent on a number of variables, many of which are interlinked. Also, one person may experience severe health effects, another mild effects and a third no effect at all.
The risks to the world's population from hazards associated with food depend largely on the degree to which producers and official food control authorities act to prevent or minimize the risks to acceptable safe levels. Unfortunately, there is no such thing as "zero risk" for food (or for anything else). Consequently, analysis is needed to determine what the hazards are and to identify their immediate, interim and long-term effects on human health, Analysis is needed to establish the appropriate measures of control to prevent, reduce or minimize these risks and the best way to communicate this information to the affected population, This is the risk analysis process, which consists of three elements: risk assessment, risk management and risk communication.
The risk associated with any hazard in food can be assessed, Risk assessment is the first element in the risk analysis process. It involves four steps:
· hazard identification: identification of the hazard, the danger it presents, the impact in terms of human health and the circumstances under which it has an impact;
· hazard characterization: qualitative and/or quantitative evaluation of the adverse effects of the hazard on human health;
· exposure assessment: qualitative and quantitative evaluation of the degree of consumption or intake of the hazardous agent that is likely to occur;
· risk characterization: integration of the three prior steps into an estimate of the adverse effect likely to occur in the target population.
The entire risk assessment process requires the use of sound and scientifically derived information and the application of established scientific procedures carried out in a transparent manner. Unfortunately, sound scientific information is not always available to make the qualitative and quantitative evaluations necessary for absolute certainty about the final decision; consequently a degree of uncertainty must be factored into the decision, The degree of uncertainty can often lead to an improper or misleading decision which confuses the public and scientific experts alike.
Hazards in food can be controlled by establishing safe handling procedures and practices, food processing quality and safety assurance controls and food quality and safety standards, These standards must take into consideration the proper use of food additives at permitted levels that have been determined to be safe and scientifically determined acceptable safe limits for contaminants and agricultural chemical residues in food established using the risk assessment process. These controls, undertaken with other socio-economic and cultural considerations, make up the risk management element of the risk analysis process.
While research and scientific studies continue to provide answers needed to make informed decisions in risk analysis related to hazards in food, uncertainty and unresolved questions still cause concern to decision-makers, Only continued research and scientific study can provide the answers needed, Until these answers are available, much of the knowledge about the hazards as well as assessing and controlling the risk is based on partial information with the uncertainties factored into the analysis.
Communicating the results of the risk analysis process serves many purposes, It provides the public with the results of expert scientific review of food hazard identification and an assessment of the risks to the general population or specific target groups such as infants or the elderly, Certain people, such as those who are immunodeficient, allergic or nutritionally deficient, have a special need for information. Communication provides the private and public sectors with the information necessary for preventing, reducing or minimizing food risks to acceptably safe levels through mandatory or voluntary systems of food quality and safety management. It also provides sufficient information for the populations with the greatest level of risk with respect to any particular hazard to exercise their own options to achieve even greater levels of protection, Risk communication is the final element of the risk analysis process.
One means by which risks related to food are reduced or minimized to acceptable safe levels is through the establishment of food quality and safety standards, Establishing these standards for food has been the role of the Joint FAO/WHO Food Standards Programme, through the Codex Alimentarius Commission, since its beginning in 1962, Since that time, science has contributed considerable information to the scientific evaluation of hazards and the assessment of the associated risks. The Codex Alimentarius Commission has used this scientific information in setting quality and safety standards for food in international trade, These standards, along with the many codes of practice, guidelines and other recommendations prepared by the commission, also serve national governments as guides and models for national food standards, However, there is a continuing need to update this guidance as new information is being developed constantly in this field.
An expert consultation
Also important is the need to harmonize the process of risk analysis so that comparable results can be derived from country to country and harmonized standards can be established for food distributed throughout the world, The most recent attempt to harmonize the method of risk analysis related to food standards, particularly the component of risk analysis dealing with the scientific issues related to risk assessment, was the Joint FAO/WHO Expert Consultation on Risk Analysis Related to Food Standard Issues, held in Geneva from 13 to 17 March 1995, This expert consultation was convened at the request of the Executive Committee of the Codex Alimentarius Commission to ensure that the food standards work of the commission was keeping abreast of modern developments.
The Executive Committee was aware of the heavy onus on the Codex Alimentarius Commission to ensure consistency and transparency in the establishment of its international food standards. In particular, the decisions related to health issues that have come out of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT), as embodied in the Agreement on the Application of Sanitary and Phytosanitary Measures (the SPS Agreement), have placed emphasis on risk analysis in implementing sanitary and phytosanitary measures.
FAG and WHO invited experts from Brazil, India, Japan, New Zealand, South Africa, Sweden, Thailand and the United States to participate in the expert consultation. Observers from a number of Codex committees and from other relevant international organizations also attended. The experts attended the meeting in a personal capacity rather than as representatives of their employers or governments.
The consultation was requested "to recommend to FAO, WHO and the Codex Alimentarius Commission, the most appropriate approaches to the application of risk analysis, including risk management, to food standards and food safety issues", The experts were told that in developing their recommended approach, they were to take into consideration the needs of FAO and WHO in food standards development and application, as well as the wider needs of FAG and WHO member countries in relation to food standards and food safety issues, They were asked to provide, to the greatest extent possible, an applied approach suitable for early adoption by FAO, WHO and the Codex Alimentarius Commission and its advisory and subsidiary bodies.
The subject of risk analysis is complex and comprehensive; consequently, the consultation restricted itself to risk assessment and the mechanisms that the Codex Alimentarius Commission should use in this pivotal phase of food standards setting. Despite this focus, the consultation recognized that risk management and risk communications have a number of significant interfaces with risk assessment, For example, risk management is often taken into consideration in establishing priorities and policies for risk assessment.
The consultation commenced by agreeing on a number of definitions for food safety risk analysis and on a model for risk assessment which consisted of four distinct methodologies, namely, hazard identification, hazard characterization, exposure assessment and risk characterization. These definitions and the model are currently being considered by the Codex Alimentarius Commission for use throughout the Codex Alimentarius system.
The consultation considered current Codex practices in the context of the risk assessment model it had adopted and recommended several changes. In general, the consultation supported the separation of risk assessment and risk management activities. This separation was considered important to maintain the scientific integrity of the risk assessment decisions before introducing other non-scientific considerations which are required for risk management decisions. The separation was also seen as particularly important in the light of the SPS Agreement, The consultation also recommended that the assessment of exposure to hazards be strengthened, and that risk managers in the Codex Alimentarius system be informed of the degree of uncertainty associated with advice given them by risk assessors.
Regarding risk assessment for chemical hazards, the consultation stressed the need for better information if risk assessment was to be improved. Of particular importance is better knowledge of how specific chemicals act on life processes. While recognizing that only rarely would all the necessary information be available, the consultation expressed the opinion that the Codex Alimentarius Commission had a responsibility to force technology (i.e. to use the existing technology to the fullest extent possible to force research and development of new technology) and strongly recommended the development of further knowledge.
The consultation next turned its attention to estimating risk from biological agents. It recognized that though less is known about the process of evaluating microbiological risks, they pose in many ways a bigger and more immediate problem to human health than risks associated with chemicals. The consultation found that while it would be possible to develop useful techniques for assessment of biological risks, more information and knowledge would be needed to develop an understanding of the mechanisms of pathogenic agents and to reduce the level of uncertainty.
The association of uncertainty with risk analysis was also a subject of consideration. The consultation recognized that the process of risk assessment inevitably leads to an estimate of the risk to human health or life, and when that estimate is expressed in numbers, the numbers are often perceived to be highly accurate. Recognizing that in reality such numbers usually have large boundaries of uncertainty about them, the consultation pointed out that risk managers must understand the nature of the uncertainty when weighing risk management options.
A number of specific recommendations were made, most of them directed at the Codex Alimentarius Commission. These were considered by the twenty-first session of the commission, and in view of the process followed and the prestige of the experts at the consultation, they were adopted, FAO recognizes that, important though it was, the joint FAO/WHO expert consultation on the application of risk analysis to food standards was only a step along an important path. FAO is in the process of considering the need for further expert consultations on risk analysis to extend the issues beyond risk assessment to the areas of risk management and risk communication.
The report of the expert consultation has been published in English, French and Spanish and has been distributed to all Codex Contact Points, Copies of the report may be obtained by writing to the Chief, Food Quality and Standards Service, Food and Nutrition Division, FAO, Viale delle Terme di Caracalla, 00100 Rome, Italy.