The international food safety environment is currently in a unique period of reevaluation and change. In an emerging trading environment regulated more according to food safety requirements than nontariff trade protection barriers, food safety risk analysis is pivotal to future Codex activities and implementation of the World Trade Organisation (WTO) Sanitary and Phytosanitary (SPS) Agreement. Development of guidelines for food safety risk assessment requires determination of scope, internationally agreed definitions, general principles, guidelines tailored for each class of foodborne hazards, and linkages and interactions with risk management and risk communication. Food safety risk assessments need to be soundly based on science, should incorporate the four analytical steps of the risk assessment paradigm, and should be documented in a transparent and readily understandable form. The particular needs of Codex, the WTO, national governments, industry, and consumers need to be taken into account, and this includes identification of the essential linkages between risk assessment and the design of HACCP plans. With respect to chemical hazards in food, a risk assessment approach provides the opportunity to broaden the understanding of acceptable daily intakes, maximum residue levels, and their public health significance. Guidelines for chemicals in foods will inevitably have to address the differences between safety evaluation and a genuine risk assessment approach. With respect to microbiological hazards, the unique problems associated with risk assessment of living organisms in food make it likely that application of guidelines in the medium term will more commonly use qualitative approaches. In the absence of a history of safety evaluation according to a notionally zero risk baseline, as is the case with chemicals, the objective of microbiological risk analysis to reduce microbial risks to “the minimum which is technologically feasible and practical” represents a genuine focus for risk assessment. As risk assessment is increasing applied and internationally accepted guidelines become established, decision criteria for risk management arguably present the greatest challenge in establishing and maintaining quantitative SPS measures for food in international trade and judging their equivalence. However, the desire of all interested parties for scientifically justified food safety measures may be tempered according to the ability of the global scientific community to generate the necessary data and the political will to accept food safety programmes in different countries that have equivalent outputs.
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