Hathaway Steve C
Regulatory Authority of the Ministry of Agriculture, P.O. Box 646, Gisborne, New Zealand.
J Food Prot. 1997 Nov;60(11):1432-1438. doi: 10.4315/0362-028X-60.11.1432.
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.
当前,国际食品安全环境正处于一个重新评估和变革的特殊时期。在一个更多依据食品安全要求而非非关税贸易保护壁垒进行监管的新兴贸易环境中,食品安全风险分析对于未来食品法典委员会的活动以及世界贸易组织(WTO)《卫生与植物卫生措施协定》(SPS协定)的实施至关重要。制定食品安全风险评估指南需要确定范围、国际商定的定义、一般原则、针对各类食源性危害量身定制的指南,以及与风险管理和风险沟通的联系与互动。食品安全风险评估需要有坚实的科学依据,应纳入风险评估范式的四个分析步骤,并应以透明且易于理解的形式记录。需要考虑食品法典委员会、WTO、各国政府、行业和消费者的特殊需求,这包括确定风险评估与危害分析关键控制点(HACCP)计划设计之间的基本联系。就食品中的化学危害而言,风险评估方法为拓宽对每日允许摄入量、最大残留限量及其公共卫生意义的理解提供了契机。食品中化学物质的指南必然要解决安全评估与真正的风险评估方法之间的差异。就微生物危害而言,与食品中生物风险评估相关的独特问题使得中期应用指南更可能采用定性方法。与化学物质不同,食品微生物风险分析没有基于理论上零风险基线的安全评估历史,其将微生物风险降低到“技术上可行且实际可行的最低水平”这一目标代表了风险评估的真正重点。随着风险评估的应用日益广泛且国际认可的指南得以确立,风险管理的决策标准无疑是在国际贸易中建立和维持食品定量SPS措施并判断其等效性方面面临的最大挑战。然而,所有利益相关方对科学合理的食品安全措施的期望可能会根据全球科学界生成必要数据的能力以及接受不同国家具有同等成效的食品安全计划的政治意愿而有所缓和。