Dragula C, Burin G
Technology Sciences Group Inc., Washington, DC 20036, USA.
Regul Toxicol Pharmacol. 1994 Dec;20(3 Pt 1):337-53. doi: 10.1006/rtph.1994.1079.
Risk assessment harmonization has become an important issue on the environmental agendas of numerous countries. The benefits of an international consensus on risk assessment methodologies include decreased duplication of toxicity testing through the sharing of experimental data, decreased barriers to trade, and more consistency and cooperation within the scientific community. This paper presents the findings of an international survey of regulatory scientists in OECD and select non-OECD countries. The survey was sponsored by the International Programme on Chemical Safety (IPCS), which itself was formed by a cooperative agreement between the World Health Organization, the International Labor Organization, and the United Nations Environment Program. The survey results represent the first step in a project initiated by the IPCS to harmonize risk assessment methodologies used worldwide for the toxicological evaluation of chemicals. In this phase, the primary focus was on the health risk assessment of pesticides. Participants responded to questions regarding: (1) the support or review documents relied on for performing risk assessments; (2) procedures used and criteria applied when evaluating carcinogenicity data, including issues relating to mechanism of action, the maximum tolerated dose, and doses used in carcinogenicity bioassays; (3) risk assessment methodologies, such as the use no effect levels with safety factors or risk assessment models; (4) methods for assessing occupational and dietary exposure to pesticides; and (5) the primary areas of interest for the commencement of international harmonization efforts. There was significant consensus on specific issues relating to risk assessment methods and carcinogenicity assessment, as well as strong positive support for international harmonization activities. Differences existed with respect to the doses used in bioassays and data interpretation.
风险评估协调已成为众多国家环境议程上的一个重要问题。就风险评估方法达成国际共识的好处包括：通过共享实验数据减少毒性测试的重复工作、降低贸易壁垒以及科学界内部增强一致性与合作。本文介绍了对经合组织（OECD）及部分非经合组织国家的监管科学家进行的一项国际调查的结果。该调查由国际化学品安全规划署（IPCS）赞助，IPCS本身是由世界卫生组织、国际劳工组织和联合国环境规划署之间的合作协议组建而成。调查结果是IPCS发起的一个项目的第一步，该项目旨在协调全球用于化学品毒理学评估的风险评估方法。在这个阶段，主要重点是农药的健康风险评估。参与者回答了有关以下方面的问题：（1）进行风险评估所依据的支持文件或审查文件；（2）评估致癌性数据时使用的程序和应用的标准，包括与作用机制、最大耐受剂量以及致癌性生物测定中使用的剂量相关的问题；（3）风险评估方法，例如使用带有安全系数的无效应水平或风险评估模型；（4）评估职业和膳食中农药暴露的方法；以及（5）开展国际协调工作的主要关注领域。在与风险评估方法和致癌性评估相关的具体问题上存在显著共识，并且对国际协调活动给予了有力的积极支持。在生物测定中使用的剂量和数据解释方面存在差异。
