Nilsson R, Tasheva M, Jaeger B
Department of Genetic and Cellular Toxicology, Wallenberg Laboratory, University of Stockholm, Sweden.
Regul Toxicol Pharmacol. 1993 Jun;17(3):292-332. doi: 10.1006/rtph.1993.1033.
The main objective of this analysis has been to characterize the role of science, in a broad sense, in relation to social, economical, political, and other factors in explaining why regulatory decisions vary in different countries, although they are based on more or less identical scientific data. Eleven countries from different geographical areas and with varying cultural background have provided information in response to an extensive questionnaire aimed at identifying procedures for registration, restricting, or banning registration for certain selected pesticides. Although many of these responses lacked sufficient detail in certain aspects, together with other documentary sources they nonetheless provided insight with respect to some of the main concerns among and between nations regarding decisions in pesticide management. Among the main conclusions presented in this analysis, the following deserves particular emphasis: The underlying reasons for introducing restrictions on pesticide use on the national level will have to be more explicitly stated and openly declared by regulatory bodies of all nations. Although more pronounced in some countries, there is a strong influence of nonscientific considerations in pesticide management, that is not always based on rational considerations. In the field of hazard and risk assessment differences in scientific opinion have primarily, but not exclusively been identified regarding the evaluation of carcinogenic effects in experimental animals. In this area debated issues are the interpretation of the significance for man of certain types of tumors, methods for dose-response extrapolation, genotoxic versus nongenotoxic carcinogens, the use of MTD in long-term studies, mechanistic approaches to interpret cancer induction, and others. Another area identified to cause divergence is exposure assessment. Evaluation of pesticides on the national level for the purpose of regulation involves a tremendous duplication of efforts that could be substantially reduced by effective cooperation on the international level.
本分析的主要目的是从广义上描述科学在与社会、经济、政治及其他因素相关联时所起的作用，以此解释为何尽管基于或多或少相同的科学数据，但不同国家的监管决策却存在差异。来自不同地理区域、具有不同文化背景的11个国家针对一份广泛的调查问卷提供了信息，该问卷旨在确定某些选定农药的登记、限制或禁止登记程序。尽管这些答复中有许多在某些方面缺乏足够的细节，但与其他文献资料一起，它们仍就各国之间以及国家内部在农药管理决策方面的一些主要关切提供了见解。在本分析提出的主要结论中，以下这点值得特别强调：各国监管机构必须更明确地说明并公开宣布在国家层面上对农药使用实施限制的根本原因。尽管在某些国家更为明显，但在农药管理中存在非科学因素的强烈影响，而且这种影响并不总是基于理性考虑。在危害和风险评估领域，关于实验动物致癌效应的评估，科学观点存在主要但并非唯一的差异。在这一领域存在争议的问题包括某些类型肿瘤对人类的意义的解释、剂量反应外推方法、遗传毒性致癌物与非遗传毒性致癌物、长期研究中最大耐受剂量的使用、解释癌症诱发的机制方法等等。另一个被确定会导致分歧的领域是暴露评估。为监管目的在国家层面上对农药进行评估涉及大量的重复工作，而通过国际层面的有效合作，这些工作可大幅减少。
