文章基本信息

标题：Precision requirements in pesticide risk assessments: Contrasting value-of-information recommendations with the regulatory practice in the EU
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作者：Timo Goeschl ; Daniel Heyen
期刊名称：Discussion Paper Series / Universität Heidelberg, Department of Economics
出版年度：2016
出版社：Universität Heidelberg, Department of Economics
摘要：Pesticides, while rendering immense agricultural benefits, potentially entail risks to human health and the environment. To limit these risks, market approval of a p esticide is typically conditional on an extensive risk assessment demonstrating its safety. The asso ciated testing procedures, often involving significant numbers of animals, however are not only costly; as has b ecome apparent from recent discus- sions about the active substance glyphosate, testing is often incapable of providing definitive answers on concerns like human carcinogenicity. An important regula- tory task, whether explicitly acknowledged or not, is hence to decide what level of remaining uncertainty is deemed acceptable in making the final market approval decision. Economic principles suggest a value-of-information (VoI) approach for this informational task. After presenting the basics of the VoI framework, this pa- per analyzes the actual regulatory practice in the EU's pesticide approval process, pointing out the defaults and substance-specific procedures that shape the precision of the European Foo d Safety Authority's (EFSA) risk assessment and hence the level of knowledge under which the European Commission decides on the approval of substances. The comparison between theory and practice uncovers substantial de- viations, providing valuable insights for restructuring the risk assessment guidelines
关键词：risk assessment; pesticide; regulation; value-of-information; animal ; testing; uncertainty; active learning