Operational, procedural and scientific challenges for industries regulated by the European Food Safety Authority EFSA have been identified recently by 11 industry associations in Europe representing > 10000 companies. EFSA guidance development and resulting impact on pesticide exposure assessment for industry is specifically of concern. EFSA aims to develop regulatory guidance according to best scientific knowledge. Pressure on EFSA over supposed influence from notifiers, despite the lack of examples, has led to a very narrow definition of conflict of interest. As applied by EFSA, this frequently leads to the exclusion of scientists � generally from industry but also from academia � with relevant practical experience in risk assessment as well as in the development and application of guidance. Academic conflicts of interest arising from research and the requirement for funding are often ignored. Regulatory science should be developed on practical, transparent, accessible and open basis. By involving all stakeholders, a much more efficient process could be established. This would assure not only practicability and completeness of new guidance, but also the opportunity to highlight consequences and impacts early in the process, thus promoting discussion and dialogue. Concrete examples of the practical implications and impact of EFSA guidance in the area of exposure assessment are given from recent guidance papers on protected crops, DegT50 and exposure scenarios for soil.

Practical implications and impact of the guidance development on pesticide fate and exposure assessment by the European Food Safety Authority (EFSA) for industry stakeholders

248th National Meeting (2014)

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