Proposal of critical appraisal tools for the evaluation of ecotoxicology studies

According to Regulation (EC) No 1107/2009, pesticide active substance to be approved shall not pose unacceptable effects for human health, animal health and the environment. For this purpose, applicants must submit a dossier, containing a data package including ecotoxicity studies in line with the EU data requirements. The evaluation of such studies, particularly when a standard test guideline is not available, may be challenging and result in inconsistent outcomes. The scope of the procurement described in this report was to develop Critical Appraisal Tools (CATs) to support the evaluation of seven types of non‐standard higher tier ecotoxicity studies submitted with these dossiers (for both aquatic and terrestrial risk assessment: aquatic organisms, bees, non‐target arthropods other than bees, birds and mammals). CATs provide a structured and transparent approach to assess the internal and external validity (i.e., reliability and relevance) of individual studies. The project included a systematic literature review of existing CATs and study evaluation methods in ecotoxicology and environmental risk assessment. Based on this review, it was decided to base the CATs to be developed on the CRED approach (Criteria for Reporting and Evaluating Ecotoxicity Data) for evaluating reliability and relevance of studies. The CATs consist of MS Excel spreadsheets with criteria and scoring tables, accompanied by handbooks with detailed instructions for appraising the individual criteria. A method for evaluating the overall validity of these ecotoxicity studies, based on both a (semi‐) quantitative scoring system and expert judgement, is also proposed. The adoption of common appraisal tools will enhance the harmonisation and transparency of the study evaluations performed by the experts in the area of ecotoxicology and it will increase the trust of the scientific assessments conducted by National competent authorities and EFSA.