Proposal of critical appraisal tools for the evaluation of ecotoxicology studies
Meta data
Disclaimer: The present document has been produced and adopted by the bodies identified above as authors. This task has been carried out exclusively by the authors in the context of a contract between the European Food Safety Authority and the authors, awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. The European Food Safety Authority reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the authors.
The critical appraisal tools (CATs) are the outcome of the contract procurement OC/EFSA/PREV/2020/01 for the development of critical appraisal tools for the evaluation of ecotoxicology studies.
The use of these draft CATs and their accompanying handbooks is not currently mandatory in the framework of the peer‐review for active substances at European level but establishes a methodology for ensuring the harmonised appraisal of a number of studies for which standard agreed guidelines/guidances are not in place.
Eventual changes may also occur in those documents in light of their use in a testing phase. Risk assessors in ecotoxicology are encouraged to test them outside of the regulatory context and provide recommendations for their improvement in a later stage.
Abstract
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.