4.2 Article

Application of Evidence-Based Methods to Construct Mechanism-Driven Chemical Assessment Frameworks

Journal

ALTEX-ALTERNATIVES TO ANIMAL EXPERIMENTATION
Volume 39, Issue 3, Pages 499-518

Publisher

SPEKTRUM AKADEMISCHER VERLAG-SPRINGER-VERLAG GMBH
DOI: 10.14573/altex.2202141

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The workshop aimed to explore the integration of evidence-based methods with mechanistic evidence evaluation, specifically focusing on their application in the development and assessment of adverse outcome pathways (AOP) in chemical risk assessment. The discussions revolved around assessing certainty in AOPs, literature-based AOP development, and the incorporation of certainty and non-animal evidence into decision frameworks. Challenges related to methodology were identified, leading to recommendations such as aligning the processes of AOP development and systematic review methodology, improving evidence mapping and text mining methods, and fundamentally changing the approach to chemical risk and uncertainty assessment.
The workshop titled Application of evidence-based methods to construct mechanism-driven chemical assessment frameworks was co-organized by the Evidence-based Toxicology Collaboration and the European Food Safety Authority (EFSA) and hosted by EFSA at its headquarters in Parma, Italy on October 2 and 3, 2019. The goal was to explore integration of systematic review with mechanistic evidence evaluation. Participants were invited to work on concrete products to advance the exploration of how evidence-based approaches can support the development and application of adverse outcome pathways (AOP) in chemical risk assessment. The workshop discussions were centered around three related themes: 1) assessing certainty in AOPs, 2) literature-based AOP development, and 3) integrating certainty in AOPs and non-animal evidence into decision frameworks. Several challenges, mostly related to methodology, were identified and largely determined the workshop recommendations. The workshop recommendations included the comparison and potential alignment of processes used to develop AOP and systematic review methodology, including the translation of vocabulary of evidence-based methods to AOP and vice versa, the development and improvement of evidence mapping and text mining methods and tools, as well as a call for a fundamental change in chemical risk and uncertainty assessment methodology if to be conducted based on AOPs and new approach methodologies (NAM). The usefulness of evidence-based approaches for mechanism-based chemical risk assessments was stressed, particularly the potential contribution of the rigor and transparency inherent to such approaches in building stakeholders' trust for imple-mentation of NAM evidence and AOPs into chemical risk assessment.

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