Application of evidence-based methods to construct mechanism-driven chemical assessment frameworks

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Sebastian Hoffmann, Elisa Aiassa, Michelle Angrish, Claire Beausoleil, Frederic Y. Bois, Laura Ciccolallo, Peter S. Craig, Rob B. M. de Vries, Jean Lou C. M. Dorne, Ingrid L. Druwe, Stephen W. Edwards, Chantra Eskes, Marios Georgiadis, Thomas Hartung, Aude Kienzler, Elisabeth A. Kristjansson, Juleen Lam, Laura Martino, Bette Meek, Rebecca L. Morgan, Irene Munoz-Guajardo, Pamela D. Noyes, Elena Parmelli, Aldert Piersma, Andrew Rooney, Emily Sena, Kristie Sullivan, José Tarazona, Andrea Terron, Kris Thayer, Jan Turner, Jos Verbeek, Didier Verloo, Mathieu Vinken, Sean Watford, Paul Whaley, Daniele Wikoff, Kate Willett, Katya Tsaioun
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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 implementation of NAM evidence and AOPs into chemical risk assessment.

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Hoffmann, S. (2022) “Application of evidence-based methods to construct mechanism-driven chemical assessment frameworks ”, ALTEX - Alternatives to animal experimentation, 39(3), pp. 499–518. doi: 10.14573/altex.2202141.
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