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

Hoffmann, Sebastian and Aiassa, Elisa and Angrish, Michelle and Beausoleil, Claire and Bois, Frederic Y and Ciccolallo, Laura and Craig, Peter S and De Vries, Rob B M and Dorne, Jean Lou C M and Druwe, Ingrid L and Edwards, Stephen W and Eskes, Chantra and Georgiadis, Marios and Hartung, Thomas and Kienzler, Aude and Kristjansson, Elisabeth A and Lam, Juleen and Martino, Laura and Meek, Bette and Morgan, Rebecca L and Munoz-Guajardo, Irene and Noyes, Pamela D and Parmelli, Elena and Piersma, Aldert and Rooney, Andrew and Sena, Emily and Sullivan, Kristie and Tarazona, José and Terron, Andrea and Thayer, Kris and Turner, Jan and Verbeek, Jos and Verloo, Didier and Vinken, Mathieu and Watford, Sean and Whaley, Paul and Wikoff, Daniele and Willett, Kate and Tsaioun, Katya (2022) Application of evidence-based methods to construct mechanism-driven chemical assessment frameworks. Altex, 39 (3). 499–518. ISSN 1868-596X

Abstract

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 methods 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 AOP into chemical risk assessment.