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Envisioning an international validation process for New Approach Methodologies in chemical hazard and risk assessment

To build trust across many sites (laboratories, regulatory agencies, contract research organizations, chemical producers, and the public), stakeholders will need to agree on validation requirements for particular uses (content in relation to context) as well as how results are to be communicated (data format), and measured (metrics). There is also a need for a global orchestrator, who can exert leadership and inspire voluntary cooperation of diverse organizations to address shared validation goals, to play a key role. | Environmental Advances 4 2021 100061 Contents lists available at ScienceDirect Environmental Advances journal homepage www.elsevier.com locate envadv Envisioning an international validation process for New Approach Methodologies in chemical hazard and risk assessment Matthieu Mondou a Steve Maguire b c Guillaume Pain a d Doug Crump e Markus Hecker f Niladri Basu a Gordon M. Hickey a a Department of Natural Resource Sciences Faculty of Agricultural and Environmental Sciences McGill University Montreal Quebec Canada b University of Sydney Business School amp University of Sydney Nano Institute Sydney Nano The University of Sydney New South Wales Australia c Department of Chemistry Faculty of Science McGill University Montreal Quebec Canada d Faculté des sciences de l administration Université Laval Sainte-Foy Québec Canada e National Wildlife Research Center Environment and Climate Change Canada Ottawa Ontario Canada f Toxicology Center University of Saskatchewan Saskatoon Saskatchewan Canada a r t i c l e i n f o a b s t r a c t Keywords Despite the global toxicology community discussing New Approach Methodologies NAMs for chemical haz- Regulatory science ard and risk assessment such as in vitro in silico and omics-based approaches for some 30 years their for- Innovation mal adoption by regulators remains limited. Previous research suggests that insufficient validation complexity Ecotoxicology of interpretation and lack of standardization are salient obstacles to adoption. In this paper we aim to better Pollution understand the policy challenges associated with adopting NAMs in chemical risk assessment and to identify Governance Risk Assessment and Management actions that could facilitate and accelerate their formal adoption internationally. We conducted a Delphi study a group communication process that solicits expert judgments through iterative questioning and feedback with panelists from government industry and non-governmental organizations in Europe and North .