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Translating Scientific Advances in the AOP Framework to Decision Making for Nanomaterials

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Vireo Advisors, LLC, Boston, MA 02130, USA
2
School of Physics, University College Dublin, Belfield, Dublin 4, Ireland
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National Research Centre for the Working Environment, DK-2100 Copenhagen, Denmark
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School of Geography, Earth and Environmental Sciences, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK
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Environmental Health Science and Research Bureau, Health Canada, Ottawa, ON K1A 0K9, Canada
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Institute of Life Sciences, Swansea University Medical School, Singleton Park, Swansea SA2 8PP, UK
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Department of Chemistry, University of Toronto, Toronto, ON M5S 3H6, Canada
*
Author to whom correspondence should be addressed.
Nanomaterials 2020, 10(6), 1229; https://doi.org/10.3390/nano10061229
Received: 29 May 2020 / Revised: 18 June 2020 / Accepted: 19 June 2020 / Published: 24 June 2020
(This article belongs to the Special Issue From Nanoinformatics to Nanomaterials Risk Assessment and Governance)
Much of the current innovation in advanced materials is occurring at the nanoscale, specifically in manufactured nanomaterials (MNs). MNs display unique attributes and behaviors, and may be biologically and physically unique, making them valuable across a wide range of applications. However, as the number, diversity and complexity of MNs coming to market continue to grow, assessing their health and environmental risks with traditional animal testing approaches is too time- and cost-intensive to be practical, and is undesirable for ethical reasons. New approaches are needed that meet current requirements for regulatory risk assessment while reducing reliance on animal testing and enabling safer-by-design product development strategies to be implemented. The adverse outcome pathway (AOP) framework presents a sound model for the advancement of MN decision making. Yet, there are currently gaps in technical and policy aspects of AOPs that hinder the adoption and use for MN risk assessment and regulatory decision making. This review outlines the current status and next steps for the development and use of the AOP framework in decision making regarding the safety of MNs. Opportunities and challenges are identified concerning the advancement and adoption of AOPs as part of an integrated approach to testing and assessing (IATA) MNs, as are specific actions proposed to advance the development, use and acceptance of the AOP framework and associated testing strategies for MN risk assessment and decision making. The intention of this review is to reflect the views of a diversity of stakeholders including experts, researchers, policymakers, regulators, risk assessors and industry representatives on the current status, needs and requirements to facilitate the future use of AOPs in MN risk assessment. It incorporates the views and feedback of experts that participated in two workshops hosted as part of an Organization for Economic Cooperation and Development (OECD) Working Party on Manufactured Nanomaterials (WPMN) project titled, “Advancing AOP Development for Nanomaterial Risk Assessment and Categorization”, as well as input from several EU-funded nanosafety research consortia. View Full-Text
Keywords: adverse outcome pathway; nanomaterials; decision making; risk assessment adverse outcome pathway; nanomaterials; decision making; risk assessment
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Ede, J.D.; Lobaskin, V.; Vogel, U.; Lynch, I.; Halappanavar, S.; Doak, S.H.; Roberts, M.G.; Shatkin, J.A. Translating Scientific Advances in the AOP Framework to Decision Making for Nanomaterials. Nanomaterials 2020, 10, 1229.

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