Abstract
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.
Highlights
Manufactured nanomaterials (MNs), as well as other advanced and emerging materials, offer significant benefits to consumers, including technological innovation, improved product performance and more sustainable alternatives to current technologies [1]
Significant progress has been made in adverse outcome pathway (AOP) development, application and use over the last decade, including methods, resources and tools to adopt AOPs as part of an integrated approach to testing and assessment (IATA) that utilizes alternative testing data for decision making
This review describes the AOP framework and its current status in greater detail, outlines challenges facing its advancement and adoption, and recommends specific actions needed to mature the concept and advance its use for decision making which is specific to manufactured nanomaterials (MNs)
Summary
Manufactured nanomaterials (MNs), as well as other advanced and emerging materials (e.g., composites incorporating MNs), offer significant benefits to consumers, including technological innovation, improved product performance and more sustainable alternatives to current technologies [1]. Safety evaluations of these materials are lagging due to testing challenges, the number, diversity and complexity of MNs coming to market, and the fact that the requirements of regulatory organizations are evolving as understanding of the technology develops. Toxicological assessments of MNs require individual assessments of health and environmental endpoints using traditional animal testing methods, an approach that is too time- and cost-intensive to be practical, as well as being ethically concerning. Policy is shifting globally toward the reduction and eventual elimination of animal studies, favoring alternative methods for all chemicals
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