Citation:

Gwinn, M., R. Thomas, R. Kavlock, M. Rasenberg, AND T. Barton-Maclaren. Advancing new approach methodologies for chemical risk assessment. IN: Chemical Watch, CW Research Ltd, Shrewsbury, Uk, (N/A):N/A, (2020).

Impact/Purpose:

Meeting overview of the Accelerating the Pace of Chemical Risk Assessment (APCRA) held in October 2019 in Research Triangle Park, NC. This meeting focused on three topics: review of ongoing and proposed case studies, the current status of NAMs in regulatory decision making, and strategic directions for the effort.

Description:

New Approach Methodologies, or NAMs, are technologies, methods or approaches that do not rely on, or reduce, the use of vertebrates for chemical safety testing and evaluation. NAMs for chemical hazard, exposure and risk assessment continue to emerge as alternatives to traditional animal-based testing for potential human and environmental health effects. If accepted and used in regulatory decision-making, they have the potential to enhance the pace of work, yield better informed, more relevant decisions, and reduce/replace the need for studies on animals. Pressures to accelerate the development and use of NAMs include the EU cosmetics regulation, a proposed cosmetic regulation in Australia, a recent directive from the US EPA on reducing mammalian toxicity studies, a continual stream of new and more complex chemistries and the need to evaluate chemical mixtures and cumulative risk. Recognizing early that any movement toward the use of NAMs in chemical risk assessment activities must involve coordination amongst international regulatory agencies, the EPA convened the first meeting of the Accelerating the Pace of Chemical Risk Assessment (APCRA) effort in 2016. At that initial meeting, the desire of the participants from a wide spectrum of regulatory agencies (e.g., EPA, the European Chemicals Agency (ECHA), the European Food Safety Authority (EFSA), Health Canada (HC), Environment and Climate Change Canada (ECCC), Singapore’s Agency for Science, Technology and Research (A*STAR) and the Australian National Industrial Chemical Notification and Assessment Scheme (NICNAS) to explore the use of NAMs and to identify barriers to their application were discussed. A number of case studies were then proposed to move the field forward in a coordinated fashion. The case studies needed to have regulatory relevance, involve the use of NAMs and engage multiple participating organizations. The views expressed are those of the authors and do not necessarily represent the policies of the US EPA, the European Chemicals Agency, or Health Canada

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