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Accelerating the Pace of Chemical Risk Assessment (APCRA): Continuing the Discussion of Regulatory Application of New Approach Methodologies
Citation:
Gwinn, M., T. Barton-Maclaren, M. Rasenberg, AND R. Thomas. Accelerating the Pace of Chemical Risk Assessment (APCRA): Continuing the Discussion of Regulatory Application of New Approach Methodologies. Presented at Society of Toxicology annual meeting, Baltimore, MD, March 10 - 14, 2019.
Impact/Purpose:
Abstract for presentation at Society of Toxicology annual meeting in March 2019
Description:
New approach methodologies (NAMs) play a key role in accelerating the pace of chemical risk assessment, and are an important tool for the future of regulatory decision making. Accelerating the Pace of Chemical Risk Assessment (APCRA) is a government-to-government initiative whose aim is to promote collaboration and dialogue on the scientific and regulatory needs for the application and acceptance of NAMs in regulatory decision making. A third annual workshop of APCRA hosted by Health Canada brought together a group of international regulatory agencies and science support colleagues to discuss progress and experiences in applying NAMs to prioritization, screening, and quantitative risk assessment. Workshop discussions focused on establishing confidence in the use of NAMs, both in terms of comparisons to traditional methods and integrating divergent data streams, as well as the state of the science on ecological NAMs and their use in ecological risk assessment. To continue to enhance sharing of APCRA efforts beyond regulatory agencies, a public webinar was included this year for the opening session to disseminate the results of three ongoing collaborative case studies more broadly and respond to questions posed by the stakeholder communities. Criteria for collaborative case studies include the use of a NAM in a clear regulatory application and the involvement of multiple regulatory agencies. Outcomes from the meeting will be described, including plans to discuss future mechanisms to enhance outreach and communication of these activities, and how the new proposed collaborative case studies will aid in increasing acceptance of these new alternative methods and tools in regulatory decisions. The views expressed are those of the authors and do not necessarily represent the policies of the US Environmental Protection Agency, Health Canada or European Chemicals Agency.