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Outcomes and Significance of U.S. EPA’s New Approach Methodologies (NAMs) Training Program and NAMs Tools in Hazard Evaluation And Exposures Assessment
Citation:
Mutlu, E., J. Daniel, S. Vandyke, C. Baghdikian Raybern, AND M. Linnenbrink. Outcomes and Significance of U.S. EPA’s New Approach Methodologies (NAMs) Training Program and NAMs Tools in Hazard Evaluation And Exposures Assessment. SOT, Salt Lake City, UT, March 10 - 14, 2024. https://doi.org/10.23645/epacomptox.25400380
Impact/Purpose:
Presentation to the Society of Toxicology (SOT) 63rd Annual Meeting and ToxExpo March 2024
Description:
Background and Purpose: The U.S. EPA’s New Approach Methodologies (NAMs) Work Plan was created to prioritize Agency efforts and resources to reduce the use of vertebrate animal testing while continuing to protect human health and the environment. NAMs are defined as any technology, methodology, approach, or combination that can provide information on chemical hazard and risk to avoid the use of animal testing. The EPA develops and implements NAMs for new and existing chemicals to evaluate hazard, exposure, and environmental fate, which reflects the commitment to using NAMs for decision making under the Toxic Substances Control Act. EPA scientists lead NAMs research by generating data and developing models and tools used more broadly by the Agency for problem formulation and scoping; to analyze human health and ecological risks; and to ensure continuous progress toward reducing animal testing. It is integral to have an effective communication, outreach, and engagement strategy to understand stakeholders’ ongoing needs; identify training, data, and methodology gaps; address concerns, and incorporate their knowledge and experience to establish scientific confidence in NAMs for regulatory decisions. Methods: To achieve the communication, outreach, and engagement objectives of the NAMs Work Plan, the NAMs Training Pilot Program was developed to provide interactive training opportunities and materials for various stakeholders interested in using NAMs to inform chemical risk assessments. The Program regularly collects and integrates stakeholder comments and feedback into training materials and plans to make the information more accessible. In 2020, EPA-related NAM information that includes regular updates and summaries of NAMs research were published on EPA’s website and data to ensure transparency and accountability. Stakeholders can access the portal to get timely information on upcoming training courses, workshops, and conferences held by EPA. Since 2022, the Program has provided virtual trainings (n=5) demonstrating widely used NAMs tools such as the CompTox Chemicals Dashboard, Generalized Read Across, ECOTOXicology Knowledgebase, and high throughput toxicokinetics. These trainings aim to provide users the opportunity to engage with the tools and experts to better understand how these EPA NAMs tools, resources, and approaches can be used in their own work. Each training provides users with guided hands-on use of the tools with support from experts and interactive worksheets which are later provided via the NAMs website to extend the reach. Pre- and post-training surveys are utilized to understand the overall level of understanding of each tool, likelihood of use or increased use of each tool in the attendee’s occupation, value and usefulness of information presented, room for improvement, and to identify stakeholder needs to build confidence in using NAMs tools. Results: In 2022, EPA launched a centralized NAMs Training website that stores all training materials and related information on NAMs tools and resources to make sure users have easy access to available tool materials. Over time, the number of registrants for NAMs trainings have increased (from the 600s to 1000s). Attendees represented various stakeholders including industry, academia, federal and state government within and outside of USA. In addition, post-training survey results from over 200 responders indicated that 70-80% of the current tool users would increase their use and 20-25% of nonusers would likely to start using them. Trainees described their experience mainly as ‘excellent’ and ‘good’ when asked about the quality of the training materials, usefulness of information presented, value of hands-on sessions, and attendee interaction opportunities...
URLs/Downloads:
DOI: Outcomes and Significance of U.S. EPA’s New Approach Methodologies (NAMs) Training Program and NAMs Tools in Hazard Evaluation And Exposures Assessment
POSTER.PDF (PDF, NA pp, 584.496 KB, about PDF)