EPA New Approach Methods Work Plan: Reducing Use of Animals in Chemical Testing
EPA uses information from a broad range of animal tests to evaluate the potential risks of chemicals, assess potential impacts on the environment, and approve chemicals for certain uses. Given the large number of chemicals regulated by EPA, the number of animals used to generate the necessary information is substantial.
EPA's New Approach Methods (NAMs) Work Plan was created in response to EPA Administrator Andrew Wheeler's 2019 directive to prioritize agency efforts and resources toward activities that will reduce the use of animal testing while continuing to protect human health and the environment. This work plan was developed by experts across the agency to set the objectives and strategies for using New Approach Methods to meet the ambitious goals set out in the Administrator's directive.
The Work Plan includes the following objectives:
- Evaluate Regulatory Flexibility for Accomodating NAMs
- Develop Baselines and Metrics for Assessing Progress
- Establish Scientific Confidence and Demonstrate Application
- Develop NAMs that Fill Critical Information Gaps
- Engage and Communicate with Stakeholders
To consider options for using appropriate NAMs for regulatory purposes, EPA staff will perform a thorough review of existing statutes and programmatic regulations, policies and guidance to identify mammalian testing requirements that may allow flexibility for the Agency to apply NAMs.
A report will be issued in 2021 detailing the findings of this review.
EPA will build on previously established baselines and metrics for animal use within the Office of Chemical Safety and Pollution Prevention and Office of Research and Development. This approach will then be progressively extended to other EPA offices, taking into account that specific baselines and metrics will need to be customized to fit the specifc needs of each program.
Progress and summary metrics will be reported annually as part of the EPA's New Approach Methods annual conference.
Establish Scientific Confidence in NAMs and Demonstrate Application to Regulatory Decisions
To establish scientific confidence in NAMs EPA will first characterize the scientific quality and relevance of existing animal tests, then develop a scientific confidence framework to evaluate the quality, reliability and relevance of NAMs.
The application of NAMs to different regulatory decisions will be demonstrated through case studies, with approximately one case study each year beginning in 2022.
Develop NAMs to Address Scientific Challenges and Fill Important Information Gaps
To help fill important information gaps in chemical safety research EPA will facilitate joint development of NAMs by EPA scientists and regulators. To foster this collaboration EPA wil develop research plans on a regular 4-year planning cycle.
EPA will also collaborate with stakeholders outside the agency to encourage the development and evaluation of NAMs through STAR grants and partnerships with organizations working to establish scientific confidence in alternative methods.
A centralized portal for releasing EPA-related NAM information will be developed to ensure transparency and accountability, with comments and feedback from stakeholders being actively solicited.
EPA will also hold training courses, workshops and conferences for interested stakeholders to learn more about NAM research and data.