EPA Continues to Implement Administrator Wheeler’s Directive to Reduce Animal Testing
WASHINGTON (June 24, 2020) — Today, the U.S. Environmental Protection Agency (EPA) released a work plan that serves as a roadmap for meeting its animal testing reduction goals set forth in Administrator Andrew Wheeler's 2019 Directive . The release of this New Approach Methods (NAMs) Work Plan coincides with the 4th anniversary of the Frank. R. Lautenberg Amendments to the Toxic Substances Control Act (TSCA), which required that EPA take similar actions to reduce reliance on animal testing.
“The use of alternative testing methods will better predict chemical or pesticide hazards without relying on potentially fatal testing on mammals,” said EPA Administrator Andrew Wheeler. “I’m proud to announce this work plan that can both decrease the use of animals in testing while being fully protective of human health and the environment.”
The work plan describes how the agency plans to develop, test, and apply chemical safety testing approaches that reduce or replace the use of animals. Compared to traditional animal testing, NAMs allow researchers to better predict potential hazards for risk assessment purposes without the use of traditional methods that rely on animal testing.
To develop the work plan, EPA convened experts across the agency to identify objectives and milestones that ensure regulatory, compliance, and enforcement activities – including chemical and pesticide approvals and research – remain fully protective of human health and the environment while pursuing the Administrator’s Directive goals.
The objectives of the work plan include:
- Evaluating regulatory flexibility for the use of NAMs.
- Establishing baselines and metrics for assessing progress.
- Developing NAMs that fill critical information gaps.
- Establishing scientific confidence in NAMs.
- Demonstrating NAMs application to regulatory decisions.
- Engaging with stakeholders to incorporates their knowledge and address their concerns regarding EPA’s phase out of mammalian testing.
The work plan will evolve as EPA’s knowledge and experience grows and as outside experts offer their perspectives and contributions. EPA will regularly review the work plan to ensure the efforts involved provide the best path to success. EPA will host a webinar for the public and all interested stakeholders on June 30 at 9:30 AM EDT to discuss its NAM Work Plan. To register, visit https://www.eventbrite.com/e/us-epa-new-approach-methods-work-plan-release-webinar-tickets-109687299666.
Feedback on the work plan can be provided to EPA by sending an email to NAM@epa.gov.
Follow the hashtag #TSCAis4 to hear about the agency’s TSCA 4th anniversary celebrations and #EPANAM to stay engaged in the agency’s actions to reduce the use of animals in chemical testing.
In September 2019, Administrator Wheeler issued a directive that called for the agency to reduce animal testing and funding 30 percent by 2025 and eliminate it by 2035. To support these efforts, EPA announced $4.25 million in funding for five universities to research and develop alternative test methods for evaluating chemical safety. The agency alsoconvened a conference in December 2019 to discuss New Approach Methods (NAMS). for achieving reduced animal testing in chemical safety research and issued a policy in February 2020 waiving the testing of pesticides on birds when the additional information is unnecessary to support a pesticide registration decision.
In support of this directive, EPA has been working to reduce animal testing in the TSCA program. In 2018, the agency published a strategy to reduce the use of vertebrate animals in chemical testing, fulfilling another requirement of the Lautenberg Act amendments to TSCA. In 2019, EPA updated its list of NAMs that could be used in the TSCA program, including adding 21 new test guidelines related to health and ecological effects and six additional EPA policies that reduce the use of animal testing.
To learn more about the agency’s efforts to reduce animal testing, visit: https://www.epa.gov/nam