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EPA Announces Guidance to Waive Toxicity Tests on Animal Skin

Proposed guidance is expected to save up to 750 animals from unnecessary testing annually

WASHINGTON (October 7, 2020) — Today, the U.S. Environmental Protection Agency (EPA) is continuing to follow through on EPA Administrator Andrew Wheeler’s commitment to reduce animal testing by seeking public comment on draft guidance that would allow researchers to forego testing chemicals on animal skin in certain circumstances to determine whether pesticides lead to adverse effects.

“This proposed guidance is a great example of how we can continue to protect human health and the environment and make science-based decisions about pesticide registrations without needing to conduct unnecessary tests on the skin of animals,” said EPA Administrator Andrew Wheeler. “Today’s action puts EPA on a path of eliminating the need for all mammal testing by 2035.”

“With this draft policy the Agency continues to make real progress in reducing animal testing requirements, saving animals and resources while maintaining environmental and human health protections,” said Physicians Committee for Responsible Medicine Vice President for Research Policy Kristie Sullivan. “The Physicians Committee encourages companies to consider this draft guidance to avoid dermal toxicity tests and thanks those involved in this analysis and resulting policy.”

The proposed dermal toxicity guidance would allow waivers for studies on single-active ingredients used to develop end use products to apply for waivers. In developing the guidance, EPA conducted a retrospective analysis and concluded that its requirements for such studies provides little to no added value in regulatory decision making. This guidance, when finalized, is expected to save up to 750 test animals annually from unnecessary testing as well as EPA, industry and laboratory resources.

EPA will take comments on the proposed guidance for 30 days after publication in the Federal Register. Comments can be submitted online at http://www.regulations.gov (Docket ID No. EPA-HQ-OPP-2016-0093). After carefully considering public input, EPA will finalize the Guidance.

In addition, EPA has launched a new webpage  that provides metrics and strategies for reducing and replacing animal testing, including links and resources to all pertinent guidance and workplans tied to the larger Toxicology in the 21st Century Initiative across the federal government.

Background

In September 2019, Administrator Wheeler issued a directive calling for the Agency to reduce animal testing and funding 30 percent by 2025 and eliminate it by 2035. To support these efforts:

• In September 2019, EPA announced $4.25 million in funding for five universities to research and develop alternative test methods for evaluating chemical safety.
• In December 2019, EPA convened a conference for achieving reduced animal testing in chemical safety research and updated its list of NAMs that could be used in the agency's work under the amended Toxic Substances Control Act , including adding 21 new test guidelines related to health and ecological effects and six additional EPA policies that reduce the use of animal testing.
• In June 2020, released a NAMs workplan in June that details how the Agency plans to develop, test and apply chemical safety testing approaches without the use of animals.
• In February 2020, issued a policy waiving the testing of pesticides on birds when the additional information is unnecessary to support a pesticide registration decision, expected to save 720 test animals annually.
• In July 2020, announced new guidance to reduce unnecessary testing on fish , expected to save 240 test animals annually.

EPA will host its Second Annual Conference on the State of the Science on Development and Use of New Approach Methods (NAMs) for Chemical Safety Testing  virtually on October 19 and 20, 2020.

To learn more about EPA efforts to reduce animal testing, visit: https://www.epa.gov/research/efforts-reduce-animal-testing-epa.