Draft EPA guidance to waive toxicity tests on animal skin

The U.S. Environmental Protection Agency (EPA) is seeking public comment on draft guidance that would allow researchers to forego testing chemicals on animal skin in certain circumstances to determine whether pesticides lead to adverse effects.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 Andrew Wheeler, EPA Administrator. “Today’s action puts EPA on a path of eliminating the need for all mammal testing by 2035.”

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, the 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 the 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, the 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.

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