EPA Finalizes Guidance to Waive Toxicity Tests on Animal Skin

the U.S. Environmental Protection Agency (EPA) delivered on EPA Administrator’s directive to reduce animal testing by finalizing guidance that will allow researchers to forego testing chemicals on animal skin in certain circumstances to determine whether pesticides lead to adverse effects.

“Today’s action is another example of how EPA is moving closer to achieve our goal of eliminating the use of mammals in chemical testing by 2035,” said EPA Office of Chemical Safety and Pollution Prevention Assistant Administrator Alexandra Dapolito Dunn. “Our guidance expands the ability for waivers for dermal toxicity studies while allowing the agency to continue to make science-based decisions about pesticide registrations without the need to conduct unnecessary additional animal tests.”

In October 2020, EPA released the proposed guidance for a 30-day comment period which received stakeholder input. In developing the guidance, EPA conducted a retrospective analysis with the U.S. Department of Health and Human Service. The joint analysis found that requirements for such studies provides little to no added value in the regulatory decision-making process.

The final dermal toxicity guidance will allow registrants to apply for waivers for studies on single-active ingredients used to develop end use products. This guidance is expected to save up to 750 test animals annually from unnecessary testing as well as EPA, industry, and laboratory resources.