Today, 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,” saidEPA 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. 

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. In support of this directive, EPA has taken many steps since then to reduce, replace, and refine animal testing requirements: 

  • 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 TSCA. The updated list includes 21 new test guidelines related to health and ecological effects and six additional EPA policies that reduce the use of animal testing.