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.  

EPA Office of Chemical Safety and Pollution Prevention Assistant Administrator Alexandra Dapolito Dunn stated that this 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. Further this 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. 

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.  

In January 2020, EPA launched an EPA NAMs website  – a comprehensive resource for all updates about the agency’s efforts to reduce the use of animal testing.  

In February 2020, EPA issued final guidance that reduces unnecessary testing on birds in the pesticide registration review process. This is expected to save 720 test animals annually.  

In June 2020, EPA released the NAMs work plan , which outlines the objectives, strategies and deliverables that are important guideposts in reaching the 2035 goal. EPA also convened a meeting of the Science Advisory Board to offer advice on using NAMs to help reinvent the cancer bioassay.  

In July 2020, EPA released guidance that reduces unnecessary testing on fish in the pesticide registration process. This is expected to save 240 test animals annually.   

In October 2020, EPA hosted the Second Annual Conference on the State of the Science on the Development and use of NAMs for Chemical Safety Testing.  

As required under TSCA Section 4, EPA regularly maintains and updates a list of NAMs and plan to release a draft proposal for selecting which NAMs will be included on future versions of the list.  

This draft proposal is expected to be released for public comments early this year.