Endocrine Society Raises Concerns about EPA’s New Animal Testing Directive

On September 10, the United States Environmental Protection Agency (EPA) issued a directive to aggressively prioritize reductions in animal testing towards a 30% decrease in such tests by 2025, and complete elimination of requests by the EPA for animal studies by 2035. In a companion memo by EPA Administrator Andrew Wheeler, the EPA also announced $4.25 million in research funding to advance the development of alternative test methods for the evaluation of chemicals for toxic effects and directed responsible offices within EPA to provide resources towards activities in support of these goals.

Although we share the goal of minimizing animal testing and developing robust alternative methods that can reliably screen and evaluate chemicals for harmful effects, the Endocrine Society and other organizations within the biomedical research community have expressed concern with the unrealistic timeframes and lack of validated alternative methods to interrogate complex biological processes such as hormonal signaling pathways. We have consistently maintained that current testing strategies are insufficient for the evaluation of the effects of chemicals on hormonal systems, and in our communications with EPA and other regulatory agencies we argue that biomedical research, including research in animals, will continue to be necessary for the foreseeable future to inform the development of better testing strategies.

We remain committed to continuing to work with EPA and international testing authorities to enhance the development of accurate methods to protect human health and the environment from endocrine-disrupting chemicals and other toxicant-induced harms.

In response to the directive, we joined with the Federation of American Societies for Experimental Biology (FASEB) to highlight the limitations of the existing suite of alternative methods and emphasize the current necessity of conducting toxicological assessments in animal models capable of complete physiological responses to chemical exposures.

The EPA directive follows from previous efforts to support alternatives to animal testing. We also commented on EPA’s draft strategic plan to promote the development and implementation of new and alternative test methods (NAMs) in the context of updates to the Toxic Substances Control Act (TSCA) contained in the Frank R. Lautenberg Chemical Safety in the 21^st Century Act. In our comments we expressed concern about the proposed timeframes for the adoption of alternative methods and urged EPA to clearly and transparently describe how alternative methods would be compared to existing testing strategies and evaluated for their efficacy.

We remain committed to continuing to work with EPA and international testing authorities to enhance the development of accurate methods to protect human health and the environment from endocrine-disrupting chemicals and other toxicant-induced harms. We encourage interested members of the Society to stay tuned for future announcements, as EPA seeks to engage stakeholders in annual meetings to discuss the development of NAMs.