US EPA publishes report as part of agency strategy to reduce animal testing

On September 24, 2024, the U.S. Environmental Protection Agency (EPA) released a detailed review of major environmental statutes that summarizes which EPA laws or regulations require vertebrate animal testing, such as laboratory testing done on rats, mice or rabbits. The report concludes that many statutes and regulations guiding EPA’s authority are broadly written and do not preclude the use of scientific information from New Approach Methods (NAMs), which are defined as any technology, methodology, approach, or combination that can provide information on chemical hazard and risk assessment to avoid the use of animal testing.

This report is a deliverable in EPA’s NAMs Work Plan, which was originally released in June 2020 and updated in November 2021. The Work Plan outlines the Agency’s strategies and objectives for increasing the rigor and sophistication of Agency assessments while reducing the reliance on vertebrate animals to test chemicals in regulatory, compliance, enforcement, and research activities through the use of NAMs. The assessments will remain fully protective of human health and the environment. The first objective in the Work Plan was to evaluate regulatory flexibility for accommodating NAMs, and the report released today accomplishes that objective.

The report released today finds that different laws and regulations have different approaches to NAMs and vertebrate testing. For example, the Toxic Substances Control Act directs EPA to reduce and replace the use of vertebrate animals in the testing of chemical substances or mixtures to the extent practicable and scientifically justified. On the other hand, vertebrate testing is mandated for certain toxicity and health effects evaluations in Title 40 of the Code of Federal Regulations (CFR), which applies to pesticides. Title 40 of the CFR also provides EPA flexibility to determine the type of data needed for assessments, and alternative tests are accepted. NAMs are not necessarily newly developed methods. Historically, OCSPP has used NAMs, such as in vitro (tests on cells outside a living organism) and in silico (using computer models to predict a chemical’s hazard), in addition to animal studies in its scientific evaluations.

EPA is required to make decisions using information that is high-quality and rigorous, developed with scientifically sound methodologies, and subjected to peer-review. These principles apply to both vertebrate animal testing and NAMs. The report concludes that the use of NAMs for decision making vary across program offices. With flexible regulatory statutes, EPA can successfully incorporate NAMs data in a range of chemical decisions, as long as it prioritizes scientific rigor and fully acknowledges the chosen method’s advantages and limitations.

For further information on the NAMs Work Plan and to read the report, please visit EPA’s website.