The U.S. Environmental Protection Agency (EPA) has released a comprehensive report that reviews which regulations require vertebrate animal testing, while highlighting opportunities for adopting New Approach Methods (NAMs) in chemical assessments. This report, part of the EPA’s NAMs Work Plan, focuses on the regulatory frameworks of major statutes such as the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and how these frameworks can incorporate NAMs to reduce reliance on traditional animal testing.
TSCA: Promoting Alternatives to Animal Testing
Under TSCA, the EPA regulates the safety of chemical substances and is actively encouraged to minimize animal testing where scientifically feasible. Section 4(h) of TSCA directs the agency to prioritize the use of alternative methods that reduce or replace vertebrate animal testing, such as computational models and in vitro testing. According to the report, the EPA has successfully integrated NAMs in certain chemical risk assessments, and ongoing research supports their broader application.
FIFRA: Balancing Regulatory Requirements and NAM Flexibility
FIFRA mandates vertebrate animal testing for the registration and evaluation of pesticides, making it one of the stricter regulatory frameworks in terms of required animal testing. However, the EPA's report highlights that FIFRA also offers flexibility in accepting NAMs when they meet scientific standards. This has led to the successful use of in vitro assays and in silico models for some pesticide safety evaluations, but vertebrate testing is still required in many cases to ensure comprehensive risk assessments.
Impact on Other Major Environmental Statutes
In addition to TSCA and FIFRA, the EPA report impacts several other critical environmental regulations:
- Clean Air Act (CAA): The report explains that vertebrate testing is often required for evaluating the health effects of air pollutants, such as in the Significant New Alternatives Policy (SNAP) program. However, NAMs can be used as long as they provide scientifically valid data.
- Clean Water Act (CWA): The EPA uses animal testing for whole effluent toxicity (WET) testing to regulate water quality. While vertebrate species are commonly used, there is potential to replace these tests with NAMs in certain contexts.
- Safe Drinking Water Act (SDWA): The SDWA mandates the EPA to regulate contaminants in drinking water, often relying on vertebrate testing. However, NAMs are increasingly being considered, particularly in the regulation of emerging contaminants like PFAS.
- Resource Conservation and Recovery Act (RCRA): The EPA utilizes vertebrate testing to determine the toxicity of hazardous waste under RCRA. The report suggests that NAMs could be incorporated in future assessments to reduce animal use.
- Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA): Also known as Superfund, CERCLA governs the cleanup of hazardous waste sites. While vertebrate testing is used to assess health risks, NAMs could play a role in future cleanups.
The Future of Chemical Testing at the EPA
The EPA’s report emphasizes that while regulations like TSCA and FIFRA still rely heavily on vertebrate animal testing, there is growing flexibility for integrating NAMs as long as they meet rigorous scientific standards. This flexibility is part of the EPA’s broader strategy to reduce animal testing while maintaining public and environmental safety.
