In a significant move toward modernizing chemical safety assessments, on June 2, 2026, the U.S. Environmental Protection Agency (EPA) announced two major actions aimed at replacing traditional, animal-based testing with advanced scientific alternatives, typically known as New Approach Methods (NAM), for chemical assessments under the Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA is also introducing a streamlined process for researchers, companies, and other stakeholders to nominate NAMs for consideration in pesticide and chemical assessments.
According to EPA, these two actions mark major strides in meeting its goal of eliminating all mammalian animal testing by 2035 — an ambitious target set during the first Trump Administration that Administrator Lee Zeldin recommitted to meeting earlier this year. EPA has made gradual progress toward this goal in the past few years, including implementation of its first-ever lab animal adoption program in April 2025 at one of its premiere research laboratories in Research Triangle Park, North Carolina.
This initiative aligns with a long-term commitment to phase out legacy, slow, and inhumane animal studies in favor of test designs with reduced numbers of animals and, whenever possible, NAMs for chemical assessments. TSCA directs EPA to use NAMs whenever scientifically appropriate when evaluating chemicals, and to reduce, refine, or replace vertebrate mammal testing. Modern NAMs, including human cell models and advanced computer-based methods, may help EPA identify hazards and exposures faster and often with results that are more relevant to people, not laboratory animals. These tools aim to reduce costs, time, and animal use, and provide clearer insight into how a chemical behaves in the human body. The intended result is quicker, more transparent safety decisions that better protect families, workers, and communities while giving businesses clear, up-to-date expectations.
EPA is adding 13 new NAMs from external authoritative bodies to its approved list that industry, researchers, and other stakeholders use to comply with TSCA testing requirements. New additions to the list include:
- A new method to evaluate eye hazards with reconstructed human cells;
- A method to evaluate phototoxicity using a 3D human cell-based tissue model; and
- Combinations of Organisation for Economic Co-operation and Development (OECD)-validated in chemico and in vitro test data to identify potential dermal sensitization hazard, dermal sensitization potency, and a quantitative point of departure.
EPA last updated its NAMs list in 2021. By updating the list and committing to do so regularly, EPA provides certainty for industry, which anticipates regular updates on the tools EPA recognizes, and increases transparency, helping stakeholders keep track of and contribute to the development of newly identified methods. Additional information regarding NAMs progress in the United States can be found on EPA’s NAMs website and on the Interagency Coordinating Committee on the Validation of Alternative Methods’ (ICCVAM) website. ICCVAM was formed as a collaborative effort among 17 U.S. federal regulatory and research agencies focused on the development and validation of non-animal testing. Industry members also are encouraged to develop, validate, and nominate NAMs for consideration by EPA and other regulatory authorities. EPA summarizes its process for evaluating the relevance, reliability, transparency, and reproducibility of nominated NAMs to assess whether it aligns with specific pesticide and chemical risk decisions and endpoints.
This news release reflects a broader, accelerating global shift toward non-animal testing paradigms. Regulatory bodies worldwide (and test facilities in response) are increasingly aligning their frameworks (and services) to incorporate NAMs.
- European Union (EU): Under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation, the European Chemicals Agency (ECHA) continues to expand its acceptance of alternative methods, driven by strict EU bans on animal testing for cosmetics and a broader mandate to minimize vertebrate testing. The European Food Safety Authority (EFSA) also published a procedural roadmap for action on NAMs in risk assessment, and continues updating its methodologies under its Innovative Risk Assessment Methodologies Program (IRMA).
- Asia-Pacific: Countries like South Korea (via K-REACH) and China have made substantial regulatory updates that suggest a move toward NAMs. K-REACH has prioritized alternative test methods and established the Korean Center for the Validation of Alternative Methods (KoCVAM) to systematically validate NAMs for local registration. China, for instance, has progressively removed mandatory animal testing requirements for many imported general cosmetics and is actively researching non-animal alternatives for broader chemical safety. For pesticide registration, the Southeast Asian region has historically collaborated via the Asia-Pacific Plant Protection Commission (APPPC) and the Food and Agriculture Organization (FAO) to align pesticide regulatory requirements, though animal-free pesticide registries remain secondary to industrial chemical frameworks.
- International Harmonization: Organizations like the OECD play a critical role globally by continuously updating and validating international Test Guidelines, ensuring that a NAM approved in one jurisdiction can be accepted across member nations and other adherents to the OECD Mutual Acceptance of Data agreement, reducing redundant testing. This harmonization also enables test facilities worldwide to expand testing capabilities to meet increasing regulatory demand for novel testing approaches.
By updating its approved list, EPA ensures that U.S. chemical and pesticide manufacturers can confidently utilize validated, internationally recognized alternatives to address regulatory requirements.
Commentary
While EPA’s announcement highlights progress under both TSCA and FIFRA, the practical integration of NAMs under FIFRA presents unique scientific and regulatory complexities. Unlike industrial chemicals evaluated under TSCA, pesticides governed by FIFRA are intentionally designed to be biologically active, meaning they are engineered to prevent, repel, kill, or mitigate pests. Consequently, evaluating their safety requires an intensely granular understanding of systemic toxicity, ecological impacts, and sometimes multi-generational reproductive and developmental effects. Registration under FIFRA is heavily reliant upon complex, multi-species animal studies, due to the historically stringent data requirements, especially for new pesticide active ingredients and registration review of old pesticide active ingredients.
Updating EPA’s approved alternative test list is a crucial step forward, but the true measure of progress will be seen in how seamlessly registrants can integrate these NAMs into their submission packages to satisfy successfully the rigorous and very specific data demands of FIFRA’s registration and registration review requirements. Globally, the pesticide sector has been slower to adopt non-animal methods than the cosmetics or general chemical sectors due to these inherent risks of regulatory acceptance. The international bodies and now EPA’s TSCA evaluations, however, are paving the way. OECD has successfully established adverse outcome pathways (AOP) specifically designed to link molecular-level data from NAMs to systemic ecological effects in wildlife, and EPA has utilized high-quality, alternative scientific methods to replace animal testing in its cancer evaluations under TSCA for dibutyl phthalate and di(2-ethylhexyl) phthalate for the first time in 2025. For EPA’s new actions to achieve maximum impact for pesticide registration or re-evaluation, EPA must actively collaborate with international counterparts to ensure that cell-based and computational data can definitively answer complex safety questions unique to pesticide active ingredients and products.
