Sponsors (7)
The bill modernizes safety testing by encouraging validated non-animal methods and greater transparency—improving animal welfare and potentially lowering long-term costs—while imposing transition risks, administrative burdens, possible approval delays, and financial penalties on companies that still depend on animal data.
Manufacturers and small businesses will be able to rely more on validated non-animal safety-testing methods, reducing the number of animals used and limiting pain when animal tests remain necessary — aligning approvals with modern science and improving animal welfare.
Regulators may remove outdated animal-data requirements and accept validated non-animal methods, potentially lowering testing costs and regulatory burden for manufacturers and small businesses over time.
The public gains more transparency because agencies must publish annual reports on animal testing, waiver use, and the stated purposes of tests, increasing oversight and accountability.
Companies that continue to rely on animal testing face financial risks — compliance costs, potential lost approvals if non-animal methods are not practicable, and civil penalties (up to $10,000 per violation) for submitting disallowed animal data.
Disagreements between agencies and industry about whether non-animal methods are adequate could trigger additional testing or regulatory delays, slowing product approvals and delaying access for patients (including those with chronic conditions).
New public reporting requirements may increase administrative burden for firms preparing submissions and raise disclosure concerns, even though personally identifying and proprietary information is excluded.
Based on analysis of 2 sections of legislative text.
Bans submission of animal-test data to FDA, EPA, USDA, or CPSC when an agency-accepted non-animal test method is available, with narrow exceptions.
Official title: To ensure that non-animal methods for regulatory testing are used in lieu of animal tests whenever scientifically satisfactory non-animal test methods are available and accepted by regulatory agencies for meeting regulatory requirements, and for other purposes.
Introduced December 11, 2025 by Jared Moskowitz · Last progress December 11, 2025
Prohibits submitting animal-test-derived data to FDA, EPA, USDA, or CPSC when the agency has determined an accepted non-animal test method is available or has waived the animal-test requirement. It creates limited exceptions, requires agencies to update guidance and regulations and publish annual progress reports, and authorizes civil penalties for violations and agency refusal to accept noncompliant data. Applies to new submissions after enactment (with defined exceptions), requires minimizing animal use and suffering when animal tests are nonetheless performed, and defines key terms (animal, animal test method, non-animal test method). Agencies must issue guidance and public progress reports within one year and thereafter.