HR6660-119

What This Bill Does

The Replace Animal Tests Act restricts animal testing data submitted to covered agencies for products or substances. Covered agencies are CPSC, USDA, EPA, and FDA. Regulated entities may not submit data derived from animal test methods if a covered agency determines that a non-animal test method is available to meet the relevant information requirement or if the agency has issued a waiver from animal-test data. Exceptions cover pre-enactment data, animal tests conducted outside the United States to satisfy foreign regulators, data requested after an agency finds existing data insufficient and no scientifically satisfactory non-animal method was practicably available, and animal tests specifically requested in writing with a clear agency justification. When animal testing is still used, entities must minimize the number of animals and reduce pain, suffering, distress, or lasting harm. Agencies may refuse violative data and impose civil penalties up to $10,000 per violation. Within one year, each covered agency must issue guidance on non-animal methods, revise regulations where appropriate, eliminate corresponding animal-data requirements, publish annual progress reports, and make non-proprietary data public.

Who Benefits and How

Non-animal test developers benefit because covered agencies must issue guidance and accept non-animal methods where available. Animal welfare advocates benefit from restrictions on unnecessary animal testing and minimization rules when testing remains unavoidable. Regulated companies benefit from clearer pathways to use accepted non-animal methods. Consumers and patients may benefit if modern test methods produce useful safety data without duplicative animal studies. The public benefits from annual agency progress reports and public data on animals used, species, test types, waivers, and accepted methods.

Who Bears the Burden and How

Regulated entities must determine whether accepted non-animal methods are available, justify animal-test submissions, minimize animal use, and face refusal or civil penalties for violations. CPSC, USDA, EPA, and FDA must write guidance, revise regulations, track waivers, publish annual reports, protect proprietary and personal information, and maintain public web data. Companies relying on legacy animal testing may need to change study design and compliance systems. Foreign-compliance animal data must be separated from domestic submissions. Federal taxpayers fund agency guidance, reporting, and enforcement work.

Key Provisions

• Prohibits animal-test-derived data submissions when accepted non-animal methods are available or an animal-data waiver has been issued.
• Allows exceptions for pre-enactment data, foreign regulatory data, agency-requested data, and justified animal tests.
• Requires regulated entities to minimize animal numbers and animal suffering when animal testing is unavoidable.
• Authorizes agencies to refuse violative data and impose civil penalties up to $10,000 per violation.
• Requires covered agencies within one year to issue guidance, revise regulations, eliminate corresponding animal-data requirements, and publish annual progress reports.