The American Regulatory Framework
The US regulatory system for laboratory animals is split across federal agencies — USDA enforces the Animal Welfare Act, FDA approves drugs and historically mandated animal testing — and 50 state legislatures with their own anti-cruelty laws, beagle freedom laws, zoning ordinances, and veterinary oversight boards. The system is fragmented by design: no single agency has comprehensive authority over the breeding, sale, housing, use, and disposition of laboratory dogs.
USDA & APHIS
The Enforcer
Administers the Animal Welfare Act, licenses breeders and research facilities, conducts inspections, and pursues enforcement actions. The agency with the mandate — and the troubled track record.
FDA & Drug Approval
The Demand Driver
Does not regulate animal welfare directly, but its drug approval requirements historically mandated animal testing. The FDA Modernization Acts (2022, 2025) removed that mandate and began the shift toward alternatives.
State-Level Law
50 Laboratories of Democracy
Anti-cruelty statutes, beagle freedom laws, zoning bans, environmental enforcement, veterinary oversight, and transparency requirements. Some of the hardest enforcement actions have come from state agencies, not federal.