HR7165-119

What This Bill Does

The WATCH Act amends Public Health Service Act section 495 to add inspection and certification requirements for foreign laboratories that receive federal funding for animal research under NIH or national research institute grants, contracts, or cooperative agreements. As a condition of eligibility, laboratories outside the United States must undergo quarterly inspections to evaluate compliance with animal-research requirements. The Secretary, in consultation with foreign regulators and international organizations, must establish a process for inspecting foreign laboratories with Animal Welfare Assurances. Inspections must evaluate animal care committees, review and evaluation of animal care and treatment, and recordkeeping and reporting procedures. After each inspection, the inspecting authority must issue a certification of compliance for laboratories that comply, and the Office of Laboratory Animal Welfare must keep those certificates publicly accessible with Animal Welfare Assurance information. Noncompliant laboratories get a reasonable opportunity for corrective action. If a foreign facility remains noncompliant, the Secretary must suspend or revoke the relevant grant, contract, or cooperative agreement under NIH Director conditions. The Secretary must designate the inspecting authority, coordinate with foreign regulators, and enter foreign-government agreements as needed. The amendment takes effect 180 days after enactment.

Who Benefits and How

Animal welfare advocates, NIH oversight officials, the Office of Laboratory Animal Welfare, and U.S. research sponsors benefit from stronger visibility into foreign laboratory compliance. Compliant foreign laboratories benefit from public certifications that show continued adherence to Animal Welfare Assurance obligations. U.S. taxpayers and research institutions benefit if federal funds are less likely to support animal research at foreign facilities with weak oversight.

Who Bears the Burden and How

Foreign laboratories receiving NIH funds must undergo quarterly inspections, maintain animal care committees, document care and treatment review, keep records, correct deficiencies, and risk suspension or revocation of funding. NIH, HHS, Office of Laboratory Animal Welfare staff, designated inspecting authorities, and foreign regulatory partners must build an inspection and certification process, publish certificates, coordinate across borders, and enforce corrective action. Research projects using foreign laboratories may face delays or funding risk if inspections identify noncompliance.

Key Provisions

• Requires quarterly inspections for foreign laboratories receiving NIH or national research institute funds for animal research.
• Requires inspections to evaluate animal care committees, care and treatment review, recordkeeping, and reporting.
• Requires compliance certifications after each successful inspection and public access through the Office of Laboratory Animal Welfare.
• Requires corrective-action opportunities for deficient laboratories.
• Requires suspension or revocation of grants, contracts, or cooperative agreements when foreign facilities fail to correct noncompliance.
• Directs HHS and NIH to designate inspectors and coordinate with foreign regulators and governments.