S. 1104: Worldwide Animal Testing Compliance and Harmonization Act of 2025

This bill, known as the Worldwide Animal Testing Compliance and Harmonization Act of 2025 (also referred to as the WATCH Act), seeks to amend existing regulations regarding animal research conducted in foreign laboratories that receive federal funding. Here is a summary of the key components of the bill:

Inspection Requirements

The bill mandates that all foreign laboratories receiving federal funds for research involving animals must undergo quarterly inspections. The primary aim of these inspections is to ensure compliance with applicable animal welfare standards.

Inspection Process

• The Secretary of Health, in consultation with relevant foreign regulatory authorities and international organizations, will be responsible for establishing a process to conduct these inspections.
• The inspections will assess whether these laboratories:
  • Have appropriate animal care committees.
  • Conduct reviews and evaluations of animal care and treatment.
  • Maintain proper record-keeping and reporting procedures.

Certification of Compliance

After each inspection, if a laboratory meets the required standards, the inspecting authority will issue a certificate of compliance. This information will be made publicly accessible through the Office of Laboratory Animal Welfare, which will also provide other details concerning animal welfare assurances.

Addressing Non-compliance

• Laboratories that are found to be non-compliant will be given a reasonable opportunity to correct any issues.
• If a laboratory fails to comply after being given a chance to rectify the situation, the Secretary may suspend or revoke the relevant grants or contracts for research involving animals.

Coordination with Foreign Authorities

The Secretary and the Director of the National Institutes of Health (NIH) are required to work with foreign regulatory bodies and form agreements where necessary to ensure the enforcement of these inspections, while respecting the laws and sovereignty of each foreign nation.

Effective Date

The new regulations outlined in this bill will take effect 180 days after the bill is enacted.

Relevant Companies

• PFE (Pfizer Inc.) - Could be impacted due to their involvement in animal research for drug development and testing.
• NVS (Novartis AG) - As a pharmaceutical company involved in biomedical research, they may be affected by increased compliance regulations in foreign laboratories they work with.
• BMY (Bristol-Myers Squibb Company) - Their operations in animal testing for research purposes may be influenced by new inspection and compliance requirements.