[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 1104 Introduced in Senate (IS)]
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119th CONGRESS
1st Session
S. 1104
To amend section 495 of the Public Health Service Act to require
inspections of foreign laboratories conducting biomedical and
behavioral research to ensure compliance with applicable animal welfare
requirements, and for other purposes
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 25, 2025
Mr. Schmitt (for himself, Mr. Merkley, Mr. Ricketts, Mr. Fetterman, Mr.
Scott of Florida, Mr. Peters, and Ms. Ernst) introduced the following
bill; which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend section 495 of the Public Health Service Act to require
inspections of foreign laboratories conducting biomedical and
behavioral research to ensure compliance with applicable animal welfare
requirements, and for other purposes
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLES.
This Act may be cited as the ``Worldwide Animal Testing Compliance
and Harmonization Act of 2025'' or the ``WATCH Act''.
SEC. 2. FOREIGN LABORATORY INSPECTIONS AND CERTIFICATION.
(a) In General.--Section 495 of the Public Health Service Act (42
U.S.C. 289d) is amended by adding at the end the following:
``(f) Inspection and Certification of Foreign Laboratories.--
``(1) In general.--As a condition of eligibility to perform
research involving animals under a grant, contract, or
cooperative agreement administered by the National Institutes
of Health or any national research institute, a laboratory
located outside the United States that receives Federal funds
shall be subject to quarterly inspections to evaluate
compliance with the requirements under this title.
``(2) Inspection and certification requirements.--
``(A) Quarterly inspection process.--The Secretary,
in consultation with appropriate foreign regulatory
authorities and international organizations, shall
establish and implement a process for conducting
quarterly inspections of foreign laboratories that have
received an Animal Welfare Assurance (as defined in
section 9.2 of title 42, Code of Federal Regulations)
to ensure their continued compliance with the
requirements under this title.
``(B) Assurances.--The inspection process
established by the Secretary pursuant to subparagraph
(A) shall evaluate the compliance of foreign
laboratories with the requirements under subsection
(c)(1), including--
``(i) the establishment and operation of
animal care committees;
``(ii) the review and evaluation of animal
care and treatment; and
``(iii) proper record-keeping and reporting
procedures.
``(3) Certification of compliance and public access.--
``(A) Issuance.--Following each quarterly
inspection required under paragraph (2)(A), the
inspecting authority shall issue a certification of
compliance to the laboratories determined to be in
compliance with the requirements under paragraph
(2)(B).
``(B) Public access.--Copies of the certificates of
compliance issued pursuant to subparagraph (A) shall be
maintained by the Office of Laboratory Animal Welfare
and shall remain publicly accessible with other
information about currently issued Animal Welfare
Assurances.
``(C) Corrective action.--Laboratories that fail to
comply with the requirements under paragraph (2)(B)
shall be given a reasonable opportunity to take
corrective action.
``(4) Suspension or revocation of grant or contract for
non-compliant foreign laboratories.--If the Secretary
determines that a foreign facility is not in compliance with
the requirements under subsection (c)(1) and does not take
appropriate corrective action after given a reasonable
opportunity to do so, the Secretary shall suspend or revoke the
applicable grant, contract, or cooperative agreement involving
research on animals under such conditions as the Director of
NIH determines appropriate, in accordance with subsection (d).
``(5) Designation of inspecting authority.--The Secretary,
in consultation with the Director of NIH, shall designate an
appropriate authority to conduct the quarterly inspections
required under paragraph (2)(A) and issue certifications of
compliance in accordance with paragraph (3).
``(6) Coordination with foreign authorities.--The Secretary
and the Director of NIH shall coordinate with appropriate
foreign regulatory authorities and enter into agreements with
foreign governments, as needed, to facilitate the
implementation and enforcement of this subsection, while
respecting the sovereignty and laws of foreign nations.''.
(b) Effective Date.--The amendment made by subsection (a) shall
take effect on the date that is 180 days after the date of the
enactment of this Act.
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