119-s1104

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 1104 Introduced in Senate

    (IS) ]

<DOC>

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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