[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2397 Introduced in Senate (IS)]

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118th CONGRESS
  1st Session
                                S. 2397

   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

                             July 19, 2023

  Mr. Schmitt (for himself and Mr. Merkley) 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 2023'' 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), 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) 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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