[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 3558 Introduced in Senate (IS)]

<DOC>






118th CONGRESS
  1st Session
                                S. 3558

 To prohibit contracting with certain biotechnology providers, and for 
                            other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           December 20, 2023

Mr. Peters (for himself and Mr. Hagerty) introduced the following bill; 
which was read twice and referred to the Committee on Homeland Security 
                        and Governmental Affairs

_______________________________________________________________________

                                 A BILL


 
 To prohibit contracting with certain biotechnology providers, 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. PROHIBITION ON CONTRACTING WITH CERTAIN BIOTECHNOLOGY 
              PROVIDERS.

    (a) In General.--The head of an executive agency may not--
            (1) procure or obtain any biotechnology equipment or 
        service produced or provided by a biotechnology company of 
        concern; or
            (2) enter into a contract or extend or renew a contract 
        with any entity that--
                    (A) uses biotechnology equipment or services 
                produced or provided by a biotechnology company of 
                concern and acquired after the applicable effective 
                date in subsection (c) in performance of the contract; 
                or
                    (B) enters into any contract the performance of 
                which will require the direct use of biotechnology 
                equipment or services produced or provided by a 
                biotechnology company of concern and acquired after the 
                applicable effective date in subsection (c).
    (b) Prohibition on Loan and Grant Funds.--The head of an executive 
agency may not obligate or expend loan or grant funds to--
            (1) procure or obtain any biotechnology equipment or 
        services produced or provided by a biotechnology company of 
        concern; or
            (2) enter into a contract or extend or renew a contract 
        with an entity described in subsection (a)(2).
    (c) Effective Dates.--
            (1) Certain entities.--With respect to the biotechnology 
        companies of concern covered by subsection (f)(2)(A), the 
        prohibitions under subsections (a) and (b) shall take effect 60 
        days after the issuance of the implementing guidance in 
        subsection (f)(3) or the expiration of the deadline set forth 
        in subsection (f)(3), whichever occurs first.
            (2) Other entities.--With respect to the biotechnology 
        companies of concern covered by subsection (f)(2)(B), the 
        prohibitions under subsections (a) and (b) shall take effect 
        180 days after the issuance of the implementing guidance in 
        subsection (f)(3).
    (d) Waiver Authorities.--
            (1) Specific biotechnology exception.--
                    (A) Waiver.--The head of an executive agency may 
                waive the prohibition under subsection (a) and (b) on a 
                case-by-case basis--
                            (i) with the approval of the Director of 
                        the Office of Management and Budget, in 
                        consultation with the Federal Acquisition 
                        Security Council and the Secretary of Defense; 
                        and
                            (ii) if such head submits a notification 
                        and justification to the appropriate 
                        congressional committees not later than 30 days 
                        after granting such waiver.
                    (B) Duration.--
                            (i) In general.--Except as provided in 
                        clause (ii), a waiver granted under 
                        subparagraph (A) shall last for a period of not 
                        more than 365 days.
                            (ii) Extension.--The Director of the Office 
                        of Management and Budget, in consultation with 
                        the Federal Acquisition Security Council and 
                        the Secretary of Defense, may extend a waiver 
                        granted under subparagraph (A) one time, for a 
                        period up to 180 days after the date on which 
                        the waiver would otherwise expire, if such an 
                        extension is in the national security interests 
                        of the United States and the Director submits 
                        to the appropriate congressional committees a 
                        notification of such waiver.
            (2) Overseas health care services.--The head of an 
        executive agency may waive the prohibitions under subsections 
        (a) and (b) with respect to a contract, subcontract, or 
        transaction for the acquisition or provision of health care 
        services overseas on a case-by-case basis--
                    (A) if the head of such executive agency determines 
                that the waiver is--
                            (i) necessary to support the mission or 
                        activities of the employees of such executive 
                        agency described in subsection (e)(2)(A); and
                            (ii) in the interest of the United States;
                    (B) with the approval of the Director of the Office 
                of Management and Budget, in consultation with the 
                Federal Acquisition Security Council and the Secretary 
                of Defense; and
                    (C) if such head submits a notification and 
                justification to the appropriate congressional 
                committees not later than 30 days after granting such 
                waiver.
    (e) Exceptions.--The prohibitions under subsections (a) and (b) 
shall not apply to--
            (1) any activity subject to the reporting requirements 
        under title V of the National Security Act of 1947 (50 U.S.C. 
        3091 et seq.) or any authorized intelligence activities of the 
        United States;
            (2) the acquisition or provision of health care services 
        overseas for--
                    (A) employees of the United States, including 
                members of the uniformed services (as defined in 
                section 101(a) of title 10, United States Code), whose 
                official duty stations are located overseas or are on 
                permissive temporary duty travel overseas; or
                    (B) employees of contractors or subcontractors of 
                the United States--
                            (i) who are performing under a contract 
                        that directly supports the missions or 
                        activities of individuals described in 
                        subparagraph (A); and
                            (ii) whose primary duty stations are 
                        located overseas or are on permissive temporary 
                        duty travel overseas; or
            (3) the acquisition, use, or distribution of human 
        multiomic data, however compiled, that is commercially or 
        publicly available.
    (f) Evaluation of Certain Biotechnology Entities.--
            (1) Entity consideration.--Not later than 120 days after 
        the date of the enactment of this Act, the Director of the 
        Office of Management and Budget, in consultation with the 
        Secretary of Defense, the Attorney General, the Secretary of 
        Health and Human Services, the Secretary of Commerce, the 
        Director of National Intelligence, the Secretary of Homeland 
        Security, and the Secretary of State, shall develop a list of 
        the entities that constitute biotechnology companies of 
        concern.
            (2) Biotechnology companies of concern defined.--The term 
        ``biotechnology company of concern'' means--
                    (A) BGI, MGI, Complete Genomics, Wuxi Apptec, and 
                any subsidiary, parent affiliate, or successor of such 
                entities; and
                    (B) any entity that--
                            (i) is subject to the jurisdiction, 
                        direction, control, or operates on behalf of 
                        the government of a foreign adversary;
                            (ii) is to any extent involved in the 
                        manufacturing, distribution, provision, or 
                        procurement of a biotechnology equipment or 
                        service; and
                            (iii) poses a risk to the national security 
                        of the United States based on--
                                    (I) engaging in joint research 
                                with, being supported by, or being 
                                affiliated with a foreign adversary's 
                                military, internal security forces, or 
                                intelligence agencies;
                                    (II) providing multiomic data 
                                obtained via biotechnology equipment or 
                                services to the government of a foreign 
                                adversary; or
                                    (III) obtaining human multiomic 
                                data via the biotechnology equipment or 
                                services without express and informed 
                                consent.
            (3) Guidance.--Not later than 120 days after the date of 
        the enactment of this Act, the Director of the Office of 
        Management and Budget, in consultation with the Secretary of 
        Defense, the Attorney General, the Secretary of Health and 
        Human Services, the Secretary of Commerce, the Director of 
        National Intelligence, the Secretary of Homeland Security, and 
        the Secretary of State, shall establish guidance necessary to 
        implement the requirements of this section.
            (4) Updates.--The Director of the Office of Management and 
        Budget, in consultation with the Secretary of Defense, the 
        Attorney General, the Secretary of Health and Human Services, 
        the Secretary of Commerce, the Director of National 
        Intelligence, the Secretary of Homeland Security, and the 
        Secretary of State, shall periodically, though not less than 
        annually, review and, as appropriate, make a determination to 
        modify the list of biotechnology companies of concern.
    (g) Regulations.--Not later than one year after the date of 
establishment of guidance required under subsection (f)(3), the Federal 
Acquisition Regulatory Council shall revise the Federal Acquisition 
Regulation as necessary to implement the requirements of this section.
    (h) No Additional Funds.--No additional funds are authorized to be 
appropriated for the purpose of carrying out this section.
    (i) Definitions.--In this section:
            (1) Appropriate congressional committees.--The term 
        ``appropriate congressional committees'' means--
                    (A) the Committee on Armed Services and the 
                Committee on Homeland Security and Governmental Affairs 
                of the Senate; and
                    (B) the Committee on Armed Services, the Committee 
                on Foreign Affairs, the Committee on Oversight and 
                Accountability, the Committee on Energy and Commerce, 
                and the Select Committee on Strategic Competition 
                between the United States and the Chinese Communist 
                Party of the House of Representatives.
            (2) Biotechnology equipment or service.--The term 
        ``biotechnology equipment or service'' means--
                    (A) equipment, including genetic sequencers, mass 
                spectrometers, polymerase chain reaction machines, or 
                any other instrument, apparatus, machine, or device, 
                including components and accessories thereof, that is 
                designed for use in the research, development, 
                production, or analysis of biological materials as well 
                as any software, firmware, or other digital components 
                that are specifically designed for use in, and 
                necessary for the operation of, such equipment;
                    (B) any service for the research, development, 
                production, analysis, detection, or provision of 
                information, including data storage and transmission 
                related to biological materials, including--
                            (i) advising, consulting, or support 
                        services with respect to the use or 
                        implementation of a instrument, apparatus, 
                        machine, or device described in subparagraph 
                        (A); and
                            (ii) disease detection, genealogical 
                        information, and related services; and
                    (C) any other service, instrument, apparatus, 
                machine, component, accessory, device, software, or 
                firmware that the Director of the Office of Management 
                and Budget, in consultation with the heads of Executive 
                agencies, as determined appropriate by the Director of 
                the Office of Management and Budget, determines 
                appropriate.
            (3) Control.--The term ``control'' has the meaning given to 
        that term in section 800.208 of title 31, Code of Federal 
        Regulations, or any successor regulations.
            (4) Executive agency.--The term ``executive agency'' has 
        the meaning given the term ``Executive agency'' in section 105 
        of title 5, United States Code.
            (5) Foreign adversary.--The term ``foreign adversary'' has 
        the meaning given the term ``covered nation'' in section 
        4872(d) of title 10, United States Code.
            (6) Multiomic.--The term ``multiomic'' means data types 
        that include genomics, epigenomics, transcriptomics, 
        proteomics, and metabolomics.
            (7) Overseas.--The term ``overseas'' means any area outside 
        of the United States, the Commonwealth of Puerto Rico, or a 
        territory or possession of the United States.
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