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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8333 Engrossed in House (EH)]

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118th CONGRESS
  2d Session
                                H. R. 8333

_______________________________________________________________________

                                 AN ACT

 
 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. SHORT TITLE.

    This Act may be cited as the ``BIOSECURE Act''.

SEC. 2. 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 
                with the executive agency; or
                    (B) enters into any contract the performance of 
                which such entity knows or has reason to believe will 
                require, in performance of the contract with the 
                executive agency, the 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, and a loan or 
grant recipient may not use loan or grant funds to--
            (1) procure, obtain, or use 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 regulation in subsection (h).
            (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 regulation in subsection 
        (h).
            (3) Rules of construction.--
                    (A) Certain entities.--Prior to January 1, 2032, 
                with respect to biotechnology companies of concern 
                covered by subsections (f)(2)(A), subsections (a)(2) 
                and (b)(2) shall not apply to biotechnology equipment 
                or services produced or provided under a contract or 
                agreement, including previously negotiated contract 
                options, entered into before the effective date under 
                paragraph (1).
                    (B) Other entities.--Prior to the date that is five 
                years after the issuance of the regulation in 
                subsection (h) that identifies a biotechnology company 
                of concern covered by subsections (f)(2)(B), 
                subsections (a)(2) and (b)(2) shall not apply to 
                biotechnology equipment or services produced or 
                provided under a contract or agreement, including 
                previously negotiated contract options, entered into 
                before the effective date under paragraph (2).
                    (C) Safe harbor.--The term ``biotechnology 
                equipment or services produced or provided by a 
                biotechnology company of concern'' shall not be 
                construed to refer to any biotechnology equipment or 
                services that were formerly, but are no longer, 
                produced or provided by biotechnology companies of 
                concern.
    (d) Waiver Authorities.--
            (1) Specific biotechnology exception.--
                    (A) Waiver.--The head of the applicable executive 
                agency may waive the prohibition under subsections (a) 
                and (b) on a case-by-case basis--
                            (i) with the approval of the Director of 
                        the Office of Management and Budget, in 
                        coordination with 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 head of the applicable 
                        executive agency, with the approval of the 
                        Director of the Office of Management and 
                        Budget, and in coordination with 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 if such head submits a 
                        notification and justification to the 
                        appropriate congressional committees not later 
                        than 10 days after granting such waiver 
                        extension.
            (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 
                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, lawfully compiled, that is commercially or 
        publicly available.
    (f) Evaluation of Certain Biotechnology Entities.--
            (1) Entity consideration.--Not later than 365 days after 
        the date of the enactment of this Act, the Director of the 
        Office of Management and Budget shall publish a list of the 
        entities that constitute biotechnology companies of concern 
        based on a list of suggested entities that shall be provided by 
        the Secretary of Defense in coordination with the Attorney 
        General, the Secretary of Health and Human Services, the 
        Secretary of Commerce, the Director of National Intelligence, 
        the Secretary of Homeland Security, the Secretary of State, and 
        the National Cyber Director.
            (2) Biotechnology companies of concern defined.--The term 
        ``biotechnology company of concern'' means--
                    (A) BGI, MGI, Complete Genomics, WuXi AppTec, and 
                WuXi Biologics;
                    (B) any entity that is determined by the process 
                established in paragraph (1) to meet the following 
                criteria--
                            (i) is subject to the administrative 
                        governance structure, 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; and
                    (C) any subsidiary, parent, affiliate, or successor 
                of entities listed in subparagraphs (A) and (B), 
                provided they meet the criteria in subparagraph (B)(i).
            (3) Guidance.--Not later than 120 days after the date of 
        the enactment of this Act for the biotechnology companies of 
        concern named in paragraph (2)(A), and not later than 180 days 
        after the development of the list pursuant to paragraph (1) and 
        any update to the list pursuant to paragraph (4), the Director 
        of the Office of Management and Budget, in coordination 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, the Secretary of State, and the National Cyber 
        Director, shall establish guidance as necessary to implement 
        the requirements of this section.
            (4) Updates.--The Director of the Office of Management and 
        Budget, in coordination with or based on a recommendation 
        provided by 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, the Secretary of State, and the National 
        Cyber Director, shall periodically, though not less than 
        annually, review and, as appropriate, modify the list of 
        biotechnology companies of concern, and notify the appropriate 
        congressional committees of any such modifications.
            (5) Notice of a designation and review.--
                    (A) In general.--A notice of a designation as a 
                biotechnology company of concern under paragraph (2)(B) 
                shall be issued to any biotechnology company of concern 
                named in the designation--
                            (i) advising that a designation has been 
                        made;
                            (ii) identifying the criteria relied upon 
                        under such subparagraph and, to the extent 
                        consistent with national security and law 
                        enforcement interests, the information that 
                        formed the basis for the designation;
                            (iii) advising that, within 90 days after 
                        receipt of notice, the biotechnology company of 
                        concern may submit information and argument in 
                        opposition to the designation;
                            (iv) describing the procedures governing 
                        the review and possible issuance of a 
                        designation pursuant to paragraph (1); and
                            (v) where practicable, identifying 
                        mitigation steps that could be taken by the 
                        biotechnology company of concern that may 
                        result in the rescission of the designation.
                    (B) Congressional notification requirements.--
                            (i) Notice of designation.--The Director of 
                        the Office of Management and Budget shall 
                        submit the notice required under subparagraph 
                        (A) to the Committee on Homeland Security and 
                        Governmental Affairs of the Senate and the 
                        Committee on Oversight and Accountability of 
                        the House of Representatives.
                            (ii) Information and argument in opposition 
                        to designations.--Not later than 7 days after 
                        receiving any information and argument in 
                        opposition to a designation pursuant to 
                        subparagraph (A)(iii), the Director of the 
                        Office of Management and Budget shall submit 
                        such information to the Committee on Homeland 
                        Security and Governmental Affairs of the Senate 
                        and the Committee on Oversight and 
                        Accountability of the House of Representatives.
                    (C) Exceptions.--The provisions under subparagraphs 
                (A) and (B) shall not apply to an entity listed under 
                paragraph (2)(A).
            (6) No immediate public release.--Any designation made 
        under paragraph (1) or paragraph (4) shall not be made publicly 
        available until the Director of the Office of Management and 
        Budget, in coordination with appropriate agencies, reviews all 
        information submitted under paragraph (5)(A)(iii) and issues a 
        final determination that a company shall remain listed as a 
        biotechnology company of concern.
    (g) Evaluation of National Security Risks Posed by Foreign 
Adversary Acquisition of American Multiomic Data.--
            (1) Assessment.--Not later than 270 days after the 
        enactment of this Act, the Director of National Intelligence, 
        in consultation with the Secretary of Defense, the Attorney 
        General of the United States, the Secretary of Health and Human 
        Services, the Secretary of Commerce, the Secretary of Homeland 
        Security, the Secretary of State, and the National Cyber 
        Director, shall complete an assessment of risks to national 
        security posed by human multiomic data from United States 
        citizens that is collected or stored by a foreign adversary 
        from the provision of biotechnology equipment or services.
            (2) Report requirement.--Not later than 30 days after the 
        completion of the assessment developed under paragraph (1), the 
        Director of National Intelligence shall submit a report with 
        such assessment to the appropriate congressional committees.
            (3) Form.--The report required under paragraph (2) shall be 
        in unclassified form accompanied by a classified annex.
    (h) Regulations.--Not later than one year after the date of 
establishment of guidance required under subsection (f)(3), and as 
necessary for subsequent updates, the Federal Acquisition Regulatory 
Council shall revise the Federal Acquisition Regulation as necessary to 
implement the requirements of this section.
    (i) Reporting on Intelligence on Nefarious Activities of 
Biotechnology Companies With Human Multiomic Data.--Not later than 180 
days after the date of the enactment of this Act, and annually 
thereafter, the Director of National Intelligence, in consultation with 
the heads of executive agencies, shall submit to the appropriate 
congressional committees a report on any intelligence in possession of 
such agencies related to nefarious activities conducted by 
biotechnology companies with human multiomic data. The report shall 
include information pertaining to potential threats to national 
security or public safety from the selling, reselling, licensing, 
trading, transferring, sharing, or otherwise providing or making 
available to any foreign country of any forms of multiomic data of a 
United States citizen.
    (j) No Additional Funds.--No additional funds are authorized to be 
appropriated for the purpose of carrying out this section.
    (k) Definitions.--In this section:
            (1) Appropriate congressional committees.--The term 
        ``appropriate congressional committees'' means--
                    (A) the Committee on Armed Services, the Select 
                Committee on Intelligence, and the Committee on 
                Homeland Security and Governmental Affairs of the 
                Senate; and
                    (B) the Committee on Armed Services, the Permanent 
                Select Committee on Intelligence, 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, 
                combined mass spectrometry technologies, 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 is designed for use in the research, 
                development, production, or analysis of biological 
                materials 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 in the interest of national security.
            (3) Contract.--Except as the term is used under subsection 
        (b)(2) and subsection (c)(3), the term ``contract'' means any 
        contract subject to the Federal Acquisition Regulation issued 
        under section 1303(a)(1) of title 41, United States Code.
            (4) 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.
            (5) Executive agency.--The term ``executive agency'' has 
        the meaning given the term ``Executive agency'' in section 105 
        of title 5, United States Code.
            (6) Foreign adversary.--The term ``foreign adversary'' has 
        the meaning given the term ``covered nation'' in section 
        4872(d) of title 10, United States Code.
            (7) Multiomic.--The term ``multiomic'' means data types 
        that include genomics, epigenomics, transcriptomics, 
        proteomics, and metabolomics.
            (8) 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.

            Passed the House of Representatives September 9, 2024.

            Attest:

                                                                 Clerk.
118th CONGRESS

  2d Session

                               H. R. 8333

_______________________________________________________________________

                                 AN ACT

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