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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 3411 Introduced in Senate (IS)]

<DOC>

118th CONGRESS
  1st Session
                                S. 3411

     To prohibit contracting with certain biotechnology providers.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                            December 5, 2023

  Mr. Peters 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.

    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 ``Safeguarding American Genetic Data 
Act of 2023''.

SEC. 2. PROHIBITION ON CONTRACTING WITH CERTAIN BIOTECHNOLOGY 
              PROVIDERS.

    (a) Designation of Federal Entity.--Not later than 30 days after 
the date of the enactment of this Act, the President shall designate a 
Federal entity (in this section referred to as the ``Federal entity'') 
to establish guidance to ensure that Executive agencies do not directly 
procure or obtain any covered biotechnology equipment or service. The 
Federal entity, the head of which shall be the Director of the Office 
of Management and Budget, shall include 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 heads 
of other appropriate Federal agencies as identified by the President.
    (b) Policy, Guidance, and Regulations.--
            (1) Recommendations.--Not later than one year after the 
        date of the enactment of this Act, the Federal entity, in 
        coordination with the Federal Acquisition Regulatory Council 
        and other heads of Executive agencies as determined appropriate 
        by the President, shall issue guidance and recommend the 
        establishment of policy and regulations, as necessary, to 
        implement the requirements of this section.
            (2) OMB policy.--Not later than 180 days after the date of 
        issuance of recommendations under paragraph (1), the Director 
        of the Office of Management and Budget shall issue any policy 
        necessary to effectuate the recommendations.
            (3) Federal acquisition regulation.--Not later than one 
        year after the date of issuance of recommendations under 
        paragraph (1), the Federal Acquisition Regulatory Council shall 
        revise the Federal Acquisition Regulation as necessary to 
        implement the requirements of this section.
            (4) Effective date.--Any prohibition included in the 
        guidance established by the Federal entity in accordance with 
        paragraph (1) shall take effect not later than one year after 
        the establishment of such guidance.
    (c) Rule of Construction.--Nothing in this section shall be 
construed--
            (1) to require any covered biotechnology equipment or 
        service in use or resident in equipment, systems, or services 
        as of the day before the applicable effective date specified in 
        subsection (b)(4) to be removed or replaced; or
            (2) to prohibit or limit the utilization of such covered 
        biotechnology equipment or service throughout the lifecycle of 
        such existing equipment.
    (d) Exceptions.--Any prohibition included in the guidance 
established by the Federal entity under subsection (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 defense or intelligence 
        activities of the United States Government;
            (2) health care services and related equipment and supplies 
        for--
                    (A) employees of the United States Government, 
                including members of the uniformed services (as that 
                term is 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 
                outside of the continental United States; 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 official duty stations are 
                        located overseas or are on permissive temporary 
                        duty travel outside of the continental United 
                        States.
            (3) the acquisition, use, or distribution of multiomic 
        data, however compiled, that is commercially or publicly 
        available.
    (e) Waiver Authorities.--
            (1) In general.--The policy, guidance, and regulations 
        established under subsection (b) shall allow the head of an 
        Executive agency to waive any prohibition implemented in 
        connection with such guidance on a case-by-case basis after 
        consultation with the Federal entity.
            (2) Duration.--
                    (A) In general.--Except as provided in subparagraph 
                (B), a waiver granted under paragraph (1) shall last 
                for a period of not more than one year.
                    (B) Extension.--The head of an Executive agency may 
                extend a waiver granted to an Executive agency under 
                paragraph (1) 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 
                Executive agency submits to the appropriate 
                congressional committees a notification of such waiver 
                not later than 30 days after granting the waiver.
    (f) Determination of Certain Biotechnology Entities.--
            (1) In general.--Not later than 180 days after the date of 
        the enactment of this Act, the Federal entity shall develop a 
        list of entities determined to be a biotechnology company of 
        concern. The Federal entity shall define a biotechnology 
        company of concern as any entity that--
                    (A) is subject to the jurisdiction, direction, 
                control, or operates on behalf of the government of a 
                foreign adversary;
                    (B) is to any extent involved in the manufacturing, 
                distribution, provision, or procurement of 
                biotechnology equipment or services; and
                    (C) 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 
                        biotechnology equipment or services without 
                        expressed and informed consent.
            (2) Updates.--The Federal entity shall periodically, but 
        not less than annually, review and, as appropriate, modify the 
        list of biotechnology companies of concern.
    (g) Evaluation of Certain Biotechnology Entities.--Not later than 
180 days after the date of the enactment of this Act, the Federal 
entity shall determine whether BGI, MGI, Complete Genomics, and any 
subsidiary, affiliate, or successor of such entities, are biotechnology 
companies of concern. If any such entities, subsidiaries, affiliates, 
or successors are identified as biotechnology companies of concern, no 
Executive agency shall directly procure or obtain any biotechnology 
equipment or services from such entities, subsidiaries, affiliates, or 
successors. The Director of the Office of Management and Budget shall 
issue such policy, and the Federal Acquisition Regulatory Council shall 
promulgate such regulations, as may be necessary to effectuate this 
prohibition.
    (h) Analysis, Assessment, and Strategy.--Not later than 180 days 
after developing the list of entities under subsection (f)(1) and the 
determination of entities under subsection (g), the Federal entity, to 
the greatest extent practicable, leveraging relevant previous analyses 
and assessments, shall--
            (1) conduct an analysis of the list of entities identified 
        under subsections (f)(1) and (g), including--
                    (A) active Federal grants to or contracts with 
                private companies, academic institutions, and public 
                sector entities, including--
                            (i) the number and type of covered 
                        biotechnology equipment or services already or 
                        expected to be procured;
                            (ii) the anticipated lifespan of covered 
                        biotechnology equipment or services already or 
                        expected to be procured;
                            (iii) the estimated costs and timeline to 
                        replace covered biotechnology equipment or 
                        services already procured; and
                    (B) the domestic and international market share;
            (2) assess risks to national security posed by the entities 
        identified under subsections (f)(1) and (g), obtaining active 
        and future Federal grants to or contracts with private 
        companies, academic institutions, and public sector entities;
            (3) develop a strategy to--
                    (A) mitigate the risks to national security 
                identified in the assessment conducted under paragraph 
                (2); and
                    (B) support private companies, academic 
                institutions, and public sector entities seeking to 
                acquire covered biotechnology equipment or services 
                from alternative entities; and
            (4) provide the results of the analysis, assessment, and 
        strategy developed under this subsection to the Federal 
        Acquisition Regulatory Council and the appropriate 
        congressional committees.
    (i) Report Requirement.--
            (1) In general.--Not later than 180 days after the date of 
        the enactment of this Act, the Federal entity shall submit to 
        the Federal Acquisition Regulatory Council and the appropriate 
        congressional committees a report including the following:
                    (A) The name of and justification for each entity 
                meeting the criteria for a biotechnology company of 
                concern under subsections (f)(1) and (g).
                    (B) A catalog of all active or planned grants or 
                contracts any Executive agency has with any entity 
                determined to be a biotechnology company of concern 
                related to biotechnology equipment or services.
                    (C) Recommendations, as applicable, on alternative 
                entities to a biotechnology company of concern capable 
                of providing the Federal Government with required 
                biotechnology equipment or services.
                    (D) Recommendations, as applicable, on the 
                feasibility of implementing prohibitions implemented in 
                connection with the guidance established under 
                subsection (b) or exercising waiver authorities under 
                subsection (e), to ensure uninterrupted Federal 
                Government access to required biotechnology equipment 
                and services, and any further changes to legislation 
                needed to mitigate supply chain risks or increase 
                availability and enhance capabilities of biotechnology 
                equipment and services.
            (2) Form.--The report required under paragraph (1) shall be 
        in unclassified form accompanied by a classified annex.
    (j) Definitions.--In this section:
            (1) Appropriate congressional committees.--The term 
        ``appropriate congressional committees'' means--
                    (A) the Committee on Armed Services, the Committee 
                on Commerce, Science, and Transportation, the Committee 
                on Foreign Relations, the Committee on Health, 
                Education, Labor, and Pensions, 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 provided by a biotechnology company of 
                        concern with respect to the use or 
                        implementation of an instrument, apparatus, 
                        machine, or device described in subparagraph 
                        (A); or
                            (ii) disease detection, genealogical 
                        information, and related services; and
                    (C) any other service, instrument, apparatus, 
                machine, component, accessory, device, software, or 
                firmware that the Federal entity determines 
                appropriate.
            (3) Control.--The term ``control'' has the meaning given 
        the term in section 800.208 of title 31, Code of Federal 
        Regulations, or any successor regulations.
            (4) Covered biotechnology equipment or service.--The term 
        ``covered biotechnology equipment or service'' means a 
        biotechnology equipment or service produced or provided by a 
        biotechnology company of concern.
            (5) Executive agency.--The term ``Executive agency'' has 
        the meaning given the term 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.
                                 <all>
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