[Congressional Record Volume 170, Number 114 (Wednesday, July 10, 2024)]
[Senate]
[Pages S4411-S4412]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 2166. Mr. HAGERTY (for himself and Mr. Peters) submitted an 
amendment intended to be proposed by him to the bill S. 4638, to 
authorize appropriations for fiscal year 2025 for military activities 
of the Department of Defense, for military construction, and for 
defense activities of the Department of Energy, to prescribe military 
personnel strengths for such fiscal year, and for other purposes; which 
was ordered to lie on the table; as follows:

       At the appropriate place in title VIII, insert the 
     following:

     SEC. __. 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;

[[Page S4412]]

       (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.
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