II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. PROHIBITION ON CONTRACTING WITH CER4 TAIN BIOTECHNOLOGY PROVIDERS. 

5 (a) IN GENERAL.—The head of an executive agency 

6 may not— 

7 (1) procure or obtain any biotechnology equip8 ment or service produced or provided by a bio9 technology company of concern; or 


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1 (2) enter into a contract or extend or renew a 

2 contract with any entity that— 

3 (A) uses biotechnology equipment or serv4 ices produced or provided by a biotechnology 

5 company of concern and acquired after the ap6 plicable effective date in subsection (c) in per7 formance of the contract; or 

8 (B) enters into any contract the perform9 ance of which will require the direct use of bio10 technology equipment or services produced or 

11 provided by a biotechnology company of concern 

12 and acquired after the applicable effective date 

13 in subsection (c). 

14 (b) PROHIBITION ON LOAN AND GRANT FUNDS.— 

15 The head of an executive agency may not obligate or ex16 pend loan or grant funds to— 

17 (1) procure or obtain any biotechnology equip18 ment or services produced or provided by a bio19 technology company of concern; or 

20 (2) enter into a contract or extend or renew a 

21 contract with an entity described in subsection 

22 (a)(2). 

23 (c) EFFECTIVE DATES.— 

24 (1) CERTAIN ENTITIES.—With respect to the 

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1 section (f)(2)(A), the prohibitions under subsections 

2 (a) and (b) shall take effect 60 days after the 

3 issuance of the implementing guidance in subsection 

4 (f)(3) or the expiration of the deadline set forth in 

5 subsection (f)(3), whichever occurs first. 

6 (2) OTHER ENTITIES.—With respect to the bio7 technology companies of concern covered by sub8 section (f)(2)(B), the prohibitions under subsections 

9 (a) and (b) shall take effect 180 days after the 

10 issuance of the implementing guidance in subsection 

11 (f)(3). 

12 (d) WAIVER AUTHORITIES.— 

13 (1) SPECIFIC BIOTECHNOLOGY EXCEPTION.— 

14 (A) WAIVER.—The head of an executive 

15 agency may waive the prohibition under sub16 section (a) and (b) on a case-by-case basis— 

17 (i) with the approval of the Director 

18 of the Office of Management and Budget, 

19 in consultation with the Federal Acquisi20 tion Security Council and the Secretary of 

21 Defense; and 

22 (ii) if such head submits a notification 

23 and justification to the appropriate con24 gressional committees not later than 30 

25 days after granting such waiver. 


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1 (B) DURATION.— 

2 (i) IN GENERAL.—Except as provided 

3 in clause (ii), a waiver granted under sub4 paragraph (A) shall last for a period of not 

5 more than 365 days. 

6 (ii) EXTENSION.—The Director of the 

7 Office of Management and Budget, in con8 sultation with the Federal Acquisition Se9 curity Council and the Secretary of De10 fense, may extend a waiver granted under 

11 subparagraph (A) one time, for a period 

12 up to 180 days after the date on which the 

13 waiver would otherwise expire, if such an 

14 extension is in the national security inter15 ests of the United States and the Director 

16 submits to the appropriate congressional 

17 committees a notification of such waiver. 

18 (2) OVERSEAS HEALTH CARE SERVICES.—The 

19 head of an executive agency may waive the prohibi20 tions under subsections (a) and (b) with respect to 

21 a contract, subcontract, or transaction for the acqui22 sition or provision of health care services overseas on 

23 a case-by-case basis— 

24 (A) if the head of such executive agency 

25 determines that the waiver is— 


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1 (i) necessary to support the mission or 

2 activities of the employees of such execu3 tive agency described in subsection 

4 (e)(2)(A); and 

5 (ii) in the interest of the United 

6 States; 

7 (B) with the approval of the Director of 

8 the Office of Management and Budget, in con9 sultation with the Federal Acquisition Security 

10 Council and the Secretary of Defense; and 

11 (C) if such head submits a notification and 

12 justification to the appropriate congressional 

13 committees not later than 30 days after grant14 ing such waiver. 

15 (e) EXCEPTIONS.—The prohibitions under sub16 sections (a) and (b) shall not apply to— 

17 (1) any activity subject to the reporting require18 ments under title V of the National Security Act of 

19 1947 (50 U.S.C. 3091 et seq.) or any authorized in20 telligence activities of the United States; 

21 (2) the acquisition or provision of health care 

22 services overseas for— 

23 (A) employees of the United States, includ24 ing members of the uniformed services (as de25 fined in section 101(a) of title 10, United 


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1 States Code), whose official duty stations are 

2 located overseas or are on permissive temporary 

3 duty travel overseas; or 

4 (B) employees of contractors or sub5 contractors of the United States— 

6 (i) who are performing under a con7 tract that directly supports the missions or 

8 activities of individuals described in sub9 paragraph (A); and 

10 (ii) whose primary duty stations are 

11 located overseas or are on permissive tem12 porary duty travel overseas; or 

13 (3) the acquisition, use, or distribution of 

14 human multiomic data, however compiled, that is 

15 commercially or publicly available. 

16 (f) EVALUATION OF CERTAIN BIOTECHNOLOGY EN17 TITIES.— 

18 (1) ENTITY CONSIDERATION.—Not later than 

19 120 days after the date of the enactment of this Act, 

20 the Director of the Office of Management and Budg21 et, in consultation with the Secretary of Defense, the 

22 Attorney General, the Secretary of Health and 

23 Human Services, the Secretary of Commerce, the 

24 Director of National Intelligence, the Secretary of 

25 Homeland Security, and the Secretary of State, shall 


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1 develop a list of the entities that constitute bio2 technology companies of concern. 

3 (2) BIOTECHNOLOGY COMPANIES OF CONCERN

4 DEFINED.—The term ‘‘biotechnology company of 

5 concern’’ means— 

6 (A) BGI, MGI, Complete Genomics, Wuxi 

7 Apptec, and any subsidiary, parent affiliate, or 

8 successor of such entities; and 

9 (B) any entity that— 

10 (i) is subject to the jurisdiction, direc11 tion, control, or operates on behalf of the 

12 government of a foreign adversary; 

13 (ii) is to any extent involved in the 

14 manufacturing, distribution, provision, or 

15 procurement of a biotechnology equipment 

16 or service; and 

17 (iii) poses a risk to the national secu18 rity of the United States based on— 

19 (I) engaging in joint research 

20 with, being supported by, or being af21 filiated with a foreign adversary’s 

22 military, internal security forces, or 

23 intelligence agencies; 

24 (II) providing multiomic data ob25 tained via biotechnology equipment or 


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1 services to the government of a for2 eign adversary; or 

3 (III) obtaining human multiomic 

4 data via the biotechnology equipment 

5 or services without express and in6 formed consent. 

7 (3) GUIDANCE.—Not later than 120 days after 

8 the date of the enactment of this Act, the Director 

9 of the Office of Management and Budget, in con10 sultation with the Secretary of Defense, the Attor11 ney General, the Secretary of Health and Human 

12 Services, the Secretary of Commerce, the Director of 

13 National Intelligence, the Secretary of Homeland Se14 curity, and the Secretary of State, shall establish 

15 guidance necessary to implement the requirements of 

16 this section. 

17 (4) UPDATES.—The Director of the Office of 

18 Management and Budget, in consultation with the 

19 Secretary of Defense, the Attorney General, the Sec20 retary of Health and Human Services, the Secretary 

21 of Commerce, the Director of National Intelligence, 

22 the Secretary of Homeland Security, and the Sec23 retary of State, shall periodically, though not less 

24 than annually, review and, as appropriate, make a 


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1 determination to modify the list of biotechnology 

2 companies of concern. 

3 (g) REGULATIONS.—Not later than one year after the 

4 date of establishment of guidance required under sub5 section (f)(3), the Federal Acquisition Regulatory Council 

6 shall revise the Federal Acquisition Regulation as nec7 essary to implement the requirements of this section. 

8 (h) NO ADDITIONAL FUNDS.—No additional funds 

9 are authorized to be appropriated for the purpose of car10 rying out this section. 

11 (i) DEFINITIONS.—In this section: 

12 (1) APPROPRIATE CONGRESSIONAL COMMIT13 TEES.—The term ‘‘appropriate congressional com14 mittees’’ means— 

15 (A) the Committee on Armed Services and 

16 the Committee on Homeland Security and Gov17 ernmental Affairs of the Senate; and 

18 (B) the Committee on Armed Services, the 

19 Committee on Foreign Affairs, the Committee 

20 on Oversight and Accountability, the Committee 

21 on Energy and Commerce, and the Select Com22 mittee on Strategic Competition between the 

23 United States and the Chinese Communist 

24 Party of the House of Representatives. 


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1 (2) BIOTECHNOLOGY EQUIPMENT OR SERV2 ICE.—The term ‘‘biotechnology equipment or serv3 ice’’ means— 

4 (A) equipment, including genetic sequenc5 ers, mass spectrometers, polymerase chain reac6 tion machines, or any other instrument, appa7 ratus, machine, or device, including components 

8 and accessories thereof, that is designed for use 

9 in the research, development, production, or 

10 analysis of biological materials as well as any 

11 software, firmware, or other digital components 

12 that are specifically designed for use in, and 

13 necessary for the operation of, such equipment; 

14 (B) any service for the research, develop15 ment, production, analysis, detection, or provi16 sion of information, including data storage and 

17 transmission related to biological materials, in18 cluding— 

19 (i) advising, consulting, or support 

20 services with respect to the use or imple21 mentation of a instrument, apparatus, ma22 chine, or device described in subparagraph 

23 (A); and 

24 (ii) disease detection, genealogical in25 formation, and related services; and 


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1 (C) any other service, instrument, appa2 ratus, machine, component, accessory, device, 

3 software, or firmware that the Director of the 

4 Office of Management and Budget, in consulta5 tion with the heads of Executive agencies, as 

6 determined appropriate by the Director of the 

7 Office of Management and Budget, determines 

8 appropriate. 

9 (3) CONTROL.—The term ‘‘control’’ has the 

10 meaning given to that term in section 800.208 of 

11 title 31, Code of Federal Regulations, or any suc12 cessor regulations. 

13 (4) EXECUTIVE AGENCY.—The term ‘‘executive 

14 agency’’ has the meaning given the term ‘‘Executive 

15 agency’’ in section 105 of title 5, United States 

16 Code. 

17 (5) FOREIGN ADVERSARY.—The term ‘‘foreign 

18 adversary’’ has the meaning given the term ‘‘covered 

19 nation’’ in section 4872(d) of title 10, United States 

20 Code. 

21 (6) MULTIOMIC.—The term ‘‘multiomic’’ means 

22 data types that include genomics, epigenomics, 

23 transcriptomics, proteomics, and metabolomics. 

24 (7) OVERSEAS.—The term ‘‘overseas’’ means 

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1 wealth of Puerto Rico, or a territory or possession 

2 of the United States. 

Æ 


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