I 

118TH CONGRESS 

2D SESSION H. R. 8333 

To prohibit contracting with certain biotechnology providers, and for other 

purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 10, 2024 

Mr. WENSTRUP (for himself, Mr. KRISHNAMOORTHI, Mr. MOOLENAAR, Ms. 

ESHOO, Mr. DUNN of Florida, Mr. MOULTON, Ms. STEFANIK, and Mr. 

DAVIS of North Carolina) introduced the following bill; which was referred to the Committee on Oversight and Accountability, and in addition 

to the Permanent Select Committee on Intelligence, for a period to be 

subsequently determined by the Speaker, in each case for consideration 

of such provisions as fall within the jurisdiction of the committee concerned 

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. SHORT TITLE. 

4 This Act may be cited as the ‘‘BIOSECURE Act’’. 


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1 SEC. 2. PROHIBITION ON CONTRACTING WITH CERTAIN 

2 BIOTECHNOLOGY PROVIDERS. 

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

4 may not— 

5 (1) procure or obtain any biotechnology equip6 ment or service produced or provided by a bio7 technology company of concern; or 

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

9 contract with any entity that— 

10 (A) uses biotechnology equipment or serv11 ices produced or provided by a biotechnology 

12 company of concern and acquired after the ap13 plicable effective date in subsection (c) in per14 formance of the contract with the executive 

15 agency; or 

16 (B) enters into any contract the perform17 ance of which such entity knows or has reason 

18 to believe will require, in performance of the 

19 contract with the executive agency, the use of 

20 biotechnology equipment or services produced or 

21 provided by a biotechnology company of concern 

22 and acquired after the applicable effective date 

23 in subsection (c). 

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

25 The head of an executive agency may not obligate or exVerDate Sep 11 2014 16:03 Jun 08, 2024 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H8333.IH H8333

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1 pend loan or grant funds to, and a loan or grant recipient 

2 may not use loan or grant funds to— 

3 (1) procure, obtain, or use any biotechnology 

4 equipment or services produced or provided by a bio5 technology company of concern; or 

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

7 contract with an entity described in subsection 

8 (a)(2). 

9 (c) EFFECTIVE DATES.— 

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

11 biotechnology companies of concern covered by sub12 section (f)(2)(A), the prohibitions under subsections 

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

14 issuance of the regulation in subsection (h). 

15 (2) OTHER ENTITIES.—With respect to the bio16 technology companies of concern covered by sub17 section (f)(2)(B), the prohibitions under subsections 

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

19 issuance of the regulation in subsection (h). 

20 (3) RULES OF CONSTRUCTION.— 

21 (A) CERTAIN ENTITIES.—Prior to January 

22 1, 2032, with respect to biotechnology compa23 nies of concern covered by subsections 

24 (f)(2)(A), (a)(2), and (b)(2) shall not apply to 

25 biotechnology equipment or services produced or 


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1 provided under a contract or agreement, includ2 ing currently negotiated contract option years, 

3 entered into before the effective date under sub4 section (c)(1). 

5 (B) OTHER ENTITIES.—Prior to the date 

6 that is five years after the identification of a 

7 biotechnology company of concern covered by 

8 subsections (f)(2)(B), (a)(2), and (b)(2) shall 

9 not apply to biotechnology equipment or serv10 ices produced or provided under a contract or 

11 agreement entered into before the effective date 

12 under subsection (c)(2). 

13 (C) SAFE HARBOR.—The term ‘‘bio14 technology equipment or services produced or 

15 provided by a biotechnology company of con16 cern’’ shall not be construed to refer to any bio17 technology equipment or services that were for18 merly, but are no longer, produced or provided 

19 by biotechnology companies of concern. 

20 (d) WAIVER AUTHORITIES.— 

21 (1) SPECIFIC BIOTECHNOLOGY EXCEPTION.— 

22 (A) WAIVER.—The head of the applicable 

23 executive agency may waive the prohibition 

24 under subsections (a) and (b) on a case-by-case 

25 basis— 


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1 (i) with the approval of the Director 

2 of the Office of Management and Budget, 

3 in coordination with the Secretary of De4 fense; and 

5 (ii) if such head submits a notification 

6 and justification to the appropriate con7 gressional committees not later than 30 

8 days after granting such waiver. 

9 (B) DURATION.— 

10 (i) IN GENERAL.—Except as provided 

11 in clause (ii), a waiver granted under sub12 paragraph (A) shall last for a period of not 

13 more than 365 days. 

14 (ii) EXTENSION.—The head of the ap15 plicable executive agency, with the ap16 proval of the Director of the Office of 

17 Management and Budget, and in coordina18 tion with the Secretary of Defense, may 

19 extend a waiver granted under subpara20 graph (A) one time, for a period up to 180 

21 days after the date on which the waiver 

22 would otherwise expire, if such an exten23 sion is in the national security interests of 

24 the United States and if such head sub25 mits a notification and justification to the 


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1 appropriate congressional committees not 

2 later than 10 days after granting such 

3 waiver extension. 

4 (2) OVERSEAS HEALTH CARE SERVICES.—The 

5 head of an executive agency may waive the prohibi6 tions under subsections (a) and (b) with respect to 

7 a contract, subcontract, or transaction for the acqui8 sition or provision of health care services overseas on 

9 a case-by-case basis— 

10 (A) if the head of such executive agency 

11 determines that the waiver is— 

12 (i) necessary to support the mission or 

13 activities of the employees of such execu14 tive agency described in subsection 

15 (e)(2)(A); and 

16 (ii) in the interest of the United 

17 States; 

18 (B) with the approval of the Director of 

19 the Office of Management and Budget, in con20 sultation with the Secretary of Defense; and 

21 (C) if such head submits a notification and 

22 justification to the appropriate congressional 

23 committees not later than 30 days after grant24 ing such waiver. 


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1 (e) EXCEPTIONS.—The prohibitions under sub2 sections (a) and (b) shall not apply to— 

3 (1) any activity subject to the reporting require4 ments under title V of the National Security Act of 

5 1947 (50 U.S.C. 3091 et seq.) or any authorized in6 telligence activities of the United States; 

7 (2) the acquisition or provision of health care 

8 services overseas for— 

9 (A) employees of the United States, includ10 ing members of the uniformed services (as de11 fined in section 101(a) of title 10, United 

12 States Code), whose official duty stations are 

13 located overseas or are on permissive temporary 

14 duty travel overseas; or 

15 (B) employees of contractors or sub16 contractors of the United States— 

17 (i) who are performing under a con18 tract that directly supports the missions or 

19 activities of individuals described in sub20 paragraph (A); and 

21 (ii) whose primary duty stations are 

22 located overseas or are on permissive tem23 porary duty travel overseas; or 


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

2 human multiomic data, lawfully compiled, that is 

3 commercially or publicly available. 

4 (f) EVALUATION OF CERTAIN BIOTECHNOLOGY EN5 TITIES.— 

6 (1) ENTITY CONSIDERATION.—Not later than 

7 365 days after the date of the enactment of this Act, 

8 the Director of the Office of Management and Budg9 et shall publish a list of the entities that constitute 

10 biotechnology companies of concern based on a list 

11 of suggested entities that shall be provided by the 

12 Secretary of Defense in coordination with the Attor13 ney General, the Secretary of Health and Human 

14 Services, the Secretary of Commerce, the Director of 

15 National Intelligence, the Secretary of Homeland Se16 curity, the Secretary of State, and the National 

17 Cyber Director. 

18 (2) BIOTECHNOLOGY COMPANIES OF CONCERN

19 DEFINED.—The term ‘‘biotechnology company of 

20 concern’’ means— 

21 (A) BGI, MGI, Complete Genomics, WuXi 

22 AppTec, and WuXi Biologics; 

23 (B) any entity that is determined by the 

24 process established in paragraph (1) to meet 

25 the following criteria— 


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1 (i) is subject to the administrative 

2 governance structure, direction, control, or 

3 operates on behalf of the government of a 

4 foreign adversary; 

5 (ii) is to any extent involved in the 

6 manufacturing, distribution, provision, or 

7 procurement of a biotechnology equipment 

8 or service; and 

9 (iii) poses a risk to the national secu10 rity of the United States based on— 

11 (I) engaging in joint research 

12 with, being supported by, or being af13 filiated with a foreign adversary’s 

14 military, internal security forces, or 

15 intelligence agencies; 

16 (II) providing multiomic data ob17 tained via biotechnology equipment or 

18 services to the government of a for19 eign adversary; or 

20 (III) obtaining human multiomic 

21 data via the biotechnology equipment 

22 or services without express and in23 formed consent; and 

24 (C) any subsidiary, parent, affiliate, or 

25 successor of entities listed in subparagraphs (A) 


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1 and (B), provided they meet the criteria in sub2 paragraph (B)(i). 

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

4 the date of the enactment of this Act for the bio5 technology companies of concern named in para6 graph (2)(A), and not later than 180 days after the 

7 development of the list pursuant to paragraph (1) 

8 and any update to the list pursuant to paragraph 

9 (4), the Director of the Office of Management and 

10 Budget, in coordination with the Secretary of De11 fense, the Attorney General, the Secretary of Health 

12 and Human Services, the Secretary of Commerce, 

13 the Director of National Intelligence, the Secretary 

14 of Homeland Security, and the Secretary of State, 

15 shall establish guidance as necessary to implement 

16 the requirements of this section. 

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

18 Management and Budget, in coordination with or 

19 based on a recommendation provided by the Sec20 retary of Defense, the Attorney General, the Sec21 retary of Health and Human Services, the Secretary 

22 of Commerce, the Director of National Intelligence, 

23 the Secretary of Homeland Security, and the Sec24 retary of State, shall periodically, though not less 

25 than annually, review and, as appropriate, modify 


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1 the list of biotechnology companies of concern, and 

2 notify the appropriate congressional committees of 

3 any such modifications. 

4 (5) NOTICE OF A DESIGNATION AND REVIEW.— 

5 (A) IN GENERAL.—A notice of a designa6 tion as a biotechnology company of concern 

7 under paragraph (2)(B) shall be issued to any 

8 biotechnology company of concern named in the 

9 designation— 

10 (i) advising that a designation has 

11 been made; 

12 (ii) identifying the criteria relied upon 

13 under such subparagraph and, to the ex14 tent consistent with national security and 

15 law enforcement interests, the information 

16 that formed the basis for the designation; 

17 (iii) advising that, within 90 days 

18 after receipt of notice, the biotechnology 

19 company of concern may submit informa20 tion and argument in opposition to the 

21 designation; 

22 (iv) describing the procedures gov23 erning the review and possible issuance of 

24 a designation pursuant to paragraph (1); 

25 and 


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1 (v) where practicable, identifying miti2 gation steps that could be taken by the 

3 biotechnology company of concern that 

4 may result in the rescission of the designa5 tion. 

6 (B) CONGRESSIONAL NOTIFICATION RE7 QUIREMENTS.— 

8 (i) NOTICE OF DESIGNATION.—The 

9 Director of the Office of Management and 

10 Budget shall submit the notice required 

11 under subparagraph (A) to the Committee 

12 on Homeland Security and Governmental 

13 Affairs of the Senate and the Committee 

14 on Oversight and Accountability of the 

15 House of Representatives. 

16 (ii) INFORMATION AND ARGUMENT IN

17 OPPOSITION TO DESIGNATIONS.—Not later 

18 than 7 days after receiving any informa19 tion and argument in opposition to a des20 ignation pursuant to subparagraph (A)(iii), 

21 the Director of the Office of Management 

22 and Budget shall submit such information 

23 to the Committee on Homeland Security 

24 and Governmental Affairs of the Senate 

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1 countability of the House of Representa2 tives. 

3 (C) EXCEPTIONS.—The provisions under 

4 subparagraphs (A) and (B) shall not apply to 

5 an entity listed under paragraph (2)(A). 

6 (6) NO IMMEDIATE PUBLIC RELEASE.—Any 

7 designation made under paragraph (1) or paragraph 

8 (4) shall not be made publicly available until the Di9 rector of the Office of Management and Budget, in 

10 coordination with appropriate agencies, reviews all 

11 information submitted under paragraph (5)(A)(iii) 

12 and issues a final determination that a company 

13 shall remain listed as a biotechnology company of 

14 concern. 

15 (g) EVALUATION OF NATIONAL SECURITY RISKS

16 POSED BY FOREIGN ADVERSARY ACQUISITION OF AMER17 ICAN MULTIOMIC DATA.— 

18 (1) ASSESSMENT.—Not later than 270 days 

19 after the enactment of this Act, the Director of Na20 tional Intelligence, in consultation with the Secretary 

21 of Defense, the Attorney General of the United 

22 States, the Secretary of Health and Human Serv23 ices, the Secretary of Commerce, the Secretary of 

24 Homeland Security, and the Secretary of State, shall 

25 complete an assessment of risks to national security 


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1 posed by human multiomic data from United States 

2 citizens that is collected or stored by a foreign ad3 versary from the provision of biotechnology equip4 ment or services. 

5 (2) REPORT REQUIREMENT.—Not later than 30 

6 days after the completion of the assessment devel7 oped under paragraph (1), the Director of National 

8 Intelligence shall submit a report with such assess9 ment to the appropriate congressional committees. 

10 (3) FORM.—The report required under para11 graph (2) shall be in unclassified form accompanied 

12 by a classified annex. 

13 (h) REGULATIONS.—Not later than one year after 

14 the date of establishment of guidance required under sub15 section (f)(3), and as necessary for subsequent updates, 

16 the Federal Acquisition Regulatory Council shall revise 

17 the Federal Acquisition Regulation as necessary to imple18 ment the requirements of this section. 

19 (i) REPORTING ON INTELLIGENCE ON NEFARIOUS

20 ACTIVITIES OF BIOTECHNOLOGY COMPANIES WITH

21 HUMAN MULTIOMIC DATA.—Not later than 180 days 

22 after the date of the enactment of this Act, and annually 

23 thereafter, the Director of National Intelligence, in con24 sultation with the heads of executive agencies, shall submit 

25 to the appropriate congressional committees a report on 


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1 any intelligence in possession of such agencies related to 

2 nefarious activities conducted by biotechnology companies 

3 with human multiomic data. The report shall include in4 formation pertaining to potential threats to national secu5 rity or public safety from the selling, reselling, licensing, 

6 trading, transferring, sharing, or otherwise providing or 

7 making available to any foreign country of any forms of 

8 multiomic data of a United States citizen. 

9 (j) NO ADDITIONAL FUNDS.—No additional funds 

10 are authorized to be appropriated for the purpose of car11 rying out this section. 

12 (k) DEFINITIONS.—In this section: 

13 (1) APPROPRIATE CONGRESSIONAL COMMIT14 TEES.—The term ‘‘appropriate congressional com15 mittees’’ means— 

16 (A) the Committee on Armed Services and 

17 the Committee on Homeland Security and Gov18 ernmental Affairs of the Senate; and 

19 (B) the Committee on Armed Services, the 

20 Committee on Foreign Affairs, the Committee 

21 on Oversight and Accountability, the Committee 

22 on Energy and Commerce, and the Select Com23 mittee on Strategic Competition between the 

24 United States and the Chinese Communist 

25 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, combined mass spectrometry technologies, 

6 polymerase chain reaction machines, or any 

7 other instrument, apparatus, machine, or de8 vice, including components and accessories 

9 thereof, that is designed for use in the research, 

10 development, production, or analysis of biologi11 cal materials as well as any software, firmware, 

12 or other digital components that are specifically 

13 designed for use in, and necessary for the oper14 ation of, such equipment; 

15 (B) any service for the research, develop16 ment, production, analysis, detection, or provi17 sion of information, including data storage and 

18 transmission related to biological materials, in19 cluding— 

20 (i) advising, consulting, or support 

21 services with respect to the use or imple22 mentation of a instrument, apparatus, ma23 chine, or device described in subparagraph 

24 (A); and 


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1 (ii) disease detection, genealogical in2 formation, and related services; and 

3 (C) any other service, instrument, appa4 ratus, machine, component, accessory, device, 

5 software, or firmware that is designed for use 

6 in the research, development, production, or 

7 analysis of biological materials that the Direc8 tor of the Office of Management and Budget, in 

9 consultation with the heads of Executive agen10 cies, as determined appropriate by the Director 

11 of the Office of Management and Budget, de12 termines appropriate in the interest of national 

13 security. 

14 (3) CONTRACT.—The term ‘‘contract’’ means 

15 any contract subject to the Federal Acquisition Reg16 ulation issued under section 1303(a)(1) of title 41, 

17 United States Code. 

18 (4) CONTROL.—The term ‘‘control’’ has the 

19 meaning given to that term in section 800.208 of 

20 title 31, Code of Federal Regulations, or any suc21 cessor regulations. 

22 (5) EXECUTIVE AGENCY.—The term ‘‘executive 

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

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

25 Code. 


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1 (6) FOREIGN ADVERSARY.—The term ‘‘foreign 

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

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

4 Code. 

5 (7) MULTIOMIC.—The term ‘‘multiomic’’ means 

6 data types that include genomics, epigenomics, 

7 transcriptomics, proteomics, and metabolomics. 

8 (8) OVERSEAS.—The term ‘‘overseas’’ means 

9 any area outside of the United States, the Common10 wealth of Puerto Rico, or a territory or possession 

11 of the United States. 

Æ 


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