IIB 

118TH CONGRESS 

2D SESSION H. R. 8333 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 10, 2024 

Received; read twice and referred to the Committee on Homeland Security and 

Governmental Affairs 

AN ACT 

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, 


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1 SECTION 1. SHORT TITLE. 

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

3 SEC. 2. PROHIBITION ON CONTRACTING WITH CERTAIN 

4 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 

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

11 contract with any entity that— 

12 (A) uses biotechnology equipment or serv13 ices produced or provided by a biotechnology 

14 company of concern and acquired after the ap15 plicable effective date in subsection (c) in per16 formance of the contract with the executive 

17 agency; or 

18 (B) enters into any contract the perform19 ance of which such entity knows or has reason 

20 to believe will require, in performance of the 

21 contract with the executive agency, the use of 

22 biotechnology equipment or services produced or 

23 provided by a biotechnology company of concern 

24 and acquired after the applicable effective date 

25 in subsection (c). 


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

2 The head of an executive agency may not obligate or ex3 pend loan or grant funds to, and a loan or grant recipient 

4 may not use loan or grant funds to— 

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

6 equipment or services 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 an entity described in subsection 

10 (a)(2). 

11 (c) EFFECTIVE DATES.— 

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

13 biotechnology companies of concern covered by sub14 section (f)(2)(A), the prohibitions under subsections 

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

16 issuance of the regulation in subsection (h). 

17 (2) OTHER ENTITIES.—With respect to the bio18 technology companies of concern covered by sub19 section (f)(2)(B), the prohibitions under subsections 

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

21 issuance of the regulation in subsection (h). 

22 (3) RULES OF CONSTRUCTION.— 

23 (A) CERTAIN ENTITIES.—Prior to January 

24 1, 2032, with respect to biotechnology compa25 nies of concern covered by subsections 


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1 (f)(2)(A), subsections (a)(2) and (b)(2) shall 

2 not apply to biotechnology equipment or serv3 ices produced or provided under a contract or 

4 agreement, including previously negotiated con5 tract options, entered into before the effective 

6 date under paragraph (1). 

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

8 that is five years after the issuance of the regu9 lation in subsection (h) that identifies a bio10 technology company of concern covered by sub11 sections (f)(2)(B), subsections (a)(2) and (b)(2) 

12 shall not apply to biotechnology equipment or 

13 services produced or provided under a contract 

14 or agreement, including previously negotiated 

15 contract options, entered into before the effec16 tive date under paragraph (2). 

17 (C) SAFE HARBOR.—The term ‘‘bio18 technology equipment or services produced or 

19 provided by a biotechnology company of con20 cern’’ shall not be construed to refer to any bio21 technology equipment or services that were for22 merly, but are no longer, produced or provided 

23 by biotechnology companies of concern. 

24 (d) WAIVER AUTHORITIES.— 

25 (1) SPECIFIC BIOTECHNOLOGY EXCEPTION.— 


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

2 executive agency may waive the prohibition 

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

4 basis— 

5 (i) with the approval of the Director 

6 of the Office of Management and Budget, 

7 in coordination with the Secretary of De8 fense; and 

9 (ii) if such head submits a notification 

10 and justification to the appropriate con11 gressional committees not later than 30 

12 days after granting such waiver. 

13 (B) DURATION.— 

14 (i) IN GENERAL.—Except as provided 

15 in clause (ii), a waiver granted under sub16 paragraph (A) shall last for a period of not 

17 more than 365 days. 

18 (ii) EXTENSION.—The head of the ap19 plicable executive agency, with the ap20 proval of the Director of the Office of 

21 Management and Budget, and in coordina22 tion with the Secretary of Defense, may 

23 extend a waiver granted under subpara24 graph (A) one time, for a period up to 180 

25 days after the date on which the waiver 


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1 would otherwise expire, if such an exten2 sion is in the national security interests of 

3 the United States and if such head sub4 mits a notification and justification to the 

5 appropriate congressional committees not 

6 later than 10 days after granting such 

7 waiver extension. 

8 (2) OVERSEAS HEALTH CARE SERVICES.—The 

9 head of an executive agency may waive the prohibi10 tions under subsections (a) and (b) with respect to 

11 a contract, subcontract, or transaction for the acqui12 sition or provision of health care services overseas on 

13 a case-by-case basis— 

14 (A) if the head of such executive agency 

15 determines that the waiver is— 

16 (i) necessary to support the mission or 

17 activities of the employees of such execu18 tive agency described in subsection 

19 (e)(2)(A); and 

20 (ii) in the interest of the United 

21 States; 

22 (B) with the approval of the Director of 

23 the Office of Management and Budget, in con24 sultation with the Secretary of Defense; and 


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1 (C) if such head submits a notification and 

2 justification to the appropriate congressional 

3 committees not later than 30 days after grant4 ing such waiver. 

5 (e) EXCEPTIONS.—The prohibitions under sub6 sections (a) and (b) shall not apply to— 

7 (1) any activity subject to the reporting require8 ments under title V of the National Security Act of 

9 1947 (50 U.S.C. 3091 et seq.) or any authorized in10 telligence activities of the United States; 

11 (2) the acquisition or provision of health care 

12 services overseas for— 

13 (A) employees of the United States, includ14 ing members of the uniformed services (as de15 fined in section 101(a) of title 10, United 

16 States Code), whose official duty stations are 

17 located overseas or are on permissive temporary 

18 duty travel overseas; or 

19 (B) employees of contractors or sub20 contractors of the United States— 

21 (i) who are performing under a con22 tract that directly supports the missions or 

23 activities of individuals described in sub24 paragraph (A); and 


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1 (ii) whose primary duty stations are 

2 located overseas or are on permissive tem3 porary duty travel overseas; or 

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

5 human multiomic data, lawfully compiled, that is 

6 commercially or publicly available. 

7 (f) EVALUATION OF CERTAIN BIOTECHNOLOGY EN8 TITIES.— 

9 (1) ENTITY CONSIDERATION.—Not later than 

10 365 days after the date of the enactment of this Act, 

11 the Director of the Office of Management and Budg12 et shall publish a list of the entities that constitute 

13 biotechnology companies of concern based on a list 

14 of suggested entities that shall be provided by the 

15 Secretary of Defense in coordination with the Attor16 ney General, the Secretary of Health and Human 

17 Services, the Secretary of Commerce, the Director of 

18 National Intelligence, the Secretary of Homeland Se19 curity, the Secretary of State, and the National 

20 Cyber Director. 

21 (2) BIOTECHNOLOGY COMPANIES OF CONCERN

22 DEFINED.—The term ‘‘biotechnology company of 

23 concern’’ means— 

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

25 AppTec, and WuXi Biologics; 


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1 (B) any entity that is determined by the 

2 process established in paragraph (1) to meet 

3 the following criteria— 

4 (i) is subject to the administrative 

5 governance structure, direction, control, or 

6 operates on behalf of the government of a 

7 foreign adversary; 

8 (ii) is to any extent involved in the 

9 manufacturing, distribution, provision, or 

10 procurement of a biotechnology equipment 

11 or service; and 

12 (iii) poses a risk to the national secu13 rity of the United States based on— 

14 (I) engaging in joint research 

15 with, being supported by, or being af16 filiated with a foreign adversary’s 

17 military, internal security forces, or 

18 intelligence agencies; 

19 (II) providing multiomic data ob20 tained via biotechnology equipment or 

21 services to the government of a for22 eign adversary; or 

23 (III) obtaining human multiomic 

24 data via the biotechnology equipment 


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1 or services without express and in2 formed consent; and 

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

4 successor of entities listed in subparagraphs (A) 

5 and (B), provided they meet the criteria in sub6 paragraph (B)(i). 

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

8 the date of the enactment of this Act for the bio9 technology companies of concern named in para10 graph (2)(A), and not later than 180 days after the 

11 development of the list pursuant to paragraph (1) 

12 and any update to the list pursuant to paragraph 

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

14 Budget, in coordination with the Secretary of De15 fense, the Attorney General, the Secretary of Health 

16 and Human Services, the Secretary of Commerce, 

17 the Director of National Intelligence, the Secretary 

18 of Homeland Security, the Secretary of State, and 

19 the National Cyber Director, shall establish guidance 

20 as necessary to implement the requirements of this 

21 section. 

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

23 Management and Budget, in coordination with or 

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1 retary of Health and Human Services, the Secretary 

2 of Commerce, the Director of National Intelligence, 

3 the Secretary of Homeland Security, the Secretary 

4 of State, and the National Cyber Director, shall pe5 riodically, though not less than annually, review and, 

6 as appropriate, modify the list of biotechnology com7 panies of concern, and notify the appropriate con8 gressional committees of any such modifications. 

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

10 (A) IN GENERAL.—A notice of a designa11 tion as a biotechnology company of concern 

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

13 biotechnology company of concern named in the 

14 designation— 

15 (i) advising that a designation has 

16 been made; 

17 (ii) identifying the criteria relied upon 

18 under such subparagraph and, to the ex19 tent consistent with national security and 

20 law enforcement interests, the information 

21 that formed the basis for the designation; 

22 (iii) advising that, within 90 days 

23 after receipt of notice, the biotechnology 

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1 tion and argument in opposition to the 

2 designation; 

3 (iv) describing the procedures gov4 erning the review and possible issuance of 

5 a designation pursuant to paragraph (1); 

6 and 

7 (v) where practicable, identifying miti8 gation steps that could be taken by the 

9 biotechnology company of concern that 

10 may result in the rescission of the designa11 tion. 

12 (B) CONGRESSIONAL NOTIFICATION RE13 QUIREMENTS.— 

14 (i) NOTICE OF DESIGNATION.—The 

15 Director of the Office of Management and 

16 Budget shall submit the notice required 

17 under subparagraph (A) to the Committee 

18 on Homeland Security and Governmental 

19 Affairs of the Senate and the Committee 

20 on Oversight and Accountability of the 

21 House of Representatives. 

22 (ii) INFORMATION AND ARGUMENT IN

23 OPPOSITION TO DESIGNATIONS.—Not later 

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1 ignation pursuant to subparagraph (A)(iii), 

2 the Director of the Office of Management 

3 and Budget shall submit such information 

4 to the Committee on Homeland Security 

5 and Governmental Affairs of the Senate 

6 and the Committee on Oversight and Ac7 countability of the House of Representa8 tives. 

9 (C) EXCEPTIONS.—The provisions under 

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

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

12 (6) NO IMMEDIATE PUBLIC RELEASE.—Any 

13 designation made under paragraph (1) or paragraph 

14 (4) shall not be made publicly available until the Di15 rector of the Office of Management and Budget, in 

16 coordination with appropriate agencies, reviews all 

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

18 and issues a final determination that a company 

19 shall remain listed as a biotechnology company of 

20 concern. 

21 (g) EVALUATION OF NATIONAL SECURITY RISKS

22 POSED BY FOREIGN ADVERSARY ACQUISITION OF AMER23 ICAN MULTIOMIC DATA.— 

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

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1 tional Intelligence, in consultation with the Secretary 

2 of Defense, the Attorney General of the United 

3 States, the Secretary of Health and Human Serv4 ices, the Secretary of Commerce, the Secretary of 

5 Homeland Security, the Secretary of State, and the 

6 National Cyber Director, shall complete an assess7 ment of risks to national security posed by human 

8 multiomic data from United States citizens that is 

9 collected or stored by a foreign adversary from the 

10 provision of biotechnology equipment or services. 

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

12 days after the completion of the assessment devel13 oped under paragraph (1), the Director of National 

14 Intelligence shall submit a report with such assess15 ment to the appropriate congressional committees. 

16 (3) FORM.—The report required under para17 graph (2) shall be in unclassified form accompanied 

18 by a classified annex. 

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

20 the date of establishment of guidance required under sub21 section (f)(3), and as necessary for subsequent updates, 

22 the Federal Acquisition Regulatory Council shall revise 

23 the Federal Acquisition Regulation as necessary to imple24 ment the requirements of this section. 


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1 (i) REPORTING ON INTELLIGENCE ON NEFARIOUS

2 ACTIVITIES OF BIOTECHNOLOGY COMPANIES WITH

3 HUMAN MULTIOMIC DATA.—Not later than 180 days 

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

5 thereafter, the Director of National Intelligence, in con6 sultation with the heads of executive agencies, shall submit 

7 to the appropriate congressional committees a report on 

8 any intelligence in possession of such agencies related to 

9 nefarious activities conducted by biotechnology companies 

10 with human multiomic data. The report shall include in11 formation pertaining to potential threats to national secu12 rity or public safety from the selling, reselling, licensing, 

13 trading, transferring, sharing, or otherwise providing or 

14 making available to any foreign country of any forms of 

15 multiomic data of a United States citizen. 

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

17 are authorized to be appropriated for the purpose of car18 rying out this section. 

19 (k) DEFINITIONS.—In this section: 

20 (1) APPROPRIATE CONGRESSIONAL COMMIT21 TEES.—The term ‘‘appropriate congressional com22 mittees’’ means— 

23 (A) the Committee on Armed Services, the 

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1 mittee on Homeland Security and Govern2 mental Affairs of the Senate; and 

3 (B) the Committee on Armed Services, the 

4 Permanent Select Committee on Intelligence, 

5 the Committee on Foreign Affairs, the Com6 mittee on Oversight and Accountability, the 

7 Committee on Energy and Commerce, and the 

8 Select Committee on Strategic Competition be9 tween the United States and the Chinese Com10 munist Party of the House of Representatives. 

11 (2) BIOTECHNOLOGY EQUIPMENT OR SERV12 ICE.—The term ‘‘biotechnology equipment or serv13 ice’’ means— 

14 (A) equipment, including genetic sequenc15 ers, combined mass spectrometry technologies, 

16 polymerase chain reaction machines, or any 

17 other instrument, apparatus, machine, or de18 vice, including components and accessories 

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

20 development, production, or analysis of biologi21 cal materials as well as any software, firmware, 

22 or other digital components that are specifically 

23 designed for use in, and necessary for the oper24 ation of, such equipment; 


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1 (B) any service for the research, develop2 ment, production, analysis, detection, or provi3 sion of information, including data storage and 

4 transmission related to biological materials, in5 cluding— 

6 (i) advising, consulting, or support 

7 services with respect to the use or imple8 mentation of a instrument, apparatus, ma9 chine, or device described in subparagraph 

10 (A); and 

11 (ii) disease detection, genealogical in12 formation, and related services; and 

13 (C) any other service, instrument, appa14 ratus, machine, component, accessory, device, 

15 software, or firmware that is designed for use 

16 in the research, development, production, or 

17 analysis of biological materials that the Direc18 tor of the Office of Management and Budget, in 

19 consultation with the heads of Executive agen20 cies, as determined appropriate by the Director 

21 of the Office of Management and Budget, de22 termines appropriate in the interest of national 

23 security. 

24 (3) CONTRACT.—Except as the term is used 

25 under subsection (b)(2) and subsection (c)(3), the 


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1 term ‘‘contract’’ means any contract subject to the 

2 Federal Acquisition Regulation issued under section 

3 1303(a)(1) of title 41, United States Code. 

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

5 meaning given to that term in section 800.208 of 

6 title 31, Code of Federal Regulations, or any suc7 cessor regulations. 

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

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

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

11 Code. 

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

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

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

15 Code. 

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

17 data types that include genomics, epigenomics, 

18 transcriptomics, proteomics, and metabolomics. 

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

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1 wealth of Puerto Rico, or a territory or possession 

2 of the United States. 

Passed the House of Representatives September 9, 

2024. 

Attest: KEVIN F. MCCUMBER, 

Clerk. 


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