II 

Calendar No. 521 

118TH CONGRESS 

2D SESSION S. 3558 

[Report No. 118–229] 

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, Mr. HAGERTY, Mr. ROMNEY, Mr. MARSHALL, Mr. 

LANKFORD, Mr. SCOTT of Florida, Mr. HAWLEY, Mr. WARNER, Mr. 

RUBIO, Mrs. BRITT, and Mr. HOEVEN) introduced the following bill; 

which was read twice and referred to the Committee on Homeland Security and Governmental Affairs 

SEPTEMBER 23, 2024 

Reported by Mr. PETERS, with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

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, 


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1 SECTION 1. PROHIBITION ON CONTRACTING WITH CER2 TAIN 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; or 

15 (B) enters into any contract the perform16 ance of which will require the direct use of bio17 technology equipment or services produced or 

18 provided by a biotechnology company of concern 

19 and acquired after the applicable effective date 

20 in subsection (c). 

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

22 The head of an executive agency may not obligate or ex23 pend loan or grant funds to— 

24 (1) procure or obtain any biotechnology equip25 ment or services produced or provided by a bio26 technology company of concern; or 


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

2 contract with an entity described in subsection 

3 (a)(2). 

4 (c) EFFECTIVE DATES.— 

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

6 biotechnology companies of concern covered by sub7 section (f)(2)(A), the prohibitions under subsections 

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

9 issuance of the implementing guidance in subsection 

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

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

12 (2) OTHER ENTITIES.—With respect to the bio13 technology companies of concern covered by sub14 section (f)(2)(B), the prohibitions under subsections 

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

16 issuance of the implementing guidance in subsection 

17 (f)(3). 

18 (d) WAIVER AUTHORITIES.— 

19 (1) SPECIFIC BIOTECHNOLOGY EXCEPTION.— 

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

21 agency may waive the prohibition under sub22 section (a) and (b) on a case-by-case basis— 

23 (i) with the approval of the Director 

24 of the Office of Management and Budget, 

25 in consultation with the Federal AcquisiVerDate Sep 11 2014 00:34 Sep 24, 2024 Jkt 049200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6401 E:\BILLS\S3558.RS S3558

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1 tion Security Council and the Secretary of 

2 Defense; and 

3 (ii) if such head submits a notification 

4 and justification to the appropriate con5 gressional committees not later than 30 

6 days after granting such waiver. 

7 (B) DURATION.— 

8 (i) IN GENERAL.—Except as provided 

9 in clause (ii), a waiver granted under sub10 paragraph (A) shall last for a period of not 

11 more than 365 days. 

12 (ii) EXTENSION.—The Director of the 

13 Office of Management and Budget, in con14 sultation with the Federal Acquisition Se15 curity Council and the Secretary of De16 fense, may extend a waiver granted under 

17 subparagraph (A) one time, for a period 

18 up to 180 days after the date on which the 

19 waiver would otherwise expire, if such an 

20 extension is in the national security inter21 ests of the United States and the Director 

22 submits to the appropriate congressional 

23 committees a notification of such waiver. 

24 (2) OVERSEAS HEALTH CARE SERVICES.—The 

25 head of an executive agency may waive the prohibiVerDate Sep 11 2014 00:34 Sep 24, 2024 Jkt 049200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6401 E:\BILLS\S3558.RS S3558

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1 tions under subsections (a) and (b) with respect to 

2 a contract, subcontract, or transaction for the acqui3 sition or provision of health care services overseas on 

4 a case-by-case basis— 

5 (A) if the head of such executive agency 

6 determines that the waiver is— 

7 (i) necessary to support the mission or 

8 activities of the employees of such execu9 tive agency described in subsection 

10 (e)(2)(A); and 

11 (ii) in the interest of the United 

12 States; 

13 (B) with the approval of the Director of 

14 the Office of Management and Budget, in con15 sultation with the Federal Acquisition Security 

16 Council and the Secretary of Defense; and 

17 (C) if such head submits a notification and 

18 justification to the appropriate congressional 

19 committees not later than 30 days after grant20 ing such waiver. 

21 (e) EXCEPTIONS.—The prohibitions under sub22 sections (a) and (b) shall not apply to— 

23 (1) any activity subject to the reporting require24 ments under title V of the National Security Act of 


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1 1947 (50 U.S.C. 3091 et seq.) or any authorized in2 telligence activities of the United States; 

3 (2) the acquisition or provision of health care 

4 services overseas for— 

5 (A) employees of the United States, includ6 ing members of the uniformed services (as de7 fined in section 101(a) of title 10, United 

8 States Code), whose official duty stations are 

9 located overseas or are on permissive temporary 

10 duty travel overseas; or 

11 (B) employees of contractors or sub12 contractors of the United States— 

13 (i) who are performing under a con14 tract that directly supports the missions or 

15 activities of individuals described in sub16 paragraph (A); and 

17 (ii) whose primary duty stations are 

18 located overseas or are on permissive tem19 porary duty travel overseas; or 

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

21 human multiomic data, however compiled, that is 

22 commercially or publicly available. 

23 (f) EVALUATION OF CERTAIN BIOTECHNOLOGY EN24 TITIES.— 


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1 (1) ENTITY CONSIDERATION.—Not later than 

2 120 days after the date of the enactment of this Act, 

3 the Director of the Office of Management and Budg4 et, in consultation with the Secretary of Defense, the 

5 Attorney General, the Secretary of Health and 

6 Human Services, the Secretary of Commerce, the 

7 Director of National Intelligence, the Secretary of 

8 Homeland Security, and the Secretary of State, shall 

9 develop a list of the entities that constitute bio10 technology companies of concern. 

11 (2) BIOTECHNOLOGY COMPANIES OF CONCERN

12 DEFINED.—The term ‘‘biotechnology company of 

13 concern’’ means— 

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

15 Apptec, and any subsidiary, parent affiliate, or 

16 successor of such entities; and 

17 (B) any entity that— 

18 (i) is subject to the jurisdiction, direc19 tion, control, or operates on behalf of the 

20 government of a foreign adversary; 

21 (ii) is to any extent involved in the 

22 manufacturing, distribution, provision, or 

23 procurement of a biotechnology equipment 

24 or service; and 


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1 (iii) poses a risk to the national secu2 rity of the United States based on— 

3 (I) engaging in joint research 

4 with, being supported by, or being af5 filiated with a foreign adversary’s 

6 military, internal security forces, or 

7 intelligence agencies; 

8 (II) providing multiomic data ob9 tained via biotechnology equipment or 

10 services to the government of a for11 eign adversary; or 

12 (III) obtaining human multiomic 

13 data via the biotechnology equipment 

14 or services without express and in15 formed consent. 

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

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

18 of the Office of Management and Budget, in con19 sultation with the Secretary of Defense, the Attor20 ney General, the Secretary of Health and Human 

21 Services, the Secretary of Commerce, the Director of 

22 National Intelligence, the Secretary of Homeland Se23 curity, and the Secretary of State, shall establish 

24 guidance necessary to implement the requirements of 

25 this section. 


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

2 Management and Budget, in consultation with the 

3 Secretary of Defense, the Attorney General, the Sec4 retary of Health and Human Services, the Secretary 

5 of Commerce, the Director of National Intelligence, 

6 the Secretary of Homeland Security, and the Sec7 retary of State, shall periodically, though not less 

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

9 determination to modify the list of biotechnology 

10 companies of concern. 

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

12 date of establishment of guidance required under sub13 section (f)(3), the Federal Acquisition Regulatory Council 

14 shall revise the Federal Acquisition Regulation as nec15 essary to implement the requirements of this section. 

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

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

19 (i) DEFINITIONS.—In this section: 

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

23 (A) the Committee on Armed Services and 

24 the Committee on Homeland Security and Gov25 ernmental Affairs of the Senate; and 


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1 (B) the Committee on Armed Services, the 

2 Committee on Foreign Affairs, the Committee 

3 on Oversight and Accountability, the Committee 

4 on Energy and Commerce, and the Select Com5 mittee on Strategic Competition between the 

6 United States and the Chinese Communist 

7 Party of the House of Representatives. 

8 (2) BIOTECHNOLOGY EQUIPMENT OR SERV9 ICE.—The term ‘‘biotechnology equipment or serv10 ice’’ means— 

11 (A) equipment, including genetic sequenc12 ers, mass spectrometers, polymerase chain reac13 tion machines, or any other instrument, appa14 ratus, machine, or device, including components 

15 and accessories thereof, that is designed for use 

16 in the research, development, production, or 

17 analysis of biological materials as well as any 

18 software, firmware, or other digital components 

19 that are specifically designed for use in, and 

20 necessary for the operation of, such equipment; 

21 (B) any service for the research, develop22 ment, production, analysis, detection, or provi23 sion of information, including data storage and 

24 transmission related to biological materials, in25 cluding— 


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1 (i) advising, consulting, or support 

2 services with respect to the use or imple3 mentation of a instrument, apparatus, ma4 chine, or device described in subparagraph 

5 (A); and 

6 (ii) disease detection, genealogical in7 formation, and related services; and 

8 (C) any other service, instrument, appa9 ratus, machine, component, accessory, device, 

10 software, or firmware that the Director of the 

11 Office of Management and Budget, in consulta12 tion with the heads of Executive agencies, as 

13 determined appropriate by the Director of the 

14 Office of Management and Budget, determines 

15 appropriate. 

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

17 meaning given to that term in section 800.208 of 

18 title 31, Code of Federal Regulations, or any suc19 cessor regulations. 

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

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

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

23 Code. 

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

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


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

2 Code. 

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

4 data types that include genomics, epigenomics, 

5 transcriptomics, proteomics, and metabolomics. 

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

7 any area outside of the United States, the Common8 wealth of Puerto Rico, or a territory or possession 

9 of the United States. 

10 SECTION 1. SHORT TITLE. 

11 This Act may be cited as the ‘‘Prohibiting Foreign Ac12 cess to American Genetic Information Act of 2024’’. 

13 SEC. 2. PROHIBITION ON CONTRACTING WITH CERTAIN 

14 BIOTECHNOLOGY PROVIDERS. 

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

16 may not— 

17 (1) procure or obtain any biotechnology equip18 ment or service 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 any entity that— 

22 (A) uses biotechnology equipment or services 

23 produced or provided by a biotechnology com24 pany of concern and acquired after the applicaVerDate Sep 11 2014 00:34 Sep 24, 2024 Jkt 049200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6203 E:\BILLS\S3558.RS S3558

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1 ble effective date in subsection (c) in performance 

2 of the contract with the executive agency; or 

3 (B) enters into any contract the perform4 ance of which such entity knows or has reason 

5 to believe will require, in performance of the con6 tract with the executive agency, the use of bio7 technology equipment or services produced or 

8 provided by a biotechnology company of concern 

9 and acquired after the applicable effective date 

10 in subsection (c). 

11 (b) PROHIBITION ON LOAN AND GRANT FUNDS.—The 

12 head of an executive agency may not obligate or expend loan 

13 or grant funds to, and a loan or grant recipient may not 

14 use loan or grant funds to— 

15 (1) procure or obtain any biotechnology equip16 ment or services produced or provided by a bio17 technology company of concern; or 

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

19 contract with an entity described in subsection (a)(2). 

20 (c) EFFECTIVE DATES.— 

21 (1) CERTAIN ENTITIES.—With respect to the bio22 technology companies of concern covered by subsection 

23 (f)(2)(A), the prohibitions under subsections (a) and 

24 (b) shall take effect 60 days after the issuance of the 

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1 piration of the deadline set forth in subsection (f)(3), 

2 whichever occurs first. 

3 (2) OTHER ENTITIES.—With respect to the bio4 technology companies of concern covered by subsection 

5 (f)(2)(B), the prohibitions under subsections (a) and 

6 (b) shall take effect 180 days after the issuance of the 

7 implementing guidance in subsection (f)(3) or the ex8 piration of the deadline set forth in subsection (f)(3), 

9 whichever occurs first. 

10 (3) RULES OF CONSTRUCTION.— 

11 (A) CERTAIN ENTITIES.—With respect to 

12 biotechnology companies of concern covered by 

13 subsection (f)(2)(A), subsections (a)(2) and (b)(2) 

14 shall not apply to biotechnology equipment or 

15 services produced or provided under a contract 

16 or agreement entered into before the effective date 

17 under subsection (c)(1). 

18 (B) OTHER ENTITIES.—With respect to the 

19 biotechnology companies of concern covered by 

20 subsection (f)(2)(B), subsections (a)(2) and (b)(2) 

21 shall not apply to biotechnology equipment or 

22 services produced or provided under a contract 

23 or agreement entered into before the effective date 

24 under subsection (c)(2). 

25 (d) WAIVER AUTHORITIES.— 


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1 (1) SPECIFIC BIOTECHNOLOGY EXCEPTION.— 

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

3 executive agency may waive the prohibition 

4 under subsection (a) and (b) on a case-by-case 

5 basis— 

6 (i) with the approval of the Director of 

7 the Office of Management and Budget, in 

8 consultation with the Federal Acquisition 

9 Security Council and the Secretary of De10 fense; and 

11 (ii) if such head submits a notification 

12 and justification to the appropriate congres13 sional committees not later than 30 days 

14 after granting such waiver. 

15 (B) DURATION.— 

16 (i) IN GENERAL.—Except as provided 

17 in clause (ii), a waiver granted under sub18 paragraph (A) shall last for a period of not 

19 more than 365 days. 

20 (ii) EXTENSION.—The head of the ap21 plicable executive agency, with the approval 

22 of the Director of the Office of Management 

23 and Budget, and in consultation with the 

24 Federal Acquisition Security Council and 

25 the Secretary of Defense, may extend a 


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1 waiver granted under subparagraph (A) one 

2 time, for a period up to 180 days after the 

3 date on which the waiver would otherwise 

4 expire, if such an extension is in the na5 tional security interests of the United States 

6 and the Director submits to the appropriate 

7 congressional committees a notification of 

8 such waiver. 

9 (2) OVERSEAS HEALTH CARE SERVICES.—The 

10 head of an executive agency may waive the prohibi11 tions under subsections (a) and (b) with respect to a 

12 contract, subcontract, or transaction for the acquisi13 tion or provision of health care services overseas on 

14 a case-by-case basis— 

15 (A) if the head of such executive agency de16 termines that the waiver is— 

17 (i) necessary to support the mission or 

18 activities of the employees of such executive 

19 agency described in subsection (e)(2)(A); 

20 and 

21 (ii) in the interest of the United States; 

22 (B) with the approval of the Director of the 

23 Office of Management and Budget, in consulta24 tion with the Federal Acquisition Security Coun25 cil and 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 granting 

4 such waiver. 

5 (e) EXCEPTIONS.—The prohibitions under subsections 

6 (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 intel10 ligence 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 States 

16 Code), whose official duty stations are located 

17 overseas or are on permissive temporary duty 

18 travel overseas; or 

19 (B) employees of contractors or subcontrac20 tors 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 human 

5 multiomic data, lawfully compiled, that is commer6 cially or publicly available. 

7 (f) EVALUATION OF CERTAIN BIOTECHNOLOGY ENTI8 TIES.— 

9 (1) ENTITY CONSIDERATION.—Not later than 120 

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

11 Director of the Office of Management and Budget, in 

12 consultation with the Secretary of Defense, 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, and the Secretary of State, shall develop a list 

17 of the entities that constitute biotechnology companies 

18 of concern. 

19 (2) BIOTECHNOLOGY COMPANIES OF CONCERN

20 DEFINED.—The term ‘‘biotechnology company of con21 cern’’ means— 

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

23 AppTec, and any subsidiary, parent affiliate, or 

24 successor of such entities; and 

25 (B) any entity that— 


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1 (i) is subject to the jurisdiction, direc2 tion, control, or operates on behalf of the 

3 government of a foreign adversary; 

4 (ii) is to any extent involved in the 

5 manufacturing, distribution, provision, or 

6 procurement of a biotechnology equipment 

7 or service; and 

8 (iii) poses a risk to the national secu9 rity of the United States based on— 

10 (I) engaging in joint research 

11 with, being supported by, or being af12 filiated with a foreign adversary’s 

13 military, internal security forces, or 

14 intelligence agencies; 

15 (II) providing multiomic data ob16 tained via biotechnology equipment or 

17 services to the government of a foreign 

18 adversary; or 

19 (III) obtaining human multiomic 

20 data via the biotechnology equipment 

21 or services without express and in22 formed consent. 

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

24 the date of the enactment of this Act for the bio25 technology companies of concern named in paragraph 


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1 (2)(A), and not later than 180 days after the develop2 ment of the list pursuant to paragraph (1) and any 

3 update to the list pursuant to paragraph (4), the Di4 rector of the Office of Management and Budget, in 

5 consultation with the Secretary of Defense, the Attor6 ney General, the Secretary of Health and Human 

7 Services, the Secretary of Commerce, the Director of 

8 National Intelligence, the Secretary of Homeland Se9 curity, and the Secretary of State, shall establish 

10 guidance necessary to implement the requirements of 

11 this section. 

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

13 Management and Budget, in consultation with the 

14 Secretary of Defense, the Attorney General, the Sec15 retary of Health and Human Services, the Secretary 

16 of Commerce, the Director of National Intelligence, 

17 the Secretary of Homeland Security, and the Sec18 retary of State, shall periodically, though not less 

19 than annually, review and, as appropriate, modify 

20 the list of biotechnology companies of concern, and 

21 notify the appropriate congressional committees of 

22 any such modifications. 

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

24 (A) IN GENERAL.—A notice of a designation 

25 as a biotechnology company of concern under 


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1 subparagraph (B) of paragraph (2) shall be 

2 issued to any source named in the designation— 

3 (i) advising that a designation has 

4 been made; 

5 (ii) identifying the criteria relied upon 

6 under such subparagraph and, to the extent 

7 consistent with national security and law 

8 enforcement interests, the information that 

9 formed the basis for the designation; 

10 (iii) advising that, within 90 days 

11 after receipt of notice, the source may sub12 mit information and argument in opposi13 tion to the designation; 

14 (iv) describing the procedures gov15 erning the review and possible issuance of a 

16 designation pursuant to paragraph (1); and 

17 (v) where practicable, identifying miti18 gation steps that could be taken by the 

19 source that may result in the rescission of 

20 the designation. 

21 (B) CONGRESSIONAL NOTIFICATION RE22 QUIREMENTS.— 

23 (i) NOTICE OF DESIGNATION.—The Di24 rector of the Office of Management and 

25 Budget shall submit the notice required 


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1 under subparagraph (A) to the Committee 

2 on Homeland Security and Governmental 

3 Affairs of the Senate and the Committee on 

4 Oversight and Accountability of the House 

5 of Representatives. 

6 (ii) INFORMATION AND ARGUMENT IN

7 OPPOSITION TO DESIGNATIONS.—Not later 

8 than 7 days after receiving any information 

9 and argument in opposition to a designa10 tion pursuant to subparagraph (A)(iii), the 

11 Director of the Office of Management and 

12 Budget shall submit such information to the 

13 Committee on Homeland Security and Gov14 ernmental Affairs of the Senate and the 

15 Committee on Oversight and Accountability 

16 of the House of Representatives. 

17 (C) EXCEPTIONS.—The provisions under 

18 subparagraph (A) and (B) shall not apply to an 

19 entity listed under paragraph (2)(A). 

20 (6) NO IMMEDIATE PUBLIC RELEASE.—Any des21 ignation made under paragraph (1) or paragraph (4) 

22 shall not be made publicly available until the Direc23 tor of the Office of Management and Budget, in co24 ordination with appropriate agencies, reviews all in25 formation submitted under paragraph (5)(A)(iii) and 


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1 issues a final determination that a company shall re2 main listed as a biotechnology company of concern. 

3 (g) EVALUATION OF NATIONAL SECURITY RISKS

4 POSED BY FOREIGN ADVERSARY ACQUISITION OF AMER5 ICAN MULTIOMIC DATA.— 

6 (1) ASSESSMENT.—Not later than 270 days after 

7 the enactment of this Act, the Director of National In8 telligence, in consultation with the Secretary of De9 fense, the Attorney General of the United States, the 

10 Secretary of Health and Human Services, the Sec11 retary of Commerce, the Secretary of Homeland Secu12 rity, and the Secretary of State, shall complete an as13 sessment of risks to national security posed by human 

14 multiomic data from United States citizens that is 

15 collected or stored by a foreign adversary from the 

16 provision of biotechnology equipment or services. 

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

18 days after the completion of the assessment developed 

19 under paragraph (1), the Director of National Intel20 ligence shall submit a report with such assessment to 

21 the appropriate congressional committees. 

22 (3) FORM.—The report required under para23 graph (2) shall be in unclassified form accompanied 

24 by a classified annex. 


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

2 date of establishment of guidance required under subsection 

3 (f)(3), the Federal Acquisition Regulatory Council shall re4 vise the Federal Acquisition Regulation as necessary to im5 plement the requirements of this section. 

6 (i) NO ADDITIONAL FUNDS.—No additional funds are 

7 authorized to be appropriated for the purpose of carrying 

8 out this section. 

9 (j) REPORTING ON INTELLIGENCE ON NEFARIOUS AC10 TIVITIES OF BIOTECHNOLOGY COMPANIES WITH HUMAN

11 MULTIOMIC DATA.—Not later than 180 days after the date 

12 of the enactment of this Act, and annually thereafter, the 

13 Director of National Intelligence, in consultation with the 

14 heads of executive agencies, shall submit to the appropriate 

15 congressional committees a report on any intelligence in 

16 possession of such agencies related to nefarious activities 

17 conducted by biotechnology companies with human 

18 multiomic data. The report shall include information per19 taining to potential threats to national security or public 

20 safety from the selling, reselling, licensing, trading, trans21 ferring, sharing, or otherwise providing or making avail22 able to any foreign country of any forms of multiomic data 

23 of a United States citizen. 

24 (k) DEFINITIONS.—In this section: 


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1 (1) APPROPRIATE CONGRESSIONAL COMMIT2 TEES.—The term ‘‘appropriate congressional commit3 tees’’ means— 

4 (A) the Committee on Armed Services and 

5 the Committee on Homeland Security and Gov6 ernmental Affairs of the Senate; and 

7 (B) the Committee on Armed Services, the 

8 Committee on Foreign Affairs, the Committee on 

9 Oversight and Accountability, the Committee on 

10 Energy and Commerce, and the Select Com11 mittee on Strategic Competition between the 

12 United States and the Chinese Communist Party 

13 of the House of Representatives. 

14 (2) BIOTECHNOLOGY EQUIPMENT OR SERVICE.— 

15 The term ‘‘biotechnology equipment or service’’ 

16 means— 

17 (A) equipment, including genetic sequencers, 

18 mass spectrometers, polymerase chain reaction 

19 machines, or any other instrument, apparatus, 

20 machine, or device, including components and 

21 accessories thereof, that is designed for use in the 

22 research, development, production, or analysis of 

23 biological materials as well as any software, 

24 firmware, or other digital components that are 


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1 specifically designed for use in, and necessary for 

2 the operation of, such equipment; 

3 (B) any service for the research, develop4 ment, production, analysis, detection, or provi5 sion of information, including data storage and 

6 transmission related to biological materials, in7 cluding— 

8 (i) advising, consulting, or support 

9 services with respect to the use or imple10 mentation of a instrument, apparatus, ma11 chine, or device described in subparagraph 

12 (A); and 

13 (ii) disease detection, genealogical in14 formation, and related services; and 

15 (C) any other service, instrument, appa16 ratus, machine, component, accessory, device, 

17 software, or firmware that the Director of the Of18 fice of Management and Budget, in consultation 

19 with the heads of Executive agencies, as deter20 mined appropriate by the Director of the Office 

21 of Management and Budget, determines appro22 priate. 

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

24 meaning given to that term in section 800.208 of title 


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27 

•S 3558 RS

1 31, Code of Federal Regulations, or any successor reg2 ulations. 

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

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

5 agency’’ in section 105 of title 5, United States Code. 

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

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

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

9 Code. 

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

11 data types that include genomics, epigenomics, 

12 transcriptomics, proteomics, and metabolomics. 

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

14 area outside of the United States, the Commonwealth 

15 of Puerto Rico, or a territory or possession of the 

16 United States. 


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Calendar No. 521 

118TH CONGRESS 

2D SESSION S. 3558 

[Report No. 118–229] 

A BILL 

To prohibit contracting with certain biotechnology 

providers, and for other purposes. 

SEPTEMBER 23, 2024 

Reported with an amendment 


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