II 

118TH CONGRESS 

1ST SESSION S. 3411 

To prohibit contracting with certain biotechnology providers. 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 5, 2023 

Mr. PETERS 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. 

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 ‘‘Safeguarding Amer5 ican Genetic Data Act of 2023’’. 

6 SEC. 2. PROHIBITION ON CONTRACTING WITH CERTAIN 

7 BIOTECHNOLOGY PROVIDERS. 

8 (a) DESIGNATION OF FEDERAL ENTITY.—Not later 

9 than 30 days after the date of the enactment of this Act, 

10 the President shall designate a Federal entity (in this sec11 tion referred to as the ‘‘Federal entity’’) to establish guid12 ance to ensure that Executive agencies do not directly proVerDate Sep 11 2014 05:09 Dec 12, 2023 Jkt 049200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S3411.IS S3411

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1 cure or obtain any covered biotechnology equipment or 

2 service. The Federal entity, the head of which shall be the 

3 Director of the Office of Management and Budget, shall 

4 include the Secretary of Defense, the Attorney General, 

5 the Secretary of Health and Human Services, the Sec6 retary of Commerce, the Director of National Intelligence, 

7 the Secretary of Homeland Security, the Secretary of 

8 State, and the heads of other appropriate Federal agencies 

9 as identified by the President. 

10 (b) POLICY, GUIDANCE, AND REGULATIONS.— 

11 (1) RECOMMENDATIONS.—Not later than one 

12 year after the date of the enactment of this Act, the 

13 Federal entity, in coordination with the Federal Ac14 quisition Regulatory Council and other heads of Ex15 ecutive agencies as determined appropriate by the 

16 President, shall issue guidance and recommend the 

17 establishment of policy and regulations, as nec18 essary, to implement the requirements of this sec19 tion. 

20 (2) OMB POLICY.—Not later than 180 days 

21 after the date of issuance of recommendations under 

22 paragraph (1), the Director of the Office of Manage23 ment and Budget shall issue any policy necessary to 

24 effectuate the recommendations. 


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1 (3) FEDERAL ACQUISITION REGULATION.—Not 

2 later than one year after the date of issuance of rec3 ommendations under paragraph (1), the Federal Ac4 quisition Regulatory Council shall revise the Federal 

5 Acquisition Regulation as necessary to implement 

6 the requirements of this section. 

7 (4) EFFECTIVE DATE.—Any prohibition in8 cluded in the guidance established by the Federal 

9 entity in accordance with paragraph (1) shall take 

10 effect not later than one year after the establishment 

11 of such guidance. 

12 (c) RULE OF CONSTRUCTION.—Nothing in this sec13 tion shall be construed— 

14 (1) to require any covered biotechnology equip15 ment or service in use or resident in equipment, sys16 tems, or services as of the day before the applicable 

17 effective date specified in subsection (b)(4) to be re18 moved or replaced; or 

19 (2) to prohibit or limit the utilization of such 

20 covered biotechnology equipment or service through21 out the lifecycle of such existing equipment. 

22 (d) EXCEPTIONS.—Any prohibition included in the 

23 guidance established by the Federal entity under sub24 section (b) shall not apply to— 


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1 (1) any activity subject to the reporting require2 ments under title V of the National Security Act of 

3 1947 (50 U.S.C. 3091 et seq.) or any authorized de4 fense or intelligence activities of the United States 

5 Government; 

6 (2) health care services and related equipment 

7 and supplies for— 

8 (A) employees of the United States Gov9 ernment, including members of the uniformed 

10 services (as that term is defined in section 

11 101(a) of title 10, United States Code), whose 

12 official duty stations are located overseas or are 

13 on permissive temporary duty travel outside of 

14 the continental United States; 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 official duty stations are lo22 cated overseas or are on permissive tem23 porary duty travel outside of the conti24 nental United States. 


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

2 multiomic data, however compiled, that is commer3 cially or publicly available. 

4 (e) WAIVER AUTHORITIES.— 

5 (1) IN GENERAL.—The policy, guidance, and 

6 regulations established under subsection (b) shall 

7 allow the head of an Executive agency to waive any 

8 prohibition implemented in connection with such 

9 guidance on a case-by-case basis after consultation 

10 with the Federal entity. 

11 (2) DURATION.— 

12 (A) IN GENERAL.—Except as provided in 

13 subparagraph (B), a waiver granted under 

14 paragraph (1) shall last for a period of not 

15 more than one year. 

16 (B) EXTENSION.—The head of an Execu17 tive agency may extend a waiver granted to an 

18 Executive agency under paragraph (1) one 

19 time, for a period up to 180 days after the date 

20 on which the waiver would otherwise expire, if 

21 such an extension is in the national security in22 terests of the United States and the Executive 

23 agency submits to the appropriate congressional 

24 committees a notification of such waiver not 

25 later than 30 days after granting the waiver. 


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1 (f) DETERMINATION OF CERTAIN BIOTECHNOLOGY

2 ENTITIES.— 

3 (1) IN GENERAL.—Not later than 180 days 

4 after the date of the enactment of this Act, the Fed5 eral entity shall develop a list of entities determined 

6 to be a biotechnology company of concern. The Fed7 eral entity shall define a biotechnology company of 

8 concern as any entity that— 

9 (A) is subject to the jurisdiction, direction, 

10 control, or operates on behalf of the government 

11 of a foreign adversary; 

12 (B) is to any extent involved in the manu13 facturing, distribution, provision, or procure14 ment of biotechnology equipment or services; 

15 and 

16 (C) poses a risk to the national security of 

17 the United States based on— 

18 (i) engaging in joint research with, 

19 being supported by, or being affiliated with 

20 a foreign adversary’s military, internal se21 curity forces, or intelligence agencies; 

22 (ii) providing multiomic data obtained 

23 via biotechnology equipment or services to 

24 the government of a foreign adversary; or 


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1 (iii) obtaining human multiomic data 

2 via biotechnology equipment or services 

3 without expressed and informed consent. 

4 (2) UPDATES.—The Federal entity shall peri5 odically, but not less than annually, review and, as 

6 appropriate, modify the list of biotechnology compa7 nies of concern. 

8 (g) EVALUATION OF CERTAIN BIOTECHNOLOGY EN9 TITIES.—Not later than 180 days after the date of the 

10 enactment of this Act, the Federal entity shall determine 

11 whether BGI, MGI, Complete Genomics, and any sub12 sidiary, affiliate, or successor of such entities, are bio13 technology companies of concern. If any such entities, sub14 sidiaries, affiliates, or successors are identified as bio15 technology companies of concern, no Executive agency 

16 shall directly procure or obtain any biotechnology equip17 ment or services from such entities, subsidiaries, affiliates, 

18 or successors. The Director of the Office of Management 

19 and Budget shall issue such policy, and the Federal Acqui20 sition Regulatory Council shall promulgate such regula21 tions, as may be necessary to effectuate this prohibition. 

22 (h) ANALYSIS, ASSESSMENT, AND STRATEGY.—Not 

23 later than 180 days after developing the list of entities 

24 under subsection (f)(1) and the determination of entities 

25 under subsection (g), the Federal entity, to the greatest 


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1 extent practicable, leveraging relevant previous analyses 

2 and assessments, shall— 

3 (1) conduct an analysis of the list of entities 

4 identified under subsections (f)(1) and (g), includ5 ing— 

6 (A) active Federal grants to or contracts 

7 with private companies, academic institutions, 

8 and public sector entities, including— 

9 (i) the number and type of covered 

10 biotechnology equipment or services al11 ready or expected to be procured; 

12 (ii) the anticipated lifespan of covered 

13 biotechnology equipment or services al14 ready or expected to be procured; 

15 (iii) the estimated costs and timeline 

16 to replace covered biotechnology equipment 

17 or services already procured; and 

18 (B) the domestic and international market 

19 share; 

20 (2) assess risks to national security posed by 

21 the entities identified under subsections (f)(1) and 

22 (g), obtaining active and future Federal grants to or 

23 contracts with private companies, academic institu24 tions, and public sector entities; 

25 (3) develop a strategy to— 


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1 (A) mitigate the risks to national security 

2 identified in the assessment conducted under 

3 paragraph (2); and 

4 (B) support private companies, academic 

5 institutions, and public sector entities seeking 

6 to acquire covered biotechnology equipment or 

7 services from alternative entities; and 

8 (4) provide the results of the analysis, assess9 ment, and strategy developed under this subsection 

10 to the Federal Acquisition Regulatory Council and 

11 the appropriate congressional committees. 

12 (i) REPORT REQUIREMENT.— 

13 (1) IN GENERAL.—Not later than 180 days 

14 after the date of the enactment of this Act, the Fed15 eral entity shall submit to the Federal Acquisition 

16 Regulatory Council and the appropriate congres17 sional committees a report including the following: 

18 (A) The name of and justification for each 

19 entity meeting the criteria for a biotechnology 

20 company of concern under subsections (f)(1) 

21 and (g). 

22 (B) A catalog of all active or planned 

23 grants or contracts any Executive agency has 

24 with any entity determined to be a bioVerDate Sep 11 2014 05:09 Dec 12, 2023 Jkt 049200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S3411.IS S3411

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1 technology company of concern related to bio2 technology equipment or services. 

3 (C) Recommendations, as applicable, on al4 ternative entities to a biotechnology company of 

5 concern capable of providing the Federal Gov6 ernment with required biotechnology equipment 

7 or services. 

8 (D) Recommendations, as applicable, on 

9 the feasibility of implementing prohibitions im10 plemented in connection with the guidance es11 tablished under subsection (b) or exercising 

12 waiver authorities under subsection (e), to en13 sure uninterrupted Federal Government access 

14 to required biotechnology equipment and serv15 ices, and any further changes to legislation 

16 needed to mitigate supply chain risks or in17 crease availability and enhance capabilities of 

18 biotechnology equipment and services. 

19 (2) FORM.—The report required under para20 graph (1) shall be in unclassified form accompanied 

21 by a classified annex. 

22 (j) DEFINITIONS.—In this section: 

23 (1) APPROPRIATE CONGRESSIONAL COMMIT24 TEES.—The term ‘‘appropriate congressional com25 mittees’’ means— 


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1 (A) the Committee on Armed Services, the 

2 Committee on Commerce, Science, and Trans3 portation, the Committee on Foreign Relations, 

4 the Committee on Health, Education, Labor, 

5 and Pensions, and the Committee on Homeland 

6 Security and Governmental Affairs of the Sen7 ate; and 

8 (B) the Committee on Armed Services, the 

9 Committee on Foreign Affairs, the Committee 

10 on Oversight and Accountability, the Committee 

11 on Energy and Commerce, and the Select Com12 mittee on Strategic Competition between the 

13 United States and the Chinese Communist 

14 Party of the House of Representatives. 

15 (2) BIOTECHNOLOGY EQUIPMENT OR SERV16 ICE.—The term ‘‘biotechnology equipment or serv17 ice’’ means— 

18 (A) equipment, including genetic sequenc19 ers, mass spectrometers, polymerase chain reac20 tion machines, or any other instrument, appa21 ratus, machine, or device, including components 

22 and accessories thereof, that is designed for use 

23 in the research, development, production, or 

24 analysis of biological materials, as well as any 

25 software, firmware, or other digital components 


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1 that are specifically designed for use in, and 

2 necessary for 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 provided by a biotechnology com10 pany of concern with respect to the use or 

11 implementation of an instrument, appa12 ratus, machine, or device described in sub13 paragraph (A); or 

14 (ii) disease detection, genealogical in15 formation, and related services; and 

16 (C) any other service, instrument, appa17 ratus, machine, component, accessory, device, 

18 software, or firmware that the Federal entity 

19 determines appropriate. 

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

21 meaning given the term in section 800.208 of title 

22 31, Code of Federal Regulations, or any successor 

23 regulations. 

24 (4) COVERED BIOTECHNOLOGY EQUIPMENT OR

25 SERVICE.—The term ‘‘covered biotechnology equipVerDate Sep 11 2014 05:09 Dec 12, 2023 Jkt 049200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S3411.IS S3411

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1 ment or service’’ means a biotechnology equipment 

2 or service produced or provided by a biotechnology 

3 company of concern. 

4 (5) EXECUTIVE AGENCY.—The term ‘‘Executive 

5 agency’’ has the meaning given the term in section 

6 105 of title 5, United States Code. 

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

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

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

10 Code. 

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

12 data types that include genomics, epigenomics, 

13 transcriptomics, proteomics, and metabolomics. 

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

15 any area outside of the United States, the Common16 wealth of Puerto Rico, or a territory or possession 

17 of the United States. 

Æ 


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