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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘BIOSECURE Act’’. 
SEC. 2. PROHIBITION ON CONTRACTING WITH CERTAIN 
BIOTECHNOLOGY PROVIDERS. 
(a) IN GENERAL.—The head of an executive agency 
may not— 
(1) procure or obtain any biotechnology equip-
ment or service produced or provided by a bio-
technology company of concern; or 
(2) enter into a contract or extend or renew a 
contract with any entity that— 
(A) uses biotechnology equipment or serv-
ices produced or provided by a biotechnology 
company of concern and acquired after the ap-
plicable effective date in subsection (c) in per-
formance of the contract with the executive 
agency; or 
(B) enters into any contract the perform-
ance of which such entity knows or has reason 
to believe will require, in performance of the 
contract with the executive agency, the use of 
biotechnology equipment or services produced or 
provided by a biotechnology company of concern 
and acquired after the applicable effective date 
in subsection (c). 
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(b) PROHIBITION ON LOAN AND GRANT FUNDS.— 
The head of an executive agency may not obligate or ex-
pend loan or grant funds to, and a loan or grant recipient 
may not use loan or grant funds to— 
(1) procure, obtain, or use any biotechnology 
equipment or services produced or provided by a bio-
technology company of concern; or 
(2) enter into a contract or extend or renew a 
contract with an entity described in subsection 
(a)(2). 
(c) EFFECTIVE DATES.— 
(1) CERTAIN ENTITIES.—With respect to the 
biotechnology companies of concern covered by sub-
section (f)(2)(A), the prohibitions under subsections 
(a) and (b) shall take effect 60 days after the 
issuance of the regulation in subsection (h). 
(2) OTHER ENTITIES.—With respect to the bio-
technology companies of concern covered by sub-
section (f)(2)(B), the prohibitions under subsections 
(a) and (b) shall take effect 180 days after the 
issuance of the regulation in subsection (h). 
(3) RULES OF CONSTRUCTION.— 
(A) CERTAIN ENTITIES.—Prior to January 
1, 2032, with respect to biotechnology compa-
nies 
of 
concern 
covered 
by 
subsections 
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(f)(2)(A), subsections (a)(2) and (b)(2) shall 
not apply to biotechnology equipment or serv-
ices produced or provided under a contract or 
agreement, including previously negotiated con-
tract options, entered into before the effective 
date under paragraph (1). 
(B) OTHER ENTITIES.—Prior to the date 
that is five years after the issuance of the regu-
lation in subsection (h) that identifies a bio-
technology company of concern covered by sub-
sections (f)(2)(B), subsections (a)(2) and (b)(2) 
shall not apply to biotechnology equipment or 
services produced or provided under a contract 
or agreement, including previously negotiated 
contract options, entered into before the effec-
tive date under paragraph (2). 
(C) 
SAFE
HARBOR.—The 
term 
‘‘bio-
technology equipment or services produced or 
provided by a biotechnology company of con-
cern’’ shall not be construed to refer to any bio-
technology equipment or services that were for-
merly, but are no longer, produced or provided 
by biotechnology companies of concern. 
(d) WAIVER AUTHORITIES.— 
(1) SPECIFIC BIOTECHNOLOGY EXCEPTION.— 
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(A) WAIVER.—The head of the applicable 
executive agency may waive the prohibition 
under subsections (a) and (b) on a case-by-case 
basis— 
(i) with the approval of the Director 
of the Office of Management and Budget, 
in coordination with the Secretary of De-
fense; and 
(ii) if such head submits a notification 
and justification to the appropriate con-
gressional committees not later than 30 
days after granting such waiver. 
(B) DURATION.— 
(i) IN GENERAL.—Except as provided 
in clause (ii), a waiver granted under sub-
paragraph (A) shall last for a period of not 
more than 365 days. 
(ii) EXTENSION.—The head of the ap-
plicable executive agency, with the ap-
proval of the Director of the Office of 
Management and Budget, and in coordina-
tion with the Secretary of Defense, may 
extend a waiver granted under subpara-
graph (A) one time, for a period up to 180 
days after the date on which the waiver 
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would otherwise expire, if such an exten-
sion is in the national security interests of 
the United States and if such head sub-
mits a notification and justification to the 
appropriate congressional committees not 
later than 10 days after granting such 
waiver extension. 
(2) OVERSEAS HEALTH CARE SERVICES.—The 
head of an executive agency may waive the prohibi-
tions under subsections (a) and (b) with respect to 
a contract, subcontract, or transaction for the acqui-
sition or provision of health care services overseas on 
a case-by-case basis— 
(A) if the head of such executive agency 
determines that the waiver is— 
(i) necessary to support the mission or 
activities of the employees of such execu-
tive 
agency 
described 
in 
subsection 
(e)(2)(A); and 
(ii) in the interest of the United 
States; 
(B) with the approval of the Director of 
the Office of Management and Budget, in con-
sultation with the Secretary of Defense; and 
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(C) if such head submits a notification and 
justification to the appropriate congressional 
committees not later than 30 days after grant-
ing such waiver. 
(e) EXCEPTIONS.—The prohibitions under sub-
sections (a) and (b) shall not apply to— 
(1) any activity subject to the reporting require-
ments under title V of the National Security Act of 
1947 (50 U.S.C. 3091 et seq.) or any authorized in-
telligence activities of the United States; 
(2) the acquisition or provision of health care 
services overseas for— 
(A) employees of the United States, includ-
ing members of the uniformed services (as de-
fined in section 101(a) of title 10, United 
States Code), whose official duty stations are 
located overseas or are on permissive temporary 
duty travel overseas; or 
(B) employees of contractors or sub-
contractors of the United States— 
(i) who are performing under a con-
tract that directly supports the missions or 
activities of individuals described in sub-
paragraph (A); and 
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(ii) whose primary duty stations are 
located overseas or are on permissive tem-
porary duty travel overseas; or 
(3) the acquisition, use, or distribution of 
human multiomic data, lawfully compiled, that is 
commercially or publicly available. 
(f) EVALUATION OF CERTAIN BIOTECHNOLOGY EN-
TITIES.— 
(1) ENTITY CONSIDERATION.—Not later than 
365 days after the date of the enactment of this Act, 
the Director of the Office of Management and Budg-
et shall publish a list of the entities that constitute 
biotechnology companies of concern based on a list 
of suggested entities that shall be provided by the 
Secretary of Defense in coordination with the Attor-
ney General, the Secretary of Health and Human 
Services, the Secretary of Commerce, the Director of 
National Intelligence, the Secretary of Homeland Se-
curity, the Secretary of State, and the National 
Cyber Director. 
(2) BIOTECHNOLOGY COMPANIES OF CONCERN 
DEFINED.—The term ‘‘biotechnology company of 
concern’’ means— 
(A) BGI, MGI, Complete Genomics, WuXi 
AppTec, and WuXi Biologics; 
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(B) any entity that is determined by the 
process established in paragraph (1) to meet 
the following criteria— 
(i) is subject to the administrative 
governance structure, direction, control, or 
operates on behalf of the government of a 
foreign adversary; 
(ii) is to any extent involved in the 
manufacturing, distribution, provision, or 
procurement of a biotechnology equipment 
or service; and 
(iii) poses a risk to the national secu-
rity of the United States based on— 
(I) engaging in joint research 
with, being supported by, or being af-
filiated with a foreign adversary’s 
military, internal security forces, or 
intelligence agencies; 
(II) providing multiomic data ob-
tained via biotechnology equipment or 
services to the government of a for-
eign adversary; or 
(III) obtaining human multiomic 
data via the biotechnology equipment 
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or services without express and in-
formed consent; and 
(C) any subsidiary, parent, affiliate, or 
successor of entities listed in subparagraphs (A) 
and (B), provided they meet the criteria in sub-
paragraph (B)(i). 
(3) GUIDANCE.—Not later than 120 days after 
the date of the enactment of this Act for the bio-
technology companies of concern named in para-
graph (2)(A), and not later than 180 days after the 
development of the list pursuant to paragraph (1) 
and any update to the list pursuant to paragraph 
(4), the Director of the Office of Management and 
Budget, in coordination with the Secretary of De-
fense, the Attorney General, the Secretary of Health 
and Human Services, the Secretary of Commerce, 
the Director of National Intelligence, the Secretary 
of Homeland Security, the Secretary of State, and 
the National Cyber Director, shall establish guidance 
as necessary to implement the requirements of this 
section. 
(4) UPDATES.—The Director of the Office of 
Management and Budget, in coordination with or 
based on a recommendation provided by the Sec-
retary of Defense, the Attorney General, the Sec-
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retary of Health and Human Services, the Secretary 
of Commerce, the Director of National Intelligence, 
the Secretary of Homeland Security, the Secretary 
of State, and the National Cyber Director, shall pe-
riodically, though not less than annually, review and, 
as appropriate, modify the list of biotechnology com-
panies of concern, and notify the appropriate con-
gressional committees of any such modifications. 
(5) NOTICE OF A DESIGNATION AND REVIEW.— 
(A) IN GENERAL.—A notice of a designa-
tion as a biotechnology company of concern 
under paragraph (2)(B) shall be issued to any 
biotechnology company of concern named in the 
designation— 
(i) advising that a designation has 
been made; 
(ii) identifying the criteria relied upon 
under such subparagraph and, to the ex-
tent consistent with national security and 
law enforcement interests, the information 
that formed the basis for the designation; 
(iii) advising that, within 90 days 
after receipt of notice, the biotechnology 
company of concern may submit informa-
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tion and argument in opposition to the 
designation; 
(iv) describing the procedures gov-
erning the review and possible issuance of 
a designation pursuant to paragraph (1); 
and 
(v) where practicable, identifying miti-
gation steps that could be taken by the 
biotechnology company of concern that 
may result in the rescission of the designa-
tion. 
(B) CONGRESSIONAL
NOTIFICATION
RE-
QUIREMENTS.— 
(i) NOTICE
OF
DESIGNATION.—The 
Director of the Office of Management and 
Budget shall submit the notice required 
under subparagraph (A) to the Committee 
on Homeland Security and Governmental 
Affairs of the Senate and the Committee 
on Oversight and Accountability of the 
House of Representatives. 
(ii) INFORMATION AND ARGUMENT IN 
OPPOSITION TO DESIGNATIONS.—Not later 
than 7 days after receiving any informa-
tion and argument in opposition to a des-
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ignation pursuant to subparagraph (A)(iii), 
the Director of the Office of Management 
and Budget shall submit such information 
to the Committee on Homeland Security 
and Governmental Affairs of the Senate 
and the Committee on Oversight and Ac-
countability of the House of Representa-
tives. 
(C) EXCEPTIONS.—The provisions under 
subparagraphs (A) and (B) shall not apply to 
an entity listed under paragraph (2)(A). 
(6) NO
IMMEDIATE
PUBLIC
RELEASE.—Any 
designation made under paragraph (1) or paragraph 
(4) shall not be made publicly available until the Di-
rector of the Office of Management and Budget, in 
coordination with appropriate agencies, reviews all 
information submitted under paragraph (5)(A)(iii) 
and issues a final determination that a company 
shall remain listed as a biotechnology company of 
concern. 
(g) EVALUATION
OF NATIONAL SECURITY RISKS 
POSED BY FOREIGN ADVERSARY ACQUISITION OF AMER-
ICAN MULTIOMIC DATA.— 
(1) ASSESSMENT.—Not later than 270 days 
after the enactment of this Act, the Director of Na-
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tional Intelligence, in consultation with the Secretary 
of Defense, the Attorney General of the United 
States, the Secretary of Health and Human Serv-
ices, the Secretary of Commerce, the Secretary of 
Homeland Security, the Secretary of State, and the 
National Cyber Director, shall complete an assess-
ment of risks to national security posed by human 
multiomic data from United States citizens that is 
collected or stored by a foreign adversary from the 
provision of biotechnology equipment or services. 
(2) REPORT REQUIREMENT.—Not later than 30 
days after the completion of the assessment devel-
oped under paragraph (1), the Director of National 
Intelligence shall submit a report with such assess-
ment to the appropriate congressional committees. 
(3) FORM.—The report required under para-
graph (2) shall be in unclassified form accompanied 
by a classified annex. 
(h) REGULATIONS.—Not later than one year after 
the date of establishment of guidance required under sub-
section (f)(3), and as necessary for subsequent updates, 
the Federal Acquisition Regulatory Council shall revise 
the Federal Acquisition Regulation as necessary to imple-
ment the requirements of this section. 
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(i) REPORTING ON INTELLIGENCE ON NEFARIOUS 
ACTIVITIES
OF
BIOTECHNOLOGY
COMPANIES
WITH 
HUMAN MULTIOMIC DATA.—Not later than 180 days 
after the date of the enactment of this Act, and annually 
thereafter, the Director of National Intelligence, in con-
sultation with the heads of executive agencies, shall submit 
to the appropriate congressional committees a report on 
any intelligence in possession of such agencies related to 
nefarious activities conducted by biotechnology companies 
with human multiomic data. The report shall include in-
formation pertaining to potential threats to national secu-
rity or public safety from the selling, reselling, licensing, 
trading, transferring, sharing, or otherwise providing or 
making available to any foreign country of any forms of 
multiomic data of a United States citizen. 
(j) NO ADDITIONAL FUNDS.—No additional funds 
are authorized to be appropriated for the purpose of car-
rying out this section. 
(k) DEFINITIONS.—In this section: 
(1) APPROPRIATE
CONGRESSIONAL
COMMIT-
TEES.—The term ‘‘appropriate congressional com-
mittees’’ means— 
(A) the Committee on Armed Services, the 
Select Committee on Intelligence, and the Com-
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mittee on Homeland Security and Govern-
mental Affairs of the Senate; and 
(B) the Committee on Armed Services, the 
Permanent Select Committee on Intelligence, 
the Committee on Foreign Affairs, the Com-
mittee on Oversight and Accountability, the 
Committee on Energy and Commerce, and the 
Select Committee on Strategic Competition be-
tween the United States and the Chinese Com-
munist Party of the House of Representatives. 
(2) BIOTECHNOLOGY
EQUIPMENT
OR
SERV-
ICE.—The term ‘‘biotechnology equipment or serv-
ice’’ means— 
(A) equipment, including genetic sequenc-
ers, combined mass spectrometry technologies, 
polymerase chain reaction machines, or any 
other instrument, apparatus, machine, or de-
vice, including components and accessories 
thereof, that is designed for use in the research, 
development, production, or analysis of biologi-
cal materials as well as any software, firmware, 
or other digital components that are specifically 
designed for use in, and necessary for the oper-
ation of, such equipment; 
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(B) any service for the research, develop-
ment, production, analysis, detection, or provi-
sion of information, including data storage and 
transmission related to biological materials, in-
cluding— 
(i) advising, consulting, or support 
services with respect to the use or imple-
mentation of a instrument, apparatus, ma-
chine, or device described in subparagraph 
(A); and 
(ii) disease detection, genealogical in-
formation, and related services; and 
(C) any other service, instrument, appa-
ratus, machine, component, accessory, device, 
software, or firmware that is designed for use 
in the research, development, production, or 
analysis of biological materials that the Direc-
tor of the Office of Management and Budget, in 
consultation with the heads of Executive agen-
cies, as determined appropriate by the Director 
of the Office of Management and Budget, de-
termines appropriate in the interest of national 
security. 
(3) CONTRACT.—Except as the term is used 
under subsection (b)(2) and subsection (c)(3), the 
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term ‘‘contract’’ means any contract subject to the 
Federal Acquisition Regulation issued under section 
1303(a)(1) of title 41, United States Code. 
(4) CONTROL.—The term ‘‘control’’ has the 
meaning given to that term in section 800.208 of 
title 31, Code of Federal Regulations, or any suc-
cessor regulations. 
(5) EXECUTIVE AGENCY.—The term ‘‘executive 
agency’’ has the meaning given the term ‘‘Executive 
agency’’ in section 105 of title 5, United States 
Code. 
(6) FOREIGN ADVERSARY.—The term ‘‘foreign 
adversary’’ has the meaning given the term ‘‘covered 
nation’’ in section 4872(d) of title 10, United States 
Code. 
(7) MULTIOMIC.—The term ‘‘multiomic’’ means 
data types that include genomics, epigenomics, 
transcriptomics, proteomics, and metabolomics. 
(8) OVERSEAS.—The term ‘‘overseas’’ means 
any area outside of the United States, the Common- 
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wealth of Puerto Rico, or a territory or possession 
of the United States. 
Passed the House of Representatives September 9, 
2024. 
Attest: 
KEVIN F. MCCUMBER, 
Clerk. 
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