BIOSECURE Act
This bill prohibits federal contracting with certain biotechnology providers connected to foreign adversaries, with exceptions.
Specifically, the bill prohibits executive agencies from (1) procuring or obtaining any biotechnology equipment or service produced or provided by a biotechnology company of concern, or (2) entering into a contract or extending or renewing a contract that uses such equipment or service or that will require the direct use of such equipment or services. Those agencies may not obligate or expend loan or grant funds for such purposes.
A biotechnology company of concern includes BGI, MGI, Complete Genomics, WuXi AppTec, and any subsidiary, parent affiliate, or successor of such entities, and any entity that
Executive agencies may waive the prohibitions on a case-by-case basis under specified circumstances.
The Office of Management and Budget must develop and periodically update a list of the entities that constitute biotechnology companies of concern.
[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7085 Introduced in House (IH)]
<DOC>
118th CONGRESS
2d Session
H. R. 7085
To prohibit contracting with certain biotechnology providers, and for
other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
January 25, 2024
Mr. Gallagher (for himself, Mr. Krishnamoorthi, Mr. Auchincloss, Mr.
Moulton, and Mr. Dunn of Florida) introduced the following bill; which
was referred to the Committee on Oversight and Accountability
_______________________________________________________________________
A BILL
To prohibit contracting with certain biotechnology providers, and for
other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``BIOSECURE Act''.
SEC. 2. FINDINGS; SENSE OF CONGRESS.
(a) Findings.--Congress finds the following:
(1) The Government of the People's Republic of China (PRC)
seeks to dominate biotechnology as an industry of the future.
(2) In recent years, the PRC has pursued a strategy known
as ``military-civil fusion'' that merges public and private
industries to enable the military modernization of the People's
Liberation Army (PLA).
(3) In the PRC's 14th Five-Year Plan, the PRC emphasized
the use of artificial intelligence for biological discovery and
called to accelerate the development of biotechnology.
(4) PRC biotechnology companies have repeatedly
collaborated with PLA entities, including Third Military
Medical University and the PLA's Key Laboratory of High-
Altitude Medicine.
(5) PRC law requires companies that are controlled by a PRC
entity, like BGI, to comply with PRC national security laws,
which provide the Chinese Communist Party (CCP) with the power
to compel Chinese companies to turn over their data.
(6) Pursuant to the PRC's laws, the PRC can require a
company headquartered in the PRC to surrender all its data to
the Government of the PRC, making it an espionage tool of the
CCP.
(7) The National Intelligence Law, passed in China in 2017,
states that ``any organization'' must assist or cooperate with
CCP intelligence work.
(8) China's 2014 counter-espionage law also states that
``relevant organizations . . . may not refuse'' to collect
evidence for an investigation.
(9) The PRC's Data Security Law of 2021 states that the
Government has the power to access and control private data.
(10) The PRC's counter-espionage law grants PRC state
security agencies nearly unfettered discretion, if acting under
an effectively limitlessly capacious understanding of national
security, to access data from companies.
(11) The executive branch has determined that BGI, formerly
known as Beijing Genomics Institute, is a national security
threat.
(12) In October 2022, the Department of Defense added BGI
Genomics Co., LTD (BGI) to the Department of Defense's list of
PRC Military Companies.
(13) In March 2023, the Department of Commerce added BGI
Tech Solutions (Hong Kong) a subsidiary of BGI, to the Entity
List for concerns the unit poses a significant risk to
contributing to PRC Government surveillance.
(14) In February 2021, the National Counterintelligence and
Security Center published a public advisory that the Government
of the PRC seeks to leverage access to genetic data to conduct
repression and surveillance with mention of BGI's role in this
campaign.
(15) BGI is engaged in global campaign to collect foreign
person's genetic data.
(16) As of October 2023, United States press reports BGI
operates genetic collection sites or ``Fire-Eye'' laboratories,
in over 30 countries.
(17) According to a July 2021 United States press report,
BGI collected genetic data from millions of pregnant women
through prenatal tests. BGI reportedly has worked with the PLA
to improve ``population quality'' in the PRC.
(18) BGI operates the China National GeneBank, the world's
largest repository of genetic data.
(19) MGI and Complete Genomics are subsidiaries and direct
affiliates of BGI that have access to the United States market
and population.
(20) In 2013, BGI purchased United States genomic
sequencing firm Complete Genomics.
(21) According to MGI's previous Securities and Exchange
Commission disclosures, MGI is ``part of the BGI'' group and
BGI ``established'' MGI.
(22) According to an April 2023 United States press report,
BGI founder, Wang Jian, holds 47 percent of MGI shares.
(23) According to corporate disclosures, Complete Genomics
is owned by MGI and is therefore owned by BGI.
(24) WuXi Apptec presents a national security threat to the
United States.
(25) According to PRC press, WuXi Apptec has sponsored
Military-Civil Fusion events in the PRC.
(26) WuXi AppTec has received investments from a
``Military-Civil Integration Selected Hybrid Securities
Investment Fund''.
(27) According to PRC press, WuXi AppTec has granted awards
to PLA researchers and invited PLA institutes to participate in
the selection process of company awards.
(28) Chris Chen, CEO of WuXi Biologics, was previously an
adjunct professor at the PLA's Academy of Military Medical
Sciences.
(b) Sense of Congress.--It is the sense of Congress that the time
has come to--
(1) stop United States taxpayer dollars from flowing to
foreign adversary biotech companies like BGI that have ties to
the PLA; and
(2) prevent United States taxpayers from buying biotech
equipment from foreign adversaries that facilitate the transfer
of United States persons genetic data to a foreign adversary.
SEC. 3. PROHIBITION ON CONTRACTING WITH CERTAIN BIOTECHNOLOGY
PROVIDERS.
(a) In General.--The head of an executive agency may not--
(1) procure or obtain any biotechnology equipment or
service produced or provided by a biotechnology company of
concern; or
(2) enter into a contract or extend or renew a contract
with any entity that--
(A) uses biotechnology equipment or services
produced or provided by a biotechnology company of
concern and acquired after the applicable effective
date in subsection (c) in performance of the contract;
or
(B) enters into any contract the performance of
which will require the direct 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).
(b) Prohibition on Loan and Grant Funds.--The head of an executive
agency may not obligate or expend loan or grant funds to--
(1) procure or obtain any biotechnology equipment or
services produced or provided by a biotechnology 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 subsection (f)(2)(A), the
prohibitions under subsections (a) and (b) shall take effect 60
days after the issuance of the implementing guidance in
subsection (f)(3) or the expiration of the deadline set forth
in subsection (f)(3), whichever occurs first.
(2) Other entities.--With respect to the biotechnology
companies of concern covered by subsection (f)(2)(B), the
prohibitions under subsections (a) and (b) shall take effect
180 days after the issuance of the implementing guidance in
subsection (f)(3) .
(d) Waiver Authorities.--
(1) Specific biotechnology exception.--
(A) Waiver.--The head of an executive agency may
waive the prohibition under subsection (a) and (b) on a
case-by-case basis--
(i) with the approval of the Director of
the Office of Management and Budget, in
consultation with the Federal Acquisition
Security Council and the Secretary of Defense;
and
(ii) if such head submits a notification
and justification to the appropriate
congressional 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
subparagraph (A) shall last for a period of not
more than 365 days.
(ii) Extension.--The Director of the Office
of Management and Budget, in consultation with
the Federal Acquisition Security Council and
the Secretary of Defense, may extend a waiver
granted under subparagraph (A) one time, for a
period up to 180 days after the date on which
the waiver would otherwise expire, if such an
extension is in the national security interests
of the United States and the Director submits
to the appropriate congressional committees a
notification of such waiver.
(2) Overseas health care services.--The head of an
executive agency may waive the prohibitions under subsections
(a) and (b) with respect to a contract, subcontract, or
transaction for the acquisition 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 executive
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 consultation with the
Federal Acquisition Security Council and the Secretary
of Defense; and
(C) if such head submits a notification and
justification to the appropriate congressional
committees not later than 30 days after granting such
waiver.
(e) Exceptions.--The prohibitions under subsections (a) and (b)
shall not apply to--
(1) any activity subject to the reporting requirements
under title V of the National Security Act of 1947 (50 U.S.C.
3091 et seq.) or any authorized intelligence activities of the
United States;
(2) the acquisition or provision of health care services
overseas for--
(A) employees of the United States, including
members of the uniformed services (as defined 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 subcontractors of
the United States--
(i) who are performing under a contract
that directly supports the missions or
activities of individuals described in
subparagraph (A); and
(ii) whose primary duty stations are
located overseas or are on permissive temporary
duty travel overseas; or
(3) the acquisition, use, or distribution of human
multiomic data, however compiled, that is commercially or
publicly available.
(f) Evaluation of Certain Biotechnology Entities.--
(1) Entity consideration.--Not later than 120 days after
the date of the enactment of this Act, the Director of the
Office of Management and Budget, in consultation with the
Secretary of Defense, the Attorney General, the Secretary of
Health and Human Services, the Secretary of Commerce, the
Director of National Intelligence, the Secretary of Homeland
Security, and the Secretary of State, shall develop a list of
the entities that constitute biotechnology companies of
concern.
(2) Biotechnology companies of concern defined.--The term
``biotechnology company of concern'' means--
(A) BGI, MGI, Complete Genomics, Wuxi Apptec, and
any subsidiary, parent affiliate, or successor of such
entities; and
(B) any entity that--
(i) is subject to the jurisdiction,
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 security
of the United States based on--
(I) engaging in joint research
with, being supported by, or being
affiliated with a foreign adversary's
military, internal security forces, or
intelligence agencies;
(II) providing multiomic data
obtained via biotechnology equipment or
services to the government of a foreign
adversary; or
(III) obtaining human multiomic
data via the biotechnology equipment or
services without express and informed
consent.
(3) Guidance.--Not later than 120 days after the date of
the enactment of this Act, the Director of the Office of
Management and Budget, in consultation with the Secretary of
Defense, the Attorney General, the Secretary of Health and
Human Services, the Secretary of Commerce, the Director of
National Intelligence, the Secretary of Homeland Security, and
the Secretary of State, shall establish guidance necessary to
implement the requirements of this section.
(4) Updates.--The Director of the Office of Management and
Budget, in consultation with the Secretary of Defense, the
Attorney General, the Secretary of Health and Human Services,
the Secretary of Commerce, the Director of National
Intelligence, the Secretary of Homeland Security, and the
Secretary of State, shall periodically, though not less than
annually, review and, as appropriate, make a determination to
modify the list of biotechnology companies of concern.
(g) Regulations.--Not later than one year after the date of
establishment of guidance required under subsection (f)(3), the Federal
Acquisition Regulatory Council shall revise the Federal Acquisition
Regulation as necessary to implement the requirements of this section.
(h) No Additional Funds.--No additional funds are authorized to be
appropriated for the purpose of carrying out this section.
(i) Definitions.--In this section:
(1) Appropriate congressional committees.--The term
``appropriate congressional committees'' means--
(A) the Committee on Armed Services and the
Committee on Homeland Security and Governmental Affairs
of the Senate; and
(B) the Committee on Armed Services, the Committee
on Foreign Affairs, the Committee on Oversight and
Accountability, the Committee on Energy and Commerce,
and the Select Committee on Strategic Competition
between the United States and the Chinese Communist
Party of the House of Representatives.
(2) Biotechnology equipment or service.--The term
``biotechnology equipment or service'' means--
(A) equipment, including genetic sequencers, mass
spectrometers, polymerase chain reaction machines, or
any other instrument, apparatus, machine, or device,
including components and accessories thereof, that is
designed for use in the research, development,
production, or analysis of biological materials as well
as any software, firmware, or other digital components
that are specifically designed for use in, and
necessary for the operation of, such equipment;
(B) any service for the research, development,
production, analysis, detection, or provision of
information, including data storage and transmission
related to biological materials, including--
(i) advising, consulting, or support
services with respect to the use or
implementation of a instrument, apparatus,
machine, or device described in subparagraph
(A); and
(ii) disease detection, genealogical
information, and related services; and
(C) any other service, instrument, apparatus,
machine, component, accessory, device, software, or
firmware that the Director of the Office of Management
and Budget, in consultation with the heads of Executive
agencies, as determined appropriate by the Director of
the Office of Management and Budget, determines
appropriate.
(3) Control.--The term ``control'' has the meaning given to
that term in section 800.208 of title 31, Code of Federal
Regulations, or any successor regulations.
(4) Executive agency.--The term ``executive agency'' has
the meaning given the term ``Executive agency'' in section 105
of title 5, United States Code.
(5) Foreign adversary.--The term ``foreign adversary'' has
the meaning given the term ``covered nation'' in section
4872(d) of title 10, United States Code.
(6) Multiomic.--The term ``multiomic'' means data types
that include genomics, epigenomics, transcriptomics,
proteomics, and metabolomics.
(7) Overseas.--The term ``overseas'' means any area outside
of the United States, the Commonwealth of Puerto Rico, or a
territory or possession of the United States.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Oversight and Accountability.
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