[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8333 Referred in Senate (RFS)]
<DOC>
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 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. 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
with the executive agency; or
(B) enters into any contract the performance 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).
(b) Prohibition on Loan and Grant Funds.--The head of an executive
agency may not obligate or expend 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 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 regulation in subsection (h).
(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 regulation in subsection
(h).
(3) Rules of construction.--
(A) Certain entities.--Prior to January 1, 2032,
with respect to biotechnology companies of concern
covered by subsections (f)(2)(A), 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 effective date under
paragraph (1).
(B) Other entities.--Prior to the date that is five
years after the issuance of the regulation in
subsection (h) that identifies a biotechnology company
of concern covered by subsections (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 effective date under paragraph (2).
(C) Safe harbor.--The term ``biotechnology
equipment or services produced or provided by a
biotechnology company of concern'' shall not be
construed to refer to any biotechnology equipment or
services that were formerly, but are no longer,
produced or provided by biotechnology companies of
concern.
(d) Waiver Authorities.--
(1) Specific biotechnology exception.--
(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 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 head of the applicable
executive agency, with the approval of the
Director of the Office of Management and
Budget, and in coordination with 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 if such head submits 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 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
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, lawfully compiled, that is commercially or
publicly available.
(f) Evaluation of Certain Biotechnology Entities.--
(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 Budget 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 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.
(2) Biotechnology companies of concern defined.--The term
``biotechnology company of concern'' means--
(A) BGI, MGI, Complete Genomics, WuXi AppTec, and
WuXi Biologics;
(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 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; and
(C) any subsidiary, parent, affiliate, or successor
of entities listed in subparagraphs (A) and (B),
provided they meet the criteria in subparagraph (B)(i).
(3) Guidance.--Not later than 120 days after the date of
the enactment of this Act for the biotechnology companies of
concern named in paragraph (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 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, 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 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, the Secretary of State, and the National
Cyber Director, shall periodically, though not less than
annually, review and, as appropriate, modify the list of
biotechnology companies of concern, and notify the appropriate
congressional committees of any such modifications.
(5) Notice of a designation and review.--
(A) In general.--A notice of a designation 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 extent
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 information and argument in
opposition to the designation;
(iv) describing the procedures governing
the review and possible issuance of a
designation pursuant to paragraph (1); and
(v) where practicable, identifying
mitigation steps that could be taken by the
biotechnology company of concern that may
result in the rescission of the designation.
(B) Congressional notification requirements.--
(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 information and argument in
opposition to a designation 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
Accountability of the House of Representatives.
(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 Director 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 American Multiomic Data.--
(1) Assessment.--Not later than 270 days after the
enactment of this Act, the Director of National Intelligence,
in consultation with the Secretary of Defense, the Attorney
General of the United States, the Secretary of Health and Human
Services, the Secretary of Commerce, the Secretary of Homeland
Security, the Secretary of State, and the National Cyber
Director, shall complete an assessment 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 developed under paragraph (1), the
Director of National Intelligence shall submit a report with
such assessment to the appropriate congressional committees.
(3) Form.--The report required under paragraph (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 subsection (f)(3), and as
necessary for subsequent updates, the Federal Acquisition Regulatory
Council shall revise the Federal Acquisition Regulation as necessary to
implement the requirements of this section.
(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 consultation 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 information pertaining to potential threats to national
security 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 carrying out this section.
(k) Definitions.--In this section:
(1) Appropriate congressional committees.--The term
``appropriate congressional committees'' means--
(A) the Committee on Armed Services, the Select
Committee on Intelligence, and the Committee on
Homeland Security and Governmental Affairs of the
Senate; and
(B) the Committee on Armed Services, the Permanent
Select Committee on Intelligence, 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,
combined mass spectrometry technologies, 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 is designed for use in the research,
development, production, or analysis of biological
materials 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 in the interest of national security.
(3) Contract.--Except as the term is used under subsection
(b)(2) and subsection (c)(3), the 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 successor 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-
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.