[Congressional Record Volume 170, Number 114 (Wednesday, July 10, 2024)]
[Senate]
[Pages S4411-S4412]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 2166. Mr. HAGERTY (for himself and Mr. Peters) submitted an
amendment intended to be proposed by him to the bill S. 4638, to
authorize appropriations for fiscal year 2025 for military activities
of the Department of Defense, for military construction, and for
defense activities of the Department of Energy, to prescribe military
personnel strengths for such fiscal year, and for other purposes; which
was ordered to lie on the table; as follows:
At the appropriate place in title VIII, insert the
following:
SEC. __. 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;
[[Page S4412]]
(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 Commonwealth of Puerto Rico, or a
territory or possession of the United States.
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