This bill prohibits federal contracting with certain biotechnology providers connected to foreign adversaries, with exceptions.
Specifically, the bill prohibits executive agencies from (1) procuring, obtaining, extending, or renewing a contract to procure or obtain 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 Group, MGI Group, Complete Genomics, any subsidiary, parent affiliate, or successor of such entities, and any entity that
DOD must determine, within 90 days after this bill's enactment, whether WuXi AppTec, Axbio, and any subsidiary, affiliate, or successor of such entities, or any other entity headquartered in or organized under the laws of China, is a biotechnology company of concern.
Executive agencies may waive the prohibitions on a case-by-case basis under specified circumstances.
[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 3385 Introduced in Senate (IS)]
<DOC>
118th CONGRESS
1st Session
S. 3385
To prohibit contracting with certain biotechnology providers.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
December 4, 2023
Mr. Hagerty 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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. PROHIBITION ON CONTRACTING WITH CERTAIN BIOTECHNOLOGY
PROVIDERS.
(a) In General.--The head of an Executive agency may not--
(1) procure or obtain or extend or renew a contract to
procure or obtain any covered biotechnology equipment or
service; or
(2) enter into a contract or extend or renew a contract
with any entity that--
(A) uses covered biotechnology equipment or
services acquired after the date of the enactment of
this Act; or
(B) that enters into any contract the performance
of which such entity knows or has reason to believe
will require the direct use of covered biotechnology
equipment or services.
(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 or extend or renew a contract to
procure or obtain any covered biotechnology equipment or
service; or
(2) enter into a contract or extend or renew a contract
with an entity described in subsection (a)(2).
(c) Effective Date.--The prohibitions under subsections (a) and (b)
shall take effect 180 days after the date of the enactment of this Act.
(d) Waiver Authorities.--
(1) Specific biotechnology exception.--
(A) Waiver.--The head of an Executive agency may
waive the prohibitions 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 180 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 Security Acquisition 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
(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
(3) the acquisition, use, or distribution of genetic
sequencing data, however complied, that is commercially
available.
(f) Evaluation of Certain Biotechnology Entities.--Not later than
90 days after the date of the enactment of this Act, the Secretary of
Defense shall determine whether Wuxi AppTec, AxBio, and any subsidiary,
affiliate, or successor of such entities, or any other entity
headquartered in or organized under the laws of the People's Republic
of China is a biotechnology company of concern.
(g) Regulations.--
(1) Guidance.--Not later than 180 days after the date of
the enactment of this Act, the Director of the Office of
Management and Budget, in coordination with the Federal
Acquisition Security Council, the Federal Acquisition
Regulatory Council, the Secretary of Defense, and other heads
of Executive agencies as determined appropriate by the Director
of the Office of Management and Budget, shall establish
guidance, as necessary, to implement the requirements of this
section.
(2) Federal acquisition regulation.--Not later than 270
days after the date of the enactment of this Act, the Federal
Acquisition Regulatory Council shall revise the Federal
Acquisition Regulation as necessary to implement the
requirements of this section.
(h) 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 company of concern.--The term
``biotechnology company of concern'' means--
(A) the BGI Group, MGI Group, or Complete Genomics,
or any subsidiary, parent, affiliate, or successor of
such entities; and
(B) any entity that--
(i) is subject to the jurisdiction,
direction, or control of a foreign adversary;
(ii) operates primarily in the
biotechnology industry; and
(iii) the Secretary of Defense deems to
pose a risk to the national security of the
United States.
(3) Biotechnology equipment or service.--The term
``biotechnology equipment or service'' means--
(A) any 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 an instrument,
apparatus, machine, or device;
(B) any service for the research, development,
production, analysis, detection, or provision of
information related to biological materials,
including--
(i) advising, consulting, or support
services provided by a biotechnology company of
concern 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 Federal Acquisition Security Council,
in coordination with the Secretary of Defense and such
other heads of Executive agencies (as determined by the
Federal Acquisition Security Council), determines
appropriate.
(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) Covered biotechnology equipment or service.--The term
``covered biotechnology equipment or service'' means a
biotechnology equipment or service produced or provided by a
biotechnology company of concern.
(6) Executive agency.--The term ``Executive agency'' has
the meaning given such term in section 105 of title 5, United
States Code.
(7) Foreign adversary.--The term ``foreign adversary'' has
the meaning given the term ``covered nation'' in section
4872(d) of title 10, United States Code.
(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.
<all>
Introduced in Senate
Read twice and referred to the Committee on Homeland Security and Governmental Affairs.
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