[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 3469 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
1st Session
S. 3469
To prohibit contracting with certain biotechnology providers.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
December 11, 2025
Mr. Peters (for himself and 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. SHORT TITLE.
This Act may be cited as the ``BIOSECURE Act of 2025''.
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 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 Federal Acquisition Regulation is revised
pursuant to subsection (h).
(2) Other entities.--With respect to the biotechnology
companies of concern covered by subparagraphs (B) or (C) of
subsection (f)(2), the prohibitions under subsections (a) and
(b) shall take effect 90 days after the Federal Acquisition
Regulation is revised pursuant to subsection (h).
(3) Rules of construction.--
(A) Exclusions.--Prior to the date that is five
years after a revision to the Federal Acquisition
Regulation pursuant to subsection (h) that identifies a
biotechnology company of concern covered by subsection
(f)(2), 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 applicable effective date under paragraphs
(1) and (2).
(B) 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; 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)(i) employees of the United States, including
members of the uniformed services (as defined in
section 101(a) of title 10, United States Code), and
dependents of such employees;
(ii) covered beneficiaries (as defined in section
1072 of title 10, United States Code) not otherwise
described in clause (i); or
(iii) any other beneficiary if such acquisition or
provision is carried out or administered by the head of
a department or agency of the Federal Government; 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)(i); and
(ii) whose primary duty stations are
located overseas or are on permissive temporary
duty travel overseas;
(3) the acquisition, use, or distribution of human
multiomic data, lawfully compiled, that is commercially or
publicly available; or
(4) the procurement of medical countermeasures, medical
products, and related supplies, including ancillary medical
supplies, in direct response to a public health emergency
declared pursuant to section 319 of the Public Health Service
Act (42 U.S.C. 247d).
(f) Evaluation of Certain Biotechnology Entities.--
(1) Entity consideration.--Not later than one year 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.--In this
section, the term ``biotechnology company of concern'' means
any of the following:
(A) An entity that--
(i) is to any extent involved in the
manufacturing, distribution, provision, or
procurement of any biotechnology equipment or
service, as determined by the process
established in paragraph (1); and
(ii) is identified in the annual list
published in the Federal Register by the
Department of Defense of Chinese military
companies operating in the United States
pursuant to section 1260H of the William M.
(Mac) Thornberry National Defense Authorization
Act for Fiscal Year 2021 (Public Law 116-283;
134 Stat. 3965; 10 U.S.C. 113 note).
(B) Any entity that is determined by the process
established in paragraph (1) to meet each of 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.
(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.
(C) Any subsidiary, parent, or successor of an
entity described in subparagraphs (A) or (B), provided
it meets the criteria set forth in clauses (i) through
(iii) of subparagraph (B), as determined by the process
established in paragraph (1).
(3) Guidance.--Not later than 180 days after publication 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, or upon receipt of a request pursuant to
paragraph (7), shall periodically, though not less than
annually, review and, as appropriate, add entities to or remove
entities from 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 arguments 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 Government Reform of
the House of Representatives.
(ii) Information and argument in opposition
to designations.--Not later than 7 days after
receiving any information and arguments 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 Government
Reform of the House of Representatives.
(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.
(7) Removal requests.--If an entity on the list of
biotechnology companies of concern believes it no longer meets
the definition of a biotechnology company of concern as
described in paragraph (2), then it may provide information and
arguments to request removal from the list of biotechnology
companies of concern to the Director of the Office of
Management and Budget. The Director shall review such
information and reply to the entity within 90 days.
(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, but may include 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, the Committee on Homeland
Security and Governmental Affairs, the Committee on
Health, Education, Labor, and Pensions, the Committee
on Commerce, Science, and Transportation, and the
Committee on Foreign Relations 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
Government Reform, 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, 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 an 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--
(A) any contract subject to the Federal Acquisition
Regulation issued under section 1303(a)(1) of title 41,
United States Code; or
(B) any transaction (other than a contract, a
grant, or a cooperative agreement) entered into under
section 4021 of title 10, 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(f) 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.
(l) Compliance With Limitation on Drug Prices.--For the purposes of
section 1927(a)(1) of the Social Security Act (42 U.S.C. 1396r-
8(a)(1)), a manufacturer is deemed to meet the requirements of section
8126 of title 38, United States Code, including the requirement of
entering into a master agreement with the Secretary of Veterans Affairs
under such section, if the Secretary of Veterans Affairs determines
that the manufacturer would comply (and has offered to comply) with the
provisions of section 8126 of title 38, United States Code, and would
have entered into a master agreement under such section, but for the
prohibitions under subsections (a) and (b) of this section.
<all>