[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 3411 Introduced in Senate (IS)]
<DOC>
118th CONGRESS
1st Session
S. 3411
To prohibit contracting with certain biotechnology providers.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
December 5, 2023
Mr. Peters 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 ``Safeguarding American Genetic Data
Act of 2023''.
SEC. 2. PROHIBITION ON CONTRACTING WITH CERTAIN BIOTECHNOLOGY
PROVIDERS.
(a) Designation of Federal Entity.--Not later than 30 days after
the date of the enactment of this Act, the President shall designate a
Federal entity (in this section referred to as the ``Federal entity'')
to establish guidance to ensure that Executive agencies do not directly
procure or obtain any covered biotechnology equipment or service. The
Federal entity, the head of which shall be the Director of the Office
of Management and Budget, shall include 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 heads
of other appropriate Federal agencies as identified by the President.
(b) Policy, Guidance, and Regulations.--
(1) Recommendations.--Not later than one year after the
date of the enactment of this Act, the Federal entity, in
coordination with the Federal Acquisition Regulatory Council
and other heads of Executive agencies as determined appropriate
by the President, shall issue guidance and recommend the
establishment of policy and regulations, as necessary, to
implement the requirements of this section.
(2) OMB policy.--Not later than 180 days after the date of
issuance of recommendations under paragraph (1), the Director
of the Office of Management and Budget shall issue any policy
necessary to effectuate the recommendations.
(3) Federal acquisition regulation.--Not later than one
year after the date of issuance of recommendations under
paragraph (1), the Federal Acquisition Regulatory Council shall
revise the Federal Acquisition Regulation as necessary to
implement the requirements of this section.
(4) Effective date.--Any prohibition included in the
guidance established by the Federal entity in accordance with
paragraph (1) shall take effect not later than one year after
the establishment of such guidance.
(c) Rule of Construction.--Nothing in this section shall be
construed--
(1) to require any covered biotechnology equipment or
service in use or resident in equipment, systems, or services
as of the day before the applicable effective date specified in
subsection (b)(4) to be removed or replaced; or
(2) to prohibit or limit the utilization of such covered
biotechnology equipment or service throughout the lifecycle of
such existing equipment.
(d) Exceptions.--Any prohibition included in the guidance
established by the Federal entity under subsection (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 defense or intelligence
activities of the United States Government;
(2) health care services and related equipment and supplies
for--
(A) employees of the United States Government,
including members of the uniformed services (as that
term is 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
outside of the continental United States; 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 official duty stations are
located overseas or are on permissive temporary
duty travel outside of the continental United
States.
(3) the acquisition, use, or distribution of multiomic
data, however compiled, that is commercially or publicly
available.
(e) Waiver Authorities.--
(1) In general.--The policy, guidance, and regulations
established under subsection (b) shall allow the head of an
Executive agency to waive any prohibition implemented in
connection with such guidance on a case-by-case basis after
consultation with the Federal entity.
(2) Duration.--
(A) In general.--Except as provided in subparagraph
(B), a waiver granted under paragraph (1) shall last
for a period of not more than one year.
(B) Extension.--The head of an Executive agency may
extend a waiver granted to an Executive agency under
paragraph (1) 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
Executive agency submits to the appropriate
congressional committees a notification of such waiver
not later than 30 days after granting the waiver.
(f) Determination of Certain Biotechnology Entities.--
(1) In general.--Not later than 180 days after the date of
the enactment of this Act, the Federal entity shall develop a
list of entities determined to be a biotechnology company of
concern. The Federal entity shall define a biotechnology
company of concern as any entity that--
(A) is subject to the jurisdiction, direction,
control, or operates on behalf of the government of a
foreign adversary;
(B) is to any extent involved in the manufacturing,
distribution, provision, or procurement of
biotechnology equipment or services; and
(C) 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
biotechnology equipment or services without
expressed and informed consent.
(2) Updates.--The Federal entity shall periodically, but
not less than annually, review and, as appropriate, modify the
list of biotechnology companies of concern.
(g) Evaluation of Certain Biotechnology Entities.--Not later than
180 days after the date of the enactment of this Act, the Federal
entity shall determine whether BGI, MGI, Complete Genomics, and any
subsidiary, affiliate, or successor of such entities, are biotechnology
companies of concern. If any such entities, subsidiaries, affiliates,
or successors are identified as biotechnology companies of concern, no
Executive agency shall directly procure or obtain any biotechnology
equipment or services from such entities, subsidiaries, affiliates, or
successors. The Director of the Office of Management and Budget shall
issue such policy, and the Federal Acquisition Regulatory Council shall
promulgate such regulations, as may be necessary to effectuate this
prohibition.
(h) Analysis, Assessment, and Strategy.--Not later than 180 days
after developing the list of entities under subsection (f)(1) and the
determination of entities under subsection (g), the Federal entity, to
the greatest extent practicable, leveraging relevant previous analyses
and assessments, shall--
(1) conduct an analysis of the list of entities identified
under subsections (f)(1) and (g), including--
(A) active Federal grants to or contracts with
private companies, academic institutions, and public
sector entities, including--
(i) the number and type of covered
biotechnology equipment or services already or
expected to be procured;
(ii) the anticipated lifespan of covered
biotechnology equipment or services already or
expected to be procured;
(iii) the estimated costs and timeline to
replace covered biotechnology equipment or
services already procured; and
(B) the domestic and international market share;
(2) assess risks to national security posed by the entities
identified under subsections (f)(1) and (g), obtaining active
and future Federal grants to or contracts with private
companies, academic institutions, and public sector entities;
(3) develop a strategy to--
(A) mitigate the risks to national security
identified in the assessment conducted under paragraph
(2); and
(B) support private companies, academic
institutions, and public sector entities seeking to
acquire covered biotechnology equipment or services
from alternative entities; and
(4) provide the results of the analysis, assessment, and
strategy developed under this subsection to the Federal
Acquisition Regulatory Council and the appropriate
congressional committees.
(i) Report Requirement.--
(1) In general.--Not later than 180 days after the date of
the enactment of this Act, the Federal entity shall submit to
the Federal Acquisition Regulatory Council and the appropriate
congressional committees a report including the following:
(A) The name of and justification for each entity
meeting the criteria for a biotechnology company of
concern under subsections (f)(1) and (g).
(B) A catalog of all active or planned grants or
contracts any Executive agency has with any entity
determined to be a biotechnology company of concern
related to biotechnology equipment or services.
(C) Recommendations, as applicable, on alternative
entities to a biotechnology company of concern capable
of providing the Federal Government with required
biotechnology equipment or services.
(D) Recommendations, as applicable, on the
feasibility of implementing prohibitions implemented in
connection with the guidance established under
subsection (b) or exercising waiver authorities under
subsection (e), to ensure uninterrupted Federal
Government access to required biotechnology equipment
and services, and any further changes to legislation
needed to mitigate supply chain risks or increase
availability and enhance capabilities of biotechnology
equipment and services.
(2) Form.--The report required under paragraph (1) shall be
in unclassified form accompanied by a classified annex.
(j) Definitions.--In this section:
(1) Appropriate congressional committees.--The term
``appropriate congressional committees'' means--
(A) the Committee on Armed Services, the Committee
on Commerce, Science, and Transportation, the Committee
on Foreign Relations, the Committee on Health,
Education, Labor, and Pensions, 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 provided by a biotechnology company of
concern with respect to the use or
implementation of an instrument, apparatus,
machine, or device described in subparagraph
(A); or
(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 entity determines
appropriate.
(3) Control.--The term ``control'' has the meaning given
the term in section 800.208 of title 31, Code of Federal
Regulations, or any successor regulations.
(4) 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.
(5) Executive agency.--The term ``Executive agency'' has
the meaning given the term 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.
<all>