[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 3558 Reported in Senate (RS)]
<DOC>
Calendar No. 521
118th CONGRESS
2d Session
S. 3558
[Report No. 118-229]
To prohibit contracting with certain biotechnology providers, and for
other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
December 20, 2023
Mr. Peters (for himself, Mr. Hagerty, Mr. Romney, Mr. Marshall, Mr.
Lankford, Mr. Scott of Florida, Mr. Hawley, Mr. Warner, Mr. Rubio, Mrs.
Britt, and Mr. Hoeven) introduced the following bill; which was read
twice and referred to the Committee on Homeland Security and
Governmental Affairs
September 23, 2024
Reported by Mr. Peters, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
A BILL
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,
<DELETED>SECTION 1. PROHIBITION ON CONTRACTING WITH CERTAIN
BIOTECHNOLOGY PROVIDERS.</DELETED>
<DELETED> (a) In General.--The head of an executive agency may not--
</DELETED>
<DELETED> (1) procure or obtain any biotechnology equipment
or service produced or provided by a biotechnology company of
concern; or</DELETED>
<DELETED> (2) enter into a contract or extend or renew a
contract with any entity that--</DELETED>
<DELETED> (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; or</DELETED>
<DELETED> (B) enters into any contract the
performance of which will require the direct 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).</DELETED>
<DELETED> (b) Prohibition on Loan and Grant Funds.--The head of an
executive agency may not obligate or expend loan or grant funds to--
</DELETED>
<DELETED> (1) procure or obtain any biotechnology equipment
or services produced or provided by a biotechnology company of
concern; or</DELETED>
<DELETED> (2) enter into a contract or extend or renew a
contract with an entity described in subsection
(a)(2).</DELETED>
<DELETED> (c) Effective Dates.--</DELETED>
<DELETED> (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 implementing
guidance in subsection (f)(3) or the expiration of the deadline
set forth in subsection (f)(3), whichever occurs
first.</DELETED>
<DELETED> (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 implementing
guidance in subsection (f)(3).</DELETED>
<DELETED> (d) Waiver Authorities.--</DELETED>
<DELETED> (1) Specific biotechnology exception.--</DELETED>
<DELETED> (A) Waiver.--The head of an executive
agency may waive the prohibition under subsection (a)
and (b) on a case-by-case basis--</DELETED>
<DELETED> (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</DELETED>
<DELETED> (ii) if such head submits a
notification and justification to the
appropriate congressional committees not later
than 30 days after granting such
waiver.</DELETED>
<DELETED> (B) Duration.--</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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--</DELETED>
<DELETED> (A) if the head of such executive agency
determines that the waiver is--</DELETED>
<DELETED> (i) necessary to support the
mission or activities of the employees of such
executive agency described in subsection
(e)(2)(A); and</DELETED>
<DELETED> (ii) in the interest of the United
States;</DELETED>
<DELETED> (B) 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</DELETED>
<DELETED> (C) if such head submits a notification
and justification to the appropriate congressional
committees not later than 30 days after granting such
waiver.</DELETED>
<DELETED> (e) Exceptions.--The prohibitions under subsections (a)
and (b) shall not apply to--</DELETED>
<DELETED> (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;</DELETED>
<DELETED> (2) the acquisition or provision of health care
services overseas for--</DELETED>
<DELETED> (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</DELETED>
<DELETED> (B) employees of contractors or
subcontractors of the United States--</DELETED>
<DELETED> (i) who are performing under a
contract that directly supports the missions or
activities of individuals described in
subparagraph (A); and</DELETED>
<DELETED> (ii) whose primary duty stations
are located overseas or are on permissive
temporary duty travel overseas; or</DELETED>
<DELETED> (3) the acquisition, use, or distribution of human
multiomic data, however compiled, that is commercially or
publicly available.</DELETED>
<DELETED> (f) Evaluation of Certain Biotechnology Entities.--
</DELETED>
<DELETED> (1) Entity consideration.--Not later than 120 days
after the date of the enactment of this Act, the Director of
the Office of Management and Budget, in consultation 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, and the Secretary of State, shall develop a list of
the entities that constitute biotechnology companies of
concern.</DELETED>
<DELETED> (2) Biotechnology companies of concern defined.--
The term ``biotechnology company of concern'' means--</DELETED>
<DELETED> (A) BGI, MGI, Complete Genomics, Wuxi
Apptec, and any subsidiary, parent affiliate, or
successor of such entities; and</DELETED>
<DELETED> (B) any entity that--</DELETED>
<DELETED> (i) is subject to the
jurisdiction, direction, control, or operates
on behalf of the government of a foreign
adversary;</DELETED>
<DELETED> (ii) is to any extent involved in
the manufacturing, distribution, provision, or
procurement of a biotechnology equipment or
service; and</DELETED>
<DELETED> (iii) poses a risk to the national
security of the United States based on--
</DELETED>
<DELETED> (I) engaging in joint
research with, being supported by, or
being affiliated with a foreign
adversary's military, internal security
forces, or intelligence
agencies;</DELETED>
<DELETED> (II) providing multiomic
data obtained via biotechnology
equipment or services to the government
of a foreign adversary; or</DELETED>
<DELETED> (III) obtaining human
multiomic data via the biotechnology
equipment or services without express
and informed consent.</DELETED>
<DELETED> (3) Guidance.--Not later than 120 days after the
date of the enactment of this Act, the Director of the Office
of Management and Budget, in consultation 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, and
the Secretary of State, shall establish guidance necessary to
implement the requirements of this section.</DELETED>
<DELETED> (4) Updates.--The Director of the Office of
Management and Budget, in consultation 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, and
the Secretary of State, shall periodically, though not less
than annually, review and, as appropriate, make a determination
to modify the list of biotechnology companies of
concern.</DELETED>
<DELETED> (g) Regulations.--Not later than one year after the date
of establishment of guidance required under subsection (f)(3), the
Federal Acquisition Regulatory Council shall revise the Federal
Acquisition Regulation as necessary to implement the requirements of
this section.</DELETED>
<DELETED> (h) No Additional Funds.--No additional funds are
authorized to be appropriated for the purpose of carrying out this
section.</DELETED>
<DELETED> (i) Definitions.--In this section:</DELETED>
<DELETED> (1) Appropriate congressional committees.--The
term ``appropriate congressional committees'' means--</DELETED>
<DELETED> (A) the Committee on Armed Services and
the Committee on Homeland Security and Governmental
Affairs of the Senate; and</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (2) Biotechnology equipment or service.--The term
``biotechnology equipment or service'' means--</DELETED>
<DELETED> (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;</DELETED>
<DELETED> (B) any service for the research,
development, production, analysis, detection, or
provision of information, including data storage and
transmission related to biological materials,
including--</DELETED>
<DELETED> (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</DELETED>
<DELETED> (ii) disease detection,
genealogical information, and related services;
and</DELETED>
<DELETED> (C) any other service, instrument,
apparatus, machine, component, accessory, device,
software, or firmware 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.</DELETED>
<DELETED> (3) 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.</DELETED>
<DELETED> (4) Executive agency.--The term ``executive
agency'' has the meaning given the term ``Executive agency'' in
section 105 of title 5, United States Code.</DELETED>
<DELETED> (5) Foreign adversary.--The term ``foreign
adversary'' has the meaning given the term ``covered nation''
in section 4872(d) of title 10, United States Code.</DELETED>
<DELETED> (6) Multiomic.--The term ``multiomic'' means data
types that include genomics, epigenomics, transcriptomics,
proteomics, and metabolomics.</DELETED>
<DELETED> (7) 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.</DELETED>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Prohibiting Foreign Access to
American Genetic Information Act of 2024''.
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 or obtain 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 implementing guidance in
subsection (f)(3) or the expiration of the deadline set forth
in subsection (f)(3), whichever occurs first.
(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 implementing guidance in
subsection (f)(3) or the expiration of the deadline set forth
in subsection (f)(3), whichever occurs first.
(3) Rules of construction.--
(A) Certain entities.--With respect to
biotechnology companies of concern covered by
subsection (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
entered into before the effective date under subsection
(c)(1).
(B) Other entities.--With respect to the
biotechnology companies of concern covered by
subsection (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
entered into before the effective date under subsection
(c)(2).
(d) Waiver Authorities.--
(1) Specific biotechnology exception.--
(A) Waiver.--The head of the applicable executive
agency may waive the prohibition 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 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 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 Acquisition Security 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 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 120 days after
the date of the enactment of this Act, the Director of the
Office of Management and Budget, in consultation 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, and the Secretary of State, shall develop a list of
the entities that constitute biotechnology companies of
concern.
(2) Biotechnology companies of concern defined.--The term
``biotechnology company of concern'' means--
(A) BGI, MGI, Complete Genomics, WuXi AppTec, and
any subsidiary, parent affiliate, or successor of such
entities; and
(B) any entity that--
(i) is subject to the jurisdiction,
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.
(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 consultation 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, and the Secretary of State, shall establish guidance
necessary to implement the requirements of this section.
(4) Updates.--The Director of the Office of Management and
Budget, in consultation 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, and the
Secretary of State, 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 subparagraph (B)
of paragraph (2) shall be issued to any source 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 source 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
source 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 subparagraph
(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, and the Secretary of State, 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), the Federal
Acquisition Regulatory Council shall revise the Federal Acquisition
Regulation as necessary to implement the requirements of this section.
(i) No Additional Funds.--No additional funds are authorized to be
appropriated for the purpose of carrying out this section.
(j) 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.
(k) 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 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 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 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.
(3) 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.
(4) Executive agency.--The term ``executive agency'' has
the meaning given the term ``Executive agency'' in section 105
of title 5, United States Code.
(5) Foreign adversary.--The term ``foreign adversary'' has
the meaning given the term ``covered nation'' in section
4872(d) of title 10, United States Code.
(6) Multiomic.--The term ``multiomic'' means data types
that include genomics, epigenomics, transcriptomics,
proteomics, and metabolomics.
(7) 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.
Calendar No. 521
118th CONGRESS
2d Session
S. 3558
[Report No. 118-229]
_______________________________________________________________________
A BILL
To prohibit contracting with certain biotechnology providers, and for
other purposes.
_______________________________________________________________________
September 23, 2024
Reported with an amendment