[Senate Report 118-264]
[From the U.S. Government Publishing Office]
Calendar No. 667
118th Congress } { Report
SENATE
2d Session } { 118-264
_______________________________________________________________________
RISKY RESEARCH REVIEW ACT
__________
R E P O R T
of the
COMMITTEE ON HOMELAND SECURITY AND
GOVERNMENTAL AFFAIRS
UNITED STATES SENATE
to accompany
S. 4667
TO AMEND TITLE 31, UNITED STATES CODE, TO
ESTABLISH THE LIFE SCIENCES RESEARCH SECURITY
BOARD, AND FOR OTHER PURPOSES
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
December 5, 2024.--Ordered to be printed
_______
U.S. GOVERNMENT PUBLISHING OFFICE
59-010 WASHINGTON : 2025
COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
GARY C. PETERS, Michigan, Chairman
THOMAS R. CARPER, Delaware RAND PAUL, Kentucky
MAGGIE HASSAN, New Hampshire RON JOHNSON, Wisconsin
KYRSTEN SINEMA, Arizona JAMES LANKFORD, Oklahoma
JACKY ROSEN, Nevada MITT ROMNEY, Utah
JON OSSOFF, Georgia RICK SCOTT, Florida
RICHARD BLUMENTHAL, Connecticut JOSH HAWLEY, Missouri
LAPHONZA R. BUTLER, California ROGER MARSHALL, Kansas
David M. Weinberg, Staff Director
Alan S. Kahn, Chief Counsel
Christopher J. Mulkins, Director of Homeland Security
Sapana R. Vora, Senior Professional Staff Member
William E. Henderson III, Minority Staff Director
Christina N. Salazar, Minority Chief Counsel
Andrew J. Hopkins, Minority Counsel
Megan M. Krynen, Minority Professional Staff Member
Laura W. Kilbride, Chief Clerk
Calendar No. 667
118th Congress } { Report
SENATE
2d Session } { 118-264
======================================================================
RISKY RESEARCH REVIEW ACT
_______
December 5, 2024.--Ordered to be printed
_______
Mr. Peters, from the Committee on Homeland Security and Governmental
Affairs, submitted the following
R E P O R T
[To accompany S. 4667]
[Including cost estimate of the Congressional Budget Office]
The Committee on Homeland Security and Governmental
Affairs, to which was referred the bill (S. 4667) to amend
title 31, United States Code, to establish the Life Sciences
Research Security Board, and for other purposes, having
considered the same, reports favorably thereon with an
amendment, in the nature of a substitute, and recommends that
the bill, as amended, do pass.
CONTENTS
Page
I. Purpose and Summary.............................................. 1
II. Background and Need for the Legislation.......................... 2
III. Legislative History.............................................. 4
IV. Section-by-Section Analysis of the Bill, as Reported............. 5
V. Evaluation of Regulatory Impact.................................. 7
VI. Congressional Budget Office Cost Estimate........................ 7
VII. Changes in Existing Law Made by the Bill, as Reported............ 8
I. Purpose and Summary
S. 4667, the Risky Research Review Act establishes the
`Life Sciences Research Security Board' as an independent
agency in the Executive branch to review proposed Federal
funding for life sciences research. The bill requires the
President to appoint nine individuals to serve on the Board for
not more than two terms of four years each. The nine
individuals must be comprised of: one Executive Director, five
nongovernmental scientists in a life sciences field, two
nongovernmental national security experts, and one
nongovernmental biosafety expert. The Risky Research Review Act
tasks the Board with issuing an independent determination as to
whether a federal agency may award federal funding for proposed
high-risk life sciences research and makes that determination
binding on the relevant federal agency. The bill also requires
the Comptroller General of the United States to periodically
audit the board and requires each Board member to file
disclosure reports.
II. Background and Need for the Legislation
Under current law, there is no government-wide independent
oversight mechanism for monitoring federal funding of high-risk
life sciences research, despite its potential to cause a public
health or national security catastrophe.
There has been a debate on the risks and benefits of gain-
of-function research since 2011 following the publication of
several NIH funded studies on the avian influenza virus
H5N1.\1\ In response, the U.S. government issued a pause on
federal funding for ``Gain-of-Function'' (GOF) research in
October 2014.\2\ The 2014 pause only applied to new, federally
funded research. In addition to pausing all new funding for
potential GOF research, the National Institutes of Health (NIH)
asked existing, NIH-funded researchers to voluntarily pause and
review their research.
---------------------------------------------------------------------------
\1\Todd Kuiken, Global Pandemics: Gain-of-Function Research of
Concern, CONG. RSCH. SERV., IF12021, at 1 (2022), https://www.crs.gov/
Reports/IF12021?source=search.
\2\ Todd Kuiken, Global Pandemics: Gain-of-Function Research of
Concern, CONG. RSCH. SERV., IF12021, at 1 (2022), https://www.crs.gov/
Reports/IF12021?source=search.
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In January 2017, the White House Office of Science and
Technology Policy (OSTP) released guidance to agencies that
would enable them to lift the funding pause on GOF research.\3\
In December 2017, the Department of Health and Human Services
(HHS) adopted the Framework for Guiding Funding Decisions about
Proposed Research Involving Enhanced Potential Pandemic
Pathogens (P3CO), which lifted the 2014 GOF research funding
pause only for HHS.\4\ The HHS P3CO Framework establishes a
pre-funding departmental-level review process for research
proposals reasonably anticipated to create, transfer, or use
enhanced potential pandemic pathogens (ePPP).\5\ Following
review of proposed ePPP research activity, the departmental
review group makes a nonbinding recommendation to the relevant
HHS funding entity, which the HHS funding entity considers in
deciding whether to fund the research. As of November 2024,
under the HHS P3CO Framework, only four research projects have
undergone review: two of which were not funded, and two were
granted waivers with the justification that no alternative
research methods were feasible to achieve project aims.\6\
---------------------------------------------------------------------------
\3\Recommended Policy Guidance for Potential Pandemic Pathogen Care
and Oversight, White House OSTP (Jan. 9, 2017),
obamawhitehouse.archives.gov/blog/2017/01/09/recommended-policy-
guidance-potential-pandemic-pathogen-care-and-oversight.
\4\Framework for Guiding Funding Decisions about Proposed Research
Involving Enhanced Potential Pandemic Pathogens, U.S. Dept. Health &
Human Servs. (Dec. 19, 2017), www.phe.gov/s3/dualuse/Documents/
P3CO.pdf.
\5\Id. at 4.
\6\Research Reviewed Under the HHS P3CO Framework, S3: Science
Safety Security (last accessed Oct. 28, 2024), https://aspr.hhs.gov/S3/
Pages/Research-Reviewed-Under-the-HHS-P3CO-Framework.aspx.
---------------------------------------------------------------------------
In 2014, prior to the GOF pause, the NIH awarded grant
funding to EcoHealth Alliance for a project, ``Understanding
the Risk of Bat Coronavirus Emergence,'' which was meant to
study the risk of bat coronavirus spillover to humans. When the
GOF pause went into effect, the NIH sent a notice to EcoHealth
Alliance that some of the proposed experiments may be subject
to the GOF pause.\7\ NIH ultimately determined that the project
was not subject to the pause and continued to fund the
research.
---------------------------------------------------------------------------
\7\Action Referral Memorandum from the United States Department of
Health and Human Services for the Wuhan Institute of Virology (July 17,
2023), oversight.house.gov/wp-content/uploads/2023/07/Notice-Memo.pdf.
---------------------------------------------------------------------------
Through its grant, EcoHealth Alliance provided subawards to
several recipients, including the Wuhan Institute of Virology
(WIV).\8\ Subsequent Executive Branch investigations revealed
that EcoHealth Alliance violated NIH grant rules, filed
progress reports more than two years late, and misrepresented
the risks of experiments conducted through its subaward to
WIV.\9\ EcoHealth Alliance failed to ``adequately monitor the
virus growth in [Wuhan Institute of Virology's] experiments,''
and did so with little to no institutional oversight as NIH did
not undertake any corrective actions for research that produced
results exceeding limits set by NIH.\10\ As a result, on May
15, 2024, HHS suspended and proposed for debarment EcoHealth
Alliance, Inc. from participating in U.S. Federal Government
procurement and nonprocurement programs.
---------------------------------------------------------------------------
\8\Federal Research: NIH Could Take Additional Actions to Manage
Risks Involving Foreign Subrecipients, GAO (June 2023), www.gao.gov/
assets/gao-23-106119.pdf.
\9\Letter from Henrietta K. Brisbon to Peter Daszak (May 15, 2024),
https://oversight.house.gov/wp-content/uploads/2024/05/Tab-1-EHA-
SUSP4D-Notice_5.15.2024_signed.pdf.
\10\Sharon Lerner & Mara Hvistendahl, NIH Officials Worked with
EcoHealth Alliance to Evade Restrictions on Coronavirus Experiments,
The Intercept (Nov. 3, 2021), https://theintercept.com/2021/11/03/
coronavirus-research-ecohealth-nih-emails/.; Action Referral Memorandum
from the United States Department of Health and Human Services for the
Wuhan Institute of Virology (July 17, 2023), oversight.house.gov/wp-
content/uploads/2023/07/Notice-Memo.pdf.
---------------------------------------------------------------------------
A 2023 Government Accountability Office (GAO) report on HHS
oversight of research involving potential pandemic pathogens
found that the departmental review group can only review
research referred to it by a funding agency, and there are
unclear standards for such referrals. Additionally, GAO
identified the organization conducting oversight should have
the ability to perform reviews, including the working knowledge
necessary to review compliance with requirements. GAO also
found that HHS lacks transparency regarding the composition of
the departmental review group as HHS does not publicly share
the qualifications or expertise of those involved in the review
process.\11\ Furthermore, biosafety experts have criticized the
HHS P3CO Framework as being overly narrow in scope by setting
the bar too high for the types of anticipated risks that merit
additional scrutiny.\12\ Although the 2024 OSTP policy
regarding high-risk life sciences research expands the types of
experiments that must be subject to additional agency
oversight, this policy is nonbinding and allows agencies that
fund life sciences research to make the final determination of
what constitutes high-risk life sciences research.\13\
Moreover, the policy authorizes the head of the agency to waive
the additional agency oversight in certain circumstances.\14\
It also lacks robust mechanisms to ensure congressional
oversight and public transparency.
---------------------------------------------------------------------------
\11\Public Health Preparedness: HHS Could Improve Oversight of
Research Involving Enhanced Potential Pandemic Pathogens, GAO (Jan.
2023), https://www.gao.gov/assets/d23105455.pdf.
\12\Lynn Klotz and Gregory D. Koblentz, New pathogen research
rules: Gain of function, loss of clarity, the Bulletin of the Atomic
Scientists (February 26, 2018).
\13\White House Office of Science and Technology Policy, United
States Government Policy for Oversight of Dual Use Research of Concern
and Pathogens with Enhanced Pandemic Potential (May 6, 2024).
\14\White House Office of Science and Technology Policy, United
States Government Policy for Oversight of Dual Use Research of Concern
and Pathogens with Enhanced Pandemic Potential (May 6, 2024).
---------------------------------------------------------------------------
HHS is only one of several federal agencies that conduct
research with potential pandemic pathogens.\15\ On June 20,
2024, the Department of Defense (DoD) Inspector General
identified numerous DoD awards to entities in China and other
foreign countries that involve pathogens of pandemic potential.
Although the DoD IG found that none of the awards it reviewed
involved pathogen enhancement, the full extent of DoD funds
provided to foreign countries for research related to
enhancement of pathogens of pandemic potential is unknown due
to limitations in the DoD's systems used to track contracts and
grants.\16\
---------------------------------------------------------------------------
\15\U.S. Department of Defense, Office of Inspector General, Report
No. DODIG-2024-099, ``Audit of the Department of Defense's
Cybersecurity Practices'' (June 18, 2024), available at https://
media.defense.gov/2024/Jun/20/2003488653/-1/-1/1/DODIG-2024-
099_SECURED.PDF.
\16\U.S. Department of Defense, Office of Inspector General, Report
No. DODIG-2024-099, ``Audit of the Department of Defense's
Cybersecurity Practices'' (June 18, 2024), available at https://
media.defense.gov/2024/Jun/20/2003488653/-1/-1/1/DODIG-2024-
099_SECURED.PDF.
---------------------------------------------------------------------------
S. 4667 increases oversight of high-risk life sciences
research by establishing an independent entity within the
Executive Branch responsible for reviewing and approving
federal funding for high-risk life sciences research to
safeguard public health, safety, and national security.
III. Legislative History
Senator Rand Paul (R-KY) introduced S. 4667, the Risky
Research Review Act, on July 10, 2024. The bill was referred to
the Committee on Homeland Security and Governmental Affairs.
The Committee considered S. 4667 at a business meeting on
September 25, 2024. At the business meeting, Senator Paul
offered a substitute amendment to the bill, as well as a
modification to the substitute amendment, on behalf of himself
and Senator Peters. The Paul-Peters substitute amendment, as
modified, updated definitions for `Dual Use Research of
Concern,' `Gain of Function Research,' and `High-Consequence
Pathogen.'. It also provides the Board with final determination
authority in regard to determining whether life sciences
research is high-risk life sciences research, dual use research
of concern involving a high-consequence pathogen, or gain of
function research.
The Committee adopted the modification to the Paul-Peters
substitute amendment, and the Paul-Peters substitute, by
unanimous consent with Senators Peters, Carper Hassan, Rosen,
Blumenthal, Butler, Paul, Lankford, and Hawley present. The
bill, as amended by the Peters-Paul substitute amendment, as
modified, was ordered reported favorably by roll call vote of 8
yeas to 1 nay, with Senators Peters, Carper, Hassan, Rosen,
Blumenthal, Paul, Lankford, and Hawley voting in the
affirmative, and Senator Butler voting in the negative.
Senators Sinema, Ossoff, Johnson, Romney, Scott, and Marshall
voted yea by proxy and for the record only.
IV. Section-by-Section Analysis of the Bill, as Reported
Section 1. Short title
Provides the Act may be cited as the ``Risky Research
Review Act.''
Section 2. Life Sciences Research Security Board
Subsection (a) amends Subtitle V of title 31, United States
Code by adding ``Chapter 79--Life Sciences Research Board'' and
Secs. 7901-7909, each is addressed below.
Section 7901 provides definitions for various terms used
throughout the Chapter, including `Agency,' `Appropriate
Congressional Committees,' `Board,' `Dual Use Research of
Concern,' `Employee,' `Federal Funding,' `Gain of Function
Research,' `High-Consequence Pathogen,' `High-Risk Life
Sciences Research,' `Life Sciences Research,' and `Select Agent
or Toxin.'
Section 7902 establishes the `Life Sciences Research
Security Board' as an independent agency within the Executive
Branch to review Federal funding for life sciences research. It
further defines the appointment of members, including who is
eligible to serve on the board, their qualifications,
limitations on members, the process for filling vacancies, and
the process for removing a member.
Section 7903 clarifies the roles, capabilities,
qualifications, and procedure associated with Board personnel
and their staff. This includes describing the appointment
procedure for the Executive Director of the Board, as well as
the Executive Director's qualifications. It further requires
the head of each Federal agency to designate at least one full-
time employee of the agency as the agency's representative to
provide technical assistance to and support the review process
of the Board. It goes on to give the Board compensation
authority for staff.
Section 7904 provides for the mission and functions of the
Board to provide Federal funding for high-risk life sciences
research. It gives the Board's authority to carry out such
determinations. It also describes the initial requirements
where the board shall, no later than 180 days after the date of
appointment of initial member, publish procedures in the
Federal Register for the review process. The board must consult
with the appropriate congressional committees and heads of
agencies; and no later than 270 days after enactment, begin
carrying out its prescribed duties. Next, it mandates the Board
respond within 30 days to a Member of Congress's request for
information and requires the board brief the appropriate
congressional committee. Finally, it gives the Board authority
to determine any dispute with an agency or entity related to
life science research classifications.
Section 7905 provides for agency procedures prior and
subsequent to the Board's ruling on federal funding for life
sciences research. It also clarifies the procedure for referral
to the Board. It describes that the head of an agency may not
award federal funding for high-risk life science research
without board approval. This section provides an attestation,
disclosure, and certification requirement, and requires an
entity seeking Federal funding from the agency to disclose the
source of funding for all active research. It also provides
that within thirty days before the head of an agency awards
Federal funding to an entity for life sciences research, the
agency submits a notification to the Board, which shall include
the required attestation and certifications. The Board can
request additional information from the head of an agency
relating to this notification, which shall be provided by the
agency head in a timely manner. It further requires the head of
each agency publish prepayment and pre-award procedures with
respect to life science research funding on its website. It
requires agencies to provide additional information related to
funding of life science research when requested by the Board.
This section also provides that if circumstances arise such
that life sciences research in progress may constitute high-
risk life sciences research after funding approval, the
relevant entity shall, within 24 hours, pause the research and
submit written and detailed notification to the agency head
within 5 days. The head of the relevant agency will then decide
whether the life sciences research in progress constitutes
high-risk life sciences research, in accordance with Board
procedure. Next it provides that if an entity knowingly fails
to make true attestation or promptly notify the agency of a
change in circumstance, the agency shall refer the entity for
suspension and debarment proceedings. Finally, it provides the
subaward and subcontractor disclosure requirements for entities
engaged in high-risk life sciences research with federal
funding.
Section 7906 provides the procedure and criteria for Board
review of high-risk life sciences research. It establishes that
the Board shall, within 120 days after being notified of
research that constitutes high-risk life sciences research,
review, vote, and determine whether the proposed Federal
funding may be awarded or continued to be awarded. By a
majority vote the Board shall also determine the minimum
biosafety containment level, biosecurity engineering controls
and operational controls, and personnel assurance controls. It
further provides the Board with factors for consideration when
determining whether an entity will receive or continue to
receive Federal funding for high-risk life sciences research
already in progress. It mandates that within 5 days of the
Board making a determination with respect to Federal funding by
an agency, the Executive Director of the Board will notify the
head of the agency of the determination. No later than 10 days
after that notification, the head of the agency may request a
meeting with the Board to discuss the determination. If the
Board determines the head of an agency may not proceed with an
award, the Executive Director shall notify the appropriate
congressional committees. It creates an expedited review
process for `emergency research' of high-risk life sciences
related to a public health emergency or a specific national
security concern. This section also permits the Board to
establish a non-governmental panel of experts to advise the
Board in the review of life sciences research. Finally, it
mandates that the Board submit a report to appropriate
congressional committees including their findings,
determinations, entities proposing life sciences research, and
locations and names of subcontractors of entities proposing
life sciences research and for the Board to produce a public
version on its website.
Section 7907 requires the Comptroller General to conduct
periodic audits of the Board.
Section 7908 authorizes $30,000,000 for each fiscal years
2025 to 2034 to carry out its duties.
Subsection (b) includes clerical amendments to add Chapter
79--Life Sciences Research Security Board and its component
sections 7901 to 7908 as added by this act to subtitle V of
title 31 of the United States Code.
Subsection (c) requires Board members to provide financial
disclosures in accordance with title 5 of the U.S. Code.
V. Evaluation of Regulatory Impact
Pursuant to the requirements of paragraph 11(b) of rule
XXVI of the Standing Rules of the Senate, the Committee has
considered the regulatory impact of this bill and determined
that the bill will have no regulatory impact within the meaning
of the rules. The Committee agrees with [note the CBO has not
yet issued a cost estimate/regulatory impact assessment].
VI. Congressional Budget Office Cost Estimate
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
S. 4667 would establish the Life Sciences Research Security
Board as an independent executive branch agency to review and
approve federal funding requests for what is termed high-risk
life sciences research, which involves pathogens that are
particularly dangerous to humans. The board's members would be
appointed by the President and subject to Senate confirmation.
S. 4667 would require the board to receive funding
proposals from federal agencies for projects or grant programs
at least 30 days before a project or program is funded. Within
120 days, board members would be required to determine whether
a proposal involves high-risk life sciences research and, if
so, whether the project requires biosafety controls to proceed.
The board also could review and audit research projects using
federal funds awarded before the bill's enactment and could
direct such funding to be suspended.
S. 4667 would authorize $30 million in annual
appropriations to operate the board over the 2025-2034 period.
CBO estimates that the cost to implement the bill would be $293
million over the 2025-2034 period, assuming appropriation of
the authorized amounts. CBO expects that the costs of the
legislation, detailed in Table 1, would fall within budget
function 550 (health), but that determination will be made by
the Office of Management and Budget.
TABLE 1.--ESTIMATED SPENDING SUBJECT TO APPROPRIATION UNDER S. 4667
--------------------------------------------------------------------------------------------------------------------------------------------------------
By fiscal year, millions of dollars--
-------------------------------------------------------------------------------------------------
2025- 2025-
2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 2029 2034
--------------------------------------------------------------------------------------------------------------------------------------------------------
Authorization......................................... 30 30 30 30 30 30 30 30 30 30 150 300
Estimated Outlays..................................... 5 20 37 45 36 30 30 30 30 30 143 293
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The CBO staff contact for this estimate is Ryan Greenfield.
The estimate was reviewed by Chad Chirico, Director of Budget
Analysis.
Phillip L. Swagel,
Director, Congressional Budget Office.
VII. Changes in Existing Law Made by the Bill, as Reported
In compliance with paragraph 12 of rule XXVI of the
Standing Rules of the Senate, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in brackets, new matter is
printed in italic, and existing law in which no change is
proposed is shown in roman):
UNITED STATES CODE
* * * * * * *
TITLE 5--GOVERNMENT ORGANIZATION AND EMPLOYEES
* * * * * * *
Subtitle IV--Ethics Requirements
* * * * * * *
CHAPTER 131--ETHICS IN GOVERNMENT
* * * * * * *
Subchapter I--Financial Disclosure Requirements of Federal Personnel
* * * * * * *
SEC. 13103--PERSONS REQUIRED TO FILE
(a) * * *
(b) * * *
(c) * * *
(d) * * *
(e) * * *
(f) * * *
(1) * * *
(2) * * *
(3) * * *
(4) * * *
(5) * * *
(6) * * *
(7) * * *
(8) * * *
(9) * * *
(10) * * *
(11) a judicial officer as defined in section 13101
of this title; [and]
(12) a judicial employee as defined in section 13101
of this title[.] and;
(13) a member of the Life Sciences Research Security
Board established under section 7902 of title 31.
* * * * * * *
TITLE 31--MONEY AND FINANCE
* * * * * * *
Subtitle V--General Assistance Administration
* * * * * * *
CHAPTER 79--LIFE SCIENCES RESEARCH SECURITY BOARD
Section 7901. Definitions.
Section 7902. Establishment and membership.
Section 7903. Board personnel.
Section 7904. Board mission and functions.
Section 7905. Agency procedures; referral to Board.
Section 7906. Board review.
Section 7907. GAO Audits.
Section 7908. Funding.
* * * * * * *
SEC. 7901. DEFINITIONS
In this chapter:
(1) Agency.--The term `agency' has the meaning given
the term in section 552(f) of title 5.
(2) Appropriate congressional committees.--The term
`appropriate congressional committees' means the
Committee on Homeland Security and Governmental Affairs
of the Senate and the Committee on Oversight and
Accountability of the House of Representatives.
(3) Board.--The term `Board' means the Life Sciences
Research Security Board established under section
7902(a).
(4) Dual use research of concern.--The term `dual use
research of concern'--
(A) means life sciences research that, based
on current understanding, can be reasonably
anticipated to provide knowledge, information,
products, or technologies that could--
(i) be misapplied to do harm with no
modification or only a minor
modification; and
(ii) pose a significant threat with
potential consequences to public health
and safety, agricultural crops and
other plants, animals, materiel, or
national security; and
(B) includes--
(i) life sciences research that
could--
(I) increase transmissibility
of a pathogen within or between
host species;
(II) increase the virulence
of a pathogen or convey
virulence to a non-pathogen;
(III) increase the toxicity
of a known toxin or produce a
novel toxin;
(IV) increase--
(aa) the stability of
a pathogen or toxin in
the environment; or
(bb) the ability to
disseminate a pathogen
or toxin;
(V) alter the host range or
tropism of a pathogen or toxin;
(VI) decrease the ability for
a human or veterinary pathogen
or toxin to be detected using
standard diagnostic or
analytical methods;
(VII) increase resistance of
a pathogen or toxin to clinical
or veterinary prophylactic or
therapeutic interventions;
(VIII) alter a human or
veterinary pathogen or toxin to
disrupt the effectiveness of
pre-existing immunity, via
immunization or natural
infection, against the pathogen
or toxin;
(IX) enhance the
susceptibility of a host
population to a pathogen or
toxin;
(X) enhance transmissibility
of a pathogen in humans;
(XI) enhance the virulence of
a pathogen in humans;
(XII) enhance the immune
evasion of a pathogen in
humans, such as by modifying
the pathogen to disrupt the
effectiveness of pre-existing
immunity via immunization or
natural infection; or
(XIII) generate, use,
reconstitute, or transfer an
eradicated or extinct high-
consequence pathogen; and
(ii) any other category of life
sciences research that the Board, by
majority vote of the members of the
Board, identifies and publishes in the
Federal Register.
(5) Employee.--The term `employee' means an
individual described in section 2105(a) of title 5.
(6) Federal funding.--The term `Federal funding'
means amounts awarded by an agency pursuant to an
intramural or extramural grant, cooperative agreement,
interagency agreement, contract, or other instrument.
(7) Gain of function research.--The term `gain of
function research' means a research experiment that may
enhance the transmissibility or virulence of a high-
consequence pathogen.
(8) High consequence pathogen.--The term `high-
consequence pathogen'--
(A) means a wild-type or synthetic pathogen
that--
(i)(I) is likely capable of wide and
uncontrollable spread in human
populations; and
(II) would likely cause moderate to
severe disease or mortality in humans;
or
(ii) is--
(I) subject to subparagraph
(B), influenza A virus;
(II) classified under
subgenus Sarbecovirus;
(III) classified under
subgenus Merbecovirus;
(IV) Variola orthopoxvirus;
(V) Mpox orthopoxvirus;
(VI) Nipah henipavirus;
(VII) Hendra henipavirus;
(VIII) Ebola orthoebolavirus;
(IX) Marburg marburgvirus
(X) Lassa mammarenavirus;
(XI) Junin arenavirus;
(XII) Crimean-Congo
hemorrhagic fever
orthonairovirus;
(XIII) Hantaan
orthohantavirus;
(XIV) Sin Nombre
orthohantavirus;
(XV) Yersinia pestis;
(XVI) a select agent or
toxin, work with which poses a
significant risk of deliberate
misuse;
(XVII) any other pathogen or
category of pathogen that a
majority of members of the
Board--
(aa) identifies as a
high-consequence
pathogen; and
(bb) publishes in the
Federal Register; or
(XVIII) any synthetic
construct of a pathogen or
category of pathogen described
in this clause; and
(B) does not include a seasonal influenza
virus, unless a seasonal influenza virus has
been manipulated to include genetic sequences
from a pathogen described in subparagraph (A).
(9) High risk life sciences research.--The term
`high-risk life sciences research' means life sciences
research that is--
(A) dual use research of concern involving a
high-consequence pathogen; or
(B) gain of function research.
(10) Life sciences research.--The term `life sciences
research'--
(A) means the study or use of a living
organism, a virus, or a product of a living
organism or virus; and
(B) includes each discipline, methodology,
and application of biology, including
biotechnology, genomics, proteomics,
bioinformatics, and pharmaceutical and
biomedical research and techniques.
(11) Select agent or toxin.--The term `select agent
or toxin' means a select agent or toxin identified
under--
(A) section 73.3(b) of title 42, Code of
Federal Regulations, as in effect on the date
of enactment of the Risky Research Review Act;
(B) section 331.3(b) of title 7, Code of
Federal Regulations, as in effect on the date
of enactment of the Risky Research Review Act;
or
(C) section 121.3(b) of title 9, Code of
Federal Regulations, as in effect on the date
of enactment of the Risky Research Review Act.
SEC. 7902. ESTABLISHMENT AND MEMBERSHIP
(a) Establishment.--There is established as an independent
agency within the Executive Branch a board to be known as the
`Life Sciences Research Security Board' to review proposed
Federal funding for life sciences research in accordance with
section 7906.
(b) Appointment of Members.--
(1) In general.--The President shall appoint, without
regard to political affiliation, 9 individuals who are
citizens of the United States to serve as members of
the Board for not more than 2 terms of 4 years each,
including--
(A) the Executive Director appointed under
section 7903(a);
(B) 5 nongovernmental scientists in a life
sciences field;
(C) 2 nongovernmental national security
experts; and
(D) 1 nongovernmental biosafety expert.
(2) Period for nominations.--The President shall make
appointments, other than the Executive Director, to the
Board not later than 30 days after the date of
enactment of this chapter.
(3) Considerations of recommendations.--The President
shall make appointments to the Board after considering
individuals recommended by the chair and ranking member
of the appropriate congressional committees.
(4) Qualifications.--Individuals appointed to the
Board--
(A) shall--
(i) be impartial individuals;
and
(ii) be distinguished
individuals of high national
professional reputation in
their respective fields who are
capable of exercising the
independent and objective
judgment necessary to conduct
an impartial assessment of the
potential risks and benefits
associated with Federal funding
of high-risk life sciences
research to public health and
national security; and
(B) may not be an employee on the date of the
appointment or during the 3-year period
preceding the date of the appointment.
(5) Limitations.--Not more than 4 concurrent members
of the Board may be an employee, a subcontractor, a
previous employee, or a previous subcontractor of--
(A) the Department of Defense;
(B) the Department of Homeland Security;
(C) the National Institute of Allergy and
Infectious Diseases of the Department of Health
and Human Services;
(D) the Office of the Director of National
Intelligence; or
(E) the Department of Energy.
(6) Consideration by the senate.--
(A) In general.--Nominations for appointment
to the Executive Director of the Board shall be
referred to the Committee on Homeland Security
and Governmental Affairs of the Senate for
consideration.
(B) Renomination.--A member of the Board who
is recommended to serve a second term shall be
nominated for appointment to the Board, and
such nomination shall be referred pursuant to
subparagraph (A).
(7) Vacancy.--Not later than 30 days after the date
on which a vacancy on the Board occurs, the vacancy
shall be filled in the same manner as specified for the
original appointment.
(8) Removal.--
(A) In general.--No member of the Board shall
be removed from office, other than by--
(i) impeachment and conviction;
(ii) the action of the President for
inefficiency, neglect of duty,
malfeasance in office, physical
disability, mental incapacity, or any
other condition that substantially
impairs the performance of the member's
duties; or
(iii) the Board in accordance with
subparagraph (B).
(B) Action by board.--If the Director of the
Office of Government Ethics determines that
participation by a member of the Board in high-
risk life sciences research constitutes a
conflict of interest, the Board shall take
steps to mitigate or manage the conflict, which
may include removal.
(C) Notice of removal by president.--
(i) In general.--In the case of the
removal of a member of the Board by the
President as described in subparagraph
(A)(ii), not later than 10 days after
the removal, the President shall submit
to the chair and ranking member of the
appropriate congressional committees a
report specifying the facts found and
the grounds for removal.
(ii) Publication of report.--The
President shall publish in the Federal
Register each report submitted under
clause (i), except that the President
may, if necessary to protect the rights
of a person named in the report or to
prevent undue interference with any
pending prosecution, postpone or
refrain from publicly publishing any or
all of the report until the completion
of such pending cases or pursuant to
privacy protection requirements in law.
(c) Mandatory Conflicts of Interest Review.--
(1) In general.--The Board, in consultation with the
Director of the Office of Government Ethics, shall--
(A) not later than 180 days after the date of
the enactment of this chapter--
(i) establish criteria to determine
whether there is a conflict of interest
with respect to any individual
appointed to the Board, taking into
consideration requirements under
Federal law relating to ethics
requirements for employees; and
(ii) upon an appointment of a member to
the Board under subsection (a)(1)
thereafter, conduct a review of each
individual nominated and appointed to
the Board to ensure the individual does
not have any conflict of interest under
the criteria established pursuant to
clause (i); and
(B) periodically thereafter, conduct a review
of each individual nominated and appointed to
the Board to ensure the individual does not
have any conflict of interest under the
criteria established pursuant to subparagraph
(A)(i) during the term of service of the
individual.
(2) Notification.--
(A) In general.--Not later than 3 days after
the date on which the Director of the Office of
Government Ethics becomes aware that a member
of the Board possesses a potential conflict of
interest under the criteria established
pursuant to paragraph (1)(A)(i), the Director
of the Office of Government Ethics shall notify
the chair and ranking member of the appropriate
congressional committees of the potential
conflict of interest.
(B) Notification by member.--Not later than
30 days after the date on which a member of the
Board becomes aware that another member of the
Board possesses a potential conflict of
interest under the criteria established
pursuant to paragraph (1)(A)(i), the member of
the Board or the Executive Director of the
Board shall notify the chair and ranking member
of the appropriate congressional committees of
the potential conflict of interest.
(d) Security Clearances.--All members of the Board shall be
granted all the necessary security clearances and accesses,
including to relevant Presidential and department or agency
special access and compartmented access programs, in an
accelerated manner, subject to the standard procedures for
granting such clearances. All nominees for appointment to the
Board shall qualify for the necessary security clearances and
accesses prior to being considered for confirmation by the
Committee on Homeland Security and Governmental Affairs of the
Senate.
(e) Participation in High-Risk Life Sciences Research.--
(1) Disclosure required.--A member of the Board shall
disclose whether the member has participated in or is
currently participating in high-risk life sciences
research.
(2) Conflicts of interest.--
(A) In general.--The participation in high-
risk life sciences research by a member of the
Board--
(i) shall be considered a potential
conflict of interest; and
(ii) shall be subject to scrutiny by
the Director of the Office of
Government Ethics.
(B) Determination.--If the Director of the
Office of Government Ethics determines that
participation by a member of the Board in high-
risk life sciences research constitutes a
conflict of interest, the Board shall take
steps to mitigate or manage the conflict, which
may include--
(i) the recusal of the affected
member from relevant discussions and
determinations; and
(ii) removal of the affected member
from the Board.
(f) Compensation of Members.--
(1) In general.--Subject to such rules as may be
adopted by the Board, without regard to the provisions
of chapter 51 and subchapter III of chapter 53 of title
5 relating to classification and General Schedule pay
rates, a member of the Board, other than the Executive
Director, shall be compensated at a rate--
(A) proposed by the Executive Director and
approved by the Board;
(B) not to exceed the rate of basic pay for
level II of the Executive Schedule; and
(C) that is commensurate with--
(i) the time a member of the Board
spends engaged in the performance of
duties on the Board; and
(ii) necessary traveling expenses.
(2) Outside employment.--Subject to terms and
approval determined by the Director of the Office of
Government Ethics, a member of the Board may maintain
outside employment and affiliations while serving on
the Board.
(g) Oversight.--
(1) Senate.--The Committee on Homeland Security and
Governmental Affairs of the Senate shall--
(A) have continuing legislative oversight
jurisdiction in the Senate with respect to the
official conduct of the Board and agency
compliance with requirements issued by the
Board; and
(B) have access to any records provided to or
created by the Board.
(2) House of representatives.--The Committee on
Oversight and Accountability of the House of
Representatives shall--
(A) have continuing legislative oversight
jurisdiction in the House of Representatives
with respect to the official conduct of the
Board and agency compliance with requirements
issued by the Board; and
(B) have access to any records provided to or
created by the Board.
(3) Duty to cooperate.--The Board shall have the duty
to cooperate with the exercise of oversight
jurisdiction described in this subsection.
(4) Security clearances.--The chair and ranking
member of the appropriate congressional committees, and
designated committee staff, shall be granted all
security clearances and accesses held by the Board,
including to relevant Presidential and department or
agency special access and compartmented access
programs.
(h) Office Space.--
(1) In general.--In selecting office space for the
Board, the Board shall exhaust options for unused
office spaces owned by the Federal Government as of the
date of enactment of this chapter.
(2) Secure office space.--
(A) Requests.--In order to review or discuss
classified information, the Board shall request
an accommodation from relevant agencies to
access sensitive compartmented information
facilities on an as-needed basis.
(B) Fulfilment.--The head of an agency from
which the Board requests an accommodation under
subparagraph (A) shall accommodate the request
in a timely manner.
SEC. 7903. BOARD PERSONNEL
(a) Executive Director.--
(1) Appointment.--Not later than 45 days after the
date of enactment of this chapter, the President shall
appoint, by and with the advice and consent of the
Senate, 1 individual who is a citizen of the United
States, without regard to political affiliation, to the
position of Executive Director of the Board for a term
of 4 years.
(2) Qualifications.--The individual appointed as
Executive Director under paragraph (1) shall be a
private individual of integrity and impartiality who--
(A) is a distinguished scientist in a life
sciences field; and
(B) is not, and has not been for the 3-year
period preceding the date of the appointment--
(i) an employee; or
(ii) a participant in high-risk life
sciences research supported by Federal
funding.
(3) Security clearances.--
(A) In general.--A candidate for Executive
Director of the Board shall be granted all
security clearances and accesses held by the
Board, including to relevant Presidential and
department or agency special access and
compartmented access programs in an accelerated
manner, subject to the standard procedures for
granting such clearances.
(B) Qualification prior to appointment.--The
President shall ensure that a candidate for
Executive Director of the Board qualifies for
the security clearances and accesses described
in subparagraph (A) prior to appointment.
(4) Functions.--The Executive Director of the Board
shall--
(A) serve as principal liaison to Congress
and agencies;
(B) serve as chair of the Board;
(C) be responsible for the administration and
coordination of the responsibilities of the
Board; and
(D) be responsible for the administration of
all official activities conducted by the Board.
(5) Removal.--Notwithstanding section 7902(b)(8), the
Executive Director shall not be removed for reasons
other than for cause on the grounds of inefficiency,
neglect of duty, malfeasance in office, physical
disability, mental incapacity, or any other condition
that substantially impairs the performance of the
responsibilities of the Executive Director or the staff
of the Board.
(6) Terms.--An Executive Director of the Board shall
not serve more than 2 terms.
(b) Staff.--
(1) In general.--Without regard to the provisions of
subchapter I of chapter 33 of title 5 governing
appointments in the competitive service, the Board may
appoint not more than 25 additional personnel to enable
the Board and the Executive Director to perform the
duties of the Board.
(2) Qualifications.--Each individual appointed to the
staff of the Board--
(A) shall be a citizen of the United States
of integrity and impartiality;
(B) shall have expertise in the life sciences
field or the national security field; and
(C) may not be a participant in any federally
funded research activity on the date of the
appointment or during the course of service of
the individual on the Board.
(3) Security clearances.--
(A) In general.--A candidate for appointment
to the staff of the Board shall be granted all
security clearances and accesses held by the
Board, including to relevant Presidential and
department or agency special access and
compartmented access programs, in an
accelerated manner, subject to the standard
procedures for granting such clearances.
(B) Conditional employment.--
(i) In general.--The Board may offer
conditional employment to a candidate
for a staff position of the Board
pending the completion of security
clearance background investigations.
During the pendency of such
investigations, the Board shall ensure
that any such employee does not have
access to, or responsibility involving,
classified or otherwise restricted
materials.
(ii) Unqualified staff.--If the Board
determines that an individual hired on
a conditional basis under clause (i) is
not eligible or otherwise does not
qualify for all security clearances
necessary to carry out the
responsibilities of the position for
which conditional employment has been
offered, the Board shall immediately
terminate the individual's employment.
(4) Support from agencies.--
(A) In general.--The head of each agency
shall designate not less than 1 full-time
employee of the agency as the representative of
the agency to--
(i) provide technical assistance to
the Board; and
(ii) support the review process of
the Board with respect to the agency
under section 7906 in a non-voting
staff capacity.
(B) Prohibition.--A representative of an
agency designated under subparagraph (A) and
any employee of an agency may not directly or
indirectly influence in any capacity a
determination by the Board under section 7906
with respect to life sciences research funded
by the agency.
(c) Compensation.--Subject to such rules as may be adopted
by the Board, without regard to the provisions of title 5
governing appointments in the competitive service and without
regard to the provisions of chapter 51 and subchapter III of
chapter 53 of that title relating to classification and General
Schedule pay rates, the Executive Director of the Board shall--
(1) be compensated at a rate not to exceed the rate
of basic pay for level II of the Executive Schedule;
(2) serve the entire tenure as Executive Director as
1 full-time employee; and
(3) appoint and fix the compensation of such other
personnel as may be necessary to carry out this
chapter.
SEC. 7904. BOARD MISSION AND FUNCTIONS
(a) Mission.--The mission of the Board shall be to issue an
independent determination as to whether an agency may award
Federal funding for proposed high-risk life sciences research,
which shall be binding upon the agency.
(b) Powers.--The Board shall have the authority to act in a
manner to carry out the mission described in subsection (a),
including authority to--
(1) prescribe regulations to carry out the
responsibilities of the Board;
(2) establish a process for the review of Federal
funding for high-risk life sciences research prior to
the award of the Federal funding, which shall be
binding upon an agency, including information
designated as classified or otherwise protected from
disclosure;
(3) direct an agency to make available to the Board
additional information and records, including
information designated as classified or otherwise
protected from disclosure, that the Board determines
are required to fulfill the functions and
responsibilities Board under this chapter;
(4) review any classified research conducted or
funded by any agency to determine whether the research
would be considered high-risk life sciences research;
and
(5) through the promulgation of regulations,
establish processes, policies, and procedures of the
Board for rendering decisions under this chapter.
(c) Initial Requirements.--The Board shall--
(1) not later than 180 days after the date of
appointment of the initial members of the Board under
section 7902, publish procedures in the Federal
Register establishing the process for the review by the
Board under section 7906;
(2) prior to the establishment of the procedures
under paragraph (1), consult with the appropriate
congressional committees and heads of agencies for
purposes of developing such procedures; and
(3) not later than 270 days after the date of the
enactment of this chapter, begin carrying out the
duties described in section 7906.
(d) Responsiveness to Congress.--Notwithstanding any other
provision of law, not later than 30 days after the date on
which the Board receives a request for information from a
Member of Congress, the Board shall respond to the request.
(e) Congressional Briefings.--Not less frequently than
quarterly, the Board shall brief the appropriate congressional
committees on the work of the Board.
(f) Select Agent or Toxin Updates.--
(1) In general.--Not later than 15 days after the
date on which the Board receives a notification that a
select agent or toxin has been added to a list of agent
or toxins under a regulation described in paragraph
(2), the Board shall--
(A) review the select agent or toxin;
(B) by majority vote of members of the Board,
determine whether the select agent or toxin
should be added into the definition of `select
agent or toxin' under section 7901; and
(C) publish any addition determined under
subparagraph (B) in the Federal Register.
(2) Regulations described.--A regulation described in
this paragraph is--
(A) section 73.3(b) of title 42, Code of
Federal Regulations, or any successor
regulation;
(B) section 331.3(b) of title 7, Code of
Federal Regulations, or any successor
regulation; and
(C) section 121.3(b) of title 9, Code of
Federal Regulations, or any successor
regulation.
(g) Final Determination Authority.--In any dispute with an
agency or entity relating to the classification of life
sciences research under this chapter, the Board shall retain
final and ultimate authority in--
(1) determining whether the life sciences research is
high-risk life sciences research, dual use research of
concern involving a high-consequence pathogen or gain
of function research;
(2) interpreting definitions in section 7901; and
(3) determining whether a proposed Federal award for
life sciences research is subject to the review process
of the Board under section 7906(a)(1).
SEC. 7905. AGENCY PROCEDURES; REFERRAL TO BOARD
(a) In General.--
(1) Prohibition.--The head of an agency may not award
Federal funding for--
(A) high-risk life sciences research without
approval by the Board under section
7906(a)(1)(B); or
(B) life sciences research if the Board, in
accordance with section 7906(a)(2)(A)(ii),
submits notification to the agency under
section 7906(a)(2)(B)(i) that Board is
reviewing the Federal funding for life sciences
research under section 7906(a) until the date
on which the Board makes a final determination
with respect to the proposed Federal funding.
(2) Effective date.--Paragraph (1) shall take effect
on the date that is 180 days after the date of
enactment of this chapter.
(b) High-Risk Attestation; Select Agent or Toxin
Disclosure; Certification.--
(1) In general.--An entity seeking Federal funding
from an agency for life sciences research shall, under
the penalty of perjury--
(A) attest whether--
(i) the life sciences research will
constitute high-risk life sciences
research; and
(ii) the entity is performing active
research with a select agent or toxin;
and
(B) if the entity is makes a positive
attestation under subparagraph (A), disclose
the source of funding for all active research.
(2) Active research with select agents or toxins.--
(A) In general.--The head of an agency that
receives a disclosure from an entity under
paragraph (1)(B) shall submit to the Board the
disclosure.
(B) Board inquiries.--The Board may contact
an entity that submits a disclosure under
paragraph (1)(B) to request additional
information relating to the disclosure.
(3) Agency certification.--
(A) Positive attestations.--The head of an
agency making an award of Federal funding to an
entity that makes a positive attestation under
paragraph (1)(A)(i) shall--
(i) submit to the Board the high-risk
life sciences proposal; and
(ii) using the process established by
the head of the agency under paragraph
(4), certify the validity of the
attestation.
(B) Negative attestations.--The head of an
agency making an award of Federal funding to an
entity that makes a negative attestation under
paragraph (1)(A)(i) shall--
(i) review the attestation; and
(ii) using the process established by
the head of the agency under paragraph
(4), certify the validity of the
attestation.
(4) Process for review.--The head of each agency that
awards Federal funding for life sciences research, in
consultation with the Board, shall establish and
implement a process for identifying proposals from
entities seeking Federal funding for life sciences
research from the agency that will constitute high-risk
life sciences research.
(5) Maintenance of records.--The head of each agency
shall--
(A) maintain records of the certification
process described in paragraph (3) for each
application for Federal funding in accordance
with chapter 31 of title 44; and
(B) make the records maintained under
subparagraph (A) available for audit and review
upon request by the Board.
(c) Notification.--
(1) In general.--Not later than 30 days before the
date on which the head of an agency plans to award
Federal funding to an entity for life sciences
research, the head of the agency shall submit to the
Board a notification of the proposed Federal funding.
(2) Contents.--The notification of Federal funding
for life sciences research required under paragraph (1)
shall include the attestation and certification
required under subsection (b).
(3) Board requests.--
(A) In general.--The Board may request
additional information from the head of an
agency relating to a notification submitted
under paragraph (1).
(B) Provision of information.--The head of an
agency from which the Board request additional
information under subparagraph (A) shall
provide the information in a timely manner.
(d) Agency Procedures.--Not later than 180 days after the
date on which the Board publishes the process of the Board in
the Federal Register pursuant to section 7904(c), the head of
each agency shall publish on the website of the agency
prepayment and preaward procedures of the agency with respect
to Federal funding for life sciences research to--
(1) Guarantee that--
(A) all high-risk life science research
proposals are referred to the Board before the
award of Federal funding by the agency;
(B) no Federal funding for high-risk life
sciences research is awarded by the agency
without approval by the Board; and
(C) not later than 30 days before the date on
which the head of the agency plans to award the
Federal funding, the agency notifies the Board
of the proposal for Federal funding; and
(2) otherwise ensure compliance with this chapter.
(e) Provision of Additional Information.--Upon request by
the Board, the head of an agency shall provide any information
relating to Federal funding awards for life sciences research
determined necessary by the Board to provide oversight of the
agency.
(f) Change in Circumstances During Research.--If, during
the course of life sciences research in progress performed by
an entity supported by Federal funding from an agency,
circumstances arise such that the life sciences research in
progress may constitute high-risk life sciences research in
contravention to the attestation of the entity under subsection
(b)(1)(A)(i)--
(1) The entity shall--
(A) not later than 24 hours after the
identification of the change in circumstance,
pause the life sciences research in progress;
and
(B) not later than 5 days after the date of
the identification of the change in
circumstance, submit to the head of the agency
a written notification through an electronic or
nonelectronic communication method that--
(i) notifies the head of the agency
of the possibility that the life
sciences research in progress may
constitute high-risk life sciences
research; and
(ii) includes a detailed description
of each change in circumstance that may
transform the life sciences research in
progress into high-risk life sciences
research; and
(2) The head of the agency shall--
(A) using the process of the agency
established under subsection (b)(4), determine
whether the life sciences research in progress
constitutes high-risk life sciences research;
(B) if the head of the agency makes a
negative determination under subparagraph (A),
inform the entity that the entity may resume
the life sciences research in progress; and
(C) if the head of the agency makes a
positive determination under subparagraph (A),
immediately submit to the Board a notification
of the Federal funding of high-risk life
sciences research in progress for review under
section 7906(a)(1).
(g) Enforcement.--
(1) Applicant requirements.--If an entity seeking or
receiving Federal funding from an agency knowingly
fails to make a true attestation under subsection
(b)(1) or promptly notify the agency of a change in
circumstance in accordance with subsection (f)(1), the
head of the agency shall refer the entity to the
appropriate entity for suspension and debarment
proceedings relating to the receipt of Federal funding.
(2) Referral to inspector general.--The Board shall
refer any employee of an agency responsible for
overseeing and reviewing research proposals relating to
Federal funding that knowingly fails to comply with
subsection (b)(3) to the inspector general of the
agency.
(3) Employee discipline.--
(A) In general.--The head of an agency
employing an employee who knowingly violates
any provision of subsection (b)(3) (or, in the
case of the head of an agency who violates any
provision of subsection (b)(3), the President)
shall impose on that employee--
(i) disciplinary action in accordance
with chapter 75 of title 5 or an
equivalent procedure of the agency; and
(ii) permanent revocation of any
applicable security clearance held by
the employee.
(B) Contractor penalty.--In the case of
contractor working under a contract with an
agency who knowingly violates subsection
(b)(1), the head of the agency shall refer the
contractor to the appropriate entity for
suspension and debarment proceedings relating
to the receipt of Federal funding.
(C) Employee discipline reports.--
(i) In general.--Not later than 360
days after the date of enactment of
this Act, and not less frequently than
once every 90 days thereafter, the head
of each agency shall submit to the
Board and the appropriate congressional
committees a report that discloses, for
the period covered by the report, each
violation by an employee of the agency
of subsection (b)(3).
(ii) Contents.--Each report submitted
under clause (i) shall include, with
respect to a violation described in
that clause--
(I) the name and professional
title of each employee engaged
in the violation;
(II) a detailed explanation
of the nature of the violation;
and
(III) the date of the
violation.
(iii) Publication.--Not later than 5
days after the date on which the Board
receives a report under clause (i), the
Board shall publish on a publicly
accessible and searchable website the
amount of violations that have been
committed under clause (i).
(h) Subaward and Subcontractor Disclosure.--
(1) In general.--During the course of high-risk life
sciences research in progress performed by an entity
supported by Federal funding from an agency, the entity
shall--
(A) continuously disclose to the head of the
agency any subcontracts or subawards made or
planned to be made with the Federal funding;
and
(B) obtain consent from the head of the
agency before awarding a subcontract or award
described in subparagraph (A).
(2) Agency submission.--Not later than 30 days after
the date on which the head of an agency receives a
disclosure under paragraph (1), the head of the agency
shall submit to the Board the disclosure.
(3) Board inquiries.--
(A) In general.--The Board may contact an
entity that submits a disclosure under
paragraph (1) to request additional information
relating to the disclosure.
(B) Access to reports.--During the course of
high-risk life sciences research in progress
performed by an entity supported by Federal
funding from an agency, upon request, the Board
shall have access to every annual report of--
(i) the agency;
(ii) the entity performing the high-
risk life sciences research; and
(iii) any subcontractor or subawardee
of an entity described in clause (ii).
SEC. 7906. BOARD REVIEW
(a) In General.--
(1) High risk life sciences research.--Not later than
120 days after the date on which the Board receives a
notification from an agency under section 7905(c)
relating to proposed Federal funding for life sciences
research that constitutes high-risk life sciences
research or the Board receives a notification from an
agency under section 7905(f)(2)(C) relating to Federal
funding of research in progress that constitutes high-
risk life sciences research, the Board shall--
(A) review the proposed Federal funding or
high-risk life sciences research in progress;
(B) by a majority vote, determine whether the
agency may award the proposed Federal funding
or continue to award the Federal funding for
the high-risk life sciences research in
progress; and
(C) by a majority vote, determine with
respect to the high-risk life sciences research
funded by the proposed Federal funding or
Federal funding for high-risk life sciences
research in progress--
(i) the minimum required biosafety
containment level, engineering
controls, and operational controls;
(ii) the minimum required biosecurity
engineering controls and operational
controls; and
(iii) the minimum required personnel
assurance controls.
(2) Proposed life sciences research.--
(A) In general.--With respect to proposed
Federal funding by an agency for life sciences
research, the Board may--
(i) review the proposed Federal
funding; and
(ii) determine whether the Board
should review the proposed Federal
funding in accordance with paragraph
(1).
(B) Notification.--If the Board makes a
positive determination under subparagraph
(A)(ii) with respect to proposed Federal
funding by an agency--
(i) the Board shall notify the head
of the agency; and
(ii) the head of the agency may not
award the proposed Federal funding
until the date on which the Board makes
a final determination with respect to
the proposed Federal funding under
paragraph (1).
(3) Past funding.--With respect to life sciences
research performed with Federal funding awarded by an
agency before the date of enactment of this chapter,
the Board may review and audit the research in order to
assess the compliance of the agency with the provisions
of this chapter.
(4) Ongoing funding for life sciences research.--With
respect to Federal funding for life sciences research
in progress awarded by an agency before the date of
enactment of this Act that the Board determines may
constitute high-risk life sciences research, the Board
may--
(A) direct the agency to temporarily suspend
the Federal funding;
(B) require the agency to provide complete
information on the Federal funding in order for
the Board to complete a review of the life
sciences research under paragraph (1); and
(C) by a majority vote of members of the
Board, determine whether the agency may
continue the Federal funding.
(b) Considerations.--
(1) In general.--In making a determination under
subsection (a)(1)(B), the Board shall consider, with
respect to the high-risk life sciences research that
will be conducted with the proposed Federal funding or
high-risk life sciences research in progress--
(A) whether the research poses a threat to
public health;
(B) whether the research poses a threat to
public safety;
(C) whether the research has a high
probability of producing benefits for public
health;
(D) whether the research poses a threat to
large populations of animals and plants;
(E) whether the research poses a threat to
national security;
(F) whether the research is proposed to be
conducted at least in part in a foreign
country;
(G) the reasonably anticipated material risks
of the research;
(H) the reasonably anticipated information
risks of the research;
(I) the reasonably anticipated benefits of
the research;
(J) whether the reasonably anticipated
benefits of the research outweigh the
reasonably anticipated risks; and
(K) whether the benefits of the research
could be obtained through procedures posing
lower risks.
(2) Weight of factors.--The presence or absence of
any factor under paragraph (1) shall not be decisive
with respect to the determination of the Board under
subsection (a)(1)(B).
(c) Notice Following Review and Determination.--
(1) Agency notification.--Not later than 5 days after
the date on which the Board makes a determination under
subsection (a)(1)(B) with respect to Federal funding by
an agency, the Executive Director of the Board shall
notify the head of the agency of the determination.
(2) Board consultation.--
(A) In general.--Not later than 10 days after
receiving a notification from the Board under
paragraph (1), the head of an agency may
request a meeting with the Board to discuss the
determination of the Board.
(B) Board response.--The Board shall schedule
a meeting requested by the head of an agency
under subparagraph (A) in a timely manner.
(3) Notification to appropriate congressional
committees.--If the Board determines that the head of
an agency may not proceed with an award of proposed
Federal funding under this section, the Executive
Director of the Board shall notify the appropriate
congressional committees when the Board notifies the
head of the agency.
(d) Request for Expedited Review.--
(1) Definition.--In this subsection, the term
`emergency research' means high-risk life sciences
research submitted to the Board that relates to a
public health emergency or addresses a specific
national security concern.
(2) Request; notification.--The head of an agency
seeking expedited review from the Board to award
Federal funding for emergency research shall--
(A) include a request for expedited review in
the notification required under section
7905(c); and
(B) on the date of the notification described
in subparagraph (A), submit to the Board and
the appropriate congressional committees a
notification that explains why the specific
public health emergency or national security
concern necessitates expedited review under
this subsection.
(3) Internal process.--The Board shall establish an
internal process under which the Board will give
proposed emergency research expedited review under this
section.
(4) Temporary emergency research.--If the Board does
not notify the head of an agency with a determination
under subsection (a)(1)(B) with respect to proposed
emergency research by the 15 days after the date on
which the head of the agency submits a request under
paragraph (2)(A), the head of the agency may award
Federal funding for the emergency research on a
temporary basis.
(e) Scientific Expert Panels.--
(1) In general.--The Board may establish a scientific
panel of nongovernmental experts to advise the Board in
the review by the Board of life sciences research
pursuant to this chapter.
(2) Policies and procedures.--The Board shall
establish and publish in the Federal Register
procedures and policies relating to conflicts of
interest, recusal, expertise, and related matters
before the establishment of the panel described in
paragraph (1).
(3) Prohibition.--An individual serving on the panel
established under paragraph (1) may not advise the
Board on any matter with respect to which the
individuals has an identified or perceived conflict of
interest.
(4) Report.--
(A) In general.--Not later than 30 days after
the date on which the Board establishes a panel
established under paragraph (1), the Board
shall submit to the appropriate congressional
committees a report that includes the names,
qualifications, and any identified or perceived
conflicts of interest of individuals who serve
on the panel.
(B) Panel changes.--Upon a change of
personnel on the panel established under
paragraph (1), the Board shall immediately
submit to the appropriate congressional
committees an update to the report required
under subparagraph (A).
(f) Report.--
(1) In general.--Not later than 360 days after the
date on which the Board establishes the panel described
in subsection (e)(1), and annually thereafter, the
Board shall submit to the appropriate congressional
committees a report, which shall include a classified
annex, summarizing, with respect to each determination
by the Board under this section relating to high-risk
life sciences research--
(A) the findings of the Board;
(B) the determination of the Board;
(C) the name and location of the entity
proposing the life sciences research;
(D) the name and location of any recipient of
a subaward or subcontractor of an entity
proposing life sciences research and the nature
of the participation of such a recipient or
subcontractor; and
(E) an account of significant challenges or
problems, including procedural or substantive
challenges or problems, that arise during the
course of the work of the Board, including the
views of any member of the Board who wishes to
have those views included in the report.
(2) Public report.--On the date on which the Board
submits a report required under paragraph (1), the
Board shall make the report, other than the classified
annex included in the report, available on a website.
(g) Effective Date.--This section shall take effect on the
date that is 270 days after the date of enactment of this
chapter.
SEC. 7907. GAO AUDITS
The Comptroller General of the United States shall
periodically audit the Board.
SEC. 7908. FUNDING
There is authorized to be appropriated to the Board to
carry out this chapter $30,000,000 for each of fiscal years
2025 through 2034.
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