[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 4667 Reported in Senate (RS)]
<DOC>
Calendar No. 667
118th CONGRESS
2d Session
S. 4667
[Report No. 118-264]
To amend title 31, United States Code, to establish the Life Sciences
Research Security Board, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 10, 2024
Mr. Paul (for himself and Mr. Peters) introduced the following bill;
which was read twice and referred to the Committee on Homeland Security
and Governmental Affairs
December 5, 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 amend title 31, United States Code, to establish the Life Sciences
Research Security Board, 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. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Risky Research Review
Act''.</DELETED>
<DELETED>SEC. 2. LIFE SCIENCES RESEARCH SECURITY BOARD.</DELETED>
<DELETED> (a) In General.--Subtitle V of title 31, United States
Code, is amended by adding at the end the following:</DELETED>
<DELETED>``CHAPTER 79--LIFE SCIENCES RESEARCH SECURITY BOARD</DELETED>
<DELETED>``Sec. 7901. Definitions</DELETED>
<DELETED> ``In this chapter:</DELETED>
<DELETED> ``(1) Agency.--The term `agency' has the meaning
given the term in section 552(f) of title 5.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(3) Board.--The term `Board' means the Life
Sciences Research Security Board established under section
7902(a).</DELETED>
<DELETED> ``(4) Dual use.--The term `dual use', with respect
to research, means research that, based on current
understanding as of the date of research, can be reasonably
anticipated to provide knowledge, information, products, or
technologies that could directly or with only minor
modification be misapplied to pose a significant threat with
broad potential consequences to public health and safety,
agricultural crops or other plants, animals, materiel, or
national security.</DELETED>
<DELETED> ``(5) Employee.--</DELETED>
<DELETED> ``(A) In general.--The term `employee'--
</DELETED>
<DELETED> ``(i) means an employee of an
agency; and</DELETED>
<DELETED> ``(ii) includes an individual,
other than an employee of an agency, working
under a contract with an agency.</DELETED>
<DELETED> ``(B) Rule of construction.--With respect
to an individual described in subparagraph (A)(ii),
solely for the purposes of this chapter, the agency
that has entered into the contract under which the
employee is working shall be construed to be the agency
employing the employee.</DELETED>
<DELETED> ``(6) Federal funding.--The term `Federal
funding'--</DELETED>
<DELETED> ``(A) means amounts awarded by an agency
pursuant to a grant, cooperative agreement, interagency
agreement, contract, or other instrument; and</DELETED>
<DELETED> ``(B) includes--</DELETED>
<DELETED> ``(i) an in-kind contribution by
an agency used for life sciences research
purposes; and</DELETED>
<DELETED> ``(ii) research conducted by an
agency to which funds were appropriated for
conducting research.</DELETED>
<DELETED> ``(7) Gain of function research.--The term `gain
of function research' means research that has the potential to
enhance the transmissibility or virulence of a potential
pandemic pathogen.</DELETED>
<DELETED> ``(8) High-risk life sciences research.--The term
`high-risk life sciences research'--</DELETED>
<DELETED> ``(A) means life sciences research that--
</DELETED>
<DELETED> ``(i) has a potential dual use
nature; or</DELETED>
<DELETED> ``(ii) could pose a threat to
public health, safety, or national security;
and</DELETED>
<DELETED> ``(B) includes--</DELETED>
<DELETED> ``(i) gain of function
research;</DELETED>
<DELETED> ``(ii) research involving a
potential pandemic pathogen, including genetic
modification of a potential pandemic pathogen
and the synthetic creation of a potential
pandemic pathogen; and</DELETED>
<DELETED> ``(iii) an activity involving the
collection or surveillance of a potential
pandemic pathogen.</DELETED>
<DELETED> ``(9) Life sciences research.--The term `life
sciences research' means research in agricultural
biotechnology, biogenerics, bioinformatics, biomedical
engineering, biopharmaceuticals, academic medical centers,
biotechnology, chemical synthesis, chemistry technology,
medical diagnostics, genomics, medical image analysis, marine
biology, medical devices, medical nanotechnology, natural
product pharmaceuticals proteomics, regenerative medicine, RNA
interference, stem cell research, medical and neurological
clinical trials, health robotics, and veterinary
science.</DELETED>
<DELETED> ``(10) Potential pandemic pathogen.--The term
`potential pandemic pathogen'--</DELETED>
<DELETED> ``(A) means a virus, natural or synthetic,
bacteria, fungus, prion, or eukaryotic parasite, or any
strain or variant of a virus, bacterium, fungus, prion,
or eukaryotic parasite--</DELETED>
<DELETED> ``(i) that--</DELETED>
<DELETED> ``(I) is reasonably
anticipated to be moderately or highly
transmissible and likely capable of
wide and uncontrollable spread in human
populations; and</DELETED>
<DELETED> ``(II) is described in
clause (ii) or (iii); and</DELETED>
<DELETED> ``(ii) reasonably anticipated to
be of low, moderate, or high virulence and
likely to cause significant morbidity or
mortality in humans; or</DELETED>
<DELETED> ``(iii) reasonably anticipated to
pose a severe threat to public health, the
capacity of public health systems to function,
or national security if allowed to spread
within the general population; and</DELETED>
<DELETED> ``(B) includes--</DELETED>
<DELETED> ``(i) subject to subparagraph (C),
influenza viruses;</DELETED>
<DELETED> ``(ii) sarbecoviruses;</DELETED>
<DELETED> ``(iii) merbecoviruses;</DELETED>
<DELETED> ``(iv) henipaviruses, including
Nipah virus;</DELETED>
<DELETED> ``(v) filoviruses;</DELETED>
<DELETED> ``(vi) arenaviruses;</DELETED>
<DELETED> ``(vii) orthopoxviruses;</DELETED>
<DELETED> ``(viii) Yersinia
pestis;</DELETED>
<DELETED> ``(ix) any synthetic construct of
such viruses; and</DELETED>
<DELETED> ``(x) a select agent or toxin,
work with which poses a significant risk of
deliberate misuse; and</DELETED>
<DELETED> ``(C) does not include seasonal influenza
viruses, unless such viruses have been manipulated to
include genetic sequences from a potential pandemic
pathogen.</DELETED>
<DELETED> ``(11) Select agent or toxin.--The term `select
agent or toxin' means an agent or toxin identified under--
</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED>``Sec. 7902. Establishment and membership</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(b) Appointment of Members.--</DELETED>
<DELETED> ``(1) In general.--The President, by and with the
advice and consent of the Senate, 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--</DELETED>
<DELETED> ``(A) the Executive Director appointed
under section 7903(a);</DELETED>
<DELETED> ``(B) 5 nongovernmental scientists in a
life sciences field; and</DELETED>
<DELETED> ``(C) 2 nongovernmental national security
experts.</DELETED>
<DELETED> ``(2) Period for nominations.--The President shall
make nominations to the Board not later than 30 days after the
date of enactment of this chapter. If the Senate votes not to
confirm a nomination to the Board, the President shall make an
additional nomination not later than 10 days after such vote by
the Senate.</DELETED>
<DELETED> ``(3) Considerations of recommendations.--The
President shall make nominations to the Board after considering
individuals recommended by the Chair and Ranking Member of the
appropriate congressional committees.</DELETED>
<DELETED> ``(4) Qualifications.--Individuals nominated to
the Board--</DELETED>
<DELETED> ``(A) shall--</DELETED>
<DELETED> ``(i) be impartial individuals;
and</DELETED>
<DELETED> ``(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
life sciences research to public health and
national security; and</DELETED>
<DELETED> ``(B) may not be an employee of the
Federal Government on the date of the appointment or
during the 3-year period preceding the date of the
appointment.</DELETED>
<DELETED> ``(5) Limitations.--Not more than 4 concurrent
members of the Board may be employed by, a subcontractor of, a
previous employee of, or a previous subcontractor of--
</DELETED>
<DELETED> ``(A) the Department of Defense;</DELETED>
<DELETED> ``(B) the Department of Homeland
Security;</DELETED>
<DELETED> ``(C) the National Institute of Allergy
and Infectious Diseases of the Department of Health and
Human Services;</DELETED>
<DELETED> ``(D) the Office of the Director of
National Intelligence; or</DELETED>
<DELETED> ``(E) the Department of Energy.</DELETED>
<DELETED> ``(6) Consideration by the senate.--</DELETED>
<DELETED> ``(A) In general.--Nominations for
appointment to the Board shall be referred to the
Committee on Homeland Security and Governmental Affairs
of the Senate for consideration.</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(8) Removal.--</DELETED>
<DELETED> ``(A) In general.--No member of the Board
shall be removed from office, other than by--</DELETED>
<DELETED> ``(i) impeachment and
conviction;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(iii) the Board in accordance
with subparagraph (B).</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(C) Notice of removal by president.--
</DELETED>
<DELETED> ``(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
Members of the appropriate congressional
committees a report specifying the facts found
and the grounds for removal.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(c) Mandatory Conflicts of Interest Review.--</DELETED>
<DELETED> ``(1) In general.--The Director of the Office of
Government Ethics shall--</DELETED>
<DELETED> ``(A) not later than 180 days after the
date of the enactment of this chapter, and 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 such
individual does not have any conflict of interest;
and</DELETED>
<DELETED> ``(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 during the term of service of the
individual.</DELETED>
<DELETED> ``(2) Notification.--</DELETED>
<DELETED> ``(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 to the
mission of the Board, the Director shall notify the
Chair and Ranking Members of the appropriate
congressional committees of the potential conflict of
interest.</DELETED>
<DELETED> ``(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 to the
mission of the Board, the member of the Board or the
Executive Director of the Board shall notify the Chair
and Ranking Members of the appropriate congressional
committees of the potential conflict of
interest.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(e) Participation in High-Risk Life Sciences Research.--
</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(2) Conflicts of interest.--</DELETED>
<DELETED> ``(A) In general.--The participation in
high-risk life sciences research by a member of the
Board--</DELETED>
<DELETED> ``(i) shall be considered a
potential conflict of interest; and</DELETED>
<DELETED> ``(ii) shall be subject to
scrutiny by the Director of the Office of
Government Ethics.</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(i) the recusal of the affected
member from relevant discussions and
determinations; and</DELETED>
<DELETED> ``(ii) removal of the affected
member from the Board.</DELETED>
<DELETED> ``(f) Compensation of Members.--</DELETED>
<DELETED> ``(1) In general.--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, a member of the Board, other than the
Executive Director, shall be compensated at a rate--</DELETED>
<DELETED> ``(A) proposed by the Executive Director
and approved by the Board;</DELETED>
<DELETED> ``(B) not to exceed the rate of basic pay
for level II of the Executive Schedule; and</DELETED>
<DELETED> ``(C) that is commensurate with--
</DELETED>
<DELETED> ``(i) the time a member of the
Board spends engaged in the performance of
duties on the Board; and</DELETED>
<DELETED> ``(ii) necessary traveling
expenses.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(g) Oversight.--</DELETED>
<DELETED> ``(1) Senate.--The Committee on Homeland Security
and Governmental Affairs of the Senate shall--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(B) have access to any records provided
to or created by the Board.</DELETED>
<DELETED> ``(2) House of representatives.--The Committee on
Oversight and Accountability of the House of Representatives
shall--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(B) have access to any records provided
to or created by the Board.</DELETED>
<DELETED> ``(3) Duty to cooperate.--The Board shall have the
duty to cooperate with the exercise of oversight jurisdiction
described in this subsection.</DELETED>
<DELETED> ``(4) Security clearances.--The Chair and Ranking
Members 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.</DELETED>
<DELETED> ``(h) Office Space.--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.</DELETED>
<DELETED>``Sec. 7903. Board personnel</DELETED>
<DELETED> ``(a) Executive Director.--</DELETED>
<DELETED> ``(1) Appointment.--Not later than 45 days after
the date of the enactment of this chapter, the President shall
appoint 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.</DELETED>
<DELETED> ``(2) Qualifications.--The individual appointed as
Executive Director under paragraph (1) shall be a private
individual of integrity and impartiality who--</DELETED>
<DELETED> ``(A) is a distinguished scientist in a
life sciences field; and</DELETED>
<DELETED> ``(B) is not, and has not been for the 3-
year period preceding the date of the appointment--
</DELETED>
<DELETED> ``(i) an employee of the Federal
Government; or</DELETED>
<DELETED> ``(ii) a participant in high-risk
life sciences research supported by Federal
funding.</DELETED>
<DELETED> ``(3) Security clearances.--</DELETED>
<DELETED> ``(A) In general.--A candidate for
Executive Director 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.</DELETED>
<DELETED> ``(B) Qualification prior to
appointment.--The President shall ensure that a
candidate for Executive Director qualifies for the
security clearances and accesses described in
subparagraph (A) prior to appointment.</DELETED>
<DELETED> ``(4) Functions.--The Executive Director shall--
</DELETED>
<DELETED> ``(A) serve as principal liaison to
Congress and agencies;</DELETED>
<DELETED> ``(B) serve as Chair of the
Board;</DELETED>
<DELETED> ``(C) be responsible for the
administration and coordination of the responsibilities
of the Board; and</DELETED>
<DELETED> ``(D) be responsible for the
administration of all official activities conducted by
the Board.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(6) Terms.--An Executive Director shall not
serve more than 2 terms.</DELETED>
<DELETED> ``(b) Staff.--</DELETED>
<DELETED> ``(1) In general.--The Board, without regard to
the civil service laws, may appoint additional personnel as
necessary to enable the Board and the Executive Director to
perform the duties of the Board.</DELETED>
<DELETED> ``(2) Qualifications.--Each individual appointed
to the staff of the Board--</DELETED>
<DELETED> ``(A) shall be a citizen of the United
States of integrity and impartiality;</DELETED>
<DELETED> ``(B) shall have expertise in the life
sciences field or the national security field;
and</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(3) Security clearances.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(B) Conditional employment.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(ii) Unqualified staff.--If an
individual hired on a conditional basis under
clause (i) is denied 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.</DELETED>
<DELETED> ``(4) Support from agencies.--</DELETED>
<DELETED> ``(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--
</DELETED>
<DELETED> ``(i) provide technical assistance
to the Board; and</DELETED>
<DELETED> ``(ii) support the review process
of the Board with respect to the agency under
section 7906 in a non-voting staff
capacity.</DELETED>
<DELETED> ``(B) Prohibition.--A representative
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.</DELETED>
<DELETED> ``(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 shall--</DELETED>
<DELETED> ``(1) be compensated at a rate not to exceed the
rate of basic pay for level II of the Executive
Schedule;</DELETED>
<DELETED> ``(2) serve the entire tenure as Executive
Director as one full-time employee; and</DELETED>
<DELETED> ``(3) appoint and fix the compensation of such
other personnel as may be necessary to carry out this
chapter.</DELETED>
<DELETED>``Sec. 7904. Board mission and functions</DELETED>
<DELETED> ``(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 life sciences research, which shall be binding
upon the agency.</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(1) prescribe regulations to carry out the
responsibilities of the Board;</DELETED>
<DELETED> ``(2) establish a process for the review of
Federal funding for 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;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(4) review any classified research conducted or
funded by any agency to determine whether the research would be
considered high-risk life sciences research;</DELETED>
<DELETED> ``(5) through the promulgation of regulations,
establish processes, policies, and procedures of the Board for
rendering decisions under this chapter; and</DELETED>
<DELETED> ``(6) by majority vote, add an agent or toxin to
the definition of `agent or toxin' under section
7901.</DELETED>
<DELETED> ``(c) Initial Requirements.--The Board shall--</DELETED>
<DELETED> ``(1) not later than 90 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
;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(3) not later than 180 days after the date of
the enactment of this chapter, begin carrying out the duties
described in section 7906.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(e) Congressional Briefings.--Not less frequently than
quarterly, the Board shall brief the appropriate congressional
committees on the work of the Board.</DELETED>
<DELETED>``Sec. 7905. Agency procedures; referral to Board</DELETED>
<DELETED> ``(a) In General.--Beginning 180 days after the date of
enactment of this chapter, the head of an agency--</DELETED>
<DELETED> ``(1) may not award Federal funding for high-risk
life sciences research without approval by the Board under
section 7906(a)(1)(B); and</DELETED>
<DELETED> ``(2) may not award Federal funding for life
sciences research disapproved of by the Board under section
7906(a)(2)(A)(i)(II).</DELETED>
<DELETED> ``(b) High-Risk Attestation; Select Agent or Toxin
Disclosure; Certification.--</DELETED>
<DELETED> ``(1) In general.--An entity seeking Federal
funding from an agency for life sciences research shall, under
the penalty of perjury--</DELETED>
<DELETED> ``(A) attest whether--</DELETED>
<DELETED> ``(i) the life sciences research
will constitute high-risk life sciences
research; and</DELETED>
<DELETED> ``(ii) the entity is performing
active research with a select agent or toxin;
and</DELETED>
<DELETED> ``(B) if the entity is makes a positive
attestation under subparagraph (A), disclose the source
of funding for all active research.</DELETED>
<DELETED> ``(2) Active research with select agents or
toxins.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(3) Agency certification.--</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(i) submit to the Board the
high-risk life sciences proposal; and</DELETED>
<DELETED> ``(ii) using the process
established by the head of the agency under
paragraph (4), certify the validity of the
attestation.</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(i) review the attestation;
and</DELETED>
<DELETED> ``(ii) using the process
established by the head of the agency under
paragraph (4), certify the validity of the
attestation.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(5) Maintenance of records.--The head of each
agency shall--</DELETED>
<DELETED> ``(A) maintain records of the
certification process described in paragraph (3)(B) for
each application for Federal funding; and</DELETED>
<DELETED> ``(B) make the records maintained under
subparagraph (A) available for audit and review upon
request by the Board.</DELETED>
<DELETED> ``(c) Notification.--</DELETED>
<DELETED> ``(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 for review under section
7906(a).</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(1) guarantee that--</DELETED>
<DELETED> ``(A) all life science research proposals
are referred to the Board before the award of Federal
funding by the agency; and</DELETED>
<DELETED> ``(B) no Federal funding for high-risk
life sciences research is awarded by the agency without
approval by the Board; and</DELETED>
<DELETED> ``(2) otherwise ensure compliance with this
chapter.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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)--</DELETED>
<DELETED> ``(1) the entity shall--</DELETED>
<DELETED> ``(A) pause the life sciences research in
progress; and</DELETED>
<DELETED> ``(B) notify the head of the agency of the
possibility that the life sciences research in progress
may constitute high-risk life sciences research;
and</DELETED>
<DELETED> ``(2) the head of the agency shall--</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(g) Enforcement.--</DELETED>
<DELETED> ``(1) Applicant requirements.--If an entity
seeking or receiving Federal funding from an agency fails to
make a true attestation under subsection (b)(1) or promptly
notify the agency of changes described in subsection (f), the
inspector general of the agency may permanently disqualify the
entity from receiving any Federal funding.</DELETED>
<DELETED> ``(2) Referral to attorney general.--The Board
shall refer any official of an agency responsible for
overseeing and reviewing research proposals relating to Federal
funding that fails to comply with subsection (b)(3) to the
inspector general of the agency.</DELETED>
<DELETED> ``(3) Employee discipline.--</DELETED>
<DELETED> ``(A) In general.--Notwithstanding any
provision of title 5, and subject to subparagraph (B),
the head of an agency employing an employee who
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--</DELETED>
<DELETED> ``(i) disciplinary action
consisting of removal, reduction in grade,
suspension, or debarment from employment with
the United States;</DELETED>
<DELETED> ``(ii) a civil penalty in an
amount that is not less than $10,000;</DELETED>
<DELETED> ``(iii) ineligibility for any
annuity under chapter 83 or 84 of title 5;
and</DELETED>
<DELETED> ``(iv) permanent revocation of any
applicable security clearance held by the
employee.</DELETED>
<DELETED> ``(B) Specific contractor discipline.--In
the case of an individual described in section 7901(5)
working under a contract with an agency who violates
any provision of subsection (b)(2), in addition to any
discipline that may be applicable under subparagraph
(A) of this paragraph, that individual shall be barred
from working under any contract with the Federal
Government.</DELETED>
<DELETED> ``(C) Employee discipline reports.--
</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(ii) Contents.--Each report
submitted under clause (i) shall include, with
respect to a violation described in that
clause--</DELETED>
<DELETED> ``(I) the name and
professional title of each employee
engaged in the violation;</DELETED>
<DELETED> ``(II) a detailed
explanation of the nature of the
violation; and</DELETED>
<DELETED> ``(III) the date of the
violation.</DELETED>
<DELETED> ``(iii) Publication.--Not later
than 5 days after the date on which the Board
receives a report under clause (i), the Board
shall--</DELETED>
<DELETED> ``(I) collect the report
and assign the report a unique tracking
number; and</DELETED>
<DELETED> ``(II) publish on a
publicly accessible and searchable
website the contents of the report and
the tracking number for the
report.</DELETED>
<DELETED> ``(h) Subaward and Subcontractor Disclosure.--</DELETED>
<DELETED> ``(1) In general.--During the course of life
sciences research in progress performed by an entity supported
by Federal funding from an agency, the entity shall
continuously disclose to the head of the agency any
subcontracts or subawards made with the Federal
funding.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(3) Board inquiries.--</DELETED>
<DELETED> ``(A) In general.--The Board may contact
an entity that submits a disclosure under paragraph (1)
to request additional information relating to the
disclosure.</DELETED>
<DELETED> ``(B) Access to reports.--During the
course of 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--</DELETED>
<DELETED> ``(i) of the agency;</DELETED>
<DELETED> ``(ii) of the entity performing
the life sciences research; and</DELETED>
<DELETED> ``(iii) of any subawardee of an
entity described in clause (ii).</DELETED>
<DELETED>``Sec. 7906. Board review</DELETED>
<DELETED> ``(a) In General.--</DELETED>
<DELETED> ``(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 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--</DELETED>
<DELETED> ``(A) review the proposed Federal funding
or research in progress;</DELETED>
<DELETED> ``(B) by a majority vote, determine
whether the agency may award the proposed Federal
funding or continue to award the Federal funding for
the research in progress; and</DELETED>
<DELETED> ``(C) by a majority vote, determine with
respect to the life sciences research funded by the
proposed Federal funding or Federal funding for
research in progress--</DELETED>
<DELETED> ``(i) the minimum required
biosafety containment level, engineering
controls, and operational controls;</DELETED>
<DELETED> ``(ii) the minimum required
biosecurity engineering controls and
operational controls; and</DELETED>
<DELETED> ``(iii) the minimum required
personnel assurance controls.</DELETED>
<DELETED> ``(2) Life sciences research.--</DELETED>
<DELETED> ``(A) Proposed funding.--</DELETED>
<DELETED> ``(i) In general.--With respect to
proposed Federal funding by an agency for life
sciences research that does not constitute
high-risk life sciences research, the Board
may--</DELETED>
<DELETED> ``(I) review the proposed
Federal funding; and</DELETED>
<DELETED> ``(II) by a majority vote,
determine whether the agency may award
the proposed Federal funding.</DELETED>
<DELETED> ``(ii) Notification.--If the Board
determines not to permit the award of Federal
funding proposed by an agency pursuant to
clause (i)(II), the Board shall notify the head
of the agency and identify the factors that
contributed to the determination of the
Board.</DELETED>
<DELETED> ``(B) Past funding.--With respect to
Federal funding that has already been awarded by an
agency for life sciences research that does not
constitute high-risk life sciences research, the Board
may review and audit the life sciences
research.</DELETED>
<DELETED> ``(b) Considerations.--</DELETED>
<DELETED> ``(1) In general.--In making a determination under
paragraph (1)(B) and (2)(A)(i)(II) of subsection (a), the Board
shall consider, with respect to the life sciences research that
will be conducted with the proposed Federal funding or research
in progress--</DELETED>
<DELETED> ``(A) whether the research poses a threat
to public health;</DELETED>
<DELETED> ``(B) whether the research poses a threat
to public safety;</DELETED>
<DELETED> ``(C) whether the research has a high
probability of producing benefits for public
health;</DELETED>
<DELETED> ``(D) whether the research poses a threat
to large populations of animals, and plants;</DELETED>
<DELETED> ``(E) whether the research poses a threat
to national security;</DELETED>
<DELETED> ``(F) whether the research is proposed to
be conducted in a foreign country;</DELETED>
<DELETED> ``(G) the reasonably anticipated material
risks;</DELETED>
<DELETED> ``(H) the reasonably anticipated
information risks;</DELETED>
<DELETED> ``(I) the reasonably anticipated
benefits;</DELETED>
<DELETED> ``(J) whether the reasonably anticipated
benefits outweigh the reasonably anticipated risks;
and</DELETED>
<DELETED> ``(K) whether the benefits could be
obtained through procedures posing lower
risks.</DELETED>
<DELETED> ``(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 paragraph
(1)(B) and (2)(A)(i)(II) of subsection (a).</DELETED>
<DELETED> ``(c) Notice Following Review and Determination.--
</DELETED>
<DELETED> ``(1) Agency notification.--Not later than 5 days
after the date on which the Board makes a determination under
subsection (a)(1)(B), the Executive Director of the Board shall
notify the head of the agency of the determination.</DELETED>
<DELETED> ``(2) 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.</DELETED>
<DELETED> ``(d) Board Delegation of Decisionmaking to Authorized
Personnel.--</DELETED>
<DELETED> ``(1) In general.--The Board may vote to delegate
to designated personnel of the Board appointed under section
7903(b) the authority to determine whether to review proposed
Federal funding for life sciences research under subsection
(a)(2)(A)(i)(I).</DELETED>
<DELETED> ``(2) Policies and procedures.--The delegation
authorized under paragraph (1) shall be subject to policies and
procedures--</DELETED>
<DELETED> ``(A) unanimously approved by the
Board;</DELETED>
<DELETED> ``(B) established in consultation with the
appropriate congressional committees; and</DELETED>
<DELETED> ``(C) published in the Federal
Register.</DELETED>
<DELETED> ``(3) High-risk life sciences research approval.--
The Board may not delegate the requirement to make a review and
determination under subsection (a)(1)(i) with respect to
Federal funding for high-risk life sciences research.</DELETED>
<DELETED> ``(e) Scientific Expert Panels.--</DELETED>
<DELETED> ``(1) In general.--The Board may establish a
scientific panel of experts to advise the Board in the review
by the Board of life sciences research pursuant to this
chapter.</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(4) Report.--</DELETED>
<DELETED> ``(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 of individuals who serve on the
panel.</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(f) Report.--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 and make available on a website a report
summarizing, with respect to each determination by the Board under this
section relating to life sciences research--</DELETED>
<DELETED> ``(1) the findings of the Board;</DELETED>
<DELETED> ``(2) the determination of the Board;</DELETED>
<DELETED> ``(3) the name and location of the entity
proposing the life sciences research;</DELETED>
<DELETED> ``(4) 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</DELETED>
<DELETED> ``(5) 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.</DELETED>
<DELETED> ``(g) Effective Date.--This section shall take effect on
the date that is 180 days after the date of enactment of this
chapter.</DELETED>
<DELETED>``Sec. 7907. Funding</DELETED>
<DELETED> ``(a) Authorization of Appropriations.--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.</DELETED>
<DELETED> ``(b) DHS Transfer.--</DELETED>
<DELETED> ``(1) In general.--Subject to paragraph (2) and
notwithstanding any other law, in any fiscal year for which
amounts are authorized to be appropriated under subsection (a),
of the amounts the Secretary of Homeland Security would
otherwise award as grants, the Secretary of Homeland Security
shall transfer $30,000,000 to the Board.</DELETED>
<DELETED> ``(2) Exception.--A transfer under paragraph (1)
shall not apply to amounts awarded as grants from the Disaster
Relief Fund of the Federal Emergency Management
Agency.''.</DELETED>
<DELETED> (b) Clerical Amendment.--The table of sections for
subtitle V of title 31, United States Code, is amended by adding at the
end the following:</DELETED>
<DELETED>``Chapter 79--Life Sciences Research Security Board
<DELETED>``7901. Definitions.
<DELETED>``7902. Establishment and membership.
<DELETED>``7903. Board personnel.
<DELETED>``7904. Board mission and functions.
<DELETED>``7905. Agency procedures; referral to Board.
<DELETED>``7906. Board review.
<DELETED>``7907. Funding.''.
<DELETED> (c) Financial Disclosure Reports of Board Members.--
Section 13103(f) of title 5, United States Code, is amended--</DELETED>
<DELETED> (1) in paragraph (11), by striking ``and'' at the
end;</DELETED>
<DELETED> (2) in paragraph (12), by striking the period at
the end and inserting ``; and''; and</DELETED>
<DELETED> (3) by adding at the end the following:</DELETED>
<DELETED> ``(13) a member of the Life Sciences Research
Security Board established under section 7902 of title
31.''.</DELETED>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Risky Research Review Act''.
SEC. 2. LIFE SCIENCES RESEARCH SECURITY BOARD.
(a) In General.--Subtitle V of title 31, United States Code, is
amended by adding at the end the following:
``CHAPTER 79--LIFE SCIENCES RESEARCH SECURITY BOARD
``7901. Definitions.
``7902. Establishment and membership.
``7903. Board personnel.
``7904. Board mission and functions.
``7905. Agency procedures; referral to Board.
``7906. Board review.
``7907. GAO Audits.
``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.''.
(b) Clerical Amendment.--The table of chapters for subtitle V of
title 31, United States Code, is amended by adding at the end the
following:
``79. Life Sciences Research Security Board................ 7901''.
(c) Financial Disclosure Reports of Board Members.--Section
13103(f) of title 5, United States Code, is amended--
(1) in paragraph (11), by striking ``and'' at the end;
(2) in paragraph (12), by striking the period at the end
and inserting ``; and''; and
(3) by adding at the end the following:
``(13) a member of the Life Sciences Research Security
Board established under section 7902 of title 31.''.
Calendar No. 667
118th CONGRESS
2d Session
S. 4667
[Report No. 118-264]
_______________________________________________________________________
A BILL
To amend title 31, United States Code, to establish the Life Sciences
Research Security Board, and for other purposes.
_______________________________________________________________________
December 5, 2024
Reported with an amendment