[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 th