Risky Research Review Act

Bill: 119-s-854
Sponsor: full_name: Sen. Paul, Rand [R-KY]
Introduced: 2025-03-05
Policy area: Health
Subjects: Accounting and auditing

Advisory bodies

Biological and life sciences

Congressional oversight

Employee performance

Federal officials

Government employee pay, benefits, personnel management

Government ethics and transparency, public corruption

Government information and archives

Government studies and investigations

Infectious and parasitic diseases

Public contracts and procurement

Research administration and funding
Latest action: action_date: 2025-09-17
text: Placed on Senate Legislative Calendar under General Orders. Calendar No. 164.

Summaries:
action_date: 2025-03-05
action_desc: Introduced in Senate
text: <p><strong>Risky Research Review Act</strong></p><p>This bill establishes the Life Sciences Research Security Board to oversee the award of federal funding for high-risk life sciences research.&nbsp;<em>High-risk life sciences research </em>means&nbsp;the study of an organism,&nbsp;virus, or related product that could be misapplied to pose a significant threat to the public or could enhance the transmissibility or&nbsp;virulence of certain high-risk&nbsp;pathogens (e.g., Ebola).</p><p>Specifically, the bill establishes the board as an independent agency that must review proposed high-risk life sciences research, determine whether a federal agency may award funding for the research, and determine minimum required controls for funded research. Entities that are seeking federal funding must attest to whether their research is high-risk life sciences research. Agencies must certify the validity of these attestations and submit proposed high-risk life sciences research to the board. Agencies must also notify the board of intended awards for other life sciences research for potential review.&nbsp;</p><p>In making&nbsp;its determinations, the board must consider specified&nbsp;factors,&nbsp;including whether the benefits of the research outweigh the&nbsp;risks. The bill prohibits agencies from awarding federal funding for high-risk life sciences research without approval of the board or for life sciences research currently under board review. The board may also&nbsp;review awards that were made&nbsp;before the bill’s enactment.</p><p>Entities that fail to properly&nbsp;attest to the nature of their research may lose their eligibility for funding. Additionally, agency employees who fail to comply with the bill's requirements are subject to disciplinary action.</p>

tv_txt: II Calendar No. 164 119th CONGRESS 1st Session S. 854 IN THE SENATE OF THE UNITED STATES March 5, 2025 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 September 17 (legislative day, September 16), 2025 Reported by Mr. Paul , without amendment A BILL To amend title 31, United States Code, to establish the Life Sciences Research Security Board, and for other purposes.

1. Short title This Act may be cited as the Risky Research Review Act . 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: 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. 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 Energy and Commerce 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 . 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 Energy and Commerce 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. 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. 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). 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 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). 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 in whole or 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. 7907. GAO Audits The Comptroller General of the United States shall periodically audit the Board. 7908. Funding There is authorized to be appropriated to the Board to carry out this chapter $30,000,000 for each of fiscal years 2026 through 2035. . (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. .

September 17 (legislative day, September 16), 2025 Reported without amendment

tv_txt: II 119th CONGRESS 1st Session S. 854 IN THE SENATE OF THE UNITED STATES March 5, 2025 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 A BILL To amend title 31, United States Code, to establish the Life Sciences Research Security Board, and for other purposes.

1. Short title This Act may be cited as the Risky Research Review Act . 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: 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. 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 Energy and Commerce 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 . 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 Energy and Commerce 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. 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. 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). 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 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). 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 in whole or 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. 7907. GAO Audits The Comptroller General of the United States shall periodically audit the Board. 7908. Funding There is authorized to be appropriated to the Board to carry out this chapter $30,000,000 for each of fiscal years 2026 through 2035. . (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. .