[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8065 Introduced in House (IH)]

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118th CONGRESS
  2d Session
                                H. R. 8065

 To require the Secretary of Health and Human Services, acting through 
 the Assistant Secretary for Preparedness and Response, to carry out a 
 program under which the Secretary requires each regulated seller of a 
 highly infectious agent to comply with certain logbook requirements, 
                        and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 18, 2024

 Mr. Costa (for himself and Mr. Kiley) introduced the following bill; 
       which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To require the Secretary of Health and Human Services, acting through 
 the Assistant Secretary for Preparedness and Response, to carry out a 
 program under which the Secretary requires each regulated seller of a 
 highly infectious agent to comply with certain logbook requirements, 
                        and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Preventing Illegal Laboratories and 
Protecting Public Health Act of 2024''.

SEC. 2. REQUIRING CERTAIN SELLERS OF HIGHLY INFECTIOUS AGENTS TO KEEP A 
              LOGBOOK OF SALES.

    (a) Program.--The Secretary of Health and Human Services, acting 
through the Assistant Secretary for Preparedness and Response, shall 
carry out a program under which the Secretary requires each regulated 
seller of a highly infectious agent to comply with the logbook 
requirements of subsection (c).
    (b) List of Highly Infectious Agents.--
            (1) Development.--The Secretary shall develop and maintain 
        a list of all agents that meet the definition of a highly 
        infectious agent in subsection (e).
            (2) Initial list.--The Secretary shall develop the initial 
        list required by paragraph (1) not later than 12 months after 
        the date of enactment of this Act.
            (3) Periodic review.--The Secretary shall periodically 
        review and update the list required by paragraph (1).
            (4) Consultation; consideration.--In developing and 
        updating the list required by paragraph (1), the Secretary 
        shall--
                    (A) consult with relevant agencies, including the 
                Centers for Disease Control and Prevention, the 
                National Institutes of Health, and the Department of 
                Homeland Security;
                    (B) take into consideration the latest edition of 
                ``Biosafety in Microbiological and Biomedical 
                Laboratories'' published by the Centers for Disease 
                Control and Prevention and the National Institutes of 
                Health (or any successor to such publication); and
                    (C) take into consideration the latest edition of 
                ``NIH Guidelines for Research Involving Recombinant or 
                Synthetic Nucleic Acid Molecules'' published by the 
                National Institutes of Health (or any successor to such 
                publication).
    (c) Logbook Requirements.--
            (1) In general.--Each regulated seller shall maintain, in 
        accordance with criteria issued by the Secretary, an electronic 
        list (in this section referred to as a ``logbook'') of the 
        sales by such seller of each highly infectious agent on the 
        list under subsection (b) that identifies--
                    (A) the agent by name;
                    (B) the quantity sold;
                    (C) the name and address of each purchaser, 
                including relevant identifying business information as 
                deemed necessary by the Secretary;
                    (D) a short description of the purchaser's intended 
                use of the agent; and
                    (E) the date and time of the sale.
            (2) Sale requirements.--In the case of a sale to which the 
        requirement of paragraph (1) applies, the regulated seller 
        shall not sell the highly infectious agent unless--
                    (A) the prospective purchaser--
                            (i) presents an identification card that 
                        provides a photograph and is issued by a State 
                        or the Federal Government, or a document that, 
                        with respect to identification, is considered 
                        acceptable for purposes of sections 
                        274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B) of 
                        title 8, Code of Federal Regulations (or 
                        successor regulations); and
                            (ii) signs the logbook and enters in the 
                        logbook--
                                    (I) the purchaser's name and 
                                address;
                                    (II) a short description of the 
                                purchaser's intended use of the agent; 
                                and
                                    (III) the date and time of the 
                                sale; and
                    (B) the regulated seller--
                            (i) determines that the name entered in the 
                        logbook corresponds to the name provided on 
                        such identification and that the date and time 
                        entered are correct; and
                            (ii) enters in the logbook the name of the 
                        highly infectious agent and the quantity sold.
            (3) Contents.--The regulated seller shall include in the 
        logbook, in accordance with criteria of the Secretary, a notice 
        to purchasers that entering false statements or 
        misrepresentations in the logbook may subject the purchasers to 
        criminal penalties under section 1001 of title 18, United 
        States Code, which notice specifies the maximum fine and term 
        of imprisonment under such section.
            (4) Duration of maintenance of entries.--The regulated 
        seller shall maintain each entry in the logbook for not fewer 
        than five years after the date on which the entry is made.
            (5) Disclosure of logbooks.--The Secretary shall establish 
        restrictions on disclosure of information in logbooks. Such 
        regulations shall--
                    (A) provide for the disclosure of the information 
                as appropriate to the Secretary and to Federal, State, 
                and local law enforcement agencies; and
                    (B) prohibit accessing, using, or sharing 
                information in the logbooks for any purpose other than 
                to ensure compliance with this section or to protect 
                public health and safety.
    (d) False Statements or Misrepresentations by Purchasers.--For 
purposes of section 1001 of title 18, United States Code, entering 
information in a logbook shall be considered a matter within the 
jurisdiction of the executive, legislative, or judicial branch of the 
Government of the United States.
    (e) Definitions.--In this section:
            (1) The term ``highly infectious agent'' means an 
        infectious agent that meets the criteria of ``risk group 3'' or 
        ``risk group 4'' as such risk groups are defined in the latest 
        edition of ``NIH Guidelines for Research Involving Recombinant 
        or Synthetic Nucleic Acid Molecules'' published by the National 
        Institutes of Health (or any successor to such publication).
            (2) The term ``regulated seller'' means a seller of highly 
        infectious agents, except that such term does not include an 
        employee or agent of such a seller.
            (3) The term ``Secretary'' means the Secretary of Health 
        and Human Services, acting through the Assistant Secretary for 
        Preparedness and Response.

SEC. 3. EVALUATION OF HIGH-CONTAINMENT LABORATORIES.

    (a) In General.--The National Security Advisor, in consultation 
with the Secretary of Health and Human Services, the Secretary of 
Agriculture, the Secretary of Defense, the Secretary of Homeland 
Security, the National Intelligence Council, and such other Federal 
officials as the National Security Advisor determines appropriate, 
shall identify a single Federal official to oversee a periodic 
strategic evaluation of high-containment laboratories in the United 
States.
    (b) Topics.--Each strategic evaluation under subsection (a) shall 
include--
            (1) an assessment of--
                    (A) the number, location, and mission of high-
                containment laboratories;
                    (B) the capacity of such existing laboratories to 
                effectively meet national goals to counter threats to 
                biosafety and biosecurity;
                    (C) the aggregate risks associated with--
                            (i) such existing laboratories; and
                            (ii) expanding the numbers and facilities 
                        of such laboratories; and
                    (D) the type of oversight needed for high-
                containment laboratories; and
            (2) up-to-date national standards, developed by the Federal 
        official designated under subsection (a) in consultation with 
        the scientific community, for the design, construction, 
        commissioning, operation, and long-term maintenance of high-
        containment laboratories.
    (c) Reporting.--Upon completion of each strategic evaluation under 
subsection, (a), the Federal official designated under subsection (a) 
shall submit to the President and the Congress a report on the results 
of such evaluation and include in each such report recommendations on--
            (1) addressing gaps in Federal oversight of high-
        containment laboratories; and
            (2) utilizing high-containment laboratories for protecting 
        public health and ensuring biosecurity in the United States.
    (d) Public Health and Biosecurity Team.--
            (1) In general.--The Federal official designated under 
        subsection (a) shall maintain a team, to be known as the Public 
        Health and Biosecurity Team, to serve as a single point of 
        contact for State and local agencies regarding questions of 
        public health relating to laboratory biosafety and biosecurity.
            (2) Establishment.--The Federal official designated under 
        subsection (a) shall establish the Public Health and 
        Biosecurity Team, as required by paragraph (1), not later than 
        one year after such official is first designated.
            (3) Duties.--The Public Health and Biosecurity Team shall 
        be the primary point of contact in the Federal Government for 
        State and local agencies on--
                    (A) issues related to--
                            (i) oversight of high-containment 
                        laboratories;
                            (ii) the impact of high-containment 
                        laboratories on public health; or
                            (iii) connecting State and local officials 
                        with the relevant Federal agency or agencies on 
                        matters related to high-containment 
                        laboratories; and
                    (B) other issues as determined necessary by the 
                Federal official designated under subsection (a).
    (e) Feasibility Study.--
            (1) In general.--The Federal official designated under 
        subsection (a) shall conduct a feasibility study on 
        establishing and maintaining a database on existing high-
        containment laboratories in the United States and making such 
        database accessible to State and local officials.
            (2) Database described.--The database to be studied under 
        paragraph (1) should be designed to include, with respect to 
        each high-containment laboratory, the following information:
                    (A) The identity of the owners of the laboratory.
                    (B) The status of any licensing or certification of 
                the laboratory required under Federal, State, or local 
                law.
                    (C) Any legal violations by, and disciplinary 
                action taken against, the laboratory.
            (3) Report to congress.--Upon completion of the feasibility 
        study under this subsection, the Federal official designated 
        under subsection (a) shall submit to the Congress a report on 
        the results of such study.
    (f) Definition.--In this section, the term ``high-containment 
laboratory'' means laboratories that are suitable for ``biosafety level 
3'' or ``biosafety level 4'' procedures as defined in the latest 
edition of ``Biosafety in Microbiological and Biomedical Laboratories'' 
published by the Centers for Disease Control and Prevention and the 
National Institutes of Health (or any successor to such publication).
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