H.R. 5747

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5747 Introduced in House (IH)]

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119th CONGRESS
1st Session
H. R. 5747

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 covered distributor of 
a highly pathogenic agent to comply with certain logbook requirements, 
and for other purposes.

_______________________________________________________________________

IN THE HOUSE OF REPRESENTATIVES

October 14, 2025

Mr. Costa (for himself and Mr. Valadao) 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 covered distributor of 
a highly pathogenic 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 2025''.

SEC. 2. REQUIRING CERTAIN DISTRIBUTORS OF HIGHLY PATHOGENIC AGENTS TO 
KEEP A LOGBOOK OF SALES, LEASES, LOANS, AND OTHER 
TRANSFERS.

(a) Program.--The Secretary of Health and Human Services, acting 
through the Administration for Strategic Preparedness and Response, 
shall carry out a program under which the Secretary requires each 
covered distributor of a highly pathogenic agent to comply with the 
logbook requirements of subsection (c).
(b) List of Highly Pathogenic Agents.--
(1) Development.--The Secretary shall develop and maintain 
a list of all agents that meet the definition of a highly 
pathogenic agent in subsection (e).
(2) Initial list.--The Secretary shall develop the initial 
list required by paragraph (1) not later than 6 months after 
the date of enactment of this Act.
(3) Periodic review.--The Secretary shall annually 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, the Department of 
Homeland Security, the Department of Agriculture, the 
Department of the Interior, and the Department of 
Defense;
(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 covered distributor shall maintain, 
in accordance with such criteria and format as the Secretary 
may require, an electronic list (in this section referred to as 
a ``logbook'') of the sales, leases, loans, or other transfers 
by such distributor of each highly pathogenic agent on the list 
under subsection (b).
(2) Contents.--The covered distributor shall, for each 
sale, lease, loan, or other transfer referred to in paragraph 
(1), include in the logbook--
(A) the agent by name;
(B) the name, address, telephone number, and email 
address of the purchaser;
(C) other relevant identifying business information 
of the purchaser, as deemed necessary by the Secretary;
(D) a short description of--
(i) the purchaser's intended use of the 
highly pathogenic agent; and
(ii) where the purchaser will house the 
agent;
(E) the date and time of the sale, lease, loan, or 
other transfer;
(F) the method, date, and time of transfer of the 
highly pathogenic agent;
(G) a physical or electronic signature of the 
purchaser; and
(H) such other data elements as the Secretary may 
require.
(3) Sale requirements.--In the case of a sale, lease, loan, 
or other transfer to which paragraph (1) applies, the covered 
distributor shall not sell the highly pathogenic agent unless--
(A) the prospective purchaser, in physical form or 
electronically in compliance with the Electronic 
Signatures in Global and National Commerce Act (42 
U.S.C. 7001 et seq.)--
(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) verifies by signature in the logbook--
(I) the purchaser's name and 
address;
(II) a short description of--
(aa) the purchaser's 
intended use of the agent; and
(bb) where the purchaser 
will house the agent;
(III) the date and time of the 
sale, lease, loan, or other transfer; 
and
(IV) the method, date, and time of 
transfer of the agent; and
(B) the covered distributor--
(i) determines that the name entered in the 
logbook corresponds to the name provided on the 
identification card referred to in subparagraph 
(A)(i), and that the information entered 
pursuant to subparagraph (A)(ii) is correct; 
and
(ii) enters in the logbook the name of the 
highly pathogenic agent.
(4) Contents.--The covered distributor 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.
(5) Duration of maintenance of entries.--
(A) Retention period.--The covered distributor 
shall maintain each entry in the logbook for not fewer 
than three years after the date on which the entry is 
made.
(B) Successor entity.--If ownership of a covered 
distributor changes, the successor entity shall assume 
custody of and responsibility for all logbooks for the 
balance of the three-year retention period required by 
subparagraph (A).
(6) 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, Federal, State, local, 
Tribal, and territorial law enforcement agencies, and 
State health officials; and
(B) prohibit accessing, using, or sharing 
information in the logbooks for any purpose other 
than--
(i) to ensure compliance with this section;
(ii) to protect public health and safety; 
or
(iii) to protect national security.
(7) FOIA exemption.--Logbooks and any derivative data are 
exempt from disclosure under section 552(b)(3) of title 5, 
United States Code.
(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 pathogenic agent''--
(A) subject to subparagraph (B), means a pathogenic 
agent that meets the criteria of ``risk group 3'' or 
any higher level risk groups 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); and
(B) excludes any biological agent or toxin that is 
regulated under section 351A of the Public Health 
Service Act (42 U.S.C. 262a) or section 212 of the 
Agricultural Bioterrorism Protection Act of 2002 (7 
U.S.C. 8401).
(2) The term ``covered distributor''--
(A) means an entity that sells, leases, loans, or 
otherwise transfers for value or without value a highly 
pathogenic agent, except that such term does not 
include an employee or agent of such a distributor; and
(B) includes a publicly funded repository or 
biobank that sells, leases, loans, or otherwise 
transfers a highly pathogenic agent, as described in 
subparagraph (A).
(3) The term ``Secretary'' means the Secretary of Health 
and Human Services, acting through the Administration for 
Strategic Preparedness and Response.
(f) Rule of Construction.--Nothing in this section shall be 
construed to supersede or otherwise affect the Federal Select Agent 
Program under section 351A of the Public Health Service Act (42 U.S.C. 
262a) and section 212 of the Agricultural Bioterrorism Protection Act 
of 2002 (7 U.S.C. 8401).

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 Secretary of the Interior, the Director of National 
Intelligence, and such other Federal officials as the National Security 
Advisor determines appropriate, shall identify a single Federal entity 
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 physical security measures at high-
containment laboratories;
(D) the aggregate risks associated with--
(i) such existing laboratories; and
(ii) expanding the numbers and facilities 
of such laboratories; and
(E) the type of oversight needed for high-
containment laboratories; and
(2) up-to-date national standards, developed by the Federal 
entity identified under subsection (a)--
(A) are developed by the Federal entity identified 
under subsection (a) in consultation with members of 
the scientific community, for the design, construction, 
commissioning, operation, and long-term maintenance of 
high-containment laboratories; and
(B) take into consideration applicable regulations 
and guidance for high-containment laboratories.
(c) Reporting.--Upon completion of each strategic evaluation under 
subsection (a), the Federal entity identified 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 biosafety and biosecurity in the 
United States.
(d) Public Health Biosafety and Biosecurity Team.--
(1) In general.--The Federal entity identified under 
subsection (a) shall maintain a team, to be known as the Public 
Health Biosafety and Biosecurity Team, to serve as a single 
point of contact for State, local, Tribal, and territorial 
agencies regarding questions relating to laboratory biosafety 
and biosecurity.
(2) Establishment.--The Federal entity identified 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 Biosafety and Biosecurity 
Team shall be the single point of contact in the Federal 
Government for State, local, Tribal, and territorial 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, local, Tribal, and 
territorial 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 entity identified under subsection (a).
(e) Feasibility Study.--
(1) In general.--The Federal entity identified under 
subsection (a) shall conduct a feasibility study on 
establishing and maintaining a database on existing high-
containment laboratories in the United States for the purpose 
of making such database accessible to Federal, State, local, 
Tribal, and territorial 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 address of the laboratory.
(C) The status of any licensing or certification of 
the laboratory required under Federal, State, local, 
Tribal, or territorial law.
(D) Any legal violations by, and disciplinary 
action taken against, the laboratory.
(E) Such additional information as the Federal 
entity identified under subsection (a) determines 
appropriate to protect biosafety and biosecurity.
(3) Report to congress.--Upon completion of the feasibility 
study under this subsection, the Federal entity identified 
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 any higher biosafety level 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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