[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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