Bill Summary
The "Preventing Illegal Laboratories and Protecting Public Health Act of 2026" is a piece of legislation aimed at enhancing the regulation of highly pathogenic agents, which are biological agents posing significant health risks. The Act mandates that the Secretary of Health and Human Services, through the Assistant Secretary for Preparedness and Response, implement a comprehensive program to ensure that distributors of these agents maintain detailed logbooks documenting all sales, leases, loans, and other transfers.
Key provisions include:
1. **Logbook Requirements**: Covered distributors must keep an electronic logbook detailing the transaction of highly pathogenic agents, including the purchaser's information, intended use, and transfer details.
2. **List of Agents**: The Secretary is tasked with developing and regularly updating a list of agents classified as highly pathogenic, based on established guidelines and expert consultations.
3. **Compliance and Audits**: The Secretary will have the authority to conduct audits to ensure compliance with logbook requirements, focusing on higher-risk distributors.
4. **False Statements**: The Act stipulates that providing false information for logbook entries may lead to criminal penalties.
5. **Evaluation of Laboratories**: The legislation also mandates a strategic evaluation of high-containment laboratories in the U.S. to assess their security, capacity, and potential risks, with the establishment of a dedicated team to oversee biosafety and biosecurity issues.
Overall, the act seeks to strengthen oversight of potentially dangerous biological materials to protect public health and prevent illegal laboratory operations.
Possible Impacts
The "Preventing Illegal Laboratories and Protecting Public Health Act of 2026" could affect people in the following ways:
1. **Increased Safety and Transparency in Handling Pathogenic Agents**: The legislation mandates that covered distributors of highly pathogenic agents maintain detailed logbooks of all transactions involving these agents. This requirement aims to enhance accountability and traceability, which can help prevent the mishandling or illegal distribution of dangerous pathogens, ultimately protecting public health. Individuals may feel more secure knowing that there are stringent regulations governing the sale and transfer of potentially harmful biological agents.
2. **Legal Consequences for Non-compliance**: The act stipulates that providing false information in logbooks can lead to criminal penalties. This provision could lead to individuals or organizations facing legal repercussions if they fail to comply with the law. As a result, participants in the scientific and medical fields may need to invest more time and resources into ensuring compliance with these regulations, affecting their operations and possibly leading to increased costs.
3. **Impact on Research Institutions and Laboratories**: The evaluation and oversight of high-containment laboratories are emphasized in the legislation. As a result, research institutions may face additional scrutiny and administrative burdens to comply with new oversight measures, which could impact their funding and ability to conduct research involving highly pathogenic agents. This could lead to delays in research projects, affecting scientists, students, and the broader community that relies on advancements in biomedical research and public health initiatives.
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 4227 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
2d Session
S. 4227
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 SENATE OF THE UNITED STATES
March 26, 2026
Ms. Cortez Masto (for herself and Mr. Banks) introduced the following
bill; which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
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 2026''.
SEC. 2. REQUIRING CERTAIN DISTRIBUTORS OF HIGHLY PATHOGENIC AGENTS TO
KEEP A LOGBOOK OF SALES, LEASES, LOANS, AND OTHER
TRANSFERS.
(a) Program.--The Secretary 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 the Secretary determines
appropriate;
(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 described 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) Notice.--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 3 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
remainder of the 3-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.
(8) Applicability.--A transfer of a highly pathogenic agent
between laboratories within a single institution of higher
education (as defined in section 101 of the Higher Education
Act of 1965 (20 U.S.C. 1001)) does not constitute a sale,
lease, loan, or other transfer of the agent for purposes of
paragraph (1).
(9) Audits.--The Secretary shall establish a risk-based
compliance review process by which the Secretary may conduct
audits of logbooks when the Secretary has cause to believe a
violation of this section has occurred. The Secretary shall
focus audits conducted under this paragraph on higher-risk
distributors and suspicious patterns.
(d) False Statements or Misrepresentations by Purchasers.--For
purposes of section 1001 of title 18, United States Code, providing
information to a covered distributor for purposes of entering such
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 ``covered distributor''--
(A) means an entity that sells, leases, loans, or
otherwise transfers for value or not for 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).
(2) 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).
(3) The term ``Secretary'' means the Secretary of Health
and Human Services, acting through the Assistant Secretary 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), that--
(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 to 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 the Federal entity identified
under subsection (a) determines appropriate.
(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 considered under
paragraph (1) shall be a database 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 Congress a report on the
results of such study.
(f) Definition.--In this section, the term ``high-containment
laboratory'' means a laboratory that is 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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