Presidential DocumentExecutive Order 142922025-08266
Improving the Safety and Security of Biological Research
Primary source
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Published
May 8, 2025
Signed
May 5, 2025
Issuing agencies
Executive Office of the President
Full Text
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<title>Federal Register, Volume 90 Issue 88 (Thursday, May 8, 2025)</title>
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[Federal Register Volume 90, Number 88 (Thursday, May 8, 2025)]
[Presidential Documents]
[Pages 19611-19614]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-08266]
Presidential Documents
Federal Register / Vol. 90 , No. 88 / Thursday, May 8, 2025 /
Presidential Documents
[[Page 19611]]
Executive Order 14292 of May 5, 2025
Improving the Safety and Security of Biological
Research
By the authority vested in me as President by the
Constitution and the laws of the United States of
America, it is hereby ordered:
Section 1. Purpose. Dangerous gain-of-function research
on biological agents and pathogens has the potential to
significantly endanger the lives of American citizens.
If left unrestricted, its effects can include
widespread mortality, an impaired public health system,
disrupted American livelihoods, and diminished economic
and national security.
The Biden Administration allowed dangerous gain-of-
function research within the United States with
insufficient levels of oversight. It also actively
approved, through the National Institutes of Health,
Federal life-science research funding in China and
other countries where there is limited United States
oversight or reasonable expectation of biosafety
enforcement.
This recklessness, if unaddressed, may lead to the
proliferation of research on pathogens (and potential
pathogens) in settings without adequate safeguards,
even after COVID-19 revealed the risk of such
practices.
Sec. 2. Policy. It is the policy of the United States
to ensure that United States federally funded research
benefits American citizens without jeopardizing our
Nation's security, strength, or prosperity. My
Administration will balance the prevention of
catastrophic consequences with maintaining readiness
against biological threats and driving global
leadership in biotechnology, biological
countermeasures, biosecurity, and health research.
Sec. 3. Stop Dangerous Gain-of-Function Research. (a)
The Director of the Office of Science and Technology
Policy (OSTP), in coordination with the Director of the
Office of Management and Budget and the Assistant to
the President for National Security Affairs (APNSA),
and in consultation with the Secretary of Health and
Human Services and the heads of other relevant
executive departments and agencies (agencies)
identified by the Director of OSTP, shall establish
guidance for the heads of relevant agencies, to the
extent consistent with the terms and conditions of the
funding, to immediately:
(i) end Federal funding of dangerous gain-of-function research conducted by
foreign entities in countries of concern (e.g., China) pursuant to 42
U.S.C. 6627(c), or in other countries where there is not adequate oversight
to ensure that the countries are compliant with United States oversight
standards and policies; and
(ii) end Federal funding of other life-science research that is occurring
in countries of concern or foreign countries where there is not adequate
oversight to ensure that the countries are compliant with United States
oversight standards and policies and that could reasonably pose a threat to
public health, public safety, and economic or national security, as
determined by the heads of relevant agencies.
(b) The Director of OSTP, in coordination with the
Director of the Office of Management and Budget and the
APNSA, and in consultation with the Secretary of Health
and Human Services and the heads of other relevant
agencies, shall establish guidance for the Secretary of
Health and Human Services and the heads of other
relevant agencies with respect to suspension of
federally funded dangerous gain-of-function research,
pursuant to the terms and conditions of the relevant
research funding, at least until the
[[Page 19612]]
completion of the policy called for in section 4(a) of
this order. Heads of agencies shall report any
exception to a suspension to the Director of OSTP for
review in consultation with the APNSA and the heads of
relevant agencies.
Sec. 4. Secure Future Research Through Commonsense
Frameworks. (a) Within 120 days of the date of this
order, the Director of OSTP, pursuant to 42 U.S.C. 6627
and in coordination with the APNSA and the heads of
relevant agencies, shall revise or replace the 2024
``United States Government Policy for Oversight of Dual
Use Research of Concern and Pathogens with Enhanced
Pandemic Potential'' to:
(i) strengthen top-down independent oversight; increase accountability
through enforcement, audits, and improved public transparency; and clearly
define the scope of covered research while ensuring the United States
remains the global leader in biotechnology, biological countermeasures, and
health research;
(ii) incorporate enforcement mechanisms, including those described in
section 7 of this order, into Federal funding agreements to ensure
compliance with all Federal policies governing dangerous gain-of-function
research; and
(iii) provide for review and revision at least every 4 years, or as
appropriate.
(b) Within 90 days of the date of this order, the
Director of OSTP, in coordination with the APNSA and
the heads of relevant agencies, shall revise or replace
the 2024 ``Framework for Nucleic Acid Synthesis
Screening'' (Framework) to ensure it takes a
commonsense approach and effectively encourages
providers of synthetic nucleic acid sequences to
implement comprehensive, scalable, and verifiable
synthetic nucleic acid procurement screening mechanisms
to minimize the risk of misuse. The heads of all
agencies that fund life-science research shall ensure
that synthetic nucleic acid procurement is conducted
through providers or manufacturers that adhere to the
updated Framework. To ensure compliance, the updated
Framework shall incorporate the enforcement mechanisms
described in section 7 of this order. The Framework
shall be reviewed and revised at least every 4 years,
or as appropriate.
Sec. 5. Manage Risks Associated with Non-federally
Funded Research. Within 180 days of the date of this
order, the Director of OSTP, in coordination with the
Director of the Office of Management and Budget, the
APNSA, the Assistant to the President for Domestic
Policy, and the heads of other relevant agencies, shall
develop and implement a strategy to govern, limit, and
track dangerous gain-of-function research across the
United States that occurs without Federal funding and
other life-science research that could cause
significant societal consequences. This strategy shall
include actions to achieve comprehensive, scalable, and
verifiable nucleic acid synthesis screening in non-
federally funded settings. Any gaps in authorities
necessary to achieve the goals of this strategy shall
be addressed in a legislative proposal to be sent to
the President, through the Director of OSTP and the
APNSA, within 180 days of the date of this order.
Sec. 6. Increase Accountability and Public Transparency
of Dangerous Gain-of-Function Research. The Director of
OSTP, in coordination with the APNSA and the heads of
relevant agencies, shall ensure that the revised policy
called for in section 4(a) of this order includes a
mechanism whereby research institutions that receive
Federal funding must report dangerous gain-of-function
research, and to the maximum extent permitted by law,
include research that is supported by non-Federal
funding mechanisms. The reporting mechanism shall
provide a publicly available source of information
about research programs and awards identified pursuant
to this section, including, where permitted by law,
those that have been stopped or suspended pursuant to
sections 3(a) and 3(b) of this order, and all future
programs and awards that are covered by the updated
policy developed in section 4(a) of this order. This
reporting shall be conducted in a way that does not
compromise
[[Page 19613]]
national security or legitimate intellectual property
interests of subject institutions.
Sec. 7. Future Enforcement Terms. The Secretary of
Health and Human Services and the heads of other
relevant agencies shall, consistent with existing laws
and regulations, include in every life-science research
contract or grant award:
(a) a term requiring the contractual counterparty
or grant recipient to agree that its compliance in all
respects with the terms of this order and any
applicable regulations promulgated by the contracting
or grant-offering agency is material to the
Government's payment decisions for purposes of 31
U.S.C. 3729(b)(4);
(b) a term requiring such counterparty or recipient
to certify that it does not operate, participate in, or
fund any dangerous gain-of-function research or other
life-science research in foreign countries that could
cause significant societal consequences or generate
unnecessary national security risks, and that does not
comply with this order and the policies ordered herein;
(c) a term stating that a violation of the terms of
this order or any applicable regulations promulgated by
the contracting or grant-offering agency by any grant
recipient may be considered a violation of such term by
the recipient's employer or institution; and
(d) a term stating that any grant recipient,
employer, or institution found to be in violation of
the terms of this order or any applicable regulations
promulgated by the contracting or grant-making agency
may be subject to immediate revocation of ongoing
Federal funding, and up to a 5-year period of
ineligibility for Federal life-sciences grant funds
offered by the Department of Health and Human Services
and other relevant agencies.
Sec. 8. Definitions. For the purposes of this order,
``dangerous gain-of-function research'' means
scientific research on an infectious agent or toxin
with the potential to cause disease by enhancing its
pathogenicity or increasing its transmissibility.
Covered research activities are those that could result
in significant societal consequences and that seek or
achieve one or more of the following outcomes:
(a) enhancing the harmful consequences of the agent
or toxin;
(b) disrupting beneficial immunological response or
the effectiveness of an immunization against the agent
or toxin;
(c) conferring to the agent or toxin resistance to
clinically or agriculturally useful prophylactic or
therapeutic interventions against that agent or toxin
or facilitating their ability to evade detection
methodologies;
(d) increasing the stability, transmissibility, or
the ability to disseminate the agent or toxin;
(e) altering the host range or tropism of the agent
or toxin;
(f) enhancing the susceptibility of a human host
population to the agent or toxin; or
(g) generating or reconstituting an eradicated or
extinct agent or toxin.
Sec. 9. General Provisions. (a) Nothing in this order
shall be construed to impair or otherwise affect:
(i) the authority granted by law to an executive department or agency, or
the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget
relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with
applicable law and subject to the availability of
appropriations.
(c) This order is not intended to, and does not,
create any right or benefit, substantive or procedural,
enforceable at law or in equity by any party against
the United States, its departments, agencies, or
entities, its officers, employees, or agents, or any
other person.
[[Page 19614]]
(d) The Department of Health and Human Services
shall provide funding for this order's publication in
the Federal Register.
<GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT>
(Presidential Sig.)
THE WHITE HOUSE,
May 5, 2025.
[FR Doc. 2025-08266
Filed 5-7-25; 11:15 am]
Billing code 4150-28-P
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</html>Indexed from Federal Register on May 8, 2025.
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