In my capacity as President, empowered by the Constitution and the laws of the United States, I hereby decree:
Section 1. Purpose
Gain-of-function research on biological agents poses serious risks to the health and safety of American citizens. Left unchecked, such research could lead to widespread mortality, weaken public health systems, disrupt livelihoods across the nation, and jeopardize both economic and national security. Under the Biden Administration, there was a troubling lack of oversight regarding these dangerous practices, particularly with the approval of funding for life-science research in countries like China, where U.S. oversight is minimal. This negligence could result in a resurgence of risky pathogen research in environments that lack proper safety measures, highlighting the lessons of the COVID-19 pandemic that remain unheeded.
Sec. 2. Policy
The United States is committed to ensuring that federally funded research serves the interests of American citizens without compromising national security, strength, or prosperity. My Administration will endeavor to balance the prevention of catastrophic outcomes with the readiness to confront biological threats while enhancing our global leadership in biotechnology, biosecurity, and health research.
Sec. 3. Stop Dangerous Gain-of-Function Research
(a) The Director of the Office of Science and Technology Policy (OSTP) shall, in coordination with the Office of Management and Budget, the Assistant to the President for National Security Affairs, and relevant agency heads, establish immediate guidance to:
- (i) Cease Federal funding for hazardous gain-of-function research conducted by foreign entities in nations of concern, such as China, or in other countries lacking adequate oversight to meet U.S. standards;
- (ii) Halt Federal funding for other life-science research in these same countries if such research poses a potential threat to public health, safety, or national security, as determined by agency heads.
(b) The OSTP Director shall also provide guidance on suspending federally funded gain-of-function research until the completion of the policy outlined in Section 4(a) of this order. Any exceptions to this suspension must be reported to the OSTP Director for review.
Sec. 4. Secure Future Research Through Commonsense Frameworks
(a) Within 120 days, the OSTP Director, in collaboration with relevant agency heads, 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) Enhance independent oversight, boost accountability through audits, and improve public transparency while ensuring U.S. leadership in biotechnology and health research;
- (ii) Incorporate enforcement mechanisms into Federal funding agreements for compliance with policies governing risky gain-of-function research;
- (iii) Mandate review and revision at least every four years, or as necessary.
(b) Within 90 days, the OSTP Director shall also update the 2024 “Framework for Nucleic Acid Synthesis Screening” to promote a practical approach encouraging comprehensive screening mechanisms for synthetic nucleic acid procurement to minimize misuse risks. All funding agencies must ensure compliance with this updated Framework, which will also include enforcement mechanisms detailed in Section 7 of this order.
Sec. 5. Manage Risks Associated with Non-Federally Funded Research
Within 180 days, the OSTP Director, alongside relevant officials, shall devise and implement a strategy to regulate, limit, and monitor dangerous gain-of-function research that occurs without Federal funding. This strategy will encompass comprehensive screening for nucleic acid synthesis in such non-funded settings, addressing any legislative gaps necessary for implementation.
Sec. 6. Increase Accountability and Public Transparency of Dangerous Gain-of-Function Research
The OSTP Director, in collaboration with relevant agency heads, will ensure that the revised policy requires research institutions receiving Federal funding to report any gain-of-function research. This reporting mechanism will include publicly accessible information about research programs and awards, while safeguarding national security and intellectual property interests.
Sec. 7. Future Enforcement Terms
The Secretary of Health and Human Services and relevant agencies shall include in all life-science research contracts:
- (a) A requirement for compliance with this order as a material condition for Government payment;
- (b) A certification that no dangerous gain-of-function research is conducted or funded in foreign countries posing significant societal risks;
- (c) A stipulation that violations may be considered breaches by the recipient’s institution;
- (d) A provision for immediate funding revocation and potential ineligibility for up to five years for any violators.
Sec. 8. Definitions
For the purposes of this order, “dangerous gain-of-function research” refers to scientific investigations on infectious agents or toxins that potentially enhance their pathogenicity or transmissibility. Covered activities include any that could lead to adverse societal impacts by:
- (a) Increasing the harmful effects of the agent;
- (b) Disrupting beneficial immunological responses or vaccine effectiveness;
- (c) Granting resistance to therapeutic interventions;
- (d) Enhancing stability and transmissibility;
- (e) Altering host range or tropism;
- (f) Heightening susceptibility of human populations;
- (g) Recreating eradicated agents.
Sec. 9. General Provisions
(a) This order shall not impair the authority granted by law to any executive department or agency, nor affect the functions of the Office of Management and Budget regarding budgetary proposals.
(b) Implementation of this order will comply with applicable law and depend on available appropriations.
(c) This order does not create any enforceable rights or benefits for any parties against the U.S. or its entities.
(d) The Department of Health and Human Services will provide funding for the publication of this order in the Federal Register.
DONALD J. TRUMP
THE WHITE HOUSE,
May 5, 2025.
