Improving the Safety and Security of Biological Research

Executive Orders

TLDR

This executive order halts federal funding for dangerous gain-of-function research in countries of concern and strengthens oversight of biological research. It mandates revised policies within 120 days, requires public reporting of research activities, imposes strict contractual requirements with penalties for violations, addresses privately funded research, and provides a detailed definition of dangerous gain-of-function research. The order aims to prevent potential threats to public health and national security while maintaining scientific progress.

This executive order is aimed at overhauling federal oversight and funding of “dangerous gain-of-function” research involving biological agents and pathogens. The order asserts that such research, if left unchecked, poses significant risks to public health, national security, and the economy, referencing both domestic and international research activities, particularly those in countries like China. The order criticizes the previous administration for insufficient oversight and seeks to implement stricter controls and greater transparency.

Key provisions include:

  1. Immediate Halt to Funding for Certain Research

    • The order directs the Office of Science and Technology Policy (OSTP) to immediately end federal funding for dangerous gain-of-function research in countries of concern (such as China) or any country lacking adequate U.S.-equivalent oversight. It also halts funding for other life-science research abroad that could threaten U.S. security or public health, pending new policy development.

  2. Strengthening Oversight and Enforcement

    • Within 120 days, OSTP must revise or replace the 2024 federal policy on dual-use research and pandemic pathogens to:
      • Increase independent oversight and accountability.
      • Incorporate enforcement mechanisms (including audits and penalties).
      • Ensure regular review and updates to these frameworks.
    • The order also mandates revision of the framework for nucleic acid synthesis screening to minimize misuse, requiring all federally funded research to procure synthetic DNA from compliant providers.

  3. Addressing Non-Federally Funded Research

  • The order instructs OSTP to devise a strategy to track, limit, and govern dangerous gain-of-function research in the U.S. that does not receive federal funding. This includes proposing new legislation if existing authorities are insufficient.
  1. Enhanced Transparency and Reporting
  • Institutions receiving federal funds must report dangerous gain-of-function research activities, including those funded privately, to a public database-while safeguarding national security and intellectual property.
  1. Strict Contractual Terms and Penalties
  • All federal life-science research contracts must include:
    • Certification of compliance with the order.
    • Prohibition on participation in non-compliant foreign research.
    • Provisions for revocation of funding and up to a five-year ban for violations.
  1. Definition of Dangerous Gain-of-Function Research
    • The order provides a detailed definition, focusing on research that enhances the pathogenicity, transmissibility, or societal impact of biological agents, including reviving eradicated pathogens.

The order asserts that the Biden Administration allowed dangerous research with “insufficient oversight.” In reality, U.S. policy on gain-of-function research has been subject to ongoing review and multiple layers of oversight, especially after the 2014 moratorium and subsequent policy frameworks. While some critics have argued for stricter controls, the claim of “active approval” of risky research in China is not substantiated by public evidence. Most U.S. funding for foreign research is subject to review, and direct funding for high-risk work in adversarial countries has been rare and controversial.

The order’s attempt to regulate non-federally funded research is ambitious but faces significant legal and practical hurdles. The federal government has limited authority over privately funded research conducted entirely within the U.S. unless new legislation is passed.

Public reporting of sensitive research projects increases transparency but could also risk exposing information that may be misused, a challenge acknowledged in the order’s caveats.

The broad definitions and punitive measures may have a chilling effect on legitimate biomedical research, especially collaborations with international partners and work on emerging infectious diseases. The requirement for DNA synthesis screening is technically feasible but may increase costs and administrative burdens.

This executive order represents a sweeping attempt to clamp down on gain-of-function research, especially with foreign entities and in countries deemed adversarial. While it addresses legitimate concerns about biosafety and national security, its framing overstates prior administrative failings and may overreach in its efforts to regulate non-federally funded research. The order’s strict enforcement and reporting requirements could slow scientific progress and international collaboration, but may also spur needed updates to oversight frameworks and encourage greater transparency. The ultimate effectiveness of these measures will depend on their implementation, the cooperation of the research community, and the ability to balance security with scientific advancement.

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 42U.S.C. 6627©, 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 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 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;

© 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;

© 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.

© 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.

(d) The Department of Health and Human Services shall provide funding for this order’s publication in the_Federal Register_.

DONALD J. TRUMP THE WHITE HOUSE,
May 5, 2025.