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Editorial · CASRAI · Compliance and regulatory

Executive Order 14292: New Biological Research Security Requirements

Executive Order 14292 (May 2025) paused federal funding for dangerous gain-of-function research and set OSTP deadlines for oversight rules, now overdue.

Published 23 Jul 2026· 6 minute read

TL;DR: Executive Order 14292, “Improving the Safety and Security of Biological Research,” signed May 5, 2025, immediately paused new federal funding for research meeting its definition of “dangerous gain-of-function research,” rescinded the 2024 US Government DURC/PEPP oversight policy, and gave the Office of Science and Technology Policy (OSTP) three deadlines to replace it. All three deadlines — 90, 120, and 180 days from signing — have now passed. This piece covers what the order actually requires and what CASRAI could and could not independently confirm about implementation status as of this writing.

What Executive Order 14292 Actually Requires

EO 14292 was signed on May 5, 2025 and published in the Federal Register shortly after. Per the order’s text on whitehouse.gov, its core provisions are:

  • Immediate funding pause. The order directs an immediate suspension of federal funding for research that meets its definition of dangerous gain-of-function research — research on an infectious agent or toxin with the potential to cause disease, where the research enhances the agent’s pathogenicity or increases its transmissibility — and states the pause holds at least until the Section 4(a) policy referenced below is complete.
  • Rescission of the 2024 policy. The order supersedes the May 2024 “United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential” (the DURC/PEPP policy), which had itself only recently unified the 2014 DURC policy and the 2017 P3CO Framework.
  • Restrictions on foreign entities. The order directs federal agencies to end funding for dangerous gain-of-function research conducted by foreign entities located in “countries of concern” (the order cites China as an example) or in countries that do not meet US oversight and compliance standards.

Three OSTP Deadlines — All Now Past Due

The order sets three sequential deadlines for OSTP, measured from the May 5, 2025 signing date:

90 days (early August 2025): revised nucleic acid synthesis screening framework

OSTP was directed to revise or replace the existing Framework for Nucleic Acid Synthesis Screening so that it promotes “comprehensive, scalable, and verifiable” procurement screening by providers of synthetic DNA/RNA sequences, with compliance and enforcement mechanisms built in.

120 days (early September 2025): replacement DURC/PEPP oversight policy

OSTP was directed to revise or replace the rescinded 2024 DURC/PEPP policy with a version that strengthens independent oversight, increases accountability through audits and enforcement built into funding agreements, more clearly defines the scope of covered research, and mandates review of the policy at least every four years.

180 days (early November 2025): strategy for non-federally-funded gain-of-function research

The order also directed OSTP to develop and implement a strategy to govern, limit, and track dangerous gain-of-function research that occurs without federal funding — work the prior DURC/PEPP framework, built around federal funding agreements, had no mechanism to reach at all — including comprehensive nucleic acid synthesis screening coverage in non-federally-funded settings.

Where Implementation Actually Stands

Institutions need to know not just what the order says but whether its deadlines were met. Here CASRAI’s research surfaced a genuine gap between the order’s requirements and confirmable public record. NIH issued an early implementation notice (NOT-OD-25-112) stating it would not accept new competitive applications for research meeting the order’s dangerous-gain-of-function definition and would move to suspend affected ongoing funding consistent with the order. That confirms agencies began complying with the immediate funding pause. What CASRAI could not independently confirm as of this writing is whether OSTP has actually published a finalized replacement for the 2024 DURC/PEPP policy, a revised nucleic acid synthesis screening framework, or the non-federally-funded research strategy — the three OSTP deliverables described above. All three statutory deadlines have now passed by a wide margin. Research administrators and biosafety offices should not assume any of the three has shipped, or infer its contents from the order’s text alone, without checking current status directly.

What This Means for Institutional Biosafety Committees and Grants Offices

Until OSTP’s replacement policy is confirmed published, institutions are effectively operating in a gap between a rescinded 2024 framework and an unconfirmed successor. Practical implications for research administration:

  • Ongoing awards involving gain-of-function work should be flagged for review against the order’s dangerous-gain-of-function definition, in coordination with sponsored-programs and biosafety offices, even absent new agency-specific guidance.
  • New proposals in this space should expect delay or non-acceptance at agencies that have issued their own implementation notices (NIH being the clearest confirmed example), independent of whether OSTP’s policy has shipped.
  • The order’s requirements are additive to, not a replacement for, standard Institutional Biosafety Committee (IBC) review under the NIH Guidelines and BMBL containment requirements — a protocol still needs ordinary biosafety sign-off regardless of where DURC/PEPP-level federal review stands.
  • International collaborations should specifically check whether a foreign collaborator sits in a jurisdiction the order would treat as a country of concern, since that funding restriction is not contingent on the OSTP policy being finalized — it applies from the order’s text directly.

How This Relates to Existing DURC/PEPP and Gain-of-Function Oversight

EO 14292 is a change to the federal oversight mechanism, not to the underlying concepts research administrators already need to know. For the fuller picture of what counts as gain-of-function research, how it differs from an enhanced potential pandemic pathogen (ePPP), and how the 2014-2024 policy evolution led up to this order, see CASRAI’s guide, What Is Gain-of-Function Research? Gain-of-function work of regulatory concern is a subset of the broader Dual Use Research of Concern (DURC) category, and containment requirements are set independently via Biosafety Level (BSL) designations, up to BSL-4 for the highest-consequence agents.

Frequently Asked Questions

Does Executive Order 14292 ban gain-of-function research?

No. It pauses federal funding for the narrower category the order defines as “dangerous” gain-of-function research, and directs new oversight and tracking mechanisms — it does not prohibit the broader category of ordinary, low-risk gain-of-function techniques used throughout routine laboratory research.

Has OSTP published the replacement DURC/PEPP policy required by EO 14292?

CASRAI could not independently confirm publication of a finalized replacement policy as of this writing, despite the order’s 120-day deadline (early September 2025) having passed. Institutions should verify current status directly with OSTP, their federal funding agency, and their institution’s biosafety office rather than assume the deadline was met.

Does the pause apply to research that isn’t federally funded?

The immediate funding pause applies to federally funded research. EO 14292 separately directed OSTP to develop, within 180 days, a strategy specifically to govern, limit, and track dangerous gain-of-function research occurring without federal funding — a gap the prior framework did not address, since it operated entirely through federal funding agreements.

Which countries does the “countries of concern” restriction cover?

The order’s text cites China as an example of a country of concern and also restricts funding to foreign entities in any country that does not meet US oversight and compliance standards, without publishing an exhaustive named list in the order itself. Institutions with international collaborators conducting relevant research should confirm current agency guidance on scope.

Referenced across the research world

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