May 2025 Executive Order "Improving the Safety and Security of Biological Research"

On May 5, 2025, the Executive Order on Biological Research directed federal agencies to end funding for “dangerous gain-of-function research," including research subject to Category 1 and Category 2 oversight under DURC/PEPP policy. This suspension will remain in effect until the DURC/PEPP policy is revised or replaiced.

July 2026 United States Government (USG) Policy for Stopping High-Risk Life Sciences Research

On July 28, 2026, the United States Government released a new US Government Policy for Stopping High-Risk Life Sciences Research, issued pursuant to the May 2025 executive order.

The Missouri S&T Biosafety Office and Environmental Health and Safety (EHS) are actively coordinating with internal leadership and external partners to evaluate the requirements and implement institutional compliance procedures within the mandated 180-day window. Federal agencies are expected to publish formal implementation guidance within 120 days of issuance, which will serve as the framework for Missouri S&T's updated campus policies and eCompliance workflows.

Of note, the new policy requires institutional compliance for all research at the entity, irrespective of funding source, as a condition of receipt of federal funding.

Please continue to consult the OVCRI office, Associate Director of Compliance, Jessica Convertine (jnhkk7@(mst.edu) regarding compliance with any terms and conditions associated with federally or non-federally funded awards that may pertain to gain-of-function research, dual use research, research involving potential pandemic pathogens, or any other requirements that reference this policy.

“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.

Researchers are asked whether their research can be reasonably anticipated to produce one or more of the experimental effects/categories listed below:

a) Could result in significant societal consequences.

b) Seek or achieve one or more of the following outcomes:

• Enhancing the harmful consequences of the agent or toxin.
• 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.
• Increasing the stability, transmissibility, or the ability to disseminate the agent or toxin.
• Altering the host range or tropism of the agent or toxin.
• Enhancing the susceptibility of a human host population to the agent or toxin.
• Generating or reconstituting an eradicated or extinct agent or toxin

Affirmative answers do not automatically indicate research is DURC, nor will it usually delay experimental progress, it will indicate further consideration or awareness is warranted as the research advances, or as research results are published. For any question answered ‘yes’, investigators are asked to provide additional information to explain how the concern is addressed, and to allow for an assessment of all parameters related to the experimental result to demonstrate whether DURC criteria are met. If the criteria defining DURC is potentially met (in that the immediate products of the research could be readily used to do harm), the IRE will work with the PI to perform a risk assessment and develop the DURMP for IRE review.
 

Dual-Use Research of Concern

In May 2024, the United States Government (USG) reworked its policies pertaining to Dual Use Research of Concern and the “P3CO Framework” designed to address research with Potential Pandemic Pathogens (PPPs).  The result of this effort was the new USG Policy for Oversight of Dual Use Research of Concern and pathogens with Enhanced Pandemic Potential (DURC/PEPP), which became effective on May 6, 2025. This updated policy significantly expands the agents covered by both types of research, the applicable experimental outcomes, and the required review process. 

DURC (NIH Dual-Use Research) is defined as "life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be misapplied to do harm with no, or only minor, modification to pose a significant threat with potential consequences to public health and safety, agricultural crops or other plants, animals, the environment, materiel, or national security.” 

Under the U.S. Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (DURC/PEPP), Category 1 DURC research applies to studies involving any of the following biological agents or toxins:

• Select Agents & Toxins: All agents and toxins listed under the Federal Select Agents Program (FSAP), regulated by the USDA and/or HHS.

• Risk Group 4 (RG4) Pathogens: All RG4 pathogens listed in Appendix B of the NIH Guidelines

• Risk Group 3 (RG3) Pathogens: All RG3 pathogens listed in Appendix B of the NIH Guidelines, with the exception of: Human Immunodeficiency Virus (HIV), Human T-Lymphotropic Virus (HTLV), Simian immunodeficiency Virus (SIV), Mycobacterium tuberculosis or Mycobacterium bovis, Clade II Mpox virus MPXV), unless containing nucleic acid sequences encoding Clade I virulence factors, Vesicular Stomatitis Virus (VSV), Coccidioides immitis or Coccidioides posadasii, Histoplasma capsulatum or capsulatum var. duboisii.

• Unclassified Human Pathogens: Any human pathogen not explicitly assigned a Risk Group in the NIH Guidelines that is recommended for Biosafety Level 3 (BSL-3) or Biosafety Level 4 (BSL-4) containment per the current edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition

Note that research with Risk Group 3 or 4 biological agents is not permitted at the MS&T.

Pathogens with Enhanced Pandemic Potential (PEPP)

The USG DURC/PEPP policy classifies research involving PPPs and PEPPs as Category 2.

• Pathogen with Pandemic Potential (PPP): A pathogen capable of wide, uncontrollable spread in a human population that would likely cause moderate to severe disease or mortality. PPPs are not defined by a static list of species; rather, they are evaluated based on their potential to cause significant public health impact if introduced into the environment or human population.

• Pathogen with Enhanced Pandemic Potential (PEPP): A specific type of PPP created through research that enhances a pathogen's transmissibility, increases its virulence, or disrupts pre-existing human immunity—regardless of the progenitor agent used. PEPPs can result from modifying an existing PPP or altering a non-PPP so that it becomes a PPP (e.g., introducing virulence factors into an avirulent strain).

Category 2 Scope & Triggers Research falls under Category 2 oversight if it meets either of the following criteria:

1. Research involving an existing PPP that includes any of the following:

   • Enhancement of transmissibility in humans;

   • Enhancement of virulence (severity of disease) in humans;

   • Enhancement of immune evasion in humans (e.g., disrupting protection from vaccines or prior infection); OR

   • Generation, use, reconstitution, or transfer of an eradicated/extinct PPP or previously identified PEPP.

2. Research involving a non-PPP where modifications generate a potential PPP.