Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential

May 2025 Executive Order

On May 5, 2025, President Trump signed an Executive Order titled “Improving the Safety and Security of Biological Research.” This directive instructs federal agencies to develop guidance for suspending federal funding for “dangerous gain-of-function research,” including research subject to Category 1 and Category 2 oversight under the DURC/PEPP Policy. This suspension will remain in effect until the DURC/PEPP Policy is revised or replaced.

Until a new federal policy is issued and procedures implemented to ensure compliance by the University of Florida, please consult with the UF Biosafety Office (bso@ehs.ufl.edu) for compliance with any terms and conditions associated with federal awards which may pertain to gain-of-function research, dual use research, research with potential pandemic pathogens, or any other such terms which reference the White House’s Executive Order linked to above.

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. Per University of Florida policy, the USG DURC/PEPP policy applies to both federally-funded and non-federally funded research.

Dual Use Research of Concern

DURC 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.” The USG DURC/PEPP policy defines DURC research as “Category 1,” involving any of the following biological agents or toxins:

All Biological Select Agents and Toxins as listed on the Federal Select Agents Program (FSAP) website, regulated by USDA and/or HHS.
All Risk Group 4 pathogens listed in Appendix B of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines).
All Risk Group 3 pathogens, also listed in Appendix B of the NIH Guidelines, except for the following: Human immunodeficiency virus, human T-lymphotrophic virus, simian immunodeficiency virus, Mycobacterium tuberculosis or bovis, clade II of MPVX viruses unless containing nucleic acids coding for clade I virulence factors, vesicular stomatitis virus, Coccidioides immitis or posadasii, Histoplasma capsulatum or capsulatum var. duboisii.
For biological agents affecting humans that have not been assigned a Risk Group in the NIH Guidelines, all agents affecting humans that are recommended to be handled at Biosafety Level 3 or 4 per the current edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL).

Note that research with Risk Group 4 biological agents is not permitted at the University of Florida.

Any UF researcher proposing to work with any of the above, including exempt quantities of select toxins or select toxin nucleic acids, must contact the EH&S Biosafety Office (bso@ehs.ufl.edu) for consultation. Researchers will be required to complete the UF DURC/PEPP Assessment Form to determine if the USG DURC/PEPP policy applies to their research.

Research Involving Pathogens with Enhanced Pandemic Potential

A pathogen with pandemic potential (PPP) is “a pathogen that is likely capable of wide and uncontrollable spread in a human population and would likely cause moderate to severe disease and/or mortality in humans.” PPPs are not explicitly defined by a list of agents, but can be determined for those agents that have a significant possible or known public health impact were the agent to be introduced into the environment or human population.

A pathogen with enhanced pandemic potential (PEPP) is “a type of pathogen with pandemic potential (PPP) resulting from experiments that enhance a pathogen’s transmissibility or virulence, or disrupt the effectiveness of pre-existing immunity, regardless of its progenitor agent, such that it may pose a significant threat to public health, the capacity of health systems to function, or national security.” A PEPP can result from genetic modification of an existing PPP, or significant modification of a non-PPP such that it becomes a PPP, such as by introducing virulence factors from a pathogenic strain of a biological agent of an agent into an avirulent strain.

The USG DURC/PEPP policy defines PPP/PEPP research as “Category 2” and may be identified by the following (1 or 2 below):

Research with a PPP, AND:
1. Enhancement of transmissibility in humans, OR;
2. Enhancement of virulence (capability of causing disease) in humans; OR;
3. Enhancement of the immune evasion of the pathogen in humans, such as by modifying the pathogen to disrupt the effectiveness of pre-existing immunity via immunization or natural infection, OR;
4. Generation, use, reconstitution, or transfer of an eradicated or extinct PPP, or a previously identified PEPP.
Research with a non-PPP with modifications that result in a potential PPP.

Researchers working with pathogens with a significant public health impact or manipulating non-pathogens or avirulent biological agents in a way that may enhance transmissibility, virulence, or immune evasion of the pathogen must complete the UF DURC/PEPP Assessment Form.

The EH&S Biosafety Office encourages consultation to determine whether research may be subject to assessment (bso@ehs.ufl.edu). To determine if your research requires submission of the UF DURC/PEPP Assessment Form, you can also use the Quick Assessment Tool.