UPDATE: The White House issued an executive order on May 5, 2025, directing federal agencies to end funding for "dangerous gain-of-function research” and develop a new oversight policy within 120 days. Such research is defined in Section 8 of the order. The NIH issued an updated notice on May 7, 2025, rescinding their previous DURC-PEPP Policy implementation guidance.
This webpage will be updated as new information becomes available.
If you have questions or concerns related to oversight of your research, please contact EH&S Biosafety at ehsbio@uw.edu or 206-221-7770.
The United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (DURC-PEPP Policy) goes into effect on May 6, 2025. The DURC-PEPP Policy applies to federally-funded research that involves certain biological agents and toxins or modification of pathogens. The federal government has not published further information about the DURC-PEPP Policy since it was issued on May 6, 2024. If the policy or implementation changes, EH&S will adjust requirements and notify the research community accordingly. We appreciate your attention and cooperation in adapting to these research oversight updates.
The DURC-PEPP Policy outlines assessment processes to identify two categories of research: Category 1 (DURC) and Category 2 (PEPP). Assessment of research for DURC-PEPP is in addition to existing research approval requirements (e.g., Institutional Biosafety Committee (IBC), select agent regulations).
If you work with select toxins in any amount, infectious biological agents, or modify biological agents, you are required to:
- Familiarize yourself with the Principal Investigator requirements as outlined in “DURC-PEPP Policy” on the EH&S DURC-PEPP webpage.
- Complete the DURC-PEPP training.
- Assess your existing research. You can use the Self-Assessment Worksheet as a tool. If Category 1 or 2 research is identified, follow the steps on the DURC-PEPP webpage.
Be aware that federal funding agencies may request an Institutional Review Entity (IRE) assessment as part of grant application materials and research progress reports for existing grants. The UW Institutional Review Entity (IRE) is a standing subcommittee of the UW IBC that is responsible for assessing research for potential DURC and PEPP.
If your research has previously been assessed for DURC, EH&S Biosafety will reach out to you directly.
Biological agents and toxins within the policy scope
The Category 1 (DURC) research scope includes an expanded list of biological agents and toxins, including:
- All select agents and toxins in any amount
- All Risk Group 4 and a subset of Risk Group 3 microorganisms*
- Biological agents recommended to be handled at BSL-3 or ABSL-3
- West Nile virus and St. Louis encephalitis virus (now Risk Group 2 but were Risk Group 3 when policy was published)
The Category 2 (PEPP) research scope includes:
- Any microorganism that will be modified (genetically or by other means) to reasonably create a pathogen with pandemic potential (PPP)
- Existing potential pandemic pathogens (PPPs): SARS-CoV, SARS-CoV-2, and Ebolaviruses
- Any use, generation, reconstitution, or transfer of an extinct or eradicated PPP, specifically smallpox or 1918 influenza virus
DURC-PEPP Policy Information
The purpose of the DURC-PEPP oversight policy is to minimize biosafety and biosecurity risks of life sciences research and potential misuse of research knowledge. This policy supersedes the previous DURC and P3CO (Enhanced Potential Pandemic Pathogens) policies.
Questions or assistance
Contact EH&S Biosafety at ehsbio@uw.edu or 206-221-7770.
*Excluded Risk Group 3 microorganisms include Coccidioides immitis and posadasii, Human immunodeficiency virus (HIV) types 1 and 2, Human T cell lymphotropic virus (HTLV) types 1 and 2, Mycobacterium bovis and tuberculosis, Simian immunodeficiency virus (SIV), Vesicular stomatitis virus, and others. A full list is available on the DURC-PEPP webpage.