The Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP)

 

On May 5, 2025, a new Executive Order (EO) was issued calling for modifications to the 2024 United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (often referred to as the “USG DURC-PEPP Policy”). 

As the institution awaits additional guidance on how the provisions outlined in the May 5, 2025, EO may impact future research operations, researchers should continue to adhere to all applicable rules, regulations, and processes under the purview of University of Miami’s DURC and PEPP Committee, including all expectations set forth by the current USG-DURC-PEPP Policy (outlined in greater detail below).  

Pending Further Guidance from the US Government 

The U.S. Government’s new policy for research involving Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP) is effective on May 6, 2025. This Policy is a unified federal oversight framework for conducting and managing certain types of federally funded life sciences research on biological agents and toxins and addresses oversight of research on biological agents and toxins that, when enhanced, have the potential to pose risks to public health, agriculture, food security, economic security, or national security It supersedes all previous versions (2012 and 2014). 

The US Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (USG Policy) identifies two categories of research that must be proactively assessed by the PI when described as part of a federal grant application: 

Category 1 Research (DURC) 

  • Involves one or more biological agents and toxins from a pre-determined list. 
  • Is reasonably anticipated to result, or does result, in one of nine experimental outcomes 

Category 2 Research (PEPP) 

  • Involves, or is reasonably anticipated to result in, a Pathogen with Pandemic Potential (PPP)2, the development, use, or transfer of a Pathogen with Enhanced Pandemic Potential (PEPP), or an eradicated or extinct PPP that may pose a significant public health threat. 
  • Is reasonably anticipated to result in, or does result in, one or more experimental outcomes or actions

PI Responsibilities: 

  • PIs must assess proposed and ongoing research to determine if it falls under Category 1or Category 2 criteria. Research that qualifies as both Category 1 and Category 2 is classified as Category 2. 
  • If you believe your research may fall within the scope of Category 1 or Category 2 research, please complete the Self-Assessment Form to notify the Biosafety Office for further guidance and next steps. 

There are a minumum of 5 members on the Committe. Individuals with expertise in biosafety, recombinant DNA technology, toxins, pathogenic micro-organisms, animal containment principles are respresented on the committee. 

This committee meets as needed. 

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