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DUAL USE RESEARCH OF CONCERN – PATHOGENS WITH ENHANCED PANDEMIC POTENTIAL (DURC-PEPP)

 

   

   

Contact Us

  jacervantes5@utep.edu

About DURC-PEPP

Dual use research refers to scientific activities conducted for legitimate purposes that generate knowledge, information, technologies, and/or products that can be utilized for both benevolent and harmful purposes. Effective oversight of dual use research is based on identifying associated risks and devising ways to mitigate these risks. The 2025 United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential ( USG Policy ) consolidates and replaces the 2012 Federal DURC Policy, the 2014 Institutional DURC Policy, and the 2017 P3CO Framework, creating a single, streamlined framework for governance. It provides an oversight framework for research with biological agents or toxins that is within what is referred to as Category 1 or Category 2 research.

Definitions

Dual use research is research conducted for legitimate purposes that generates knowledge, information, technologies, and/or products that can be utilized for benevolent or harmful purposes. 

DURC is 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 and other plants, animals, the environment, material, or national security

The IRE is the entity established by the University of Texas at El Paso to execute the institutional oversight responsibilities described in the USG policy.

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. Wild-type pathogens that are circulating in or have been recovered from nature are not PEPPs but may be considered PPPs because of their pandemic potential.
Developed by the IRE in partnership with the PI, the RMP describes measures to be instituted for the conduct and communication of Category 1 and Category 2 research. The RMP will include details of the risks identified by the IRE in its review of the research, and an explanation of the risk mitigation strategy or strategies that are being implemented to address those risks.

DURC-PEPP Categories

Involves one or more of the specified biological agents and toxins in the following categories.

    1. All Federally Regulated Select Agents and Toxins including those at amounts below the Permissible Toxin Amounts.
    2. All Risk Group 4 pathogens listed in Appendix B of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines).
    3. A subset of Risk Group 3 pathogens listed in Appendix B of the NIH Guidelines.
    4. For biological agents affecting humans that have not been assigned a Risk Group in the NIH Guidelines, agents affecting humans that are recommended to be handled at BSL3 or BSL4 per the BMBL guidance are subject to the USG DURC-PEPP Policy.

And may meet one of the following:

Is reasonably anticipated to result, or does result, in one of the experimental outcomes specified below:

    1. Increase transmissibility of a pathogen within or between host species;
    2. Increase the virulence (e.g. ability to cause disease) of a pathogen or convey virulence to a non-pathogen;
    3. Increase the toxicity of a known toxin or produce a novel toxin;
    4. Increase the stability of a pathogen or toxin in the environment, or increase the ability to disseminate a pathogen or toxin (e.g. environmental stability or aerosolubility);
    5. Alter the host range or tropism of a pathogen or toxin;
    6. Decrease the ability for a human or veterinary pathogen or toxin to be detected using standard diagnostic or analytical methods;
    7. Increase resistance of a pathogen or toxin to clinical and/or veterinary prophylactic or therapeutic interventions (e.g., antimicrobials, antivirals, antitoxins, vaccines);
    8. Alter a human or veterinary pathogen or toxin to disrupt the effectiveness of preexisting immunity, via immunization or natural infection, against the pathogen or toxin; or
    9. Enhance the susceptibility of a host population to a pathogen or toxin.

Based on current understanding, the research can be reasonably anticipated to provide, or does 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 and other plants, animals, the environment, materiel, or national security.

Involves, or is reasonably anticipated to result in, a pathogen with pandemic potential (PPP), or any pathogen that will be modified in such a way that is reasonably anticipated to result in a PPP (e.g., SARS-CoV2, MERS-CoV, Influenza strains).

And may meet one of the following:

Is reasonably anticipated to result in, or does result in, one or more of the experimental outcomes or actions specified here:

  1. Enhance transmissibility of the pathogen in humans;
  2. Enhance the virulence of the pathogen in humans;
  3. Enhance 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. Generate, use, reconstitute, or transfer an eradicated or extinct PPP, or a previously identified PEPP.

The research can be reasonably anticipated to result in the development, use, or transfer of a PEPP or an eradicated or extinct PPP that may pose a significant threat to public health, the capacity of health systems to function, or national security.

Forms/Policies