Dual Use Research for Concern – Pathogens with Enhanced Pandemic Potential (DURC-PEPP) 

Category 1 Research must meet all three criteria listed:

1. It involves one or more of the biological agents and toxins specified in Appendix C of implementation guide.
   *Exceptions made: HIV, HTLV, SIV, Mtb (including mycobacterium bovis), Clade II of MPVX viruses unless containing nucleic acids coding for clade I MPVX virus virulence factors, vesicular stomatitis virus, Coccidioides immitis, Coccidioides posadasii, Histoplasma capsulatum, and Histoplasma capsulatum var. duboisii. 
   *A newly emerging pathogen or chimeric agent for which a Risk Group or Biosafety Level (BSL) has not been assigned to an agent should be evaluated by the IBC. If the determination is that handling should be BSL3 or BSL4, then it is included in the list subject to the DURC-PEPP policy.
2. It is reasonably anticipated to result, or does result, in one of the experimental outcomes specified:
   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.
3. 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.

Category 2 Research must meet all three criteria listed:

1. Research involves, or is reasonably anticipated to result in, a PPP or any pathogen that will be modified in such a way that is reasonably anticipated to result in a PPP (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); E.g. SARS-CoV-2, Ebola virus, Highly Pathogenic Avian Influenza A (H5 and A(H7) subtypes. 
2. Research is reasonably anticipated to result in, or does result in, one or more of the experimental outcomes or actions specified:
   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.
3. The research is 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.