Category 1

1. It 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.

1. It is reasonably anticipated to result, or does result, in one of the experimental outcomes specified below:
2. Increase transmissibility of a pathogen within or between host species;
3. Increase the virulence (e.g. ability to cause disease) of a pathogen or convey virulence to a non-pathogen;
4. Increase the toxicity of a known toxin or produce a novel toxin;
5. 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);
6. Alter the host range or tropism of a pathogen or toxin;
7. Decrease the ability for a human or veterinary pathogen or toxin to be detected using standard diagnostic or analytical methods;
8. Increase resistance of a pathogen or toxin to clinical and/or veterinary prophylactic or therapeutic interventions (e.g., antimicrobials, antivirals, antitoxins, vaccines);
9. 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
10. 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.

Category 2

1. It 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.

1. It is reasonably anticipated to result in, or does result in, one or more of the experimental outcomes or actions specified here:
2. Enhance transmissibility of the pathogen in humans;
3. Enhance the virulence of the pathogen in humans;
4. 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
5. Generate, use, reconstitute, or transfer an eradicated or extinct PPP, or a previously identified PEPP.

1. 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.

Agents and Toxins

• Avian influenza virus (highly pathogenic)
• Bacillus anthracis
• Botulinum neurotoxin (any quantity)
• Burkholderia mallei
• Burkholderia pseudomallei
• Ebola virus
• Foot-and-mouth disease virus
• Francisella tularensis
• Marburg virus
• Reconstructed 1918 influenza virus
• Rinderpest virus
• Toxin-producing strains of Clostridium botulinum
• Variola major virus
• Variola minor virus
• Yersinia pestis

Experimental Effects

• Enhances the harmful consequences of the agent or toxin
• Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical and/or agricultural justification
• Confers to the agent or toxin resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitates their ability to evade detection methodologies
• Increases the stability, transmissibility, or the ability to disseminate the agent or toxin
• Alters the host range or tropism of the agent or toxin
• Enhances the susceptibility of a host population to the agent or toxin
• Generates or reconstitutes an eradicated or extinct agent or toxin listed above