Division of Research

Category 1 Research

Breadcrumb

Category 1 Research

Research that is subject to Category 1 oversight must meet the following criteria:

Involves one or more of the biological agents or toxins listed in Section A; and
Is reasonably anticipated to result, or does result, in one or more of the experimental outcomes listed in Section B; and
Based on current understanding, the research institution and/or federal funding agency assesses that the research constitutes DURC, as specified in Section C.

Section A: Biological Agents and Toxins within Scope of Category 1 Research

All Select Agents and Toxins listed in 9 CFR 121.3–121.4, 42 CFR 73.3–73.4, and 7 CFR 331.3 and regulated by USDA and/or HHS, including toxins used within permissible amounts.
All Risk Group 4 pathogens listed in Appendix B of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines).
A subset of Risk Group 3 pathogens) listed in Appendix B of the NIH Guidelines
For biological agents affecting humans that have not been assigned a Risk Group in the NIH Guidelines, refer to the current edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL).

List of all biological agents and toxins within the scope of Category 1 Research

Section B: Category 1 Research Experimental Outcomes

Research within the scope of Category 1 with a biological agent or toxin outlined in Section A with experimental outcomes are reasonably anticipated to:

Increase the transmissibility of a pathogen within or between host species;
Increase the virulence19 of a pathogen or convey virulence to a non-pathogen;
Increase the toxicity of a known toxin or produce a novel toxin;
Increase the stability of a pathogen or toxin in the environment, or increase the ability to disseminate a pathogen or toxin;
Alter the host range or tropism of a pathogen or toxin;
Decrease the ability for a human or veterinary pathogen or toxin to be detected using standard diagnostic or analytical methods;
Increase resistance of a pathogen or toxin to clinical and/or veterinary prophylactic or therapeutic interventions;
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
Enhance the susceptibility of a host population to a pathogen or toxin.

Section C: Category 1 Risk Assessment

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.