DURC-PEPP Category 1 Agent List

The specific biological agents and toxins currently on the USG DURC-PEPP Policy Category 1 List are shown under the expandable headings below. It is important to note that the Category 1 List is subject to change depending upon amendments to the source documents, which are identified further below on this page.

Source Documents

The biological agents, viruses, and pathogens on the DURC-PEPP Policy Category 1 list include:

• All Select Agents and Toxins controlled by Federal Select Agent Regulations, including those at amounts below the Permissible Toxin Amounts.  For purposes of the DURC-PEPP Policy, there are no exempt quantities for these agents and toxins.  Refer to the Select Agents and Toxins list for any relevant strain exclusions.


• All Risk Group 4 pathogens listed in Appendix B-IV of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). Risk Group 4 agents are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available. Refer to Appendix B-IV of the NIH Guidelines for any relevant strain exclusions.


• A subset of Risk Group 3 pathogens listed in Appendix B-III of the NIH Guidelines (see Exceptions). Risk Group 3 agents are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available, but are not controlled by the Select Agent Regulations. Refer to Appendix B-III of the NIH Guidelines for any relevant strain exclusions


• Other biological agents affecting humans that have not been assigned a Risk Group in the NIH Guidelines, and are recommended to be handled at BSL3 or BSL4 per CDC guidance in the Biosafety in Microbiological and Biomedical Laboratories (BMBL).


• Biological agents added during future updates to the USG Implementation Guidance.