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DHHS/USDA Select Agents List

This section of the website is devoted to biological safety topics that impact all University faculty and staff. Information regarding regulatory developments or general program changes will be presented here. Please check this page frequently for new information.

Select Agents and Toxins

Infectious agents and toxins that are considered by the Department of Health & Human Services (DHHS) or the United State Department of Agriculture (USDA) as having the potential to pose substantial harm or a severe threat to human, animal or plant health or plant products are regulated as “select agents.”

Under the DHHS and USDA regulations, anyone who wishes to transfer or possess any quantity of a select agent pathogen must successfully complete a time and labor-intensive registration and approval process with the appropriate regulatory agency. This process includes a security clearance component for all who will have access to the select agent.

Impact of Select Agent Regulations for UT Personnel

Currently, no laboratory at the UT Knoxville area campuses is approved to possess or use select agents (excluding de minimis quantities of listed toxins; see below). It is essential for all departments who conduct research with biological materials to have a general awareness of these regulations, the listed pathogens and toxins, and the need for communication with the Biosafety Officer in order to address all regulatory requirements.

Personnel Considerations

  • When considering research/faculty candidates, departments must inquire about any intentions of the candidate to conduct work with select agents. Work of this nature will require specific facilities with enhanced security features. Additionally, all personnel will have to successfully complete the registration security clearance process through the appropriate federal agency before select agents may be transferred to campus.
  • Before visiting research personnel from other countries come to campus, the UT employee who will be responsible for the visitor must assure that the visitor is aware of the Select Agents rule, and that no select agent materials are brought to campus by the visitor.

Managing Discoveries

  • In the event that a select agent is isolated in a clinical or diagnostic environment, terminate work with sample and lab materials and close all associated containers. Contact the Biosafety Officer immediately at (865) 974-1938.
  • In the event that a select agent is “discovered” in the course of lab clean-outs, move-ins, or in materials received by the lab, isolate the area and contact the Biosafety Officer immediately at (865) 974-1938.

Important Considerations for Select Agent Toxin Use

Select agent toxins are regulated as such if a Principal Investigator wishes to possess a quantity in excess of the permissible limit. However, researchers using listed toxins need to be aware of the following:

Commercial suppliers of toxins are likely to have additional requirements for those who attempt to purchase these materials. It is likely that suppliers will require documentation or a signed acknowledgment of regulatory compliance in order to release the materials for purchase. Contact the Biosafety Officer for assistance.

Users of select agent toxins are exempt from registration if they stay under the “amount permissible per Principal Investigator” limit. If you use or possess select agent toxins, you must know how much you have at all times, and know that it is secure in order to demonstrate exemption. To ensure that proper inventory control and security measures are in place, all select agent toxins must be registered with the Institutional Biosafety Committee.

Shipment and transfer of select agent toxins to off-site collaborators is regulated by a number of federal agencies including the Department of Transportation and the Department of Commerce (if export attempted). Contact the Biosafety Officer for assistance.

Below are links to Section VIII-G and Appendix I of the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories document which outlines handling and storage considerations for toxins.

Adoption of these practices is strongly recommended for any researcher working with toxins. These practices will be required for any lab pursuing registration as a select agent toxin lab.

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