Select Agents are those that have been identified by the U.S. Government as agents with the potential for use as biological weapons. Select Agents and Toxins are regulated by the Department of Health and Human Services (DHHS), through the Centers for Disease Control and Prevention (CDC), and the United States Department of Agriculture (USDA) via the Animal Plant Health Inspection Service (APHIS).
Under the Select Agent Regulations, any entity or organization that works with Select Agents must appoint a Responsible Official (RO) who is responsible for the management of Select Agents at the institution. Possession use or transfer (intramural or extramural) is prohibited without prior approval from the RO (also the UVA Biosafety Officer) and the Institutional Biosafety Committee (IBC). If planning any work with Select Agents you must contact the Responsible Official at 434-982-4911.
For initial approval of Select Agent work seek IBC/RO approval BEFORE:
For ongoing Select Agent work seek IBC/RO approval BEFORE:
For more information regarding the Select Agent Program at the University of Virginia, you may contact either:
All individuals with access to Select Agents are required to obtain a security clearance (Security Risk Assessment or SRA) from the Department of Justice. The RO facilitates the SRA approval process and submits names and fingerprints of all individuals slated to work with Select Agents to the Department of Justice.
Every person who enters a laboratory containing Select Agents must either have a security risk assessment (SRA) clearance or must be escorted by an SRA approved person. This includes visitors and employees performing routine or emergency maintenance and repairs.
Principal Investigators who are approved and registered with the appropriate authorities to work with Select Agents must have a three-tiered biosafety and security set of operating procedures in place. These include a Biosafety Level 3 (BSL-3) Manual, a Biosecurity Manual, and an Incident Response (emergency) Plan. The BSL-3 Biological Safety Manual must include all BSL-3 (or ABSL-3) requirements in the CDC-NIH Guidelines Biosafety in Microbiological and Biomedical Laboratories
The Biosecurity Plan must include physical security, inventory, and provisions for activity reporting. The Incident Response Plan must include emergency response procedures and plans. There are additional biosafety and biosecurity annual training requirements for all approved users of select agents.
Report theft or loss of Select Agents immediately to the Responsible Official, who in turn will report to CDC and/or APHIS.
Toxins on the Select Agent list include many commonly used research materials. All toxins on the list below are required to be registered with the IBC; however, the following toxins are not subject to Select Agent regulations if the amount under the control of a principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor does not exceed, at any time, the amounts indicated in the table below.
|HHS Toxins [§73.3(d)(7)]||Amount|
|Botulinum neurotoxins||1 mg|
|Short, paralytic alpha conotoxins||100 mg|
|Diacetoxyscirpenol (DAS)||10,000 mg|
|Staphylococcal Enterotoxins (Subtypes A, B, C, D, and E)||100 mg|
|T-2 toxin||10,000 mg|