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).

The current list of Select Agents can be found here.

Responsible Official

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:

  • Acquiring any agent or toxin* (see Select Agent Toxins below)
  • Initiating experiments with any new select agent or strain

For ongoing Select Agent work seek IBC/RO approval BEFORE:

  • Changing the scope of work (e.g., antibiotic resistance)
  • Adding new personnel
  • Changing the location of existing experiments
  • Transferring select agents to another investigator on or off UVA (see APHIS/CDC Form 2)
  • Arranging for visiting researchers to work in your Select Agent laboratory

For more information regarding the Select Agent Program at the University of Virginia, you may contact either:

Responsible Official: Dr. Tom Leonard at rtl5p@virginia.edu or 434-982-4911.
OR
Alternate Responsible Official: Ericka Pearce at eep3e@virginia.edu or 434-982-4911.
OR
Alternate Responsible Official: Jennifer Branum at jmw4qs@virginia.edu or 434-982-4911.

Security Requirements

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.

Click here for more information on the SRA process.

Laboratory Biosafety, Biosecurity, and Incident Response Plan

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.

Theft or loss or release

Report theft or loss of Select Agents immediately to the Responsible Official, who in turn will report to CDC and/or APHIS.

Form 3 can be found here.

Responsible Official: Dr. Tom Leonard at rtl5p@virginia.edu or 434-982-4911.
OR
Alternate Responsible Official: Ericka Pearce at eep3e@virginia.edu or 434-982-4911.
OR
Alternate Responsible Official: Jennifer Branum at jmw4qs@virginia.edu or 434-982-4911.

*Select Agent Toxins

Toxins on the Select Agent list include many commonly used research materials. There are threshold limits that are allowed under the regulations and are as follows. All toxins on this list are required to be registered with the IBC. Any possession, use, or transfer above the limits below REQUIRES select agent registration with the appropriate authorities.

If the aggregate amounts of the following agents or toxins under the control of a principal investigator do not, at any time, exceed the limits below, they are exempt:

  • 0.5 milligrams (mg) of Botulinum neurotoxins
  • 5 mg of Staphylococcal enterotoxins
  • 100 mg of Abrin, Clostridium perfringens epsilon toxin, Conotoxin, Ricin, Saxitoxin, Shigatoxin, Shiga-like ribosome inactivating protein, and Tetrodotoxin
  • 1,000 mg of diacetoxyscirpenol and T-2 toxin
 
 
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PHONE 434.982.4911
FAX 434.982.4915
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Suite 320
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PHONE 434.243.1711
FAX 434.243.1735
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