Select Agents: Requirements
Learn about eligibility and security requirements for the use of Select Agents.
The United States Department of Health and Human Services (HHS) and the United States Department of Agriculture (USDA) have identified bacteria, viruses, toxins, rickettsia, and fungi that pose a potential threat to public health or welfare. These organisms, called Select Agents and High Consequence Livestock Pathogens and Toxins, are strictly regulated.
Research authorization
Principal investigators (PI) must obtain a Biohazardous Materials Use Authorization (BUA) to receive, possess, use, or transfer Select Agents in isolated form above exempt quantities.
The BUA approval process for Select Agents includes registration with the Centers for Disease Control and Prevention (CDC) and/or the Animal and Plant Health Inspection Service (APHIS).
Security requirements
Individual security clearance
All individuals with access to Select Agents are required to obtain a security clearance from the Department of Justice. Environment, Health & Safety (EH&S) submits names and fingerprints of all individuals listed in the BUA as working with Select Agents to the Department of Justice.
Every person who enters a laboratory containing Select Agents must either have a security clearance or must be accompanied and monitored by such a person. This includes visitors and employees performing routine cleaning, maintenance, and repairs.
Laboratory security plan
PIs submitting a BUA for approval to use Select Agents must include a security plan that addresses the following elements:
- Physical security
- Cyber security
- Inventory
- Material transfers
- Training
- Suspicious persons and activity reporting
- Provisions for cleaning and maintenance
Physical security requirements are addressed through a risked-based analysis performed by EH&S for each laboratory proposing to use Select Agents.
Theft, loss, or discovery of unregistered materials
- Report discovery to EH&S, (858) 534-8035.
- Review with EH&S the findings that indicate the identity of the material and the security of the discovery location.
- EH&S will report discovery to appropriate regulatory agency (CDC or USDA).
Related policies
- Select Agent Regulations, 42 CFR Part 73 (PDF)
- National Select Agent Registry, Centers for Disease Control and Prevention