Select Agents Overview

Summary: Principal investigators must obtain a Biohazardous Materials Use Authorization to receive, possess, use, or transfer Select Agents. Learn about eligibility and security requirements for the use of Select Agents.

The United States Department of Health and Human Services (HHS), Centers for Disease Control and Prevention (CDC), the United States Department of Agriculture (USDA), and the Animal and Plant Health Inspection Service (APHIS ) 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.

Authorization to use Select Agents: An IBC protocol must be approved by the Institutional Biosafety Committee (IBC) prior to receiving or using any Select Agent in isolated form even if it is in exempt quantities.

Security requirements: All individuals with access to registered Select Agents are required to obtain a security clearance from the Department of Justice. Environmental Health & Safety (EH&S) submits names and fingerprints of all individuals listed on the IBC protocol form as working with Select Agents to the Department of Justice.

Every person who enters a laboratory containing registered Select Agents must either have a FBI security clearance or must be accompanied and monitored by such a cleared person. This includes visitors and employees performing routine cleaning, maintenance, and repairs.

Principal investigators submitting an IBC protocol 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 risk-based analysis performed by EH&S for each laboratory proposing to use Select Agents.

Theft or loss of Select Agents must be immediately reported to campus police, and EH&S who in turn will report it to CDC and/or APHIS.

Campus Police
Phone: (949) 824-5222
Environmental Health and Safety
Phone: (949) 824-6200

Need an expert? Contact the UC Irvine EH&S Biosafety Officer at (949) 824-9888.

Notice: Research safety information, training, and services are intended exclusively for UC Irvine employees and affiliates.

rev. 10/07