Program: Select Agents

Lead: Bob Hashimoto
Phone: (510) 643-6562
E-mail: bso@berkeley.edu

Team:Health & Safety
Associate Director: Brandon DeFrancisci

Description

Background
The University of California, Berkeley, in order to comply with the USA PATRIOT Act of 2001, and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, is required to register the possession, use, and transfer of select biological agents and toxins. The United States Department of Health and Human Services (HHS) and the United States Department of Agriculture (USDA) have established these requirements, which were published on December 13, 2002, in the Federal Register by HHS (42 CFR Part 73) and by USDA (7 CFR Part 331 and 9 CFR Part 121).

What is a Select Agent?
A Select Agent is one of approximately 40 viruses, bacteria, rickettsiae, fungi, and toxins that are considered to potentially pose substantial harm to human health. The list of select agents in 42 CFR 73 is available at: http://www.cdc.gov/od/sap/docs/salist.pdf. Certain strains of organisms and quantities of toxins are exempt from the regulations. For information about exemptions, contact the Campus Biosafety Office at 643-6562.

Summary of Registration, Use and Possession Requirements:
EH&S has developed a Select Agent packet of checklists, forms and templates to help guide Principal Investigators (PIs) who wish to conduct research with select agents. First, in order to lawfully possess select agents (microorganisms and/or toxins), PIs must contact the Campus Biosafety Office at 643-6562 to obtain this packet and receive guidance.

The Campus Biosafety Office will work with the PI to file an application under the new rule, unless the select agents meet exclusion criteria. The application will be sent to the appropriate federal agency, which is determined by the type of select biological agent or toxin possessed. Approval may take several months before work with the Select Agent(s) is allowed.

All transfers of HHS or USDA select biological agents and toxins must be pre-authorized. Before receiving select agents, the PI must establish a Safety Plan, Emergency Response Plan, and Security Plan. Templates for each of these plans are found in the packet provided by the Campus Biosafety Office. The Biosafety Office will assist in completing the plans and in coordinating the subsequent required training for laboratory staff authorized to access locations where select agents are stored or used.

Note: One major element of the Security Plan is that authorized staff must pass background checks by the US Department of Justice (DOJ). People from certain "countries of interest" as defined by the DOJ will not pass the background check and may not be authorized. Please check with UCPD for information related to background checks.

For more information, visit the CDC website http://www.cdc.gov/od/sap