Guidance for Select Agent Regulation Training Requirements

Changes & Highlights

This is a living document subject to ongoing improvement. Feedback or suggestions for improvement from registered Select Agent entities or the public are welcomed. Submit comments directly to the Federal Select Agent Program at:

CDC: LRSAT@cdc.gov
APHIS: AgSAS@aphis.usda.gov

Revision History:

October 12, 2012: Initial posting
July 5, 2013 (Revision 1): The revisions are primarily changes to correct editorial errors from previous version.
March 2017:The revisions are based on changes to select agent regulations.

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Introduction

Section 15 of the select agent regulations (7 CFR §331.15, 9 CFR §121.15, and 42 CFR §73.15) requires that individuals that access select agents and toxins must receive information and training concerning biocontainment, biosafety, security (including security awareness), and incident response. Section 15 also requires that each entity visitor (an individual not approved for access to select agents and toxins)  receive information and training on biocontainment, biosafety, security (including security awareness), and incident response based on the risk associated with that person accessing areas where selects agents and toxins are used and/or stored. The Responsible Official (RO) must ensure a record of the training is maintained for each individual with access to select agents and toxins and any individual that enters areas under escort where select agents or toxins are handled or stored. The record must include the name of the individual, the date of the training provided, and the means used to verify that the employee understood the training.