Guidance for Select Agent Regulation Training Requirements

Changes and 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: DASAT@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.
• March 2021: Clarified language and added section on non-FSAP-approved individuals.

Introduction

Section 15 of the select agent regulations (7 CFR §331.15,external icon 9 CFR §121.15,external icon and 42 CFR §73.15external icon) 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 accessing areas where select agents and toxins are used and/or stored receive risk-based training. A visitor is an individual not approved for access to select agents and toxins (non-FSAP approved). The training should address biocontainment, biosafety, security (including security awareness), and incident response. The Responsible Official (RO) must ensure a record of the training provided to each individual with access to select agents and toxins and each escorted individual (e.g., laboratory workers, visitors, etc.) is maintained. The record must include the name of the individual, the date of the training, a description of the training provided, and the means used to verify that the employee understood the training.