Drills and Exercises Guidance

Changes/Highlights

Revisions: 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:


Revision History:

  • May 2016: Initial Draft


Introduction

Registered entities are required to conduct drills or exercises at least annually to test and evaluate the effectiveness of their security, biosafety and incident response plans. This regulatory requirement is specified in the select agents and toxins regulations (42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331) in sections 11 (Security), 12 (Biosafety), and 14 (Incident Response). The terms “drills” and “exercises” are used to denote an activity that can be used to test and evaluate the efficacy of an entity’s security plan, biosafety plan, and/or incident response plan.  A drill and/or exercise provides an opportunity to detect flaws in an entity’s plan by identifying possible gaps and shortfalls in policies and/or procedures. The intent of this guidance is to assist the regulated community in developing and planning drills or exercises.

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