Annual Inspection Guidance
Changes and Highlights
This is a living document subject to ongoing improvement. Feedback or suggestions for improvement from entities registered with the Federal Select Agent Program, as well as from the general public, are welcome. Submit comments directly to the Federal Select Agent Program at:
- August 2018: Initial posting
This document is intended to provide guidance and assist entities regarding the regulatory requirement that the Responsible Official (RO) ensure that an annual inspection is conducted for each registered space where select agents or toxins are stored or used. See sections 7 C.F.R. §331external icon.9(a)(6), 9 C.F.R. §121external icon.9(a)(6), and 42 C.F.R. §73external icon.9(a)(6)).
Establishing an internal annual inspection program provides a means for the RO to monitor compliance with the select agent regulations and identify deviations from acceptable laboratory safety, containment, or security practices. This action can be separate from an overall periodic reconciliation of the entire select agent and toxin inventory.