Guidance on the Transfer of Select Agents and Toxins

Print
Related Pages

Changes and Highlights

Revisions:

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 the general public, are welcomed. Submit comments directly to the Federal Select Agent Program at:

Revision History:
  • June 2020: Updated to include eFSAP information, updated links, and removed appendices
  • September 2017: Initial posting
  • February 2021: Updated Packaging and Labeling section based on clarification of Department of Transportation regulations.
Download:

Introduction

This document is intended to provide guidance and assist entities in meeting Federal regulatory requirements when transferring or importing a select agent or toxin (7 C.F.R. §331.16, 9 C.F.R. §121.16, and 42 C.F.R. §73.16).

Within the United States (U.S.), other than law enforcement, only entities that are registered with the Federal Select Agent Program (FSAP) are allowed to receive material that has been identified as a select agent or toxin. This includes the importation of select agents and toxins from outside the U.S.

The APHIS/CDC Form 2: Request to Transfer Select Agents and Toxins can be submitted directly using electronic Federal Select Agent Program (eFSAP) portal, email, fax or mail to the Federal Select Agent Program (FSAP).

The exportation of a select agent or toxin requires an export license issued by the Department of Commerce (DOC). Information may be obtained by contacting the DOC Bureau of Industry and Security.