Guidance on the Transfer of Select Agents and Toxins

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:

  • September 2017: Initial posting

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.), 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 (Form 2), Request to Transfer Select Agents and Toxins, can be submitted by mail, fax or email to FSAP at either:

Animal and Plant Health Inspection Service
Agriculture Select Agent Services
4700 River Road Unit 2, Mailstop 22, Cubicle 1A07
Riverdale, MD 20737
FAX: 301-734-3652
Email: cdcform2@cdc.gov
Centers for Disease Control and Prevention
Division of Select Agents and Toxins
1600 Clifton Road NE, Mailstop A-46
Atlanta, GA 30329
FAX: 404-471-8468
Email: cdcform2@cdc.gov


Approval for an entity to transfer a select agent or toxin is valid for only one transfer. The actual transfer must be completed within 30 days from the date of FSAP authorization. The sender must submit a Form 2 in order to transfer select agents or toxins. Multiple transfers of a select agent or toxin occurring on different days require separate FSAP authorizations for each transfer. Multiple select agents or toxins can be listed on the same Form 2 and be approved if they are in the same package. Large shipments of select agents and toxins that require multiple packages shipped to the same recipient on the same day can be shipped under the same transfer authorization number. Transfers being shipped to multiple recipients each require their own Form 2. Tracking information for each package of a large shipment will need to be provided on the Form 2. Approval of a transfer becomes void should there be a change in any of the conditions upon which the approval was based (e.g., change in the certificate of registration for the sender or recipient).

A transfer authorization is required for the transfer of any identified select agent or toxin in a specimen presented for diagnosis, verification, or proficiency testing. This would include susceptibility testing. However, a sponsor may send a select agent or toxin that is contained in a specimen for proficiency testing that has the potential to contain a select agent or toxin to a recipient without obtaining prior authorization from FSAP provided that, at least seven calendar days prior to the transfer, the sponsor sends FSAP a written report that includes the select agent or toxin to be transferred and the name and address of the recipient.

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