Policy Statement

Date: September 1, 2016

Subject: FSAP Policy Statement: Requests for Transfer of Select Agents and Toxins

The Federal Select Agent Program (FSAP) is a collaboration between the Centers for Disease Control and Prevention (CDC), Division of Select Agents and Toxins (DSAT) and the Animal and Plant Health Inspection Service (APHIS) Agriculture Select Agent Services (AgSAS) to regulate the possession, use, and transfer of biological agents listed in 7 C.F.R. Part 331, 9 C.F.R. Part 121, and 42 C.F.R. Part 73 (select agents and toxins).  The FSAP administers the select agents and toxins regulations in close coordination with the Federal Bureau of Investigation’s Criminal Justice Information Services (CJIS).

Authority:

For biological agents and toxins determined by HHS to have the potential to pose a severe threat to public health and safety (HHS and Overlap select agents and toxins), the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (42 U.S.C. 262a) directs the regulations of transfers of such select agents and toxins, including measures to ensure proper training and appropriate skills to handle such select agents and toxins.  42 U.S.C. § 262a(b).  

For biological agents and toxins determined by USDA to have the potential to pose a severe threat to animal health or animal products (USDA and Overlap select agents and toxins), the Agricultural Bioterrorism Act of 2002 (7 U.S.C. 8401) directs the regulations of transfers of such select agents and toxins, including measures to ensure proper training and appropriate skills to handle such select agents and toxins.  7 U.S.C. 8401(b).

In accord with section 16 of the select agents and toxins regulations, unless expressly exempted by the select agents and toxins regulations or otherwise specifically approved by the HHS Secretary or the APHIS Administrator (on a case-by-case basis), the transfer of a select agent or toxin must be approved by CDC or APHIS prior to transfer.  To obtain CDC or APHIS approval for a transfer, an APHIS/CDC Form 2 must be submitted.  Completion of the APHIS/CDC Form 2 requires the “shipper” to, for shipments other than by hand delivery, list the “name of carrier” in block 39 of the APHIS/CDC Form 2. 

Policy Statement:

It is the policy of the Federal Select Agent Program (FSAP) that the “name of carrier” required to be listed in block 39 of the APHIS/CDC Form 2 consists of the name of the commercial carrier plus the U.S. Department of Transportation (USDOT) number for that commercial carrier.  An entity may acquire a commercial carrier’s USDOT number by directly contacting the commercial carrier and requesting this information.  Accordingly, in order for FSAP to authorize a transfer of a select agent or toxin as required by section 16 of the select agent regulations (7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73), the shipper must provide the commercial carrier’s name and USDOT registration number in block 39 of the Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2).     

This policy statement is effective September 1, 2016.

This policy statement will be provided to the Responsible Official via SA Gram for each registered entity on or before the effective date; and to the Responsible Official for each newly registered entity during the registration process.

Any questions concerning this policy may be addressed by contacting the Federal Select Agent Program at lrsat@cdc.gov or AgSAS@aphis.usda.gov.

null
Daniel Sosin, MD, MPH, FACP
Acting Director, Division of Select Agents and Toxins
Department of Health and Human Services
Centers for Disease Control and Prevention

null
Freeda E. Isaac, DVM
Director, Agriculture Select Agent Services
United States Department of Agriculture
Animal and Plant Health Inspection Service