Transfer of Select Agents and Toxins: 2003-2013.

The Federal Select Agent Program, which is composed of the Centers for Disease Control and Prevention Division of Select Agents and Toxins and the Animal and Plant Health Inspection Service Agricultural Select Agent Services, regulates entities that possess, use, or transfer biological select agents and toxins in the United States and must preapprove all transfers within or into the US. The requirement to preapprove transfers allows the Federal Select Agent Program to monitor and track shipments to receive alerts of theft, loss, or release during shipment, thereby protecting public health and safety. As part of the program, the Division of Select Agents and Toxins regulates biological select agents and toxins that have been identified by the US government as posing a severe threat to public health and safety. The division analyzed 4,402 transfers that occurred between March 2003 and December 2013 to identify frequently transferred biological select agents and toxins and the types of entities involved in transfers. During the study period, 1 package was lost during shipment and it was determined not to pose a threat to public health. The Federal Bureau of Investigation investigated the loss and concluded that the package was most likely damaged by the commercial carrier and discarded. Further, there were no reports of theft or release associated with biological select agents and toxins shipments. This report represents the first in-depth review of biological select agent and toxin transfers that were approved by the Division of Select Agents and Toxins.