Federal Select Agent Program SA-Grams
Date of issuance: 3/15/13 Title: Use of “Lost in the crowd” concept for shipping select agent and toxin Text: The Federal Select Agent Program (FSAP) has amended the select agent regulations so regulated entities that maintain shipping and receiving facilities, and have procedures that are able to maintain select agent and toxin anonymity in shipping/receiving facilities, i.e., preserving "lost in the crowd," will not be required to register these areas if packages containing select agents or toxins will temporarily be stored in these areas awaiting transportation pickup. For entities preserving the "lost in the crowd" concept during shipping and receiving, the select agent regulatory oversight for recipients begins when a select agent or toxin package arrives at its ultimate destination for unpacking by an individual approved for access by the Department of Health and Human Services (HHS) Secretary or Animal and Plant Health Inspection Service (APHIS) Administrator. Select agent and toxin oversight for senders covers all use of a select agent and toxin up to the time that the materials are packaged for shipment, in compliance with Department of Transportation (DOT) hazardous materials regulations, by an individual approved for access by the HHS Secretary or APHIS Administrator. If packages are labeled as containing "Suspected Category A infectious substances" and temporarily stored in the shipping/receiving area, there is no need to develop and implement security practices (e.g., securing packages, registering the shipping/receiving area, and meeting Tier 1 requirements) for the area as the "lost in the crowd" concept is being preserved.
The FSAP approves and DOT recommends the use of "lost in the crowd" for all shipments of a select agent and toxin. To comply with this approach, “suspected Category A infectious substance” can be used as the technical name on the Shipper’s Declaration of Dangerous Goods in-lieu of identifying the select agent in the technical name, such as by listing the specific genus and species. Note: the technical name is included in parenthesis after the proper shipping name in the “Proper Shipping Name” section of the form. This approach will assist in maintaining anonymity for select agent and toxin packages during transit and avert additional security risks for couriers. Also, the technical name should not be placed on the package itself; instead the area for the technical name should be left blank.
In collaboration with DOT, the FSAP has developed guidance for the regulated community on the packaging and shipping of select agents and toxins. This guidance is available at http://www.selectagents.gov/FAQ_TransferForm2.html and includes information on all applicable domestic and international shipping regulations.
If you have any questions regarding this email, please contact the Select Agent Program: for APHIS entities, 301-851-3300 option 1 (voice only) and for CDC entities, 404-718-2000.