Monitoring Select Agent Theft, Loss and Release Reports in the United States—2004-2010

The APHIS/CDC Form 3, Report of Theft, Loss or Release of Select Agents and Toxins (TLR incident report) is the mechanism by which the theft, loss or release of a biological select agent and toxin (BSAT) is reported to the United States Department of Agriculture (USDA)/Animal and Plant Health Inspection Service (APHIS) or Health and Human Services (HHS)/Center for Disease Control and Prevention (CDC). A total of seven hundred and twenty seven (727) TLR Incident Reports were received by CDC between 2004 and 2010. Based on information contained in these reports, there were: No reports of the theft of any BSATs, One confirmed loss of a BSAT occurred during shipment out of 3412 transfers of BSAT conducted during that time period. Eleven total laboratory acquired infections (LAIs) associated with BSAT releases reported to CDC between 2004 and 2010, in an average annual population of approximately 10,000 individuals with approved access to BSATs. No fatalities resulted from these infections and there were no reported cases of secondary transmission to other humans. Annual increases in the number of TLR reports submitted to CDC from 16 reports in 2004 to 269 reports in 2010. Approximately half of the reports were submitted by entities registered with CDC and approved to possess BSATs (59%) with slightly less than half submitted by entities exempt from registration and inspection (41%), (primarily diagnostic laboratories). In 2009 and 2010, the number of TLR incident reports from exempt entities 104 and 148, respectively) exceeded those submitted by registered entities (88 & 96, respectively). The majority of TLR Incident Reports from registered entities involved Biosafety Level 3 (BSL-3) laboratories. Most reports from exempt entities involved Biosafety Level 2 (BSL-2) laboratories. The majority of reports from both registered and exempt entities involved bacterial agents. These results show that the Federal Select Agent Program has been successful in implementing a monitoring program, increasing compliance of registered and exempt laboratories (as evidenced by increasing numbers of reports) and effective investigation that identified some LAIs, and resolved other loss & release reports to determine that biosafety and security in U.S. labs is being sustained.