Executive Summary
The revelation in 2007 of an initially unreported incident from 2006 at Texas A&M University, in which a laboratory researcher was accidentally infected with Brucella, apathogen that infects both humans and animals, and which was formerly weaponized by the Soviet Union, spurred a series of inquiries by Congress and the Executive Branch. Their focus was on the safety regulations and physical security of high-containment laboratories working on select agents (pathogens and toxins itemized by the U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) that pose significant risks to human, animal, and/or plant health organizations (42 CFR 73)). By February 2009, 336 entities were registered with the Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS) to work with select agents, and 14,612 laboratory researchers and support staff were registered to work with these agents. Along with the expansion of biodefense research on select agents and high-containment laboratories to accommodate that research came increased concern about pathogen security and laboratory safety. To address this concern, HHS established the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight to consider oversight of research conducted in high-containment laboratories, including but not limited to certification and training of scientists and appropriate non-scientists on biosafety. In 2008, the Commission on the Prevention for WMD Proliferation and Terrorism recommended in its report, World at Risk, that biosafety training for all life scientists should be mandatory. With the allegation against Bruce Ivins, a researcher at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), the U.S. government became concerned about the “insider threat” and vetting personnel seekingaccess to select agents, termed “personnel reliability.” In January 2009, President George W. Bush issued an Executive Order (EO13486), which called for an interagency review of laboratory biosecurity, including personnel reliability. Biosafety training is a cornerstone to preparing anyone entering a high-containment laboratory, and biosafety professionals generally act as gate-keepers to those laboratories.