of these most dangerous bacteria, viruses, toxins, and fungi have been officially listed by the U.S. government as biological select agents and toxins (BSAT) and are subject to special security requirements.

Whether deliberately deployed as a biological weapon or the result of a natural outbreak, the potential for mass human casualty or potentially catastrophic impact on plants or animals as a direct or indirect result of select agents is omnipresent. This report focuses on how to secure access to these dangerous pathogens to diminish their potential for use by terrorists as a biothreat agent. Discussion includes consideration of the physical security of facilities that work with these materials and steps to ensure that personnel with access to select agents and toxins can be trusted.

The Current Select Agent Program

Since the list of select agents and toxins was first introduced in 1997, the U.S. government has created a formal regulatory structure to oversee BSAT research and to decide who could possess microorganisms and toxins that could be used as weapons and how facilities that did possess them would be protected. The scope of the program is determined by a formal list of select agents and toxins; the Department of Health and Human Services’ Centers for Disease Control and Prevention (CDC) maintains the list for human pathogens, while the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) maintains the list for plant and animal pathogens.

As of September 2009, 388 entities were registered and 13,609 individuals—administrators, research scientists, students and postdoctoral researchers, technical staff, and maintenance and animal care workers—were cleared to have access to BSAT materials.

Origin and Charge to the Committee

Concerns about whether the regulations in place for BSAT research in U.S. laboratories were adequate to address the risks of theft, misuse, or diversion of materials grew after the Federal Bureau of Investigation (FBI) announced in August 2008 that it had concluded that a researcher at the U.S. Army Medical Research Institute of Infectious Diseases was the perpetrator of the anthrax letter attacks in October 2001. There were also other concerns about whether the growth in the number of high containment laboratories as part of expanded funding for biodefense research after 2001 was increasing the risks of laboratory accidents as well as providing more targets for those who could pose security threats from either outside or inside the facilities.

An interagency process was initiated to consider the efficiency and effectiveness of all laws, regulations, guidance, and practices related to physical, facility, and personnel security and assurance for BSAT research. As part of that



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