several select agents—has increased from two before 1990 to five before the terrorist attacks of 2001 to 15 or more that are operational or under development at the time of this report (GAO 2007).2 Such laboratories are no longer limited to the federal government but now include facilities in academic institutions, state and local public health departments, and in the private sector. This expansion can be attributed to growing concerns about our limited understanding of dangerous pathogens, increasing ability to add to this understanding, and an influx of federal support for these activities. One large federally supported program highlights the growth as a result of increasing government support: since 2003, NIAID has supported the development of 11 Regional Centers of Excellence (RCEs) for Biodefense and Emerging Infectious Diseases,3 which involve nearly 500 principal investigators (PIs)—most new to biodefense—at almost 300 institutions participating in RCE research activities (Concept Systems 2008). The laboratories provide a venue for work with potentially dangerous pathogens, including those on the list of select agents and toxins.

THE NATURE OF THE THREAT

BSAT materials have the potential for dramatic impact on human, plant, and animal health. For this reason, there is a growing concern that these agents may be used for intentional harm or to induce public panic. The anthrax attacks of 2001 are a prime example. In addition to killing five people and infecting 22, this attack had a dramatic impact on our nation and was estimated to have had a direct economic impact of more than $1 billion.

Clearly, there is genuine and legitimate concern that laboratories working with select agents and toxins should receive special security and safety attention that other types of biological research would not require. Even though many of the materials on the select agent list may be found in natural environments, some laboratories maintain purified strains of the most dangerous pathogens. In addition, laboratory workers not only have access to these materials but also may possess the technical knowledge of how to grow them in the laboratory, although not necessarily the technical knowledge needed to weaponize them.

This report therefore addresses policies and practices directed at securing those laboratory facilities in which work is done with BSAT materials. The intent is to protect the laboratories and the agents from threats posed by outsiders as well as insiders. Although the report does not focus on biosafety, some of the methods that prevent accidental infection or release also serve to enhance

2

A 2009 Government Accountability Office (GAO) report lists seven operational labs as of 2009—four operated by the federal government, two by academic institutions, and one by a private nonprofit organization. GAO counts seven additional facilities in development, including one that will replace an existing facility (GAO 2009c).

3

See <http://www3.niaid.nih.gov/LabsAndResources/resources/rce/introduction.htm> for more information about the RCEs.



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