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Responsible Research with Biological Select Agents and Toxins
increasing concern for safety and security and implementation of protective measures that minimize risk.
Among the larger group of pathogenic materials is a set of organisms and chemicals that pose not only a severe threat to the health of humans, plants, and animals, but also have the potential to be used deliberately to cause disease, prompt fear, or destroy agricultural or animal products. More than 80 of these most dangerous bacteria, viruses, toxins, and fungi have been officially listed as biological select agents and toxins (BSAT) and are subject to special security requirements.1
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. As the National Institute of Allergy and Infectious Diseases (NIAID) opened its most recent strategic plan for biodefense research, “biological weapons in the possession of hostile states or terrorists, as well as naturally occurring emerging and reemerging infectious diseases, are among the greatest security challenges to the United States” (NIAID 2007). The security and safety of our nation—as well as human and agricultural health around the world—depend upon a deep understanding of these organisms and toxins.
The most direct impact of research with BSAT is in the development of countermeasures against the agents themselves. Previous investment in research using what are now classified as select agents has yielded vaccines, drugs, and other treatments to combat agents such as smallpox, anthrax, and Ebola virus (Auchincloss 2007). Continuing efforts against these dangerous pathogens will improve our capacity to treat and prevent outbreaks when they occur, and advances in technology will enable more rapid detection of the presence of BSAT materials in the environment.
But the value of BSAT research is not limited to the development of medical countermeasures; in fact, greater understanding of BSAT materials will also enhance our ability to respond to a wide range of infectious diseases (NIAID 2008). What is learned about this small subset of pathogens can lead to strategies for responding to a much wider range of infectious diseases, extending the reach of BSAT research beyond the agents of acute concern to the much wider array of organisms with significant public health implications.
The nation’s capacity to conduct research on BSAT materials has expanded significantly over the past several years. For example, the number of laboratories either in operation or under development that have the capacity to conduct research on the most dangerous pathogens—agents that pose the highest risk of life-threatening disease for which no vaccine or therapy is available, including
These agents are defined in three sections of federal regulations: 42 CFR 73 for threats to “public health and safety,” 7 CFR 331 for threats to “plant health or to plant products,” and 9 CFR 121 for threats to “animal health or to animal products.”