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Responsible Research with Biological Select Agents and Toxins
technology to detect and diagnose the presence of select agents in a patient or in an environment will greatly enhance our ability to respond to—and potentially contain—the release of the agent, whether it occurs from natural infection or the deliberate use of select agents.1 At the same time, enhanced understanding of these agents and the ability to prevent or mitigate their effects diminishes the potential impact of these agents, and thereby decreases their value as a potential terrorist weapon.
PRINCIPLE 2: Research with biological select agents and toxins introduces potential security and safety concerns.
Because BSAT materials can pose such a severe threat to health and the environment, institutions housing BSAT laboratories must do everything in their power to prevent the release of these dangerous pathogens, whether by accident or deliberate act. In fact, many of the elements of a biosafety laboratory are designed for just this purpose, but there are steps, in addition to safety procedures, that can be taken in the name of security.
The potential for use of BSAT materials in criminal or bioterrorist acts cannot be disputed. Carus (2001) has identified a number of confirmed uses of biological agents in the conduct of criminal or terrorist acts. While many involved materials not on the select agent list, several did involve the use of select agents and toxins, including Bacillus anthracis (anthrax), ricin toxin, Yersiniapestis (plague), botulinum toxin, and Burkholderia mallei (glanders)—which cause disease in both animals and humans. Bioagent cases are not new, extending back to the 1900s and even earlier in human history.
This emphasizes the need for robust security infrastructure designed to prevent unauthorized access to select agents facilities and to the agents themselves, as well as appropriate procedures to guard against potential insider threats, beyond those that are customary in non-select agent research. The specific security requirements should be based upon a risk analysis applicable to the particular situation and environment. Many of these procedures will also protect personnel working with select agents, as well as others, from accidental exposure in the laboratory or in the surrounding community.
PRINCIPLE 3: The Select Agent Program should focus on those biological agents and toxins that might be used as biothreat agents.
As described in more detail in Chapter 2, the listing of select agents and toxins is motivated primarily by concerns about security, not about safety.
For example, the BioWatch program includes a network of monitoring units to detect the presence of harmful agents (see IOM/NRC 2009 for an interim report from an ongoing National Academies evaluation).