Preparing for Nontraditional Biothreats.

Biological threats consist of traditional, emerging, enhanced, and advanced threats, but current biodefense approaches focus almost entirely on a subset of traditional threats. There is an urgent need to develop a comprehensive, rational, and systematic plan to address and mitigate the broader risk space. Myriad possible strategies exist, but an ideal strategy will extend beyond a list of agents. This article proposes a functionality-based approach based on systematic identification of key functional elements, essentially focusing on mechanisms of what constitutes a threat: The key threat element is addressed directly instead of extensive characterization of ancillary details. Examples might include a potent toxin, long-term environmental stability, or a specific protein causing morbidity/mortality. By identifying the critical components leading to disease, limited time, efforts, and resources can be focused to address the greatest risks. Further, as future threats will likely contain critical aspects of known agents, this approach will potentially address a large area of uncharacterized risk space. Thus, focused research can buy down a large area of risk space while still addressing traditional threats and mission needs. Application of this strategy will move the field away from agent-based lists toward a more comprehensive hazard analysis and will position biodefense and health communities to prepare for the threats of the future.