Classifying and Regulating Biological Agents in the United States: Problems Posed to Global Biosecurity

Over the years, there have been many different classifications of biological agents. In the 20th century, classifications often revolved around and highlighted the weaponized potential of certain pathogens and chemicals.1 Since then, the official worldview of biological agents has shifted to a defensive stance, focusing more on classifying agents for public health preparedness and bio-risk prevention.2 However, an offense focused classification system is still utilized for militaristic purposes.3 Outside of military classifications, there are two major classification systems in the United States that have evolved from the days of the U.S.’s biological weapons program. The Select Agent Program holds regulatory power and determines which biological agents are regulated and what facilities must do to possess, use, or transfer them within the bounds of the law. The other classification system, disseminated by the National Institute of Health, takes no part in regulation, and instead provides insight into which agents scientifically pose the highest risk to global biosecurity. Navigating this broad and confusing framework can be challenging, and as with many administrative regulations, there are multiple problems associated with the implementation and enforcement of these policies that pose significant risks to global biosecurity.