Laboratory biosecurity in the United States: Evolution and regulation

In light of terrorist events in the United States and in recognition of the potential for diversion of highly pathogenic organisms for illicit purposes, the US Congress has in the past 15 years enacted a series of laws designed to enhance laboratory biosecurity. The Office of the President has also issued orders intended to implement and augment these new statutes imposing additional procedural and technical requirements on laboratories working with Select Agents and Toxins. Researchers and laboratory managers can substantially influence the implementation of new mandates with a thorough understanding of the regulatory process, reviewed in this chapter from a historical perspective with an emphasis on the practical aspects of rule-making procedures carried out by the Departments of Agriculture and Health and Human Services.