Select agent and toxin regulations: beyond the eighth edition of the Guide for the Care and Use of Laboratory Animals.

In the interval between the publication of the seventh and eighth editions of the Guide for the Care and Use of Laboratory Animals (Guide), much has changed with regard to the regulation and funding of highly pathogenic biologic agents and toxins (Select Agents). Funding of research involving highly pathogenic agents has increased dramatically during this time, thus increasing the demand for facilities capable of supporting this work. The eighth edition of the Guide briefly mentions Select Agents and provides a limited set of references. Here we provide some background information regarding the relevant laws and regulations, as well as an overview of the programmatic requirements pertaining to the use of Select Agents, with a focus on use in animals.

Clinical laboratories, the select agent program, and biological surety (biosurety).

The threat of bioterrorism has led to increased concerns over the availability of biological select agents and toxins (BSAT). Congress has implemented several public laws that have led to the development of federal regulations by the Centers for Disease Control and Prevention (CDC) and the US Department of Agriculture. The CDC regulation 42 CFR 73 has a direct impact on all clinical laboratories that may at some time identify BSAT in a clinical specimen. The Department of Defense has imposed a more stringent layer of regulation called biological surety (biosurety) on top of the requirements of 42 CFR 73 for military laboratories that possess BSAT. However,42 CFR 73 falls into the framework of biosurety. Both sets of regulations have four pillars (safety, physical security, agent account-ability, and personnel reliability) that are built on a foundation of training and covered by a roof of management (operations and plans).