title: Clinical laboratories, the select agent program, and biological surety (biosurety).
abstract: 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).
authors.affiliation: United States Army Medical Research Institute of Infectious Diseases (USAMRIID), 1425 Porter Street, Fort Detrick, MD 21702, USA. ross.pastel@amedd.army.mil
authors.forename: Ross H
authors.initials: RH
authors.lastname: Pastel
authors.forename: Gretchen
authors.initials: G
authors.lastname: Demmin
authors.forename: Grant
authors.initials: G
authors.lastname: Severson
authors.forename: Rafael
authors.initials: R
authors.lastname: Torres-Cruz
authors.forename: Jorge
authors.initials: J
authors.lastname: Trevino
authors.forename: John
authors.initials: J
authors.lastname: Kelly
authors.forename: Jay
authors.initials: J
authors.lastname: Arrison
authors.forename: Joy
authors.initials: J
authors.lastname: Christman
mesh_terms: D023482:Bioterrorism; D002487:Centers for Disease Control and Prevention, U.S. / Q000331:legislation & jurisprudence / Q000458:organization & administration; D003264:Containment of Biohazards; D015386:Hazardous Substances; D006801:Humans; D007753:Laboratories / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D012637:Security Measures / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D014481:United States; D014483:United States Dept. of Health and Human Services / Q000331:legislation & jurisprudence / Q000458:organization & administration
chemical_list: D015386:Hazardous Substances