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).
Pastel
Ross H
RH
United States Army Medical Research Institute of Infectious Diseases (USAMRIID), 1425 Porter Street, Fort Detrick, MD 21702, USA. ross.pastel@amedd.army.mil
Demmin
Gretchen
G
Severson
Grant
G
Torres-Cruz
Rafael
R
Trevino
Jorge
J
Kelly
John
J
Arrison
Jay
J
Christman
Joy
J
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
D015386:Hazardous Substances