July/August 2008
Laboratories engaged in work on biological agents or toxins categorized as "select agents or toxins" are subject to a complex regulatory regime. Under the Select Agent Regulations, 42 C.F.R. Part 73, the U.S. Department of Health and Human Services (HHS), through the Centers for Disease Control (CDC) and the Office of the Inspector General (OIG), wields substantial authority to mandate strict compliance with the select agent regulations.
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