Title: Sentry at the Gate: A History of the CDC’s Regulation of Biological Agents (2004 Third Year Paper)
Author(s): Catherine Manzi
Subject & Subject keywords: Food and Drug Law "cdc" "" "biological agents"
Abstract:This paper charts the history of the CDC’s role in the regulation of biological agents, from its origins in the early 1970s as a monitor of physical package security to its current position as a barrier between would-be terrorists and their weapons. First, the paper discusses CDC regulation between 1971 and 1996, an era characterized by a narrow CDC approach to oversight focused on the physical safety of packages moving in interstate commerce. Next, the paper analyzes the rapid expansion of the CDC’s regulatory authority in the late 1990s to respond to the rising threat of bioterrorism, highlighting the challenges that emerged for an agency with little enforcement experience and possessing conflicting obligations towards the “industry” it regulated: the scientific community. Finally, the paper highlights several outstanding issues facing the CDC as it continues to enhance its regulatory mission.