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Lynn L. Bergeson, "Industrial Biotechnology: Coordinated Framework Make-Over and Lots More," Industrial Biotechnology, Vol. 11 No. 5, October 2015.

The summer of 2015 was surprisingly busy in the industrial biotechnology policy and regulatory arenas with three important announcements regenerating lots of buzz.  On July 2, 2015, the White House Office of Science and Technology Policy, the Office of Management and Budget, the US Trade Representative, and the Council on Environmental Quality issued a memorandum directing EPA, FDA, and USDA to update and modernize the Coordinated Framework for the Regulation of Biotechnology.  A few weeks later, EPA’s Office of Pollution Prevention and Toxics (OPPT) announced a project intended to support public dialog concerning the development and use of biotechnology by developing a new algae “how to” document for Toxic Substances Control Act Purposes, and to help jump start much needed public discourse around the topic of biotechnology in general.  Finally, OPPT also announced that it is updating its Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms. Each of these developments is important. This article discusses these initiatives, offers insights on why stakeholders should applaud these opportunities, and urges stakeholders to seize the moment and to engage vigorously in them.  


 
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