Friday, July 3, 2015

Executive Memorandum Issued Ordering Modernization of Biotechnology Regulations

  On July 2, 2015, the White House issued an executive memorandum directed towards the FDA, EPA, and USDA, requiring modernization of their biotechnology regulations.

  The order states the existing regulations adequately protect health and safety, but there are “…in some cases, unnecessary costs and burdens associated with uncertainty about agency jurisdiction, lack of predictability of timeframes for review, and other processes…”  These uncertainties have created difficulties for both small and mid-sized companies as well as the public to understand the regulatory process and food safety.  The memorandums objective is to ensure public confidence and prevent “unnecessary barriers to future innovation and competitiveness by improving transparency, coordination, predictability, and efficiency of the regulation of biotechnology products…”  

  The memorandum requires an updated federal Coordinated Framework for the Regulation of Biotechnology (CF) within a year of the memorandum issue date.  The CF provides the outline for the federal regulatory policy that ensures the safety of biotechnology products.  Updating the CF could clarify each agency’s role in biotechnology regulation as well as create a long-term strategy to ensure inadequacies in the current system are addressed.

  The group responsible for updating the CF will be a “new Biotechnology Working Group under the Emerging Technologies Interagency Policy Coordination Committee (ETIPC).”  The Working Group will have representatives from the Executive Office of the President, EPA, FDA, and the USDA.    Further, the EPA, FDA, and USDA are required to have an external, independent analysis of “the future landscape of biotechnology” every five years in order to make informed policy decisions due to biotechnology products and processes rapid changes.

Written by Katharine Richter - Research Assistant

July 3, 2015 

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