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March 4, 2016

More Information Available On Upcoming “Modernizing The Regulatory System For Biotechnology Products


On February 1, 2016, the White House Office of Science and Technology Policy (OSTP) announced the dates and locations for the final two public engagement sessions covering the July 2, 2015 memorandum "Modernizing the Regulatory System for Biotechnology Products." The memorandum, issued under the Executive Office of the President (EOP) and jointly by (OSTP), the Office of Management and Budget, the U.S. Trade Representative, and the Council on Environmental Quality, directs the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to update the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework). Three public engagement meetings were announced to develop a strategy to prepare the federal biotechnology regulatory system for the future of the biobased industry. The first meeting occurred on October 30, 2015, and more information has recently become available for the second and third meetings.

The second meeting will focus on current federal roles and responsibilities regarding biotechnology products. This meeting will occur on March 9, 2016, from 9:30 a.m. to 1:00 p.m. at EPA's Region 6 Office in Dallas, Texas. Registration is now open. To participate in person, registration should be completed by March 4, 2016. Registration is also required to view and participate in a live streaming of the public meeting. The third and final meeting does not yet have an agenda, but will be held on March 30, 2016, at the University of California's Davis Conference Center in Davis, California.

The Administration's efforts to modernize the Coordinated Framework are essential, laudable, and timely. It is imperative that stakeholders participate actively and effectively in sharing their experiences under the Coordinated Framework with the Administration. The forthcoming public meeting in Dallas is an excellent opportunity to communicate both successes and less successful experiences with the government's regulation of products of biotechnology. There is only one remaining public meeting opportunity after Dallas. After the third and final meeting, the Administration will assess all of the comments provided in response to the public meetings, and then will seek the public's comments on its thoughts on modernizing the Coordinated Framework. Stakeholders are urged to attend or participate virtually in the public meeting, and to help develop a more timely, efficient, and current governance framework for products of biotechnology.

Sign up through the EOP's website to be notified of future modernizing the biotechnology regulatory system activities.