Modernizing the Regulatory System for Biotechnology Products

Modernizing the Regulatory System for Biotechnology Products

On January 4, 2017, the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) released the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology and accompanying National Strategy for Modernizing the Regulatory System for Biotechnology Products

This update represents the first time in 30 years that the Federal government has produced a comprehensive summary of the roles and responsibilities of the three principal regulatory agencies with respect to regulating biotechnology products. 

As part of this process, on October 30, 2015, under the auspices of the National Science and Technology Council, the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), the United States Department of Agriculture (USDA), and the Office of Science and Technology Policy (OSTP) held a public meeting to discuss the memorandum entitled, "Modernizing the Regulatory System for Biotechnology Products," issued by the Executive Office of the President (EOP) in July, 2015. This meeting was the first of three public engagement sessions on this topic.

On February 1, 2016, we announced the dates and locations for the second and third public engagement sessions. The second public meeting was held on March 9, 2016, at EPA’s Region 6 Office in Dallas, Texas.

The third public meeting was held on March 30, 2016, at the University of California's Davis Conference Center in Davis, California.    

At this public meeting representatives from the EPA, FDA, USDA, and the White House OSTP reviewed progress made on efforts to modernize the regulatory system for biotechnology products and illustrated the current roles and responsibilities of the EPA, FDA, and USDA regarding biotechnology products by discussing case studies of hypothetical products.

There are two draft documents available that were the basis for discussion at the March 30 meeting: a document with eight case studies of hypothetical biotechnology products, and a table of oversight authorities related to biotechnology products.

To view the agenda, case studies, and other supporting documents, see below or Docket No. FDA-2015-N-3403.   

Additional details on the meeting time, agenda, and how to participate were announced in a Federal Register notice and posted on other relevant agency websites prior to the public meetings.

Associated Documents

2017 Update to the Coordinated Framework for the Regulation of Biotechnology 

National Strategy for Modernizing the Regulatory System for Biotechnology Products

Federal Register Notice: Request for Information (Closed November 13, 2015) 

Direct Link to Docket No. FDA-2015-N-3403 

March 30, 2016 Meeting Transcripts

March 30, 2016 Meeting Documents

March 30, 2016 Meeting Announcements

Other Meetings


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