Modernizing the Regulatory System for Biotechnology Products

The White House has posted a blog (January 4, 2017) unveiling the final version of the Update to the Coordinated Framework for the Regulation of Biotechnology as well as information on the National Strategy for Modernizing the Regulatory System for Biotechnology Products. View the blog announcing these documents. 

The national strategy and update of the coordinated framework are part of the Administration’s continuing effort to modernize the federal regulatory system for biotechnology products as well as clarify various roles of the Environmental Protection Agency, Food and Drug Administration and Department of Agriculture in evaluating new biotechnologies:

• Update to the Coordinated Framework for the Regulation of Biotechnology to clarify current roles and responsibilities. View the update to the coordinated framework.
• National Strategy for Modernizing the Regulatory System for Biotechnology Products to set forth a vision for ensuring that the federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology. Read this national strategy. 

This Update and the accompanying Strategy offer the public a complete picture of a robust and flexible regulatory structure that provides appropriate oversight for products of modern biotechnology.

Background

On July 2, 2015, the Executive Office of the President (EOP) issued a memorandum directing the primary agencies that regulate the products of biotechnology—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, develop a long-term strategy to ensure that the Federal biotechnology regulatory system is prepared for the future products of biotechnology, and commission an expert analysis of the future landscape of biotechnology products to support this effort.  View the memorandum directing this regulatory update. 

As part of this process, the Administration announced that it would hold three public engagement sessions in different regions of the country:

• On October 30, 2015, under the auspices of the National Science and Technology Council, the Food and Drug Administration (FDA), along with the Office of Science and Technology Policy (OSTP), and the United States Department of Agriculture (USDA), held the first of the public engagement sessions. View Modernizing the Regulatory System for Biotechnology Products: First Public Meeting October 30, 2015.
• The second public meeting was held on March 9, 2016, from 9:30 AM to 1:00 PM at EPA’s Region 6 Office in Dallas, Texas and illustrated the current federal roles and responsibilities regarding biotechnology products. View the meeting documents, including video recordings of the meeting.
• The third public meeting was held on March 30, 2016, at the University of California's Davis Conference Center in Davis, California. View information on the March 30th Meeting.

For More Information

• Direct Link to Docket No. FDA-2015-N-3403
• Updating Biotechnology Regulations, USDA
• June 26, 1986, Federal Register notice:  Coordinated Framework for Regulation of Biotechnology