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Documents on Regulatory Authority for Biotechnology Products Released

Mar 16, 2016

The White House, together with Environmental Protection Agency (EPA), the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA), recently released two draft documents that clarify the responsibilities each agency has for regulating genetically engineered crops, also known as genetically modified organisms (GMOs). Under direction from the Obama administration, the agencies are tasked with revising the Coordinate Framework, reviewing and updating regulations related to production of biotechnology and identifying ways to improve coordination among federal agencies.

“These two draft documents are important tools to help food companies better understand the agencies’ current responsibility, and should improve the coordination between agencies necessary for a biotechnology product to reach the market,” said  Emily Lyons, IDFA director of regulatory affairs and counsel.

The “Table of the oversight of biotechnology products and relevant coordination across EPA, FDA, and USDA” document summarizes the statutory and regulatory authorities that EPA, FDA, and USDA have when reviewing biotechnology products and discusses how the agencies coordinate when approving products. This table will eventually become part of the Coordinated Framework to help clarify the various agencies’ roles in biotechnology product regulation.

The second document “Regulation of Biotechnology Products—Clarifying Roles and Responsibilities through Hypothetical Case Studies,” provides examples of biotechnology products and how federal agencies would regulate that specific product. The document is intended to assist biotechnology product developers in navigating the regulatory framework from research to full commercialization of the product. Examples of biotechnology products in the document include genetically engineered corn, plums, canola, roses, microbial pesticides, algae for biofuel products and rabbits to produce insulin for human use.

Listening Sessions

To date, the agencies have held two listening sessions in different parts of the country to allow the public to participate. The first session was held last October in Washington, D.C., and the second was held in Dallas, Texas on March 9th. The third and final listening session held by the White House and agencies will be on March 30 at the University of California-Davis in Davis, Calif. Additional details on the meeting time, agenda and how to participate will be announced in a Federal Register notice and on agency websites prior to the meeting.

For more information, contact Emily Lyons, IDFA director of regulatory affairs and counsel, at

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