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On October 2, 2024, the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA) announced the release of a new web-based tool on the Unified Website for Biotechnology Regulation for companies that develop microbial biotechnology products. EPA notes that biotechnology products include plants, animals, and microorganisms developed through genetic engineering or the targeted manipulation of genetic information. According to EPA,...

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. The 2017 Update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products. Together with the National Strategy for Modernizing the Regulatory System for...

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (2017 Update).  The Update to the Coordinated Framework provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products.  Together with...

By Lynn L. Bergeson and Carla N. Hutton On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (2017 Update).  The Update to the Coordinated Framework provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology...

As previously reported in the Biobased and Renewable Products Advocacy Group’s (BRAG®) Biobased and Renewable Products Update of September 22, 2016, Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology (Update to the Coordinated Framework) was published in the Federal Register .  The Update to the Coordinated Framework provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental...

On September 22, 2016,  Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology (Update to the Coordinated Framework) was published in the  Federal Register . This proposed update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA) with respect to the regulation of...

By Lynn L. Bergeson and Margaret R. Graham On September 16, 2016, the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA), in collaboration with the White House, released two documents that will update the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework) that was first rolled out by the White House Office of Science and Technology Policy (OSTP) in 1986 and updated in...

On August 3, 2016, 24 farmer and public interest organizations wrote to the Obama Administration expressing their disappointment with the direction that the White House Office of Science and Technology Policy (OSTP) has taken with the proposed modernization of the Coordinated Framework for Regulation of Biotechnology (Coordinated Framework). The letter argues that an overly permissive regulatory framework for genetically engineered (GE) products has resulted in negative consequences, and that GE...

According to a Federal Register notice published on February 5, 2016, 81 Fed. Reg. 6225, the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) announced its intent to "prepare a programmatic environmental impact statement (EIS) in connection with potential changes to the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered [(GE)] organisms." The notice identifies...

On February 1, 2016, the White House Office of Science and Technology Policy (OSTP) announced the dates and locations for the second and third public engagement sessions that will discuss the July 2, 2015, memorandum entitled “Modernizing the Regulatory System for Biotechnology Products.”  The second public meeting will be held on March 9, 2016, at the U.S. Environmental Protection Agency’s (EPA) Region 6 office at 1445 Ross Avenue in Dallas, Texas.  The third public...