On March 14, 2025, President Trump signed Executive Order (EO) 14236, rescinding 19 executive actions, including former President Biden’s September 2022 EO 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.” 90 Fed. Reg. 13037. According to the White House’s March 14, 2025, fact sheet, EO 14081 “funneled Federal resources into radical biotech and biomanufacturing initiatives under the guise of environmental...
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October 2, 2024
EPA, FDA, and USDA Release Tool to Help Companies Developing Microbial Biotechnology Products Navigate Regulatory Landscape
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,...
January 13, 2017
White House Releases Updated Coordinated Framework for the Regulation of Biotechnology
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...
January 5, 2017
White House Announces Release of Final Update to the Coordinated Framework for the Regulation of Biotechnology
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...
January 5, 2017
White House Announces Release of Final Update to the Coordinated Framework for the Regulation of Bio
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...
October 28, 2016
Comment Deadline Approaches On Update To The Coordinated Framework For The Regulation Of Biotechnolo
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...
September 30, 2016
Update To The Coordinated Framework For The Regulation Of Biotechnology Published In The Federal Reg
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...
September 19, 2016
EPA, FDA, and USDA Release Updates to Coordinated Framework on Biotechnology
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...
August 12, 2016
US Environmentalist And Organic Crop Farm Groups Want Overhaul Of Federal Biotechnology Strategy
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...
February 5, 2016
Biotechnology: APHIS Seeks Comment on Potentially Significant Changes to Regulations Regarding GE Or
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...