From: JDSupra Business Advisor
The U.S. Environmental Protection Agency (EPA) announced last week that it is developing a project intended to support public dialog concerning the development and use of synthetic biology (synbio). EPA has oversight responsibility for the production and use of intergeneric microorganisms, including cyanobacteria, eukaryotic microalgae (genetically modified (GM) algae), and their products by application of genetic engineering approaches, including those called synbio. EPA’s recently posted document, US Environmental Protection Agency GM/Synbio Algae Project, states that it is focusing its project around GM/synbio algae applications.
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First, on July 2, 2015, the White House Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality issued a memorandum directing the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to update the Coordinated Framework for the Regulation of Biotechnology. The memorandum reflects the Administration’s acknowledgement that the Framework needs to be updated to reflect the tremendous explosion of new technologies addressed by the federal family or regulatory agencies and the lack, in some instances, of a coherent regulatory framework that innovators and others can anticipate and follow in commercializing their products. More information on the update to the coordinated framework in available in our memoranda “Biotechnology: White House Directs EPA, FDA, and USDA to Update the Coordinated Framework for the Regulation of Biotechnology.”