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On October 6, 2015, the White House Office of Science and Technology Policy (OSTP) issued a Request for Information (RFI) to solicit relevant data and information, including case studies that may assist in the development of the proposed update to the Coordinated Framework for the Regulation of Biotechnology (CF). The RFI will assist OSTP in clarifying the current roles and responsibilities of the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and...
Category: Biotechnology/Synthetic Biology
The U.S. Environmental Protection Agency (EPA) published a notice in the August 25, 2015, Federal Register announcing a public meeting on September 30, 2015, to receive public input and comments on EPA's data needs to support risk assessments of biotechnology products subject to oversight under the Toxic Substances Control Act (TSCA) that make use of genetically engineered algae and cyanobacteria. The notice states that the...
The U.S. Environmental Protection Agency (EPA) has posted a document concerning its development of a project intended to support public dialog concerning the development and use of biotechnology. EPA has oversight responsibility for the production and use of intergeneric cyanobacteria, eukaryotic microalgae, and their products by application of genetic engineering approaches. EPA’s recently posted document, US Environmental Protection Agency Biotechnology Algae...
With little fanfare or advanced notice to the general public, 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...
Warm spring-like weather welcomed participants to the 4th Annual Next Generation Bio-Based Chemicals Summit at the Hilton San Diego/Del Mar. As a Platinum Sponsor of this premier event, Bergeson & Campbell, P.C. (B&C) professionals participated in four major events at the Summit. Attendees from many countries enjoyed the opportunity to become updated on the latest technologies and business developments in a well-organized program consisting of two days of concurrent pre-summit...
The Acta Group's (Acta) thoughts are below on what may be headed our way in 2013 from the U.S. Environmental Protection Agency's (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP). Although the 2012 Presidential Election is over, environmental issues will continue to be used to make distinctions between the two parties (or between the House and Senate). Speculation is currently rife with what directions a re-elected Obama Administration might take: seek a middle-ground approach to...
June 23, 2010
Supreme Court Sets Aside Injunction That Prohibited APHIS from Partially Deregulating Genetically Engineered Alfalfa
On June 21, 2010, the Supreme Court issued a decision in Monsanto, et al v. Geertson Seed Farms, et al. In the 7-1 decision, the Court reversed a decision by the 9th Circuit Court of Appeals. The Court held that the District Court that reviewed a decision by the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture abused its discretion when it issued an injunction precluding APHIS from allowing any sale or use of Roundup Ready Alfalfa (RRA), a...