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EPA, FDA, and USDA Release Tool to Help Companies Developing Microbial Biotechnology Products Navigate Regulatory Landscape

Nanotech

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. Food and Drug Administration (FDA), and U.S.

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EPA, FDA, and USDA Issue Joint Regulatory Plan for Biotechnology

Nanotech

Department of Agriculture (USDA) released a plan to update, streamline, and clarify their regulations and oversight mechanisms for products of biotechnology.

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CRS Publishes Report on Regulation of Gene-Edited Plants and Issues for Congress

Nanotech

The Congressional Research Service (CRS) published a report on March 22, 2024, on “Gene-Edited Plants: Regulation and Issues for Congress.” Gene-edited plants are regulated under the U.S. Coordinated Framework for Regulation of Biotechnology, which coordinates how the U.S. Department of Agriculture (USDA), the U.S.

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APHIS Issues RSR Responses under Revised Biotechnology Regulations

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APHIS found the plant is unlikely to pose an increased plant pest risk compared to other cultivated tomatoes and is not subject to regulation under 7 C.F.R. APHIS’s Regulatory Status Review (RSR) responses under the revised biotechnology regulations at 7 C.F.R. Part 340 are available online.

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APHIS Releases New Strategic Plan for 2023-2027, Includes Biotechnology Objectives

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Objective 5 is “Ensure the development of safe agricultural biotechnology products using a science-based regulatory framework.” Environmental Protection Agency (EPA) and the U.S. Objective 3 is “Mitigate and adapt to the effects of climate change.”

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EPA Issues Final Rule to Accelerate Use of Plant-Incorporated Biotechnologies

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According to EPA’s May 25, 2023, press release , this rule will reduce costs for the regulated community and result in increased research and development activities, consistent with Executive Order 14081 on advancing biotechnology. Section 174.26); and allowing the existing inert ingredient exemption at 40 C.F.R.

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APHIS 2022 Impact Report Includes Summary of Biotechnology Activities

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Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the release of its 2022 impact report.