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US agencies unveil plan for biotechnology regulatory framework

Initiative aims to improve transparency, efficiency and public trust by updating and streamlining the oversight of biotech innovations

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In alignment with President Biden's Executive Order 14081, the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) have unveiled a joint plan to enhance the regulatory framework overseeing biotechnology products. The initiative aims to update, streamline, and clarify oversight mechanisms, addressing public confidence and regulatory transparency.

The executive order, titled “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy,” sets forth ambitions to improve the predictability, coordination, and efficiency of biotechnology regulations. The collaborative plan developed by the EPA, FDA, and USDA includes engagement with various stakeholders, horizon scanning for new biotech products, and the formulation of a cohesive strategy for regulatory reform.

Key focus areas under the new regulatory plan include modified plants, animals, and microorganisms, as well as human drugs, biologics, and medical devices, along with cross-cutting issues in biotechnology. Planned actions involve clarifying regulatory oversight for genetically engineered organisms, enhancing information sharing through a Memorandum of Understanding (MOU) to coordinate modified microbe oversight, and launching a pilot project aimed at assessing the viability of a web-based tool to guide developers on agency regulations pertaining to specific product categories.

This initiative builds on the Coordinated Framework for the Regulation of Biotechnology, established in 1986 and most recently updated in 2017, which outlines the roles of the EPA, FDA, and USDA in ensuring biotechnology product safety.

Following the executive order, the agencies, in consultation with the Office of Science and Technology Policy (OSTP), issued a Request for Information (RFI) to identify regulatory ambiguities and inefficiencies, receiving 88 distinct public comments. This feedback included contributions from over 6,000 stakeholders ranging from biotechnology developers to academic institutions.

As the agencies move forward with implementing the new regulatory enhancements, they continue to invite input from all interested parties to ensure a robust and responsive regulatory system. For further details on these regulatory updates and Executive Order 14081, stakeholders and the public can visit the Unified Website for Biotechnology Regulation.

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