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. Food and Drug Administration (FDA), and the U.S. Environmental Protection Agency (EPA) regulate biotechnology products to ensure their safety. Over time, the agencies have been directed by Executive Orders (EO) to update their regulatory approaches to promote innovation in biotechnology and to protect human health and the environment, most recently in September 2022. The report notes that the following agency actions align with the goals of President Biden’s September 12, 2022, EO on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy:

• USDA’s Animal and Plant Health Inspection Service’s (APHIS) November 15, 2023, proposal for five additional exemptions for plants modified or produced through genetic engineering;

• FDA’s clarification of guidance for industry on voluntary engagement before marketing food from gene-edited plants; and

• EPA’s changes to regulations regarding plant-incorporated protectants (PIP).

According to the report, potential congressional concerns “could include examining whether current policies appropriately weigh the potential risks and rewards of new plant varieties developed using gene editing and whether regulatory agencies are efficiently coordinating their efforts.”

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