On September 7, 2023, the Congressional Research Service (CRS) published a report entitled Gene-Edited Plants: Regulation and Issues for Congress. The report notes that the U.S. regulation and oversight of gene editing in plants is facilitated by the Coordinated Framework for Regulation of Biotechnology, which involves the U.S. Department of Agriculture (USDA), the U.S. Food and Drug Administration (FDA), and the U.S. Environmental Protection Agency (EPA). Established in 1986 by the White House Office of Science and Technology Policy (OSTP), the framework outlines how the agencies apply their existing statutory authority to evaluate and ensure that gene-edited products in the United States are safe. As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative that aims to improve regulatory clarity and efficiency, enhance coordination among federal agencies, and encourage international regulatory cooperation.

The report states that public policy issues concerning gene editing in agriculture that could require Congressional consideration are multifaceted. The report suggests that Congress may examine whether federal labeling standards such as the National Bioengineered Food Disclosure Standard (NBFDS) adequately address issues raised by gene-edited plants. The three agencies that oversee agricultural products produced with biotechnology — USDA, FDA, and EPA — have been directed to update the federal regulatory system for the products of biotechnology and to establish mechanisms for periodic updates of that system. According to the report, Congress may review whether the agencies are effectively coordinating with each other to align their regulations with the state of biotechnology developments and whether the updates fulfill their mandates to accelerate innovation in plant biotechnology and to safeguard human health and the environment. The report notes that possible future policy challenges regarding gene editing include managing different types of plants and other gene-edited products as they are released into the environment; legal issues; and the impact of gene-edited plants on ecosystems and biodiversity.