The Congressional Research Service (CRS) posted a November 30, 2024, update to its report entitled “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. CRS states that issues for Congress include.
- Examining the effectiveness of USDA, FDA, and EPA efforts to regulate gene-edited products, particularly new plant varieties, and considering whether these agencies need additional direction or amended authorities to increase or decrease regulatory scrutiny;
- Clarifying related definitions in statutes, amending processes based on deemed risk, or changing research funding or agency capacity;
- Holding oversight hearings to assess how and whether the implementation of the regulatory revisions achieve the goals of balancing safety and scientific advancements in new biotechnology products; and
- As differences in regulations and labeling requirements between countries could potentially lead to important trade issues, assessing the potential impacts of regulations on gene-edited plants on market access for agricultural producers and evaluating any trade barriers that may arise as a result of limited export opportunities and possible hindrances to the free flow of goods.
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