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CSPI Calls for National Registry of Gene-Edited Agricultural Crops

  • Criticizing the US Department of Agriculture (USDA) and Food and Drug Administration (FDA) for lack of oversight over foods produced with gene editing technology (e.g., Zinc Finger Nucleases, TALENS, or CRISPR/Cas 9), the Center for Science in the Public Interest (CSPI) is calling for a federal registry of all gene-edited agricultural crops.

  • CSPI is not requesting a registry of genetically-modified (GM) agricultural crops, which CSPI notes are subject to government oversight under 7 CFR Part 340 of USDA’s regulations and which are evaluated by FDA under its voluntary plant biotechnology consultation program.  It is focused on gene-edited crops in particular because they have not historically been subject to 7 CFR Part 340 or any other mandatory federal regulations.  According to CSPI, at least 11 developers of gene-edited crops have gone through USDA’s “Am I regulated?” process to inquire into whether they are subject to USDA regulations on GM crops, and all have been informed that they are outside of the scope of those regulations.

  • Consistent with a recent FDA reminder encouraging industry to participate in its voluntary consultation program in part to foster public confidence in the safety of biotechnology, CSPI is encouraging the establishment of the registry to “allay consumer concerns about this emerging technology and allow the benefits of this new technology to be realized.”

© 2020 Keller and Heckman LLPNational Law Review, Volume IX, Number 115


About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...