July 4, 2022

Volume XII, Number 185

Advertisement
Advertisement

July 01, 2022

Subscribe to Latest Legal News and Analysis
Advertisement

FDA Completes Review of GE Canola Seeds After Response to Last Year’s Inadvertent Release

  • Plants produced through genetic engineering (GE) are subject to the same FDA safety standards as other plants.  Given the possibility for food from some GE plants to have new allergens, an unapproved food additive, reduced levels of important nutrients, or significantly increased levels of toxicants or anti-nutrients, FDA has established its voluntary Plant Biotechnology Consultation Program whereby companies may submit notices, which FDA reviews and responds to with respect to whether food derived from the new plant variety presents safety and regulatory issues.  We reported last year, before the completion of FDA’s review of two new GE canola seeds from BASF Agricultural Solutions (BASF) and Nuseed, on FDA’s April 13, 2021 response, which indicated no safety concern, on the inadvertent presence of low levels of genetic material in specific lots of canola seed and a small number of canola fields.

  • On March 28, 2022, FDA announced the completion of the voluntary pre-market consultations on BASF’s LBFLFK canola and Nuseed’s NS-B5ØØ27-4 canola, which are genetically engineered to produce long chain polyunsaturated fatty acids (LCPUFAs), including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and also to tolerate treatment with herbicides, i.e., imidazolinone and glufosinate ammonium, respectively.  As stated in FDA’s response letters to BASF and Nuseed, FDA has no questions about the safety of food from these canola varieties when used as described.  Specifically, oil from the GE canola seed is intended for use in human food subject to the limitations in the Generally Recognized As Safe (GRAS) affirmation regulation for menhaden oil (21 CFR 184.1472), which are related to the intake of EPA and DHA from menhaden oil; canola meal derived from the seeds is used in human food as a source of protein isolates; and solvent-extracted meal derived from the seeds will be used in animal feed in the same manner as compositionally equivalent canola meal from other canola seeds.

  • Issues preventing unintended spread to non-GE crops are not unique to BASF’s LBFLFK canola and Nuseed’s NS-B5ØØ27-4 canola, and are not addressed in FDA’s response letters.

© 2022 Keller and Heckman LLPNational Law Review, Volume XII, Number 101
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement

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...

202-434-4100
Advertisement
Advertisement
Advertisement