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FDA Responds to Inadvertent Presence of Two New Varieties of GE Canola Seeds

On April 13, the FDA published a constituent update advising companies about the inadvertent presence of low levels of certain genetically engineered canola seeds. The FDA was notified by BASF Agricultural Solutions (BASF) and Nuseed that low levels of genetic material from two new varieties of canola seed that are currently under review by the FDA have been found in specific lots of canola seed and a small number of canola fields. The two new varieties are altered to produce certain omega-3 long chain fatty acids. One of the new canola varieties is produced by BASF and the other by Nuseed.

The FDA is currently conducting a voluntary, premarket food safety consultation with BASF and Nuseed, but the reviews have not been fully completed. Premarket reviews are voluntary, but companies typically do not market their products until the consultations are finished.

On April 9, the FDA issued letters to BASF and Nuseed stating that the Agency has no questions about the safety of the new varieties of canola when inadvertently present in the food supply at low levels. As stated in the constituent update, one of the factors the FDA looks at when evaluating safety when genetic material is present at low levels is whether a protein expressed by a new plant variety may cause an allergic reaction or could be a toxin in people or animals. The data and other information in the voluntary premarket consultations for the two new varieties of canola establish that the new proteins expressed in the canola are not likely to be allergenic to humans and are not toxins to people or animals.

The FDA is continuing to evaluate the two consultations and will provide an update once the consultations are complete.

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 104
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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...

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