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          FDA Advises Companies Regarding Inadvertent Presence of Low Levels of Certain Genetically Engineered Canola SeedsCFSAN Constituent Updates FDA Advises Companies Regarding Inadvertent Presence of Low Levels of Certain Genetically Engineered Canola Seeds
  
  	
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March 28, 2022

The U.S. Food and Drug Administration (FDA) completed voluntary pre-market consultations on two canola varieties that are genetically altered to produce certain omega-3 long chain fatty acids. These canola varieties are made by BASF Agricultural Solutions (BASF) and Nuseed. The agency has no questions about the safety of food from these canola varieties when used as described in the FDA’s response letters. More details can be found in the FDA’s response letters to BASF and Nuseed.


Original Constituent Update

April 13, 2021

The U.S. Food and Drug Administration has been 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 canola varieties are altered to produce certain omega-3 long chain fatty acids.

BASF informed the FDA that it found, through testing, low levels of genetic material from the two canola varieties inadvertently present in some lots of its hybrid canola seed and a small number of canola fields. 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 each company on its new canola seed variety but hasn’t fully completed these reviews. Although premarket consultations are voluntary, companies typically do not market their products until the consultations are completed.

The FDA issued letters to BASF and Nuseed stating that the FDA has no questions about the safety of these new varieties of canola when inadvertently present in the human and animal food supply at these low levels. 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 in susceptible people or could be a toxin in people or animals. The data and other information in each company’s voluntary premarket biotechnology consultation on food from their respective new canola variety 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 expects to complete the food safety consultations of both the new canola seed varieties from BASF and Nuseed in the coming weeks and will provide an update when the consultations are complete.

For more information

New Plant Variety Regulatory Information
	Consultation Programs on Food from New Plant Varieties
	Letter to BASF Agricultural Solutions
	Letter to Nuseed

                                                                                  Content current as of:
      03/28/2022
              
              
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