Race to create omega-3-rich canola contaminates ‘small number of canola fields,’ but doesn’t trigger FDA safety questions

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Source: Getty/AVTG (Getty Images/iStockphoto)

FDA is not worried about the safety of specific lots of canola seed and “a small number of canola fields” for human and animal consumption that inadvertently were contaminated with low levels of two new genetically modified varieties of canola seed currently undergoing premarket food safety reviews.

But, the agency’s lack of concern about the contamination should not be mistaken for an endorsement of the varietals’ safety in broader use, yet, FDA notes in an April 13 Constituent Update. It explains it is still conducting a premarket food safety consultation for each of the varietals – a voluntary step that most companies complete before marketing new products.

BASF Agricultural Solutions alerted FDA in late March that through testing it found low levels of two new canola varieties altered by BASF and Nuseed to produce certain omega-3 long chain fatty acids in two canola hybrid-seed production fields and in a small number of commodity canola fields.

According to FDA, the new seeds include BASF’s LBFLFK canola, which BASF genetically engineered to enable biosynthesis of long chain polyunsaturated fatty acids, including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and Nuseed’s NS-B50027-4 canola, which also is genetically engineered to biosynthesize long chain polyunsaturated fatty acids, including DHA and EPA, through fatty acid desaturases and elongases in the seed.

Other than the altered fatty acid profile, both canola seeds are similar to conventional canola, and the low levels inadvertently in the food supply will not impact the composition of canola oil and meal, FDA confirms in letters sent to each company – echoing reports from BASF and Nuseed.

Based on data and other information provided to FDA by BASF and Nuseed, FDA told the companies in letters dated April 9 that it does not believe the new varieties are likely to cause allergic reactions or be toxic to people or animals, and as such “has no questions about the safety” of the canola “when inadvertently present in the food supply at low levels” as described by the companies.

Despite this determination, FDA says in the Constituent Update that it will continue its ongoing voluntary, premarket food safety consultation with each company on their new canola seed varieties. This review is more comprehensive than that required for an early food safety evaluation and includes “the full complement of food safety and regulatory issues based on the characteristics of the food for humans and animals, including potential unintended changes in the composition of the food.”

Wanted: high-quality omega-3 alterantives

The two canola variants are part of fast and furious race to bring to market high-quality omega-3 alternatives to complement or replace those sourced from seafood, which represents a finite resource that is under increased pressure as demand for omega-3s continue to rise.

While omega-3 oils from krill, algae and copepods already are on the market as an alternative to traditional fish oil as a source for omega-3, NutraIngredients-USA reports that “the potential to source omega-3 oils from plants … is exciting some very big players,” including Nuseed and BASF.

In 2018, USDA approved pre-commercial production of Nuseed’s omega-3 canola in Montana, where some of the contamination was reported. More recently, Health Canada approved Nuseed’s proprietary DHA refined canola oil for human consumption and from the Canadian Food Inspection Agency for its omega-3 canola meal use in livestock feed and the oil for use in fish feed – a victory that offers significant sustainability benefits as Nuseed estimates that one hectare of its omega-3 canola could provide the same omega-3 yield as 10,000 kg of wild caught fish.

BASF also plans to use its omega-3-rich canola as a plant-based and scalable production system for omega-3 fatty acids and as a source of EPA and DHA for consumers either as a food ingredient and aquaculture feed ingredient available through its partnership with Cargill.