BASF has detected the presence of two genetically engineered traits in canola seed samples taken from BASF’s hybrid seed production fields in the United States. These events are designed to increase Omega-3 fatty acid content in the seed oil for use in aquaculture and human foods. While the detected events, LBFLFK or BASF-Cargill Omega-3 and NS-B50027-4, owned by Nuseed, are approved for cultivation in the United States, they have not yet received approval in key export countries.
The U.S. Canola Association – a non-profit representing the entire canola industry, including canola growers, seed companies, processors and traders – was notified by BASF Agricultural Solutions and Nuseed about the inadvertent presence of low levels of genetic material from their respective omega-3 canola varieties in limited commercial canola fields and hybrid seed production.
“All affected 2020 hybrid seed lots were isolated and contained on farm or recalled from the commercial channel,” says Odessa Hines, BASF external affairs manager. “BASF is working with customers to replace this recalled seed in time for the 2021 planting season.”
In letters to BASF and Nuseed April 9, the U.S. Food and Drug Administration said that based on data the companies previously submitted, it has no concern about the specialty canola varieties causing allergic reactions or harm to people or animals or altering the fatty acid profile of commercial canola oil.
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,” FDA says.
“The USCA supports the FDA’s assessment to date about the safety of these new varieties, especially when inadvertently present at low levels in the human and animal food supplies. We are confident that the FDA will reach a favorable conclusion to its food safety consultations on these new canola varieties,” says Andrew Moore, USCA president.
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.
Hines says based on their findings and information regarding additional field activities with the Omega-3 events in 2018 and 2019, BASF immediately initiated testing of retained lots from hybrid canola seed produced in these years in Montana and Washington State.
Until February 2021, no Nuseed authorized third party laboratory was available to test for Nuseed's NS-B50027-4 event. “BASF’s investigation and retained seed sample testing is ongoing,” Hines adds.
BASF is working with the canola seed distribution channel on product recalls in an effort to prevent seed containing the presence of Nuseed's NS-B50027-4 event or LBFLFK from being planted in 2021.
“Recall efforts are ongoing and will be adjusted as additional information becomes available to BASF,” Hines says. “BASF does not anticipate that this issue will cause a shortage of InVigor Canola varieties based on our current commitments for the 2021 season.”
The FDA says it 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.
“BASF has extensive data on the composition, safety and characteristics of canola containing the LBFLFK event that has been provided to regulatory bodies, including the United States and Canada,” Hines says, adding the FDA has confirmed it "has no questions about the safety of LBFLFK canola when inadvertently present in the food supply at low levels" in a letter dated April 9.
USCA says both varieties have been approved by USDA for cultivation in the United States and are grown in closed-loop systems to maintain seed purity. In addition, this identity preservation supports co-existence with commercial canola production. “Based on these developments, the USCA has set up a committee to address the co-existence of novel canola traits with commercial production,” Moore says.
Hines adds, “BASF is committed to stewardship standards from research through the entire lifecycle of our seed products. We are working with canola industry groups in the US and Canada, including Excellence Through Stewardship, to share information and reach consensus on a path forward.”