April 9, 2021 

Dr. Ali Scott 

Global Head Regulatory Affairs- Seeds 

BASF Agricultural Solutions 

2 TW Alexander Dr. 

Research Triangle Park, NC 27709 

Dear Dr. Scott: 

This responds to your letter of March 26, 2021, regarding LBFLFK canola. In your letter, you 

state that low levels of LBFLFK canola have been detected in two canola hybrid-seed production 

fields and in a small number of commodity canola fields. Based on your description, our 

understanding is that these low levels of LBFLFK canola are inadvertently present in these 

seeds. LBFLFK canola is genetically engineered to enable biosynthesis of long chain 

polyunsaturated fatty acids (LCPUFAs), including eicosapentaenoic acid (EPA) and 

docosahexaenoic acid (DHA), through expression of several fatty acid desaturases and elongases 

in the seed. You explain that LBFLFK canola is the subject of an ongoing voluntary premarket 

biotechnology consultation with FDA. Your letter states that food containing LBFLFK canola 

does not present a food safety concern and that the low levels of LBFLFK canola inadvertently 

present in the food supply will not impact the use of canola oil, the use of canola meal, or the 

overall composition of human or animal food. You follow with a request for FDA’s views on the 

safety of LBFLFK canola when inadvertently present in food at low levels. 

In its June 2006, “Guidance for Industry: Recommendations for the Early Food Safety 

Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food 

Use,”1 FDA explained that it believes that any food safety concern related to material from new 

plant varieties inadvertently present in the human and animal food supply at low levels would 

be limited to the potential that a new protein in food from the plant variety could cause an 

allergic reaction in susceptible people or could be a toxin in people or animals. The data and 

other information in your voluntary premarket biotechnology consultation on food from 

LBFLFK canola establish that the new proteins expressed in LBFLFK canola are not likely to be 

allergenic to humans and are not toxins to people or animals. Additionally, you state in your 

letter of March 26, 2021, that the low levels of LBFLFK canola inadvertently present in the food 

supply will not impact the use of canola oil, the use of canola meal, or the overall composition of 

human or animal food. Based on information supplied during your voluntary premarket 

biotechnology consultation for LBFLFK canola and in your letter of March 26, 2021, FDA has no 

questions about the safety of LBFLFK canola when inadvertently present in the food supply at 

low levels, as you have described. 

While this letter addresses low levels of LBFLFK canola inadvertently present in the human and 

animal food supply, FDA is continuing to evaluate your voluntary premarket biotechnology 

1 Guidance available at: https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/guidance-industry-recommendations-early-food-safety-evaluation-new-non-pesticidalproteins-produced 

U.S. Food and Drug Administration 

5001 Campus Drive 

College Park, MD 20740 

www.fda.gov 
Page 2 – Dr. Ali Scott 

consultation on human and animal food from this variety. The biotechnology consultation 

process evaluates 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. 

Sincerely, 

Digitally signed by Dennis M. Dennis M. Keefe -S 

Date: 2021.04.09 Keefe -S 12:33:04 -04'00' 

Dennis M. Keefe, Ph.D. 

Director 

Office of Food Additive Safety 

Center for Food Safety 

and Applied Nutrition