April 9, 2021 

June Yao, Ph.D. 

Global Regulatory Lead 

Nuseed 

990 Riverside Parkway, Suite 140 

West Sacramento, CA 95605 

Dear Dr. Yao: 

This responds to your letter of March 26, 2021, regarding NS-B50027-4 canola. In your letter, 

you state that low levels of Nuseed’s NS-B50027-4 canola have been detected in specific grain 

and seed lots in Montana and Washington states. Based on your description, our understanding 

is that these low levels of NS-B50027-4 canola are inadvertently present in these seeds. NSB50027-4 canola is genetically engineered to enable biosynthesis of long chain polyunsaturated 

fatty acids (LCPUFAs), including docosahexaenoic acid (DHA) and eicosapentaenoic 

acid (EPA), through expression of several fatty acid desaturases and elongases in the seed. You 

explain that NS-B50027-4 canola is the subject of an ongoing voluntary premarket 

biotechnology consultation with FDA. Your letter states that human and animal food containing 

NS-B50027-4 canola does not present a food safety concern; that NS-B50027-4 canola seed, 

meal, and oil are comparable to those of conventional canola except for the intended changes to 

the fatty acid profile; and that the low levels of NS-B50027-4 canola inadvertently present in the 

food supply would result in a negligible difference in the composition of canola oil. You follow 

with a request for FDA’s views on the safety of NS-B50027-4 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 NSB50027-4 canola establish that the new proteins expressed in NS-B50027-4 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 NS-B50027-4 canola seed, meal, and oil are comparable to 

those of conventional canola except for the intended changes to the fatty acid profile, and that 

the low levels of NS-B50027-4 canola inadvertently present in the food supply would result in a 

negligible difference in the composition of canola oil. Based on information supplied during 

your voluntary premarket biotechnology consultation for NS-B50027-4 canola and in your letter 

of March 26, 2021, FDA has no questions about the safety of NS-B50027-4 canola when 

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 – June Yao, Ph.D. 

inadvertently present in the food supply at low levels, as you have described. 

While this letter addresses low levels of NS-B50027-4 canola inadvertently present in the 

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

biotechnology 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 12:33:42 -04'00' 

Dennis M. Keefe, Ph.D. 

Director 

Office of Food Additive Safety 

Center for Food Safety 

and Applied Nutrition