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Low Linolenic Soybean Line

Health Canada has notified Pioneer Hi-Bred Production Ltd. that it has no objection to the food use of low linolenic soybean 93M01. The Department conducted a comprehensive assessment of these varieties according to its Guidelines for the Safety Assessment of Novel Foods. These guidelines are based upon internationally accepted principles for establishing the safety of foods with novel traits.

Background:

The following provides a summary of the notification from Pioneer Hi-Bred Production Ltd. and the evaluation by Health Canada and contains no confidential business information.

1. Introduction

Soybean line 93M01 was developed to possess reduced levels of linolenic acid using conventional breeding and selection techniques. The lowered linolenic acid levels are at 2.5% total fatty acid content whereas the International Life Sciences Institutes crop composition database suggests a range of 5.9-12.5% of total fatty acids. Foods fried in soybean oil produced from 93M01 will have negligible amounts of trans fat.

The assessment conducted by Food Directorate evaluators determined how low linolenic soybean was developed; how the composition and nutritional quality of low linolenic 93M01 soybean compares to non-modified varieties; and what the potential is for low linolenic 93M01 soybeans to be toxic or cause allergic reactions. Pioneer has provided data which demonstrates that low linolenic soybeans 93M01 are as safe and of the same nutritional quality as traditional soybean varieties used as food in Canada.

The Food Program has a legislated responsibility for pre-market assessment of novel foods and novel food ingredients as detailed in the Food and Drug Regulations (Division 28). Food use of low linolenic soybean is considered a novel food under the following part of the definition of novel foods:

" c) a food that is derived from a plant, animal or microorganism that has been genetically modified such that

(iii) one or more characteristics of the plant, animal or microorganism no longer fall within the anticipated range for that plant, animal or microorganism."

2. Development of the Modified Plant

A mutation breeding program at Iowa State University in the late 1970's produced low linolenic soybean germplasm. The A16 experimental line from Iowa State University was obtained by Pioneer who then began to integrate the trait into elite germplasm of their own which improved yield and agronomic traits. Several rounds of crossing and selection for desirable traits have led to the development of low linolenic soybean variety 93M01.

3. Characterization of the Modified Plant

The characterization of the low linolenic soybean 93M01was not required because no novel DNA was introduced. Also, a low linolenic soybean variety had been approved previously (OT96-15, 2000) and thus the Directorate was already familiar with the novel trait.

4. Product Information

Low linolenic soybean 93M01 differs from its traditional counterpart in its lowered linolenic acid levels (2.5% of the total fatty acid content as opposed to the normal level of 8.6%).

5. Dietary Exposure

Low linolenic soybean 93M01 is expected to be used in similar applications as traditional soybean varieties. Refined, bleached, and deodorized soybean can be processed to produce cooking oils, shortening, margarine, mayonnaise, salad dressings, and a wide variety of products that are either based entirely on fats and oils or contain fat or oil as a principle ingredient.

6. Nutrition

The nutritional data represented six samples of each test (93M01) and control (93M11) whole soybean seeds analysed in duplicate. The fatty acid profile, triglycerides, crude fat content and trypsin inhibitor levels were examined. Linolenic acid content of the test soybean was lower than the control (2.5% and 7.0% total fatty acid respectively). The lower levels of linolenic acid in the test (93M01) soybean was compensated for by higher levels of palmitic, palmitoleic, heptadecanoic, heptadecenoic, and oleic acid. There were no significant differences for the other fatty acids or trypsin inhibitor between the test and control whole soybean. Mean crude fat content in the test soybean was lower than the control (15.0 vs 16.3%).

7. Chemistry/Toxicology

No toxicity concerns are associated with the expression of the low linolenic trait. Apart from the reduced linolenic acid content developed through traditional breeding practices, no new proteins or traits are expressed as a result of the development of soybean 93M01. No allergenicity concerns are associated with soybean 93M01.

Conclusion:

Health Canada's review of the information presented in support of the food use of low linolenic soybean 93M01 does not raise concerns related to food safety. Health Canada is of the opinion that food derived from low linolenic soybean 93M01 is as safe and nutritious as food from current commercial soybean varieties.

Health Canada's opinion deals only with the food use of low linolenic soybean 93M01. Issues related to its use as animal feed have been addressed separately through existing regulatory processes in the Canadian Food Inspection Agency.

This Novel Food Information document has been prepared to summarize the opinion regarding the subject product provided by the Food Directorate, Health Products and Food Branch, Health Canada. This opinion is based upon the comprehensive review of information submitted by the petitioner according to the Guidelines for the Safety Assessment of Novel Foods.

(Également disponible en français)

For further information, please contact:

Novel Foods Section
Food Directorate
Health Products and Food Branch
Health Canada
Tunney's Pasture
Ottawa, Ontario K1A 0L2

Telephone: (613) 941-5535
Facsimile: (613) 952-6400

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