ARCHIVED - Insect Resistant Corn, Mon 810
Novel Food Information - Food Biotechnology
Health Canada has notified Monsanto Canada Inc. that it has no objection to the food use of the transgenic corn line MON810, which is resistant to insect damage. The Department conducted a comprehensive assessment of MON810 according to its Guidelines for the Safety Assessment of Novel Foods (September, 1994). These guidelines are based upon internationally accepted principles for establishing the safety of foods derived from genetically modified organisms.
The following provides a summary regarding the Monsanto Canada Inc. notification to Health Canada and contains no confidential business information.
MON810 offers the Canadian grower protection against the loss of yield due to infestation with the European Corn Borer (ECB), a damaging lepidopteran insect pest in Canadian corn production.
2. Development of the Modified Plant
A commercial corn line was transformed by particle gun acceleration technology. Molecular analysis of the resultant corn line, MON810, established that the line only contains one new gene, the cryIA(b) gene derived from the common soil bacterium Bacillus thuringiensis subsp. kurstaki (B.t.k). The introduced gene encodes the production of the Cry1A(b) protein which imparts protection from ECB. The CryIA(b) protein encoded by the introduced gene used to produce line MON810 is identical to the insect control protein found in nature and in commercially registered microbial pesticide formulations.
This Novel Food Information document has been prepared to summarize the opinion regarding the subject product provided by the Food Directorate, Health Protection 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.
For further information, please contact:
Office of Food Biotechnology
Health Protection Branch
Ottawa, Ontario K1A 0L2
Facsimile: (613) 952-6400
Telephone: (613) 952-5137
3. Product Information
Insect resistant corn line MON810 differs from its parental corn line in the insertion of a single gene, cryIA(b), and the insect control protein, CryIA(b), expressed by that gene. The introduced protein is expressed throughout the plant tissues and throughout the life of the plant. The levels of the expressed protein averaged 0.31 and 4.15 µg/g tissue fresh weight in the grain and the whole plant, respectively.
Corn grain is composed of approximately 61% starch, 19.2% protein and fiber, 3.8% oil and 16% water (U.S. National Corn Growers Association, 1997).
4. Dietary Exposure
Little whole kernel or processed corn is directly consumed by humans worldwide when compared to corn-based food ingredients. Corn is a raw material for the manufacture of starch. The majority of corn starch is converted to a variety of sweetner and fermentation products, including high fructose corn syrup and ethanol. Corn oil is commercially processed from the germ. These materials are components of many foods including bakery and dairy goods. The human food uses of grain from MON810 are not expected to be different from the uses of non-transgenic field corn varieties. As such, the dietary exposure of Canadians to grain from insect resistant hybrids will not be different from that for other commercially available field corn varieties.
The major components of corn grain were analyzed on plant material harvested from field trials. Compositional data for protein, fat, ash, carbohydrates, calories, moisture, amino acids, and fatty acids for line MON810 grain were comparable to the data to the data from the non-transgenic contro line and within published ranges for commercial corn hybrids.
a) Potential Toxicity:
The human safety assessment of of the CryIA(b) protein was confirmed in experiments which included protein characterization, digestive fate in simulated gastric and intestinal fluids, and acute oral toxicity in mice. Data were generated that demonstrated that the active CryIA(b) protein product in MON810 was equivalent to that produced in the naturally occurring B.t.k. The CryIA(b) protein is rapidly degraded and its insecticidal activity lost under conditions that simulate mammalian digestion. There was no indication of toxicity as measured by treatment-related adverse effects in mice administered CryIA(b) protein by oral gavage. The introduced protein was compared to databases of known protein toxins and did not show any meaningful amino acid sequence similarity to known protein toxins, with the exception of other Bacillus thuringiensis (B.t.) proteins. The studies support the safety of the CryIA(b) protein and are consistent with the history of safe use of B.t. and CryIA(b) which has been demonstrated to be highly selective for insects, with no activity agains other organisms such as mammals, fish, birds, or invertebrates (U.S. EPA, 1988)
b) Potential Allergenicity:
The introduced CryIA(b) protein was compared to known allergens. Using sophisticated computerized search capablities, the evidence showed that the CryIA(b) protein did not show meaningful amino acid sequence homology to known allergens. In addition, the potential for allergenicity was assessed based upon other characteristics of known food allergens (stability to digestion, stability to processing). The introduced proteins do not possess characteristics typical of known protein allergens.
Health Canada's review of the information presented in support of the food use of insect-resistant corn line MON810 concluded that this corn does not raise concerns related to safety. Health Canada is of the opinion that MON810 is as safe and nutritious as current commercial corn varieties.
Health Canada's opinion deals only with the food use of insect-resistant corn. Issues related to growing insect resistant corn in Canada and its use as animal feed have been addressed separately through existing regulatory processes in Agriculture & Agri-Food Canada.
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