Health Canada has notified Monsanto Canada Inc., that it has no objection to the food use of tomato line 5345, which has been developed to be resistant to insect pests (Lepidopteran species). The Department conducted a comprehensive assessment of the tomato line according to the 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.
The following provides a summary regarding the Monsanto Canada Inc. notification to Health Canada and contains no confidential business information.
Bt tomato line 5345 was developed through a specific genetic modification to be resistant to lepidopteran insects. The genetically modified tomato contains two novel proteins; Cry1Ac and neomycin phosphotransferase (NPTII). The Cry1Ac protein confers resistance to certain lepidopteran insects, including the Colorado Potato Beetle. The NPTII protein confers resistance to kanamycin and is commonly used as a selectable marker for transformed cells. The Bt tomato line 5345 is intended to be used in raw form or in a variety of processed forms, in the same manner conventional tomatoes are used.
Recombinant DNA was introduced into tomato plant cells using an Agrobacterium tumefaciens transformation system. Three genes were introduced into the tomato genome; cry1Ac, aad, and nptII. The cry1Ac gene is derived from the common soil microorganism Bacillus thuringiensis subsp. kurstaki HD-73 and encodes a protein which provides insect resistance. The aad marker gene is derived from transposon Tn7 and encodes the enzyme aminoglycoside adenyltransferase (AAD), which confers resistance to streptomycin/ spectinomycin. This gene is under the control of a bacterial promoter and is not expressed in the tomato plant. The nptII marker gene was originally derived from Escherichia coli and codes for NPTII, an enzyme that confers resistance to aminoglycoside antibiotics, including kanamycin. The modification results in the addition of three novel genes into the tomato genome, and the production of two novel protein products. The petitioner has provided data to indicate that the novel phenotype has been stably incorporated into the tomato genome.
Compositional analyses demonstrated that the levels of significant constituents (macro and micro nutrients, endogenous toxicants and anti-nutrients) for line 5345 fall within the anticipated range for unmodified parental tomato cultivars. Cry1Ac protein levels ranged from 11.76 to 16.63 (mean 13.2) and 0.39 to 1.26 (mean 0.70) ug/g fresh weight for the leaf and ripe fruit respectively.
Bt tomato line 5345 is expected to be used in similar applications as traditional tomato varieties by the food industry. The modification of this tomato will not result in a change in consumption patterns for this product. Dietary exposure of Canadians to this tomato will be the same as for other tomatoes.
Based on studies of total solids, protein, ash, carbohydrates, calories, vitamin A, vitamin C and folic acid, there is no apparent difference between the composition of the tomato line 5345 and traditional tomatoes. The use of these tomatoes should have no significant impact on the nutritional quality of the Canadian food supply.
The petitioner has provided data to indicate that there are no allergy or toxicity concerns with the two novel proteins expressed by Bt tomato line 5345, NPTII and Cry1Ac. As expected, the aad gene is not expressed in the tomato plant as it is controlled by a bacterial promoter. The naturally occurring glycoalkaloid tomatine was found at similar levels in both modified and unmodified tomatoes.
Health Canada's review of the information presented in support of the food use of Bt tomato line 5345 concluded that this line does not raise concerns related to human food safety. Health Canada is of the opinion that products from this tomato line are as safe and nutritious as those made from currently available commercial tomato varieties. Health Canada's opinion pertains only to the food use of Bt tomato line 5345. Issues relating to growing Bt tomato in Canada and its use as animal feed are addressed separately through existing regulatory processes in the Canadian Food Inspection Agency.