<p style="text-align: justify;"><b>Dietary Exposure</b></p>

<p style="text-align: justify;">The human consumption of the 1401F, H282F, 11013F and 7913F hybrids will be mainly as processed tomato product in the form of soups, preserves, ketchup, paste and prepared sauces. The genetic modification of these novel hybrids will not result in any change in the consumption pattern for processed tomato products. The novel hybrids are expected to replace other tomato cultivars currently in use due to improved quality and handling characteristics. Hence, they will provide an alternate or additional choice to consumers and food manufacturers.</p>

<p style="text-align: justify;"><b>Nutritional Data</b></p>

<p style="text-align: justify;">The analysis of nutrients from the novel 1401F hybrid line and the non-transgenic 1401 hybrid did not reveal any significant differences in the levels of macro- and micronutrients in either fresh tomatoes or processed tomato paste. The consumption of this product will, therefore, have no significant impact on the nutritional quality of the food supply in Canada and the United States.</p>

<p style="text-align: justify;">An extensive analysis of fresh fruit and tomato paste samples derived from tomato line F was made and results compared to the range of values produced by non-modified, commercial tomato varieties. Results for the bulk components (soluble sugars, structural carbohydrate, moisture, ash, fat, carbohydrates including soluble sugars and dietary fibre, protein and oil) and for mineral (Na, K, Ca, Mg, P, Fe) and vitamin (A, E, B1, B2, niacin, B6, folate, C) content fell within the range expected of commercial tomato fruit and fruit purees.</p>

<p style="text-align: justify;">Analysis of known anti-nutritional factors and potential toxins (lectins and alpha-tomatine, solanine, chaconine, tyramine, nicotine and serotonin) demonstrated that a similar range of concentrations of these compounds are present in both modified and unmodified fruit and tomato paste.</p>

<p style="text-align: justify;">Alpha-tomatine is the principal naturally occurring glycoalkaloid in tomato, and the level of alpha-tomatine decreases as the fruit matures, so that the amounts in vine-ripened red tomatoes are negligible. Solanine and chaconine, which are the main glycoalkaloids occurring in potato, have been found in tomato in lesser amounts. The level of a-tomatine in tomato paste prepared from transgenic line F was 58 ppm as compared with 74 ppm for the unmodified TGT7 parental line. The additional glycoalkaloids, solanine and chaconine, were undetectable in either the transgenic or unmodified lines. An analysis of the levels of biogenic amines (tyramine, tryptamine and serotonin), which are considered as potential toxins in tomato, did not reveal any significant differences in the respective concentrations of these compounds in raw tomatoes from either transgenic line F or the unmodified parental line. Tomatoes from the novel hybrid lines 1401F and 282F contained undetectable levels of histamine and nicotine, as did their unmodified counterparts. Other than reduced polygalacturonase activity, the disease, pest and other agronomic characteristics of the 1401F, H282F, 11013F and 7913F hybrids were comparable to the unmodified hybrids.</p>

<p style="text-align: justify;"><b>Toxicity and Allergenicity</b></p>

<p style="text-align: justify;">The reduced synthesis of native PG and the presence of the novel protein NPTII were not judged to have any potential for human toxicity or allergenicity. Polygalacturonase is a natural component of all food plants. The partial sense PG gene present in transformation event F was identical to the corresponding endogenous tomato gene and conferred no additional risks. The antisense PG gene did not encode for any new protein products, and therefore should not have any toxic properties.</p>

<p style="text-align: justify;">Heat processing ensures that the enzyme NPTII does not survive in a biologically active form. Regular human consumption of tomato products containing the heat-denatured protein has not caused recognized problems relating to toxicity or allergenicity. Neither effect would have been expected as judged by comparisons of amino acid sequences made with known antigens, the published lack of effects of the intact NPTII protein in chronic toxicity studies in rats and the recorded ease of degradation of this protein in the digestive tract.</p>
