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

<p style="text-align: justify;">The human consumption of the modified tomato line 5345 will be as both fresh and processed tomato products. Fresh market tomatoes are eaten whole and sliced or diced in a variety of foods. Processed tomatoes are consumed in the form of soups, preserves, ketchup, paste and prepared sauces. The genetic modification introduced into this transgenic line will not result in any change in the consumption pattern for fresh or processed tomato products. Line 5345 is expected to replace other tomato cultivars currently in use due to improved quality and handling characteristics. Hence, it 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;">Compositional analyses were conducted to compare transgenic line 5345 tomato fruit with fruit obtained from control non-transgenic plants grown and processed under the same conditions. The measured parameters included total solids, protein, ash, carbohydrates, calories, vitamin A, vitamin C, and folic acid. There were no statistically significant differences for any of the parameters between insect-resistant 5345 tomatoes and control tomatoes. The presence of NPTII protein was judged to be insignificant with respect to any human health risk due to exposure. 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;">Tomatoes produce naturally occurring glycoalkaloids, alpha-tomatine being the most common. The level of alpha-tomatine decreases as the fruit matures so that the amounts in vine-ripened red tomatoes are negligible. The concentration of alpha-tomatine in immature tomatoes from transgenic line 5345 was 5.15 mg/100g fresh weight tissue, as compared with 3.79 mg/100g fresh weight tissue for the unmodified parental line. However, these levels evened out once the fruit ripened into mature red tomatoes and were within the range of alpha-tomatine levels reported in the literature for tomatoes (4.9-90 mg/100g fresh fruit).</p>

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

<p style="text-align: justify;">The likelihood of the Cry1Ac protein being allergenic was judged to be remote. No homologies were found when the deduced amino acid sequence of the introduced protein was compared to the sequences of known allergens. In addition, the potential for allergenicity was assessed based upon the physiochemical properties of known food allergens, such as stability to acid and/or proteolytic digestion, heat stability, glycosylation, and molecular weight. The Cry1Ac protein does not possess these characteristics normally associated with food allergens.</p>
