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

<p style="text-align: justify;">The human consumption of the FLAVR SAVR&trade; tomato 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 of these novel tomatoes will not result in any change in the consumption pattern for fresh or processed tomato products. The transgenic FLAVR SAVR&trade; lines are 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;">The analysis of nutrients from the novel FLAVR SAVR&trade; tomatoes and non-transgenic control lines did not reveal any significant differences in the levels of macro- and micronutrients, pH, total acidity, total solids, and sugars. 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;">The presence of NPTII protein has been judged to be insignificant with respect to any human health risk due to exposure.</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. A comparison of the amounts of alpha-tomatine in transgenic and non-transgenic tomatoes did not reveal any statistically significant difference and the levels were within the normal range reported for tomatoes. Alpha-tomatine was detected (at a limit of detection of 2.5 ppm) in only one out of 38 red ripe FLAVR SAVR&trade; fruits and four out of 60 red ripe commercial tomato fruits. Other than reduced polygalacturonase activity, the disease, pest and other agronomic characteristics of the FLAVR SAVR&trade; tomato were comparable to unmodified varieties.</p>

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

<p style="text-align: justify;">The reduced synthesis of native PG was not judged to have any potential for human toxicity or allergenicity. Analysis of biochemical components of FLAVR SAVR&trade; tomatoes were compared to nontransgenic tomatoes and no toxic components were identified in concentrations that differed significantly from the concentrations in nontransgenic tomatoes. The antisense PG gene did not encode for any new protein products and therefore, should not have any toxic properties. The novel protein NPTII expressed by the <i>neo</i> gene is widespread in nature and no toxic or allergenic effects have ever been reported.</p>

<p style="text-align: justify;">Additional data from three 28-day rat feeding trials demonstrated no biologically significant changes in body weight, organ weight, food consumption, hematologic parameters, and clinical chemistry findings. There was disparity among the three studies regarding the incidence of rats with gastric erosions. Although no definitive conclusions could be drawn regarding the etiology(ies) of these erosions, it was determined that they were also present in rats fed non-transgenic tomatoes and that, where they occurred, they were no more severe in rats fed FLAVR SAVR&trade; tomatoes than in rats fed non-transgenic tomatoes.</p>
