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

<p style="text-align: justify;">Potatoes are considered to be a staple food, constituting up to 37% of the total average vegetable intake. The genetic modification present in the BT06, BT10, BT12, BT16, BT17, BT18 and BT23 transgenic lines will not result in any change in the consumption pattern for potatoes. Due to their protection from CPB damage, the CPB-resistant potato lines may replace some existing commercial potato cultivars in all potato product applications. 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 major components of CPB-resistant potato lines were analyzed for nutritional constituents, proximate composition (protein, fat, ash, total dietary fiber, carbohydrate, and calories), internal quality characteristics (hollow heart and brown center, internal brown spots, vascular discoloration, and blackspot bruise), and French fry quality characteristics and compared with those of Russet Burbank tubers. The analysis of nutrients from each of the seven transgenic potato lines and non-transgenic potato did not reveal any significant differences in the levels of crude protein, ash, and starch. Similarly, the levels of micronutrients and trace elements, including thiamine, niacin, riboflavin, vitamin C, calcium, iron and zinc, were comparable to those of unmodified Russet Burbank. There were significant differences in carbohydrate, fat and fibre although in each case the measured concentration was within the range normally reported for potatoes. It was concluded that the consumption of products from CPB-resistant potatoes has no significant impact on the nutritional quality of the Canadian and American food supply.</p>

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

<p style="text-align: justify;">The glycoalkaloids, solanine and chaconine, are naturally occurring toxicants found in potato tubers, particularly green tubers that have been exposed to sunlight. Analyses of total glycoalkaloid (TGA) levels in each of the transgenic lines demonstrated that in each case the level was below the administrative guideline of 20 mg/100g fresh weight that has previously been established for TGA in potato. Line BT17 was found to have significantly higher glycoalkaloid levels (pThe amino acid sequence of the Cry3A protein expressed in CPB-resistant potato lines is closely related to the sequence of the same proteins that are present in strains of <i>B. thuringiensis</i> that have been used for over 30 years as commercial organic microbial insecticides. An analysis of the amino acid sequence of the inserted Cry3A protein did not show homologies with known mammalian protein toxins and was not judged to have any potential for human toxicity. Additionally, acute oral toxicity studies with purified Cry3A protein did not reveal any deleterious effects when mice were administered a dose of 5220 mg/kg body weight.</p>

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

<p style="text-align: justify;">The likelihood of the Cry3A and NPTII proteins being allergens was judged to be remote. No homologies were found when the deduced amino acid sequences of the introduced proteins were compared to the sequences of known allergens.</p>

<p style="text-align: justify;">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, and glycosylation. The Cry3A and NPTII proteins did not demonstrate any characteristics normally associated with food allergens. Unlike known protein allergens, which are normally resistant to digestion, the Cry3A and NPTII proteins were rapidly inactivated and degraded when subjected to typical mammalian acidic stomach conditions, <i>i.e.</i> in simulated gastric fluids.</p>
