<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 new trait introduced into these transgenic potatoes was not expected to result in any change in the consumption pattern for potatoes. The occurrence of PLRV, including the replicase protein component, is ubiquitous in the agricultural environment and commonly occurs in the tubers of conventional potato plants. The use of replicase protein of PLRV and the genetic material necessary for its production was therefore determined not to pose a dietary risk under normal conditions. Due to their protection from CPB damage and resistance to infection by PLRV, these potato lines are expected to 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 analysis of macro- and micronutrients from these bioengineered lines revealed only small differences with the respective values from non-transgenic controls and in each case the level was within the normal range of variation reported for commercial potatoes.</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 in green tubers that have been exposed to sunlight. The concentration of total glycoalkaloids (TGA) in transgenic tubers ranged between 4.3-17.1 mg/100g fresh weight tissue, with a mean value of 6.7 mg/100g fresh weight tissue. This was comparable to the TGA range of 2.5-16.1 mg/100g fresh weight tissue, previously measured in tubers from commercial non-transgenic cultivars of Atlantic, Gemchip, Norchip and Russet Burbank. In each case, the TGA concentration in transgenic tubers was below the administrative guideline of 20 mg/100g fresh weight that has previously been established for TGA in potato. The toxicity of the Cry3A, and NPTII proteins was previously assessed, using toxicity testing in mice, with no adverse findings. Furthermore, the amino acid sequence of the Cry3A protein expressed in these potato lines is closely related to the sequence of the same protein that is present in strains of <i>B. thuringiensis</i> that have been used for over 30 years as commercial organic microbial insecticides. Toxicity testing was not considered necessary for the PLRV replicase because of the long history of exposure of human beings to this protein through the consumption of PLRV-infected potatoes. An analysis of the amino acid sequences of the inserted Cry3A protein and PLRV replicase did not show homologies with known mammalian protein toxins and they are not judged to have any potential for human toxicity. Based on the evidence presented, it was concluded that all four novel proteins were non-toxic to humans.</p>

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

<p style="text-align: justify;">The Cry3A protein and PLRV replicase do not possess characteristics typical of known protein allergens. There were no regions of homology when the sequences of these introduced proteins were compared to the amino acid sequences of known protein allergens. Unlike known protein allergens, the Cry3A protein was rapidly degraded by acid and/or enzymatic hydrolysis when exposed to simulated gastric or intestinal fluids. It was determined that these two proteins were highly unlikely to be allergenic.</p>
