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

<p style="text-align: justify;">The modification to the AHAS enzyme in BW7 will not result in any change in the consumption or use pattern of wheat and wheat-based products. The availability of many wheat cultivars for cultivation, the diversity of wheat in phenotypic traits, and the normal variation in wheat composition due to differences in growing conditions all result in a wide variation in the composition of conventional wheat grain. Since the modification to the AHAS enzyme would not be expected to change the gluten content in BW7, the cultivation and use of this wheat would not result in any new or additional concern for individuals with celiac disease. Thus, the cultivation of BW7 would not be expected to change the dietary exposure in Canada and the United States, any more than commercially available wheat cultivars.</p>

<p style="text-align: justify;">Nutritional composition data was obtained from wheat event BW7 and a parental control. Grain samples were collected from replicated plots in 8 field sites in 2002, 2003 and 2005. Note that the data from 2002 and 2003 was combined. These samples were analyzed for proximates, ADF, NDF, TDF, amino acids, fatty acids, minerals and vitamins. There were no statistically significant differences between BW7 and the parental control for crude fat, protein, crude fibre, ADF, NDF, TDF in the 2002/2003 and 2005 grain samples. No statistically significant differences were observed between BW7 and the parental control for the branched- chain amino acids (valine, isoleucine and leucine). Lysine, methionine, cystine and threonine levels were not statistically significantly different between BW7 and the parental control. Stearic, oleic and linoleic acids in BW7 were statistically significantly lower than the parental control in the 2002/2003 samples, while palmitic and oleic acids in BW7 were significantly higher than the parental control in 2005. However, all fatty acids levels were shown to be comparable to those of conventional bread wheat varieties. No statistically significant differences were observed between BW7 and the parental control for all minerals in 2002/2003 samples. There were significant differences between BW7 and the parental control for phosphorous and zinc in the 2005 data, however these levels were shown to be comparable to those of conventional bread wheat varieties. All other minerals were similar for BW7 and the parental control. In 2002/2003 vitamin B6 was significantly lower in BW7 than the parental control, but the range was within the range of commercial varieties. No statistically significant differences were observed between BW7 and the parental control for all vitamins analyzed in 2005 samples.</p>

<p style="text-align: justify;">Phytic acid and trypsin inhibitor were analyzed in wheat event BW7 and compared to the parental control. There were no statistically significant differences in phytic acid between BW7 and the parental control for both 2002/2003 and 2005 grain samples. The levels of trypsin inhibitor were below the limit of detection of the assay for both BW7 and the parental control.</p>

<p style="text-align: justify;">The evidence provided supports the conclusion that the nutritional composition of wheat event BW7 is equivalent to conventional bread wheat varieties.</p>

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

<p style="text-align: justify;">The potential for toxicity and allergenicity of BW7 wheat was determined by examining the characteristics of the modified AHAS protein and the amino acid sequence homology between the modified protein and known toxins and allergens. The unmodified form of AHAS is heat sensitive and susceptible to trypsin degradation. Data from studies on the heat sensitivity and trypsin degradability of the modified AHAS in BW7 showed similar sensitivity to heat and trypsin degradability with no detectable AHAS activity after one minute at 100&deg;C. The unmodified and modified forms of AHAS show no amino acid similarity to known toxins and allergens. The modified AHAS is substantially equivalent to the unmodified enzyme in that it differs by only one amino acid. Evidence was also provided to show that the protein components of BW7 were not altered compared to those of unmodified parental controls. Results from HPLC on protein extracts demonstrated that no new major proteins or increased protein expression occurred as a result of the mutation to the AHAS enzyme. From these results it was concluded that BW7 wheat did not demonstrate any potential for toxicity and allergenicity compared to conventional unmodified wheat.</p>
