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

<p style="text-align: justify;">The modification to the AHAS enzyme in AP205CL 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 AP205CL, 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 AP205CL 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;"><b>Nutritional Data</b></p>

<p style="text-align: justify;">Nutritional components of AP205CL wheat were measured analytically and compared to those of the parental line Gunner. These components included: moisture, crude protein, crude fat, crude fibre, the amino acids valine, isoleucine, leucine, threonine, cystine, lysine and methionine. Also measured were fatty acids, B vitamins (thiamine, niacin, pantothenic acid, pyridoxine), vitamin E, and minerals (phosphorus, zinc, magnesium and iron). Significant differences were observed in the levels of palmitic and oleic acid, between AP205CL and Gunner, but these differences fell in the range of conventional wheat varieties. A small but significant difference in the concentration of thiamine was observed between AP205CL and Gunner, the slight difference was not expected to impact on livestock nutrition. There were no other observed differences in nutritional composition.</p>

<p style="text-align: justify;">The anti-nutrients phytic acid and trypsin inhibitor were measured in AP205CL and Gunner. Phytic acid occurs naturally in wheat and other cereals. It is indigestible by humans and non-ruminant livestock, and inhibits the absorption of iron and other minerals. Trypsin inhibitor interferes with protein digestion. Phytic acid levels in AP205CL were not different from those of Gunner and levels of trypsin in both lines were below the limit of detection.</p>

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

<p style="text-align: justify;">The potential for toxicity and allergenicity of AP250CL 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 AP250CL showed similar sensitivity to heat and trypsin degradability compared to unmodified AHAS. The unmodified form of AHAS shows 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 AP205CL were not altered compared to those of unmodified control. 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 AP250CL wheat did not demonstrate any potential for toxicity and allergenicity compared to conventional unmodified wheat.</p>
