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

<p style="text-align: justify;">The modification to the AHAS enzyme in Teal 11A 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 Teal 11A, the cultivation and use of this wheat would not result in any new or additional concern for individuals with celiac disease. The cultivation of Teal 11A 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 Teal 11A wheat were measured analytically and compared to those of the parental line CDC Teal. 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 HCL, niacin, pantothenic acid, pyridoxine), and minerals (phosphorus, zinc, magnesium and iron). Other than small but significant differences in crude fibre and oleic acid, which were lower in Teal 11A, there were no differences between Teal 11A and CDC Teal in the levels of all other nutritional components. The nutritional composition of Teal 11A wheat was found to be similar to its nonmodified parent, and within the range of commercial wheat varieties.</p>

<p style="text-align: justify;">The anti-nutrients phytic acid and trypsin inhibitor were measured in Teal 11A and CDC Teal. 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 Teal 11A were equivalent to those in CDC Teal. Trypsin inhibitor levels in both Teal 11A and CDC Teal 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 Teal 11A 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 Teal 11A 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 Teal 11A 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 Teal 11A wheat did not demonstrate any potential for toxicity and allergenicity compared to conventional unmodified wheat.</p>
