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

<p style="text-align: justify;">The human consumption of canola products is limited to the refined oil. Typically, canola oil is used by itself as a salad oil or cooking oil, or blended with other vegetable oils in the manufacture of margarine, shortening, salad oil and cooking oils. Refined edible canola oil consists of purified triglycerides (96-97%) and does not contain any detectable protein. As the nitrilase protein was not found in the refined oil produced from transgenic canola Oxy-235, it can be concluded that there will be no human exposure to these proteins. The genetic modification of Oxy-235 canola will not result in any change in the consumption pattern for this product.</p>

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

<p style="text-align: justify;">The nutritional composition of Oxy-235 was shown to be equivalent to non-transgenic canola. There were no significant differences in the fatty acid composition of oil from Oxy-235 and unmodified counterparts and all values were within the range of quality standards for canola. It was also found that the modification did not change the levels of sterols, tocopherols, and unsaponifiable matter in crude oil.<br />
An analysis of the nutrient value of canola meal from Oxy-235 and non-transgenic canola did not reveal any significant differences in the levels of dry matter, crude fibre, neutral detergent fibre (NDF), acid detergent fibre and lignin (ADF and ADL), crude protein, total fat, soluble sugars, amino acid content as well as gross energy level in seeds and meal. Seeds of Oxy-235 were shown to have the same levels of glucosinolates and erucic acid as commercial canola varieties.</p>

<p style="text-align: justify;">A 28-day rat feeding study was conducted where rats were fed up to 10% canola meal in their food. There were no toxic effects from the study and results were the same regardless of whether the source of canola meal was Oxy-235 or non-transgenic canola.</p>

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

<p style="text-align: justify;">It was determined that there were no toxicity or allergenicity concerns with Oxy-235, since refined canola oil is the only product for human consumption and does not contain any detectable amount of protein. The absence of toxicity was further demonstrated by examining the amino aid sequence homology and the characteristics of the novel nitrilase enzyme.</p>

<p style="text-align: justify;">The amino acid sequence of the nitrilase protein was compared to the amino acid sequences of known protein toxins and allergens and no significant similarities were found. Furthermore, the nitrilase protein did not share characteristics common to allergens.</p>

<p style="text-align: justify;">Digestive fate studies demonstrated that the nitrilase protein was rapidly inactivated in mammalian stomach and intestinal fluids by enzymatic degradation and pH-mediated proteolysis. To confirm the absence of toxic effects from nitrilase protein, a 14-day sub-acute toxicity feeding study was conducted with mice feed bacterial nitrilase protein. There were no toxic effects observed.</p>
