<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, hence no amounts of PAT and NPTII proteins were detected in the refined oil of HCN92 canola. Furthermore processing would destroy the enzymatic activity of the PAT and NPTII protein. As such, there will be no human exposure to these proteins as a result of the consumption of refined oil from line HCN92.</p>

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

<p style="text-align: justify;">The analysis of nutrients from transgenic HCN92 canola and non-transgenic canola did not reveal any significant differences in the levels crude protein, crude fat, crude fibre, ash and gross energy in either whole seed or processed meal. Compositional analysis of processed canola oil indicated that no statistically significant differences between HCN92 and current commercial canola cultivars for the components analysed including fatty acids, chlorophyll and phytosterol content. Furthermore, the content of glucosinolates and erucic acid in glufosinate tolerant canola HCN92 was identical with that of seed from non-transgenic canola. These results collectively demonstrated that the novel herbicide tolerant genes introduced into HCN92 had no observable secondary effects impacting on composition or nutritional quality. The use of refined oil from line HCN92 was judged to be equivalent to traditional canola varieties and would therefore have no significant impact on the nutritional quality of the U.S. and Canadian food supply.</p>

<p style="text-align: justify;">Canola meal was assessed to determine its safety for use in animal feed. <i>In vivo</i> tests performed on broiler chickens fed canola in their diets confirmed the safety previously established with purified PAT protein. It was also determined that PAT protein represented only 0.005% of protein in finished canola meal and enzyme activity was always destroyed in toasted canola meal. The overall results lead to the conclusion that there were no significant risks to livestock following ingestion of transgenic canola meal from HCN92.</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 HCN92, 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 proteins PAT and NPTII, and acute toxicity study in mice.</p>

<p style="text-align: justify;">The amino acid sequences of both the PAT and NPTII proteins were compared to the amino acid sequences of known protein toxins using the GENBank sequence database. No significant similarities were found. Furthermore, the acute oral toxicity of PAT protein was studied in rats and showed no negative effects.</p>
