<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 CP4 EPSPS or GOX proteins were detected in the refined oil of GT200 canola. The genetic modification of GT200 canola will not result in any change in the consumption pattern for this product. As the introduced gene products are not detectable in the refined oil produced from transgenic canola, there will be no human exposure to these proteins.</p>

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

<p style="text-align: justify;">The analysis of nutrients from transgenic GT200 canola and non-transgenic canola did not reveal any significant differences in the levels of crude protein, crude fat, crude fibre, ash and gross energy in either whole seed or processed meal. Raw seeds of GT200 were shown to have the same levels of glucosinolates and erucic acid as commercial canola varieties. Seed protein profiles, amino acid and fatty acid compositions were all within the range of the unmodified counterparts. The consumption of refined oil from GT200 was judged to have no significant impact on the nutritional quality of the food supply.</p>

<p style="text-align: justify;">Several animal feeding studies were conducted to demonstrate the wholesomeness of glyphosate tolerant canola meal. Canola meal is used only for animal feed and is not considered a human food fraction. The feeding studies were conducted to establish the nutritional adequacy of canola meal for animal feeds and represented a worse case scenario in terms of canola consumption by humans. These studies included a four-week rat study on processed and unprocessed meal, a five-day quail (Northern Bobwhite) study on unprocessed meal, and a ten-week trout study on processed meal. The studies all supported the safety of meal from glyphosate-tolerant canola as a component in animal feed.</p>

<p style="text-align: justify;">The rat feeding study examined six week-old Sprague-Dawley rats (10/sex/group) fed either 0, 5 or 15% w/w ground (unprocessed) and processed (toasted and defatted) glyphosate-tolerant canola (GT200 and GT73) and &#39;Westar&#39; canola meal and a diet control (commercial rodent chow with no added canola meal). The study determined that rats fed on diets with unprocessed glyphosate tolerant canola seed had relative liver and kidney weights 5 - 20% greater compared to the diet controls. However, there were no differences in absolute or relative organ weights between the glyphosate-tolerant canola and parental line groups.</p>

<p style="text-align: justify;">The quail feeding study examined thirty northern bobwhite (<i>Colinus virginianus</i>) chicks fed diets for five days and observed for a further three days. Treatment groups were fed a control diet, glyphosate-tolerant canola (both lines GT200 and GT73) or the parental line &#39;Westar&#39;, where canola was incorporated at a rate of 20% of the total weight of the diet. The study did not find any significant effects on body weight or feed consumption between birds in the control or treatment groups. There were no mortalities or overt signs of toxicity in either treatment or control groups.<br />
Similarly a trout feeding study examined triplicate groups of 15 fish rainbow trout (<i>Oncorhynchus mykiss</i>) fed glyphosate tolerant canola meal (both lines GT200 and GT73) at 0, 5, 10, 15 or 20% weight of the dry diet for 10 weeks (<i>i.e.</i>, 45 fish/treatment). There was statistical overlap in weight gain of fish fed each dietary treatment and no differences were detected between glyphosate-tolerant canola diets and controls. Fish fed the glyphosate-tolerant canola did not exhibit any adverse effects.</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 GT200, 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 CP4 EPSPS and GOX.</p>

<p style="text-align: justify;">The amino acid sequences of both the CP4 EPSPS and GOX proteins were compared to the amino acid sequences of known protein toxins. No significant similarities were found other than would be expected given that certain functional domains are generally conserved between proteins.</p>

<p style="text-align: justify;">The novel enzyme CP4 EPSPS is one of many EPSPS proteins that occur in plants, fungi and bacteria. The EPSPS proteins are naturally present in foods derived from plants and microbes and have no history of being toxic or allergenic. Similarly, the <i>gox</i> gene was sourced from a common soil bacterium, which has no history of pathogenicity. The GOX enzyme degrades glyphosate and experiments demonstrated that the enzyme displayed a narrow substrate specificity, and appeared not to have any secondary effects on other plant specific pathways.</p>

<p style="text-align: justify;">The digestibility of both proteins in model digestion systems was done <i>in vitro</i> using simulated gastric fluid and simulated intestinal fluid) as mammalian digestion models. Unlike typical protein toxins and allergens, both the CP4 EPSPS and GOX proteins were rapidly digested.</p>
