<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. The increased levels of lauric acid in the oil allow its use as a replacement for other lauric acid oils such as coconut and palm kernel oil in products such as confectionery coatings and fillings, margarines, spreads, shortenings and commercial frying oils. The level and composition of laurate produced by lines 23-18-17 and 23-198 was no different from that in common food sources, such as coconuts and palm oil.</p>

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

<p style="text-align: justify;">The modified fatty acid composition of the oil from transgenic canola lines 23-198 and 23-18-17 does not raise any nutritional concerns regarding the intended use of the subject oil. The analysis of levels of erucic acid and glucosinolates were within acceptable levels for canola quality. Similarly, the quality and quantity of seed protein were as expected. The fatty acid profile of high laurate canola was different from all control varieties, with increased levels of lauric acid (up to 40%) and myristic acid, and lower levels of oleic acid and linoleic acid, and less palmitic acid, less stearic, linoleic, arachidic, gadoleic, and slightly more behenic acid. Nonetheless, the overall lipid content of the seed remained unchanged. The consumption of products formulated with this oil would have no significant impact on the nutritional quality of the food supply in North America and Canada. No statistical differences in crude protein, crude fibre, gross energy content, and amino acids were noted between the processed meal of high laurate and control <i>B. napus</i> cultivars. Based on a maximum of 4% oil in the meal, the meal was expected to have 1.6% laurate and 0.16% myristate. As the use rate of meal in livestock rations ranges from 5-25%, the maximum laurate and myristate in meal would be 0.4% and 0.94% respectively. These levels would have no significant impacts on nutrition or carcass quality. In addition, the presence of the aminoglycoside resistance gene in livestock feed would not compromise the efficacy of added antibiotics. Neomycin activity when mixed with meal from high laurate canola remained stable for a period of 56 days responding in the same manner as the control line. It was determined that canola meal derived from lines 23-18-17 and 23-198 was equivalent to meal from traditional <i>B. napus</i> varieties in terms of nutritional composition and safety.</p>

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

<p style="text-align: justify;">The low potential for toxicity of the thioesterase (Bay TE) and NPTII enzymes expressed in the transgenic canola lines 23-18-17 and 23-198 was demonstrated by studies on the amino aid sequence homology and characteristics of the proteins. The amino acid sequences of the Bay TE and NPTII enzymes were compared with sequences available in GENBank databases and no significant homology was found with any known sequenced toxins or allergens. Significant homology was found with thioesterases from edible plant species. Studies showed that the introduced Bay TE enzyme was not heat stable and was fully degraded into inactive peptides and amino acids following protease digestion. Two potential glycosylation sites were identified but glycosylation of plastid proteins is not known to occur. Similarly, the NPTII enzyme was found to degrade rapidly in simulated mammalian gastric and intestinal fluids. The NPTII protein was not expected to have toxic properties since: the enzyme catalyses only a very specific reaction using aminoglycosidic antibiotics as a substrate; despite wide usage, there have been no reports of toxicity of the protein in the literature; and enzyme levels are less than 0.0008% of total protein in seeds and leaves, and undetected in meal. Both Bay TE and NPTII enzymes are ubitiquitous in nature and no toxic or allergenic effects have ever been reported.</p>

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