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

<p style="text-align: justify;">The transgenic soybean G94-1, G94-19 and G168 sublines are the same as non-modified soybeans with the exception of the fatty acid profile which is quite different from that of traditional soybean oil and more similar to that of other high oleic oils such as olive or canola oil. The genetic modifications resulted in a superior, more heat and oxidatively stable soybean oil due to the reduced levels of the oxidatively unstable polyunsaturated fatty acids. The high oleic soybean oil has improved nutritional and functional properties compared to conventional soybean oil or partially hydrogenated soybean oil and will fit into food applications where a highly stable oil is required, such as in fat frying operations. Studies in the United Kingdom determined that the use of high oleic soybean oil may lower the intake of dietary linoleic acid but concluded that the small decrease in saturated fatty acid was likely to be beneficial, by reducing the risk factor for coronary heart disease. It was further concluded that these results should generally be applicable to the European Community and most other countries.</p>

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

<p style="text-align: justify;">The analysis of nutritional properties of high oleic soybean sublines G94-1, G94-19 and G168 for total protein, oil, carbohydrate, crude fiber, ash, individual amino acid, phytic acid, trypsin inhibitor, stachyose, raffinose and isoflavone contents, determined that there were no differences in the levels of these components compared to non-transgenic soybeans. High Oleic soybean oil contains approximately 10% saturated fats, greater than 80% oleic acid, and low levels of polyunsaturated fatty acids: approximately 2% linoleic acid and 3.5% linolenic acid. Trace amounts (0.5%) of a linoleic acid 9,15 isomer were also detected, which while absent from non-hydrogenated soybean oil, is present at similar levels in butterfat, and is often found at considerably higher levels (typically 1-3%) in partially hydrogenated vegetable oils. The levels of accumulation of two important seed storage proteins, glycinin and beta-conglycinin, were changed. Glycinin levels increased while beta-conglycinin levels decreased. These differences were not expected to have a negative impact as variation in the levels of the various seed storage proteins were also noted in some commercial soybean lines. Antinutritional factors including trypsin inhibitors, phytic acid and the oligosaccharides raffinose and stachyose normally present in non-modified soybeans were similar to those found in the transgenic sublines G94-1, G94-19 and G168. Glycitein and lectin levels were somewhat elevated in the transgenic soybean sublines versus A2396, but were within the middle range reported in the literature. It was determined that the consumption of refined oil from soybean sublines G94-1, G94-19 and G168 would have no significant impact and may improve the nutritional quality of the food supply in the United States and Canada.</p>

<p style="text-align: justify;">Feeding studies carried out with pigs and chickens demonstrated that processed soybean meal derived from high oleic soybeans was nutritionally equivalent to processed soybean meal derived from the conventional soybeans. It was determined that high oleic soybeans may be used as any other non-modified soybean meal and would be treated as any other commodity soybean meal.</p>

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

<p style="text-align: justify;">A complete compositional analysis was performed on the transgenic soybean lines. High oleic soybeans did not differ in composition from the parent line or commodity soybean lines (literature ranges) regarding total fat, protein, fiber and ash, amino acids, minerals and vitamins, anti-nutritional factors (phytic acid, trypsin inhibitor, lectins, raffinose, stachyose) and isoflavones. These results demonstrated that there were no significant quantitative or qualitative differences between transgenic soybean sublines G94-1, G94-19 and G168 and elite soybean lines with regard to all of these components. Since no new proteins were expressed in these novel soybeans and the variation in seed protein was considered to be within the natural range of variation it was concluded that there was no need to carry out a complete toxicological assessment since the high oleic acid soybean lines were, with the exception of high oleic acid content, equivalent to non-modified soybeans.</p>

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

<p style="text-align: justify;">Allergenicity studies demonstrated that there were no significant quantitative or qualitative differences between the high oleic soybean and non-modified elite soybean. The allergenicity potential was the same for transgenic soybean sublines G94-1, G94-19 and G168 and elite soybean with regard to their allergen content.</p>
