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

<p style="text-align: justify;">The genetic modification of GTS 40-3-2 soybean will not result in any change in the consumption pattern of soybean products. Consequently, the dietary exposure of consumers in the United States and Canada to GTS 40-3-2 soybean products was anticipated to be the same as for other lines of commercially available soybean. Dietary exposure to EPSPS is not novel in that all plants, bacteria and fungi produce this enzyme and the CP4 EPSPS will be ingested as inactive denatured protein since all soybean-derived human food products are heated prior to consumption.</p>

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

<p style="text-align: justify;">The analysis of nutritional composition of transgenic GTS 40-3-2 soybean and non-transgenic soybean did not reveal any significant differences in the levels of protein, fat, fibre and starch. A number of these parameters were also measured in glyphosate-treated soybeans with the same results. Comparisons of the amino acid composition of the raw soybeans and the fatty acid profiles of extracted oil from transgenic and control plants did not reveal any significant differences. The anti-nutritive activity in raw soybean meal and flour is caused by soybean trypsin inhibitor, which acts to inhibit normal protein digestion in humans and animals. There was no significant difference in the trypsin inhibitor activity between transgenic GTS 40-3-2 soybeans and non-transgenic control soybeans. Likewise, there were no significant differences in the levels of plant lectins, as determined by hemagglutination assay, or isoflavone glucosides between transgenic and control soybeans. These latter substances, which include genistin and daidzin, can exhibit estrogenic and hypocholesterolemic activities. It was determined that the consumption of refined soybean oil from GTS 40-3-2 would have no significant impact on the nutritional quality of the food supply in the United States and Canada.</p>

<p style="text-align: justify;">A series of animal feeding studies were completed using diets incorporating seed or processed fractions from soybean line GTS 40-3-2. These studies addressed the nutritional equivalence of transgenic soybean when used as animal feed, the safety of any expressed protein or peptide (or any other newly produced constituent), and the potential of any pleiotropic effect caused by the insertion process or site of insertion. The animal feeding studies included two independent four week studies in rats (one with unprocessed and one with processed soybeans), a four week dairy cow study, a six week chicken study, a ten week catfish study and a five day quail study. Animals were fed either unprocessed or processed soybeans (dehulled, defatted, toasted). Included in these studies were control groups fed a non-commercial glyphosate-tolerant soybean (61-67-1) and the non-modified parental soybean line (A5403) from which both glyphosate tolerant events were derived. Results from all groups were compared using conventional statistical methods to detect differences between groups in measured parameters. All three soybean samples tested provided similar growth and feed efficiency for rats, chickens, catfish and quail. The nutritional value or wholesomeness of GTS 40-3-2, even when fed to animals at levels much higher than humans would encounter in the diet, was the same as conventional varieties of soybeans.</p>

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

<p style="text-align: justify;">The low potential for toxicity of transgenic soybean line GTS 40-3-2 was demonstrated by examining the amino acid sequence homology, acute oral toxicity studies on mice, and the characteristics of the proteins. The amino acid sequence of CP4 EPSPS was determined to be closely related to the sequence of the endogenous soybean EPSPS enzyme. An analysis of the amino acid sequence of the inserted CP4 EPSPS enzyme did not show homologies with known mammalian protein toxins and was not judged to have any potential for human toxicity. Additionally, acute oral toxicity studies with purified CP4 EPSPS did not reveal any deleterious effects when mice were administered a dose of 572 mg/kg body weight, which was approximately 1300-fold greater than the highest anticipated potential consumption of CP4 EPSPS from soybean. Furthermore, EPSPS is an enzyme that is ubiquitous in nature, present in plants, fungi and micro-organisms and therefore would not be expected to be toxic or allergenic.</p>

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

<p style="text-align: justify;">The CP4 EPSPS protein is extremely unlikely to be an allergen. A search for amino acid sequence similarity between the CP4 EPSPS protein and known allergens revealed no significant amino acid sequence homologies. In addition, the potential for allergenicity was assessed based upon the characteristics of known food allergens (stability to digestion, stability to processing). Unlike known protein allergens, CP4 EPSPS was rapidly degraded by acid and/or enzymatic hydrolysis when exposed to simulated gastric or intestinal fluids. Overall, the CP4 EPSPS does not possess characteristics typical of known protein allergens.</p>
