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

<p style="text-align: justify;">Although commercialization of soybean 356043 could potentially increase dietary exposure to the acetylated amino acids NAGlu and NAAsp, acetylated amino acids are readily metabolized in humans and raise no safety issues. In addition, neither NAGlu nor NAAsp are detectable in soybean oil, which accounts for 94% of soybean consumption.</p>

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

<p style="text-align: justify;">Compositional analyses were done to establish the nutritional adequacy of soybean event 356043, and to compare it to a non-transgenic conventional soybean under typical cultivation conditions. The components analyzed were protein, fat, carbohydrate, amino acids, fatty acids, vitamins, minerals, isoflavones, and the anti-nutrients stachyose, faffinose, lectins, phytic acid, and trypsin inhibitor.</p>

<p style="text-align: justify;">The compositional analyses of key components in soybean 356043 indicate that, for the majority of components, there are no compositional differences of biological significance in forage or grain from transgenic soybean 356043, compared to the non-GM control. Several minor differences in key nutrients and other constituents were noted, but the mean levels observed were within the range of values observed for the non transgenic comparator and within the range of natural variation.</p>

<p style="text-align: justify;">Increased levels of two fatty acids, heptadecanoic acid (C17:0) and heptadecenoic acid (C17:1) were observed. C17:0 and C17:1 in soybean 356043 together constitute approximately 0.5% of the total fatty acid content, compared to 0.2% in the conventional counterpart. C17:0 and C17:1 are present in vegetable oils and other commonly consumed foods. As these fatty acids are typical constituents of the human diet and readily metabolized, the increased levels raise no safety or nutritional concerns.</p>

<p style="text-align: justify;">The introduction of dual herbicide-tolerant soybean 356043 into the food supply would be expected to have negligible nutritional impact. This was supported by the results of a feeding study in animals, where no differences in health and growth performance were found between broiler chickens fed diets containing soybean 356043 meal and those fed conventional soybean meal diets.</p>

<p style="text-align: justify;">No potential public health and safety concerns have been identified in the assessment of dual herbicide-tolerant soybean 356043. On the basis of the data provided, and other available information, food derived from soybean 356043 is considered as safe for human consumption as food derived from conventional soybean varieties.</p>

<p style="text-align: justify;">To date, all approved GM plants with modified agronomic production traits (e.g., herbicide tolerance) have been shown to be compositionally equivalent to their conventional counterparts. In the case of soybean 356043, there are unintended changes in the levels of two fatty acids (C17.0 and C17.1) and two-acetylated amino acids (NAGlu and NAAsp), that are outside the range of natural variation for soybean. All of these components are typical constituents of the human diet, and are readily metabolizable, and thus raise no safety issues resulting from their presence in food derived from soybean 356043.</p>

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

<p style="text-align: justify;">Bioinformatics studies with the GAT4601 and GM-HRA proteins confirmed the absence of any biologically significant amino acid sequence similarity to known protein toxins or allergens and digestibility studies demonstrated that both proteins would be rapidly degraded following ingestion, similarly to other dietary proteins. Acute oral toxicity studies in mice with both proteins also confirmed the absence of toxicity. Taken together, the evidence indicated that neither protein is toxic or likely to be allergenic in humans.</p>

<p style="text-align: justify;">The metabolite residues generated by glyphosate-treated soybean 356043 plants are considered less toxic than glyphosate, which itself is considered of very low potential toxicity in animals. Hence, there is no increase in overall toxicity arising from the presence of glyphosate residues on soybean 356043, and the current acceptable daily intake (ADI) for glyphosate is considered to be protective of public health and safety.</p>

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

<p style="text-align: justify;">Soybean naturally contains allergenic proteins and is one of a group of known allergens, including milk, eggs, fish, shellfish, wheat, peanuts, tree nuts, and sesame. This group of foods accounts for approximately 90% of all food allergies. The presence of allergenic proteins in the diets of hypersensitive individuals can cause severe adverse reactions. The allergenic effect of soybeans is attributed to the globulin fraction of soybean proteins that comprises about 85% of total protein. Soybean-allergic individuals will also be allergic to soybean 356043.</p>

<p style="text-align: justify;">In order to assess whether soybean 356043 has altered endogenous allergenic potential, a study was conducted to determine binding levels of IgE antibody to protein extracts prepared from soybean 356043 and the parental soybean line &ldquo;Jack.&rdquo; The data indicate that soybean 356043 and control Jack had similar protein/allergen profiles when tested with soy-allergic material. Thus, soybean 356043 appears to be equivalent to the non-transgenic counterpart in terms of its endogenous allergenicity.</p>
