<p style="text-align: justify;"><b>Food and Feed Use</b></p>

<p style="text-align: justify;">Maize event MIR162 will be grown for the same uses as maize varieties currently commercially available in the United States. While maize grown in the United States is predominantly (roughly 60 percent) used to feed domestic animals, either as grain or silage, maize grain is also processed by wet or dry milling to yield food products such as high fructose corn syrup, starch, oil, grits, and flour. Non-food/feed purposes for grain include use for fuel ethanol production; however, the by-products of such industrial distilling processes may also be used in animal feeds. Maize event MIR162 is suitable for the same uses as conventional maize.</p>

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

<p style="text-align: justify;">Key nutritional components in maize grain and forage derived from event MIR162 and near-isogenic non-transgenic control plants were compared. Replicate trials of transgenic and corresponding near-isogenic non-transgenic control hybrids were planted in multiple locations selected to be representative of the range of environmental conditions under which the hybrid varieties would typically be grown. Samples of grain and forage were harvested from six of these trial locations and compositional data for the MIR162 and control hybrids were subjected to analysis of variance across all locations and compared to compositional analysis data for grain and forage published in the literature and in compositional analysis databases.</p>

<p style="text-align: justify;">Among the numerous compositional analyses that were carried out, most showed no consistent statistically significant differences. Statistically significant differences were noted for levels of the proximates ash, NDF and starch; the minerals calcium, iron and phosphorus; vitamins A (b-carotene), B6 and E (a-tocopherol); linoleic and linolenic fatty acids; the secondary metabolites ferulic acid and p-coumeric acid; and the phytosterol, b-sitosterol. However, the magnitudes of the differences were small and in every case the average values (when quantifiable) were all within the ranges of natural variation as reported in the literature. Overall, no consistent patterns emerged to suggest that biologically significant changes in composition or nutritive value of the grain or forage had occurred as an unintended result of the transformation process or expression of the Vip3Aa20 or PMI proteins.</p>

<p style="text-align: justify;">The conclusion based on these data was that grain and forage from MIR162 maize were substantially equivalent in composition to both the non-transgenic control hybrid included in this study, and to other commercial maize hybrids.</p>

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

<p style="text-align: justify;">The potential toxicity and allergenicity of the Vip3Aa20 and PMI proteins expressed in event MIR162 maize was evaluated by acute oral toxicity testing, digestive fate, and heat stability studies. In addition, amino acid sequence homology searches were performed against known toxins and allergens. Neither the Vip3Aa20 protein nor the PMI protein produced any adverse effects in laboratory mice challenged with a single oral dose corresponding to 1250 mg/kg body weight or 3080 mg/kg body weight, respectively. Both the Vip3Aa20 and PMI proteins were rapidly degraded following exposure to pepsincontaining simulated gastric fluid, indicating that any Vip3Aa20 or PMI protein in the diet would be readily digested as conventional dietary protein. In addition, the Vip3Aa20 and PMI proteins were both shown to lose biological (Vip3Aa20) or enzymatic (PMI) activity following incubation at 65&ordm;C for 30 minutes. Neither the Vip3Aa20 protein nor the PMI protein shows significant amino acid sequence similarity to known or putative mammalian toxins or to allergenic protein sequences that are biologically relevant or have implications for allergenic potential. Based on this weight-of-evidence approach, it was concluded that the Vip3Aa20 and PMI proteins expressed in event MIR162 were extremely unlikely to exhibit mammalian toxicity or allergenicity.</p>
