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

<p style="text-align: justify;">The genetic modification of MON 71800 spring wheat will not result in any change in the consumption pattern of wheat and wheat-based products. MON 71800 is expected to be used in similar applications as other spring wheat cultivars by the food industry. MON 71800 did not express any novel compositional characteristics, as confirmed by the similarity in composition of the modified line to its parental counterpart, and other conventional spring wheat varieties. Furthermore, the availability of many spring wheat cultivars for cultivation, and the normal variation in wheat composition due to differences in grade and growing conditions, result in a wide variation in the composition of conventional wheat grain. Consequently, the dietary exposure of consumers in the United States to MON 71800 is anticipated to be the same as for other varieties of commercially available spring wheat.</p>

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

<p style="text-align: justify;">The nutritional components of MON 71800 grain and forage were determined analytically and compared to those of the parental line &lsquo;Bobwhite&rsquo; and several commercial varieties grown at five locations in the United States and Canada. For the grain, these components included proximates (crude protein, crude fat, ash, moisture, total carbohydrates), total dietary fibre, sugars, starch, amino acids, fatty acids, B vitamins, vitamin E and minerals. Forage samples were analyzed for proximates, acid detergent fibre, neutral detergent fibre, calcium and phosphorus. At some of the locations, for both the grain and the forage, there were statistically significant differences in the levels of certain components between MON 71800 and its parental line. These differences within locations could be attributed to environmental effects rather than to any unintended effect of the genetic modification in MON 71800. However, the combined data from all test locations demonstrated that the nutritional composition of MON 71800 grain and forage was comparable to that of the parental line &lsquo;Bobwhite,&rsquo; and other commercial spring wheat varieties.<br />
Phytic acid occurs naturally in wheat and other cereals. It is indigestible by humans and non-ruminant livestock, and inhibits the absorption of iron and other minerals. Grain samples of MON 71800, the parental line &lsquo;Bobwhite,&rsquo; other commercial wheat varieties were analyzed to determine levels of phytic acid. The concentration of phytic acid in MON 71800 was comparable to that in the parental line, and was within the range of values determined for the commercial varieties and those found in the literature.</p>

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

<p style="text-align: justify;">The potential for toxicity and allergenicity of MON 71800 wheat was investigated using the following data and information: results from the determination of amino acid sequence similarity between the CP4 EPSPS proteins and known toxins and allergens; analysis for possible glycosylation of the CP4 EPSPS proteins; analysis of the stability the novel proteins in simulated gastric fluids; results from an acute oral toxicity study in mice using the CP4 EPSPS proteins; and, information on the safety of the <i>cp4 epsps</i> gene donor, <i>A. tumefaciens</i> strain CP4. The potential for increased allergenicity of the grain from MON 71800 was investigated, specifically with regard to endogenous wheat allergens that induce an IgE reaction in susceptible humans. Various immunilogical assays, using sera from humans with an IgE-mediated wheat allergy, were performed with extracts from MON 71800, the parental line, and several other commercial wheat varieties. The possibility that the genetic modification would have also altered the levels of gliadin, proteins that cause celiac enteropathy in susceptible persons, was also investigated. Gliadin levels were measured, and gluten levels calculated in MON 71800, its parental line, and other commercial varieties.</p>

<p style="text-align: justify;">The CP4 EPSPS proteins in MON 71800 showed no amino acid sequence similarity with known toxins and allergens and neither of the two forms of the protein are glycosylated. Both forms of the CP4 EPSPS protein were rapidly digested under simulated gastric fluid conditions, and the enzyme activity of each protein was substantially diminished within the same period as for the digestion. The results of the acute oral toxicity study on mice, at the highest administered dose, showed no adverse effects of the CP4 EPSPS proteins. Gluten levels were not significantly altered by the genetic modification of MON 71800, neither were the endogenous allergens, as demonstrated by the results of the immunological studies.</p>

<p style="text-align: justify;">Both forms of the CP4 EPSPS protein were expressed at very low levels in MON 71800 grain and forage. This fact, along with negative results of the various safety studies, sequence homology investigations, and immunological assays led to the conclusion that MON 71800 spring wheat did not demonstrate any potential for toxicity and novel allergenicity, nor any altered endogenous allergenicity, compared to conventional spring wheat varieties.</p>
