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

<p style="text-align: justify;">Humans consume relatively little whole kernel or processed maize, compared to maize-based food ingredients. Maize is a raw material for the manufacture of starch, the majority of which is converted to a variety of sweetener and fermentation products, including high fructose syrup and ethanol. Maize oil is commercially processed from the germ. These materials are components of many foods including bakery and dairy goods, and the human food uses of grain from MON88017 are not expected to be different from the uses of non-transgenic field maize varieties. As such, the dietary exposure to humans of grain from insect resistant hybrids will not be different from that for other commercially available field maize varieties.</p>

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

<p style="text-align: justify;">The two novel proteins present in MON88017 corn have been assessed previously for safety; the CP4 EPSPS protein is present in approved lines of canola, cotton, soybean, potato and other corn events. Previous assessments have shown that CP4 EPSPS administered directly to animals at a high dose is not toxic, and the evidence indicates no potential for this protein to be allergenic in humans. Given its widespread use in approved glyphosate-tolerant crops, it now has a history of safe use in food over 10 years.</p>

<p style="text-align: justify;">In considering the potential toxicity and allergenicity of the Cry3Bb1 variant protein, it is worth noting that Bt formulations containing Cry3Bb1 have been used safely in agriculture since 1995. Two separate acute toxicity studies in mice using the individual Cry3Bb1 variant proteins present in MON88017 and MON863 respectively confirmed the absence of mammalian toxicity in each case. Bioinformatic studies confirmed the absence of any significant amino acid similarity with known protein toxins and allergens, and <i>in vitro</i> digestibility studies demonstrated that Cry3Bb1 variants are rapidly degraded in the stomach following ingestion. Furthermore, processing involving heat treatment renders the Cry3Bb1 variant protein non-functional (i.e. unable to exert a toxic effect in insects). This weight of evidence indicates that the Cry3Bb1 variant protein is not toxic and is unlikely to pose an allergenic risk to humans.</p>

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

<p style="text-align: justify;">Forage and grain from MON 88017 maize, grown at three locations, were analyzed for nutritional composition and compared to that of a non-transgenic maize of similar genetic background (<i>i.e.</i>, the conventional maize control), and to the composition of twelve conventional maize hybrids.</p>

<p style="text-align: justify;">Forage was harvested at the late dough to early dent stages and was analyzed for proximates (crude protein, crude fat, moisture, ash and carbohydrate), acid detergent fibre, neutral detergent fibre, calcium and phosphorus. No significant differences in the levels of these components were observed between MON88017, the conventional control and the conventional hybrids.</p>

<p style="text-align: justify;">Grain samples were obtained from mature (growth stage R6) plants harvested at three locations. The levels of several nutritional components were determined, including: proximates (crude protein, crude fat, moisture, ash, and carbohydrate); acid detergent fibre, neutral detergent fibre, total dietary fibre; minerals (calcium, phosphorus, magnesium, copper, iron, manganese, potassium, and zinc); amino acids; fatty acids; vitamins (folic acid, niacin, B1, B2, B6, and E); anti-nutrients (phytic acid, raffinose); and secondary metabolites (ferulic acid, p-coumaric acid).</p>

<p style="text-align: justify;">Statistical analysis of the nutritional component data across all locations revealed no significant differences among MON 88017, the non-transgenic control, and the commercial hybrids, with the exception of levels of vitamin B1, and linolenic and arachidic acid, expressed as percentages of total fatty acids. The differences in linolenic and arachidic acids were not significant when the data was expressed on a dry matter basis. The levels of vitamin B1 were lower in MON 88017 compared to the non-transgenic control, but were within the 99% tolerance interval established using the twelve conventional commercial hybrids.</p>

<p style="text-align: justify;">The levels of the antinutritional compounds phytic acid and raffinose, as well as the secondary metabolites ferulic acid and p-coumaric acid, were determined in the grain. Phytic acid occurs naturally in maize and other cereals. It is indigestible by humans and non-ruminant livestock, and also inhibits the absorption of iron and other minerals. Raffinose is an oligosaccharide found in cereals and legumes. It is cannot be digested by humans and monogastric livestock, thereby reducing the amount of metabolizable energy in foods and livestock feeds. Ferulic acid and p-coumaric acid are phenolic compounds found in cell walls; these become covalently linked to hemicelluloses during cell wall development. In ruminants, these compounds inhibit cell wall degradation by rumen microorganisms. No significant differences were observed in the levels of these antinutrients and secondary metabolites between MON 88017 and the non-transgenic control maize line. The levels of these compounds were also within the 99% tolerance interval established for the twelve conventional maize hybrids.</p>

<p style="text-align: justify;">The results of these compositional analyses led to the conclusion that MON 88017 forage and grain is not different in nutritional and antinutritional composition compared to maize hybrids currently marketed, grown and consumed.</p>
