<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 MON89034 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. Maize grain and by-products of wet and dry milling are used as animal feed. The whole maize plant can also be harvested at an appropriate stage and fed to animals or stored as silage. As for food use, the dietary exposure of animals to grain or forage from MON89034 will not be different to exposure from other commercially available maize.</p>

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

<p style="text-align: justify;">Cry1A.105 is a chimeric Cry1A protein of <i>Bacillus thuringiensis</i> that is comprised of three N-terminal domains (I, II, and III) and the C-terminal region. The domains I and II of Cry1A.105 are 100% identical to the respective domains of Cry1Ab or Cry1Ac. The domain III of Cry1A.105 is 99% identical to the domain III of Cry1F. The C-terminal region of Cry1A.105 is 100% identical to that of Cry1Ac. The overall amino acid sequence identity of 93.6%, 90.0%, and 76.7% to Cry1Ac, Cry1Ab, and Cry1F proteins, respectively. Cry2Ab2 is a <i>Bacillus thuringiensis</i> (subsp. <i>kurstaki</i>) protein. <i>Bacillus thuringiensis</i> strains producing Cry1Ac, Cry1Ab, Cry1F, and Cry2A proteins have been used for decades as biopesticides, and pesticides that contain Cry1Ac/Cry1F chimeric protein have been used since 1997. Transgenic maize and cotton expressing Cry1Ac, Cry1Ab, Cry1F, or Cry2Ab2 proteins have been cultivated in large areas in the U.S. and other countries for up to a decade. There are no known reports of allergy or toxicity to Bt or to these Cry proteins.</p>

<p style="text-align: justify;">A dietary safety assessment was performed to evaluate the risks to humans and animals from the Cry1A.105 and Cry2Ab2 proteins present in the foods and feeds derived from MON89034. Risks are quantified as a margin of exposure (MOE), which is defined as the ratio of the No Observable Effect Level (NOEL) from an acute mouse gavage study to estimates of the dietary intake of the respective Cry protein. Mice acute oral toxicity studies demonstrated that the two proteins are not acutely toxic and do not cause any adverse effects even at the higest dose levels tested, which are 2072 and 2198 mg/kg body weight for Cry1A.105 and Cry2Ab2 proteins, respectively. The dietary safety assessment showed that the MOEs for the overall U.S. population were greater than or equal to 199,000 and 981,000 for the Cry1A.105 and Cry2Ab2 proteins, respectively. For children aged 3-5 years old, an age group with the highest corn consumption, the MOEs were greater than or equal to 79,400 and 390,000 for the Cry1A.105 and Cry2Ab2 proteins, respectively. For poultry and livestock, the MOEs ranged between 1,930 &ndash; 13,500 and 2,160 &ndash; 47,600 for the Cry1A.105 and Cry2Ab2 proteins, respectively.</p>

<p style="text-align: justify;">Cry1A.105 and Cry2Ab2 proteins do not share any amino acid sequence similarities with known allergens, gliadins, glutenins, or protein toxins which have adverse effects to mammals. This has been shown by extensive assessments with bioinformatic tools, such as FASTA sequence alignment tool and an eight amino acid sliding window search. Furthermore, Cry1A.105 and Cry2Ab2 proteins are rapidly digestible in simulated gastric fluids. Greater than 95% to 99% of the proteins were digested in simulated gastric fluids in less than 30 seconds. Proteins that are rapidly digestible in mammalian gastrointestinal systems are unlikely to be allergens when consumed.</p>

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

<p style="text-align: justify;">The composition of forage and grain from MON89034 and a non-transgenic control was compared to assess whether the transgenic corn differs from non-transgenic corn in nutritional characteristics. The non-transgenic control has a genetic background similar to that of MON89034 but does not contain the cry1A.105 and cry2Ab2 genes. In addition, grain and forage from 15 different conventional maize hybrids produced in the same field trials with MON89034 and the non-transgenic control was evaluated, with three different hybrids planted at each of the five sites. Data derived from these 15 conventional hybrids as references to generate a 99% tolerance interval for each analyzed component.<br />
The levels of proximates (ash, fat, protein and moisture), fiber (acid detergent fiber-ADF and neutral detergent fiber-NDF) and minerals (calcium and phosphorous) were compared in forage from MON89034 and the non-transgenic control. No statistically significant differences were found in the levels of all analyzed components between forage from MON89034 and forage from the conventional control, with the exception of phosphorus. MON89034 had statistically significantly higher levels of phosphorus than its control, but these levels were within the 99% tolerance intervals for the commercial varieties and within the ranges reported in the literature and the ILSI Crop Composition Database.</p>

<p style="text-align: justify;">The levels of proximates, minerals, amino acids, fatty acids, anti-nutrients, secondary metabolites and vitamins were compared in mature grain from MON89034 and control maize. A statistical analysis of the analytical results combined from all field trials found no statistically significant differences between MON89034 and the conventional non-transgenic control, except for stearic acid and arachidic acid (calculated as a percentage of total fatty acids). However, differences in the levels of these fatty acids were small. The levels of all measured components were within the ranges reported in the literature and the ILSI Crop Composition Database and within the 99% tolerance interval established from the 15 control varieties. There were several statistically significant differences in the level of nutrients within the individual locations, but these differences were not consistent across all locations and it was concluded that these differences were not biologically significant.</p>

<p style="text-align: justify;">The results of these compositional analyses led to the conclusion that MON89034 forage and grain are not different in nutritional and anti-nutritional composition compared to maize hybrids currently marketed, grown and consumed.</p>
