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

<p style="text-align: justify;">Sugar beet intended for human consumption is generally converted directly to refined white sugar through extensive purification processes. The levels of CP4 EPSPS protein introduced into H7-1 sugar beet were not measured in refined sugar. CP4 EPSPS was expressed at very low levels in the roots, and since refined sugar does not contain detectable levels of protein, there would be virtually no human exposure to CP4 EPSPS. Consequently, there is no anticipated human exposure to this protein as a result of consumption of refined sugar derived from H7-1 sugar beet.</p>

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

<p style="text-align: justify;">Detailed analyses conducted over multiple years and environments were carried out to establish the nutritional composition of H7-1 sugar beet. Analyses included crude ash, crude fibre, crude fat, crude protein, carbohydrate (by calculation), dry matter, acid detergent fibre and neutral detergent fibre in both tops and processed roots (brei). Additional quality components were measured in brei including, invert sugar content, polarization (% sucrose), sodium, potassium and alpha-amino nitrogen. No biologically meaningful differences in any compositional and quality parameters were identified between H7-1 sugar beet and the non-transgenic controls. It was concluded that H7-1 sugar beet is equivalent to other commercially available sugar beet with respect to composition and nutritional quality.<br />
The presence of naturally occurring toxins and allergens in glyphosate-tolerant sugar beet line H7-1 was investigated. Saponins are the only known toxicants found in sugar beet and are actively eliminated in sugar processing. These are also considered antinutrients; feed intake is reduced due to the bitter taste imparted by these compounds. Saponins were quantified in tops and root and compared to the non-transgenic control. Levels of saponin in H7-1 did not differ significantly from those of the control lines, and were within the range observed for conventional sugar beet cultivars.</p>

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

<p style="text-align: justify;">The potential for toxicity and allergenicity of the CP4 EPSPS protein in H7-1 sugar beet was assessed. An amino acid sequence homology search, using the ALLPEPTIDES database, revealed no similarities between CP4 EPSPS and known toxins. A sequence homology search conducted using the ALLERGEN3 database also revealed no similarities between the novel protein and known allergens, including gliadin. The CP4 EPSPS protein was degraded within one minute of exposure to simulated gastric and intestinal fluids, and the enzymatic activity reduced to less than 10% of the initial activity within 15 seconds of exposure. No adverse effects were observed in an acute toxicity study where mice were fed (by gavage) doses of CP4 EPSPS up to 572 mg/kg.</p>

<p style="text-align: justify;">The results of the digestibility and acute oral toxicity studies, sequence homology searches, and the very low expression levels of the novel protein in roots (1.44% of total protein) support the conclusion that the H7-1 is neither toxic nor allergenic, and is as safe as conventional sugar beet varieties.</p>
