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

<p style="text-align: justify;">Approximately 26% of the world sugar consumed and 47% of the sugar consumed in the United States is produced from sugar beets. Sugar beet is generally converted directly to refined white sugar (which is composed almost entirely of sucrose) through extensive purification processes. The PAT and NPTII proteins were expressed at low levels in the sugar beet roots and tops, and neither protein was detected in refined sugar or molasses derived from sugar beet T120-7, indicating no likelihood for exposure to these proteins from these products.</p>

<p style="text-align: justify;">Sugar beet pulp is a by-product and is normally dried and pelleted for use as a livestock feed. In recent years, it has been purified and used as an additive, at less than 1%, in some specific foods such as food fibre for breakfast cereals etc. The PAT protein was not detected in the pulp and NPTII was detected at very low levels.</p>

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

<p style="text-align: justify;">The transgenic T120-7 line was compared with nontransgenic sugar beets on the basis of numerous compositional components, including crude fat, crude protein, fibre, ash, carbohydrate, calories, calcium, magnesium, phosphorus, potassium, and sodium. With the exception of fibre content, no statistically significant differences were observed. The differences in fibre content were ascribed to environmental factors associated with different growing locations and conditions.</p>

<p style="text-align: justify;">The process fractions, refined sugar, molasses and dried pulp, were assessed for the proximate variables: fatty acids, amino acids, minerals and sugar profiles. Analysis of the dried pulp fraction revealed differences for ash content and some amino acids. It was determined that these differences in nutrient content would not impact on animal nutrition, as dried pulp comprises only a portion, less than 25%, of the total diet for cattle feed use. The molasses fraction revealed differences in fat, protein, calcium, C10:0 and some amino acids. These differences were small and not expected to impact the nutritional content of animal feed. Analysis of the refined sugar fraction showed a difference in tryptophan levels. Importantly, there were no significant differences between transgenic and nontransgenic sugar beets in carbohydrate content, which is the major nutrient in refined sugar (98%).</p>

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

<p style="text-align: justify;">It was determined that the PAT enzyme has a very low potential for toxic or allergenic effects based on its physiochemical characteristics (<i>e.g.</i>, rapid breakdown under mammalian digestive conditions using simulated gastric and intestinal fluids, and lack of heat stability), its low concentrations in plant tissues and thus food or livestock feed products derived from them, and the lack of amino acid sequence homology with any known protein toxins or allergens.</p>
