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

<p style="text-align: justify;">Only refined cottonseed oil and cellulose from processed linters of cottonseed are consumed by humans. Processed linters are essentially pure cellulose (&gt;99%) and are subjected to heat and solvent treatment that would be expected to remove and destroy DNA. It is generally accepted that the refined oil does not contain protein. The refining process for cottonseed oil includes heat, solvent and alkali treatments remove and destroy DNA and protein. The refined cottonseed oil from these lines was tested for the presence of nitrilase and NPTII, which were undetectable. It was concluded that there would be no dietary exposure to the novel proteins expressed in these cotton lines.</p>

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

<p style="text-align: justify;">Compositional comparison of cottonseed oil, cottonseed and meal from BXN&trade; cotton was made to the same materials from commercial non-transgenic cotton. Parameters measured included proximate analysis (moisture, crude fat/oil, protein, and ash) of cottonseed meal; fibre analysis (crude fibre, acid detergent, and neutral detergent fibres) of cottonseed; fatty acid composition of refined cottonseed oil; and amino acid profiles of cottonseed meal. No significant differences between the transgenic lines and the traditionally bred lines were observed for any of these parameters.</p>

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

<p style="text-align: justify;">Cottonseed contains a high number of anti-nutritional factors and the raw seed is unsuitable for monogastric animals. Gossypol has numerous toxic effects on mammals, including heart damage and heart failure, such that whole cottonseed or cottonseed meal is not used in human foods and the presence of gossypol limits its use in animal feed. However, removal or inactivation of gossypol during processing enables the use of some cottonseed meal in feed for fish, poultry and pigs.</p>

<p style="text-align: justify;">The cyclopropenoid fatty acids, sterculic acid (C-17), dihydrosterculic acid (C-19) and malvalic acid (C-18), are unique fatty acids common in cotton and produce undesirable biological effects, including the inhibition of biodesaturation of stearic to oleic acid, affecting phospholipid biosynthesis.</p>

<p style="text-align: justify;">The levels of gossypol and cyclopropenoid fatty acids in the transgenic cotton line were measured and found to be within the normal range of variation reported for traditionally bred cotton cultivars.</p>

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

<p style="text-align: justify;">Refined cottonseed oil and cellulose from linters are devoid of protein and, given that most allergens are proteins, their consumption is unlikely to result in an allergic reaction. Therefore the potential for cottonseed oil or linters from BXN&trade; cotton to constitute a source of allergens is extremely low. In addition, the enzyme nitrilase does not have the properties of known allergens, such as glycosylation, protease stability, and presence in food at high concentrations. Also, an amino acid sequence homology search against public domain databases did not reveal any homologies between known protein allergens or toxins and the nitrilase enzyme.</p>
