<p style="text-align: justify;">WideStrike&trade; x MON1445 (OECD identifier: DAS-21&Oslash;23-5 x DAS-24236-5 x MON-&Oslash;1445-2) was produced by crossing WideStrike&trade; insect resistant cotton (OECD identifier: DAS-21&Oslash;23-5 x DAS-24236-5) with the herbicide-tolerant cotton line MON1445 (OECD identifier: MON-&Oslash;1445-2). This stacked cotton line is a product of traditional plant breeding, and therefore is not automatically subject to regulation in all jurisdictions as are transgenic plants resulting from recombinant DNA technologies. Certain jurisdictions may request notification in advance of the release of a stacked hybrid, or may request information to conduct an environmental and food safety assessment. Examples of jurisdictions that require either notification or information about stacked hybrids prior to their release into the environment, and for use in human food and livestock feed are Canada and Japan. The United States Environmental Protection Agency (EPA) reviews stacked events when these are the result of stacking two or more plant-incorporated insecticidal proteins, such as WideStrike&trade; cotton.</p>

<p style="text-align: justify;">The stacked cotton line WideStrike&trade; x MON1445 expresses four novel proteins: the delta-endotoxins Cry1F and Cry1Ac, which confer resistance to the lepidopteran pests of cotton, such as the cotton bollworm, pink bollworm and tobacco budworm, the CP4 EPSPS protein, which confers tolerance to the herbicide glyphosate, and the PAT protein, which confers tolerance to glufosinate ammonium. The insecticidal proteins Cry1F and Cry1Ac are produced by the <i>cry</i>1F gene and <i>cry</i>1Ac genes respectively, both of which are from WideStrike&trade;. The cotton line WideStrike&trade; was produced by crossing line 281-24-236 with line 3006-210-23. The PAT protein in WideStrike&trade; is produced by the <i>pat</i> gene: this expressed novel protein was intended solely for use as a selectable marker during plant transformation. The CP4 EPSPS protein is produced by the <i>cp4 epsps</i> gene from MON1445. For a full description of each parental line please refer to the individual product descriptions in the crop database for 281-24-236 and 3006-210-23 (the parental lines of WideStrike&trade; cotton) and MON1445.</p>

<p style="text-align: justify;">The inserted genes and their gene products have a history of safe use, and have undergone prior review and approval by several regulatory agencies. No interactions among the gene products or negative synergistic effects are expected in this stacked line. Since neither Cry1F, nor Cry1Ac are enzymes, these proteins have no effect on plant metabolism. The CP4 EPSPS has a very high affinity for its substrates phosphoenolpyruvate (PEP) and shikimate-3-phosphate, which are part of the shikimate metabolic pathway. The PAT protein has a very high affinity for L-Phosphinothricin, the active ingredient in the herbicide glufosinate ammonium. CP4 EPSPS, Cry1F, Cry1Ac, and PAT are therefore not expected to interact within, nor affect the metabolism of the stacked line.</p>

<p style="text-align: justify;">The EPA conducted an environmental hazard assessment ofWideStrike&trade; cotton. Data on the effects of the Cry1F and Cry1Ac were assessed separately, and in combination to detect possible synergistic effects. No synergistic effects were observed, nor any increase in the host range of non-target organisms, from the stacking of both Cry proteins. No harmful effects to aquatic and terrestrial wildlife were observed, and if was concluded that the cultivation of the stacked line would not be hazardous to non-target terrestrial, aquatic and soil organisms.</p>
