<p style="text-align: justify;">WideStrike&trade; cotton (OECD identifier: DAS-21&Oslash;23-5 x DAS-24236-5) was produced by cross-breeding two insect-resistant cotton lines: 281-24-236 (OECD identifier: DAS-24236-5) and 3006-210-23 (OECD identifier: DAS-21&Oslash;23-5). Each of these lines expresses an insecticidal protein. 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. WideStrike&trade; expresses two novel proteins: Cry1F and Cry1Ac, delta-endotoxins which confers resistance to lepidopteran pests of cotton, such as the cotton bollworm, pink bollworm and tobacco budworm. The insecticidal protein Cry1F is produced by the <i>cry</i>1F gene from cotton line 281-24-236, and Cry1Ac is produced by the <i>cry</i>1Ac gene from the cotton line 3006-210-23. The <i>pat</i> gene is also expressed in WideStrike&trade;. This gene produces the PAT protein (phosphinothricin acetyltransferate) which confers resistance to the herbicide glufosinate ammonium, and inserted solely to be used as a selectable marker during the transformation that led to the production of 281-24-23 and 3006-210-23. 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 inserted genes and their gene products in WideStrike&trade; cotton 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 the stacked line. Since neither Cry1F, nor Cry1Ac, have enzymatic activity, these proteins have no effect on plant metabolism. The PAT protein has a very high affinity for L-Phosphinothricin, the active ingredient in the herbicide glufosinate ammonium. Cry1F, Cry1Ac and PAT are therefore not expected to interact within, nor affect the metabolism of the stacked hybrid. The EPA conducted an environmental hazard assessment of WideStrike&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>
