<p style="text-align: justify;">BT11 x MIR604 (OECD identifier: SYN-BT&Oslash;11-1 x SYN-IR6&Oslash;4-5) maize is an F1 hybrid resulting from the hybridization of the lepidopteran-resistant and glufosinate-tolerant maize line BT11 (SYN-BT&Oslash;11-1) and the coleopteran-resistant maize line MIR604 (SYN-IR6&Oslash;4-5). This stacked maize hybrid 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 Japan and Korea.</p>

<p style="text-align: justify;">The stacked hybrid BT11 x MIR604 expresses four novel proteins: the delta-endotoxin Cry1Ab which confers resistance to the European Corn Borer and other lepidopterans, the PAT protein which confers tolerance to the herbicide glufosinate ammonium, the delta-endotoxin mCry3A which confers resistance to corn rootworm (<i>Diabrotica</i> species), and the PMI protein which allows growth on mannose as a carbon source and is used as a selectable marker. The insecticidal protein Cry1Ab is produced by the <i>cry</i>1Ab gene and PAT is produced by the <i>pat</i> gene, both from BT11, the insecticidal protein mCry3A is produced by the <i>mcry</i>3A gene and PMI is produced by the <i>pmi</i> gene, both from MIR604. The novel traits of each parental line have been combined, through traditional plant breeding, to produce this new hybrid. For a full description of each parental line please refer to the individual product descriptions in the crop database for BT11 and MIR604.</p>

<p style="text-align: justify;">The inserted genes and their gene products have a history of safe use, and have undergone review and approval by several regulatory agencies. No interactions among the gene products or negative synergistic effects are expected in the stacked hybrid. The Cry1Ab and mCry3A proteins are not enzymes and therefore do not affect plant metabolism. PAT has a high affinity for L-Phosphinothricin, the active ingredient in glufosinate ammonium and PMI has a high affinity for mannose-6-phosphate, converting it to fructose-6-phosphate which is directly utilised by the plant. PMI, PAT, Cry1Ab and mCry3A are therefore not expected to interact within, nor affect the metabolism of the stacked hybrid.</p>
