<p style="text-align: justify;">MON810 X LY038 (OECD identifier: MON-&Oslash;&Oslash;81&Oslash;-6 X REN-&Oslash;&Oslash;&Oslash;38-3) maize is a stacked event resulting from the hybridization of maize inbred MON 810 (MON-&Oslash;&Oslash;81&Oslash;-6) with LY038 (REN-&Oslash;&Oslash;&Oslash;38-3). 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 the Philippines and Japan.</p>

<p style="text-align: justify;">The stacked hybrid MON810 X LY038 expresses the novel proteins expressed in the parental lines used to breed this line. The insecticidal delta-endotoxin Cry1Ab, which confers resistance to the European Corn Borer and other lepidopterans, is produced by the <i>cry</i>1Ab gene from MON810. The maize line LY038 contains the <i>cordapA</i> gene from <i>Corynebacterium glutamicum</i> to increase the level of the amino acid lysine in the grain for animal feed, primarily for poultry and swine. The use of LY038 as a feed ingredient is expected to reduce or eliminate the need for lysine supplementation. The novel traits of each parent line have been combined, through traditional plant breeding, to produce this new hybrid. For a full description of each parent line please refer to the individual product descriptions in the crop database for MON810 and LY038.</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 protein is not an enzyme and therefore does not affect plant metabolism. The <i>cordapA</i> gene isolated from <i>Corynebacterium glutamicum</i>, codes for the enzyme dihydrodipicolinate syntase (cDHDPS). This enzyme is active in the lysine metabolic pathway and mediates a critical rate-limiting step, that in maize, is controlled by feedback inhibition. DHDPS catalyzes the condensation of L-aspartate-4-semialdehyde and pyruvate , resultling in the synthesis of 2,3-dihydrodipicolinate, a substrate in the lysine metabolic pathway. The DHDPS encoded by <i>cordapA</i> is less sensitive to feedback inhibition than the native maize DHDPS. The reduction in feedback inhibition results in higher levels of free lysine accumulating in the grain of LY038, at levels higher than those typically found in conventional maize.</p>
