<p style="text-align: justify;">Maize (<i>Zea mays</i> L.), or corn, is grown primarily for its kernel, which is largely refined into products used in a wide range of food, medical, and industrial goods. Only a small amount of whole maize kernel is consumed by humans. Maize oil is extracted from the germ of the maize kernel and maize is also a raw material in the manufacture of starch. A complex refining process converts the majority of this starch into sweeteners, syrups and fermentation products, including ethanol. Refined maize products, sweeteners, starch, and oil are abundant in processed foods such as breakfast cereals, dairy goods, and chewing gum. In the United States and Canada maize is typically used as animal feed, with roughly 70% of the crop fed to livestock, although an increasing amount is being used for ethanol production. The entire maize plant, the kernels, and several refined products such as glutens and steep liquor, are used in animal feeds. Silage made from the whole maize plant makes up 10-12% of the annual corn acreage, and is a major ruminant feedstuff. Livestock that feed on maize include cattle, pigs, poultry, sheep, goats, fish and companion animals. Industrial uses for maize products include recycled paper, paints, cosmetics, pharmaceuticals and car parts. The European corn borer (ECB), <i>Ostrinia nubilalis</i>, is the most damaging insect pest of maize in the United States and Canada; losses resulting from ECB damage and control costs exceed $1 billion each year. An average of one ECB cavity per maize stalk across an entire field can reduce yield by as much as 5% when caused by first generation larvae, and 2.5% when caused by second generation larvae, with annual yield losses estimated at 5 to 10 %. Despite consistent losses to ECB, chemical insecticides are utilized on a relatively small acreage (less than 20%). Historically, this reluctance stems from the difficulties in identifying and managing ECB in maize crops: ECB larval damage is hidden, heavy infestations are unpredictable, insecticides are costly, timing of insecticide application is difficult and multiple applications may be required to guarantee ECB control. The transgenic maize line MON809 was genetically engineered to resist ECB by producing its own insecticide. This line was developed by introducing the <i>cry1Ab</i> gene, isolated from the common soil bacterium <i>Bacillus thuringiensis</i> (<i>Bt</i>), into the maize line by particle acceleration (biolistic) transformation. The <i>cry1Ab</i> gene produces the insect control protein Cry1Ab, a delta-endotoxin. The Cry1Ab protein produced by the <i>Bt</i> maize is identical to that found in nature and in commercial <i>Bt</i> spray formulations. Cry proteins, of which Cry1Ab is only one, act by selectively binding to specific sites localized on the lining of the midgut of susceptible insect species. Following binding, pores are formed that disrupt midgut ion flow, causing gut paralysis and eventual death due to bacterial sepsis. Cry1Ab is lethal only when eaten by the larvae of lepidopteran insects (moths and butterflies), and its specificity of action is directly attributable to the presence of specific binding sites in the target insects. There are no binding sites for the delta-endotoxins of <i>B. thuringiensis</i> on the surface of mammalian intestinal cells, therefore, livestock animals and humans are not susceptible to these proteins. MON809 expressed the Cry1Ab protein at an effective dosage over the growing season, as indicated by its efficacy in controlling both first and second generation infestations of ECB. Protein expression was found to decrease over the growing season, as evidenced by declining Cry1Ab protein concentrations in assayed leaves. MON809 was tested in field trials in Canada from 1994 to 1996. Data collected from these trials demonstrated that MON809 was not different from conventional maize lines; agronomic characteristics, including vegetative vigour, time to maturity, seed production, and disease and pest susceptibilities, were within the normal range reported for conventional maize lines. It was demonstrated that the transformed maize line did not exhibit weedy characteristics, or negatively affect beneficial or nontarget organisms. MON809 was not expected to impact on threatened or endangered species. Maize does not have any closely related species growing in the wild in the continental United States and Canada. Cultivated maize can naturally cross with annual teosinte (<i>Zea mays</i> ssp. mexicana) when grown in close proximity, however, these wild maize relatives are native to Central America and are not naturalized in North America. Additionally, reproductive and growth characteristics were unchanged in MON809. Gene exchange between MON809 and maize relatives was determined to be negligible in managed ecosystems, with no potential for transfer to wild species in Canada and the United States. Regulatory authorities in Canada and the United States have mandatory requirements for developers of <i>Bt</i> maize to implement specific Insect Resistant Management (IRM) Programs. The potential for ECB populations to develop tolerance or become resistant to the <i>Bt</i> toxin is expected to increase as more maize acreage is planted with <i>Bt</i> hybrids. These IRM programs are designed to reduce the potential development of <i>Bt</i>-resistant insect populations, as well as prolonging the effectiveness of plant-expressed Bt toxins, and the microbial <i>Bt</i> spray formulations of these same toxins. The food and livestock feed safety of MON809 maize was established based on several standard criteria. Analyses determined that MON809 grain was nutritionally equivalent to non-transgenic grain, posing no health risks to either humans or livestock. Proximate analysis (ash, crude fat, crude protein, and moisture content), and fatty acid and amino acid composition of MON809 grain revealed only minor differences from the levels reported for non-transgenic maize. These differences were within the normal range of variation for maize and were attributed to normal genotypic variation rather than to the presence of the introduced genes. The toxicity and allergenicity potential of the Cry1Ab protein in MON809 was assessed by examining its physiochemical characteristics, degree of amino acid sequence homology to known protein allergens, and digestibility. The Cry1Ab protein has a history of safe use, demonstrated by its use in microbial <i>Bt</i> spray formulations in agriculture for more than 40 years with no evidence of adverse effects. This fact, combined with the lack of amino acid sequence homology between the Cry1Ab protein and known allergens and toxins, and the rapid degradation of the Cry1Ab protein in acidic gastric fluids, was sufficient to provide with reasonable certainty a lack of toxicity and allergenic potential.</p>
