<p style="text-align: justify;"><b>Field Testing</b></p>

<p style="text-align: justify;">MON809 maize was field tested under confined conditions in Canada from 1994-1996. Field reports on MON809 and corn hybrids derived from MON809 determined that early stand establishment, vegetative vigour, time to maturity and seed production were within the normal range of expression of these traits in commercial corn hybrids. Hybrids derived from MON809 produced similar yields in the absence of ECB, but under heavy infestations of ECB, MON809 hybrids out-yielded their non-transgenic counterparts by 10-15%. Hybrids derived from MON809 were not tolerant to the concentrations of glyphosate herbicide that are typically used for weed control. No significant differences were observed in resistance to a number of other significant insect pests or diseases compared to non-transgenic controls. Overall the field data reports and data on agronomic traits showed that MON809 lines have no potential to pose a plant pest risk.</p>

<p style="text-align: justify;"><b>Outcrossing</b></p>

<p style="text-align: justify;">Since pollen production and viability were unchanged by the genetic modification resulting in maize line MON809, pollen dispersal by wind and outcrossing frequency should be no different than for other maize varieties. Gene exchange between MON809 and other cultivated maize varieties will be similar to that which occurs naturally between cultivated maize varieties at the present time. In Canada and the United States, where there are few plant species closely-related to maize in the wild, the risk of gene flow to other species is remote. Cultivated maize, <i>Zea mays</i> L. subsp. mays, is sexually compatible with other members of the genus Zea, and to a much lesser degree with members of the genus Tripsacum.</p>

<p style="text-align: justify;"><b>Weediness Potential</b></p>

<p style="text-align: justify;">No competitive advantage was conferred to MON809, other than that conferred by resistance to ECB, which will not, in itself, render maize weedy or invasive of natural habitats since none of the reproductive or growth characteristics were modified. Cultivated maize is unlikely to establish in non-cropped habitats and there have been no reports of maize surviving as a weed. In agriculture, maize volunteers are not uncommon but are easily controlled by mechanical means or by using herbicides. <i>Zea mays</i> is not invasive and is a weak competitor with very limited seed dispersal.</p>

<p style="text-align: justify;"><b>Secondary and Non-Target Adverse Effects</b></p>

<p style="text-align: justify;">MON809 maize and the Cry1Ab protein, in particular, should not have a significant potential to harm organisms beneficial to agricultural ecosystems. The history of use and literature suggest that the bacterial <i>Bt</i> protein is not toxic to humans, other vertebrates, and beneficial insects. Most insecticidal protein toxins from <i>B. thuringiensis</i> subspecies kurstaki, including Cry1Ab, have been shown to be specifically toxic to Lepidopteran larvae on ingestion and appear non-toxic to other species of insects, either directly or through secondary ingestion (predation). Laboratory studies of honeybee larvae and adults, predaceous insects (green lacewing larvae, ladybird beetles), and parasitic hymenoptera exposed to the Cry1Ab protein recorded no discernible effects at approximately 10 times the usual LC50 dose for a target insect. Field examination of beneficial arthropods (the Anthocorid <i>Orius insidiosus</i> and spiders) in genetically modified MON809 maize, concluded that any potential impact on non-target arthropods would be less than that from the use of conventional insecticides. Results from feeding studies of young quail fed with modified maize meal in their diet showed no adverse effects. Studies were conducted to evaluate the impact of residual MON809 maize on soil organisms and soil function. It was shown that the <i>Bt</i> endotoxin may become adsorbed to some soil fractions and that degradation was by microbial action. However, since very little of the crop material remains after harvest for incorporation it was concluded based on evidence available that the risks to organisms and soil function were very low. In summary, it was determined that genetically modified maize MON809 did not present an increased risk to, or impact on interacting organisms, including humans, with the exception of specific lepidopteran insect species. Furthermore, MON809 will not impact on threatened or endangered lepidopteran species, as none are listed which feed on maize plants in Canada or the United States. In addition, these organisms are not expected to be affected by the expressed CP4 EPSPS.</p>

<p style="text-align: justify;"><b>Impact on Biodiversity</b></p>

<p style="text-align: justify;">MON809 has no novel phenotypic characteristics that would extend its use beyond the current geographic range of maize production. Since the risk of outcrossing with wild relatives in Canada and the United States is remote, it was determined that the risk of transferring genetic traits from MON809 maize to species in unmanaged environments was insignificant.</p>

<p style="text-align: justify;"><b>Other Considerations</b></p>

<p style="text-align: justify;">In order to prolong the effectiveness of plant-expressed <i>Bt</i> toxins, and the microbial spray formulations of these same toxins, regulatory authorities in Canada and U.S. have required developers to implement specific Insect Resistant Management (IRM) Programs. These programs are mandatory for all transgenic <i>Bt</i>-expressing plants, including MON809 maize, and require that growers plant a certain percentage of their acreage to non-transgenic varieties in order to reduce the potential for selecting <i>Bt</i>-resistant insect populations. Details on the specific design and requirements of individual IRM programs are published by the relevant regulatory authority. MON809 maize plants are not likely to eliminate the use of chemical insecticides, which are traditionally applied to about 25 to 35% of the total planted maize acreage. MON809 maize may positively impact current agricultural practices used for insect control by 1) offering an alternative method for control of European corn borer (and potentially other Cry1Ab-susceptible pests of maize); 2) reducing the use of insecticides to control European corn borer and the resulting potential adverse effects of such insecticides on beneficial insects, farm worker safety, and ground water contamination; and 3) offering a new tool for managing insects that have become resistant to other insecticides currently used or expressed in maize, including other <i>Bt</i>-based insecticides.</p>
