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

<p style="text-align: justify;">The maize event BT11 has been field tested in various lines and hybrids, specifically the hybrids X4334CBR and X4734CBR, in the major maize growing regions of the United States since 1992, in Canada since 1993, and in Europe.</p>

<p style="text-align: justify;">Field reports on maize event BT11 compared to non-transgenic counterparts, determined that agronomic characteristics such as vegetative vigour, male and female fertility, time to maturity, seed yield, kernel size, weight and density, were within the normal range of expression currently displayed by commercial maize hybrids. In addition, the level of expression of the PAT enzyme in BT11 maize was found to be at a level high enough to confer tolerance to phosphinothricin herbicides. Overall the field data reports and data on agronomic traits showed that maize event BT11 and lines derived from BT11 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 BT11, pollen dispersal by wind and outcrossing frequency should be no different than for other maize varieties. Gene exchange between BT11 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 appears remote. Cultivated maize, or 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 BT11, other than that conferred by resistance to European corn borer. Resistance to European corn borer will not, in itself, render maize weedy or invasive of natural habitats since none of the reproductive or growth characteristics were modified.</p>

<p style="text-align: justify;">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;">BT11 maize and the plant-expressed insectidical protein, Cry1Ab, 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). Feeding studies conducted under laboratory conditions have produced variable results on the development of some predatory insect species which have fed on prey that have fed on Btk material. Direct feeding studies with pollen from GM maize have shown no effects on honeybee development, lady beetles, insidious flowerbug and green lacewing. Results from feeding studies of young quail fed with modified maize meal in their diet showed no adverse effects.</p>

<p style="text-align: justify;">In summary, it was determined that genetically modified maize event BT11 did not present an increased risk to, or impact on interacting organisms, including humans, with the exception of specific lepidopteran insect species. Furthermore, BT11 was not expected to impact on threatened or endangered lepidopteran species, as none were listed which feed on maize plants in North America.</p>

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

<p style="text-align: justify;">BT11 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 BT11 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 Bt 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 maize event BT11, 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.</p>

<p style="text-align: justify;">BT11 maize plants are not likely to eliminate the use of chemical insecticides which are traditionally applied to about 25 to 35% of the total maize acreage planted. BT11 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>
