<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 MON810, pollen dispersal by wind and outcropping frequency should be no different than for other maize varieties. Gene exchange between MON810 maize 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 no plant species closely-related to maize in the wild, the risk of gene flow to other species appears remote. Maize (<i>Zea mays</i> ssp. mays) freely hybridizes with annual teosinte (<i>Zea mays</i> ssp. mexicana) when in close proximity. These wild maize relatives are native to Central America and are not present in Canada and the United States, except for special plantings. Tripsacum, another genus related to Zea, contains sixteen species, of which twelve are native to Mexico and Guatemala. <i>Tripsacum floridanum</i> (Florida gamagrass) is native to the southern tip of Florida. Outcrossing with Tripsacum species is not known to occur in the wild and it is only with extreme difficulty that maize can be crossed with Tripsacum.</p>

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

<p style="text-align: justify;">No competitive advantage was conferred to MON810, other than that conferred by resistance to European Corn Borer. Resistance to ECB 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. <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;">The history of use and literature suggest that the bacterial <i>Bt</i> protein is not toxic to humans, other vertebrates, and beneficial insects. The insecticidally active core of the <i>Bt</i> protein expressed in MON810 maize (Cry1Ab) was shown to be equivalent to the original microbial protein. This protein is active only against specific lepidopteran insects and no lepidopteran species are listed as threatened or endangered species in Canada or the United States. Maize inbreds and hybrids expressing the Cry1Ab protein were compared to their non-transformed counterpart for relative abundance of beneficial arthropods. Field studies demonstrated that Cry1Ab had neither a direct nor an indirect effect on the beneficial arthropod populations. Specific feeding trials were also carried out with a number of non-target species, including honey bee larvae and adults, green lacewing, parasitic hymenopterans, ladybird beetles, daphnia (aquatic invertebrates), earthworm, and collembola (soil dwelling invertebrates). In all cases there were no observable adverse effects. In summary, it was determined that when compared with currently commercialized maize varieties, MON810 maize did not present an increased risk to or impact on interacting organisms, including humans, with the exception of specific lepidopteran insect species.</p>

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

<p style="text-align: justify;">MON810 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 North America is remote, it was determined that risk of transferring genetic traits from MON810 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 United States have required developers to implement specific Insect Resistant Management (IRM) Programs. These programs are mandatory for all transgenic <i>Bt</i>-expressing plants, including MON810 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.</p>
