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

<p style="text-align: justify;">The genetic insertion which resulted in MON 863 did not change its physiological characteristics of pollen production and pollen viability nor were there any changes in the plant&rsquo;s sexual compatibility with other maize varieties. Pollen dispersal and outcropping frequency should be equivalent to that of untransformed maize lines, therefore gene exchange between MON 863 maize and other maize varieties will be similar to that which occurs between non-transformed lines. There are no wild relatives to maize in Canada or the United States, making gene flow to wild species extremely remote.</p>

<p style="text-align: justify;">Maize (<i>Zea mays </i>ssp. <i>mays</i>) freely hybridizes with annual teosinte (<i>Zea mays</i> ssp. <i>mexicana</i>) when in close proximity. These wild maize relatives are native to Central America but 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. The lack of compatible wild relatives in Canada and the maize &ndash;growing regions in the United States makes the possibility of gene flow into wild species in these areas very remote.</p>

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

<p style="text-align: justify;">The flowering period, vegetative vigour, time to maturity and seed production of MON 863 were within the normal range currently found in commercial maize hybrids. Maize does not possess the potential to become weedy due to traits such as a lack of seed dormancy, the non-shattering nature of maize cobs and the poor competitive ability of seedlings. Resistance to maize rootworm does not, in itself, render maize weedy or invasive of natural habitats as none of the reproductive or growth characteristics were modified. It was determined that it is very unlikely that MON863 would become a weedy pest of agriculture.</p>

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

<p style="text-align: justify;">The <i>Bt</i> protein expressed in maize MON 863 (Cry3Bb1) was shown to be equivalent to microbial <i>Bt</i> used in sprays for over thirty years. The history of use and literature suggest that the bacterial <i>Bt</i> protein is not toxic to humans, other vertebrates and non-coleopteran invertebrates. This protein is active only against specific coleopteran insects. There are no coleopteran species listed as threatened or endangered in Canada or the United States.</p>

<p style="text-align: justify;">Field studies indicated that MON863 did not have a negative effect on the abundance of non-target organisms compared to a non-<i>Bt</i> hybrid. Species studied included arthropods, earthworms and soil microbes. Coleopteran families including Carabidae, Staphylinidae and Coccinellidae were observed. Consideration was also given to the exposure of fireflies (family Lampyridae) to MON 863 since fireflies are coleopterans. It was concluded that the possibility of firefly exposure to Cry3Bb1 protein from MON 863 would be very unlikely as these insects generally do not occur sub-surface and do not feed on maize.</p>

<p style="text-align: justify;">Feeding trials on non-target invertebrates, including honeybees, ladybird beetles, daphnia, collembola and earthworms, were also conducted. In addition, feeding trials were conducted on the non-target vertebrates such catfish and quail. MON 863 was demonstrated to be safe to these indicator species. MON 863 also did not demonstrate an increased level of anti-nutritional factors such as trypsin inhibitor and phytic acid when compared to unmodified control lines.</p>

<p style="text-align: justify;">When compared with currently commercialized maize lines, MON 863 did not present an elevated risk to or impact on interacting organisms, including humans, with the exception of certain target coleopterans.</p>

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

<p style="text-align: justify;">MON 863 has no novel characteristics that would extend its use beyond the current geographic range of maize production. Since the risk of outcrossing in the United States and Canada is remote, it was determined that the risk of transfer of novel traits to unmanaged environments was insignificant. The potential impact on biodiversity of MON 863 was judged to be equivalent to its unmodified counterparts.</p>

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

<p style="text-align: justify;">In Canada, the authorization for unconfined release into the environment and livestock feed use of MON 863 was limited to one year initially. Renewal of the one year authorization was conditional upon the submission of additional information requested by the CFIA. This additional information included a new beneficial insect study as the original study protocol for toxicity of the Cry3Bb1 protein to green lacewing larvae (Neuroptera: Chrysopidae) was not of an optimal design. The renewal of the permit was granted in 2004.</p>

<p style="text-align: justify;">In addition, the use of MON 863 in unconfined releases is contingent upon the implementation of specific insect resistance management (IRM) plans in Canada and the United States. IRM strategies are required to prolong the effectiveness of plant-expressed <i>Bt</i> toxins and the microbial spray formulations of these toxins. These programs are mandatory for all transgenic <i>Bt</i>-expressing plants, including MON 863 maize, and require that growers plant a minimum of 20 percent of their acreage to non-transgenic varieties in order to reduce the potential for selecting <i>Bt</i>-resistant insect populations. The refuge acres must be planted adjacent to or within the <i>Bt</i> crop. Details on the specific design and requirements of individual IRM programs are published by the relevant regulatory authority.</p>
