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

<p style="text-align: justify;">These transgenic potato lines were field tested in the United States and Canada, and their agronomic characteristics were shown to be within the range of values displayed by conventional Russet Burbank. Susceptibilities to diseases such as PVY, early blight, late blight and verticillium were unchanged. Colorado potato beetle, the target insect, was controlled in test plots throughout the growing season. Field trial reports demonstrated that these potatoes did not exhibit weedy characteristics, and had no effect on nontarget organisms or the general environment.</p>

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

<p style="text-align: justify;">In general, the natural exchange of genetic material from transgenic potato is only possible with other varieties of potato (<i>Solanum tuberosum</i>). Since the reproductive characteristics of these transgenic potatoes were unchanged by the genetic modification, they should be no different than the parent cultivar &#39;Russet Burbank&#39;. The chances for successful hybridization between bioengineered potato lines and most wild relatives is extremely unlikely, as potatoes (<i>Solanum tuberosum</i>) are unsuccessful in forming natural hybrids with the native or introduced weeds of Solanum species that do not bear tubers. In Canada there are no tuber producing wild relatives of Solanum. In the United States, tuber-bearing Solanum species include <i>S. jamesii</i>, <i>S. fendleri</i>, and <i>S. pinnatisectum</i>. However, the possibility of gene introgression is excluded due to constraints of geographical isolation and other biological barriers to natural hybridization. No natural hybrids have been observed between these species and cultivated potatoes. It was concluded that CPB and PLRV resistance were unlikely to increase weediness characteristics and that should CPB and PVY resistance genes be capable of introgression into wild species, the traits would be unlikely to provide a selective advantage sufficient to enable these hybrids to become serious weeds.</p>

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

<p style="text-align: justify;">Studies demonstrated that Cry3A protein was not toxic to non-target organisms represented by larval and adult honeybee, ladybird beetle, green lacewing, parasitic wasp, Collembola sp., earthworm, mice and bobwhite quail. It was concluded that the genes inserted into these transgenic potato lines would not result in any deleterious effects or significant impacts on nontarget organisms, including threatened and endangered species or beneficial organisms.</p>

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

<p style="text-align: justify;">These potato lines have no novel phenotypic characteristics that would extend their use beyond the current geographic range of potato production. Since there is no occurrence of wild relatives of potato in Canada or the United States, there will be no transfer of novel traits to these species in unmanaged environments.</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 the potato lines described here, and require that growers plant a certain percentage of their acreage with 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>
