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

<p style="text-align: justify;">MON802 maize has been field tested since 1993 in the major maize growing regions of the United States and Puerto Rico, as well as in Canada (1995, 1996), Chile, Argentina, France, Italy, South Africa, and Costa Rica. The studies demonstrated that MON802 maize retained the agronomic characteristics of the parental line. The transgenic line provided significant protection from feeding damage from ECB throughout the season, while some protection was noted from Southwestern corn borer (<i>Diatraea grandiosella</i>) and corn earworm (<i>Heliothis zea</i>). 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 MON802 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 MON802, pollen dispersal by wind and outcrossing frequency should be no different than for other maize varieties. Gene exchange between MON802 and other cultivated maize varieties will be similar to that which occurs naturally between cultivated maize varieties at the present time. In the United States and Canada, 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. However, none of the sexually compatible relatives of maize in the U.S. are considered to be weeds in the U.S., therefore it is unlikely that introgression of the CP4 EPSPS gene would provide a selective advantage to these populations as they would not be routinely subject to herbicide treatments.</p>

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

<p style="text-align: justify;">No competitive advantage was conferred to MON802, other than that conferred by resistance to ECB and tolerance to glyphosate herbicide, which 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 that are not based on glyphosate. <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;">MON802 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 very selective for lepidopteran insects. Dietary toxicity studies on the effect of the microbial B.t.k. protein on non-target insects, including pollinators (honeybees), predaceous insects (green lacewing larvae, ladybird beetles) and parasitic Hymenoptera demonstrated that there was no discernible effect at approximately 10 times the usual LC50 dose for a target insect. Furthermore, MON802 will not impact on threatened or endangered lepidopteran species, as none are listed which feed on maize plants in the United States or Canada. In addition, these organisms are also not expected to be affected by the CP4 EPSPS or <i>gox</i> gene products.</p>

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

<p style="text-align: justify;">MON802 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 the United States and Canada is remote, it was determined that the risk of transferring genetic traits from MON802 maize to species in unmanaged environments was not significant.</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 MON802 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>

<p style="text-align: justify;">MON802 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, since the primary target for most of these applications has been the coleopteran, corn rootworm. MON802 maize may positively impact current agricultural practices used for insect control by 1) offering an alternative method for control of ECB (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>

<p style="text-align: justify;">Consideration was given as to whether the introduction of crops tolerant to glyphosate would result in a significant increase in the use of the herbicide, and lead to the evolution of glyphosate resistant weeds. It was determined that the risk of increasing the selection of glyphosate tolerant weeds was low and could be mitigated through the use of other approved herbicides with a mode of action dissimilar to glyphosate. It was concluded that there was unlikely to be any significant adverse impact on agricultural practices associated with the use of the MON802 maize line.</p>
