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

<p style="text-align: justify;">Maize event MON88017 was field tested in Canada in 2003, and in the United States in 2001, 2002 and 2003. Agronomic characteristics of hybrids derived from MON88017 such as seed dormancy, vegetative vigour, early stand establishment, time to maturity, flowering period, susceptibilities to various pests and pathogens, and seed production were compared to those of unmodified counterparts. Nutritional components of MON88017, such as proximates, amino acids and fatty acids were compared with those of unmodified counterparts.</p>

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

<p style="text-align: justify;">Pollen production and viability were unchanged by the genetic modification resulting in MON88017, therefore pollen dispersal by wind and outcrossing frequency should be no different than for other maize varieties. Gene exchange between MON88017 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 no plant species closely-related to maize in the wild, the risk of gene flow to other species appears remote. Feral species in the United States related to corn cannot be pollinated due to differences in chromosome number, phenology (periodicity or timing of events within an organism&rsquo;s life cycle as related to climate, <i>e.g</i>., flowering time) and habitat.</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 and are not present in the United States, except for special plantings. <i>Tripsacum</i>, another genus related to <i>Zea</i>, contains sixteen species, of which twelve are native to Mexico and Guatemala. Three species of <i>Tripsacum</i> have been reported in the continental United States: <i>T. dactyloides</i>, <i>T. floridanum</i> and <i>T. lanceolatum</i>. Of these, <i>T. dactyloides</i>, Eastern Gama Grass, is the only species of widespread occurrence and of any agricultural importance. It is commonly grown as a forage grass and has been the subject of some agronomic improvement (i.e., selection and classical breeding). <i>T. floridanum</i> is known from southern Florida and <i>T. lanceolatum</i> is present in the Mule Mountains of Arizona and possibly southern New Mexico. Even though some <i>Tripsacum</i> species occur in areas where maize is cultivated, gene introgression from maize under natural conditions is highly unlikely, if not impossible. Hybrids of <i>Tripsacum</i> species with <i>Zea mays</i> are difficult to obtain outside of the controlled conditions of laboratory and greenhouse. Seed obtained from such crosses are often sterile or progeny have greatly reduced fertility.</p>

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

<p style="text-align: justify;">The history and biology of maize indicates that non-transgenic plants of this species are not invasive in unmanaged habitats. Maize does not possess the potential to become weedy due to traits such as lack of seed dormancy, the non-shattering nature of corn cobs, and the poor competitive ability of seedlings. The data generated from field trials shows that MON88017 and derived hybrids are similar to their counterparts in this respect. Data submitted by the developer on the reproductive and survival biology of hybrids derived from MON88017 determined that early stand establishment, flowering period, vegetative vigor, time to maturity and seed production were within the normal range of expression of these traits currently displayed by commercial hybrids. No competitive advantage was conferred to MON88017, other than that conferred by resistance to rootworm and tolerance to glyphosate herbicide. These traits were demonstrated not to render maize weedy or invasive of natural habitats since none of the reproductive or growth characteristics were modified. The above considerations lead to the conclusion that MON88017 has no altered weed or invasive potential compared to currently commercialized corn.</p>

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

<p style="text-align: justify;">The agronomic characteristics of MON88017 hybrids were shown to be within the range of values displayed by currently commercialized maize hybrids, and indicate that the growing habit of maize will not be inadvertently altered by cultivation of MON88017. Field observations did not indicate modifications of disease and pest susceptibilities, other than to rootworm, which is not known to be a principal factor restricting the establishment or distribution of maize.<br />
Some of the genetic elements introduced into MON88017 were derived from known plant pathogens, but in all cases the genes responsible for the pathogenic qualities of the pathogen were not introduced. Therefore, the introduction of genetic material for <i>Diabotica spp.</i> resistance and glyphosate tolerance would not be expected to result in MON88017 expressing novel pathogenic characteristics.</p>

<p style="text-align: justify;">The history of use and literature suggest that the bacterial Cry3Bb1 toxins are not toxic to humans, other vertebrates, and non-coleopteran invertebrates. This protein is active only against specific coleopteran insects. Data from dietary toxicity and field studies on the effect of the Cry3Bb1 protein on non-target organisms supported the environmental safety assessment of corn event MON863. In all cases, MON863 corn was demonstrated to be safe to non-target organisms. Given that MON88017 Cry3Bb1 protein differs from the MON863 CryBb1 protein by a single amino-acid, that both proteins were demonstrated to be equivalent in terms of insecticidal activity against susceptible pest insects and that the levels of Cry3Bb1 expression in both lines are similar, MON88017 is expected to be safe to previously assayed non-target organisms. The Cry3Bb1 protein expressed in MON88017 was also demonstrated to be safe to mammals.</p>

<p style="text-align: justify;">The impact of CP4 EPSPS protein on non-target organisms, including humans, has been thoroughly assessed in previous applications for environmental safety assessments of CP4 EPSPS-expressing crops. The CP4 EPSPS protein expressed in MON88017 tissues is the same or is &gt; 99% identical to CP4 EPSPS proteins produced in glyphosate-tolerant crops with a history of safe use. The environmental and feed safety of the CP4 EPSPS protein in corn has been previously established with, for example, the regulatory approval of NK603.</p>

<p style="text-align: justify;">Non-transgenic maize is known to produce low levels of anti-nutrients such as raffinose and phytic acid, and the levels of these compounds in MON88017 were demonstrated to be equivalent to levels found in control lines. Therefore the genetic modification did not alter the expression of endogenous anti-nutritional factors.</p>

<p style="text-align: justify;">Based on this data, it was determined that the unconfined release of MON88017 will not result in altered impacts when compared with currently commercialized corn on interacting organisms, including humans, with the exception of specific coleopteran pest species.</p>

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

<p style="text-align: justify;">MON88017 has no novel phenotypic characteristics which would extend its use beyond the current geographic range of maize production. Since maize does not out-cross to wild relatives in the united States or Canada, there will be no transfer of novel traits to unmanaged environments. In addition the novel traits were determined to pose minimal risks to non-target organisms.</p>

<p style="text-align: justify;">MON88017 provides an alternative method to existing methods of control of rootworms, an important agricultural pest of maize. The control of agricultural pest species is a common practice that is not restricted to the environmental release of transgenic plants. Therefore, the reduction in local pest species as a result of the cultivation of MON88017 does not present a significant change from existing agricultural practices.</p>

<p style="text-align: justify;">At present, the use of chemical insecticides to control rootworm is permitted, although crop rotation represents a major method of rootworm control ins some countries.</p>

<p style="text-align: justify;">MON88017 also provides an alternative method of weed control in corn production. The use of broad spectrum herbicides has the intended effect of reducing local weed populations within agricultural fields and this may reduce local weed species biodiversity, and possibly other trophic levels which utilize these weed species. It must be noted, however, that reduction in weed biodiversity in agricultural fields is not unique to the use of transgenic plants, and is a common practice in virtually all modern agricultural systems. It was therefore concluded that MON88017 does not present a significantly altered impact on biodiversity in comparison to maize varieties currently being grown.</p>
