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

<p style="text-align: justify;">MON 88913 cotton was field tested at several locations in the United States and Puerto Rico from 2000 to 2003. Several of these trials were conducted to evaluate glyphosate tolerance under a range of environmental conditions. In 2002, fourteen trials were conducted to evaluate possible unintended effects from the transformation process and subsequent tissue culture. MON 88913 was evaluated for phenotypic characteristics relating to vegetative and reproductive growth and development, seed dormancy, germination and emergence, plant maturity, boll and seed yield, fibre quality, and plant interaction with diseases and insects. Comparisons were made between the MON 88913, a null segregant (non-trangenic counterpart) of this line [MON 88913 (-)] that did not contain the <i>cp4 epsps</i> genes, and conventional cotton varieties.</p>

<p style="text-align: justify;">There were no significant differences among MON 88913 and its null counterpart for most of the measured growth and reproductive parameters, seed dormancy, germination and emergence, boll and seed yield, and fibre quality. The observed significant differences in these parameters were small, and were attributed to location rather than phenotype. Susceptibility to diseases and insects was qualitatively assessed during the field trials. Assessments were made for insects commonly found in cotton fields such as aphids, beet armyworm, cotton bollworm and thrips, and diseases such as boll rot, <i>Pythium</i> and <i>Verticillium</i>. Generally, there were no observed differences in susceptibilities to diseases and insects across locations and years. Results from these field trials demonstrate that the growth, agronomic performance, and disease and insect susceptibility of MON 88913 are similar to that of conventional cotton. MON 88913 is therefore not expected to become a plant pest risk, neither in terms of weediness, nor in becoming a more suitable host for plant diseases and insects.</p>

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

<p style="text-align: justify;">Cotton (<i>G. hirsutum</i>) is mainly a self-pollinating plant, but pollen is also routinely transferred by insects, particularly bumblebees and honey bees. The pollen is heavy and sticky and the range of natural crossing is limited. Outcrossing rates of up to 28% to other cotton cultivars grown directly adjacent to the pollen source have been observed under field conditions when sufficient insect pollinators have been present. The rate of outcrossing declines rapidly with increased distance from the pollen source. Results of outcrossing research trials in the United States have shown that pollen movement decreases rapidly at 12 metres from the pollen source. Nevertheless, certified seed cotton growers in the United States must maintain an isolation distance of 202 metres between fields. If MON 88913 was to be grown in proximity with other cotton cultivars, and sufficient insect pollinators were present and active, the <i>cp4 epsps</i> genes could possibly introgress into these cultivars. In the event of the formation of hybrids, there would no competitive advantage conferred on any hybrid progeny in the absence of glyphosate applications.</p>

<p style="text-align: justify;">In the United States, species genetically compatible cultivated cotton are <i>G. barbadense</i> (cultivated Pima cotton), and <i>G. tomentosum</i>. Outcrossing from <i>G. hirsutum</i> to <i>G. barbadense</i> is possible under suitable conditions, such as the presence of pollinators. <i>G. thurberi</i> is another wild species found in the United States, but it is genetically incompatible with <i>G. hirsutum</i>. <i>G. hirsutum</i> and <i>G. tomentosum</i> are genetically compatible (both possess the AADD genome); however, it is generally thought that gene transfer is unlikely due to the non-synchronous flowering periods (day for <i>G. hirsutum</i> and night for <i>G. tomentosum</i>), and lack of common pollinators. Preliminary results of research on <i>G. tomentosum</i> populations in Hawaii have shown that flowering occurs during the day and that bees and other hymenopterans were observed as pollinators. However, no evidence has yet been found in nature of crosses between cultivated cotton and <i>G. tomentosum</i>. Populations of wild <i>Gossypium</i> species occur in southern Florida (<i>G. hirsutum</i>), Hawaii (<i>G. tomentosum</i>), Puerto Rico and the U.S. Virgin Islands. In other cotton growing areas of the world, species that could intercross with <i>G. hirsutum</i> include <i>G. mustelinum</i> in Brazil, and <i>G. lanceolatum</i> in Mexico.</p>

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

<p style="text-align: justify;">Cultivated <i>Gossypium hirsutum</i> is not typically considered a weed species in the United States or other countries, but it is listed as a potential weed in southern Florida. Although the cotton plant is cultivated as an annual crop, it behaves as a perennial plant in undisturbed environments and suitable climatic conditions. Cotton does not tolerate cold conditions thereby limiting its overwintering potential to southern Florida, Hawaii, and Puerto Rico.</p>

<p style="text-align: justify;">Seed dormancy and germination are characteristics used to assess the weediness of plants. These characteristics were measured in MON 88913, its null counterpart and six conventional cotton cultivars. Generally, no significant differences were observed in the amount of hard seed, a seed dormancy characteristic, between MON 88913 and its null counterpart. There were some significant differences observed in seed germination, where MON 88913 displayed reduced germination compared to its counterpart. These differences were small, as were differences in the percentage of viable swollen seed, and were within the range displayed by conventional cultivars. Compared to its null counterpart and conventional cotton, MON 88913 is not expected to become weedy or invasive of natural habitats since the characteristics associated with weediness, such as seed dormancy, germination, as well as flowering, flower morphology, maturity and seed yield were not significantly altered compared to conventional cotton. No other competitive advantage was conferred to MON 88913, other than tolerance to glyphosate.</p>

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

<p style="text-align: justify;">The impact of the novel CP4 EPSPS protein in MON 88913 on non-target organisms was not directly assessed. The results of studies on CP4 EPSPS in previously approved glyphosate tolerant crops were used to evaluate the impact of this novel protein in MON 88913. These studies evaluated the effect of CP4 EPSPS on pollinators, soil organisms, and beneficial arthropods. No toxic effects were reported in these studies. Furthermore, results from field trials with MON 88913 demonstrated similar susceptibilities to cotton diseases and insect pests, compared to conventional cotton. Levels of natural toxicants (gossypol, cyclopropenoid fatty acids and aflatoxins) were quantitatively determined and compared to the null counterparts and commercial varieties. Other than significant differences in the levels of two cyclopropenoid fatty acids at one location, the levels of these toxicants among MON 88913, the null counterpart, and conventional cotton were not significantly different.</p>

<p style="text-align: justify;">Expression levels of CP4 EPSPS in MON 88913 were substantially higher than in previously approved glyphosate tolerant crops. Nevertheless, the results of previous environmental safety studies with CP4 EPSPS and field trials of MON 88913 do not indicate any increased risk to interacting organisms due to higher levels of this protein. Since the levels of natural toxicants were also not altered in MON 88913, the risk to interacting organisms is similar to conventional cotton.</p>

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

<p style="text-align: justify;">MON 88913 cotton did not exhibit any novel phenotypic characteristics that would increase its survival in either unmanaged habitats, or in areas outside of the current geographical range of cotton production. Since the potential of gene transfer to wild relatives in the United States is quite minimal, the risk of transferring the glyphosate tolerance trait to species in unmanaged habitats is insignificant. In countries (<i>e.g.</i>, Brazil, Mexico) where hybrids could form with wild relatives of cotton, the introgression of the glyphosate tolerance trait into these wild species would confer no advantage in the absence of glyphosate applications.</p>
