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

<p style="text-align: justify;">The agronomic and compositional characteristics of EH92-527-1 were compared with those of the parental cultivar Prevalent in field trials carried out over multiple growing seasons in multiple locations in Sweden. Trial site locations were representative of the typical areas for cultivation of conventional starch potatoes. Data on agronomic characteristics were obtained from field trials during 1994-1996 and variety trials during 1996-1997. Compositional data were obtained from field trials during 1996-1998. No significant differences in growth characteristics between EH92-527-1 and Prevalent were observed nor were there any differences in susceptibility to herbicide, late blight fungal disease, and frost. Additionally, EH92-527-1 did not display altered susceptibility to insects, bacteria, other fungi, nematodes, and plant viruses.</p>

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

<p style="text-align: justify;">Potato is largely propagated vegetatively via tubers, but certain varieties can also form seeds. With regard to plant-to-plant gene transfer, the natural exchange of genetic material is only possible with other varieties of <i>Solanum tuberosum</i>. No natural genetic exchange has been detected with the potato&#39;s wild relatives in Europe, i.e., <i>Solanum nigrum</i> (deadly nightshade) and <i>Solanum ducamara</i> (woody nightshade). Efficient incompatibility barriers prevent hybridization between these species and <i>Solanum tuberosum</i>. Therefore, the chances of successful hybridization between transformed potatoes and other Solanum species under field conditions are considered extremely remote.</p>

<p style="text-align: justify;">Any genetic spread is assessed as limited to cross-pollination with other potatoes. However, no changes in flower morphology have been observed for EH92-527-1 that could indicate a change in the ability to produce and release pollen. Therefore, no changes compared to conventional starch potatotes concerning the transfer of genetic material to other potato varieties is expected. The pollen production of flowers of EH92-527-1 is low and most of the flowers are shed before the pollen is ready. EH92-527-1 and Prevalent abort most flowers prematurely, and the stamen produce almost no pollen. This makes the probability of dispersal through pollen very low. Because the chance of any successful transfer is considered to be remote and would convey no selective advantage to any hybrid, the potential risk is considered to be extremely low. Therefore, the plant-to-plant gene transfer of the nptII and the antisense gbss genes is considered unlikely to be of environmental concern. Outside arable land, potato has a very low competitivelness, particularly in northern Europe, where the EH92-527-1 potatoes are intended to be cultivated.</p>

<p style="text-align: justify;">With respect to plant-to-bacteria gene transfer, potato EH92-527-1 contains an nptII gene for kanamycin resistance that could theoretically be transferred from plant material to microbes in the soil. However, it is likely that cell DNA will be degraded by autolysis in any plant material left in the soil. Secondly, kanamycin resistance already occurs naturally in soil bacteria. Consequently, any additional contribution from potential transfer of nptII to soil microbes is considered insignificant.</p>

<p style="text-align: justify;">Furthermore, studies show that a very large degree of homology is required between the plant&#39;s and the bacteria&#39;s DNA in order for horizontal gene transfer to take place at all in targeted studies. Under natural conditions, several other factors become important and these factors further limit the possibility for horizontal gene transfer that would result in a population of resistant bacteria. These factors include the absence of prokaryotic regulation sequences linked to <i>nptII</i> in the genetic construct in question and the need for selection pressure at the time of the gene transfer.<br />
In addition, gene transfer of the antisense gbss construct is not considered to pose an environmental risk. Furthermore, as demonstrated by Southern analysis, no genetic elements outside of the right and left border region of the T-DNA in construct pHoxwG that could affect the mobility of DNA have been inserted into potato event EH92-527-1. Therefore, no changes as compared to conventional starch potatoes are expected in the ability of EH92-527-1 to transfer genetic material to bacteria.</p>

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

<p style="text-align: justify;">Potato does not compete well outside the cultivated environment, but can survive mild winter temperatures as tubers in soil. The experimental data indicated that potato EH92-527-1 does not differ from its parent cultivar Prevalent with respect to frost tolerance, sensitivity to chemical treatment, and susceptibility to diseases and pests. No evidence was seen of increased competitiveness or over-winter survival that would indicate enhanced weediness or invasiveness of potato EH92-527-1. Outside the field, potato seedlings have difficulty becoming established, as they are at a competitive disadvantage relative to other plants. In general, the potato is not known as a colonizer of unmanaged ecosystems. It is not able to compete effectively with other species such as grasses, trees, and shrubs.<br />
The potato&#39;s low competitiveness outside arable land is especially true in northern Europe where EH92-527-1 is planned to be grown. EG92-527-1 and Prevalent can be assumed to have even less long-term competitive ability, because they shed most flowers prematurely and produce very little pollen. In order for the potato to establish itself and spread outside the field in northern Europe, its competitive ability would have to increase significantly.</p>

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

<p style="text-align: justify;">Data from field studies conducted in Sweden, Germany, and the Netherlands showed neither greater susceptibility nor greater resistance to pests (e.g., aphids, leafhoppers, potato cyst nematodes (sp. Globodera) and diseases (e.g., late blight (<i>Phytophthora infestans</i>), potato early blight (<i>Alternaria solani</i>), Erwinia rots) in potato EH92-527-1 versus non-GM potato lines. In addition, there was no evidence of changes in sensitivity to the plant-associated viruses PVY, PLRV, PMTV, and TRV.</p>

<p style="text-align: justify;">It is believed that altered starch composition may have an effect on certain microorganisms, and that increased sugar content and reduced glycoalkaloid content might result in pests (e.g., insects) attacking the potato to a larger extent. However, several years of field trials on large areas under production conditions have not indicated any such differences. Furthermore, the levels of these substances are within the variation for conventional potatoes.<br />
Also, the antibiotics resistance and the increased amounts of vitamin C content should not be able to affect non-target organisms.</p>

<p style="text-align: justify;">While, theoretically, event EH92-527-1 could have effects on other organisms if it were to establish itself within natural plant populations, the parent cultivar Prevalent, which has not shown spreading ability significantly different from that of EH92-527-1, has not been able to establish itself outside arable land. In addition, factors that provide for low competitive ability in the long term are that both Prevantent and EH92-527-1 shed most of their flowers prematurely, and produce almost no pollen.</p>

<p style="text-align: justify;">In view of these results and the equivalent composition of the GM potato plant, it is considered that no adverse effects on plant-associated organisms would be expected from cultivation of the potato EH92-527-1. Furthermore, due to the nature of the modified trait and to the equivalence of the agronomic traits of the GM potato relative to those of the non-GM parental line, it is considered that no adverse effects on the abiotic environment would be likely from cultivation of EH92-527-1.</p>

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

<p style="text-align: justify;">EH92-527-1 will be grown in the same regions of Europe in which starch potatoes are presently grown and it will be farmed using identical techniques. The demonstrated equivalency of the EH92-527-1 event to the parental variety Prevalent suggests that the growing of EH92-527-1 represents no greater risks to biodiversity than does the parental variety or do other starch potatoes. As noted earlier, cultivated starch potatoes do not grow well outside of the immediate cultivated area. Pollen movement from EH92-527-1 is like that of the parental variety and moves only very short distances, if at all. Considering this, together with the equivalency of EH92-527-1 to the parental variety, the effects on biodiversity in other habitats should be no different from those of other starch potatoes. In particular, both the starch component amylopectin and the NPTII protein have a safe history of use and do not engender any alteration in the interactions with the biotic environment as compared to the parental cultivar Prevalent.</p>
