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

<p style="text-align: justify;">H7-1 was field tested in the United States from 1998 to 2002, and in Europe (France and Germany) in 1998-99. In addition to evaluation in different environments, H7-1 was also evaluated in different genetic backgrounds that represented regionally adapted cultivars. Field trial evaluations included agronomic performance, disease and insect resistance, leaf morphology, seed germination and dormancy, bolting, flowering onset and seed harvest date. In most field trials, H7-1 was compared to a control that represented a nearly equivalent genotype. No significant differences were observed in any of these characteristics between H7-1 and the non-transgenic controls.</p>

<p style="text-align: justify;">In only 6 out of 98 trials conducted in the United States were significant differences in disease and insect susceptibilities observed between H7-1 and the control and conventional cultivars. No differences were observed in the European trials. Some of these differences represented increased susceptibility, while others represented a decrease compared to the controls. Since there were no trends associated with these differences for H7-1, these were likely due to interactions between environment and genotype, rather than with the novel protein in H7-1.</p>

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

<p style="text-align: justify;">Sugar beet is an outcrossing species, and is mainly wind pollinated. It is a biennial, developing a rosette of leaves and a large taproot in the first year, and bolting (<i>i.e.</i>, developing an inflorescence bearing stem) in the second year. Bolting is induced only after the plant has undergone vernalization at the end of the first season. In exceptional circumstances, bolting may be induced in the first year by low temperatures and longer daylength (<i>e.g.</i>, by growing a cultivar outside of its adapted area). Large amounts of pollen are produced during the reproductive phase; this pollen can be wind-borne over long distances.</p>

<p style="text-align: justify;">The genus <i>Beta</i> is comprised of four sections: i) Beta, to which sugar beet belongs; ii) Corollinae; iii) Nanae; and iv) Procumbentes. All species within the Beta section (<i>B. vulgaris</i> ssp. <i>maritima</i>, <i>B. macrocarpa</i>) are sexually cross-compatible and produce fertile progeny. Hybrids between sugar beet and members of the other sections do not occur naturally, and cross-breeding with other members of the Chenopodiaceae is unlikely. Assuming proximity, synchronicity of flowering, and suitable conditions sugar beet may freely hybridize with the botanical varieties within the <i>vulgaris</i> subspecies.</p>

<p style="text-align: justify;">Wild relatives that are sexually compatible with sugar beet exist in parts of Europe, Asia, and Central and South America. Hybrids resulting from crosses between cultivated sugar beets and <i>B. macrocarpa</i>, and those with <i>B. vulgaris</i> ssp. <i>maritima</i> have been reported in Europe. The potential therefore exists for introgression of the glyphosate tolerance trait from H7-1 into these wild relatives. In North America, concerns have been raised about potential outcrossing with populations of <i>B. macrocarpa</i> in the Imperial Valley of California. Studies have indicated the introgression of genes from commercial sugar beets, although other reports show that gene flow between these two populations is not likely due to non-synchronous flowering and the production of sterile F1 hybrids. Sugar beet plants have escaped from past commercial cultivation in the San Francisco Bay area and persist to this day. However, introgression of the glyphosate tolerance trait into these plants is highly unlikely as sugar beets are no longer in commercial production in that area.</p>

<p style="text-align: justify;">As with conventional sugar beet cultivars, H7-1 plants are harvested prior to the initiation of the bolting phase. Since sugar beets are usually not allowed to bolt, except in fields or plots grown for seed production, there is little opportunity for uncontrolled pollen flow. Sugar beets grown for seed production are also spatially isolated from other sugar beet fields to minimize pollen flow. Since the cultivation practices for H7-1 sugar beet are identical to those for conventional sugar beet varieties, the potential for outcrossing would only exist when H7-1 is grown for seed production.</p>

<p style="text-align: justify;">Glyphosate-tolerant hybrids resulting from the introgression of the transgene from H7-1 to commercial sugar beet cultivars, or compatible wild relatives, would possess no other competitive advantage than herbicide tolerance. This advantage would only be expressed in managed ecosystems, such as cultivated fields. Glyphosate-tolerant hybrids could be managed with conventional weed control practices, including herbicides other than glyphosate.<br />
<br />
<b>Weediness Potential</b></p>

<p style="text-align: justify;">Sugar beet plants are not a serious weed, although sugar beets have escaped cultivation and their progeny have persisted in the environment for many years. Sugar beets may also volunteer in fields the year following cultivation. Volunteers may also arise from the presence of wild beet, the bolting of beet plants, the development of groundkeepers which arise initially form vegetative growth of beet crowns or tops left after harvest or the germination of seed (which may be dormant in soil for up to 10 years). Volunteer plants may be controlled by mechanical means or by the use of herbicides registered for use on sugar beet volunteers.</p>

<p style="text-align: justify;">Field trials were conducted to address concerns that H7-1 sugar beet might become weedier, compared to conventional sugar beet cultivars. H7-1 and its control lines were evaluated for plant growth and reproductive characteristics related to persistence and competitiveness. Results from these trials revealed no significant differences between H7-1 and the control lines, for characteristics such as plant vigour, bolting, seedling emergence, seed germination, and seed dormancy. Based on these results, H7-1 is not expected to become weedier, nor is it expected to become invasive of natural habitats, compared to conventional sugar beet cultivars.</p>

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

<p style="text-align: justify;">The herbicide-tolerance trait in H7-1 sugar beet is conferred by the novel protein CP4 EPSPS, an enzyme originally isolated from the soil bacterium <i>Agrobacterium</i> sp. strain CP4. The novel form of this enzyme is similar to that naturally found in plants, bacteria and fungi. The lack of toxicity of CP4 EPSPS has been substantiated in previous regulatory approvals of glyphosate-tolerant plants, and its high substrate specificity makes it unlikely to metabolize any other endogenous substances to produce toxic compounds. The cultivation of H7-1 sugar beet would therefore not be expected to result in deleterious effects on non-target and beneficial organisms that would be attributed to the novel protein. This was also supported by field trial observations that revealed no negative effects from the cultivation of H7-1 on honeybees and earthworms, compared to conventional sugar beet cultivars.</p>

<p style="text-align: justify;">Results from field trials to evaluate disease and insect susceptibilities demonstrated generally that H7-1 was not more susceptible than conventional sugar beet cultivars. H7-1 would therefore not be expected to become a host for plant pathogens, or insect pest, any more than conventional sugar beet cultivars.</p>

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

<p style="text-align: justify;">H7-1 sugar beet did not exhibit any novel characteristics that would increase its weediness, or cause it to become an invasive species, compared to conventional sugar beet. The expression of the novel protein (CP4 EPSPS) in H7-1 has not been observed to negatively impact non-target or beneficial organisms. While the potential for gene transfer from H7-1 to cultivated sugar beet is possible, the transfer of the herbicide tolerance trait to wild relatives in the United States is insignificant. However, this is not the case in other areas, such as Europe, where wild relatives of sugar beet exist. The introgression of the glyphosate tolerance trait into wild relatives such as <i>B. vulgaris</i> ssp. <i>maritima</i> (sea beet) is therefore possible.</p>
