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## Plant Pest Risk Assessment for Event H7-1 Sugar Beet

Monsanto Company (St. Louis, MO) and KWS SAAT AG (Einbeck, Germany), petitioned APHIS (APHIS number 03-323-01p) for a determina tion that genetically e ngineered (GE) sugar beet ( Beta vulgaris L. ssp. vulgaris ) event H7-1 is unlikely to pos e a plant pest risk (Monsanto and KWS SAAT AG 2004) and, therefore, should no longer be a regulated article under APHIS’ 7 Code of Federal Regulations (CFR) part 340. APHIS administ ers 7 CFR part 340 under the authority of the plant pest provisions of the Plant Protection Act of 2000 1 . This plant pest risk assessment was conducted to determine if H7-1 is unlikely to pose a plant pest risk.

The initial request was received from Monsan to and KWS SAAT AG in 2003. Upon completing a Plant Pest Risk Assessment, an Environmental Assessment (EA) and issuing a Finding of No Significant Impact (FONSI) (70 FR 13007-13008, Do cket No. 04-075-2), APHIS advised the public of its determination, e ffective March 4, 2005, that th e Monsanto and KWS SAAT AG (2004) sugar beet event H7-1 did not pose a plant pest risk and therefore was no longer considered a regulated article under APHIS regulat ions in 7 CFR part 340. A complaint was filed in January, 2008, challenging APHIS’ decision to grant nonregulated status to event H7-1. On September 21, 2009, the US District Court for the Northern District of California ruled that APHIS should have prepared an Environmental Impact Statement before making a decision to grant nonregulated stat us to event H7-1 ( Center for Food Safety et al. vs. Thomas Vilsack et al. ). On August 13, 2010, the Court vacated APHIS’s deci sion to grant nonregulated status to the event H7-1 sugar beet varieties making them su bject to the Plant Prot ection Act of 2000 (PPA) and 7 CFR part 340 once again, and remanded the matter back to the ag ency to determine regulatory actions, if any, that should be impos ed upon event H7-1 until the completion of the EIS and a new decision could be made by APHIS as to whether it would be appropriate to grant full nonregulated status to event H7-1.

APHIS received a supplemental request from Monsanto and KWS SAAT AG (2010) to amend the petition for non-regulated status submitted in 2003 (Petition 03-323-01p) pursuant to the regulatory scheme of 7 CFR pa rt 340 (Reding 2010). These peti tioners requested that APHIS grant “partial deregulation” or similar administra tive action to authorize th e continued cultivation of event H7-1 subject to the interim measures proposed by APHI S in the lawsuit challenging its 2005 determination of non-regulated status of event H7-1. On February 8, 2011, APHIS advised the public of its decision to “p artially deregulate” event H7-1 s ugar beets as an interim action until the court-ordered EIS was completed. That “p artial deregulation” described a system in which root crop production of event H7-1 sugar beets could occur under a Compliance Agreement with USDA/APHIS and growing of ev ent H7-1 for seed production could occur under APHIS’ permitting system. The conditions under which commercial H7-1 root production

is carried out are enforceable under the mandatory compliance agreements. A Plant Pest Risk

1 Section 403 (14) of the Plant Protection Act (7USC Sec 7702(14) defi nes plant pest as: “Plant Pest - The term “plant pest” mean s any living stage of any of the following that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant p roduct: (A) A protozoan. (B) A nonhuman animal. (C) A parasitic plant. (D) A b acterium. (E) A fungus. (F) A viru s or viroid. (G) An infectiou s agent or other pathogen. (H) Any article similar to or allied with any of the articles specified in the preceding subparagraphs.”2 Assessment for root production was prepared to c onsider the plant pest ri sk potential of H7-1 sugar beet root crop under the c onditions of the interim action.

H7-1 was grown in the U.S. under APHIS pe rmits or notifications from 1998 through 2005. From 2005 to 2010, H7-1 was grown widely with out APHIS regulatory restrictions. Since February 2011, H7-1 sugar beets have been grown commercially for root production under APHIS-mandated compliance agreements and fo r seed production under APHIS issued permits.

This Plant Pest Risk Assessment was conducted to determine whether sugar beet event H7-1 is unlikely to pose a plant pest risk under full deregulation.

Sugar beet line H7-1 was produced by transf ormation of a sugar beet line (3S0057) with Agrobacterium tumefaciens. Because A. tumefaciens is a plant pest and so me of the regulatory sequences (figwort mosaic virus promoter) used to facilitate expres sion of the gene and the sequences that code for the protein ( cp4epsps gene from A. tumefaciens ) in sugar beet were derived from plant pests, H7-1 has been consid ered a regulated articl e under APHIS regulations at 7 CFR part 340. Potential impacts to be addr essed in this risk a ssessment are those that pertain to the use of H7-1 and its progeny in the absence of confinement. APHIS utilizes data

and information from current scientific litera ture, in addition to information submitted by the applicant, to determine if H7-1 is unlikely to pos e a plant pest risk. If APHIS determines that a GE organism is not a plant pest, then APHIS has no regulatory authority over that organism. Thus, if APHIS determines that H7-1 sugar beet does not pose a plant pest risk, then H7-1 sugar beet would no longer be subject to the plant pest provisions of the Plant Pr otection Act or to the regulatory requirements of 7 CF R part 340, and therefore, APHI S must grant it non-regulated

status.

Potential impacts analyzed in this Plant Pest Risk Assessment are those that pertain to plant pest risk characteristics. APHIS regulation 7 CFR 34 0.6(c) specifies the information a petitioner must include in a petition for nonregul ated status. APHIS will evaluate information submitted by the applicant related to plant pest risk characteristic s, disease and pest susc eptibilities, expression of the gene product, new enzymes, or changes to plant metabolism, weediness of the regulated article, any impacts on the weedine ss of any other plant with which it can interbreed, and transfer of genetic information to organisms with which it cannot interbreed.

Pursuant to NEPA, the EIS for this petition fo r full deregulation consid ers whether agricultural or cultivation practices associated with H7-1 may result in impacts on the environment. A thorough assessment of H7-1’s effects on the envi ronment including on non-ta rget and beneficial organisms, and threatened and endanger ed species is included in the EIS.

Development of H7-1 Herbicide Tolerant 2 Sugar beet

2 The applicant has described H7-1sugar beet as “herbicide tolerant” and historically APHIS has also referred to GE plants with diminished herbicide sensitivity as “herbicide tolerant”. However, the phenotype would fall under the Weed Science Society of America’s (WSS A) definition of “herbicide resistan ce” since H7-1 has an inherited ability to survive and reproduce following exposure to a dose of herbicide normally lethal to the wild type variety (WSSA 1998). By the WSSA definition, “resistance [to an herb icide] may be naturally occurring or induced by such techniques as genetic engineering or selection of variants produced by tissue culture or mutagenesis.” Herbicide3 Origin of Cultivated Beets

Sugar beets ( Beta vulgaris (L.) ssp. vulgaris ), a member of the genus Beta (Chenopodiaceae), are cultivated worldwide. The species B. vulgaris includes many different crop varieties including sugar beets, fodder beets, Sw iss chard, and table beets. Beta vularis L. spp. maritima (L.) Arcang. wild sea beet, is regard ed as the progenitor of the Beta crop species (fodder beet, sugar beet, Swiss chard and table or red beet) and found widely dist ributed over the Mediterranean

basin and the Near East (OECD 2001).

Plant Description and Fl owering Characteristics

Sugar beet is a biennial species (t ypically will complete its lifecycl e in 2 years) that is grown as an annual for sugar production. Since the root cr op is usually harvested during the first year while still in the vegetative phase, flowers rarely develop. The plant grows as a rosette in its first year and can be quite variable in size (from 1-6 ft. tall). If allo wed to overwinter in a moderate climate, it will “bolt” the second year and produc e a flower stalk and seeds (OECD 2001). Being a biennial, the plant typically flowers dur ing the late spring to summer of the 2 nd year of growth, usually sending up a single unbranched flower st alk. Flowers begin to re lease pollen about 4-6 weeks after the flower stalk emerges and continue to release pollen for an other 2-4 weeks. This biennial plant life cycle of reduced flowering in the first year has been selected for in sugar beets and vegetable beet varieties. Typically the level of bolting in cultivated sugar beet is reduced to 0.01 – 1 percent (Ingram 2000; Darmency 2009; OE CD 2001). However, the presence of the bolting genes and environmental triggers such as day-length, temperature or the amount of cold during the winter may induce flowering during the first year (Boudry 2002; Büttner 2010; Van Dijk 1997).

Sugar beet pollen is mostly carried by wind with insects playing a lesser role (OECD 2001). Exact percentages of outcrossing vary considerab ly at different locations based on numerous environmental conditions. Wind, however, is consider ed to be the primary vector for pollination.

H7-1 is a genetically engineered sugar beet line that was devel oped to increase tolerance to the herbicide glyphosate. Glyphosate was first introduced as an herbic ide under the tr ade name of Roundup ® by Monsanto in 1975. Glyphosate is a syst emic, post-emergence herbicide widely used on both agricultural commodities (food uses ) and non-agriculture sites (Cerdeira 2006).

The management of weeds in conven tional sugar beet fields can be an expensive, labor intensive, and sometimes complicated operation. Often farmers use pre-emergent herbic ides that will stop weed seeds from germinating. However, this requir es application of the pre-emergent herbicides on the entire field because farmers cannot predict where, on their fields, weeds will emerge. With H7-1, growers have the option of applying herbicid e after weeds have germinated and only in the

areas of the field where there are weeds.

tolerance, by the WSSA definition, only applies to plant species with an “inherent ability” to survive and reproduce

after herbicide treatment.4 These sugar beets were genetically engineered to be glyphosate tolerant by inserting a gene (from Agrobacterium sp. strain CP4) that codes for th e enzyme 5-enolpyruvylshikimate-3- phosphate synthase (EPSPS) into the sugar beet genome. This gene, along with its regulatory sequences, was introduced into these sugar beets via an Agrobacterium -mediated transformation protocol. This is a well-charact erized procedure that has been widely used for over two decades for introducing various genes di rectly into plant genomes.

APHIS authorized the first fi eld testing of these sugar beets from 1998 through 2002. Event H7-1 sugar beets have been evaluated extensively to confirm that they exhibit the desired agronomic characteristics and do not present a plant pest risk . The field tests were conducted in agricultural settings under physical and repr oductive confinement conditions.

Description of the Modification

Sugar beet H7-1 was produced by transformation using disarmed Agrobacterium tumefaciens. Sugar beet line 3S0057 (KWS SAAT AG proprieta ry line) cotyledons were infected with A. tumefaciens strain CP4 containing plasmid PV -BVGT08 (Monsanto and KWS SAAT AG 2004, pp. 20-21). This technique using disarmed Agrobacterium followed by selection (Howard 1990) has a history of use and has been used for transf ormation of a variety of plant tissues for over 20 years. Plants containing the introduced DNA were selected base d on growth in the presence of glyphosate.

The plasmid PV-BVGT08 contains a single expression cassette fl anked by the right and left border sequences from the Agrobacterium Ti plasmid (Monsanto and KWS SAAT AG 2004, p. 23). Data supplied in the petition (Monsan to and KWS SAAT AG 2004, pp. 29-47) support the conclusion that event H7-1 contains the following sequences:

5-enolpyruvylshikimate-3- phosphate synthase (EPSPS)

 The 35S gene promoter from a figwort mosaic virus (Gowda 1989; Sanger 1990) is constitutively active in plants (Sheperd 1987; Richins 1987; Gowda 1989; Sanger 1990).

 The ctp2 N-terminal chloroplast transit peptide (CTP) sequence from the Arabidopsis

thaliana cp4 epsps coding region (Timko 1988) that target s the protein to the chloroplast.

 The cp4 epsps gene from Agrobacterium sp. strain CP4 (Padgette 1995) has been sequenced and encodes a 47.6 kDa protein c onsisting of a single polypeptide of 455 amino acids (Padgette 1996).

 3’ untranslated region (trans criptional terminator and pol yadenylation site) of the rbc S E9 gene from Pisum sativum (Coruzzi 1984; Morelli 1985).

Data was provided and reviewed by APHIS that de monstrates stable integration and inheritance

of the cp4 epsps gene and its associated regulatory sequences over se veral breeding generations (Monsanto and KWS SAAT AG 2004). Statistical analyses show that glyphosate tolerance is

inherited as a dominant trait in a typical Mendelian manner.5 Potential for H7-1 to Become Invasive and/or a Weed

In the U.S., Beta vulgaris L. spp. vulgaris

, is not listed as a weed by the Weed Science Society of America (2010) nor is it listed as a noxious w eed species by the U.S. Federal government (7 CFR part 360; http://www.aphis.usda.gov/pl ant_health/plant_pest_info /weeds/downloads/weedlist2010doc.pdf). In order to assess the potential fo r H7-1 to become inva sive and/or a weed, APHIS looked to whether H7-1’s reproductive ch aracteristics and survival biology were any

different from the characteristics of conventional sugar beet varie ties. One measure of a plant’s potential to be invasive is th e potential for the plant to produ ce “volunteers.” Sugar beets possess few of the characteristics of pl ants that are notable of succe ssful weeds (Baker 1965; Keeler 1989). As part of a bilateral agreement between the United States and Canada, USDA/APHIS and the Canadian Food Inspection Agency (CFIA) have generated documents that outline basic data requirements for developers of genetically engineered plants. One of these documents, Appendix II, outlines the environmental characterization data requirements for unconfined releases. These data and the data required in a petition for non-regulated status are designed to inform APHIS of any differences between the characteristics, includ ing growth and seed

characteristics that influence re productive and survival biology of the transgenic plant compared to its non-transgenic counterpart.

Volunteer plants rarely occur in fields planted wi th a sugar beet root crop. This is because bolters in root crop fields are rare a nd generally do not produce seed a nd unharvested roots are incapable of surviving the winters in the Northern suga r beet producing regions and the summers in the Imperial Valley (USDA APHIS, 2011). In fields used to prod uce sugar beet seed, volunteer plants can occur in subsequent years. These plan ts can be controlled by mechanical means or the use of several other registered herbicides besides glyphosate (Crop Protection Chemical Reference 1996).

APHIS assessed whether H7-1 is any more likel y to become a weed than the isogenic nontransgenic sugar beet line. The assessment en compasses a thorough consid eration of the basic biology of sugar beet and an evaluation of th e unique characteristics of H7-1 under field

conditions. Monsanto conducted field trials of H7-1 between 1998 and 2002 at 98 field trial sites in the U.S. (Monsanto and KWS SAAT AG 2004, p. 62) and Europe (Monsanto and KWS SAAT AG 2004, p. 70). APHIS considered data relating to plant vigor, bolting, seedling emergence, seed germination, seed dormancy a nd other characteristics th at might relate to increased weediness (Monsanto and KWS SAAT AG 2004, pp. 70-77). Field trial data indicated

that H7-1 does not exhibit characteristics that would cause it to be weedier than the parental sugar beet line. Additionally, no characteristics rela ting to disease or insect resistance that might

affect weediness were noted that were consistent over all trial locations. H7-1 sugar beet is still susceptible to the typical insect and disease pests of sugar beet.

These results on growth characteristics, seed pr oduction and germination i ndicate that H7-1 is not different from its comparators in these resp ects. There is no indicatio n that H7-1 possesses a selective advantage that would result in increas ed weediness or invasiveness. H7-1 lacks the ability to persist as a troublesome weed, and there would be no significant impact on current6 weed management practices for sugar beet cultiva tion, because alternative methods exist that can be used to kill weeds in the absence of using glyphosate (OECD 2001).

Potential for Gene Flow and Gene Introgression from H7-1 into Sexually Compatible

Relatives

APHIS evaluated the potential for gene introgression to occur from H7-1 to sexually compatible

wild relatives and considered whether such introgression would result in weediness in those resulting hybrids. The centers of origin for Beta vulgaris is generally believed to be in the Mediterranean or Near East region and no Beta species are known to be native to the U.S. (OECD 2001; Panella 2007).

Sugar beet is strongly self-incompatible (parti cularly tetraploid plants ) although self-fertilizing plants exist in nearly ever y population (OECD 2001). Outcross ing is very important in developing hybrid seed every year for commer cial production. The use of cytoplasmic male sterile lines is used extensively for this work.

Distribution of Beta species in the United States

Beet species that have been introduc ed into the United States include B. procumbens Chr. Sm., B. vulgaris ssp. vulgaris

, B. vulgaris ssp. maritima and B. macrocarpa Guss. (USDA ARS 2011). The distribution of B. procumbens is limited to the state of Pennsylvania (USDA ARS 2011).

The only location where feral beets are record ed as having a genuine presence in the

environment is in California. The California wild beets belong to two different taxa, B. vulgaris

and B. macrocarpa , and have at least three different origins (Bartsch 2002). They evolved from escaped cultivated Swiss chard or red beet, from B. macrocarpa , or from hybridization of B. vulgaris with introduced B. macrocarpa. Research by Bartsch and Ellstrand (1999) identified that many populations of wild beets in California are actually feral varieties of Swiss chard and table beets (Bartsch 2003). Wild beets are found from the San Fran cisco Bay area to the Mexican border (Bartsch 1999) (Figures 1 and 2).7 Figure 1. Distribution of B. vulgaris (Calflora 2011)

Figure 2. Distribution of B. macrocarpa (Calflora 2011)

Potential for H7-1 to hybridize with Beta species that occur in the U.S.

Hybrids between sugar beet and B. procumbens normally die at the seedling stage (Savitsky 1975; OECD 2001). Therefore, hybridi zation of H7-1 with the wild B. procumbens in Pennsylvania is unlikely to occur due to species incompatibility.

Another Beta species, Beta macrocarpa, grows in the Imperial Valley of California (Figure 2) where sugar beet root production occu rs. Hybrids between sugar beet and B. macrocarpa are also not likely to occur. B. macrocarpa show a high degree of self-fer tilization and are known to occupy the same or overlapping geographic ar eas without interbr eeding (Lange 1999). B.

macrocarpa usually flowers earlier than suga r beet. Bartsch speculated that B. macrocarpa can8 cross with sugar beet bolters wh en flowering times overlap (Barts ch 2002) based on evidence of introgression from isozyme analys is. Lewellen, however, found that B. macrocarpa x B. vulgaris crosses in greenhouses under ideal conditions we re usually unsuccessful and the progeny were genetically unstable, further s upporting the conclusion that h ybrids between sugar beet and B.

macrocarpa are unlikely (Lewellen 2003).

Where cultivated sugar beets are gr own in close proximity to wild B. vulgaris , they can freely hybridize when flowering times overlap (Boudry 1993). In California, feral populations of Beta vulgaris, thought to be escaped table beet or Swis s chard, have established along the coast and pose a minor weed problem (Bartsch 1999; J ohnson 1958; McFarlane 1975). These plants are not serious weed problems except when they are present in table beet, Swiss chard, and sugar beet fields (Johnson 1958; Panella 2003). Confirmed populations of Beta vulgaris are found in the San Francisco Bay area and along the coast wh ere sugar beets are no l onger cultivated. Wild B. vulgaris would be capable of cro ssing with flowering sugar be et plants, however, wild populations have not been confirmed in the Impe rial Valley (Calflora, 2011, Kelly Richardson, personal communication). These beets are easily controlled with herbicides or mechanical

cultivation in non- Beta crops. Control of weed beet in Beta crop fields is mo re difficult because young plants resemble Beta crops making it difficult to remove them by mechanical means and they are tolerant of the herbicides used for weed control in beet crops.

Escape of the engineered trait in to weed beet populations is possi ble if grown in close proximity to weedy or feral beets. APHIS concludes that the potential of the glyphosate tolerance trait moving from H7-1 to other sexually compatible Beta species in the United States is low, because of lack of ability to hybridize or proximity to sexually compatible plants. If the trait did move into wild species, these could not be controlled with glyphosate in H7-1 sugar beets. As glyphosate is not used for post-emergent control of wild beets in other Beta crops and other

herbicides are effective to control wild beets in non -Beta crops, the potential for glyphosate tolerant weed beets to cause problem s in H7-1 sugar beet fields or other crops that are resistant to glyphosate would be limited. Even if these plants become tolerant to glyphosate, there are other registered herbicides that can be used to kill th em and other methods of c ontrol can still be used (OECD 2001).

Potential for Transfer of Genetic Information to Organisms with which H7-1 Cannot

Interbreed

Horizontal gene transfer and e xpression of DNA from a plant species to bacteria is unlikely to occur (Keese 2008). First, many bacter ia (or parts thereof) that are closely associated with plants have been sequenced, including Agrobacterium and Rhizobium (Kaneko 2000; Kaneko 2002; Wood 2001). There is no evidence that these or ganisms contain genes derived from plants. Second, FDA has evaluated horizontal gene transfer from the use of antibiotic resistance marker genes, and concluded that the lik elihood of transfer of antibiotic resistance genes from plant genomes to microorganisms in the gastrointestin al tract of humans or animals, or in the environment, is remote (FDA 1998). Therefore, APHI S concludes that horizontal gene transfer is unlikely to occur and thus poses no plant pest risk.

Potential for H7-1 to have Altered Disease and Pest Susceptibilities9 APHIS assessed whether H7-1is likely to ha ve significantly altere d disease and pest susceptibility. This assessment encompassed a t horough consideration of the introduced trait and disease and pest susceptibility data from H7-1field trials.

The Agrobacterium transformed plants used in the genera tion of H7-1 were treated with an

antibiotic to kill the Agrobacterium cells (Monsanto and KWS SAAT AG 2004, p. 19). Furthermore, DNA sequences derived from plant pe sts that were incorporated into H7-1 do not result in the production of infecti ous agents or disease symptoms in plants, and so it is unlikely that H7-1 could pose a plant pest risk. The de scription of the genetic modifications, including genetic elements, expression of the gene pr oduct and their functions for H7-1 has been

summarized above.

Sugar beets are susceptible to a wide variety of insect pests and plant diseases (Cattanach 1991), Both qualitative and quantitative data addressi ng disease susceptibilit y, insect damage and overall agronomic performance were collected in order to assess possible effects from

introduction of the cp4 epsps gene and its associated regulator y sequences. H7-1 was field tested in the U.S. over five years (1998-2002) at ninety-e ight field trial sites re presenting a wide range of environmental conditions (Monsanto and KWS SAAT AG 2004, p. 62). Plant disease was noted in thirty-six of the ni nety-eight trial sites (Monsanto and KWS SAAT AG 2004, p. 63-65). Susceptibility to powdery mildew ( Erysiphe betae ), Cercospora leaf spot ( Cercospora beticola ),
Rhizoctonia root rot ( Rhizoctonia solani ), fungal seedling disease (including Pythium, Rhizoctonia, and Aphanomyces , curly top virus and Rhizomania (Beet Necrotic Yellow Vein Virus – BNYVV) was similar between H71 and conve ntional sugar beet vari eties in all but six

field trial sites. Observations found that H7-1 exhibited reduced sus ceptibility to powdery mildews at three trial sites, increased susceptibi lity at one site, and no difference at nine sites where the disease was present. A slig ht increased susceptibility (10%) to Cercospora leaf spot was noted in two sites, while no difference was iden tified at eleven sites. These differing levels of resistance and susceptibly observed between H7 -1 and comparator sugar beet plants is likely due to the non-GE part of the genetic backgr ound in the H7-1 plants, because there were no trends in disease susceptibility with event H7-1 when differences were observed. European trials conducted in Germany and France over 2 years, usi ng regionally adapted conventional sugar beet lines and genetically similar lines to H7-1, noted no differences in susceptibility to 10 different sugar beet pests (Monsanto a nd KWS SAAT AG 2004, pp. 69-70).

Nursery trials tested the performance of different sugar beet plant varieties including H7-1 when challenged (artificial or natural infection) wi th plant pathogens (Mons anto and KWS SAAT AG 2004). During the 2000 and 2001 growing seasons, sugar beet nursery trials were conducted with H7-1 and conventional sugar beet vari eties to assess disease resistance (to Cercospora leaf spot, Aphanomyces root rot, and curly top and Rhizoctonia root). H7-1 infection levels were found to be within the range of ratings observed for th e conventional registered varieties. Greenhouse trials using Fusarium and Rhizoctonia isolates have found that some of the isolates produced greater disease severity on H7-1 treated w ith glyphosate (Hanson 2003; Larson 2006). Other researchers have suggested th at it may be difficult to predict field results from greenhouse/laboratory experiments (Estok 1989; Wan 1998). Subse quent field studies did not

show increased incidence to th ese root diseases (Khan 2010).10 The major insect and nematode pests in the U.S. (sugar beet root aphid ( Pemphigus populivenae ), sugar beet root maggot ( Tetanops myopaeformis ), sugar beet cyst nematode ( Heterodera schachtii ) and root knot nematode ( Meloidogyne arenaria, M. incognita, M. javanica and M. hapla ) were monitored during the U.S. fi eld trials (Dewar 2006, Monsanto and KWS SAAT AG 2004, pp. 66-68). No significant differences between H7-1 and conventional sugar beets were observed in any of the 98 field trials.

Al-Kaff (1998) noted gene silenci ng effects when transgenic plants have been infected by a virus with DNA sequence homology to a portion of the intr oduced genes. None of the viral diseases of beet is related to figwort mosaic vi rus (http://image.fs.ui daho.edu/vide/refs.htm and Whitney 1986) (a caulimovirus and from which the promoter for the cp4 epsps gene originates) so silencing of the cp4 epsps gene should not occur.

In addition to field studies on agronomic pa rameters, Monsanto and KWS SAAT AG (2004, pp. 77-84) analyzed sugar beets for compositional changes as part of their submission to FDA in the consultation process. While FDA uses these data as indicators of possible nutritional changes, APHIS views them as a general indicator of possible unintended changes. Compositional analyses evaluating carbohydrates, pr oteins, fiber, fat, sugars and eighteen amino acids (a total of 55 statistical comparisons) identified seven statisti cally different values compared with the near isogenic control line. None of the values for s eed composition characteristics were outside the range of natural variability of conventional sugar beet. Therefore, the composition of H7-1 is not biologically different than conventional suga r beets. Based on the known functions and mechanisms of actions of this protein (summarized in the petition), this prot ein is not expected to directly alter susceptibility to plant pathogens. Th us H7-1 is expected to be susceptible to the same pests as conventional sugar beet.

Conclusion

APHIS has prepared this plant pest risk assessm ent in order to determine if event H7-1 sugar beet is unlikely to pose a plant pest risk unde r full deregulation. Based on the information provided by the applicant, considerat ion of current scientific literat ure and the lack of plant pest risk from the inserted genetic material, weedy ch aracteristics, atypical re sponses to disease or plant pests in the field, effects on non-targets or benefi cial organisms in the agro-ecosystem, and horizontal gene transfer, APHIS ha s concluded that event H7-1 s ugar beet is unlikely to pose a plant pest risk.

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