1 

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 determination that genetically engineered (GE) sugar 

beet (Beta vulgaris L. ssp. vulgaris) event H7-1 is unlikely to pose 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 administers 7 CFR part 340 under the 

authority of the plant pest provisions of the Plant Protection Act of 20001

. 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 Monsanto 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, Docket No. 04-075-2), APHIS advised the 

public of its determination, effective March 4, 2005, that the 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 regulations 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 status to event H7-1 (Center for Food Safety et al. vs. Thomas Vilsack et al.). 

On August 13, 2010, the Court vacated APHIS’s decision to grant nonregulated status to the 

event H7-1 sugar beet varieties making them subject to the Plant Protection Act of 2000 (PPA) 

and 7 CFR part 340 once again, and remanded the matter back to the agency to determine 

regulatory actions, if any, that should be imposed 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 part 340 (Reding 2010). These petitioners requested that APHIS 

grant “partial deregulation” or similar administrative action to authorize the continued cultivation 

of event H7-1 subject to the interim measures proposed by APHIS 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 “partially deregulate” event H7-1 sugar beets as an interim action 

until the court-ordered EIS was completed. That “partial 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 event 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) defines plant pest as: “Plant Pest - The term “plant pest” means 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 product: (A) A 

protozoan. (B) A nonhuman animal. (C) A parasitic plant. (D) A bacterium. (E) A fungus. (F) A virus or viroid. (G) An infectious 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 consider the plant pest risk potential of H7-1 

sugar beet root crop under the conditions of the interim action. 

H7-1 was grown in the U.S. under APHIS permits or notifications from 1998 through 2005. 

From 2005 to 2010, H7-1 was grown widely without APHIS regulatory restrictions. Since 

February 2011, H7-1 sugar beets have been grown commercially for root production under 

APHIS-mandated compliance agreements and for 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 transformation of a sugar beet line (3S0057) with 

Agrobacterium tumefaciens. Because A. tumefaciens is a plant pest and some of the regulatory 

sequences (figwort mosaic virus promoter) used to facilitate expression 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 considered a regulated article under APHIS regulations 

at 7 CFR part 340. Potential impacts to be addressed in this risk assessment 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 literature, in addition to information submitted by the 

applicant, to determine if H7-1 is unlikely to pose 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 Protection Act or to the 

regulatory requirements of 7 CFR part 340, and therefore, APHIS 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 340.6(c) specifies the information a petitioner must 

include in a petition for nonregulated status. APHIS will evaluate information submitted by the 

applicant related to plant pest risk characteristics, disease and pest susceptibilities, expression of 

the gene product, new enzymes, or changes to plant metabolism, weediness of the regulated 

article, any impacts on the weediness 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 for full deregulation considers 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 environment including on non-target and beneficial 

organisms, and threatened and endangered species is included in the EIS. 

Development of H7-1 Herbicide Tolerant2

 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 (WSSA) definition of “herbicide resistance” 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 herbicide] may be naturally occurring or induced by such 

techniques as genetic engineering or selection of variants produced by tissue culture or mutagenesis.” Herbicide 
3 

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, Swiss chard, and table beets. Beta vularis L. spp. maritima (L.) 

Arcang. wild sea beet, is regarded as the progenitor of the Beta crop species (fodder beet, sugar 

beet, Swiss chard and table or red beet) and found widely distributed over the Mediterranean 

basin and the Near East (OECD 2001). 

Plant Description and Flowering Characteristics 

Sugar beet is a biennial species (typically will complete its lifecycle in 2 years) that is grown as 

an annual for sugar production. Since the root crop 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 allowed to overwinter in a moderate 

climate, it will “bolt” the second year and produce a flower stalk and seeds (OECD 2001). Being 

a biennial, the plant typically flowers during the late spring to summer of the 2nd year of growth, 

usually sending up a single unbranched flower stalk. Flowers begin to release pollen about 4-6 

weeks after the flower stalk emerges and continue to release pollen for another 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; OECD 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 considerably at different locations based on numerous 

environmental conditions. Wind, however, is considered to be the primary vector for pollination. 

H7-1 is a genetically engineered sugar beet line that was developed to increase tolerance to the 

herbicide glyphosate. Glyphosate was first introduced as an herbicide under the trade name of 

Roundup® by Monsanto in 1975. Glyphosate is a systemic, post-emergence herbicide widely 

used on both agricultural commodities (food uses) and non-agriculture sites (Cerdeira 2006). 

The management of weeds in conventional sugar beet fields can be an expensive, labor intensive, 

and sometimes complicated operation. Often farmers use pre-emergent herbicides that will stop 

weed seeds from germinating. However, this requires 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 herbicide 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 the 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-characterized procedure that has been widely used for over two decades 

for introducing various genes directly into plant genomes. 

APHIS authorized the first field 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 reproductive 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 proprietary 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 transformation of a variety of plant tissues for over 20 

years. Plants containing the introduced DNA were selected based on growth in the presence of 

glyphosate. 

The plasmid PV-BVGT08 contains a single expression cassette flanked 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 (Monsanto 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 targets 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 consisting of a single polypeptide of 455 

amino acids (Padgette 1996). 

 3’ untranslated region (transcriptional terminator and polyadenylation site) of the rbcS E9 

gene from Pisum sativum (Coruzzi 1984; Morelli 1985). 

Data was provided and reviewed by APHIS that demonstrates stable integration and inheritance 

of the cp4 epsps gene and its associated regulatory sequences over several 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 weed species by the U.S. Federal government (7 

CFR part 360; 

http://www.aphis.usda.gov/plant_health/plant_pest_info/weeds/downloads/weedlist2010doc.pdf). In order to assess the potential for H7-1 to become invasive and/or a weed, 

APHIS looked to whether H7-1’s reproductive characteristics and survival biology were any 

different from the characteristics of conventional sugar beet varieties. One measure of a plant’s 

potential to be invasive is the potential for the plant to produce “volunteers.” Sugar beets possess 

few of the characteristics of plants that are notable of successful 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, including growth and seed 

characteristics that influence reproductive and survival biology of the transgenic plant compared 

to its non-transgenic counterpart. 

Volunteer plants rarely occur in fields planted with a sugar beet root crop. This is because bolters 

in root crop fields are rare and generally do not produce seed and unharvested roots are incapable 

of surviving the winters in the Northern sugar beet producing regions and the summers in the 

Imperial Valley (USDA APHIS, 2011). In fields used to produce sugar beet seed, volunteer 

plants can occur in subsequent years. These plants 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 likely to become a weed than the isogenic nontransgenic sugar beet line. The assessment encompasses a thorough consideration of the basic 

biology of sugar beet and an evaluation of the 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 and other characteristics that 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 relating 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 production and germination indicate that H7-1 is 

not different from its comparators in these respects. There is no indication that H7-1 possesses a 

selective advantage that would result in increased weediness or invasiveness. H7-1 lacks the 

ability to persist as a troublesome weed, and there would be no significant impact on current 
6 

weed management practices for sugar beet cultivation, 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 (particularly tetraploid plants) although self-fertilizing 

plants exist in nearly every population (OECD 2001). Outcrossing is very important in 

developing hybrid seed every year for commercial 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 introduced 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 recorded 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 Francisco 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, hybridization 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 occurs. Hybrids between sugar beet and B. macrocarpa are also 

not likely to occur. B. macrocarpa show a high degree of self-fertilization and are known to 

occupy the same or overlapping geographic areas without interbreeding (Lange 1999). B. 

macrocarpa usually flowers earlier than sugar beet. Bartsch speculated that B. macrocarpa can 
8 

cross with sugar beet bolters when flowering times overlap (Bartsch 2002) based on evidence of 

introgression from isozyme analysis. Lewellen, however, found that B. macrocarpa x B. vulgaris

crosses in greenhouses under ideal conditions were usually unsuccessful and the progeny were 

genetically unstable, further supporting the conclusion that hybrids between sugar beet and B. 

macrocarpa are unlikely (Lewellen 2003). 

Where cultivated sugar beets are grown 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 Swiss chard, have established along the coast and 

pose a minor weed problem (Bartsch 1999; Johnson 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 where sugar beets are no longer cultivated. Wild 

B. vulgaris would be capable of crossing with flowering sugar beet plants, however, wild 

populations have not been confirmed in the Imperial 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 more 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 into weed beet populations is possible 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 problems 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 them and other methods of control can still be used 

(OECD 2001). 

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

Interbreed 

Horizontal gene transfer and expression of DNA from a plant species to bacteria is unlikely to 

occur (Keese 2008). First, many bacteria (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 organisms contain genes derived from plants. 

Second, FDA has evaluated horizontal gene transfer from the use of antibiotic resistance marker 

genes, and concluded that the likelihood of transfer of antibiotic resistance genes from plant 

genomes to microorganisms in the gastrointestinal tract of humans or animals, or in the 

environment, is remote (FDA 1998). Therefore, APHIS 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 Susceptibilities 
9 

APHIS assessed whether H7-1is likely to have significantly altered disease and pest 

susceptibility. This assessment encompassed a thorough consideration of the introduced trait and 

disease and pest susceptibility data from H7-1field trials. 

The Agrobacterium transformed plants used in the generation 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 pests that were incorporated into H7-1 do not 

result in the production of infectious agents or disease symptoms in plants, and so it is unlikely 

that H7-1 could pose a plant pest risk. The description of the genetic modifications, including 

genetic elements, expression of the gene product 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 addressing disease susceptibility, insect damage and 

overall agronomic performance were collected in order to assess possible effects from 

introduction of the cp4 epsps gene and its associated regulatory sequences. H7-1 was field tested 

in the U.S. over five years (1998-2002) at ninety-eight field trial sites representing a wide range 

of environmental conditions (Monsanto and KWS SAAT AG 2004, p. 62). Plant disease was 

noted in thirty-six of the ninety-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 conventional sugar beet varieties in all but six 

field trial sites. Observations found that H7-1 exhibited reduced susceptibility to powdery 

mildews at three trial sites, increased susceptibility at one site, and no difference at nine sites 

where the disease was present. A slight increased susceptibility (10%) to Cercospora leaf spot 

was noted in two sites, while no difference was identified 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 background 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, using 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 and 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) with plant pathogens (Monsanto 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 varieties 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 the 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 with glyphosate (Hanson 2003; Larson 2006). Other 

researchers have suggested that it may be difficult to predict field results from 

greenhouse/laboratory experiments (Estok 1989; Wan 1998). Subsequent field studies did not 

show increased incidence to these 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. field 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 silencing effects when transgenic plants have been infected by a virus 

with DNA sequence homology to a portion of the introduced genes. None of the viral diseases of 

beet is related to figwort mosaic virus (http://image.fs.uidaho.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 parameters, 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, proteins, fiber, fat, sugars and eighteen amino acids (a total of 

55 statistical comparisons) identified seven statistically different values compared with the near 

isogenic control line. None of the values for seed 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 sugar beets. Based on the known functions and 

mechanisms of actions of this protein (summarized in the petition), this protein is not expected to 

directly alter susceptibility to plant pathogens. Thus H7-1 is expected to be susceptible to the 

same pests as conventional sugar beet. 

Conclusion 

APHIS has prepared this plant pest risk assessment in order to determine if event H7-1 sugar 

beet is unlikely to pose a plant pest risk under full deregulation. Based on the information 

provided by the applicant, consideration of current scientific literature and the lack of plant pest 

risk from the inserted genetic material, weedy characteristics, atypical responses to disease or 

plant pests in the field, effects on non-targets or beneficial organisms in the agro-ecosystem, and 

horizontal gene transfer, APHIS has concluded that event H7-1 sugar beet is unlikely to pose a 

plant pest risk. 

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York and London 
11 

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