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Plant Pest Risk Assessment of Event H7-1 Sugar Beet

Table of Contents

A. Introduction................................................................................................................................ 2

B. Development of H7-1 herbicide tolerant sugar beet .................................................................. 4

C. Description of the modification.................................................................................................. 5

D. Potential for H7-1 to have altered disease and pest susceptibilities .......................................... 5

E. Potential for effect on non-target organisms, including those beneficial to agriculture ............ 7

F. Potential for enhanced weediness or invasiveness ..................................................................... 8

G. Potential of H7-1 to impact the weediness of other plants with which it can interbreed........... 9

H. Potential changes to agricultural or cultivation practices ....................................................... 11

I. Potential impacts from transfer of genetic information to organisms with which H7-1 cannot 

interbreed ...................................................................................................................................... 11

J. Conclusion................................................................................................................................. 12

K. References................................................................................................................................ 12
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A. Introduction

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 

Final 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 

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. 

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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.” 
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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 (cp4 epsps 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, potential for 

effect on non-target organisms, weediness of the regulated article, any impacts on the weediness 

of any other plant with which it can interbreed, potential changes to agriculture or cultivation 

practices 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 Final EIS.

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).

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

an annual for sugar production. 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” 
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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). Since 

the root crop is usually harvested during the first year while still in the vegetative phase, flowers 

rarely develop in sugar beet production fields. 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. 

B. Development of H7-1 herbicide tolerant2 sugar beet

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. 

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. 

 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 

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

after herbicide treatment. 
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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.

C. 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) 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.

D. Potential for H7-1 to have altered disease and pest susceptibilities 
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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, pp. 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, curly top and Rhizoctonia root rot). 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 and/or 

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

increased incidence to these root diseases (Khan 2010).
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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://www.agls.uidaho.edu/ebi/vdie// 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.

Given the interactions between the environment, the genetic background off the cultivars used 

and some inherent genetic variability within sugar beet varieties, APHIS concludes that these 

results do not indicate an increased pest risk. Expression of CP4 EPSPS in event H7-1 sugar beet 

is not expected to cause plant disease or influence susceptibility of H7-1 or its progeny to disease 

or other pests.

E. Potential for effect on non-target organisms, including those 

beneficial to agriculture

Based on the data provided by the applicant and existing literature, APHIS evaluated the 

potential for plant pest-related impacts from event H7-1 on non-target or beneficial organisms. 

The inserted genetic material is not toxic and does not produce any substance that would be 

considered toxic (USEPA 1993). The lack of known toxicity for this enzyme suggests no 

potential for deleterious effects on beneficial organisms such as bees and earthworms. The high 

specificity of the enzyme for its substrates makes it unlikely that the introduced enzyme would 

metabolize endogenous substrates to produce compounds toxic to beneficial organisms. Field 

observations of H7-1 (Monsanto and KWS SAATAG 2004, pp. 53-70) revealed no negative 

effects on non-target organisms, suggesting that the production of the CP4 EPSPS protein in the 

plant tissues is not toxic to organisms.

Even though the likelihood of toxicity is low for the CP4 EPSPS protein, a number of 

researchers have conducted laboratory investigations with different types of arthropods exposed 

to genetically engineered crops containing the CP4 EPSPS protein (Goldstein 2003; Harvey 

2003; Jamornman 2003). Representative pollinators, soil organisms, beneficial arthropods and 

pest species were exposed to tissues (pollen, seed, and foliage) from GE crops that contain the 

CP4 EPSPS protein. These studies, although varying in design, all reported a lack of toxicity 

observed in various species exposed to these crops (Dunfield 2003; USEPA 1993; Siciliano 

1999).

APHIS has found no evidence or reason to believe that the presence of the cp4 epsps gene or the 

expressed EPSPS protein in H7-1 would have any adverse impacts on other organisms, including 

those beneficial to agriculture (such as earthworms, honeybees, predators or parasites of sugar 
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beet pests). Base on the above information, APHIS has concluded that adverse impactions to 

non-target organisms exposed to H7-1 are unlikely.

F. Potential for enhanced weediness or invasiveness

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/). 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. 

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 

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).
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G. Potential of H7-1 to impact the weediness of other plants with 

which it can interbreed

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 seed production. 

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. Wild beets are found from the San Francisco Bay area to the 

Mexican border (Bartsch 1999) (Figures 1 and 2). 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 feral varieties of 

Swiss chard and table beets (Bartsch 2003). 

Figure 1. Distribution of B. vulgaris (Calflora 2011)
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 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. This is because B. macrocarpa show a high degree of self-fertilization and 

are known to occupy the same or overlapping geographic areas without interbreeding (Lange 

1999). Also, B. macrocarpa usually flowers earlier than sugar beet. Bartsch speculated that B. 

macrocarpa can 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 when crossed in the greenhouse 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. 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 
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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). 

H. Potential changes to agricultural or cultivation practices

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, however, 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. 

Other than the use of glyphosate to control weeds, none of the management practices currently 

employed for conventional sugar beet cultivation is expected to change if H7-1 is determined to 

be no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest 

provisions of the Plant Protection Act. Monsanto and KWS SAAT AG (2004) studies 

demonstrate that the cultivation practices needed for growing H7-1 sugar beet are essentially 

indistinguishable from practices used to grow conventional sugar beet varieties with the 

exception of the glyphosate-based weed control regime. No differences in insect or disease

damage were observed in field trials with H7-1. H7-1 is comparable to currently available sugar 

beet varieties in terms of resistance to insects and disease (Monsanto and KWS SAAT 2004, pp. 

53 – 70). Because agricultural and cultivation practices would not be significantly different than 

that of conventional sugar beets, APHIS does not foresee changes in on insects or diseases 

damage or control measures employed due to agricultural or cultivation practices with H7-1.

I. Potential impacts from transfer of genetic information to organisms 

with which H7-1 cannot interbreed
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APHIS examined the potential for the new genetic material inserted into H7-1 to be horizontally 

transferred to other organisms without sexual reproduction and whether such an event could lead 

directly or indirectly to disease, damage, injury or harm to plants. Horizontal gene transfer and 

expression of DNA from a plant species to other species is highly unlikely to occur based on the 

following reasons.

The horizontal gene transfer (HGT) between unrelated organisms is one of the most intensively 

studied fields of science. Horizontal gene transfer and expression of DNA from a plant species to 

bacteria or animal species is unlikely to occur (Keese 2008). 

1. Many genomes (or parts thereof) from bacteria 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. Therefore the likelihood of any impact or new horizontal gene transfer that is not 

already capable of taking place in the soil is extremely unlikely.

2. No evidence has been identified for any mechanism by which sugar beet genes could be 

transferred to humans or animals, or any evidence that such gene transfer has occurred 

for any plant species during evolutionary history, despite animals and humans eating 

large quantities of plant DNA. In cases where review of sequence data implied that 

horizontal gene transfer occurred, these events are inferred to occur on an evolutionary 

time scale on the order of millions of years (Brown 2003; Koonin 2001). 

3. Transgene DNA promoters and coding sequences are optimized for plant expression, not 

prokaryotic bacterial expression. Thus even if horizontal gene transfer occurred, proteins 

corresponding to the transgenes are not likely to be produced. 

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 

extremely unlikely (FDA 1998). Therefore APHIS concludes that horizontal gene transfer is 

highly unlikely to occur and thus poses no significant plant pest risk.

J. 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 and the lack of atypical responses to disease or plant pests in the field, 

effects on non-targets or beneficial organisms in the agro-ecosystem, weedy characteristics of 

H7-1 or other plants with which it can interbreed, changes to agricultural or cultivation practices, 

and the unlikelihood of horizontal gene transfer, APHIS has concluded that event H7-1 sugar 

beet is highly unlikely to pose a plant pest risk. 

K. References

Al-Kaff, N.S., Covey, S.N., Kreike, M.M., Page, A.M., Pinder, R., Dale, P.J. (1998)

Transcriptional and Posttranscriptional Plant Gene Silencing in Response to a Pathogen. 

Science 279: 2113-2115
13

Baker, H.G. (1965) Characteristics and Modes of Origin of Weeds. In: The Genetics of 

Colonizing Species. pp. 147-172. Baker, H. G., Stebbins, G. L. (eds.). Academic Press, New 

York and London

Bartsch, D., Ellstrand, N.C. (1999) Genetic evidence for the origin of Californian wild beets 

(genus Beta). Theoretical and Applied Genetics 99:1120-1130 

Bartsch, D., Driessen, S., Gathmann, A., Hoffmann, A., Lehnen, M., Muecher, T., Saeglitz, C., 

Wehres, U., Schuphan, I. (2002) Monitoring the environmental consequences of gene flow 

from transgenic sugar beet. In Gene Flow Workshop, The Ohio State University, pp. 78-93 

Bartsch, D., Cuguen. J., Biancardi. E., Sweet, J. (2003) Environmental implications of gene flow 

from sugar beet to wild beet -- current status and future research needs. EnvironmentalBiosafety-Research 2:105-115 

Boudry, P., Moerchen, M., Saumitou-Laprade, P., Vernet, P., van Djik, H. (1993) The origin and 

evolution of weed beets: Consequence of the breeding and release of herbicide-resistant 

transgenic sugar beets. Theoretical and Applied Genetics 87:471-478 

Boudry, P., McCombie, H., Van Dijk, H. (2002) Vernalization requirement of wild beet Beta 

vulgaris spp. maritima: among population variation and its adaptive significance. Journal of 

Ecology 90:693-703

Brown, J.R. (2003) Ancient horizontal gene transfer. Nature Reviews Genetics 4:121-132

Büttner, B., Abou-Elwafa, S., Zhang, W., Jung, C., Müller (2010) A survey of EMS-induced 

biennial Beta vulgaris mutants reveals a novel bolting locus which is unlinked to the bolting 

gene B. Theor. App. Genet. 121:1117-1131

Calflora (2011) Search for Plants. Available at: < http://www.calflora.org>. (Accessed: June 27, 

2011)

Cattanach, A.W., Dexter, A.G., Oplinger, E.S. (1991) Sugarbeets. Alternative Field Crops 

Manual. University of Wisconsin-Extension. Avaialbe at:

http://www.hort.purdue.edu/newcrop/afcm/sugarbeet.html (Accessed: September 1, 2011).

Cerdeira, A.L., Duke, S.O. (2006) The current status and environmental impacts of glyphosateresistant crops: A review. J. Environmental Quality 35:1633-1658

Coruzzi, G., Broglie, R., Edwards, C., Chua, N. (1984) Tissue-specific and light-regulated 

expression of a pea nuclear gene encoding the small subunit of ribulose-1,5-bisphosphate 

carboxylase. EMBO J. 3:1671-1679

Darmency, H., Klein, E.K., De Garanbé, T.G., Gouyon, P.H., Richard-Molard, M., 

Muchembled, C. (2009) Pollen Dispersal in Sugar Beet Production Fields. Theoretical and 

Applied Genetics 118:1083–1092
14

Dewar, A.M., Cooke, D.A. (2006) Chapter 13: Pests. Pgs. 316–358. In: Sugar Beet. Draycott, A. 

P. (ed.). Oxford, United Kingdom: Blackwell Publishing Ltd. World Agricultural Series: 474 

pgs.

Dunfield, K.E., Germida, J.J. (2003) Seasonal changes in the rhizosphere microbial communities 

associated with field-grown genetically modified canola (Brassica napus). Appl. Environ. 

Microbiol. 69:7310-7318

Estok, D., B. Freedman, Boyle, D. (1989) Effects of the herbicides 2,4-D, glyphosate,

Hexazinone, and Triclopyr on the growth of three species of ectomycorrhizal fungi. Bull. 

Environ. Contam. Toxicol. 42:835-839

FDA (1998) Guidance for Industry: Use of Antibiotic Resistance Marker Genes in Transgenic 

Plants. pp. 28

Goldstein, S.M. (2003) Life history observations of three generations of Folsomia candida 

(Willem) (Colembola: Isotomidae) fed yeast and Roundup Ready soybeans and corn. Pp. 82.

Masters thesis. Michigan State University

Gowda, S., Wu, F.C., Sheperd, R.J. (1989) Identification of promoter sequences for the major 

RNA transcripts of figwort mosaic and peanut chlorotic streak viruses (caulimovirus group). 

J. Cell. Biochem 13D (supplement):301

Hanson, L. (2003) Effect of treating sugar beet with the herbicide glyphosate on Fusarium

yellows. Proceeding of the American Society of Agronomy, Crop Science Society of 

America, and Soil Science Society of America. Published Sept. 2, 2003

Harvey, L. H.; Martin, T.J.; D. Seifers, D. (2003) Effect of Roundup Ready wheat on greenbug,

Russian wheat aphid, and wheat curl mite. J. of Agr. and Urb. Ento. 20:203-206.

Howard, E., Citovsky, V., Zambryski, P. (1990) The T-complex of Agrobacterium tumefaciens. 

In: Plant Gene Transfer. Beachy, R.N., Lamb, C.J. (eds.), Alan R. Liss, Inc., New York, New

York. pp. 1-12

Ingram, J. (2000) Separation Distances Required to Ensure Cross-pollination is Below Specified 

Limits in Non-seed Crops of Sugar Beet, Maize and Oilseed Rape. Plant Varieties and Seeds

13:181

Jamornman, S., S. Sopa, S. Kumsri, T. Anantachaiyong, and S. Rattithumkul (2003) Roundup

Ready corn NK603 effect on Thai greenlacewing, Mallada basalis (Walker) under laboratory

condition. Proc. Sixth Nat. Plant Protec. Conf., November 24-27, 2003

Johnson, R. T., Burtch, L.M. (1958) The problem of wild annual sugar beets in California. Jour. 

Am. Soc. of Sugar Beet Tech. 10: 311-317

Kaneko, T. et al. (2000) Complete genome structure of the nitrogen-fixing symbiotic bacterium 

Mesorhizobium loti. DNA Research 7:331-338
15

Kaneko, T. et al. (2002) Complete genomic sequence of nitrogen-fixing symbiotic bacterium 

Bradyrhizobium japonicum USDA110. DNA Research 9:189-197

Keeler, K. (1989) Can genetically engineered crops become weeds? Bio/Technology 7:1134-

1139

Keese, P. (2008) Risks from GMOs due to horizontal gene transfer. Environ. Biosafety Res. 

7:123-149

Khan, M.F. (2010) Introduction of glyphosate-tolerant sugar beet in the United State. Outlooks 

on Pest Management 21:38-41

Koonin, E.V., Makarova, K.S., Aravind, L. (2001) Horizontal gene transfer in prokaryotes: 

quantification and classification. Annual Review of Microbiology 55:709-742

Lange, W., Brandenburg, W.A., De Bock, T.S.M. (1999) Taxonomy and cultonomy of beet 

(Beta vulgaris L.). Botanical Journal of the Linnean Society 130:81-96 

Larson, R.L., Hill, A.L., Fenwick, A., Kniss, A.R., Hanson, L.E., Miller, S.D. (2006) Influence 

of glyphosate on Rhizoctonia and Fusarium root rot in sugar beet. Pest Management Science 

62:1182-1192

Lewellen, R.T., Liu, H.-Y., Wintermantel, W.M., Sears, J.L. (2003) Inheritance of beet necrotic 

yellow vein virus (BNYVV) systemic infection in crosses between sugarbeet and Beta 

macrocarpa. 1st Joint IIRB-ASSBT Congress 149-160. Feb. 27-Mar. 1, 2003. San Antonio, 

TX

McFarlane, F.S. (1975) Naturally occurring hybrids between sugar beet and Beta macrocarpa in 

the Imperial Valley of California. Journal of American Society of Sugar Beet Technologists 

18:245-251 

Monsanto and KWS SAAT AG (2004) Petition for Determination of Nonregulated Status for 

Roundup Ready® Sugar Beet Event H7-1. Submitted by R. Schneider, Regulatory Affairs 

Manager. Monsanto Company, St. Louis, MO and G. Strittmatter, Head of Research and 

Breeding. KWS SAAT AG, Einbeck, Germany. (See Table

http://www.aphis.usda.gov/biotechnology/not_reg.html)

Morelli, G., Nagy, F., Fraley, R.T., Rogers, S.G., Chua, N.H. (1985) A short conserved sequence 

is involved in the light-inducibility of a gene encoding ribulose 1,5-bisphosphate carboxylase 

small subunit of pea. Nature 315:200-204

OECD (2001) Consensus Document on the biology of Beta vulgaris L. (Sugar Beet). In Series 

on Harmonization of Regulatory Oversight in Biotechnology, 40 pgs.
16

Padgette, S.R., Kolacz, K.H., Delannay, X., Re, D.B., Lavallee, B.J., Tinius, C.N., Rhodes, Y.I.,

Otero, W.K., Barry, G.F., Eichholtz, D.A., Peschke, V.M., Nida, D.L., Taylor, N.B., Kishore, 

G.M. (1995) Development, identification, and characterization of a glyphosate-tolerant 

soybean line. Crop Science 35:1451–1461

Padgette, S.R., Re, D.B., Barry, G.F., Eichholtz, D.E., Delannay, X., Fuchs, R.L., Kishore, 

G.M., Fraley, R.T. (1996) New weed control opportunities: development of soybeans with a 

Roundup readyTM gene. pp. 54-84. In Agricultural, Environmental, Econonmic, Regulatory, 

and Technical Aspects. Duke, S.O. (ed). CRC Press Inc. 4:54-84

Panella, L. (2003) USDA/ARS Research Geneticist and Sugarbeet Germplasm Committee 

Chair, Personal communication to J.R. Stander, Betaseed, Inc. (Appendix 2 of the Petition)

Panella, L., Lewellen, R.T. (2007) Broadening the genetic base of sugar beet: introgression from 

wild relatives. Euphytica 154:383-400

Reding, H.K., von dem Bussche, P., Hofmann, P. (2010) Letter to Michael C. Gregoire, USDA 

APHIS, July 29, 2010. Attached to Environmental Report submitted by Monsanto in support 

of petition 03-323-01p

Richins, R.D., Scholthof, H.B., Sheperd, R.J. (1987) Sequence of figwort mosaic virus DNA 

(Caulimovirus Group). Nucl. Acids Res. 15:8451-8466

Sanger, M., Daubert, S., Goodman, R.M. (1990) Characteristics of a strong promoter from 

figwort mosaic virus: comparison with the analogous 35S promoter from cauliflower mosaic 

virus and the regulated mannopine synthase promoter. Plant Molecular Biology 14:433-443

Savitsky, H. (1975) Hybridization between Beta vulgaris and B. procumbens and transmission 

of nematode (Heterodera schachtii) resistance to sugarbeet. Can. J. Genet. Cytol. 17:197-209

Sheperd, R.J., Richins, J.F., Duffus, J.F., Handley, M.K. (1987) Figwort mosaic virus: 

properties of the virus and it adaptation to a new host. Phytopathology 77:1668-1673

Siciliano, S.D., Germida, J.J. (1999) Taxonomic diversity of bacteria associated with the roots of 

field-grown transgenic Brassica napus cv. Quest, compared to the nontransgenic B. napus cv. 

Excel and B. rapa cv. Parkland. FEMS Microbiol. Ecol. 29:263-272

Timko, M.P., Herdies, L., de Alameida, E., Cashmore, A.R., Leemans, J., Krebbers, E. (1988) 

Genetic engineering of nuclear-encoded components of the photosynthetic apparatus of 

Arabidopsis. pp. 279-295. In: The Impact of Chemistry on Biotechnology – A 

Multidisciplinary Discussion. M. Phillips, S.P. Shoemaker, R.D. Middlekauff, R.M. 

Ottenbrite, editors. ACS Books, Washington, D.C.

USDA ARS, United States Department of Agriculture Agricultural Research Service (2010)

National Genetic Resources Program Germplasm Resources Information Network - (GRIN) 
17

[Online Database]. National Germplasm Resources Laboratory, Beltsville, Maryland. 

Available at: < http://www.ars-grin.gov/npgs/>.(Accessed: June 27, 2011)

USEPA (1993) United States Environmental Protection Agency. Reregistration Eligibility 

Decision (RED) Glyphosate. 738-R-93-014. Retrieved December, 2011, from 

http://www.epa.gov/oppsrrd1/REDs/old_reds/glyphosate.pdf

Van Dijk, H., Boudry, P., McCombie, H., Vernet, P. (1997) Flowering Time in Wild beet (Beta 

vulgaris ssp. maritima) along a Latitudinal Cline. Acta Oecology 18: 47–60

Wan, M.T., Rahe, J.E., Watts, R.G. (1998) A new technique for determining the sublethal 

toxicity of pesticides to the vesicular-arbuscular mycorrhizal fungus Glomus intraradices. 

Environ. Toxicol. Chem. 17(7):14-21

Whitney, E.D., Duffus, J.E. (1986) Compendium of Beet Diseases and Insects. pp. 26-32

Wood, D.W., et al. (2001) The genome of the natural genetic engineer Agrobacterium 

tumefaciens C58. Science. 294:2317-2323

Weed Science Society of America (WSSA) (1998) “Herbicide Resistance” and “Herbicide 

Tolerance” defined. Weed Technology 12:789 

Weed Science Society of America (WSSA) (2010) Composite List of Weeds. 

http://wssa.net/Weeds/ID/WeedNames/namesearch.php