Assessment of Plant Pest Risk for MON 87705 Soybean

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Monsanto Company (Monsanto) has petitioned APHIS for a determination that MON 

87705 soybean is unlikely to pose a plant pest risk (Rogan, 2009) 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 MON 87705 is unlikely to pose a plant pest risk.

MON 87705 was produced by transformation of soybean tissue using A. tumefaciens. 

Because A. tumefaciens is a plant pest and some of the regulatory sequences (Figwort 

Mosaic Virus promoter) used to facilitate expression of these genes in soybean were 

derived from plant pests, this soybean 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 MON 87705 and its progeny in the absence of confinement. APHIS uses data and 

information submitted by the applicant, in addition to current literature, to determine if 

MON 87705 is unlikely to pose a plant pest risk. If APHIS determines that a GE 

organism is unlikely to pose a plant pest risk, then APHIS has no regulatory authority 

over that organism. 

Potential impacts 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 needed 

for consideration 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. 

An analysis of agricultural or cultivation practices associated with MON 87705 and 

impacts on the environment will be considered in the Environmental Assessment (EA) 

for MON 87705 soybean. A thorough assessment of the effects of the determination on 

nontarget organisms, beneficial organisms and threatened and endangered species will be 

considered in the EA. 

History of Development of MON 87705 soybean with an 

improved fatty acid profile 

Soybean oil is relatively high in saturated fatty acids (15% of total fatty acids) compared 

to vegetable oil from other sources. Soybean oil is also relatively high in polyunsaturated 

fatty acids (23% of total fatty acids). These polyunsaturated fatty acids oxidize readily to 

 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.” 
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produce off-flavors and reduce the performance of unprocessed soybean oil. The 

stability and flavor of soybean oil is improved by hydrogenation, which chemically 

reduces the double bonds. However, hydrogenation has the undesirable consequence of 

creating trans-fatty acids. In recent years, trans-fatty acids have come under considerable 

scrutiny by American Heart Association and others because of the negative effects by 

these substances on human health.

Monsanto has developed a transgenic soybean, event MON 87705 (hereafter referred to 

as MON 87705), that produces soybean seeds with decreased levels of saturated (palmitic 

and stearic) and polyunsaturated (linoleic) fatty acids, and increased levels of 

monounsaturated (oleic) fatty acid. MON 87705 contains DNA segments designed to 

suppress endogenous delta-12 desaturase (FAD2) and Acyl-ACP thioesterase (FATB)

genes which encode for two enzymes in the soybean fatty acid biosynthetic pathway.

MON 87705 also contains the 5-enolpyruvylshikimate-3-phosphate synthase (cp4 epsps)

gene encoding the CP4 EPSPS protein. The cp4 epsps gene was used as a selectable 

marker to identify transgenic plants during the transformation process. The CP4 EPSPS 

protein confers tolerance to glyphosate and has been used in many Roundup Ready crops 

(e.g. canola, corn, cotton, soybean and sugar beet).

 

In plants, the microsomal delta-12 desaturase-catalyzed pathway is the primary route of 

production of polyunsaturated lipids. The FAD2 gene is strongly expressed in 

developing seeds. The seed-specific expressed FAD2 gene is likely to play a major role 

in controlling conversion of oleic acid (a monounsaturated fatty acid) to linoleic acid (a 

polyunsaturated fatty acid) within storage lipids during seed development (Heppard et al., 

1996). The delta-12 desaturase (FAD2) gene in soybean is responsible for the conversion 

of oleic acid to linoleic acid. Suppression of the FAD2 gene prevents linoleic acid from 

being synthesized and leads to the accumulation of oleic acid in the soybean seed. 

The FATB gene is one of the key enzymes for oil biosynthesis in plants. The suppression 

of FATB results in a decrease in the transport of saturated fats out of the plastid, thus 

retaining the availability of those saturated fats for desaturation to oleic acid (Petition, 

2009, page 5, panel A and B). In MON 87705, the assembled gene transcripts have an 

inverted repeat that produces double stranded RNA that, via the RNA interference 

(RNAi) pathway, suppresses endogenous FATB and FAD2 gene expression.

The increase in oleic acid and decrease in saturated fatty acids in MON 87705 is aimed at 

improving the stability of these soybean oils and promoting human heart health. The 

commercialization of MON 87705 could be beneficial for consumers. From a nutritional 

standpoint, the consumption of trans fatty acids results in considerable potential harm

with no apparent known benefit to human health (Mozaffarian et al., 2006). Increased 

intake of oils high in monounsaturated fatty acids, such as oleic acid, has been 

recommended by American Heart Association because of their positive effect on total 

cholesterol levels when compared to equal intakes of hydrogenated oils (Lichtenstein et 

al., 2006). Likewise, increased intake of oils high in oleic acid is known to decrease

LDL-cholesterol levels compared to an equal intake of oils high in saturated fats

(Mensink et al., 1989) and known to increase HDL-cholesterol levels compared to an 
Assessment of Plant Pest Risk for MON 87705 Soybean

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equal intake of polyunsaturated oils (Mata et al., 1992). Moderate consumption of oil 

high in oleic acid has also been demonstrated to result in decreased systolic blood 

pressure (Bondia-Pons et al., 2007).

Description of the modification

 

MON 88705 was produced by Agrobacterium-mediated transformation of soybean with a

binary vector that contains two T-DNAs (T-DNA I AND T-DNA II; T-DNA refers to the 

DNA that is transferred to the plant during transformation) as shown in petition (Petition, 

2009, figures IV-I and IV-II, p. 54-55 and Table V-2, p. 63-65).

(1) T-DNA I contains a cp4 epsps expression cassette and a partial suppression cassette

containing sense segments of an FAD2-1A intron and FATB1-A 5 ́ untranslated 

region (UTR) (Petition, Table IV-1, pp. 56-57).

The cp4 epsps expression cassette contains the following genetic elements: 

• FMV/TSF1 chimeric promoter: FMV/TSF1 promoter consisting of enhancer 

sequences from the promoter of the Figwort Mosaic Virus (FMV) 35S RNA 

combined with the promoter from the Tsf1 gene of Arabidopsis thaliana that

encodes elongation factor EF-1 alpha (Axelos et al., 1989). 

• cp4 epsps gene: the cp4 epsps gene is a gene fusion composed of the N-terminal 

chloroplast transit peptide (CTP2) sequence from Arabidopsis thaliana, epsps

gene and the C-terminal synthetic 5-enolpyruvylshikimate-3-phosphate synthase 

gene (CP4) from an Agrobacterium species, strain CP4 and encoding CP4 EPSPS 

protein. The CP4 EPSPS protein confers tolerance to glyphosate (Padgette et al., 

1996; Barry et al., 1997). 

• E9 3 ́ UTR as transcriptional termination: 3 ́untranslated region of the Pisum 

sativum ribulose 1,5-bisphosphate carboxylase small subunit E9 (RbcS2) gene

which functions to direct polyadenylation of the cp4 epsps mRNA (Coruzzi et al., 

1984).

The partial suppression cassette contains the following genetic elements:

• 7Sα ́ promoter: 7Sα ́ seed specific promoter is from the Sphas1 gene of Glycine 

max encoding beta-conglycinin storage protein (Doyle et al., 1986) that directs 

transcription in seed.

• The sense segment of the FAD2-1A intron: Partial sequence from the intron 

number 1 of the Glycine max FAD2-1A gene that encodes the delta-12 desaturase 

(Fillatti et al., 2003) which forms part of the suppression cassette. 

• FATB1-A 5' UTR: Partial sequence from the 5' UTR and the plastid targeting 

sequence from Glycine max FATB1-A gene that encodes the palmitoyl acyl carrier 

protein thioesterase (Fillatti et al., 2003) which forms part of the suppression 

cassette.

(2) T-DNA II contains a partial suppression cassette that consists of antisense segments 

of FAD2-1A intron and FATB1-A 5’UTR. 
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• The antisense segment of FAD2-1A intron: is an intron from FAD2-1A gene that 

encodes the delta-12 desaturase. 

• The antisense segment of FATB1-A 5’ UTR: Partial sequence from 5' UTR and 

the plastid targeting sequence is from Glycine max FATB1-A gene that encodes 

the palmitoyl acyl carrier protein thioesterase.

• H6 3’ UTR Terminator: H6 3’UTR from Gossypium barbadense is for 

transcriptional termination and polyadenylation of a fiber protein involved in 

secondary cell wall assembly. 

In addition to the above-mentioned nucleotide sequences, T-DNA I and II also contains

non-coding intervening sequences and elongation factors that facilitate DNA cloning and 

translational elongation, respectively. The assembled gene transcript has an inverted 

repeat that produces double stranded RNA (dsRNA) that, via the RNA interference 

(RNAi) pathway, suppresses endogenous FATB and FAD2 RNA. 

Transformation system. 

MON 87705 was developed using a disarmed Agrobacterium –mediated transformation 

system of soybean, which allows the generation of transformed plants without utilization 

of callus (Martinell et al., 2002),. This technique using disarmed Agrobacterium

followed by glyphosate selection has a long history of safe use. 

Plant Pest Risk Assessment

Based on information on the biology of soybean (OECD, 2000), data presented by 

Monsanto Company (Petition, 2009), and scientific data relevant to the discussion of 

plant pest risk, APHIS makes the following conclusions for MON 87705 soybean:

Potential impacts of genetic modifications on disease and pest susceptibilities

USDA-APHIS assessed whether MON 87705 is likely to have significantly increased

disease and pest susceptibility compared to its unmodified control. The assessment 

encompasses a consideration of introduced traits and interactions with pests and diseases. 

The only introduced protein produced in MON 87705 is CP4 EPSPS. The 5-

enolpyruvylshikimate-3-phosphate synthase (EPSPS) family of enzymes is ubiquitous in 

plants and microorganisms. The introduced cp4 epsps gene is from Agrobacterium sp.

strain CP4. The CP4 EPSPS protein expressed in MON 87705 is similar and functionally 

identical to endogenous plant EPSPS enzymes and is identical to the CP4 EPSPSs in 

other Roundup Ready® crops including Roundup Ready® soybean (40-3-2 and MON 

89788), Roundup Ready® canola, Roundup Ready® sugar beet and Roundup Ready flax 

and Roundup Ready® cotton. The first generation of Roundup Ready® soybean (40-3-2)

(USDA-APHIS, 1993) was deregulated in 1995. The cp4 epsps gene has been assessed 

extensively in the last 15 years to confirm that it does not alter the desired agronomic 

characteristics of transgenic crops, and that it does not present a plant pest risk. 

Therefore, incorporating cp4 epsps genes into MON 87705 is not likely to alter disease
Assessment of Plant Pest Risk for MON 87705 Soybean

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and pest susceptibility. The expression of the epsps gene is controlled by a chimeric 

promoter wherein a part of the sequence comes from Figwort Mosaic Virus. These plant 

virus-derived regulatory sequences are non-coding with known function and they are not

known, in and of themselves, to cause plant disease.The introduced endogenous FAD2

gene that suppresses lipid biosynthesis increases the amount of oleic acid in the seed, a 

constituent which is present in the parent cultivar. Such genes have been used in field 

trials previously and are not known to cause plant disease. There is no indication that 

inserting the FAD2 gene will result in increased likelihood of introduction or 

dissemination of a plant pest. The higher concentration of oleic acid is not known to pose 

a plant pest risk in unconfined releases. APHIS has not identified any plant pest risk 

associated with the introduction of the high oleic acid trait in the deregulated DuPont 

product (USDA-APHIS, 1997) and Pioneer product (USDA-APHIS, 2006). The Plant 

Biosafety Office (PBO) of the Canadian Food Inspection Agency (CFIA, 2000), which 

also reviewed a dossier on this product, also concluded that this novel trait (high oleic 

acid) will not introduce any plant pest characteristics into MON 87705 soybean. The 

introduced endogenous FATB gene suppresses the acyl-acyl carrier protein (ACP)

thioesterase and results in a decrease in the transport of saturated fats out of the plastid, 

thus retaining their availability for desaturation to 18:1 oleic acid. As a result, MON 

87705 soybean oil is lower in saturated fats. The information collected from the field 

trials and literature, there is no indication that by suppressing FATB gene will result in 

altering plant pest risk. 

Field evaluation of MON 87705 and conventional soybean varieties were carried out at 

17 sites covering 10 States and assessed for differences in plant response to abiotic stress, 

disease damage, and arthropod damage. The petitioner rated soybeans for responses to 

abiotic stress, diseases, and arthropod pests that were present or typically present at each 

site. For the assessments of the plant-insect interactions, plant-disease interactions, and 

plant responses to abiotic stress, no differences were detected between MON 87705 and 

the controls for 574 of 579 observations at the 17 sites. There were statistical differences 

noted in the disease and arthropod damage in 5 of 579 observations. In three of the 

observations, MON 87705 has less damage from bacterial blight. In the other two 

observations, MON 87705 has less damage from aphids and leafhoppers (Petition, 2009, 

p. 344-346). The 5 noted differences, however, were still within the reference response 

range of the control plants. 

Based on the analysis of genetic modifications and their functions and field testing data 

submitted by petitioner, APHIS concludes that there are no significant differences 

between MON 87705 soybean and the non-transgenic counterparts relative to pest and 

disease susceptibility. Soybean (Glycine max) is not a plant pest in the United States 

(USDA-APHIS, 2000), and the introduced DNA in MON 87705 is unlikely to pose a 

plant pest risk.

Potential impacts from new gene products, changes to plant metabolism or 

composition
Assessment of Plant Pest Risk for MON 87705 Soybean

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USDA-APHIS assessed whether changes in plant metabolism or composition in MON 

87705 is likely to alter plant pest risk. The assessment encompasses a consideration of

the inserted sequences, expressed protein and introduced traits. 

There is no new protein expressed because of the insertion of the FAD2 and FATB gene 

fragments. The only novel protein expressed in MON 87705 is EPSPS (5-

enolpyruvylshikimate-3phosphate synthase), which imparts glyphosate tolerance. 

The EPSPS protein is found naturally in plants, fungi and bacteria, but is absent in 

mammals, fish, birds, reptiles, and insects (Alibhai et al., 2001). The EPSPS in MON 

87705 is derived from an Agrobacterium sp. strain CP4. More than 200 epsps sequences 

are known (http://www.ncbi.nlm.nih.gov/nuccore). Even though there is significant 

diversity for amino acid sequences among EPSPS proteins, they all share a common 

structure and a conserved active site. The EPSPS protein in Mon 87705 is minimally 

modified compared to the endogenous form in soybean. The primary mode of action of 

glyphosate is the competitive inhibition of the plant enzyme 5-enolpyruvyl-shikimate-3-

phosphate synthase (EPSPS) which catalyses the penultimate step in the shikimate

pathway (Franz et al., 1997).

The scientific basis for glyphosate tolerance in all Monsanto Roundup Ready® GE crops 

(Petition, 2009, page 4) is identical. These products have been grown widely across the 

U.S. since the 1990’s and have a long history of safe use. Although EPSPS proteins are 

ubiquitous in nature, there is no evidence of unexpected plant pest risk from these 

proteins. Southern blots were used to determine the copy number of each of the genetic 

elements and to examine the integrity of each fragment inserted into the soybean genome. 

The petitioner has concluded that the CP4 EPSPS-expressing transgene is present in one 

copy, is integrated at a single locus, segregates as a single dominant Mendelian trait, and 

is stable within the soybean genome. The petitioner also notes that the trait is 

phenotypically stable over several generations. 

The CP4 EPSPS transcript levels were measured in leaf, seed, root and forage tissues. 

The mean protein data for the measured plants are summarized in Table VI-2 (Petition, 

2009, p.89). The Margin of Exposure (MOE) was calculated based on the EPSPS protein 

expressed in different tissues. The Margin of Exposure (MOE) is the ratio between a 

defined point on the dose-response curve (reference point) for the adverse effect of the 

compound in an animal carcinogenicity study and the estimated human intake of the 

compound. The MOE is calculated for CP4 EPSPS protein produced by MON 87705 and 

results indicate that there is no meaningful risk to human health from dietary exposure. 

The conclusions of “no further questions” on nutritional and safety issues were reached 

by FDA for the CP4 EPSPS protein (FDA, 2000; FDA, 2004; FDA, 2005; FDA, 2006). 

Petitioner submitted a summary of its safety and nutritional assessment to FDA for MON 

87705 soybean in 2009. A final FDA decision is pending. 

The compositional assessment was conducted in accordance with the Organization of 

Economic Co-operation and Development (OECD) consensus document on 

compositional considerations for new varieties of soybean (OECD, 2001). A total of 38 
Assessment of Plant Pest Risk for MON 87705 Soybean

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fatty acids were analyzed in MON 87705 and control lines. Twenty-one fatty acid 

concentrations were near or below the detection limits of the assay. Of the other acids 

that could be statistically analyzed, concentrations of 13 fatty acids showed statistically

significant differences between MON 87705 and the controls. Four of the 13 differences 

were intended changes from control soybean lines: palmitic acid (16:0), stearic acid 

(18:0), oleic acid (18:1) and linoleic acid (18:2). Nine of the 13 fatty acids were 

significantly different from the control soybean lines: myristic acid, palmitoleic acid, 

margaric acid, heptadecenoic, octadecadienoic acid, arachidic acid, eicosenoic acid, 

behenic acid and 18:2 other trans isomer fatty acids (Petition, 2009, pp.311-312, Table 

E15). However, the levels of these fatty acids were biologically not significant, as most 

of them are relatively minor fatty acids and are common at similar levels in vegetable oils 

(USDA-ARS, 2006). Therefore, APHIS concludes that MON 87705 is compositionally 

equivalent to conventional soybean with the exception of intended changes in fatty acid 

levels. 

Compositional and nutritional data were collected on MON 87705 and comparisons were 

made to a conventional control line and a set of reference soybean varieties. Based on 

the results of comparative analysis APHIS concludes that MON 87705 is compositionally 

and nutritionally equivalent to conventional soybean varieties currently in commerce,

except for the intended changes.

Based on all the considerations above, APHIS concludes that MON 87705 poses no more 

of a plant pest risk from new gene products, changes to plant metabolism or composition 

than conventional soybean.

Potential impacts from outcrossing of MON 87705 to wild relatives 

Soybean is a self-pollinated species propagated by seed (OECD, 2000). In its 

papilionaceous flower, the anthers mature in the bud and directly pollinate the stigma of 

the same flower. As a result, soybeans exhibit a high percentage of self fertilization. 

Natural or artificial cross-pollination can only take place during the short time when the 

pollen is viable. The cross pollination rate (with and without pollinators) is less than 

1.5% beyond one meter from the pollen source (Garber, et al., 1926; Carviness, 1966; 

Ahrent et al., 1994; Ray, et al., 2003; Yoshimura, et al., 2006). At greater distances from 

the pollen source, cross pollination rates decrease rapidly. Based upon these factors, it is 

unlikely that MON 87705 will naturally outcross or hybridize to a significant extent with 

other soybean varieties in agricultural settings.

In assessing the risk of gene introgression from MON 87705 into its sexually compatible 

relatives, APHIS considers two primary issues: 1) the potential for gene flow and 

introgression and, 2) the potential impact of introgression. 

Cross pollination with wild species

The genus Glycine is divided into two subgenera, Glycine and Soja. 
Assessment of Plant Pest Risk for MON 87705 Soybean

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The subgenus Soja consists of three annual species: G. soja Sieb. and Zucc., the form of 

soybean, G. gracilis Skvortz., the weedy form of soybean and G. max, the cultivated 

soybean. They grow wild or semi-wild in Asia. Fertile hybrids between G. max and G. 

soja (Broich, 1978), and between G. max and G. gracilis (Karasawa, 1952) occur. G. 

soja and G. gracilis grow naturally only in Asia and Australia, not in the United States

(Skvortzow, 1972). 

The subgenus Glycine consists of twelve wild perennial species. These species grow 

wild in Australia, South Pacific Islands and Asia (Newell et al., 1978), and do not exist 

naturally in the U.S. Hybrids between perennial Glycine species are fertile. 

G. max is the only Glycine species located in the United States, thus there are no other 

plant species with which G. max can interbreed. G. max has never been found in the wild 

(Hymowitz et al., 1987) without human intervention. Therefore, it is highly unlikely that 

soybean plants in the United States will be found outside of an agricultural setting. It is 

also highly unlikely that gene flow and introgression will occur between MON 87705 and

soybean plants in a natural environment. USDA has therefore determined that any 

adverse consequences of gene flow from MON 87705 to wild or weedy species in the 

United States are highly unlikely.

Potential impacts based on the relative weediness of MON 87705.

APHIS assessed whether MON 87705 is any more likely to become a weed than the 

non-transgenic recipient soybean line, or other soybean currently cultivated. The 

assessment encompasses a thorough consideration of the basic biology of soybean and an 

evaluation of unique characteristics of MON 87705.

In the U.S., soybean is not listed as a weed in the major weed references (Crockett, 1977; 

Holm et al., 1979; Muenscher, 1980) nor is it listed as a noxious weed species by the U.S. 

Federal Government (USDA-APHIS, 2010a) and States (USDA-APHIS 2010b). 

Soybeans are not frost tolerant, do not survive freezing winter conditions (OECD, 2000), 

and do not reproduce vegetatively. After crop harvest, soybean may germinate as a 

volunteer weed in the succeeding crop (Padgette et al., 1996). If any seeds remain viable 

and germinate the following year, mechanical methods or herbicides can be used to 

control volunteers. Soybean is one of the largest acreage crops in the world. Soybean 

has never been reported as a serious weed. In the U.S., soybean is grown on over 77

million acres (USDA-NASS, 2009a). Based on the familiarity of soybean as the parent 

plant, there has been no report of soybean escaping cultivation and becoming established 

as a weed in United States (Holm et al., 1979). 

Weediness for the purposes of this part of the plant pest risk assessment is an attribute, 

which causes a crop to act as a weed due to the addition of genes (compared to the nonGE plant). If the fitness of MON 87705 improves in natural or agricultural ecosystems 

due to the inserted DNA, the potential for weediness could increase. The following 

analysis of the inserted DNA is intended to document that MON 87705 has a negligible 

likelihood of increased weediness.
Assessment of Plant Pest Risk for MON 87705 Soybean

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MON 87705 differs from conventional soybeans only in the expression of the EPSPS

protein and silencing of the endogenous FAD2 and FATB genes. The RNA-based

suppression of FATB and FAD2 soybean genes are mediated by double stranded RNA

(dsRNA) molecules and do not code for any protein. Double stranded RNAs are 

commonly used in plants for endogenous gene suppression and pose no novel risks from 

a plant pest perspective. The only introduced protein in MON 87705 is CP4 EPSPS. 

This protein has the same functional and enzymatic activity as the CP4 EPSPS in other 

Roundup Ready® crops. The large scale commercial cultivation of glyphosate tolerant 

soybean crop acreage has steadily increased from 1996, accounting for 91 % of soybean 

acreage in 2009 (USDA-NASS, 2009b). No data of which APHIS is aware indicate that 

the presence of the cp4 epsps gene improves the ability of this soybean line to survive 

without human intervention, nor is there any foreseeable reason to conclude that this gene 

would facilitate MON 87705’s survival in unmanaged areas. 

In the 2007 growing season, Monsanto evaluated 14 phenotypic and agronomic 

characteristics in 17 field locations in the United States (Petition, 2009, p. 124, Table 

VIII-3). Data such as emergence, seedling vigor, plant height, lodging, days to maturity, 

shattering, seed weight, yields, disease incidence and insect damage were used to assess 

whether there was an increase in weediness potential. Monsanto observed four 

statistically significant differences between MON 87705 and the control: (1) early stand 

count, (2) final stand count, (3) days to 50% flowering, and (4) seed weight. MON 87705 

was lower than control for both early stand count and final stand count (Petition, 2009, p. 

349-350, Table G-3, Appendix G). MON 87705 flowered about one day later than the 

control and the weight of 100 seeds was lower for MON 87705 compared to the control 

(15.6g vs. 16.1g). APHIS is not aware of any information indicating that decreased stand 

counts, seed weight or differences in days to 50% flowering would contribute to an 

increased weediness potential of soybean.

Monsanto also did comparative assessments of seed dormancy and germination 

characteristics on MON 87705 and A3525 (a conventional variety), where A3525 served 

as a control because it has background genetics similar to MON 87705 but does not 

possess the transgenes. The data related to seed germination characteristics were used to 

assess whether there was an increase in weediness potential. Four statistically significant 

differences were detected between MON 87705 and the control: (1) MON 87705 had 

lower percent viable hard seed (0.0 vs. 0.3%) at 20°C, (2) MON 87705 had lower percent 

germinated seed at 30°C (92.8 vs. 95.5%), (3) MON 87705 had higher percent dead seed 

at 30°C (7.3 vs. 4.5%), and (4) MON 87705 had higher percent dead seed at 20/30oC (2.7 

vs. 1.3%). A decrease in hard seed, a lower percent germinated seed and higher percent 

dead seed would not contribute to increased weediness. Furthermore, all values were 

well within the recommended standards for certified soybean seed (AOSCA, 2009).

These data provide an evaluation of the phenotypic and agronomic characteristics of 

MON 87705 compared to the conventional A3525 control. Results from the phenotypic 

and agronomic assessments indicate that MON87705 does not possess characteristics that 

would confer a plant pest risk compared to conventional soybean. These data indicate
Assessment of Plant Pest Risk for MON 87705 Soybean

10

that the engineered plant is not different in any fitness characteristics from its parent that 

might cause MON 87705 to become weedy or invasive. Therefore, soybean is unlikely to 

become a weed through the introduction of the glyphosate tolerance trait. 

A few earlier investigations (Kodama et al., 1994 and Kodama et al.,1995) indicated that 

the increases in levels of trienoic fatty acids such as hexadecatrienoic acid and linolenic 

acid could enhance cold tolerance in model plants such as Arabidopsis and tobacco. In 

MON 87705, the levels of linolenic acid are significantly decreased. The decreased 

levels of linolenic acid in MON 87705 would, therefore, not be expected to enhance cold 

tolerance. If the seed overwintering capacity improved, the potential for a successful 

weed could increase. There is no indication that MON 87705 possesses a selective 

advantage that would result in increased weediness potential. Therefore, the chances for 

MON 87705 to behave as a weed are negligible.

From these observations and data submitted in the petition, APHIS concludes that there 

are no weediness risk issues associated with MON 88705.

Potential impacts from transferring genetic information from MON 87705 to 

organisms with which it cannot interbreed.

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

unlikely to occur. First, many genomes (or parts thereof) have been sequenced from 

bacteria that are closely associated with plants including Agrobacterium and Rhizobium 

(Kaneko et al., 2000; Wood et al., 2001; Kaneko et al., 2002). There is no evidence that 

these organisms contain genes derived from plants. Second, 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 (Koonin et al., 2001;

Brown, 2003). Third, 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. 

Fourth, the 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 significant 

environmental or plant pest risk. 

Conclusion 

APHIS has reviewed the potential of MON 87705 to pose a plant pest risk and conducted 

an assessment based on the information provided by the petitioner on MON 87705. 

APHIS determined no plant pest risk would derive from the inserted genetic material, 

found no atypical responses to disease or plant pests in the field, assessed that weediness 

of other plants with which MON 87705 can interbreed would be unlikely, discerned no
Assessment of Plant Pest Risk for MON 87705 Soybean

11

weediness characteristics of MON 87705, and found no expectation for horizontal gene 

transfer, so that APHIS concludes that MON 87705 is unlikely to pose a plant pest risk.

References:

Ahrent, D.K., Caviness, C.E. (1994) Natural cross-pollination of twelve soybean cultivars 

in Arkansas. Crop Sci. 34:376-378. 

Alibhai, M.F., and W.C. Stallings. (2001). Closing down on glyphosate inhibition - with 

a new structure for drug discovery. Proceedings of the National Academy of 

Sciences U.S.A. 98:2944-2946.

AOSCA (The Association of Official Seed Analysts). 2009. Operational Procedures, 

Crop Standards and Service Programs. Association of Official Seed Certifying 

Agencies, Meridian, Idaho.

Axelos, M., Bardet, C., Libox, T., Le Van Thai, A., Curie, C., Lescure, B. (1989) The 

gene family encoding the Arabidopsis thaliana translation elongation factor EF-1 

alpha: molecular cloning, characterization and expression. Molecular and 

General Genetics 219:106-112.

Barry, G., Kishore, G., Padgette, S., Stallings, W. (1997) Glyphosate-tolerant 5-

enolpyruvylshikimate-3-phosphate synthases. U.S.A. Patent 5, 633, 435.

Bondia-Pons, I., chroder, H., Covas, M., Castellote, A.I., Kaikkonen, J., Poulsen, H.E., 

gaddi, A.V., Machowetz, A., Kiesewetter, H., Lopez-Sabater, C. (2007) 

Moderate consumption of olive oil by healthy European men reduces systolic 

blood pressure in non-Mediterranean participants. The Journal of Nutrition 

(137):84-87.

Broich, S.L. (1978) The systematic relationships within the genus Glycine Willd. 

Subgenus soja (Moench) F.J. Hermann. M.S. thesis. Iowa State University, Ames.

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

Caviness, C.E. (1966) Estimates of natural cross-pollination in Jackson soybeans in 

Arkansas. Crop Science 6:21.

CFIA (Canadian Food Inspection Agency) (2000) Decision Document 2001-34:

Determination of the Safety of Optimum Quality Grains L.L.C.'s High Oleic 

Soybean (Glycine max) lines G94-1, G94-19, and G-168

Derived from Transformation Event Line 260-05 

http://www.inspection.gc.ca/english/plaveg/bio/dd/dd0134e.shtml#a13. Accessed 

on 11/03/2008
Assessment of Plant Pest Risk for MON 87705 Soybean

12

Coruzzi, G., Broglie, R., Edwards, C., Chua, N. (1984) Tissue-specific and lightregulated expression of a pea nuclear gene encoding the small subunit of ribulose1, 5- bis phosphate carboxylase. EMBO Journal 3: 1671-1679. 

Crockett, L. (1977) Wildly Successful Plants: North American Weeds. University of 

Hawaii Press, Honolulu, Hawaii. 609 pp.

Doyle, J., Schuler, M., Godette, W., Zenger, V., Beachy, R. (1986) The glycosylated seed 

storage proteins of Glycine max and Phaseolus vulgaris. Journal of Biological 

Chemistry 261:9228-9238

FDA (U.S. Food and Drug Administration) (1998) Guidance for industry: use of 

antibiotic resistance marker genes in transgenic plants, draft guidance. Sept. 4, 

1998. 

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/Guidance

Documents/Biotechnology/ucm096135.htm

FDA (U.S. Food and Drug Administration) (2000) Biotechnology Consultation Note to 

the File BNF No. 000071. 

http://www.fda.gov/Food/Biotechnology/Submissions/ucm155788.htm

FDA (U.S. Food and Drug Administration) (2004) Biotechnology Consultation Note to 

the File BNF No. 000090. 

http://www.fda.gov/Food/Biotechnology/Submissions/ucm155775.htm

FDA (U.S. Food and Drug Administration) (2005) Biotechnology Consultation Note to 

the File BNF No. 000098. 

http://www.fda.gov/Food/Biotechnology/Submissions/ucm155614.htm

FDA (U.S. Food and Drug Administration) (2006) Biotechnology Consultation Note to 

the File BNF No. 000104.

http://www.fda.gov/Food/Biotechnology/Submissions/ucm155610.htm

Fillatti, J., Bringe, N., Dehesh, K. (2003) Nucleic acid constructs and methods for 

producing altered seed oil compositions. International Patent WO 2003/080802 

A3. 

Franz, J. E., Mao, M. K.; Sikorski, J. A. Glyphosate’s Molecular Mode of Action. In 

Glyphosate: A Unique Global Herbicide. ACS Monograph 189; American 

Chemical Society: Washington, DC, 1997; pp 521-615.

Garber, R., Odland, T. (1926) Natural crossing in soybeans. Am Soc. Agron. J. 18:967-

970
Assessment of Plant Pest Risk for MON 87705 Soybean

13

Heppard, E.P., Kineey, A.J., Stecca, K.L., Miao, G.-H. (1996) Developmental and growth 

temperature regulation of two different microsomal omega-6 desaturase genes in 

soybeans. Plant Physiology 110:311-319

Holm, L., Pancho, J. V., Herbarger, J. P., and Plucknett, D. L. (1979) A Geographical 

Atlas of World Weeds. John Wiley and Sons, New York. 391 pp.

Hymowitz, T., Singh, R.J. (1987) Taxonomy and Speciation in Soybean: 

Improvement, Production, and Uses-Second Edition. American Society of 

Agronomy. 

Kaneko, T., Y. Nakamura, S. Sato, E. Asamizu, T. Kato, and S. Sasamoto. (2000)

Complete genome structure of the nitrogen-fixing xymbiotic bacterium 

Mesorhizobium loti. DNA Research. 7:331-338. 

Kaneko, T., Nakamura, Y., Sato , S., Minamisawa, K., Uchiumi, T., Sasamoto, S., 

Watanabe, A., Idesawa, K., Iriguchi, M., Kawashima, K., Kohara, M., 

Matsumoto, M., Shimpo, S., Tsuruoka, H., Wada, T., Yamada, M., Tabata, S. 

(2002) Complete genomic sequence of nitrogen-fixing symbiotic bacterium 

Bradyrhizobium japonicum USDA110. DNA Research 9(6):189-197

Karasawa, K. (1952) Crossing Experiments with Glycine soja and G. gracilis. Genetica 

26:357-358.

Kodama, H., Hamada, T., Horiguchi, G., Nishimura, M., and Iba, K. (1994) Genetic 

enhancement of cold tolerance by expression of a gene for chloroplast ω-3 fatty 

acid desaturase in transgenic tobacco. Plant Physiology 105:601-605.

Kodama, H., Horiguchi, G., Nishiuchi, M., Nishimura, M., and Iba, K. (1995) Fatty acid 

desaturation during chilling acclimation is one of the factors involved in 

conferring low temperature tolerance to young tobacco leaves. Plant Pathology 

107:1177-1185. 

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

Quantification and Classification. Annu. Rev. Microbiol. 55:709-742 

Lichtenstein, A., Mathan, N.R., Jalbert, S.M., Resteghini, N.A., Schaefer, E.j., Ausman, 

L.M. (2006) Novel soybean oils with different fatty acid profiles alter 

cardiovascular disease risk factors in moderately hyperlipidemic subjects. Am. J. 

Clin. Nutr. 84:497-504

Martinell, B., Julson, L., Emler, C., Yong, H., McCabe, D., Williams, E.,inventors. 

(2002) Soybean Agrobacterium transformation method.U.S. Patent Application 

No. 6384301.
Assessment of Plant Pest Risk for MON 87705 Soybean

14

Mata, P., Alvarez-Sala, L.A., Rubio, M.J., Oya, M.D. (1992) effects of long-term 

monounsaturated- vs polyunsaturated-enriched diets on lipoproteins in healthy 

men and women. Am J Clin Nutr 55:846-850

Mensink, R.P., Katan, M.B. (1989) Effect of a diet enriched with monounsaturated or 

polyunsaturated fatty acids on levels of low-density and high density lipoprotein 

cholesterol in healthy women and men. New England Journal of Medicine Vol. 

321 No 7.

Mozaffarian D, Katan MB, Ascherio A, Stampfer MJ, Willett WC. (2006) Trans fatty 

acids and cardiovascular disease. N Engl J Med. 13;354(15):1601-13.

Muenscher, W. C. (1980) Weeds. Second Edition. Cornell University Press, New York 

and London. 586 pp.

Newell, C.A., Hymowitz, T. (1978) A reappraisal of the subgenus. Am. J. Bot. 

65(2):168-179

OECD (Organization of Economic Co-operation and Development). (2000) Consensus 

document on the biology of Glycine max (soybean). OECD, 

ENV/JM/MONO(2000)15.

OECD (Organization of Economic Co-operation and Development) (2001) Consensus 

Document on compositional considerations for new varieties of soybean: key food 

and feed nutrients and anti-nutrients. Organisation for Economic Co-operation 

and Development ENV/JM/MONO (2001)15.

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 Ready gene. Pp53-84. In S.O. Duke 

(ed.). Herbicide Resistant Crops-Agricultural, Environmental, Economic, 

Regulatory, and Technical Aspects. CRC Press, Boca Raton, Florida.

Ray, J., Kilen, T., Abel, C., Paris, R. (2003) Soybean natural cross-pollination rates under 

field conditions. Environmental Biosafety Research 2(2003) 133-138.

Rogan, G.J. (2009). Petition for the Determination of Nonregulated Status for Improved 

Fatty Acid Profile MON 87705 Soybean. Monsanto Petition no. 09-SY-201U. 

APHIS Petition 09-201-01p.

Skvortzow, B.V. (1972). The soybean-wild and cultivated in Eastern Asia. Proc 

Manchurian Res. Soc Publ Ser A. Natural History Sect. No. 22:1-8

USDA-APHIS (1993) Monsanto Company Petition for a determination of nonregulated 

status for the glyphosate tolerant soybean (GTS) line 40-3-2: Environmental 

Assessment. http://www.aphis.usda.gov/brs/not_reg.html. Accessed 6/29/2010
Assessment of Plant Pest Risk for MON 87705 Soybean

15

USDA-APHIS (1997) DuPont Petition 97-008-01p for determination of nonregulated 

status for transgenic High Oleic Acid soybean sublines G94-1, G94-19, and G168: Environmental Assessment and Finding of No Significant Impact. 

http://www.aphis.usda.gov/brs/aphisdocs2/97_00801p_com.pdf. Accessed 

6/29/2010

USDA-APHIS (2000) U.S. Department of Agriculture, Animal and Plant Health 

Inspection Service, Regulated Plant Pest List. 

http://www.invasivespecies.org/RegulatedPestList.pdf. Accessed 10/14/2008

USDA-APHIS (2006) Pioneer Hi-Bred International Petitions 06-271-01p for 

determination of Nonregulated Status for transgenic herbicide tolerant 356043 

soybean: Environmental Assessment. 

http://www.aphis.usda.gov/brs/not_reg.html. Accessed 11/10/2008

USDA-APHIS (2010 a) Federal Noxious Weed List as of May 1, 2010 

http://plants.usda.gov/java/noxiousDriver#federal Accessed on 6/29/2010

USDA-APHIS (2010 b) States Noxious Weed Lists

http://plants.usda.gov/java/noxiousDriver#state Accessed on 6/29/2010

USDA-ARS (2006) USDA food and nutrient database for dietary studies, 2.0 (2006) 

Beltsville, MD., ARS, Food Surveys Research Group 

(http://www.ars.usda.gov/ba/bhnrc/fsrg)

USDA-NASS (2009a) Newsroom (Acrage)

http://www.nass.usda.gov/Newsroom/2010/01_12_2010.asp. Accessed 6/9/2010

USDA-NASS (2009b) Adoption of genetically engineered crops in the U.S.

http://www.ers.usda.gov/Data/biotechcrops/. Accessed 6/9/2010

Wood, D. W., J. C. Setubal, R. Kaul, D. E. Monks, J. P. Kitajima, V. K. Okura, Y. Zhou, 

L. Chen, G. E. Wood, N. F. Almeida Jr., L. Woo, Y. Chen, I. T. Paulsen, J. A. 

Eisen, P. D. Karp, D. Bovee Sr., P. Chapman, J. Clendenning, G. Deatherage, W. 

Gillet, C. Grant, T. Kutyavin, R. Levy, M.-J. Li, E. McClelland, A. Palmieri, C. 

Raymond, G. Rouse, C. Saenphimmachak, Z. Wu, P. Romero, D. Gordon, S. 

Zhang, H. Yoo, Y. Tao, P. Biddle, M. Jung, W. Krespan, M. Perry, B. GordonKamm, L. Liao, S. Kim, C. Hendrick, Z.-Y. Zhao, M. Dolan, f. Chumley, S. V. 

Tingey, J.-F. Tomb, M. P. Gordon, M. V. Olson, and E. W. Nester. (2001) The 

genome of the natural genetic engineer Agrobacterium tumefaciens C58. Science. 

294:2317-2323.

Yoshimura, Y., Matsuo, K., Yahuda, K. (2006) Gene flow from GM glyphosate-tolerant 

to conventional soybeans under field conditions in Japan. Environmental 

Biosafety Research. 5:169-173.