BASF Petition (09-015-01p) for Determination of Nonregulated Status of CV127 Herbicide Tolerant

Soybean

OECD Unique Identifier: 

BPS-CV127-9

Plant Pest Risk Assessment 

January 2014

Agency Contact 

Cindy Eck

Biotechnology Regulatory Services

4700 River Road

USDA, APHIS 

Riverdale, MD 20737 

Fax: (301) 734-8669

The U.S. Department of Agriculture (USDA) prohibits discrimination in all its programs and activities on the basis of 

race, color, national origin, sex, religion, age, disability, political beliefs, sexual orientation, or marital or family status. 

(Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for 

communication of program information (Braille, large print, audiotape, etc.) should contact USDA’S TARGET Center 

at (202) 720–2600 (voice and TDD). 

To file a complaint of discrimination, write USDA, Director, Office of Civil Rights, Room 326–W, Whitten Building, 1400 

Independence Avenue, SW, Washington, DC 20250–9410 or call (202) 720–5964 (voice and TDD). USDA is an equal 

opportunity provider and employer. 

Mention of companies or commercial products in this report does not imply recommendation or endorsement by the 

U.S. Department of Agriculture over others not mentioned. USDA neither guarantees nor warrants the standard of any 

product mentioned. Product names are mentioned solely to report factually on available data and to provide specific 

information. 

This publication reports research involving pesticides. All uses of pesticides must be registered by appropriate State 

and/or Federal agencies before they can be recommended. 
TABLE OF CONTENTS

A. Introduction................................................................................................................. 1

B. Development of CV127 Herbicide Tolerant Soybean................................................ 1

C. Expression of the Gene Product and Changes to Plant Metabolism........................... 4

D. Potential Impacts on Disease and Pest Susceptibilities.............................................. 6

E. Potential Impacts on Nontarget Organisms Beneficial to Agriculture ....................... 7

F. Potential for Enhanced Weediness of CV127 Soybean.............................................. 7

G. Potential Impacts on the Weediness of Any Other Plants with which It Can 

Interbreed................................................................................................................... 8

H. Potential Changes to Agriculture or Cultivation Practices......................................... 9

I. Potential Impacts from Transfer of Genetic Information to Organism with 

which CV127 Soybean Cannot Interbreed ................................................................ 9

J. Conclusion ................................................................................................................ 10

K. References................................................................................................................. 10

i
A. Introduction

BASF Plant Science, L.P. (BASF) has petitioned APHIS (APHIS number 09-015-01p) 

for a determination that genetically engineered (GE) soybean (Glycine max) event BPSCV127-9 (CV127) is unlikely to pose a plant pest risk (BASF, 2011) 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 whether CV127 soybean is unlikely to pose a plant pest risk. 

Event BPS-CV127-9 was produced by transformation of embryogenic axis tissue derived 

from the apical meristem of soybean (Glycine max, cv Conquista) via biolistics

transformation technology. None of the introduced genetic sequences come from plant 

pest organisms listed in 7 CFR 340.2. Because CV127 soybean was introduced 

(interstate movement and field release) under APHIS’ authorization, this soybean has 

been considered a regulated article under APHIS regulations at 7 CFR part 340.

Potential impacts considered in this Plant Pest Risk Assessment are those that pertain to 

the use of CV127 soybean and its progeny in the absence of confinement. APHIS 

regulation 7 CFR 340.6(c) specifies the information needed for consideration in a petition 

for non-regulated status. APHIS will evaluate information submitted by the applicant, in 

addition to current literature, 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, potential changes to agricultural or cultivation 

practices, potential effects on non-target organisms and transfer of genetic information to 

organisms with which it cannot interbreed, to determine if CV127 soybean is unlikely to 

pose a plant pest risk. If APHIS determines that a GE organism is not a plant pest risk, 

then APHIS has no regulatory authority over that organism. 

B. Development of CV127 Herbicide Tolerant2 Soybean 

For the past 50 years, the United States (U.S.) has been the world’s leading producer of 

soybeans and in 2010 approximately 90.6 MMT were produced in the U.S., or about 35% 

of the world’s total production (Soy Stats, 2011). The second and third largest producers 

of soybean are Brazil and Argentina who produced 70.0 and 49.5 MMT of soybeans, 

respectively, in 2010 (Soy Stats, 2011). Soybean production in Brazil has increased 

1 Section 403 (14) of the Plant Protection Act (7USC Sec 7702(14) defines plant pest as: “Plant Pest - The term “plant pest” means 

any living stage of any of the following that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant 

product: (A) A protozoan. (B) A nonhuman animal. (C) A parasitic plant. (D) A bacterium. (E) A fungus. (F) A virus or viroid. (G) An 

infectious agent or other pathogen. (H) Any article similar to or allied with any of the articles specified in the preceding 

subparagraphs.”

2

The applicant has described CV127 soybean 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 CV127 soybean 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. 

1

 
dramatically in recent years with a 31 MMT increase in production between 2000 and 

2010 (Soy Stats, 2011).

Soybean CV127 was developed for cultivation primarily in Brazil and Argentina and the 

introduction of CV127 soybean varieties will offer soybean growers an additional tool for 

controlling weeds, as well as an important option for weed resistance management. The 

major weeds in soybean cultivation in these countries are sensitive to the imidazolinone 

herbicides containing imazapyr and imazapic. Regulatory approvals for CV127 are being 

sought in Brazil and Argentina for production as well as for food and feed uses, and in 

the U.S. and other countries for importation of grain from CV127 soybean for food, feed, 

and processing uses (BASF, 2011).

Soybeans are naturally tolerant to some imidazolinone herbicides due to an ability to 

metabolize specific imidazolinones (Tecle, 1993). There are certain imidazolinone 

compounds, for example imazapyr and imazapic, which are active ingredients in a 

number of imidazolinone herbicide products and are not readily metabolized in soybeans. 

As a result, conventional soybeans are very sensitive to imazapyr and imazapic. CV127 

soybeans would be tolerant to the use of imidazolinone herbicides containing these active 

ingredients for effective weed control (BASF, 2011). 

Imidazolinone herbicides control a wide spectrum of grass and broadleaf weeds. The 

growing use of glyphosate with glyphosate-tolerant soybeans in Argentina and Brazil has 

led to a shift in the species of prevalent weeds with those that are more tolerant to 

glyphosate predominating. The most common weeds in this category include Benghal 

dayflower (Commelina benghalensis L.), morning glory (Ipomoea spp.), Brazil pusley

(Richardia brasiliensis), and winged false buttonweed (Spermacoce alata). These weeds 

are sensitive to imidazolinone herbicides (BASF, 2011).

There are many similarities in agronomic practices used in soybean production between 

the U.S. and Brazil, including weed, insect and disease control practices. The Maturity 

Groups of Brazilian soybean cultivars are common to those appropriate for cultivation in 

the southern U.S. Furthermore, environmental conditions during the growing season, 

including average temperatures and rainfall, are comparable between U.S. and Brazilian 

soybean production. Details of these similarities are presented in section IX of the 

petition (BASF, 2011). Therefore, in the event that CV127 soybean were to be introduced 

into the U.S. environment, the data generated from field studies conducted in Brazil to 

support the environmental as well as food and feed safety of CV127 soybeans are equally 

applicable to the environmental, food and feed safety assessments of CV127 in the U.S.

In the U.S., soybean was grown on approximately 75.0 million acres in 2011 (Figure 1, 

USDA NASS, 2011a) with a value of $29.6 billion in 2008/2009 (USDA ERS, 2011a). 

Growers select soybean lines adapted to the different environmental and climatic 

features, operator’s education, weed and disease pressures, cost of seed and other inputs, 

technology fees, human safety, ease and flexibility of the productions system and 

marketing reasons (USDA ERS, 2002; Brookes, 2011).

2
Figure 1. Soybean production areas in the U.S. (USDA NASS 2011b).

The presence of weeds in soybean fields can cause greater production losses than either 

insects or diseases (Gibson, 2005; Oerke, 2006). Before the development of effective 

herbicides for the selective control of weeds in soybeans in the early 1960’s, cultural 

practices including tillage, use of weed free seed, row spacing and crop rotation were the 

only ways to control weeds (Wax, 1973). By 1987, over 30 herbicides were being used 

on soybeans (Jordan, 1987). With the 1996 commercial introduction and rapid adoption 

of glyphosate tolerant soybeans, a major change in herbicide usage occurred with an 

increasing use of glyphosate concurrent with the increased planting of glyphosate tolerant 

soybeans and a decrease in use of other soybean herbicides (Figure 2; NRC, 2010;

Young, 2006). Consequently, the diversity of herbicides used for weed management has 

declined in soybean (Table 1; Young, 2006) resulting in weed species shifts (Johnson,

2009). CV127 soybean would provide soybean growers with additional options for the 

post-emergent control of both broadleaf and grass weeds. The integration of other 

herbicides with different modes of action with glyphosate has been encouraged to 

improve the duration of weed control, to enhance control of glyphosate tolerant weeds, to 

reduce the risk of developing glyphosate resistant weeds and to control glyphosateresistant weeds (WSSA, 2010). This soybean product would also provide a potential 

remedy to the increased incidence of weed species that are more tolerant to glyphosate 

(BASF, 2011; NRC, 2010; WSSA, 2010).

Figure 2. Percent acreage of genetically engineered crops in the U.S. (USDA ERS, 2011b).

3
1990 2000 2006 1990 2000 2006

2,4,D, Dimeth. salt 3 Imazamox 6

2,4,D 3 5 Imazaquin 16 4 1

Acetic acid (2,4-D) 10 4 7 Imazethapyr 11 12 3

Acifluorfen 3 Lactofen 1 2

Alachlor 13 1 Linuron 6

Bentazon 16 2 Metolachlor 10 2

Clethodim 4 3 Metribuzin 19 4 2

Clomazone 7 Paraquat 2 1

Ethalfluralin 5 Pendimethalin 14 11 3

Fenoxaprop 4 Quizalofop 3

Fluazifop 6 5 1 S-Metolachlor 1

Flumetsulam 2 2 Sethoxydim 4 2

Flumioxazin 3 Sulfentrazone 4 1

Fomesafen 4 7 2 Tribenuron, methyl 1

Glyphosate 5 62 92 Trifluralin 37 14 2

Glyphosate, diam. 

salt 4

Table 1. Average (across all states) percent of U.S. soybean acres treated with the following herbicides in 

1990, 2000 and 2006 (USDA NASS, 2011c).

CV127 is a GE soybean line that has been developed to increase tolerance to 

imidazolinone herbicides. The introduced genetic material results in the production of 

acetohydroxyacid synthase large subunit (AtAHAS) enzyme that is tolerant to 

imidazolinone herbicides due to a point mutation that results in a single amino acid 

substitution in which the serine residue at position 653 is replaced by asparagine 

(S653N). The introduced genetic material, the AtAHAS enzyme, is identical to the 

native AHAS enzyme (BASF, 2011).

C. Expression of the Gene Product and Changes to Plant Metabolism

The CV127 soybean plants are derived from a single transformation event and were 

produced by introduction of the imidazolinone-tolerant acetohydroxyacid synthase large 

subunit (AHAS) gene csr1-2 with its native promoter from Arabidopsis thaliana into the 

soybean plant genome via biolistics transformation technology. The csr1-2 gene from 

A.thaliana encodes an acetohydroxyacid synthase large subunit (AtAHAS) enzyme 

which is functionally identical to the native AtHAS enzyme except that it is tolerant to 

imidazolinone herbicides due to a point mutation that results in a single amino acid 

substitution in which the serine residue at position 653 is replaced by asparagine 

(S653N). The AtAHAS catalytic subunit encoded by the csr1-2 gene has altered 

herbicide binding properties such that imidazolinone herbicides do not bind to the 

enzyme while retaining its normal biosynthetic function in the plant (Pang, 2002).

The Arabidopsis AHAS (AtAHAS) is a member of the class of AHAS proteins found 

ubiquitously in plants. The AHAS enzyme catalyzes the first step in the biosynthesis of 

the branched-chain amino acids valine, leucine, and isoleucine. Typically, inhibition of 

the AHAS enzyme by imidazolinone herbicides leads to a deficiency in branched-chain 

4
amino acids and other compounds derived from this pathway that are needed for plant 

growth and survival, and results in plant death.

Several AHAS genes encoding AHAS enzymes that are tolerant to imidazolinone 

herbicides have been discovered in plants as naturally occurring mutations and through 

the process of chemically-induced mutagenesis. The S653N mutation in the csr1-2 gene 

is among the five most common single-point mutations in AHAS genes that result in 

tolerance to imidazolinone herbicides in plants (Tan, 2005). For example, imidazolinonetolerant maize (Zea mays L.), rice (Oryza sativa L.), bread wheat (Triticum aestivum L.), 

and oilseed rape (Brassica napus and B. juncea L. Czern.), were developed through 

mutagenesis, selection, and conventional breeding technologies and have been 

commercialized under the Clearfield® brand name since 1992, 2003, 2002, and 1996, 

respectively.

Molecular characterization of CV127 soybean demonstrated that the csr1-2 gene cassette 

was inserted into the soybean genome as a single, intact copy (BASF, 2011; Section V). 

Furthermore, it was demonstrated that there are no additional fragments of DNA derived 

from the backbone of the plasmid used to produce the DNA transformation fragment 

inserted within the genome of CV127 soybeans (BASF, 2011; Section V). In the insert, 

there is also a 376 base pair (bp) duplication of a portion of the csr1-2 coding sequence 

directly before the 3’ integration point. This duplicated 376 bp segment creates a 501 bp 

open reading frame (ORF) that extends into the 3’ flanking sequence. Reverse 

transcription-polymerase chain reaction (RT-PCR) results showed that this 501 bp ORF 

is not transcribed. In addition to the csr1-2 native gene promoter, the region upstream of 

(i.e. 5’ to) the csr1-2 coding sequence contains the complete coding sequence of the A. 

thaliana SEC61 (AtSEC61) gamma (γ) subunit protein, which is a component of the 

DNA fragment used for transformation. This protein is part of a multi-subunit secretory 

complex that is ubiquitous in all eukaryotes. The AtSEC61 γ 5’ UTR, as annotated by 

The Arabidopsis Information Resource, begins 18 nucleotides downstream from the 5’ 

transgene integration site. As such, it is extremely unlikely that the insert contains the 

complete native promoter for the AtSEC61 γ gene. Protein expression studies 

demonstrated that no detectable A. thaliana SEC61 gamma protein is produced in CV127 

soybean leaf tissue or grain (BASF, 2011; Section VI).

Southern blot analysis showed that the transgene insert in CV127 is stably integrated into 

the soybean genome across the breeding generations studied (BASF, 2011; Section V). 

This conclusion was confirmed in a study of the inheritance of the imidazolinonetolerance trait over multiple breeding generations of CV127 soybean (BASF, 2011; 

Section V). Results of this study demonstrated that the trait is stably inherited according

to classical Mendelian genetics, and results were consistent with the presence of a single 

dominant imidazolinone-tolerance gene in the soybean genome.

5
D. Potential Impacts on Disease and Pest Susceptibilities

APHIS assessed whether CV127 is likely to have significantly altered disease and pest 

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

disease and pest susceptibility data from CV127 field trials.

Soybean is not a plant pest in the U.S. (Hymowitz and Singh, 1987). DNA sequences 

that were incorporated in CV127 were not derived from plant pests and do not result in 

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

that CV127 could pose a plant pest risk. The description of the introduced genetic 

elements and expression of the gene products and their functions in CV127 has been 

summarized above. 

CV127 was released in seven different locations in Brazil during the 2006-2007 growing 

season and six locations during the 2007 growing season. These were conducted in 

geographically distinct locations that were representative of commercial soybean 

production in Brazil (BASF, 2011). BASF used well-established qualitative and 

quantitative techniques to observe insect and disease damage (BASF, 2011). The 

following insect pests were evaluated in the field: Coleopterans (Diabrotica and 

Aracanthus spp.), Lepidopterans (Anticarsia, Agrotis, Pseudoplusia, and Spodoptera

spp.), and Hemipterans (Euschistus, Piezodorus, and Nezara spp.). Resistance to insect 

damage and effects on in-field insect populations of CV127 soybean relative to the 

isoline control and conventional soybean varieties were assessed at different stages of 

plant growth and development throughout the growing season during the 2006/2007 and 

2007 growing seasons (BASF, 2011; Section VIII). Based upon the results of in-field 

evaluations for insect populations and resistance to insect damage, CV127 soybeans were 

found to be no different from that of the isoline control soybean or the conventional 

soybean varieties.

Disease susceptibility of CV127 soybeans relative to the isoline control and conventional 

soybean varieties was determined at different stages of plant growth and development 

throughout the growing season. Diseases that were assessed included Asian soybean rust 

(Phakopsora pachyrhizi), Downy mildew (Peronospora manshurica), Powdery mildew 

(Erysiphe diffusa), and end-of-cycle diseases (DC) caused mainly by Septoria glycines 

(brown spot or Septoriose) and Cercospora kikuchii (soybean leaf spot). Assessments 

were made at or near vegetative stage V4 and reproductive stages R1, R5, and R7. No 

disease infestations were observed at the V4 stage with the exception of powdery mildew 

in Santo Antônio de Goiás in 2007. Where susceptibility differences were observed, they 

were generally between varieties with the Conquista genetic background (CV127 

soybean and the isoline control) and the two conventional soybean varieties with different 

genetic backgrounds. Therefore, disease susceptibility of CV127 soybean was found to 

be no different from that of the isoline control plants. This study demonstrated that the 

insertion of the csr1-2 gene into the genome of CV127 soybean did not affect the disease 

susceptibility of CV127 soybean. A complete description of the disease assessment 

methodology is included in Appendix F of the petition (BASF, 2011). No qualitative or 

6
quantitative observations indicated any biologically meaningful differences from control 

lines or differences outside the range of different soybean varieties. 

Given the interactions between the environment, the genetic backgrounds of the cultivars 

used and some inherent genetic variability within soybean varieties, APHIS concludes 

that these results do not indicate an increased pest risk. Expression of the imidazolinonetolerant acetohydroxyacid synthase large subunit (AHAS) gene csr1-2 with its native 

promoter from Arabidopsis thaliana in CV127 soybean is not expected to cause plant 

disease or influence susceptibility of CV127 or its progeny to diseases or other pests.

E. Potential Impacts on Nontarget Organisms Beneficial to Agriculture

There is no reason to believe that deleterious effects or significant impacts on non-target 

organisms, including beneficial organisms, would result from the cultivation of CV127 

soybean. Field observations of CV127 soybean (BASF, 2011; Section IX) revealed no 

negative effects on non-target organisms, suggesting that the production of the AtAHAS 

enzyme in the plant tissues is not toxic to organisms. The introduced genetic material 

does not result in the production of novel proteins, enzymes, or metabolites in the plant 

that are known to have toxic properties. The lack of known toxicity of AtAHAS enzyme 

suggests no potential for deleterious effects on beneficial organisms such as bees and 

earthworms. The use of imidazolinone herbicides in the cultivation of CV127 soybean or 

its offspring is regulated by EPA under its existing regulations for the registration of 

pesticide use. EPA considers the impacts on the environment, including effects on nontarget organisms in establishing residue tolerances for imidazolinone tolerant lines 

(USEPA, 2006). APHIS has not identified any other potential mechanisms for deleterious 

effects on beneficial, threatened or endangered organisms.

F. Potential for Enhanced Weediness of CV127 Soybean

APHIS assessed whether CV127 soybean is any more likely to become a weed than the 

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

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

evaluation of unique characteristics of CV127 soybean.

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, in comparison to the 

non-GE comparator (isoline control). If the fitness of CV127 soybean 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 

CV127 soybean has a negligible likelihood of increased weediness. 

In the U.S., soybean is neither listed as a weed in the major weed references (Crockett,

1977; Holm, 1979; Muenscher, 1980) nor is it designated as noxious weed by the federal 

government (USDA NRCS, 2011). Soybean does not possess any of the attributes 

commonly associated with weeds (Baker, 1965), such as long persistence of seed in the 

soil, the ability to disperse, invade, and become a dominant species in new or diverse 

landscapes, or the ability to compete well with native vegetation. Furthermore, mature 

7
soybean seeds have no innate dormancy, are sensitive to cold, are not expected to survive 

in freezing winter conditions and do not reproduce vegetatively (Hermann, 1962; OECD,

2000; Padgette, 1996; Raper Jr. & Kramer, 1987). 

From 2006 through 2007, BASF conducted field trials to evaluate phenotypic 

characteristics comparing CV127 with the non-transgenic soybean isoline control and 

two conventional soybean varieties (BASF, 2011). Results on growth characteristics, 

seed production and germination indicate that CV127 is not significantly different from 

its comparators (BASF, 2011). No biologically meaningful differences were observed 

across sites between CV127and the isoline control. 

To increase weediness of the soybean plant there would have to be selection pressure on 

the line (Tiedge, 1989). Because imidazolinones will not affect the survival of CV127 

and because soybean is not itself weedy, this type of selection pressure does not now and 

is unlikely to exist.

There is no indication that CV127 possesses a selective advantage that would result in 

increased weediness. CV127 lacks the ability to persist as a troublesome weed, and there 

would be no significant impact on current weed management practices for soybean 

cultivation.

G. Potential Impacts on the Weediness of Any Other Plants with which 

It Can Interbreed

The genus Glycine, a member of the Fabaceae (= Leguminosae or pea family), consists of 

two subgenera, soja and glycine (OECD, 2000; USDA NRCS, 2012). Perennial species 

in the subgenus glycine do not occur in the U.S. (USDA NRCS, 2012), except in the U.S. 

territories in the South Pacific (Hymowitz and Singh, 1987). The subgenus soja consists 

of three annual species: G. soja Sieb. and Zucc., the wild form of soybean; G. gracilis

Skvortz., the weedy form of soybean; and G. max (L.) Merr., the cultivated soybean. G. 

soja and G. max do not occur naturally in the U.S. (Hermann, 1962; Hymowitz, 1987; 

USDA NRCS, 2012). Hybrids from crosses between the subspecies have generally been 

sterile, and further progeny have only been obtained with extreme difficulty (OECD,

2000).

Cultivated soybean is highly self-pollinating (Ahrent, 1994). When soybean plants are 

grown directly adjacent to other soybean plans, the amount of natural cross pollination 

has generally been found to be 0.5 - 1 percent (Fehr, 1980; OECD, 2000) although higher 

values (up to 2.5 percent) have been noted in some varieties (Abud, 2007). Outcrossing 

can be reduced to 0 – 0.01 percent with a separation distance of 10 meters (Abud, 2007). 

The cultivated soybean, G. max, lacks sexually compatible wild relatives in the U.S. and 

its territories. Consequently, there is no potential for gene flow from cultivated soybean 

plants to wild relatives in the U.S. Therefore, it is not likely that gene flow and 

introgression will occur between CV127 soybean and other species of soybean. APHIS 

8
has determined that any adverse consequences of gene flow from CV127 soybean to wild 

or weedy species in the United States are highly unlikely.

H. Potential Changes to Agriculture or Cultivation Practices

None of the management practices currently employed for soybean production is 

expected to change if CV127 soybean 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. BASF’s (2011) studies demonstrate that the agronomic characteristics 

and cultivation practices employed when growing CV127 soybean are essentially 

indistinguishable from practices used to grow other soybean varieties, including other 

herbicide-tolerant varieties (BASF, 2011; Section IX). Although CV127 soybean might 

be expected to replace other varieties of soybean currently cultivated, additional acreage 

is not expected to be developed to accommodate the cultivation of CV127 soybean

(BASF, 2011). CV127 soybean is comparable to currently available soybean varieties in 

terms of resistance to insects and disease (BASF, 2011; Section IX). Therefore, no 

changes are expected for insect and disease control practices with CV127 soybean. 

Based on its analysis, APHIS concludes that there would be no adverse impacts on 

agricultural practices associated with the use of the CV127 soybean.

I. Potential Impacts from Transfer of Genetic Information to 

Organism with which CV127 Soybean Cannot Interbreed

APHIS examined the potential for the new genetic material inserted into CV127 soybean

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 soybean 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 

9
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.

4. 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 BPSCV127-9 is likely to pose a plant pest risk. Based on the information provided by the 

applicant and the lack of atypical responses to disease or plant pests in the field, weedy 

characteristics of the CV127 soybean or other plants with which it can interbreed, 

changes to agricultural or cultivation practices, effects on non-targets or beneficial 

organisms in the agro-ecosystem, indirect effects on other agricultural products and the 

unlikelihood of horizontal gene transfer, APHIS has concluded that soybean event BPSCV127-9 is highly unlikely to pose a plant pest risk. 

K. References

Abud, S., de Souza, P.I.M., Vianna, G.R., Leonardecz, E., Moreira, C.T., Faleiro, F.G., 

Júnior, J.N., Monteiro, P.M.F.O., Rech, E.L., Aragão F.J.L. (2007) Gene flow 

from transgenic to nontransgenic soybean plants in the Cerrado region of Brazil. 

Genetics and Molecular Research 6:445-452.

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

Arkansas. Crop Science 34:376-378. 

BASF (2011) BASF Plant Science, L.P., Petition for the Determination of Nonregulated 

Status for Imidazolinone-tolerant Soybean BPS-CV127-9. Submitted by J.M. 

Ligon, Research Triangle Park, NC.

Baker, H. B. (1965) “Characteristics and modes of origin of weeds” pp. 147-169 In H. G. 

Baker and G. L. Stebbins (eds.) The Genetics of Colonizing Species. Academic 

Press, London. 

Brookes, G., Barfoot, P. (2011) The income and production effects of biotech crops 

globally 1996-2009. International Journal of Biotechnology 12:1-49.

10
Brown, J.R. (2003) Ancient horizontal gene transfer. Nature Reviews Genetics 4:121-

132. 

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

Hawaii Press, Honolulu, Hawaii. 609 pp.

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

Transgenic Plants. pp. 28. 

Fehr, W.R., Hadley, H.H. (1980) Hybridization of Crop Plants. American Society of 

Agronomy and Crop Science Society of America, Madison, Wisconsin. (p. 592).

Gibson, K.D., Johnson, W.G., Hillger, D.E. (2005) Farmer perceptions of problematic 

corn and soybean weeds in Indiana. Weed Technology 19:1065-1070.

Hermann, F.J. (1962) A revision of the genus Glycine and its immediate allies. Technical 

Bulletin No. 1268. United State Department of Agriculture, Agricultural Research 

Service.

Holm, L., Pancho, J. V., Herbarger, J. P., 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 Soybeans: 

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

Agronomy.

Johnson, W.G., Davis, V.M., Kruger, G.R., Weller, S.C. (2009) Influence of glyphosateresistant cropping systems on weed glyphosate-resistant weed populations. 

European Journal of Agronomy 31:162-172.

Jordan, T.N., Coble, H.D., Wax, L.M. (1987) “Weed Control” In Soybeans: 

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

Agronomy.

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

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

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

bacterium Bradyrhizobium japonicum USDA110. DNA Research 9:189-197.

Keese, P. (2008) Risks from GMOs due to horizontal gene transfer. Environmental 

Biosafety Research 7:123-149.

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

prokaryotes: quantification and classification. Annual Review of Microbiology 

55:709-742. 

11
Muenscher, W. C. (1955) Weeds. Second Edition. Cornell University Press, New York 

and London. (p. 545). 

NRC (National Research Council) (2010) Environmental Impacts of Genetically 

Engineered Crops at the Farm Level. pp. 2-1 to 2-45. In Impact of Genetically 

Engineered Crops on Farm Sustainability in the United States. The National 

Academies Press. Washington, D.C.

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

Document on the Biology of Glycine max (L.) Merr. (Soybean).

Oerke, E. C. (2006) Crop losses to pests. Journal of Agricultural Science 144:31-43.

Raper, Jr., D.C., Kramer, P.J. (1987) “Stress Physiology” pp. 589-641. In J.R. Wilcox 

(ed.). Soybean: Improvement, Production, and Uses. American Society of 

Agronomy.

Pang, S.S, Duggleby, R.G., and Guddat, L.W. (2002) Crystal structure of yeast 

acetohydroxyacid synthase: A target for herbicidal inhibitors. Journal of 

Molecular Biology 317: 249-262.

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” pp. 53-84. In S.O. Duke 

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

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

Soy Stats (2011) American Soybean Association, St. Louis, Missouri. 

http://www.soystats.com, accessed September 19, 2011.

Tan, S., Evansm, R.R., Dahmer, M.L., Singh, B.K. and Shaner, D.L. (2005) 

Imidazolinone-tolerant crops: History, current status and future. Pest Management 

Science 61: 246-257.

Tecle, B., Da Cunha, A., and Shaner, D.L. (1993) Differential routes of metabolism of 

imidazolinones: Basis for soybean (Glycine max) selectivity. Pesticide 

Biochemistry and Physiology 46:120-130.

Tiedje, J.M., Colwell, R.K., Grossman, Y.L., Hodson, R.E., Lenski, R.E., Mack, R.N., 

Regal, P.J. (1989) The planned introduction of genetically engineered organisms: 

ecological considerations and recommendations. Ecology 70:298-315.

USDA ERS (2002) United States Department of Agriculture, Economic Research 

Service. Adoption of Bioengineered Crops, Agricultural Economic Report No. 

810. J. Fernandez-Cornejo and W.D. McBride. Retrieved December, 2011, from 

http://www.ers.usda.gov/publications/aer810/aer810.pdf

12
USDA ERS (2011a) United States Department of Agriculture, Economic Research 

Service. Soybeans and Oil Crops. Retrieved December, 2011, from 

http://www.ers.usda.gov/Briefing/SoybeansOilCrops/

USDA ERS (2011b) United States Department of Agriculture, Economic Research 

Service. Adoption of Genetically Engineered Crops in the U.S.: Soybeans 

Varieties. Retrieved December, 2011, from 

http://www.ers.usda.gov/Data/BiotechCrops/ 

USDA NASS (2011a) United States Department of Agriculture, National Agricultural 

Statistics Service. National Statistics for Soybean. Soybean Acres Planted.

Retrieved December, 2011, from 

http://www.nass.usda.gov/Statistics_by_Subject/result.php?3E9BD064-FBF6-

30AD-8530-

513C0E23C55C§or=CROPS&group=FIELD%20CROPS&comm=SOYBEA

NS

USDA NASS (2011b) United States Department of Agriculture, National Agricultural 

Statistics Service. National Statistics for Soybean. Soybean Acres Planted. 

Retrieved December, 2011, from 

http://www.nass.usda.gov/Charts_and_Maps/Crops_County/pdf/SB-PL10-

RGBChor.pdf 

USDA NASS (2011c) United States Department of Agriculture, National Agricultural 

Statistics Service. Agricultural Chemical Use Database. Retrieved December, 

2011, from http://www.pestmanagement.info/nass/ 

USDA NRCS (2011) United States Department of Agriculture, Natural Resources 

Conservation Service. Invasive and noxious weeds. Retrieved December, 2011, 

from http://plants.usda.gov/java/noxiousDriver 

USDA NRCS (2012) United States Department of Agriculture, Natural Resources 

Conservation Service. The PLANTS Database. National Plant Data Team. 

Retrieved January 2012, from http://plants.usda.gov/java/ 

USEPA (2006) United States Environmental Protection Agency. Reregistration 

Eligibility Decision for Imazapyr. http://www.regulations.gov , public docket 

number OPP-2005-0495.

USEPA (1997) United States Environmental Protection Agency. Phosphinothricin 

acetyltransferase and the genetic material necessary for its production in all 

plants; exemption from the requirement of a tolerance on all raw agricultural 

commodities. 62 Federal Register 17717-17720.

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 

13
Wax, L.M., (1973) “Weed Control” in Soybeans: Improvement, Production, and Uses. 

American Society of Agronomy. Caldwell, B.E. (ed.) pp. 417-457.

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

tumefaciens C58. Science 294:2317-2323.

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

Tolerance” defined. Weed Technology. 12:789. 

WSSA Weed Science Society of America (2010) WSSA Supports NRC Findings on 

Weed Control. Retrieved January, 2012, from 

http://www.wssa.net/WSSA/Information/WSSA%20position%20paper%20on%2

0herbicide%20resistance%205-27-2010.pdf 

Young, B.G. (2006) Changes in herbicide use patterns and production practices resulting 

from glyphosate-resistant crops. Weed Technology 20:301-307.

14