Monsanto Petition (11-202-01p) for Determination of 

Non-regulated Status of MON 87712 Soybean

OECD Unique Identifier: 

MON-87712-4

Plant Pest Risk Assessment 

June 2013

Agency Contact 

Cindy Eck

Biotechnology Regulatory Services

4700 River Road

USDA, APHIS 

Riverdale, MD 20737 

Fax: (301) 734-8669

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TABLE OF CONTENTS

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

B. Development of MON 87712 Soybean....................................................................... 1

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

D. Potential Impacts on Disease and Pest Susceptibilities.............................................. 4

E. Potential Impacts on Nontarget Organisms Beneficial to Agriculture ....................... 5

F. Potential for Enhanced Weediness of MON 87712 Soybeans.................................... 5

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

Interbreed ................................................................................................................... 6

H. Potential Changes to Agriculture or Cultivation Practices......................................... 7

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

which MON 87712 Soybeans Cannot Interbreed ...................................................... 7

J. Conclusion .................................................................................................................. 8

K. References................................................................................................................... 8

i
A. Introduction

Monsanto Company has petitioned APHIS (APHIS # 11-202-01p) for a determination 

that genetically engineered (GE) soybean (Glycine max (L.) Merr.) event MON 87712 is 

unlikely to pose a plant pest risk (Monsanto 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 if 

MON 87712 is unlikely to pose a plant pest risk. 

MON 87712 utilizes the BBX32 gene from Arabidopsis thaliana that results in production 

of a protein that interacts with one or more endogenous transcription factors to regulate 

the plant’s day/night physiological processes. This results in increased availability of 

assimilates, an extended period of photosynthetic activity, changes in diurnal metabolism 

during the reproductive phase of the soybean plant, and significantly increased yield 

compared to control plants (Holtan 2011; Monsanto 2011).

Potential impacts to be addressed in this risk assessment are those that pertain to the use 

of MON 87712 and its progeny in the absence of confinement. APHIS utilizes data and 

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

MON 87712 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. 

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 evaluates 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, 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, potential indirect plant pest effects 

on other agricultural products, and transfer of genetic information to organisms with 

which it cannot interbreed.

B. Development of MON 87712 Soybean

In the U.S. soybean is grown on over 78.9 million acres (Figure 1, next page) with a 

value of $31.7 billion in 2009 (USDA ERS 2010). Growers select soybean lines adapted 

to the different environmental and climatic features, weed and disease pressures, cost of

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.” 

1

 
Figure 1. Soybean production areas in the U.S. (USDA NASS 2010b).

seed and other inputs, technology fees, human safety, ease and flexibility of the 

production system and marketing reasons (Gianessi 2006; Reddy 2001).

For the past ~28 years soybean yields in the U.S. have increased 65% at an annual rate of 

~2.3% (Figure 2, next page). In order to meet the domestic and export demands, soybean 

productivity in the U.S. has been accomplished by both increasing the area under 

cultivation and by these constant yield increases per unit area. For example, from 1924 to 

2010, soybean acreage increased almost 50-fold, but in the last decade the increase in 

planted area had been only 6% (USDA-NASS 2011). The annual improvement in U.S. 

soybean yield can be attributed to genetic and agronomic innovations and better control 

of pests and diseases that provide producers better tools to meet production demands 

(Specht et al. 1999), depending also on continuing infusions of genetic resources for yield 

stability and growth (USDA ERS 2011).

Monsanto has developed a high yielding variety MON 87712 through the insertion of the 

gene BBX32 from Arabidopsis thaliana that altered the conventional soybean variety 

A3525 to modulate aspects of its diurnal biology to enhance growth and reproductive 

development. The BBX32 gene is known to produce a protein that interacts with one or 

more endogenous transcription factors that regulate day/night processes resulting in 

increased availability of assimilates (Monsanto 2011, pp 200-224; Holtan et al. 2011). 

The increased yield results from higher canopy-level assimilate availability, as observed 

by factors associated with higher photosynthetic rate and altered diurnal plant 

metabolism. These diurnal processes involve carbon and nitrogen metabolism which 

increase the amount of assimilates that is available to potentially produce more and/or 

heavier seeds. 

2
Figure 2. Soybean yield trend in the U.S. (USDA ERS 2011).

Monsanto has initiated a food/feed safety consultation on MON 87712 with the Food and 

Drug Administration (FDA) (Monsanto 2011, p. 29). A final decision from FDA is

pending.

Description of the Modification

MON 87712 was developed through Agrobacterium-mediated transformation of soybean

variety A3525 using the plasmid vector PV-GMAP5779 to inoculate soybean meristem 

tissue. 

Plasmid Vector PV-GMAP5770 - (Monsanto 2011, p. 36):

• PV-GMAP5770 is approximately 11.4 kb and contains two T-DNA which are 

delineated by a Left and Right Border regions to facilitate this transformation. 

The first T-DNA (I) contains the BBX32 coding sequence under the regulation of 

the e35S promoter and the E6 3’ untranslated region. The second T-DNA (II) 

contains the cp4 epsps coding sequence regulated by the FMV/EF-1α promoter, 

EF-1α leader, EF-1α intron, CTP2 targeting sequence, and the E9 3’ untranslated 

region.

• The backbone region of PV-GMAP5779, located outside of both T-DNAs, 

contains two origins of replication for maintenance of the plasmid vector in 

bacteria (ori V, ori-pBR322), a bacterial selectable marker gene (aadA), and a 

coding sequence for repressor of primer protein for maintenance of plasmid 

vector copy number in E. coli (rop). 

20

25

30

35

40

45

50

Bushels per Acre

Soybean Yields in the US

3
The BBX32 Coding Sequence and the BBX32 Protein (T-DNA I)

• The expression cassette in MON 87712 contains the coding region for BBX32 

protein from Arabidopsis thaliana (Monsanto 2011, page 45). This protein 

regulates the plant’s day and night processes resulting in an increased availability 

of assimilates.

• The second T-DNA (T-DNAII) contains the cp4 epsps coding sequence with its 

associated promoter, leader, intron, targeting sequence, 3 ‘UTR-functioning as a 

marker gene. Post-transformation breeding work removed this T-DNA from 

MON 87712 (Monsanto 2011, p. 7).

 

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

The BBX32 protein regulates the activity of specific transcription factors that allow 

plants to fine-tune a transcriptional response to specific endogenous or environmental 

inputs. This protein specifically modulates light signaling by acting antagonistically with 

another protein (ELONGATED HYPOCOTYL5 (HY5)), resulting in maintaining a darkmediated pattern of gene expression and hypocotyl elongation.

D. Potential Impacts on Disease and Pest Susceptibilities

APHIS assessed whether MON 87712 is likely to have significantly altered disease and 

pest susceptibility. This assessment encompassed consideration of the introduced trait 

and disease and pest susceptibility data from MON 87712 field trials.

Soybean is not a plant pest in the United States (USDA 2011). The Agrobacterium

transformed plants used in the generation of MON 87712 were treated with an antibiotic 

to kill the Agrobacterium cells. Additionally, DNA sequences derived from plant pests 

that were incorporated in MON 87712 do not result in the production of infectious agents 

or disease symptoms in plants, and so it is unlikely that MON 87712 could pose a plant 

pest risk. The genetic modifications, including genetic elements, expression of the gene 

products and their functions have been summarized above. 

MON 87712 has been field tested in the United States since 2006. Agronomic data was 

collected in 2009 in 19 locations that represented a diverse range of environmental 

conditions where MON 87712 is expected to be grown. No statistically significant 

differences were observed for germination, emergence, seedling vigor, days to flower, 

plant height, lodging, pod shattering, grain moisture and weight (Monsanto 2011, p. 130), 

disease incidence and insect damage (Monsanto 2011, Appendix H). No qualitative or 

quantitative observations indicated any biologically meaningful differences from the 

comparator A3525 and the control lines or differences outside the range of conventional 

soybean norms.

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

used and some inherent genetic variability within soybean varieties, APHIS did not 

4
identify any results presented by Monsanto that would constitute an increased plant pest 

risk. Expression of BBX32 in event MON 87712 soybeans is not expected to cause plant 

disease or influence susceptibility of MON 87712 or its progeny to diseases or other 

pests. Therefore, pest and disease control methods are expected to be similar and no 

direct or indirect plant pest effect on raw or processed plant commodity is expected.

E. Potential Impacts on Nontarget Organisms Beneficial to Agriculture

MON 87712 was similar to its parental line A3525 in the interaction of these plants with 

the symbiotic nitrogen-fixing bacterium Bradyrhizobium japonicum (Monsanto 2011, p. 

137) under laboratory conditions. The field cultivation of MON 87712 compared with 

A3525 did not have a detrimental effect on the abundance of beneficial arthropods such 

as lacewings, ladybird and carabid beetles, spiders, parasitic wasps, and beneficial 

Heteroptera (Monsanto 2011, pp. 382-384), therefore the cultivation of MON 87712 is 

not expected to have a negative effect on organisms that are directly related with soybean 

cultivation and that are beneficial to agriculture.

F. Potential for Enhanced Weediness of MON 87712 Soybean

APHIS assessed whether MON 87712 soybeans are any more likely to become a weed 

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

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

of unique characteristics of MON 87712 soybean.

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

Holm 1979; Muenscher 1980) nor is it listed as a noxious weed species by the federal 

government (USDA 2011). 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 in the succeeding crop due to lack of dormancy (Padgette 

1996). If any seeds remain viable and germinate the following year, mechanical methods 

or herbicides can be used to control volunteers. 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 1979; Monsanto 2011). In managed 

ecosystems, soybean does not effectively compete with other cultivated plants or primary 

colonizers (OECD 2000). 

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 when compared to the 

non-GE comparator. If the fitness of MON 87712 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 MON 

87712 soybeans have a negligible likelihood of increased weediness. 

In 2009 Monsanto conducted field trials to evaluate phenotypic characteristics comparing 

MON 87712 with the non-transgenic variety A3525 lacking the BBX32 gene. Agronomic 

performance characteristics, including germination, dormancy, emergence, vegetative 

growth, reproductive development, seed retention and lodging, plant-environment 

5
interactions, plant-symbiont interactions, volunteer potential characteristics, and 

persistence outside of cultivation characteristics were evaluated (Monsanto 2011, pp. 

117-141, appendix G). There were no significant differences among all the parameters 

listed above between MON 87712 and A3525, except that MON 87712 had a ~1.6% 

higher earlier plant stand count, reached 50% senescence 2 days later and physiological 

maturity 2.5 days later, had a ~3.3% higher final plant stand and a 6.8% higher yield than 

A3525 (Monsanto 2011, p. 128, appendix G). Based on analysis of data on all these 

parameters, soybean MON 87712 is unlikely to pose any more of a plant pest risk from 

weediness than the conventional soybean from which it was derived.

APHIS also assessed whether MON 87712 is any more likely to become a weed than its 

parental comparator line A3525 or other soybean varieties currently under cultivation.

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

evaluation of the unique characteristics of MON 87712 under field conditions. To 

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

line (Tiedge 1989). Because the BBX32 gene will not affect the survival of MON 87712 

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

is unlikely ever to exist.

Results on growth characteristics, seed production and germination indicate that MON 

87712 is not significantly different from its comparators (Monsanto 2011, pp. 117-141, 

appendix G). There is no indication that MON 87712 possesses a selective advantage that 

would result in increased weediness. MON 87712 lacks the ability to persist as a 

troublesome weed and it is highly unlikely that typical weed management practices for 

soybeans will change significantly.

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

It Can Interbreed

Soybean is highly self-pollinating (Ahrent 1994). When soybean plants are grown 

directly adjacent to other soybean plants, the amount of natural cross pollination has 

generally been found to be 0.5 - 1 percent (Fehr 1980; OECD 2000; Ray 2003) although 

higher values (2.5 percent) occur in some varieties (Abud 2007). Outcrossing can be 

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

greater distances from the pollen source, cross pollination rates decrease rapidly. Based

upon these factors, it is highly unlikely for MON 87712 to naturally outcross or hybridize 

with other soybean varieties in agricultural settings.

In assessing the risk of gene introgression form MON 87712 soybeans into its sexually 

compatible relatives, APHIS considered two primary issues: 1) the potential for gene 

flow and introgression and, 2) the potential impact of introgression. 

Glycine has approximately 9 species, with G. max being placed in the subgenus Soja 

along with one other species, G. soja (previously G. ussuriensis). Glycine max is only 

sexually compatible with G. soja and no other Glycine species. Glycine max is the only

species located in the United States other than a few G. soja plants in research plots. 

Glycine max has never been found in the wild in the U.S. (Hymowitz 1987). Therefore, it 

6
is not likely that gene flow and introgression will occur between MON 87712 and other 

species of soybean. APHIS has determined that any adverse consequences of gene flow 

from MON 87712 soybean to wild or weedy species in the United States are highly 

unlikely.

H. Potential Changes to Agriculture or Cultivation Practices

MON 87712 soybeans were field-studied in a wide range of environmental conditions in 

2009. In 19 different sites that represent most of the soybean growing environments, 

MON 87712 was cultivated and compared with its parental line (A3525) and another 18 

commercial varieties under the same agronomic practices (Monsanto 2011, pp. 346-347). 

Most of the agronomic performance characteristics, including germination, dormancy, 

emergence, vegetative growth, reproductive development, seed retention and lodging, 

plant-environment interactions, plant-symbiont interactions, volunteer potential 

characteristics, and persistence outside of cultivation characteristics (Monsanto 2011, 

Appendix G), demonstrated that there were no significant differences when MON 87112 

was grown in the field compared with commercial varieties. However, MON 87712 had 

some characteristics that were different than control and/or commercial varieties: a 

~1.6% higher earlier plant stand count, reached 50% senescence 2 days later and 

physiological maturity 2.5 days later, had a ~3.3% higher final plant stand and a 6.8% 

higher yield than A3525 (Monsanto 2011, p. 128, Appendix G). None of these 

characteristics would likely require MON 87712 to be cultivated using different 

agronomic practices than other soybeans. 

MON 87712 was not more susceptible to a wide-range of soybean diseases than its 

parental line A3525 (Monsanto 2011, p. 375), nor more susceptible to pest arthropods 

(Monsanto 2011, pp. 376-381), therefore it is not expected that cultivation of MON 

87712 would require different amounts or types of pesticides for its cultivation than other 

soybean varieties.

I. Potential Impacts from Transfer of Genetic Information to 

Organism with which MON 87712 Soybeans Cannot Interbreed

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

unlikely to occur (Keese 2008). First, many bacteria (or parts thereof) that are closely 

associated with plants have been sequenced, including Agrobacterium and Rhizobium 

(Kaneko 2000; Kaneko 2002; Wood 2001). There is no evidence that these organisms 

contain genes derived from plants. Second, 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). 

Third, 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, 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 

plant pest risk.

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J. Conclusion

APHIS has prepared this plant pest risk assessment in order to determine if event MON 

87712 is likely to pose a plant pest risk. Based on the information provided by the 

applicant and the lack of plant pest risk from the inserted genetic material, weedy 

characteristics, atypical responses to disease or plant pests in the field, effects on nontargets or beneficial organisms in the agro-ecosystem, changes to agricultural practices, 

and horizontal gene transfer, APHIS has concluded that soybean event MON 87712 is 

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. 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 Sci. 34:376-378. 

Brown, J.R. (2003) Ancient horizontal gene transfer. Nat. Rev. Genet. 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).

Gianessi, L., Reigner, N. (2006) Pesticide use in U.S. crop protection: 2002 With 

Comparison to 1992 & 1997. Fungicides & Herbicides. Crop Life Foundation, 

Washington, D.C.

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. 

Holtan, H. E. et al (2011) BBX32, an Arabidopsis B-Box protein, functions in light 

signaling by suppressing HY5-regulated gene expression and interacting with 

STH2/BBX21. Plant Physiology 156: 2109-2123.

Hymowitz, T., Singh, R.J. (1987) “Taxonomy and Speciation” in Soybeans:

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

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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. 

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soybean. USDA APHIS petition number 11-202-01p.

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

and London. (p. 545). 

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

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

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. D., Kilen, T. C., Abel, C. A., and Paris, R. L. 2003. Soybean natural cross 

pollination rates under field conditions. Environmental Biosafety Research 2: 133-138.

Reddy, K.N. (2001) Glyphosate-resistant soybean as a weed management tool:

opportunities and challenges. Weed Biol. Manage. 1:193-202.

Specht, J.E., Hume, D. J., and Kumudini, S. V.. 1999. Soybean yield potential - A genetic 

and physiological perspective. Crop Science 39: 1560-1570.

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 (2011) Invasive and noxious weeds. United States Department of Agriculture. 

Accessed December 01, 2011 at: http://plants.usda.gov/java/invasiveOne?startChar=B

USDA ERS (2010) Adoption of Genetically Engineered Crops in the U.S.: Soybeans 

Varieties. Accessed May 5, 2010 at: 

http://www.ers.usda.gov/Data/BiotechCrops/ExtentofAdoptionTable3.htm. 

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USDA NASS (2011) Quick Stats. Accessed December 01, 2011 at: 

http://www.nass.usda.gov/index.asp.

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

tumefaciens C58. Science 294:2317-2323.

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