GM Crop Database

Database Product Description
 
MON-󮻙2-6 (GTS 40-3-2)
Host Organism
Glycine max L. L. (Soybean)
 
Trait
Glyphosate herbicide tolerance.
 
Trait Introduction
Microparticle bombardment of plant cells or tissue
 
Proposed Use
Production of soybeans for animal feed (mostly defatted toasted meal and flakes) and human consumption (mostly oil, protein fractions, and dietary fibre).
 
Company Information
Monsanto Company
Chesterfield Village Research Center (MO)
700 Chesterfield Parkway North
St. Louis
MO  USA
 
 
Summary of Regulatory Approvals
 
Country Environment Food and/or Feed Food Feed Marketing
Argentina 1996 1996 1996  
Australia 2000  
Brazil 1998 1998 1998  
Canada 1995 1996 1995  
China 2004  
Colombia 2005  
Czech Republic 2001 2001 2001
European Union 2005 1996
Japan 1996 1996 1996  
Korea 2000 2004  
Mexico 1998 1998 1998  
Paraguay 2004 2004  
Philippines 2003 2003  
Russia 1999 1999
South Africa 2001 2001 2001  
Switzerland 1996 1996  
Taiwan 2002  
United Kingdom 1996 1996  
United States 1994 1994  
Uruguay 1997 1997 1997  
Click on the country name for country-specific contact and regulatory information.
Notes
Mexico Date shown is the date of latest approval.
Uruguay Date shown is the date of latest approval.
Brazil Decision was reversed by the courts, reinstatement pending.
European Union For the importation, storage and use for processing to non-variable soybean fractions suitable for use in animal feeds, food and other products.
Russia This is the first licence for the import of genetically modified food into Russia. Approval for importation and food use of GTS 40-3-2 is until July 2002. It has not been given approval for planting.
European Union Notified as an existing product on 13 July 2004

Introduction
 
The soybean line GTS 40-3-2 was developed to allow for the use of glyphosate, the active ingredient in the herbicide Roundup? as a weed control option for soybean. This genetically engineered soybean variety contains a glyphosate tolerant form of the plant enzyme 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) isolated from the common soil bacterium, Agrobacterium tumefaciens strain CP4 (CP4 EPSPS).

The EPSPS enzyme is part of the shikimate pathway that is involved in the production of aromatic amino acids and other aromatic compounds in plants (Steinrucken & Amrhein, 1980). When conventional plants are treated with glyphosate, the plants cannot produce the aromatic amino acids needed to survive. This enzyme is present in all plants, bacteria, fungi, but not in animals, which do not synthesize their own aromatic amino acids. Because the aromatic amino acid biosynthetic pathway is not present in mammalian, avian or aquatic life forms, glyphosate has little if any toxicity for these organisms (U.S. EPA, 1993; WHO, 1994; Williams et al. 2000). The EPSPS enzyme is normally present in food derived from plant and microbial sources.

GTS 40-3-2 was developed by introducing the CP4 EPSPS coding sequence into the soybean variety A5403, a commercial soybean variety of Asgrow Seed Company, using particle-acceleration (biolistic) transformation. A5403 is a maturity group V cultivar that combines consistently high yield potential with resistance to races 3 and 4 of the soybean cyst nematode (SCN). It also possesses good standability, excellent emergence and tolerance to many leaf and stem diseases. The glyphosate tolerance trait has since been transferred into more than one thousand commercial soybean varieties by traditional breeding techniques. Globally, glyphosate-tolerant soybeans were planted on more than 50 million hectares in 2007. One of the reasons growers have rapidly adopted the glyphosate-tolerant soybean is the simplicity it offers in weed control. Since glyphosate containing herbicides are highly effective against the vast majority of annual and perennial grasses and broadleaf weeds, growers planting glyphosate tolerant soybeans are able to reduce the number of herbicides used to control the economically destructive weeds that grow in their fields and thereby realize a savings in weed control costs. This reduction in herbicides used has benefited the environment by reducing the number of herbicide applications and also allows growers to implement integrated weed management practices in their fields - practices that are generally not possible when pre-plant or pre-emergent herbicides are used.

General Description
 
1. Glyphosate Tolerance
Glyphosate, the active ingredient of Roundup, acts as a competitive inhibitor of 5-enol-pyruvylshikimate-3-phosphate synthase (EPSP synthase), an essential enzyme of the shikimate biochemical pathway, involved in the production of the aromatic amino acids phenylalanine, tyrosine and tryptophan. This inhibition results in growth suppression and plant death.

The inserted glyphosate tolerance gene codes for a bacterial version of this essential enzyme, ubiquitous in plants, fungi and microorganisms. This enzyme is highly insensitive to inhibition by glyphosate and therefore fulfills the aromatic amino acid metabolic needs of the plant.

A plant-derived DNA sequence coding for a chloroplast transit peptide was co-introduced with the glyphosate tolerance gene. This peptide facilitates the import of the newly translated EPSP synthase into chloroplasts, where both the shikimate pathway and glyphosate site of action are located. The transit peptide is degraded rapidly and completely by proteases after the import has occurred.

The gene, associated with its transit peptide coding sequence, is linked to a strong constitutive promoter. Protein expression was quantified, and averaged 0.239 礸/mg (f.w.) in seeds and 0.495 礸/mg (f.w.) in leaves.

The full nucleotide sequence of the inserted gene was provided. The resulting enzyme was shown to be functionally and structurally similar to bacterial enzymes of the same type frequently found in food and feed products. Molecular weights were similar, indicating that the protein had not been glycosylated, nor had it undergone post-transcriptional modifications.

Studies showed that the introduced EPSP synthase was not heat stable, and that activity was lost after incubation at 65癈 for 15 minutes. It was not stable in the presence of proteases in mammalian digestive tract, and was inactivated during processing required to manufacture soybeans into feed ingredients.

EPSP synthase is ubiquitous in nature and is not expected to be toxic or allergenic to non-target organisms. When subjected to comparative analyses with three genetic sequence databases of toxic or allergenic polypeptides, the enzyme amino acid sequence showed no significant homology with any known toxin or allergen.

2. Development Method
The soybean commercial variety A5403 (Asgrow Seed Co.) was transformed using particle bombardment, with a modified E. coli plasmid vector containing the genes coding for glyphosate tolerance and for production of -glucuronidase, a screenable marker. The original transformant selected showed two insertion sites, one with the screenable marker, and the other with the glyphosate tolerance gene. These two sites subsequently segregated independently in the following sexual generation, and line GTS 40-3-2, upon analysis, was found to contain just one insertion site in which is integrated the glyphosate tolerance gene only.

3. Stable Integration into the Plant's Genome
The data provided showed that there was no incorporation of any coding region from outside the fusion gene in the original plasmid vector, consisting of the glyphosate tolerance gene, combined with the transit peptide coding sequence, in addition to their regulatory sequences. Only one copy was integrated at the single insertion site.

Following generations demonstrated no further segregation of the fusion gene described above, showing that line GTS 40-3-2 was homozygous for that fusion gene. DNA analyses over six generations showed that the insertion was stable.

4. Updated Information (Office of Food Biotechnology, Health Canada)
On May 19, Monsanto Canada submitted additional information to Health Canada on the detection of additional DNA in their Roundup Ready soybean (glyphosate tolerant soybean GTS 40-3-2). The company had detected the additional DNA as a result of their routine quality control program. Roundup Ready Soybean was previously approved by Health Canada in 1996 for sale as food in the Canadian marketplace. Health Canada regulators conducted a thorough and rigorous review of the supplementary data and found no health or safety concerns for humans. The new data demonstrates that the additional DNA was present in the original seeds approved in 1996 and in all other progeny derived from the original line. The newly detected DNA does not express mRNA or proteins and only the expected full length mRNA and CP4 EPSPS protein is found in Roundup Ready soybean. This soybean has undergone a thorough process of testing, analysis and assessment to ensure that it is wholesome, nutritious and above all, safe to eat.

5. Updated Information From Monsanto
In 1999, Monsanto published detailed methods for the detection of Roundup Ready soybeans in processed samples using immuno-detection (ELISA and western blotting) of CP4 EPSPS, the protein conferring the Roundup Ready trait. While this work was being completed, and in response to emerging needs for detection methods on a global basis, Monsanto also developed DNA-based line identification methods, first using high sensitivity Southern blotting, and now using DNA sequence tags based on insert/genomic DNA junctions.

Monsanto previously reported to regulatory agencies (in 1994) and published in the scientific literature (in 1995) the molecular map of the functional insert of the CP4 EPSPS cassette as required by regulatory agencies at that time. Using more sensitive Southern blotting methods, a second 72 bp DNA insert (from CP4 EPSPS) was found. This non-functional second insert co-segregates with the functional insert. As a result of DNA sequencing of the insert/genomic DNA, an additional 250 bp segment of CP4 EPSPS DNA was also identified immediately 3' to the transcriptional termination signal of the primary CP4 EPSPS gene cassette. Sequence analysis, western and northern blotting confirmed that these two segments are non-functional. Pedigree analyses confirmed that these segments of CP4 EPSPS were present in RR soybeans evaluated during all safety assessment studies and are present in commercial varieties. DNA sequence determination of these inserts more precisely describes the molecular details of the inserted DNA in RR soybeans. This information does not impact the completed food and environmental safety assessments.
Reference: Canadian Food Inspection Agency, Plant Biotechnology Office; Health Canada, Office of Food Biotechnology

Summary of Introduced Genetic Elements
 
Code Name Type Promoter, other Terminator Copies Form
CP4 epsps 5-enolpyruvyl shikimate-3-phosphate synthase  (Agrobacterium tumefaciens CP4) HT enhanced CaMV 35S
chloroplast transit peptide from Petunia hybrida
A. tumefaciens nopaline synthase (nos) 3'-untranslated region 1* Native; Also 2 partial gene sequences (250 bp; 72 bp)

Characteristics of Glycine max L. (Soybean)
 
Center of Origin Reproduction Toxins Allergenicity
Southeast Asia; wild soybean species endemic in China, Korea, Japan, Taiwan self-polinated; rarely displays any dormancy characteristics; does not compete well with other cultivated plants

Donor Organism Characteristics
 
Latin Name Gene Pathogenicity
Agrobacterium tumefaciens strain CP4 CP4 EPSPS A. tumefaciens is a common soil bacterium that is responsible for causing crown gall disease in susceptible plants. There have been no reports of adverse affects on humans or animals.

Modification Method
 
Soybean line GTS 40-3-2 was produced by biolistic transformation of plant cells from soybean cultivar A5403 with DNA-coated gold particles. The plasmid PV-GMGT04 used for transformation contained the genes coding for glyphosate tolerance and for production of ?glucuronidase (gus gene), a selectable marker. Expression of the CP4 EPSPS gene was regulated by an enhanced 35S promoter (E35S) from cauliflower mosaic virus (CaMV), a chloroplast transit peptide (CTP4) coding sequence from Petunia hybrida, and a nopaline synthase (nos 3') transcriptional termination element from Agrobacterium tumefaciens. The transit peptide facilitated the translocation of newly translated EPSP synthase into chloroplasts, the site of aromatic amino acid biosynthesis and glyphosate site of action.

Characteristics of the Modification
 
The Introduced DNA
Southern blot analysis of genomic DNA from GTS 40-3-2 demonstrated that there were two sites of integration, one site containing a functional copy of CP4 EPSPS gene and a second site containing a non-functional segment of the CP4 EPSPS gene. The gus gene was not integrated into the host genome and there were no antibiotic resistance marker genes introduced into GTS 40-3-2.

Southern blots, chromosome walking and DNA sequencing were used to analyze the insertion sites. The largest insert, containing the function CP4 EPSPS gene, contained a deletion in the enhancer region of the E35S promoter and the remainder of the E35S promoter was functional. A single copy of the CP4 EPSPS gene (1365 bp) was integrated and analysis of the 3' terminus revealed a complete nos 3' transcriptional termination element, rather than a portion of nos as previously reported. Also, an additional 250 bp sequence corresponding to a portion of the CP4 EPSPS gene was recently detected adjacent to the 3' end of the nos 3' element, which was not detected in earlier studies (Additional information submitted by Monsanto to regulatory authorities in the spring of 2000).

Analysis of the second insert site showed the presence of a 72 bp sequence corresponding to a portion of the CP4 EPSPS gene. Sequence analysis, western and northern blotting confirmed that neither the additional 250 bp sequence identified in the first insertion site nor the 72 bp fragment inserted at a second site were functional. Pedigree analyses confirmed that these segments of CP4 EPSPS were present in GTS 40-3-2 soybeans evaluated during all safety assessment studies and are present in commercial varieties.

Genetic Stability of the Introduced Trait
DNA analyses over six generations demonstrated that the CP4 EPSPS gene was stably inserted. Observations over multiple generations showed the CP4 EPSPS gene was no longer segregating, demonstrating that soybean line GTS 40-3-was homozygous for the herbicide tolerance trait. These multi-generation studies on GTS 40-3-2 also demonstrated that the 72 bp CP4 EPSPS segment co-segregated with the primary insert, indicating that the two sites of integration are close linked and behave as a single locus.

Expressed Material
Expression of the full-length CP4 EPSPS gene, which encodes a 456 amino acid polypeptide (46 kDa), was confirmed by Western immunoblot analysis and the levels of expression were quantitated using enzyme linked immunosorbent assay (ELISA). The concentrations of CP4 EPSPS averaged 239 ?/g fresh weight tissue in seeds and 495 ?/g f.w.t. in leaves.

Soybean line GTS 40-3-2 was found to express only the full length mRNA and complete CP4 EPSPS protein. The additional DNA segments, the 72 bp CP4 EPSPS segment that comprises the second insert or the 250 bp of the CP4 EPSPS element adjacent to the 3' end of NOS on the functional insert, were both non-functional and did not result in the expression of any mRNA or protein. These results were expected as neither segment contained a promoter or terminator sequence, and only the full-length mRNA and full-length CP4 EPSPS protein were detected.

Environmental Safety Considerations
 
Field Testing
GTS 40-3-2 soybean has been field tested in the United States (1991-1993), Canada (1992), Puerto Rico (1993), Argentina, and Costa Rica. Agronomic studies on seed yield, and visual observations on germination characteristics of seeds, final stands, disease and insect susceptibility supported the conclusion that soybean line GTS 40-3-2 was as safe to grow as other soybean varieties and had no potential to pose a plant pest risk.

Outcrossing
Gene introgression from transformed soybean line GTS 40-3-2 was extremely unlikely as there are no relatives of cultivated soybean in the continental United States and Canada, and soybean plants are almost completely self-pollinated. Furthermore, the reproductive characteristics such as pollen production and viability were unchanged by the genetic modification resulting in GTS 40-3-2.

Cultivated soybean, Glycine max, naturally hybridizes with the wild annual species G. soja. However, G. soja is only found naturally occurring in China, Korea, Japan, Taiwan and the former USSR, and is not naturalized in North America, although it may possibly be grown in research plots. It was concluded that the potential for transfer of the glyphosate tolerance trait from the transgenic line to soybean relatives through gene flow was negligible in managed ecosystems, and that there was no potential for transfer to wild species in Canada and the continental United States

Weediness Potential
No competitive advantage was conferred to GTS 40-3-2, other than that conferred by resistance to glyphosate herbicide. Resistance to glyphosate-containing herbicides will not, in itself, render soybean weedy or invasive of natural habitats since none of the reproductive or growth characteristics were modified. In the unlikely event of the formation of a herbicide tolerant hybrid, there would be no competitive advantage conferred on any hybrid progeny in the absence of sustained glyphosate use. The glyphosate-tolerant plant could easily be controlled by mechanical means or by using herbicides that are not based on glyphosate. Cultivated soybean does not exhibit any weedy characteristics in the United States and Canada, although related species are reported as weeds in Japan and China. It was concluded that soybean line GTS 40-3-2 had no altered weed of invasiveness potential compared to commercial soybean varieties.

Secondary and Non-Target Adverse Effects
Field observations of line GTS 40-3-2 revealed no negative effects on nontarget organisms, suggesting that the relatively higher levels of the protein in the transgenic plant tissues were not toxic to beneficial organisms. The novel protein CP4 EPSPS did not result in altered toxicity or allergenicity properties as demonstrated from studies including the acute oral mouse gavage study, the digestive fate study, and the fact that homologous EPSPS proteins are ubiquitous in nature and common in plants, fungi and microbes. Furthermore, the high specificity of the enzyme for its substrates makes it unlikely that the introduced enzyme would metabolize endogenous substrates to produce compounds toxic to beneficial organisms. It was determined that the genetically modified soybean line GTS 40-3-2 did not have a significant adverse impact on organisms beneficial to plants or agriculture, or on nontarget organisms, and was not expected to impact on threatened or endangered species.

Impact on Biodiversity
GTS 40-3-2 has no novel phenotypic characteristics that would extend its use beyond the current geographic range of soybean production. Since there are no wild relatives of soybean in Canada and continental United States and since soybean is not an invasive species, the novel trait will not be transferred to unmanaged environments.

Food and/or Feed Safety Considerations
 
Dietary Exposure
The genetic modification of GTS 40-3-2 soybean will not result in any change in the consumption pattern of soybean products. Consequently, the dietary exposure of consumers in the United States and Canada to GTS 40-3-2 soybean products was anticipated to be the same as for other lines of commercially available soybean. Dietary exposure to EPSPS is not novel in that all plants, bacteria and fungi produce this enzyme and the CP4 EPSPS will be ingested as inactive denatured protein since all soybean-derived human food products are heated prior to consumption.

Nutritional Data
The analysis of nutritional composition of transgenic GTS 40-3-2 soybean and non-transgenic soybean did not reveal any significant differences in the levels of protein, fat, fibre and starch. A number of these parameters were also measured in glyphosate-treated soybeans with the same results. Comparisons of the amino acid composition of the raw soybeans and the fatty acid profiles of extracted oil from transgenic and control plants did not reveal any significant differences. The anti-nutritive activity in raw soybean meal and flour is caused by soybean trypsin inhibitor, which acts to inhibit normal protein digestion in humans and animals. There was no significant difference in the trypsin inhibitor activity between transgenic GTS 40-3-2 soybeans and non-transgenic control soybeans. Likewise, there were no significant differences in the levels of plant lectins, as determined by hemagglutination assay, or isoflavone glucosides between transgenic and control soybeans. These latter substances, which include genistin and daidzin, can exhibit estrogenic and hypocholesterolemic activities. It was determined that the consumption of refined soybean oil from GTS 40-3-2 would have no significant impact on the nutritional quality of the food supply in the United States and Canada.

A series of animal feeding studies were completed using diets incorporating seed or processed fractions from soybean line GTS 40-3-2. These studies addressed the nutritional equivalence of transgenic soybean when used as animal feed, the safety of any expressed protein or peptide (or any other newly produced constituent), and the potential of any pleiotropic effect caused by the insertion process or site of insertion. The animal feeding studies included two independent four week studies in rats (one with unprocessed and one with processed soybeans), a four week dairy cow study, a six week chicken study, a ten week catfish study and a five day quail study. Animals were fed either unprocessed or processed soybeans (dehulled, defatted, toasted). Included in these studies were control groups fed a non-commercial glyphosate-tolerant soybean (61-67-1) and the non-modified parental soybean line (A5403) from which both glyphosate tolerant events were derived. Results from all groups were compared using conventional statistical methods to detect differences between groups in measured parameters. All three soybean samples tested provided similar growth and feed efficiency for rats, chickens, catfish and quail. The nutritional value or wholesomeness of GTS 40-3-2, even when fed to animals at levels much higher than humans would encounter in the diet, was the same as conventional varieties of soybeans.

Toxicity
The low potential for toxicity of transgenic soybean line GTS 40-3-2 was demonstrated by examining the amino acid sequence homology, acute oral toxicity studies on mice, and the characteristics of the proteins. The amino acid sequence of CP4 EPSPS was determined to be closely related to the sequence of the endogenous soybean EPSPS enzyme. An analysis of the amino acid sequence of the inserted CP4 EPSPS enzyme did not show homologies with known mammalian protein toxins and was not judged to have any potential for human toxicity. Additionally, acute oral toxicity studies with purified CP4 EPSPS did not reveal any deleterious effects when mice were administered a dose of 572 mg/kg body weight, which was approximately 1300-fold greater than the highest anticipated potential consumption of CP4 EPSPS from soybean. Furthermore, EPSPS is an enzyme that is ubiquitous in nature, present in plants, fungi and micro-organisms and therefore would not be expected to be toxic or allergenic.

Allergenicity
The CP4 EPSPS protein is extremely unlikely to be an allergen. A search for amino acid sequence similarity between the CP4 EPSPS protein and known allergens revealed no significant amino acid sequence homologies. In addition, the potential for allergenicity was assessed based upon the characteristics of known food allergens (stability to digestion, stability to processing). Unlike known protein allergens, CP4 EPSPS was rapidly degraded by acid and/or enzymatic hydrolysis when exposed to simulated gastric or intestinal fluids. Overall, the CP4 EPSPS does not possess characteristics typical of known protein allergens.

Links to Further Information
 
Brazillian National Technical Biosafety Commission (CTNBio)[PDF Size: 32405 bytes]
Technical conclusive opinion - commercial use of the transgenic soybean.
Canadian Food Inspection Agency, Plant Biotechnology Office[PDF Size: 153423 bytes]
Decision Document DD95-05: Determination of Environmental Safety of Monsanto Canada Inc.'s Glyphosate Tolerant Soybean (Glycine max L.) Line GTS 40-3-2
European Commission: Community Register of GM Food and Feed[PDF Size: 12821 bytes]
Notification of the placing on the Community Register of MON-??2-6
Food Standards Australia New Zealand[PDF Size: 362739 bytes]
Application A338: Food derived from glyphosate-tolerant soybean GTS 40-3-2, full assessment report
Food Standards Australia New Zealand[PDF Size: 128685 bytes]
Application A338: FSANZ comment on new soybean data
Japan Biosafety Clearing House[PDF Size: 244393 bytes]
Type I approval for soybean tolerant to glyphosate herbicide ( cp4 epsps, Glycine max (L.) Merr.)(40-3-2, OECD UI:MON-04032-6)
Monsanto Company[PDF Size: 763734 bytes]
Molecular characterization of GTS 40-3-2 Roundup Ready Soybean (Adobe Acrobat PDF 764K)
Monsanto Company[PDF Size: 106125 bytes]
Updated molecular characterization and safety assessment of Roundup Ready soybean event 40-3-2 (Adobe Acrobat PDF 106K).
Monsanto Company[PDF Size: 16237 bytes]
Monsanto Comments on Windels et al. (2001) publication regarding Roundup Ready soybeans (August 16, 2001).
Monsanto Company[PDF Size: 255673 bytes]
Product safety description
Office of Food Biotechnology, Health Canada[PDF Size: 24984 bytes]
NOVEL FOOD INFORMATION - FOOD BIOTECHNOLOGY GLYPHOSATE TOLERANT SOYBEAN, GTS 40-3-2
Philippines Department of Agriculture, Bureau of Plant Industry[PDF Size: 24858 bytes]
Determination of the Safety of Monsanto?s Soybean Event 40-3-2 (Glyphosate-Tolerant Soybean) for Direct use as Food, Feed and for Processing
THE COMMISSION OF THE EUROPEAN COMMUNITIES[PDF Size: 101296 bytes]
96/281/EC: Commission Decision of 3 April 1996 concerning the placing on the market of genetically modified soya beans (Glycine max L.) with increased tolerance to the herbicide glyphosate, pursuant to Council Directive 90/220/EEC (Text with EEA relevance)
U.S.Department of Agriculture, Animal and Plant Health Inspection Service[PDF Size: 7000952 bytes]
Monsanto Co. Petition for Determination of Nonregulated Status: Soybeans with a Roundup ReadyTM Gene
US Food and Drug Administration[PDF Size: 353801 bytes]
Memorandum to file concerning glyphosate tolerant soybean line GTS 40-3-2
USDA-APHIS Environmental Assessment[PDF Size: 48590 bytes]
APHIS-USDA Petition 93-258-01 for Determination of Nonregulated Status for Glyphosate-Tolerant Soybean Line 40-3-2

References
 
Agronomic Evaluation
Delannay, X., Bauman, T., Beighley, D., Buettner; M., Coble, H., DeFelice, M., Derting; C., Diedrick, T., Griffin, J., Hagood, E., Hancock, F., Hart, S., LaVallee, B., Loux, M., Lueschen, W., Matson, K., Moots, C., Murdock, E., Nickell, A., Owen, M., Paschal II, E., Prochaska, L., Raymond; P., Reynolds, D., Rhodes, W., Roeth, F., Sparankle, Pl., Tarochione, L., Tinius, C., Walker, R., Wax, L., Weigelt, H. and Padgette, S. (1995). Yield evaluation of glyphosate-tolerant soybean line after treatment with glyphosate. Crop Science 35(5): 1461?1467.
Compositional Analysis
Duke, S., Rimando, A., Pace, P., Reddy, K. and Smeda, R. (2003). Isoflavone, glyphosate, and aminomethylphosphonic acid levels in seeds of glyphosate-treated, glyphosate-resistant soybean. J. Agricultural and Food Chemistry 51: 340?344.
Harrigan, GG; Ridley, WP; Riordan, SG; Nemeth, MA; Sorbet, R; Trujillo, WA; Breeze, ML; and Schneider, RW. (2007). Chemical composition of glyphosate-tolerant soybean 40-3-2 grown in Europe remains equivalent with that of conventional soybean (Glycine max L.). J. Agric. Food Chem. 55(15): 6160-6168.
List, G.R., Orthoefer, F., Taylor, N., Nelsen, T. and Abidi, S.L. (1999). Characterization of phospholipids from glyphosate-tolerant soybeans. Journal of the American Oil Chemists Society 76: 57-60.
McCann, M.C., Liu, K., Trujillo, W.A. and Dobert, R.C. (2005). Glyphosate-tolerant soybeans remain compositionally equivalent to conventional soybeans (Glycine max L.) during three years of field testing. Journal of Agricultural and Food Chemistry 53(13): 5331-5335.
Padgette, S.R., Taylor, N.B., Nida, D.L., Bailey, M.R., MacDonald, J., Holden, L.R. & Fuchs, R.L. (1995). The composition of glyphosate-tolerant soybean seeds is equivalent to that of conventional soybeans. Journal of Nutrition 126, 702-716.
Taylor, N.B.,* Fuchs, R.L., MacDonald, J., Shariff, A.R. & Padgette, S.R. (1999). Compositional Analysis of Glyphosate-Tolerant Soybeans Treated with Glyphosate. Journal of Agricultural and Food Chemistry 47(10), 4469-4473.
Development & Molecular-Genetic Characterization
Padgette, S.R., Kolacz, K.H., Delannay, X., Re, D.B., LaVallee, B.J., Tinius, C.N., Rhodes, W.K., Otero, Y.I., Barry, G.F., Eichholtz, D.A., Peschke, V.M., Nida, D.L., Taylor, N.B. & Kishore, G.M. (1995). Development, identification, and characterization of a glyphosate-tolerant soybean line. Crop Science 35, 1451-1461.
Windels, P., Taverniers, I., Depicker, A., Van Bockstaele, E. & De Loose, M. (2001). Characterization of the Roundup Ready soybean insert. Eur. Food Res. Technol. 213, 107-112.
Digestive Fate
Ash, J.A., Scheideler, S.E. and Novak, C.L. (2003). The fate of genetically modified protein from Roundup Ready soybeans in the laying hen. The Journal of Applied Poultry Research 12: 242-245.
Jennings, J., Kolwyck, D., Kays, S., Whetsell, A., Surber, J., Cromwell, G., Lirette, R. and Glenn, K. (2003). Determining whether transgenic and endogenous plant DNA and transgenic protein are detectable in muscle from swine fed Roundup Ready soybean meal. J Animal Sci. 81:1447-1455.
Phipps, R.H., Deaville, E.R. and Maddison, B.C. (2003). Detection of transgenic and endogenous plant DNA in rumen fluid, duodenal digesta, milk, blood, and feces of lactating dairy cows. Journal of Dairy Science 86:4070-4078.
Environmental Fate
Levy-Booth, D., R. Campbell, R. Gulden, M. Hart, J. Powell, J. Klironomos, K. Pauls, C. Swanton, J. Trevors and K. Dunfield (2008). Real-time polymerase chain reaction monitoring of recombinant DNA entry into soil from decomposing Roundup Ready leaf biomass. Journal of Agricultural and Food Chemistry 56: 6339?6347.
Feeding Studies
Brake, D. and Evenson, D. (2004). A generational study of glyphosate-tolerant soybeans on mouse fetal, postnatal, pubertal and adult testicular development. Food and Chemical Toxicology 42(1): 29?36.
Sakamoto, Y., Tada, Y., Fukumori, N., Tayama, K., Ando, H., Takahashi, H., Kubo, Y., Nagasawa, A., Yano, N., Yuzawa, K. and Ogata, A. (2008). A 104-week feeding study of genetically modified soybeans in F344 rats. Shokuhin Eiseigaku Zasshi 49(4): 272?282.
Teshima, R.; Akiyama, H.; Okunuki, H.; Sakushima, J.; Goda, Y.; Onodera, H.; Sawada, J.; Toyoda, M. (2000). Effect of GM and non-GM soybeans on the immune system of BN rats and B10A mice. Journal of the Food Hygienic Society of Japan vol. 41 (3) p.188-193.
Glyphosate
Giesy, J.P., Dodson, S. & Solomon, K.R. (2000). Ecotoxocological risk assessment for Roundup herbicide. Reviews of Environmental Contamination and Toxicology 167, 35-120.
Steinrucken, H.C. and Amrhein, N. (1980). The herbicide glyphosate is a potent inhibitor of 5-enolpyruvylshikimic acid-3-phosphate synthase. Biochemical and Biophysical Research Communications, 94, 1207-1212.
U.S. EPA. (1993). Reregistration Eligibility Decision (RED): Glyphosate. Office of Prevention, Pesticides and Toxic Substances, U.S. Environmental Protection Agency, Washington, D.C.
WHO. (1994). Glyphosate. World Health Organization (WHO), International Programme of Chemical Safety (IPCS), Geneva. Environmental Health Criteria No. 159.
Williams, G.M., Kroes, R. and Munro, I.C. (2000). Safety evaluation and risk assessment of the herbicide Roundup and its active ingredient, glyphosate, for humans. Regulatory Toxicology and Pharmacology 31, 117-165.
Nutritional Equivalence
Cromwell, G., Lindemann, M., Randolph, J., Stanisiewski, E. and Hartnell, G. (2002). Soybean meal from Roundup Ready or conventional soybeans in diets for growing-finishing pigs. Journal Animal Science 80: 708?715.
Hammond, B.G., Vicini, J.L., Hartnell, G.F., Naylor, M.W., Knight, C.D., Robinson, E.H., Fuchs, R.L. & Padgette, S.R. (1996). The feeding value of soybeans fed to rats, chickens, catfish and dairy cattle is not altered by genetic incorporation of glyphosate tolerance. Journal of Nutrition 126, 717-727.
Potental Non-Target Organism Effects
Buckelew, L.D., Pedigo, L.P., Mero, H.M., Owen, M.D.K. and Tylka, G.L. (2000). Effects of weed management systems on canopy insects in herbicide-resistant soybeans. J. Econ. Entomol. 93:1437-1443.
Jackson, R.E. and Pitre, H.N. (2004a) Influence of Roundup Ready soybean production systems and glyphosate application on pests and beneficial insects in narrow-row soybeans. J Entomol Sci. 39: 62-70.
McPherson, R.M., Johnson, W.C., Mullinix, B.G., Mills, W.A. and Peebles, F.S. (2003). Influence of herbicide tolerant soybean production systems on insect pest populations and pest-induced crop damage. J Econ Entomol 96(3): 690-698.
Morjan W.E. and Pedigo, L.P. (2002). Suitability of transgenic glyphosate-resistant soybeans to green cloverworm (Lepidoptera:Noctuidae) J Econ Entomol 95(6): 1275-1280.
Potential Allergenicity
Batista, R., Nunes, B., Carmo, M., Cardoso, C., S? Jos? H., Almeida, A. B. de, Manique, A., Bento, L., Ricardo, C.P. and Oliveira, M.M. (2005). Lack of detectable allergenicity of transgenic maize and soya samples. Journal of Allergy Clinical Immunology 116: 403?410.
Burks, A. and Fuchs, R. (1995). Assessment of the endogenous allergens in glyphosate-tolerant and commercial soybean varieties. Journal of Allergy and Clinical Immunology 96: 1008?1010.
Chang, H., Bae, Y.K., Lim, S.K., Jeong, T.C., Kim, H.S., Chung, S.T., Kim, D.S. and Nam, D.H. (2001). Allergenicity test of genetically modified soybean in Sprague Dawley rats. Archives of Pharmaceutical Research 24(3): 256-261.
Kim, S.H., Kim, H.M., Ye, Y.M., Kim, S.H., Nahm, D.H., Park, H.S., Ryu, S.R. and Lee, B.O. (2006). Evaluating the allergic risk of genetically modified soybean. Yonsei Medical Journal 47: 505-512.
Sten E, Skov PS, Andersen SB, Torp AM, Olesen A, Bindslev-Jensen U, Poulsen LK and Bindslev-Jensen C (2004). A comparative study of the allergenic potency of wild-type and glyphosate-tolerant gene-modified soybean cultivars. APMIS 112(1): 21-28.
Protein Safety
Acute oral toxicity study of CP4 EPSPS protein in albino mice. Unpublished study number: 92223; Project Number: ML-92-542. Monsanto Company.
Chang, H.S., Kim, N.H., Park, M.J., Lim, S.K., Kim, S.C., Kim, J.Y., Kim, J.A., Oh, H.Y., Lee, C.H., Huh, K., Jeong, T.C. and Nam, D.H. (2005). The 5-enolpyruvylshikimate-3-phosphate synthase of glyphosate-tolerant soybean expressed in Escherichia coli shows no severe allergenicity. Molecules and Cells 15(1): 20?26.
Harrison, L.A., Bailey, M.R., Naylor, M.W., Ream, J.E., Hammond, B.G., Nida, D.L., Burnette, B.L., Nickson, T.E., Mitsky, T.A., Taylor, M.L., Fucsh, R.L. & Padgette, S.R. (1996). The expressed protein in glyphosate-tolerant soybean, 5-enolypyruvylshikimate-3-phosphate synthase from Agrobacterium sp. Strain CP4, is rapidly digested in vitro and is not toxic to acutely gavaged mice. Journal of Nutrition 126(3), 728-740.
Leach, J.N., Hileman, R.E., Thorp, J.J., George, C. and Astwood, J.D. (2002). Assessment of the in vitro digestibility of purified E. coli-produced CP4 EPSPS protein in simulated gastric fluid. Unpublished study number 01-01-62-09; MSL No. 17566.
Safety Assessment
Marshall A. (2007). GM soybeans and health safety--controversy reexamined. Nature Biotechnology 25: 981?987.
Nair, R., Fuchs, R. and Schuette, S. (2002). Current methods of assessing safety of genetically modified crops as exemplified by data on Roundup Ready soybeans. Genetically Modified Food: Hazard Identification and Risk Assessment. Toxicologic Pathology 30(1): 117?125.


THIS RECORD WAS LAST MODIFIED ON FRIDAY, APRIL 03, 2009
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