GM Crop Database

Database Product Description

MON1445/1698 (MON-Ø1445-2)
Host Organism
Gossypium hirsutum (Cotton)
Trade Name
Roundup Ready®
Trait
Glyphosate herbicide tolerance.
Trait Introduction
Agrobacterium tumefaciens-mediated plant transformation.
Proposed Use

Production for fibre, livestock feed, and human consumption.

Product Developer
Monsanto Company

Summary of Regulatory Approvals

Country Food Feed Environment Notes
Argentina 2001 2001 1999 View
Australia 2000 2000
Brazil 2008 2008 2008
Canada 1996 1996 View
China 2004 2004 View
Colombia 2004 2004 View
European Union 2005 2005 View
Japan 1997 1998 1997
Korea 2003 2004
Mexico 2000 2000
New Zealand 2000
Paraguay 2013 2013 2013
Philippines 2003 2003 View
Singapore 2014
South Africa 2000 2000 2000 View
Taiwan 2015
United States 1995 1995 1995

Introduction Expand

Transgenic cotton lines 1445 and 1698 were produced using recombinant DNA techniques to allow for the use of glyphosate, the active ingredient in the non-selective herbicide Roundup®, as a weed control option in cotton crops. The novel plants express a naturally glyphosate tolerant version of the enzyme 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) gene isolated from Agrobacterium tumefaciens strain CP4 (CP4 EPSPS). Glyphosate specifically binds to and inactivates EPSPS, which is involved in the synthesis of aromatic amino acids, tyrosine, phenylalanine and tryptophan (shikimate biochemical pathway). EPSPS is present in all plants, bacteria, and fungi but not in animals, which do not synthesize their own aromatic amino acids.

An antibiotic resistance marker gene (neo) encoding the enzyme neomycin phosphotransferase II (NPTII), which inactivates aminoglycoside antibiotics such as kanamycin and neomycin, was also introduced into the genome of these transgenic lines. This gene was derived from a bacterial transposon (Tn5 transposable element from Escherichia coli) and was included as a selectable marker to identify transformed plants during tissue culture regeneration and multiplication. The expression of the neo gene in these plants has no agronomic significance, and the safety of the NPTII enzyme as a food additive was evaluated by the United States Food and Drug Administration in 1994 (US FDA, 1994).

Another selectable marker gene, aad (3"(9)-O-aminoglycoside adenylyltransferase (AAD)), was also inserted into the host genome. This gene, which was not expressed in the plants, was used during the development process to select for bacterial colonies that had been transformed with recombinant plasmid DNA.

Unless otherwise indicated, the information presented herein is based on documentation pertaining to cotton line 1445.

Summary of Introduced Genetic Elements Expand

Code Name Type Promoter, other Terminator Copies Form
CP4 epsps 5-enolpyruvyl shikimate-3-phosphate synthase HT CMoVb from modified figwort mosaic virus (FMV) chloroplast transit peptide from A. thaliana EPSPS gene (CTP2) P. sativum (pea) ribulose-1,5-bisphosphate carboxylase small subunit non-translated region 1 (line 1445) modified for plant-preferred codons; these data refer to line 1445 only
nptII neomycin phosphotransferase II SM CaMV 35S A. tumefaciens nopaline synthase (nos) 3'-untranslated region
aad 3"(9)-O-aminoglycoside adenylyltransferase SM bacterial promoter Not expressed in plant tissues

Characteristics of Gossypium hirsutum (Cotton) Expand

Center of Origin Reproduction Toxins Allergenicity

Believed to originate in Meso-America (Peruvian-Ecuadorian-Bolivian region).

Generally self-pollinating, but can be cross-pollinating in the presence of suitable insect pollinators (bees). In the U.S., compatible species include G. hirsutum, G. barbadense, and G. tomentosum.

Gossypol in cottonseed meal.

Cotton is not considered to be allergenic, although there are rare, anecdotal reports of allergic reactions in the literature.

Donor Organism Characteristics Expand

Latin Name Gene Pathogenicity
Agrobacterium tumefaciens strain CP4 CP4 epsps

Agrobacterium tumefaciens is a common soil bacterium that is responsible for causing crown gall disease in susceptible plants. There have been no reports of adverse effects on humans or animals.

Modification Method Expand

The cotton lines 1445 and 1698 were produced by Agrobacterium-mediated transformation of the cotton (Gossypium hirsutum L. ) cultivar Coker 312, with plasmid PV-GHGT07. The T-DNA region of the Agrobacterium Ti plasmid used to develop line 1445 contained sequences encoding CP4 EPSPS, glyphosate oxidase (GOX), NPTII, and AAD. The plasmid used to produce 1698 did not include the GOX encoding gene.

Plasmid PV-GHGT07 is a single border vector that has only a right border containing the following elements: the 0.4 kb oriV fragment from the RK2 plasmid fused to the 3.0 kb segment of pBR322 allowing maintenance in E. coli and in A. tumefaciens. This was fused to the 90 bp DNA fragment from pTiT37 plasmid, which contained the 25 bp nopaline-type T-DNA right border.

The nucleotide sequence of the CP4 EPSPS encoding gene was modified by site-directed mutagenesis to contain plant-preferred codons in order to maximize protein expression in plant cells. These modifications did not alter the expected amino acid sequence of the CP4 EPSPS. Expression of the CP4-EPSPS gene in plant cells was under the control of the CMoVb promoter from a modified figwort mosaic virus (FMV) and the 3’ non-translated region of the rubisco (rbcS, small subunit ribulose bisphosphate carboxylase oxygenase) E9 gene (E9 3’) terminator sequence from pea (Pisum sativum).

Additionally, the synthetic CP4 EPSPS gene was fused at the 5’ end to the region that codes for the chloroplast transit peptide (CPT2) from Arabidopsis thaliana. The CTP2 peptide sequence targets CP4 EPSPS to the chloroplasts where the aromatic amino acid biosynthetic pathway and endogenous EPSPS activity are located.

The aminoglycoside adenyltransferase (aad) gene was derived from E. coli bacterial transposon Tn7 and encodes aminoglycoside adenyltransferase (AAD), which confers resistance to the antibiotics spectinomycin and streptomycin. The aad gene was under the control of its own bacterial promoter and terminator and was not expressed in plant tissues.

The NPTII encoding neo gene was located downstream of the aad gene and was under the control of the cauliflower mosaic virus (CaMV) 35S promoter and the non-translated region of the 3’ region of the nopaline synthase gene (nos 3’) from the pTiT37 plasmid of A. tumefaciens strain T37.

The GOX encoding gox gene from the bacterium Ochromobactrum anthropii strain LBAA (formerly Achromobacter sp.) was fused at the 5’ end to the sequence coding for the chloroplast transit peptide from A. thaliana EPSPS and the CMoVb promoter. The 3’ region was derived from the 3’ non-translated region of the nopaline synthase gene (nos 3’). The gox gene was not integrated into the transgenic cotton lines.

Characteristics of the Modification Expand

The Introduced DNA

Southern blot analyses of genomic DNA from line 1445 demonstrated the insertion at a single site on a 6.1 kb restriction fragment that included sequences encoding AAD, NPTII, CP4 EPSPS, and a partial oriV sequence. These analyses failed to detect any incorporation of the gox gene sequence.

Genetic Stability of the Introduced Trait

The stability of lines 1445 and 1698 was demonstrated for 5 generations. Southern blot analysis showed that the inserted DNA from the progeny of three successive homozygous generations (R3 through R5) was stably integrated into the cotton genome. Southern and genetic analyses of line 1445 demonstrated that a single copy of the insert was transferred at one single locus.

Expressed Material

Western immunoblot analysis of samples of line 1445 tissue demonstrated the presence of 48 kD immunoreactive species, which was the same apparent molecular weight (47.5 kD) as purified CP4 EPSPS protein isolated from E. coli. These studies, also verified that the CTP2 sequence (8.2 kD) was cleaved from the mature protein and rapidly degraded, following delivery of the CP4 EPSPS to the chloroplast.

Expression levels of CP4 EPSPS protein in line 1445 were determined based on material from six different trial site locations in the United States during 1993 and 1994. Expression levels of CP4 EPSPS were measured in cottonseed and leaf, using enzyme linked immunosorbent assay (ELISA) and found to be low, ranging from 0.02% to 0.028% of total protein in cottonseed. In cottonseed the CP4 EPSPS concentration was approximately 0.08 µg/mg fresh weight while in leaves the level was approximately 0.05 µg/mg f.w. For line 1698 expression of the enzyme in the seed averaged 0.205 µg/mg (f.w) while in the leaves the level averaged 0.311 µg/mg (f.w). No expression was detected in the untransformed parental line Coker 312.

Combed lint and brown linter stock (i.e. linters after the first processing step) were tested for the presence of CP4 EPSPS protein by Western blotting. CP4 EPSPS was detected in combed lint but not in brown linter stock, the first product in the sequence of processing linters for cellulose.

The expression of the NPTII protein was determined by ELISA and detected at low levels in cottonseed and leaf material. The NPTII protein content of cottonseed was 0.0022% of total protein, present in whole seeds at concentrations of approximately 0.007 µg/mg fresh weight. In leaf material, NPTII was present in concentrations of approximately 0.045 µg/mg fresh weight. For line 1698, NPTII expression averaged 0.004 µg/mg (f.w) in the seed and 0.031 µg/mg (f.w.) in the leaf.

The effect of application of glyphosate on levels of expression during plant growth was also investigated. There were no significant differences in expression levels of CP4 EPSPS and NPTII in cottonseed between plants treated with glyphosate and those that were not treated.

Environmental Safety Considerations Expand

Field Testing

The transgenic cotton lines 1445 and 1698 were field tested in the United States (1991-1994). Compared with non-transgenic control lines, susceptibilities to diseases such as bacterial blight, boll rot, Verticillium wilt, and Ascochyta blight were unchanged. Similarly, no differences were noted in the susceptibility of the transformed cotton lines to insect pests, such as aphids, fleahoppers, boll weevils, tobacco budworm, cotton bollworm, and thrips, when compared to non-transformed cotton lines. Reports demonstrated that the cotton lines 1445 and 1698 did not exhibit weedy characteristics, and had no effect on nontarget organisms or the general environment relative to conventional cotton varieties.

Outcrossing

Cotton (Gossypium hirsutum) is mainly a self-pollinating plant, but pollen is also routinely transferred by insects, especially bumble bees and honey bees. The pollen is heavy and sticky and the range of natural crossing is limited. Outcrossing rates of up to 28% to other cotton cultivars have been observed under field conditions and decline rapidly with distance from the pollen source. Given proximity and the availability of insects as pollen vectors, transgenic cotton lines 1445 and 1698 are likely to hybridize with other cotton varieties.

In the United States, compatible species include G. hirsutum (wild or under cultivation), G. barbadense (cultivated Pima cotton), and G. tomentosum. There are no wild relatives or wild populations of cotton in Canada that can naturally hybridize with G. hirsutum. It was reported that gene movement from G. hirsutum to G. barbadense may be possible given suitable conditions, while gene transfer to G. tomentosum is less probable due to chromosomal incompatibility and non-synchronous flowering periods. Overall, the probability of gene transfer in the wild is unlikely due to the relatively isolated distribution of Gossypium species, different breeding systems, and genome incompatibility. Hybrids resulting from artificial crosses between cotton and wild species are generally sterile, unstable and of poor fitness.

Weediness Potential

The CP4 EPSPS and NPTII encoding genes are not expected to confer an ecological advantage to transgenic cotton lines 1445 and 1698 and their potential hybrid offspring. Tolerance to glyphosate and resistance to kanamycin will not render cotton weedy or invasive of natural habitats since none of the reproductive or growth characteristics have been modified. Field trial reports indicated that traits that may confer a selective advantage, such as germination, vegetative vigour, disease and insect susceptibility, and reproduction, were equivalent to non-modified varieties.
There are no specific problems with cotton as a weed. Cottonseed may remain in the field after harvesting and germinate under favourable conditions. Seeds may also survive mild and dry winters. Suitable treatments for any volunteers in the next crop include cultivation and the use of herbicides other than glyphosate.

Secondary and Non-Target Adverse Effects

It was concluded that the genes inserted into the transgenic cotton lines 1445 and 1698 would not result in any deleterious effects or significant impacts on nontarget organisms, including those that are recognized as beneficial to agriculture and those that are recognized as threatened or endangered in the United States and Canada. The CP4 EPSPS enzyme is ubiquitous in microorganisms, fungi and plants, and was rapidly inactivated in mammalian stomach and intestinal fluids by enzymatic degradation and pH-mediated proteolysis. Exposure of non-target species to seeds was considered very low, due to the morphology of the boll. Feeding studies with birds (seeds) and mammals (both proteins) did not indicate any acute toxicity of the proteins, which also occur ubiquitously in the environment in plants and microorganisms.

Impact on Biodiversity

The transgenic cotton lines 1445 and 1698 had no novel phenotypic characteristics that would extend their use beyond the current geographic range of cotton production. Since there is no occurrence of wild relatives of cotton in Canada, there will be no transfer of novel traits to unmanaged environments. Similarly, as the risk of gene transfer to wild relatives in the United States is very remote, it was determined that the risk of transferring genetic traits from cotton lines 1445 and 1698 to species in unmanaged environments was insignificant.

Food and/or Feed Safety Considerations Expand

Dietary Exposure

Only refined cottonseed oil and cellulose from processed linters of cottonseed are consumed by humans. Processed linters are essentially pure cellulose (>99%) and are subjected to heat and solvent treatment that would be expected to remove and destroy DNA. CP4 EPSPS was detected in combed lint but not in brown linter stock, the first product in the sequence of processing linters for cellulose. It is generally accepted that the refined oil does not contain protein. The refining process for cottonseed oil includes heat, solvent and alkali treatments that remove and destroy DNA and protein. Although refined cottonseed oil from these lines was not tested for the presence of CP4 EPSPS or NPTII protein, other data were presented confirming that proteins are generally not detectable in such oil at a sensitivity of 1.3 ppm. It was concluded that there would be no dietary exposure to the novel proteins expressed in cotton line 1445.

Nutritional Data

Compositional comparison of cottonseed oil from line 1445 was made to commercial non-transgenic cottonseed oil. The cottonseed used for compositional analyses was taken from six trial sites during two growing seasons. The compositional analyses of cottonseed components measured included proximates (protein, fat, ash, carbohydrates, moisture, crude fibre), amino acid composition, fatty acids profile, and levels of tocopherols.

Minor differences in proximate analysis between the control, the modified line and the treated modified line were all within the normal range for conventional cotton varieties.The composition of the oil from cotton line 1445 was comparable to that of cottonseed oil from the control line Coker 312 and components were within the normal range reported for cottonseed oil. Based on these data it was determined that refined oil and processed linters derived from glyphosate-tolerant cotton line 1445 were nutritionally and compositionally comparable to that from conventional cotton and were not considered to pose a risk to human health and safety.

Toxicity

Toxicity of cotton lines was assessed by analysis of naturally occurring toxins in cotton and an evaluation of the novel proteins CP4 EPSPS and NPTII. Toxicant analyses in cottonseed and refined oil evaluated levels of gossypol and cyclopropenoid fatty acids (sterculic and malvalic acid).

Cottonseed contains a high number of anti-nutritional factors and the raw seed is unsuitable for monogastric animals. Gossypol has numerous toxic effects on mammals, including heart damage and heart failure, such that whole cottonseed or cottonseed meal is not used in human foods and the presence of gossypol limits its use as in animal feed. However, removal or inactivation of gossypol during processing enables the use of some cottonseed meal in feed for fish, poultry and pigs.

The gossypol content was higher in the transformed line compared to the control parent line Coker 312, but still within the range found for field-grown cotton. Gossypol was below the level of detection in cottonseed oil from both the transformed lines and the control.

The cyclopropenoid fatty acids, sterculic acid (C-17), dihydrosterculic acid (C-19) and malvalic acid (C-18), are unique fatty acids common in cotton and produce undesirable biological effects. These include the inhibition of biodesaturation of stearic to oleic acid, affecting phospholipid biosynthesis. There were no statistical differences detected in the content of these fatty acids in cottonseed from the control parent line Coker 312 and from line 1445 with or without glyphosate treatment. In refined oil (single samples processed from cottonseed pooled from the six field sites) the levels of dihydrosterculic and malvalic acids were virtually identical in line 1445 and the control line Coker 312. The level of sterculic acid was slightly higher but within the range for cotton.

Anthocyanin, flavonoid and tannin in the transformed lines were within acceptable levels for cotton and within the range of the controls.

The toxicity of the CP4 EPSPS was previously tested by acute gavage exposure in mice and no deleterious effects were observed. The CP4 EPSPS protein was administered at levels 1000 fold to those anticipated in consumption of food products (high dose: 572 mg/kg body weight). A similar toxicity study on NPTII protein was performed and no deleterious effects were observed. The NPTII protein was administered in three cumulative target dosages of up to 5000 mg/kg body weight. Clinical observations in both studies detected no abnormalities and it was concluded that the toxicity of the two novel proteins was low.

The deduced amino acid sequences of both CP4 EPSPS and NPTII were compared to the amino acid sequence of known protein toxins. No significant similarities were found.

Allergenicity

The CP4 EPSPS and NPTII proteins are not likely to be toxic or allergenic. The potential for allergenicity was assessed based upon characteristics such as glycosylation, resistance to heat and digestive degradation, and sequence similarity to known allergens.

Refined cottonseed oil and cellulose from linters are devoid of protein and, given that most allergens are proteins, their consumption is unlikely to result in an allergic reaction. Therefore the potential for cottonseed oil or linters from cotton line 1445 to constitute a source of allergens is extremely low. Furthermore EPSPS proteins are naturally present in foods derived from plants and microbes and have no history of being allergenic. Both CP4 EPSPS and NPTII proteins are widespread in nature and no toxic or allergenic effects have ever been reported.

The deduced amino acid sequences of CP4 EPSPS and NPTII showed no homologies with sequences of known toxins or allergens assembled from the Swissprot, Genepept, and PIR protein databases. Unlike known allergens that are resistant to digestion, previous studies demonstrated that the CP4 EPSPS and NPTII proteins were rapidly degraded in a simulated digestive system and inactivated by heat treatment. Data presented showed that the CP4 EPSPS enzyme was rapidly inactivated by heat and by digestion in simulated mammalian gastric fluid. Similarly, NPTII was shown to be rapidly degraded under simulated mammalian digestive conditions, being completely removed after 10 seconds in simulated gastric fluid and with 50% digested after five minutes in simulated intestinal fluid.

The CP4 EPSPS protein sequence does not contain typical glycosylation sequences and comparisons between CP4 EPSPS protein in crude extracts from cottonseed of line 1445 did not differ from purified CP4 EPSPS, supporting the conclusion that the CP4 EPSPS was not glycosylated.

Residue Assessment

The metabolism of glyphosate has been investigated in several varieties of plants, the metabolic pathway in tolerant crops being the same as in non-tolerant crops. In tolerant plants containing the enzyme CP4 EPSPS, like cotton line 1445, glyphosate is only slowly metabolized to AMPA (aminomethylphosphonic acid) as in non-tolerant crops. No detectable residues would occur in cottonseed oil.

Studies with livestock animals also show that glyphosate and AMPA are not metabolized, or are only insignificantly metabolized. Therefore, residues would not be present in meat, milk and eggs of animals fed with tolerant or non-tolerant crops treated with the herbicide glyphosate.

Abstract Collapse

Cotton (Gossypium hirsutum L.) is primarily grown for its seed bolls that produce fibres used in numerous textile products. The major producers of cotton seed and lint are China, the United States, India, Pakistan, Brazil, Uzbekistan and Turkey.

About two thirds of the harvested cotton crop is seed, which is separated from the lint during ginning. The cotton seed is crushed to produce cottonseed oil, cottonseed cake (meal) and hulls. Cottonseed oil is used primarily as cooking oil, in shortening and salad dressing, and is used extensively in the preparation of snack foods such as crackers, cookies and chips. The meal and hulls are an important protein concentrate for livestock, and may also serve as bedding and fuel. Linters, or fuzz, which are not removed in ginning, are used in felts, upholstery, mattresses, twine, wicks, carpets, surgical cottons, and in industrial products such as rayon, film, shatterproof glass, plastics, sausage skins, lacquers, and cellulose explosives.

Effective weed management is critical to cotton production. The removal of weeds early in the growing season extremely important in cotton production. Young cotton seedlings grow slowly early in the season and are not very competitive. Early weed pressure has detrimental effects on final yield. Weeds can also be detrimental later in the growing season; weeds can interfere with harvesting, and can result in a reduction in lint quality due to trash or staining. Precautions such as pre-plant tillage or herbicide application are common approaches for reducing weed competition, as are multiple herbicide treatments. The broadleaf weeds are the most difficult to control because there are few herbicide options available and many producers will use as many as four herbicides per year in an effort to control weeds.

Cotton lines 1445 and 1698 were genetically engineered to express resistance to glyphosate, the active ingredient in the herbicide Roundup®, allowing for its use as a weed control option. In order to obtain field tolerance to glyphosate herbicide, a bacterial gene encoding a glyphosate-tolerant form of the enzyme 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) was introduced into the cotton genome by Agrobacterium-mediated transformation.

The EPSPS enzyme is present in all plants, bacteria, and fungi, and is part of an important biochemical pathway called the shikimate pathway, which is involved in the production of aromatic amino acids and other aromatic compounds. When conventional cotton plants are treated with glyphosate, the plants cannot produce the aromatic amino acids needed to grow and survive. EPSPS is not present in mammals, birds or aquatic life forms, which do not synthesize their own aromatic amino acids. For this reason, glyphosate has little toxicity to these organisms. The EPSPS enzyme is naturally present in foods derived from plant and microbial sources.

Cotton lines 1445 and 1698 were field tested in the United States from 1991 to 1994. Compared with non-transgenic control lines, susceptibilities to diseases such as bacterial blight, boll rot, Verticillium wilt, and Ascochyta blight were unchanged. Similarly, no differences were noted in the susceptibility of the transformed cotton lines to insect pests, such as aphids, fleahoppers, boll weevils, tobacco budworm, cotton bollworm, and thrips, when compared to non-transformed cotton lines. Reports demonstrated that the cotton lines 1445 and 1698 did not exhibit weedy characteristics, and had no effect on non-target organisms or the general environment. The transformed lines were not expected to impact on threatened or endangered species.

Cotton plants are primarily self-pollinating, but insects, especially bumblebees and honeybees, also distribute cotton pollen. Cotton can cross-pollinate with compatible species including G. hirsutum (wild or under cultivation), G. barbadense (cultivated Pima cotton), and G. tomentosum. Overall, the probability of gene transfer to wild species in unmanaged ecosystems is low due to the relatively isolated distribution of Gossypium species, different breeding systems, and genome incompatibility. Assuming proximity, synchronicity of flowering and availability of insects, transgenic cotton lines 1445 and 1698 may freely hybridize with other G. hirsutum varieties.

Human consumption of cotton products is limited to refined cottonseed oil and cellulose from processed linters of cottonseed. Processed linters are essentially pure cellulose, and are subjected to heat and solvent treatment that would be expected to remove and destroy DNA. It is generally accepted that the refined oil does not contain protein as the refining process includes heat, solvent and alkali treatments that would remove and destroy any DNA and protein present. It was concluded that there was little potential for human dietary exposure to the novel proteins expressed in these transgenic cotton lines.

A compositional comparison of cottonseed oil from each line was made to commercial non-transgenic cottonseed oil. Parameters measured included proximate analysis (protein, fat, ash, carbohydrates, crude fibre, and moisture), amino acid and fatty acid composition, and levels of tocopherols. Protein concentrations in the transgenic lines were slightly higher than in the control lines, but still fell within the normal range for cotton. Small differences were also seen in the fatty acid composition of the seed oil, and in total lipid content, however these differences were minor and values remained within the expected range. It was also determined that the transgenic lines contained levels of gossypol and cyclopropenoid fatty acids, toxic substances naturally found in cotton, within the normal range of variation reported for conventional cotton cultivars. Based on these data it was determined that the refined oil and processed linters derived from transgenic cotton lines 1445 and 1698 were nutritionally and compositionally comparable to that from conventional cotton and not likely to impact the nutritional quality of the food supply.

The assessment of the potential allergenicity of the CP4 EPSPS protein was based on an examination of its physiochemical properties, as compared with the characteristics of known protein allergens, amino acid sequence homology with known allergens, and its abundance in food. Data were presented to show that, unlike allergenic proteins, CP4 EPSPS was rapidly degraded in simulated gastric fluids and was inactivated by heat treatment. An amino acid sequence comparison did not reveal any homologies between known protein allergens or toxins and the CP4-EPSPS protein. In addition, refined cottonseed oil and cellulose from linters are devoid of protein and, given that most allergens are proteins, the consumption of these products is unlikely to result in an allergic reaction. These data supported the conclusion that the CP4-EPSPS protein, and thus 1445 and 1698 cotton, possessed little or no potential for allergenicity.

Links to Further Information Expand

Australia New Zealand Food Authority Canadian Food Inspection Agency, Plant Biosafety Office Comissão Técnica Nacional de Biossegurança - CTNBio (Brazil) European Commission Scientific Committee on Plants European Commission: Community Register of GM Food and Feed Japanese Biosafety Clearing House, Ministry of Environment Monsanto Company Office of Food Biotechnology, Health Canada Office of the Gene Technology Regulator Office of the Gene Technology Regulator, Australia U.S.Department of Agriculture, Animal and Plant Health Inspection Service US Food and Drug Administration USDA-APHIS Environmental Assessment

This record was last modified on Monday, August 22, 2016