GM Crop Database

Database Product Description

MON88913 (MON-88913-8)
Host Organism
Gossypium hirsutum (Cotton)
Trade Name
Roundup Ready® Flex
Trait
Herbicide tolerant, glyphosate.
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
Australia 2006 2006 View
Brazil 2011 2011 2011
Canada 2005 2005 View
China 2007 2007 2007
Colombia 2010 2008
European Union 2015 2015
Japan 2005 2006
Korea 2006 2006
Mexico 2006 2006
New Zealand 2006
Philippines 2005 2005
Singapore 2014
South Africa 2007 2007 2007
Taiwan 2015
United States 2005 2005 2004

Introduction Expand

MON 88913 (Roundup Ready® Flex) cotton was developed to allow the use of glyphosate, the active ingredient in the herbicide Roundup®, as a weed control option in cotton production. This genetically engineered cotton variety contains a glyphosate-tolerant form of the plant enzyme 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS), isolated from the soil bacterium Agrobacterium tumefaciens strain CP4, hereafter termed CP4 EPSPS. Compared to previously approved glyphosate tolerant lines of cotton, which will tolerate glyphosate applications only to the fifth true leaf stage, MON 88913 was developed to tolerate glyphosate applications beyond the fifth true leaf stage.

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. When conventional plants are treated with glyphosate, the herbicide binds to EPSPS, thereby preventing the synthesis of aromatic amino acids needed for plant growth. The CP4 EPSPS enzyme in MON 88913 cotton has a reduced affinity for glyphosate; its enzymatic activity is therefore not hindered by the herbicide.

EPSPS 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 to 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.

MON 88913 cotton was developed by introducing two CP4 EPSPS coding sequences into the cotton variety ‘Coker 312’ using Agrobacterium-mediated transformation.

Summary of Introduced Genetic Elements Expand

Code Name Type Promoter, other Terminator Copies Form
CP4 epsps 5-enolpyruvyl shikimate-3-phosphate synthase HT P-FMV/TSF1: chimeric promoter containing A. thaliana tsf1 promoter elongation factor EF-1 alpha; Figwort Mosaic Virus 35S promoter enhancer; A. thaliana tsf1 leader and intron; chloroplast transit peptide from A. thaliana Pisum sativum T-E9 DNA containing 3’ UTR of Rubisco small subunit E9 gene 1 functional
CP4 epsps 5-enolpyruvyl shikimate-3-phosphate synthase HT P-35S/ACT8: chimeric promoter from A. thaliana act8 f Cauliflower Mosaic Virus 35S promoter enhancer; A. thaliana act8 leader and intron; chloroplast transit peptide from A. thaliana Pisum sativum T-E9 DNA containing 3’ UTR of Rubisco small subunit E9 gene 1 functional

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.

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

MON 88913 cotton was produced by Agrobacterium-mediated transformation of hypocotyl tissue from the cotton variety ‘Coker 312.’ The binary plasmid PV-GHGT35 was used for the transformation. The T-DNA portion of the plasmid contained two tandem cp4 epsps gene expression cassettes. Joined with each cp4 epsps gene was a chloroplast transit peptide (cpt2) sequence, derived from the Arabidopsis thaliana epsps gene. Two unique promoter and enhancer sequences were used to regulate the expression of each cp4 epsps gene. In the first cassette, gene expression was regulated by P-FMV/TSF1, a chimeric promoter containing the A. thaliana tsf1 gene promoter, the encoding elongation factor EF-1 alpha, enhancer sequences from the Figwort Mosaic Virus 35S promoter, as well as the leader and intron sequences from the A. thaliana tsf1 gene. The expression of the second cp4 epsps gene was regulated by P-35S/ACT8, a chimeric promoter from the act8 gene of A. thaliana combined with enhancer sequences from the Cauliflower Mosaic Virus 35S promoter, and the leader and intron sequences from the act8 gene of A. thaliana. The transcriptional termination and polyadenylation sequences were derived from the T-E9 DNA sequences of Pisum sativum, containing the 3’ nontranslated region of the ribulose-1,5-biphosphate carboxylase (Rubisco) small subunit E9 gene.

Transformed callus was selected in vitro using culture medium to which glyphosate had been incorporated. Plants were regenerated from tolerant callus using tissue culture techniques. MON 88913 was derived from a single regenerated plant that displayed tolerance to glyphosate.

Characteristics of the Modification Expand

The Introduced DNA

Southern blot analysis of MON 88913 genomic DNA indicated the incorporation of a single intact integration of the T-DNA insert of PV-GHGT35, at a single locus. The analysis revealed the intact insertion of the two cp4 epsps cassettes, including the promoter, enhancer, terminator, and chlorophyll transit peptide (ctp2) sequences. Evidence was also provided to show that none of the plasmid backbone sequences were incorporated into the genome of MON 88913 cotton.

The cp4 epsps gene was isolated from Agrobacterium tumefaciens strain CP4 and encodes a 47.2 kDa EPSPS protein. In plants, EPSPS is a chloroplast-localized enzyme that is transported from the cytosol to the chloroplast by a chlorophyll transit peptide. In MON 88913, the inserted ctp2 gene codes for a chlorophyll transit peptide that binds to the CP4 EPSPS enzyme to enable transportation to the chloroplast.

Genetic Stability of the Trait

The stability of the glyphosate tolerance trait in MON 88913 was assessed within and across generations using Southern blot analysis. Progeny resulting from the self-pollination of first generation plants segregated in a 3:1 of resistant to non-resistant plants. Advanced generations (R4 and R5) of self-pollinated homozygous plants resulted in segregation ratios of 1:0. These results were not significantly different from the expected Mendelian segregation ratios and confirmed the homozygosity and generation stability of a single dominant trait across multiple generations.

Expressed Material

The levels of CP4 EPSPS in tissues of MON 88913 were quantified using enzyme-linked immunosorbant assay (ELISA) methods. Samples for analysis were obtained from field trials at four different locations in 2002. Levels of CP4 EPSPS expression were determined on a fresh weight basis, and also calculated on a dry weight basis from dry matter percentages determined for the various tissues. Dry matter percentage was not determined for pollen due to the limited quantifies available for analysis. The average expression of CP4 EPSPS protein, on a fresh weight (dry weight) basis, was: 170 (970) µg/g in young leaves, 160 to 270 (630 to 1400) µg/g in overseason leaves, 31 (99) µg/g in roots, 310 (340) µg/g in seeds, and 4 µg/g (fresh weight only) in pollen. The levels of expression of CP4 EPSPS are higher in MON 88913, compared to the previously approved Roundup Ready Cotton.

Environmental Safety Considerations Expand

Field Testing

MON 88913 cotton was field tested at several locations in the United States and Puerto Rico from 2000 to 2003. Several of these trials were conducted to evaluate glyphosate tolerance under a range of environmental conditions. In 2002, fourteen trials were conducted to evaluate possible unintended effects from the transformation process and subsequent tissue culture. MON 88913 was evaluated for phenotypic characteristics relating to vegetative and reproductive growth and development, seed dormancy, germination and emergence, plant maturity, boll and seed yield, fibre quality, and plant interaction with diseases and insects. Comparisons were made between the MON 88913, a null segregant (non-trangenic counterpart) of this line [MON 88913 (-)] that did not contain the cp4 epsps genes, and conventional cotton varieties.

There were no significant differences among MON 88913 and its null counterpart for most of the measured growth and reproductive parameters, seed dormancy, germination and emergence, boll and seed yield, and fibre quality. The observed significant differences in these parameters were small, and were attributed to location rather than phenotype. Susceptibility to diseases and insects was qualitatively assessed during the field trials. Assessments were made for insects commonly found in cotton fields such as aphids, beet armyworm, cotton bollworm and thrips, and diseases such as boll rot, Pythium and Verticillium. Generally, there were no observed differences in susceptibilities to diseases and insects across locations and years. Results from these field trials demonstrate that the growth, agronomic performance, and disease and insect susceptibility of MON 88913 are similar to that of conventional cotton. MON 88913 is therefore not expected to become a plant pest risk, neither in terms of weediness, nor in becoming a more suitable host for plant diseases and insects.

Outcrossing

Cotton (G. hirsutum) is mainly a self-pollinating plant, but pollen is also routinely transferred by insects, particularly bumblebees 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 grown directly adjacent to the pollen source have been observed under field conditions when sufficient insect pollinators have been present. The rate of outcrossing declines rapidly with increased distance from the pollen source. Results of outcrossing research trials in the United States have shown that pollen movement decreases rapidly at 12 metres from the pollen source. Nevertheless, certified seed cotton growers in the United States must maintain an isolation distance of 202 metres between fields. If MON 88913 was to be grown in proximity with other cotton cultivars, and sufficient insect pollinators were present and active, the cp4 epsps genes could possibly introgress into these cultivars. In the event of the formation of hybrids, there would no competitive advantage conferred on any hybrid progeny in the absence of glyphosate applications.

In the United States, species genetically compatible with cultivated cotton are G. barbadense (cultivated Pima cotton), and G. tomentosum. Outcrossing from G. hirsutum to G. barbadense is possible under suitable conditions, such as the presence of pollinators. G. thurberi is another wild species found in the United States, but it is genetically incompatible with G. hirsutum. G. hirsutum and G. tomentosum are genetically compatible (both possess the AADD genome); however, it is generally thought that gene transfer is unlikely due to the non-synchronous flowering periods (day for G. hirsutum and night for G. tomentosum), and lack of common pollinators. Preliminary results of research on G. tomentosum populations in Hawaii have shown that flowering occurs during the day and that bees and other hymenopterans were observed as pollinators. However, no evidence has yet been found in nature of crosses between cultivated cotton and G. tomentosum. Populations of wild Gossypium species occur in southern Florida (G. hirsutum), Hawaii (G. tomentosum), Puerto Rico and the U.S. Virgin Islands. In other cotton growing areas of the world, species that could intercross with G. hirsutum include G. mustelinum in Brazil, and G. lanceolatum in Mexico.

Weediness Potential

Cultivated Gossypium hirsutum is not typically considered a weed species in the United States or other countries, but it is listed as a potential weed in southern Florida. Although the cotton plant is cultivated as an annual crop, it behaves as a perennial plant in undisturbed environments and suitable climatic conditions. Cotton does not tolerate cold conditions thereby limiting its overwintering potential to southern Florida, Hawaii, and Puerto Rico.

Seed dormancy and germination are characteristics used to assess the weediness of plants. These characteristics were measured in MON 88913, its null counterpart and six conventional cotton cultivars. Generally, no significant differences were observed in the amount of hard seed, a seed dormancy characteristic, between MON 88913 and its null counterpart. There were some significant differences observed in seed germination, where MON 88913 displayed reduced germination compared to its counterpart. These differences were small, as were differences in the percentage of viable swollen seed, and were within the range displayed by conventional cultivars. Compared to its null counterpart and conventional cotton, MON 88913 is not expected to become weedy or invasive of natural habitats since the characteristics associated with weediness, such as seed dormancy, germination, as well as flowering, flower morphology, maturity and seed yield were not significantly altered compared to conventional cotton. No other competitive advantage was conferred to MON 88913, other than tolerance to glyphosate.

Secondary and Non-Target Adverse Effects

The impact of the novel CP4 EPSPS protein in MON 88913 on non-target organisms was not directly assessed. The results of studies on CP4 EPSPS in previously approved glyphosate tolerant crops were used to evaluate the impact of this novel protein in MON 88913. These studies evaluated the effect of CP4 EPSPS on pollinators, soil organisms, and beneficial arthropods. No toxic effects were reported in these studies. Furthermore, results from field trials with MON 88913 demonstrated similar susceptibilities to cotton diseases and insect pests, compared to conventional cotton. Levels of natural toxicants (gossypol, cyclopropenoid fatty acids and aflatoxins) were quantitatively determined and compared to the null counterparts and commercial varieties. Other than significant differences in the levels of two cyclopropenoid fatty acids at one location, the levels of these toxicants among MON 88913, the null counterpart, and conventional cotton were not significantly different.

Expression levels of CP4 EPSPS in MON 88913 were substantially higher than in previously approved glyphosate tolerant crops. Nevertheless, the results of previous environmental safety studies with CP4 EPSPS and field trials of MON 88913 do not indicate any increased risk to interacting organisms due to higher levels of this protein. Since the levels of natural toxicants were also not altered in MON 88913, the risk to interacting organisms is similar to conventional cotton.

Impact on Biodiversity

MON 88913 cotton did not exhibit any novel phenotypic characteristics that would increase its survival in either unmanaged habitats, or in areas outside of the current geographical range of cotton production. Since the potential of gene transfer to wild relatives in the United States is quite minimal, the risk of transferring the glyphosate tolerance trait to species in unmanaged habitats is insignificant. In countries (e.g., Brazil, Mexico) where hybrids could form with wild relatives of cotton, the introgression of the glyphosate tolerance trait into these wild species would confer no advantage in the absence of glyphosate applications.

Food and/or Feed Safety Considerations Expand

Dietary Exposure

The genetic modification of MON 88913 would not be expected to result in any change in the consumption pattern of cotton products. MON88913 did not express any novel characteristics with regard to the seed and oil that would alter the consumption pattern. This was confirmed by comparison of the levels of proximates, and fatty acids in MON 88913 to the non-transgenic counterpart and to conventional cotton cultivars.

Only refined cottonseed oil and cellulose from processed linters of cottonseed are consumed by humans. Processed linters are composed of pure (>99%) cellulose and are treated with heat and solvent that would be expected to remove and destroy any residual protein. Cottonseed oil for human consumption is highly refined and does not contain detectable levels of protein. Cottonseed oil and linters are therefore not expected to contain any detectable levels of CP4 EPSPS protein.

Nutritional Data

The nutritional components of MON 88913 whole delinted cottonseed, cottonseed meal, and refined cottonseed oil were determined analytically and compared to those of the non-transgenic control line, and several commercial cottonseed cultivars grown in replicated field trials at four locations in 2002. The non-transgenic control line consisted of a null segregant containing the same genetic background as MON 88913, with the exception of the transgenes.
The analysis of whole delinted (acid-delinted) cottonseed included proximates (crude protein, crude fibre, total fat, ash, moisture, and carbohydrates), acid detergent fibre, neutral detergent fibre, total dietary fibre, amino acids, fatty acids (C8 to C22), minerals (calcium, copper, iron, magnesium, phosphorus, potassium, sodium and zinc), and antinutritional compounds (cyclopropenoid fatty acids, gossypol [total and free]), and aflatoxins. A combined statistical analysis across all locations revealed significant differences among the cultivars in the levels of the amino acids phenylalanine and tryptophan, the fatty acids oleic acid and linoleic acid, moisture, and manganese. Phenylalanine, linoleic acid and manganese levels were higher, and tryptophan and oleic acid levels were lower in MON 88913 compared to the non-transgenic control. However, the levels of these nutrients were within the 99% tolerance interval established for the conventional cotton varieties. The moisture levels for MON 88913 were outside of the tolerance interval, but within the range of values in the literature for conventional cotton. Analyses on mechanically-delinted whole cottonseed also revealed significantly higher values of phenylalanine in MON 88913; however, these values were within the range of those in the literature, and within the 99% tolerance for the conventional cultivars.
The composition of cottonseed meal was similar to that of whole cottonseed, with the exception of analyses for fatty acids, vitamin E and total dietary fibre. No significant differences were observed in the levels of nutrients between MON 88913 and the non-transgenic control.

The analysis of refined cottonseed oil consisted of fatty acids (C8 to C22), vitamin E, cyclopropenoid fatty acids (malvalic acid, sterculic acid and dihyroterculic acid), and gossypol (free and total). Statistically significant differences were observed between MON 88913 and the non-transgenic control in the levels of the fatty acids myristic acid and behenic acid. The mean levels of these fatty acids were lower in MON 88913, but within the 99% tolerance interval established for the conventional cultivars, and the range of values in the literature. Other than for those specific fatty acids, refined cottonseed oil from MON 88913 was not significantly different in composition compared to oil from conventional cotton.

No significant differences were observed in the levels of antinutritional compounds in whole cottonseed, cottonseed meal and oil, with the exception of gossypol in cottonseed meal. The level of total gossypol were significantly lower in MON 88913 compared to the non-transgenic control, but fell within the range of literature values, and the 99% tolerance interval for conventional cotton.

Toxicity and Allergenicity

The toxicity of MON 88913 was assessed by an analysis of the levels of naturally occurring toxins in cotton and, an evaluation of the novel protein CP4 EPSPS. The levels of the toxicants gossypol (free and total) and cyclopropenoid fatty acids (malvalic, sterculic, and dihydrosterculic acid) were quantified in whole delinted cottonseed, cottonseed meal, and cottonseed oil.

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 its use as a monogastric livestock feed is limited. However, the removal or inactivation of gossypol during processing enables the use of some cottonseed meal as feed for poultry, pigs and fish.

Statistically significant differences in the levels of gossypol were observed only in cottonseed meal from MON 88913 and the non-transgenic control. Levels of total gossypol were lower in MON 88913, compared to the non-transgenic control, and were within the range observed in the published literature and in the 99% tolerance interval calculated for several commercial varieties grown at various locations.

The cyclopropenoid fatty acids, sterculic (C-17), dihydrosterculic (C-19) and malvalic (C-18), are naturally found in the seed oil of cotton and other species of the Malvales (e.g., kapok). These compounds produce undesirable biological effects, including the inhibition of biodesaturation of stearic to oleic acid, which detrimentally affects phospholipid biosynthesis. There were no statistically significant differences observed in the levels of these fatty acids in cottonseed, cottonseed meal or cottonseed oil from MON 88913 and the non-transgenic control.

The potential for toxicity of the CP4 EPSPS was previously tested by acute gavage exposure in mice, and by conducting searches for amino acid sequence homology of the novel protein with those of known toxins. No adverse effects were observed when CP4 EPSPS was administered at levels up to 572 mg/kg of body weight. This dose represented a level of CP4 EPSPS that was 1000-fold the anticipated level that would be consumed in food products. The sequence homology searches were conducted using public protein databases. The results of the searches revealed no biologically relevant sequence similarities between CP4 EPSPS and known toxins.

The CP4 EPSPS was also evaluated for potential allergenicity. An amino acid sequence homology search revealed no similarity to known allergens, including gliadin. Results of previous in vitro digestibility studies on CP4 EPSPS demonstrated its rapid digestibility in simulated gastric and intestinal fluids, which is characteristic of non-allergenic proteins. These results, and those of other studies previously submitted to regulatory authorities in support of the safety of CP4 EPSPS, substantiate its low potential for allergenicity.

Abstract Collapse

Cotton (Gossypium hirsutum L.) was grown commercially in over 80 countries with a combined production of 44.2 million metric tonnes of cotton seed and 24.8 million metric tonnes of cotton lint in 2006. The major producers of cotton seed and lint were China, the United States, India, Pakistan, Brazil, Uzbekistan and Turkey. Cotton is primarily grown for its seed bolls that produce fibres used in numerous textile products.

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 a cooking oil, in shortening, margarine 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. Weed control is more difficult in cotton than in other row crops, such as corn or soybean: cotton grows slowly early in the growing season and is thus less competitive with weeds. Competition from weeds has negative impacts on crop establishment, and ultimately, crop yield. Weeds can also be detrimental later in the growing season, interfering with harvesting, and resulting in a reduction in lint quality due to trash and possible staining. Weed control strategies include pre-plant tillage, crop rotation, and the use of herbicides. Annual grasses and some small seed broadleaf weeds are typically controlled with preplant incorporated herbicides (e.g., trifluralin, norflurazon, pendimethalin) while most broadleaf species are controlled with postermergence herbicides (e.g., fluometuron, pendimethalin, pyrithiobac sodium). Crop rotation (e.g., with soybean) prevents the build-up of problem weeds and herbicide biotypes by allowing the use of different herbicides.

Roundup Ready® Flex cotton (MON 88913) was developed to allow the use of glyphosate, the active ingredient in the herbicide Roundup®, as a weed control option in cotton production. This genetically engineered cotton contains a novel form of the plant enzyme 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) that allows MON 88913 to survive otherwise lethal applications of glyphosate. The EPSPS gene introduced into MON 88913 was isolated from a strain of the common soil bacterium Agrobacterium tumefaciens strain CP4; the EPSPS enzyme expressed by this gene is tolerant to glyphosate. MON 88913 cotton contains two copies of the EPSPS gene to confer tolerance to glyphosate later in the growing season, specifically after the fifth true leaf stage.

The EPSPS enzyme is part of the shikimate pathway, an important biochemical pathway in plants involved in the production of aromatic amino acids and other aromatic compounds. When conventional plants are treated with glyphosate, the plants cannot produce the aromatic amino acids needed for growth and survival. EPSPS is present in all plants, bacteria, and fungi. It is not present in animals, since these organisms are unable to synthesize their own aromatic amino acids. Because the aromatic amino acid pathway is not present in mammals, birds, or aquatic life forms, glyphosate has little, if any, toxicity for these organisms. The EPSPS enzyme is naturally present in foods derived from plant and microbial sources. MON 88913 was developed by introducing two CP4 EPSPS genes into the cotton variety ‘Coker 312’ using Agrobacterium-mediated transformation.

MON 88913 cotton was field tested at several locations in the United States and Puerto Rico from 2000 to 2003. Vegetative and reproductive growth, seed dormancy, emergence and germination, plant maturity, boll and seed yield, and fibre quality were found to be within the range for commercial cotton lines. Susceptibility to diseases and insects was not altered compared to conventional cotton varieties. MON 88913 did not demonstrate morphological, growth or seed dormancy characteristics such as those observed in weedy and invasive plant species.

The potential for introgression of the glyphosate-tolerance trait from MON 88913 cotton into other cotton plants, or to wild relatives of cotton, was investigated. 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) and G. barbadense (cultivated Pima cotton), and is genetically compatible with 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 genomic incompatibility. Assuming proximity, synchronicity of flowering and presence of insects, MON 88913 cotton could freely hybridize with other G. hirsutum varieties and wild plants. In the event of the formation of hybrids, there would no competitive advantage conferred on any hybrid progeny in the absence of herbicidal applications of glyphosate.

The food and livestock feed safety of MON 88913 cottonseed, cottonseed meal, and refined cottonseed oil was established based on several standard criteria. As part of the safety assessment, the nutritional composition of MON 88913 cottonseed, cottonseed meal and refined cottonseed oil was found to be equivalent to those components from conventional cotton as shown by the analyses of key nutrients including proximates (i.e., moisture, crude protein, crude fat, ash, carbohydrates) acid detergent fibre, neutral detergent fibre and total dietary fibre, amino acid composition, fatty acid profiles, minerals (e.g., calcium, phosphorus, magnesium), and vitamins E, as well as the antinutritional compounds gossypol, cyclopropenoid fatty acids and aflatoxins.

The potential for toxicity and allergenicity of the CP4 EPSPS protein in MON 88913 was assessed from the following data and information: characterization of the protein demonstrating the lack of similarity to know toxins and allergens; data confirming the in vitro digestibility of CP4 EPSPS in simulated gastric fluids; the lack of acute oral toxicity in mice; and levels of natural toxicants. This information supports the lack of toxicity and allergenicity of MON 88913 compared to conventional cotton varieties.

Links to Further Information Expand

Brazil Ministry of Science and Technology - MCT The National Biosafety Technical - CTNBio Executive Secretary Canadian Food Inspection Agency European Commission Food Standards Australia New Zealand Health Canada Novel Foods Japanese Biosafety Clearing House, Ministry of Environment Office of the Gene Technology Regulator Office of the Gene Technology Regulator, Australia Philippines Department of Agriculture, Bureau of Plant Industry U.S. Department of Agriculture, Animal and Plant Health Inspection Service U.S. Department of Agriculture, Biotechnology Regulatory Services U.S. Food and Drug Administration U.S.Department of Agriculture, Animal and Plant Health Inspection Service

This record was last modified on Friday, June 3, 2016