GM Crop Database

Database Product Description

MON 15985 (MON-15985-7)
Host Organism
Gossypium hirsutum (Cotton)
Trade Name
Bollgard II®
Trait
Resistance to lepidopteran pests including, but not limited to, cotton bollworm, pink bollworm, tobacco budworm.
Trait Introduction
Microparticle bombardment of plant cells or tissue
Proposed Use

Production for fibre, livestock feed, and human consumption.

Product Developer
Monsanto Company

Summary of Regulatory Approvals

Country Food Feed Environment Notes
Australia 2002 2002 View
Brazil 2009 2009 2009
Burkina Faso 2008
Canada 2003 2003 View
China 2006 2006 2006
Colombia 2009
European Union 2005 2005 View
India 2006
Japan 2002 2003
Korea 2003 2004
Mexico 2003 2003
New Zealand 2002
Philippines 2003 2003
Singapore 2014
South Africa 2003 2003 2003
Taiwan 2015
United States 2002 2002 2002

Introduction Expand

Event MON 15985 (tradename Bollgard II®) was derived from the hybrid cotton variety DP50B, which was a cross between DP50 and transgenic Bollgard® cotton line 531, by biolistic transformation with plasmid DNA containing the cry2Ab2 gene originally isolated from Bacillus thuringiensis subsp. kurstaki. As a result, event 15985 expresses both the Cry1Ac and Cry2Ab2 insecticidal proteins and exhibits resistance to a range of lepidopteran pests such as the cotton bollworm, tobacco budworm, pink bollworm, and armyworm.

As with other B. thuringiensis-derived delta-endotoxins, the Cry1Ac and Cry2Ab2 proteins exert their insecticidal activity by binding to specific receptors located on the brush border midgut epithelium of susceptible insect species. Following binding, cation-specific pores are formed that disrupt midgut ionic equilibrium leading to gut paralysis and eventual death due to bacterial sepsis. Cry1Ac and Cry2Ab2 are highly selective and are only active against lepidopteran insects. These proteins do, however, interact with different receptor sites in the target insects and it is expected that “stacking” these traits will result in increased protection against insect attack and a delay in the development of resistant insect populations.

In addition to the cry genes conferring insect resistance, MON 15985 also contains the nptII and aad selectable marker genes (derived from the parental cotton line containing event 531) and the beta-D-glucuronidase (GUS) encoding uidA gene from Escherichia coli. This latter gene was introduced as a visually scorable marker gene to identify transformed plantlets in tissue culture. The GUS enzyme can be used to catalyze a colorimetric reaction resulting in the production of a blue colour in transformed cells.

This product description will focus on those aspects of the risk assessment pertaining to the cry2Ab2 and uidA gene products. For additional information on the safety assessment of cry1Ac and nptII gene products, the reader is directed to the product description for line MON 531.

Summary of Introduced Genetic Elements Expand

Code Name Type Promoter, other Terminator Copies Form
aad 3"(9)-O-aminoglycoside adenylyltransferase SM

bacterial promoter

Not expressed in plant tissues

cry1Ac Cry1Ac delta-endotoxin IR

double enhanced CaMV 35S

3' poly(A) signal from soybean alpha subunit of the beta-conglycinin gene

>=1

Truncated; Line 757: 1 complete T-DNA and 1 paritial T-DNA insertion event

nptII neomycin phosphotransferase II SM

nopaline synthase (nos) from Agrobacterium tumefaciens

>=1

Native

uidA beta-D-glucuronidase SM

double enhanced CaMV 35S

A. tumefaciens nopaline synthase (nos) 3'-untranslated region

1

Native

cry2Ab2 Cry2Ab2 delta-endotoxin IR

double enhanced CaMV 35S

PetHSP70 leader sequence and the chloroplast transit peptide leader sequence (CTP2)

Agrobacterium tumefaciens nopaline synthase (nos) 3'-untranslated region

1

Modified to enhance in planta expression

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
Bacillus thuringiensis subsp. kurstaki cry1Ac

Although target insects are susceptible to oral doses of Bt proteins, there is no evidence of toxic effects in laboratory mammals or bird given up to 10 µg protein / g body wt. There are no significant mammalian toxins or allergens associated with the host organism.

Bacillus thuringiensis subsp. kurstaki cry1Ab-Ac

While target insects are susceptible to oral doses of Bt proteins, no evidence of toxic effects in laboratory mammals or birds given up to 10 µg protein/g body weight.

Modification Method Expand

Event MON 15985 was developed by biolistic transformation of cotton meristems with purified DNA containing the cry2Ab2 and uidA (GUS) expression cassettes. The parental variety used in the transformation, DP50B, was derived from a conventional cross between DP50 and the transgenic Bollgard® cotton line 531. Therefore, the parental line already contained the cry1Ac gene as well as two selectable marker genes, the nptII gene encoding neomycin phosphotransferase II (NPTII) and the aad gene encoding aminoglycoside adenyltransferase (AAD).

The DNA used for transformation was an approximately 6 kb fragment containing the expression cassettes for cry2Ab2 and uidA, and was derived from plasmid PF-GHBK11 following restriction endonuclease digestion and high pressure liquid chromatography (HPLC) purification. The purified DNA fragment did not contain any other plasmid-derived sequences, such as the bacterial origin of replication site or antibiotic resistance marker genes.

The cry2Ab2 construct consisted of a synthetic copy of the cry2Ab2 gene originally isolated from B. thuringiensis subsp. kurstaki (Btk) under the regulatory control of the doubly enhanced cauliflower mosaic virus 35S promoter (e35S) and a polyadenylation signal isolated from the 3’-terminal untranslated region of the nopaline synthase (NOS) gene from Agrobacterium tumefaciens. Transcriptional activation was modulated by inclusion of the 5’-terminal untranslated leader sequence from the petunia heat shock 70 protein (PetHSP70). Targeting of the expressed protein to chloroplasts was accomplished by fusing the sequence encoding the chloroplast transit peptide, isolated from the Arabidopsis thaliana 5-enolpyruvyl shikimate-3-phosphate synthase (EPSPS) gene, to the 5’-terminus of the cry2Ab2 gene sequence.

The cry2Ab2 gene was completely re-synthesized to incorporate plant-preferred codons, and the expressed protein was 88% identical (97% similarity with conservative substitutions) to the native Cry2Ab2 protein expressed in B. thuringiensis.

The uidA (synonym gus) gene, isolated from E. coli strain K12, encodes the enzyme ß-D-glucuronidase (GUS), and was included as a scorable marker allowing colorimetric identification of transformed plant tissue following histochemical staining. Gene expression was regulated using the same e35S promoter and NOS 3’ sequences as used for the cry2Ab gene construct.

Characteristics of the Modification Expand

The Introduced DNA

Southern blot analysis determined a single site integration of a single copy each of the cry2Ab2 and uidA gene cassettes. These cassettes contained the complete coding regions for each gene although the restriction site following the NOS 3’ polyadenylation sequence and the 260 bp of the 5’ end of the CaMV 35S promoter for the uidA gene were not present. The uidA promoter remained functional despite the truncation.

Genetic Stability of the Introduced Trait

Segregation data across four generations, including backcrosses to commercial cotton cultivars were statistically analysed, comparing frequency of observed numbers to expected numbers of progeny that expressed the Cry2Ab2 protein. Expression of the Cry2Ab2 protein was analysed using enzyme linked immunoabsorbent assay (ELISA). All generations segregated as expected for a single insertion site of the cry2Ab2 gene. The presence of the Cry2Ab2 protein across multiple generations occurred as expected, consistent with a pattern of Mendelian inheritance. The presence of the cry2Ab2 gene was confirmed using Southern blot analysis.

The stability of the insert was also demonstrated using Southern blot analysis of genomic DNA samples from leaf tissues taken across five generations. There were no differences in the pattern of hybridizing fragments among DNA extracted from any of the five plant generations. These results demonstrated that the DNA insert from plasmid PV-GHBK11 is stable in the plant genome across five breeding generations.

Expressed Material

The expression levels of the Cry2Ab2 and GUS proteins were determined using ELISA. Cotton tissue samples were taken from eight field locations in the United States to determine the levels of Cry2Ab2 and GUS activity in a range of environments. Cry2Ab2 levels were examined in leaf, seed, pollen and whole plant tissues. GUS levels were determined in leaf and seed tissues.

The mean levels of Cry2Ab2 in cottonseed, leaf tissue, and whole plants across all locations were 43.2 ± 5.7 ug/g, 23.8 ± 6.3 ug/g, 8.80 ± 1.20 ug/g, and < 0.25 ug/g respectively. The average GUS concentrations in cottonseed and leaf tissue were 106 ± 32 ug/g, and 58.8 ±13.0 ug/g, respectively.

Environmental Safety Considerations Expand

Outcrossing

Cotton (Gossypium 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. When cotton line MON 15985 (Bollgard II) is grown in proximity with other cotton cultivars and sufficient insect pollinators are present and active, the possibility exists for hybridization to occur between line MON 15985 and other cotton cultivars.

In the United States, species compatible with line MON 15985 and other transgenic cottons include G. hirsutum (wild or under cultivation), G. barbadense (cultivated Pima cotton), and G. tomentosum. 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, non-synchronous flowering periods and a lack of common pollinators. Populations of wild Gossypium species occur in southern Florida (wild G. hirsutum), Hawaii (G. tomentosum), Puerto Rico and the U.S. Virgin Islands, however, to reduce to potential for gene flow to wild species, the conditions of registration for cotton line MON 15985 include a prohibition on planting of event MON 15985 south of Route 60 (Tampa) in Florida and prohibition of commercial cultivation of the line in Hawaii, Puerto Rico and the U.S. Virgin Islands. These prohibitions, along with the different breeding systems and genome incompatibility in Gossypium species contribute to a low likelihood of gene transfer in the field.  Hybrids resulting from artificial crosses between cotton and wild species are generally sterile, unstable and of poor fitness.

Weediness Potential

Cultivated Gossypium hirsutum is not typically considered a weed species in the United States or other countries, although it is listed as a potential weed in southern Florida. Cotton does not tolerate cold conditions limiting its potential to survive the winter to southern Florida, Hawaii, and Puerto Rico. The transformation that resulted in event MON 15985 did not confer any ecological advantage to MON 15985 cotton or its offspring that would increase its potential for weediness beyond that of currently cultivated commercial varieties.

Data collected from field trials conducted in the United States, Puerto Rico, Argentina, South Africa, Costa Rica, and Australia indicated that the agronomic performance of event MON 15985 was similar to the parental cotton line. There were no reports of increased weediness in the parent line DP50B (MON 531 hybrid), a Bt-cotton engineered to express Cry1Ac protein, during its five years of commercial cultivation history in the United States. These data were used to determine that event MON 15985 did not pose any increased risk of weediness that was substantially different from that of conventional cultivars.

Secondary and Non-target Effects

Studies were conducted to determine whether beneficial insects (ladybird beetle, adult and larval honeybees, collembola, green lacewing, parasitic wasp and earthworm) were susceptible to the Cry2Ab2 protein. Due to problems with the control population in the parasitic wasp trial, Monsanto was requested to submit an additional study. However, as parasitic wasps are not likely to come into contact with the Cry2Ab2 protein expressed in cotton, it was determined that the study was not necessary for obtaining regulatory approval for environmental release of cotton line MON 15985.

For larval honeybees, the No Observed Effects Concentration (NOEC) was found to be greater than 100 ppm, which was expected to exceed the maximum concentration encountered in the field. Adult honeybee NOEC was greater than 68 ppm. Green lacewing larval NOEC was greater than 1100 ppm. All these exceeded the maximum environmental concentration expected in cotton plant tissue (51 ppm).

In the case of ladybird beetles, the reasonable route of exposure would be through contact with cotton pollen. In the test, the beetles exhibited lethargy and low motility, thus not allowing for the determination of a NOEC. However, the LC50 of Cry2Ab2 protein for ladybird beetles was >4500 ppm, which greatly exceeded the level expected in the field (Cotton event MON 15985 contains both Cry1Ac and Cry2Ab2 proteins). Non-target testing of Cry1Ac protein revealed no hazards. Unexpected synergistic effects from MON 15985 line containing both proteins were not anticipated as no adverse effects were seen in non-target tests of avian, earthworm and collembola species feeding on tissue containing both Cry1Ac and Cry2Ab2 proteins.

Impact on Biodiversity

The transgenic cotton line MON 15985 has no novel phenotypic characteristics that would extend its use beyond the current geographical range of cotton production. Since there is no occurrence of cotton species in Canada and the line is not intended for cultivation in Canada, there will be no transfer of novel traits to unmanaged environments in Canada. Similarly, the risk of gene transfer to wild relatives in the United States was determined to be very remote, thus resulting in an insignificant risk of transferring genetic traits from line MON 15985 to wild species in unmanaged environments.

Other considerations

In the United States, registration of event MON 15985 plant incorporated protectant (PIP) by the Environmental Protection Agency (EPA) was contingent upon the implementation of an Insect Resistance Management (IRM) program. IRM programs are intended to prolong the effectiveness of plant expressed Bt toxins and microbial spray formulations. In the case of cotton line MON 15985, it was proposed by Monsanto that the pyramiding effect of the two Bt toxins, Cry1Ac and Cry2Ab2 would act to delay insect resistance development, which indicated that refuge size could be reduced for this cotton line. Nonetheless, the United States EPA required the same 20% minimum non-Bt cotton refuge for event 15985 as for other Bt cotton events. In addition, monitoring requirements similar to those required for other Bt cotton lines must be adhered to.

Food and/or Feed Safety Considerations Expand

Dietary Exposure

Cotton, Gossypium hirsutum L., is grown worldwide primarily as a source of fibre in textile manufacturing. Cottonseed, the by-product of fibre production, is processed into four major products: oil, meal, hulls, and linters. Cottonseed oil is routinely used in human food. Linters are also used for human food, but to a lesser extent than oil. Both have a long history of safe use. Cottonseed meal and hulls are used in animal feed.

Cottonseed oil used for human consumption is highly purified, and contains no detectable proteins. Refined cottonseed oil is used as frying oil, salad and cooking oil and in various processed foods such as mayonnaise, salad dressing, shortening, and margarine. Linters are also highly processed to obtain pure cellulose for use in casings for processed meat products such as bologna, sausages and frankfurters. Such cellulose is also used to thicken ice cream and salad dressings.

Whole cottonseed is used as an energy feed for dairy cows and as a protein supplement in feed for other livestock. Hulls are used as a fibre component in livestock feeds.

Nutritional data

Compositional analyses were conducted on cottonseed samples from cotton line MON 15985, the parental control DP50B (MON 531 hybrid), the non-transgenic ancestral line DP50 and four commercially available non-transgenic varieties. The samples were collected from eight field trial sites at various locations in cotton producing areas of the United States. The cottonseed was analysed for protein, fat, ash, moisture, carbohydrate, fibre and caloric content, amino acid and fatty acid composition, mineral content, vitamin E and the anti-nutritional elements gossypol and cyclopropenoid fatty acid.

To perform compositional analysis on cottonseed oil, the cottonseed was pooled across the eight field sites creating one composite sample per cotton line. Each pooled sample was then processed into oil and analyzed for fatty acid composition, vitamin E content, and levels of the anti-nutritional factor gossypol and cyclopropenoid fatty acid.
For cottonseed samples, protein, fat, carbohydrate, moisture, caloric content, amino acids and minerals in the MON 15985 line and the parent lines were not significantly different and were within the published ranges and reference ranges for commercial varieties.

During the fatty acid composition analyses, small but statistically significant differences in the mean levels of myristic, stearic and linoleic acids were noted between cotton line MON 15985 and its parent. The values for these fatty acids fell within the commercial cotton ranges and were therefore not considered biologically significant.
Cyclopropenoid fatty acid levels were analysed and found to be slightly higher in cotton line MON 15985 as compared to the parental control. These levels were found to be within the reference ranges for commercial cotton varieties. There was no difference in the levels of gossypol found in the MON 15985 line compared to the parental control or commercial reference varieties. In addition, all lines were analysed for aflatoxins, potent animal toxins and carcinogens, which were not detected in cotton line MON 15985, the parental control, or any of the commercial reference varieties.

The levels of acid detergent fibre (ADF) and neutral detergent fibre (NDF) in cottonseed from line MON 15985, DP50B and DP50 were analysed. NDF was found to be elevated above the range of NDF values published for commercial varieties in all three lines, which were collected in large scale field production plots in Argentina. These NDF values were not significantly different from line to line. The ADF values were found to neither be significantly different from line to line nor were they significantly different from ADF values published in literature.

For oil, there were no differences between the MON 15985 and DP50B lines for fatty acid profile. These fatty acid profiles were also consistent with those determined for the commercial varieties. The level of vitamin E in oil from line MON 15985 was slightly above that determined for the parental varieties and the values obtained from the reference varieties, however it was still within the range reported in literature.

In the analyses of anti-nutritional factors, there was no gossypol detected in the oil of either the MON 15985 line or the parental line. The cyclopropenoid fatty acid levels were found to be similar for the MON 15985 line, its parental line and commercial varieties.

The line MON 15985 was determined to be not materially different in composition from commercial cotton varieties currently under cultivation.

To determine the performance of cottonseed meal derived from cotton event MON 15985 as a livestock feed, feeding trials of channel catfish were conducted. Channel catfish were fed a diet of containing approximately 20% processed cottonseed meal either from line MON 15985, from the parental line or from a non-transformed cotton line. There were no significant differences found between the three groups for survival, weight gain and feed conversion ratios.
As ginned cottonseed is used as a feed supplement for dairy cattle, lactating dairy cows were fed cottonseed from the transgenic parental line (DP50B, line MON 15985, the non-transgenic parental line and a transgenic line expressing CP4 EPSPS (Roundup Ready). Cottonseed comprised about 10% of the total dry matter intake of the cows. There was no significant difference in dry matter intake or cottonseed intake for the groups. Milk yield, milk composition, and body condition scores were also comparable across treatments.

From both these studies, it was concluded that processed cottonseed meal and cottonseed can be safely used as livestock feed for catfish and dairy cattle without adversely affecting behaviour, growth, feed conversion, or performance.

Toxicity

Cry2Ab2
Due to the low levels of Cry2Ab2 produced in cotton tissue, microbially-produced Cry2Ab2 protein was used for acute oral toxicity testing. The microbial form of Cry2Ab2 was determined to be equivalent to plant-expressed Cry2Ab2.
In acute oral toxicity testing, mice were exposed to the Cry2Ab2 protein through oral gavage at 1450, 359 and 67 mg/kg body weight and observed over 14 days. There were no treatment-related observable adverse effects noted at these doses. The dose of 1450 mg/kg body weight exceeded the maximum potential exposure to Cry2Ab2 in oil and linters, which is expected to be below 1 ug per day for human dietary exposure.

The Cry2Ab2 protein was also rapidly digested upon exposure to simulated gastric fluid (SGF). Within 15 seconds of exposure to SGF, there were no fragments greater than 2kDa remaining. During simulated intestinal fluid (SIF) digestion, a 50kDa trypsin fragment was produced after 1 minute. This fragment was consistent with the SIF digestion of other Bt proteins in which stable tryptic cores persist.

In addition, Bt proteins in microbial spray formulations have been used for over 30 years with no apparent toxic effects. As well, Cry2Ab2 showed no amino acid homology with known toxins.

These data contributed to a determination of no likely toxic effect of Cry2Ab2.

GUS
GUS protein produced by an E. coli platform was used in an acute oral toxicity study in mice. Mice were subjected to doses of 40, 100 and 400 mg/kg of GUS protein and observed over 8 or 9 days. There were no treatment-related adverse effects observed during the course of the study, nor at the termination of the study. GUS was also found to not be homologous to any known toxins. In SGF and SIF studies, GUS was found to degrade to non-detectable levels in 15 seconds in SGF and lost 91% of its enzymatic activity after 2 hours digestion in SIF. These data contributed to the conclusion that GUS protein is not likely to be toxic when expressed in line MON 15985 cotton.

Allergenicity

Current scientific knowledge indicates that most food allergens share common characteristics, such as being present in high concentrations in the food product, resistance to proteolytic digestion and heat activation, and they are often glycosylated. The Cry2Ab2 protein was not derived from an allergenic source, was present only at very low levels in event MON 15985 cottonseed (0.004% of protein present in the seed, <0.25 ppm in oil), was rapidly digested in SGF and SIF and did not exhibit significant amino acid sequence homology with known protein allergens.

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 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.

Tobacco budworm (Heliothis virescens), pink bollworm (Pectinophora gossypiella), and cotton bollworm (Helicoverpa zea) are three of the most destructive pests of cotton. In the United States alone, the budworm/bollworm complex reduced total cotton yield 1.39% in 2003, while total yield loss to arthropod pests was 4.16%. No other pest caused greater than 1% yield reduction in 2003. Almost 74% of the United States cotton crop was infected with the budworm/bollworm complex in 2003. The combined costs of control and yield loss attributed to these pests has been as high as US$476 million per year. In Egypt, China and Brazil, pink bollworm commonly causes cotton losses of up to 20 percent. More insecticides are applied to conventionally grown cotton than any other single crop. Each year cotton producers around the world use nearly US$2.6 billion worth of pesticides such as aldicarb, phorate, methamidophos and endosulfan. Cotton pests, such as the tobacco budworm, have developed some resistance to many of the insecticides used to control them. In regions where insecticide-resistant populations have developed, budworm damage can reduce yields by 29%, despite an average of six insecticide applications each growing season.

Event MON 15985 (tradename Bollgard II®) was derived from the hybrid cotton variety DP50B, which was a cross between DP50 and transgenic cotton line MON 531, by biolistic transformation with plasmid DNA containing the cry2Ab2 gene originally isolated from Bacillus thuringiensis subsp. kurstaki. As a result, event MON 15985 expresses both the Cry1Ac and Cry2Ab2 insecticidal proteins. MON 15985 is intended to protect cotton from feeding by a range of Lepidopteran species including tobacco budworm (Heliothis virescens), pink bollworm (Pectinophora gossypiella), cotton bollworm (Helicoverpa zea), cabbage looper (Trichoplusia ni), saltmarsh caterpillar (Estigmene acrea), cotton leaf perforator (Bucculatrix thurbeiella), soybean looper (Pseudoplusia includens), beet armyworm (Spodoptera exigua), fall armyworm (Spodoptera frugiperda), yellowstriped armyworm (Spodoptera ornithogolli) and European corn borer (Ostrinia nubilalis). Monsanto has proposed cotton line MON 15985, with its two insecticidal proteins, as a means to provide more effective insect resistance management.

As with other B. thuringiensis-derived delta-endotoxins, the Cry1Ac and Cry2Ab2 proteins exert their insecticidal activity by binding to specific receptors located on the brush border midgut epithelium of susceptible insect species. Following binding, cation-specific pores are formed that disrupt midgut ionic equilibrium leading to gut paralysis and eventual death due to bacterial sepsis. Cry1Ac and Cry2Ab2 are highly selective and are only active against Lepidopteran insects. These proteins do, however, interact with different receptor sites in the target insects and it is expected that “stacking” these traits will result in increased protection against insect attack and a delay in the development of resistant insect populations.

In addition to the cry genes conferring insect resistance, MON 15985 also contains the nptII and aad selectable marker genes (derived from the parental cotton line containing event 531) and the beta-D-glucuronidase (GUS) encoding uidA gene from Escherichia coli. This latter gene was introduced as a visually scorable marker gene to identify transformed plantlets in tissue culture. The GUS enzyme can be used to catalyze a colorimetric reaction resulting in the production of a blue colour in transformed cells.

This product description will focus on those aspects of the risk assessment pertaining to the cry2Ab2 and uidA gene products. For additional information on the safety assessment of the cry1Ac and nptII gene products, the reader is directed to the product description for line MON 531.

Links to Further Information Expand

Canadian Food Inspection Agency, Plant Biosafety Office Comissão Técnica Nacional de Biossegurança - CTNBio (Brazil) European Commission: Community Register of GM Food and Feed Food Standards Australia New Zealand Japanese Biosafety Clearing House, Ministry of Environment Monsanto Company Office of Food Biotechnology, Health Canada Office of the Gene Technology Regulator U.S. Department of Agriculture, Animal and Plant Health Inspection Service U.S. Environmental Protection Agency, Office of Pesticide Programs U.S. Food and Drug Administration U.S.Department of Agriculture, Animal and Plant Health Inspection Service United States (USDA)

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