GM Crop Database

Database Product Description

MON531 x MON1445 (MON-ØØ531-6 x MON-Ø1445-2)
Host Organism
Gossypium hirsutum (Cotton)
Resistance to lepidopteran pests and glyphosate herbicide tolerance
Trait Introduction
Traditional plant breeding and selection
Proposed Use

Production for fibre, livestock feed, and human consumption.

Product Developer
Monsanto Company

Summary of Regulatory Approvals

Country Food Feed Environment Notes
Argentina 2009 2009 2009
Australia 2003
Brazil 2009 2009 2009
Colombia 2008 2007
European Union 2005 2005 View
Japan 2003 2004
Korea 2004 2008
Mexico 2002 2002
Paraguay 2013 2013 2013
Philippines 2004 2004
South Africa 2005 2005 2005
Taiwan 2015

Introduction Expand

This stacked cotton hybrid is a product of traditional plant breeding, and is therefore not automatically subject to regulation in all countries, unlike transgenic plants resulting from recombinant-DNA technologies. The approvals table above does not include entries from these countries. Other countries may request notification in advance of the release of a stacked hybrid, or may request information to conduct an environmental and food safety assessment, and these countries’ decisions are reflected in the approvals table.

Summary of Introduced Genetic Elements Expand

Code Name Type Promoter, other Terminator Copies Form
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 A. tumefaciens >=1 Native
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
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.

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

Coming soon. 

Characteristics of the Modification Expand

Coming soon. 

Environmental Safety Considerations Expand

Coming soon. 

Food and/or Feed Safety Considerations Expand

Coming soon. 

Abstract Collapse

MON531 X MON1445 (OECD identifier: MON-ØØ531-6 x MON-Ø1445-2) cotton is the product of the cross-breeding of the insect-resistant cotton line MON531 (MON-ØØ531-6) with the herbicide-tolerant cotton line MON1445 (MON-Ø1445-2). This stacked cotton line is a product of traditional plant breeding, and therefore is not automatically subject to regulation in all jurisdictions as are transgenic plants resulting from recombinant DNA technologies. Certain jurisdictions may request notification in advance of the release of a stacked hybrid, or may request information to conduct an environmental and food safety assessment. Examples of jurisdictions that require either notification or information about stacked hybrids prior to their release into the environment, and for use in human food and livestock feed are Canada and Japan.

The stacked cotton line MON531 X MON1445 expresses two novel proteins: the delta-endotoxin Cry1Ac which confers resistance to the lepidopteran pests of cotton, such as the cotton bollworm, pink bollworm and tobacco budworm, and the CP4 EPSPS protein which confers tolerance to the herbicide glyphosate. The insecticidal protein is produced by the cry1Ac gene from MON531, and the CP4 EPSPS protein is cp4 epsps gene from MON1445. The novel traits of each parental line have been combined, through traditional plant breeding, to produce this new cotton line. For a full description of each parental line please refer to the individual product descriptions in the crop database for MON531 and MON1445.

The inserted genes and their gene products have a history of safe use, and have undergone review and approval by several regulatory agencies. No interactions among the gene products or negative synergistic effects are expected in the stacked hybrid. The Cry1Ac protein is not an enzyme and therefore does not affect plant metabolism. The CP4 EPSPS has high affinity for its substrates phosphoenolpyruvate (PEP) and shikimate-3-phosphate, which are part of the shikimate metabolic pathway. CP4 EPSPS and Cry1Ac are therefore not expected to interact within, nor affect the metabolism of the stacked line.

Studies were conducted to compare the resistance to lepidopterans and tolerance to glyphosate between the stacked cotton line and each parental line. There were no significant differences in the stacked line in the resistance to the lepidopteran pests, or in the tolerance to applications of glyphosate, compared to the parental lines.

Links to Further Information Expand

Comissão Técnica Nacional de Biossegurança - CTNBio (Brazil) European Commission: Community Register of GM Food and Feed Japanese Biosafety Clearing House, Ministry of Environment Office of the Gene Technology Regulator Philippines Department of Agriculture, Bureau of Plant Industry

This record was last modified on Tuesday, August 23, 2016