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Risk Assessment generated by a regulatory process (RA)
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BCH-RA-BR-299518-1   |   PDF   |   Print   |  
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last updated: 16 Jun 2026
General Information
Risk assessment of cotton event MON 15985 x MON 88913 - Technical Opinion No. 3365/2012.
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01 Aug 2012
Risk assessment details
  • MON-88913-8 × MON-15985-7 - Roundup Ready™ Flex™ Bollgard II™ cotton
    | Monsanto | Resistance to antibiotics (Kanamycin, Streptomycin), Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Resistance to herbicides (Glyphosate)
The combined cotton MON 15985 x MON 88913 is the result of crossing, through classical genetic improvement, the genetically modified cotton parents MON 15985 and MON 88913.
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Methodology and points to consider
Cotton MON 15985 X MON 88913 has no potential to cause adverse effects to beneficial organisms, plants or non-target organisms. The safety of Cry1Ac, Cry2Ab2 and CP4 EPSPS proteins is very well characterized and was widely discussed in the process. Evaluated together, the food and environmental safety data of MON 15985 X MON 88913 cotton showed that this plant does not pose a risk to human, animal and environmental health when compared to conventional cotton.
EN
Cotton MON 15985 X MON 88913, as well as parental events, does not have greater potential as an invasive plant than conventional cotton. This conclusion is based on studies carried out in Brazil and the United States, and on experimental evidence involving: phenotypic and agronomic characteristics, and ecological interactions that demonstrate that MON 15985 X MON 88913 cotton does not have the potential to cause negative impacts on the environment or become a weed; and assessment of the potential impact on non-target organisms showing that MON 15985 X MON 88913 cotton, as well as parental events, do not cause adverse effects on these organisms under the conditions of use of the crop.
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The use of MON 15985 X MON 88913 cotton in the world indicates that this variety is as safe for the environment and for human and animal health as conventional varieties.
of cotton that have been used.
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The genetic modification introduced in MON 15985 X MON 88913 cotton did not result in important differences in chemical composition relative to nutrients, being within the normal range of variation between conventional varieties. The possibility of the transgenic plant becoming a weed species, as well as the crossing of MON 15985 X MON 88913 cotton with other cotton plants to originate a weed is negligible. B.thuringiensis is a soil microorganism and the exposure of living organisms and the environment to this bacterium or any element extracted from it is an event that occurs abundantly in nature, not resulting in a significant risk to the soil microbiota. Genetically modified plants with the cry genes of B. thuringiensis and the cp4 epsps gene of Agrobacterium strain CP4 have been approved by regulatory agencies in several countries, including CTNBio, without reports of adverse effects on the environment and human and animal health. Field studies carried out in Brazil on insect populations present in MON 15985 X MON 88913 cotton fields showed that the abundance of non-target insects was not affected when compared to conventional cotton, which demonstrates the specificity of Cry proteins for the target pests. The history of use of this MON 15985 X MON 88913 cotton in the world indicates that this variety is as safe for the environment and for human and animal health as the conventional varieties of cotton that have been used.
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The results of the phenotypic and agronomic evaluations carried out in Brazil indicated that MON 15985 X MON 88913 cotton does not have characteristics that confer greater risk than conventional cotton of becoming a weed or causing an ecological impact. The ecological interactions evaluated also did not show greater susceptibility or tolerance to diseases, abiotic stresses or insects in MON 15985 X MON 88913 cotton. Phenotypic and ecological data indicated that the insect resistance and glyphosate tolerance characteristics present in MON 15985 X MON cotton 88913 do not confer any selective advantage, with MON 15985 X MON 88913 cotton being as safe as conventional cotton.
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MON 15985 X MON 88913 cotton is as safe as its conventional counterpart.
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The history of use of this MON 15985 X MON 88913 cotton in the world indicates that this variety is as safe for the environment and for human and animal health as the conventional varieties of cotton that have been used. MON 15985 X MON 88913 cotton is as safe as its conventional counterpart.
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Molecular traddicional methods. 
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Information sharing with other databases
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Additional information
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