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Risk Assessment generated by a regulatory process
(RA)
last updated: 08 Jan 2013
Commercial Release of Genetically Modified Cotton Insect Resistant and Glyphosate Tolerant MON 15985 x MON 88913
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16 Aug 2012
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Competent National Authority:National Technical Biosafety Commission ()Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 10 à 14Brasília, DF
CEP - 70610-200, BrazilPhone: (5561) 3411-5516,Fax: (5561) 3317-7475,Email: ctnbio@mct.gov.br,Website: http://www.ctnbio.gov.br,
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Person:Dra Maria Sueli Felipe SoaresPresident,Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 08 à 10Brasília, DF
CEP - 70610-200, BrazilPhone: (5561) 3411-5151,Fax: (5561) 3317-7475,Email: msueliunb@gmail.com,Website: http://www.ctnbio.gov.br,Related OrganizationNational Technical Biosafety Comission (CTNBio)Government agency (National/Federal)Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 08 à 10Brasília, DF
CEP - 70610-200, BrazilPhone: (5561) 3411-5151,Fax: (5561) 3317-7475,Email: msueliunb@gmail.com,Website: http://www.ctnbio.gov.br,
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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)
- National Biosafety Commitie [ Spanish ]
Ecological and phenotypic evaluations were conducted with cotton MON 15985 X MON 88913 and included features such as numbness, vigor and germination, emergence, vegetative and reproductive stage, retaining seeds, and interactions with diseases, insects and abiotic stresses. The traits analyzed for samples collected in Brazil showed that cotton MON 15985 X MON 88913 cotton and control are equivalent. The potential of cotton MON 15985 X MON 88913 to become a weed compared to conventional cotton crop was rated in 2008/2009 and 2009/2010, considering phenotypic and agronomic, ecological interactions, morphology and viability of pollen, plant evaluation voluntary and germination. The results of phenotypic and agronomic evaluations conducted in Brazil showed that cotton MON 15985 X MON 88913 has no characteristics that confer a higher risk than conventional cotton to become a weed or cause ecological impact. The ecological interactions evaluated did not show greater tolerance or susceptibility to disease, insects or abiotic stress in cotton MON 15985 X MON 88913. The data indicated that phenotypic and ecological characteristics of insect resistance and tolerance to glyphosate in cotton MON 15985 X MON 88913 does not confer any selective advantage, with cotton MON 15985 X MON 88913 as safe as conventional cotton.
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the studies indicate that cotton MON 15985 X MON 88913 does not have any features that may confer a significant risk of becoming a weed or cause ecological impact than the conventional control cotton. The impact assessment in conventional agronomic practices showed that the fact of cultivating cotton MON 15985 X MON 88913 would not impact on farming practices and rotation, and even the management of insects or diseases. The only difference would be the control of lepidopteran pests. The use of cotton MON 15985 x MON 88913 also allows control of a broad spectrum of grasses and broadleaf weeds and perennial through the application post-emergence herbicide glyphosate, similar to what occurs in cotton and cotton MON 1445 MON 88913
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Considering the studies, and considering internationally accepted criteria in the process of risk analysis of genetically modified raw materials, it can be concluded that cotton MON 15985 X MON 88913 is as safe as its conventional equivalent
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The historical use of transgenic crops over that time has no reports of any problems to human and animal health or the environment can be attributed to these cultures, including the transgenic cottons. It is necessary to emphasize that the lack of negative effects resulting from the cultivation of transgenic cotton does not mean they can not happen. There is an accumulation of reliable scientific information and a history of safe use that allow us to conclude that transgenic plants are as safe as conventional versions
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no applicable
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no applicable
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In the context of environmental safety, the results of phenotypic and agronomic evaluations performed in Brazil for cotton MON 15985 x MON 88913 corroborate the data presented above for the parental events, indicating that cotton MON 15985 x MON 88913 does not have any features that may confer a significantly altered risk of becoming a weed or different ecological impact of conventional cotton. Furthermore, data presented ecological interactions also indicated that the new features present in cotton MON 15985 x MON 88913 does not confer susceptibility or greater tolerance to diseases and abiotic stresses or insects. They also found that cotton MON 15985 X MON 88913 does not have the potential to cause adverse effects on beneficial organisms, to plants or non-target organisms. Security Cry1Ac protein, and CP4 EPSPS Cry2Ab2 is very well characterized and has been widely discussed in the process
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traditional phenotypic and molecular methods
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The full technical report is available at http://www.ctnbio.gov.br/index.php/content/view/17404.html
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- National Biosafety Comitie [ Spanish ]
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
