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Risk Assessment generated by a regulatory process
(RA)
last updated: 01 Sep 2022
Risk assessment of cotton, event MON88913xMON88701, Technical Opinion - No. 6139/2018.
EN
08 Nov 2018
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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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Organization:Monsanto do Brasil Ltda ()Private sector (business and industry)Geraldo Ubirajara Berger Avenida das Nações Unidas, 12901 - Torre Norte - 7º andarSao Paulo, SP
04578-000, BrazilPhone: +55(11) 3383-8356,Fax: +55(11) 3383-8102 ; +55 (61) 3245-2523,Email: geraldo.u.berger@monsanto.com,Website:
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MON-887Ø1-3 × MON-88913-8 - Cotton modified for herbicide tolerance| Monsanto | Resistance to Dicamba, Resistance to herbicides (Glufosinate, Glyphosate)
- commercial release 6139 - 2018.pdf [ Portuguese ]
COT102 x MON 15985 x MON 88913 x MON 88701 cotton, resistant to insects (Vip3A, Cry1Ac and Cry2Ab2) and tolerant to the herbicides glyphosate, glufosinate and dicamba (cp4epsps, PAT and DMO) and cotton MON 88913 x MON 88701, tolerant to the herbicides glyphosate, glyphosinate and dicamba (cp4epsps, PAT and
DMO).
DMO).
The National Technical Commission on Biosafety - CTNBio is in favor of commercial release, with the exemption of analysis and the issuance by CTNBio of a new Conclusive Technical Opinion by the company Monsanto do Brasil Ltda., of cotton resistant to insects and tolerant to herbicides COT102 x MON 15985 x MON 88913 x MON 88701 and herbicide-tolerant cotton MON 88913 x MON 88701, both containing individual events, combined through classical genetic improvement and which have been previously approved for commercial release by CTNBio, considering that it complies with Article 4 of Normative Resolution No. 5.
The American Academy of Sciences (NAS 2016), using evidence accumulated over the past two decades, has evaluated possible negative effects of currently commercialized transgenic crops, most of which are pyramid events today. More than 900 published reports and articles were evaluated, more than 80 speakers were heard in public meetings and webinars, in addition to hundreds of comments sent to academia, without any significant damage to human, animal, or the environment being proven.
CTNBio considers that this activity does not potentially cause significant degradation of the environment or harm to human and animal health.
The information is also useful in risk analysis so that, through bioinformatics tools, the possibility of creating ORFs (Open Reading Frames) creating fused proteins/peptides that have homology to toxins or allergens can be analyzed. It is also demonstrated that the gene construct was stably inserted into the genome and that it is maintained in subsequent generations of this plant. With this information, it is possible to expect that the inserted transgene will behave like any other DNA sequence present in the plant genome, obeying Mendel's second law, which refers to the independent segregation of factors. That said, when naturally crossing GM plants containing different gene constructs, it is to be expected that these transgenes will recombine in the same way as the thousands of other genes present in the plant. Therefore, maintaining at first, in the new hybrid plant, the same phenotypic characteristics found in plants containing the transgene individually.
The events under discussion, individually and even pyramided, have already been planted in several producing countries, with a history of safe use of more than twenty years, therefore, it is not to be expected that the combinations now presented in the two combinations in question (COT102 x MON 15985 x MON 88913 x MON 88701 and MON 88913 x MON 88701) can bring any results beyond those already expected in the control of insects and weeds.
In molecular characterization, the proposing company must show information such as the number of copies of the transgene inserted, the DNA sequence of the elements introduced in the plant genome, signaling if mutations/alterations of sequences have occurred during the transformation process.
These isolated events had their biosafety for the environment and for human and animal health tested, showing no difference in relation to conventional cotton.
Molecular traddicional methods.
Yes
Yes
Yes
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Yes
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