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Risk Assessment generated by a regulatory process
(RA)
last updated: 01 Sep 2022
Risk assessment of cotton, event MON15985, Technical Opinion - 8038/2022.
EN
05 May 2022
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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-15985-7 - Bollgard II™ cotton| Monsanto | Resistance to antibiotics (Kanamycin, Neomycin), Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Selectable marker genes and reporter genes
- commercial release 8038-2022.pdf [ Portuguese ]
Monsanto submitted to CTNBio the information required in the Normative Resolution in force at the time, relevant for commercial approval of MON 15985 cotton (Bollgard® II cotton). The commercial event MON 15985 (Bollgard® II) was obtained by genetic retransformation of MON 531 cotton (Bollgard®) using the microparticle acceleration methodology also known as bioballistics. Bollgard® cotton, commercially approved in Brazil since 2005 (EPT 0513/2005), contains the characteristic of protection against insects conferred by the Cry1Ac protein. The expression cassette was introduced by the transformation technique via Agrobacterium tumefaciens. MON 15985 cotton (Bollgard® II), also commercially approved in Brazil since 2009 (EPT 1832/2009), in turn, was generated through the introduction, by bioballistics, of the characteristic of protection against insects conferred by the protein Cry2Ab2 in the genome of the MON 531 cotton (Bollgard®). The bioballistic technique results in the insertion of the DNA fragment of interest into the plant cell.
MON 15947 cotton does not have any additional characteristics to those expressed in MON 15985 cotton (Bollgard® II), which has already had its safety evaluated by CTNBio and is already commercially approved (EPT 1832/2009). In addition, the Extract of Technical Opinion n°1832/2009 regarding the commercial approval of MON 15985 cotton (Bolgard® II) includes “...all progenies from the MON 15985 transformation event and their derivatives from crossing lines and populations non-transgenic cotton with lines carrying the MON 15985 event...”. Thus, MON 15947 cotton is considered one of the progenies obtained by classical genetic improvement, with segregation and selection of the desired trait.
As Monsanto's CIBio states in the petition for this request, the results presented in the "Food and Environmental Biosafety Report of MON 15985 cotton" demonstrate the safety of all proteins expressed in MON 15985 cotton, including the Cry2Ab2 protein which confers the characteristic of protection against insects in the MON 15947 segregating progeny.
MON 15947 cotton is a segregating strain of MON 15985 cotton (Bollgard® II) and has only the characteristic of protection against insects conferred by the Cry2Ab2 protein.
CTNBio considered that the commercial release for planting genetically modified cotton MON 15947 complies with the relevant norms and legislation that aim to guarantee the biosafety of the environment, agriculture, human and animal health. Thus, this activity is not potentially causing significant degradation of the environment or damage to human or animal health.
In your Art. 18, first paragraph, RN32 reiterated the exemption from the Commercial Post-Release Monitoring Plan for risk class 01 GMOs, when the risk assessment carried out by CIBio and rectified by CTNBio does not identify a non-negligible risk.
There was no insertion or any genetic engineering technique involved to obtain this segregating progeny called MON 15947, which was obtained by segregation and selection using classical genetic improvement techniques.
Based on Normative Resolution No. 32, of CTNBio, of June 15, 2021, and that the results found support that they are substantially equivalent to conventional cotton, CIBio of Monsanto do Brasil Ltda. considered that the cultivation, commercialization or use in human and animal food are not activities that are potentially causing significant degradation of the environment or cause harm to human and animal health, and identified only negligible risks related to the biosafety of the GMO and for this reason requests exemption from post-commercial release monitoring.
Molecular traddicional methods.
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EN
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
