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Risk Assessment generated by a regulatory process
(RA)
last updated: 01 Sep 2022
Risk assessment of cotton tolerant to the herbicides dicamba and glufosinate ammonium, event MON 87701.
EN
09 Mar 2017
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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 - Dicamba- and Glufosinate-tolerant cotton| Monsanto | Resistance to herbicides (Glufosinate)
- commercial release 5429 - 2017.pdf [ Portuguese ]
MON 88701 cotton contains the demethylase gene (dmo) from the bacterium Stenotrophomonas maltophilia, which encodes the expression of the dicamba monooxygenase (DMO) protein, thus conferring the characteristic of tolerance to dicamba. The DMO protein rapidly catalyzes the demethylation of dicamba, generating a metabolite that is inactive as a herbicide, 3,6-dichlorosalicylic acid (DCSA). DCSA was previously identified as a metabolite of dicamba in cotton, soybean, cattle and soil. MON 88701 cotton also contains the gene for tolerance to bialophos (bar), originated from the actinomycete Streptomyces hygroscopicus, which encodes the expression of the protein phosphinothricin N-acetyltransferase (PAT), thus conferring the characteristic of tolerance to the herbicide glufosinate. The PAT protein (bar) catalyzes the acetylation of the free amino acid group of glufosinate to produce the non-herbicidal N-acetyl glufosinate, a metabolite well known to be present in glufosinate-tolerant plants.
Considering that the MON88701 event had its molecular characterization defined, the analysis of protein expression, compositional analysis and agronomic and phenotypic evaluations showed no evidence of risk to human and animal health.
No discrepancies were observed from the growth stage of MON 88701 cotton and conventional control cotton in the five planting sites from the vegetative period to the end of the cycle.
CTNBio considers that this activity does not potentially cause significant degradation of the environment or harm to human and animal health. Restrictions on the use of the GMO under analysis and its derivatives are subject to the provisions of Law 11,460, of March 21, 2007
Biotic stress assessments were performed at four different times during the study and were classified as diseases or presence of arthropods. Eighteen comparisons were performed for disease assessment and differences were not observed in terms of stress intensity between MON 88701 cotton and conventional control cotton. Diseases evaluated include ramulosis, ramularia leaf spot, common mosaic, Alternaria leaf spot, Fusarium wilt, black spot, tipping and vermilion. Forty comparisons were performed to evaluate the presence of arthropods and differences were not observed regarding the intensity of stress between MON 88701 cotton and conventional control cotton. The arthropods evaluated include boll weevil, whitefly, aphids, thrips, spider mites, Astylus variegatus and defoliating caterpillars.
Field experiments were carried out to evaluate the agronomic, phenotypic characteristics and environmental interactions of MON 88710 cotton compared to COKER 130 cotton and commercial references in 5 localities (as described in the process). Phenotypic and agronomic characteristics, abundance of non-target organisms, pollen morphology and viability, evaluation of volunteer plants, vigor and germination were considered. The results obtained indicate that MON 88710 cotton did not present different results than conventional or COKER 130 cottons. The data from environmental interactions also indicate that MONO 88710 cotton does not confer differences in susceptibility or greater tolerance to diseases, abiotic stresses or arthropods when compared other conventional varieties or COKER 130. The data on morphology and pollen viability, as well as those on germination and vigor, also indicate equivalence with conventional or COKER 130 cottons. Thus, MON 88710 should not pose a greater risk to the environment when compared to conventional cottons or its parental COKER 130.
CTNBio considered that the request complies with the norms and legislation in force that aim to guarantee the biosafety of the environment, agriculture, human and animal health, and concluded that MON 88701 cotton is substantially equivalent to conventional cotton, and its consumption is safe for health human and animal.
MON 88701 genetically modified cotton is as safe as its conventional equivalent and the order complies with current regulations and legislation that aim to guarantee the biosafety of the environment, agriculture, human and animal health.
Molecular traddicional methods.
Yes
Yes
Yes
Yes
Yes
EN
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