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Risk Assessment generated by a regulatory process
(RA)
last updated: 28 Apr 2026
Risk assessment of soybean event MON87701 & MON89788 - Technical Opinion No. 2542/2010.
EN
19 Aug 2010
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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-877Ø1-2 × MON-89788-1 - Intacta™ Roundup Ready™ 2 Pro soybean| Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Resistance to herbicides (Glyphosate)
- Commercial release 2542-2010.pdf [ Portuguese ]
Insect resistant soybean MON 87701 was developed by introducing the cry1Ac gene into the genome of A5547 soybean meristematic cells mediated by Agrobacterium tumefaciens, using the transformation vector PV-GMIR9. The objective of this transformation was to reduce the use of insecticides to control lepidopteran pests in tropical and subtropical regions, especially against the attack of Anticarsia gemmatalis, soybean and Pseudoplusia includens, the false medideira, as primary targets, and Crocidosema aporema, the armpit borer, and Rachiplusia nu, also known as false medideira, as secondary but important targets in South American crops.
Soybean MON 87701 x MON 89788 presents characteristics of parental soybeans, that is, it is resistant to insects (expression of Cry1Ac protein) and presents tolerance to glyphosate (expression of protein CP4 EPSPS). For this reason, MON 87701 x MON 89788 soy is not expected to cause adverse effects in the human and animal food chain after ingestion, based on the food safety obtained from parental soy and protein expressed.
Results were presented for the tests of total composition of grain and forage produced in several Brazilian locations (Mato Grosso, Goiás, Paraná, Minas Gerais and Rio Grande do Sul) for soybean MON 87701 x MON 89788 and compared with the respective conventional and reference material. Sixty-four analytical components from two samples from each tested growing region were analyzed. The studies were conducted with test presentation (T), control (C) and references (R). Of the 64 substances analyzed, 11 fatty acids had their analytical values below the limit of quantification and were not included in the statistical analysis. Tables were presented summarizing the values obtained and their statistical analysis with a tolerance interval of 99% (p<0.05). were also Data from compositional analyzes performed on samples collected at five sites in the United States in 2007 (Alabama, Arkansas, Georgia, Illinois, and North Carolina) are presented to assess whether nutrient and anti-nutrient levels of grain and forage tissues MON 87701 soybean derivatives are comparable to those found in the conventional cultivar A5547 that originated it.
The information and studies presented, in addition to other works in the literature, establish the safety of MON 87701 x MON 89788 soybean. This soybean variant shows low risk to human and animal health and does not present a risk of becoming a plant pest.
The isolated proteins, as well as the grains used in the studies, indicate that the products do not have toxic activity for human and animal health; The histories of safe use of the isolated genes have no documented adverse human and animal health effects; No homologies were observed between the sequences of the genes and proteins tested with toxic products or known allergens available in the database; Proteins are highly digestible in gastric juice and intestinal fluid; Proteins are not thermostable; No significant differences were found between the development of animals fed material derived from transgenic plants and their respective controls; The differences observed between the components present in the transgenic plants and their respective controls were either not significant or were within a margin of acceptable tolerance for the main international parameters. It is concluded that MON 87701 x MON 89788 soy is as safe as its non-genetically modified equivalent. for human and animal consumption, offering no additional risks when compared to its equivalent.
Planned environmental release trials were carried out in the country in Não-MeToque (RS), Cachoeira Dourada (MG), Rolândia (PR) and Sorriso (MT). No signs of pleiotropic and epistatic effects were evidenced. No evidence of morphological, growth or developmental changes was observed in relation to conventional soybeans, except for tolerance to the herbicide glyphosate and resistance to
leptopterans plague. The same behavior was observed in other countries in which similar experiments were conducted, that is, there were no differences significant in the morphology, growth or development of soybean MON 87701 x MON 89788.
leptopterans plague. The same behavior was observed in other countries in which similar experiments were conducted, that is, there were no differences significant in the morphology, growth or development of soybean MON 87701 x MON 89788.
The phenotypic and agronomic characteristics in two consecutive seasons with GM soybeans, the one obtained by crossing and its mono-modified parents, compared to conventional soybeans, control and commercial references, did not differ significantly, except for the height of MON 89788 soybean plants. However, this difference remained within the range established for this parameter in commercial references planted under the same conditions. The difference was attributed to genetic variability between soybean cultivars. Therefore, there are no adverse effects on the phenotypic and agronomic characteristics of soybean with pyramided genes, MON 87701 x MON 89788, from individual genetic modifications after the introduction of insect resistance and glyphosate herbicide tolerance genes, as well as the presence of both factors in the same plant.
CTNBio considered that the request complies with the rules and legislation in force that aim to guarantee biosafety environment, agriculture, human and animal health, and concluded that Soy MON 87701 x MON 89788 is substantially equivalent to conventional soy, and its consumption is safe
for human and animal health.
for human and animal health.
Molecular traddicional methods.
Yes
Yes
Yes
Yes
Yes
EN
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| Country's Decision or any other Communication | Risk assessment | 1 | |
