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Risk Assessment generated by a regulatory process
(RA)
last updated: 28 Apr 2026
Risk assessment of soybean event MON 87708 - Technical Opinion No. 5330/2017
EN
08 Dec 2016
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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-877Ø8-9 - Dicamba Tolerant Soybean| Monsanto | Resistance to herbicides
- Commercial release 5330 - 2017.pdf [ Portuguese ]
MON 87708 soybean was developed using the transformation methodology mediated by Agrobacterium sp. whereby the dmo coding sequence was inserted into conventional soybean A3525. Soybean MON 88708 expresses the dmo gene (dicamba mono oxygenase) from the bacterium Stenotrophomonas maltophilia cpa DI-6 (Gram negative, aerobic, ubiquitous). The DMO protein catalyzes the addition of a molecule of molecular oxygen (O2) to the methyl group of dicamba leading to conversion to a non-herbicide product called 3,6-dichlorosalicylic acid (DCSA), formaldehyde (CH2O) and water.
Adverse effects on the human and animal food chain from the ingestion of MON 87708 soy and its derivatives are not expected based on the assessment of their food safety and DMO protein.
The food safety of the DMO protein present in foods and feeds derived from soy MON 87708 was evaluated for risks to humans and animals. The risks were quantified as a margin of exposure (MOE), which is defined as the no-observed-effect level (NOEL) of the mouse acute oral toxicity study to estimate the dietary intake of exogenous protein. These studies demonstrated that BMD protein is not acutely toxic and does not cause any adverse effects, even at the highest test dose, which was 140 mg/kg body weight.
The dmo gene is the only coding element for a complete protein (DMO) present in the MON 87708 soybean. Therefore, there are no additional exogenous proteins, originating from other genes introduced in the MON 87708 soybean, with which the DMO protein could interact and cause adverse effects and other consequences.
The composition data presented in the process demonstrated, in addition to the nutrient equivalence, the
equivalence of antinutrients and other components of grains and forage of MON 87708 soybean with conventional control soybean and commercial soybean references. Based on the data and information presented, the conclusion is that the MON 87708 soybean grains and forage are equivalent to the grains and conventional control soybean forage in terms of composition and nutritional value, and that toxins and secondary metabolites that cause adverse effects on human and animal health are not produced. The few statistical differences between the grain and forage composition of MON 87708 soybean and soybean conventional control in the study carried out with samples collected in the United States in 2009 reflects the natural variability of the components of the soybean crop, since the average levels of
components of the test substance (soybean MON 87708) were within the 99% tolerance range for conventional soy and/or within the ranges published in the ILSI (International Life Sciences Institute (ILSI) Crop Composition Database) composition database and in scientific literature. The proximate composition data with grain and forage samples collected in Brazil in the 2013/2014 harvest also showed nutritional equivalence between MON 87708 soybean, conventional control soybean and commercial soybean references.
equivalence of antinutrients and other components of grains and forage of MON 87708 soybean with conventional control soybean and commercial soybean references. Based on the data and information presented, the conclusion is that the MON 87708 soybean grains and forage are equivalent to the grains and conventional control soybean forage in terms of composition and nutritional value, and that toxins and secondary metabolites that cause adverse effects on human and animal health are not produced. The few statistical differences between the grain and forage composition of MON 87708 soybean and soybean conventional control in the study carried out with samples collected in the United States in 2009 reflects the natural variability of the components of the soybean crop, since the average levels of
components of the test substance (soybean MON 87708) were within the 99% tolerance range for conventional soy and/or within the ranges published in the ILSI (International Life Sciences Institute (ILSI) Crop Composition Database) composition database and in scientific literature. The proximate composition data with grain and forage samples collected in Brazil in the 2013/2014 harvest also showed nutritional equivalence between MON 87708 soybean, conventional control soybean and commercial soybean references.
The Experimental Stations where this study was conducted were: Cachoeira Dourada, MG (CAD); Smile, MT (SOR); Não-Me-Toque, RS (NMT) and Rolândia, PR (ROL). Significant differences were not
identified in the comparison of MON 87708 soybean with the conventional control soybean in the comparisons performed. Assessments of ecological interactions were conducted as part of the characterization of MON 87708 soybean to determine the potential for enhancing weed traits. The results support the conclusion that the differences detected for arthropod-related damage were not indicative of a consistent response associated with the dicamba tolerance trait and were not considered to have significant biological significance with respect to an increase in potential as a plant. weed, or an altered environmental impact when comparing the MON 87708 soybean with the conventional control soybean.
identified in the comparison of MON 87708 soybean with the conventional control soybean in the comparisons performed. Assessments of ecological interactions were conducted as part of the characterization of MON 87708 soybean to determine the potential for enhancing weed traits. The results support the conclusion that the differences detected for arthropod-related damage were not indicative of a consistent response associated with the dicamba tolerance trait and were not considered to have significant biological significance with respect to an increase in potential as a plant. weed, or an altered environmental impact when comparing the MON 87708 soybean with the conventional control soybean.
No risk of the event MON 87708 turning into a weed was identified after the transformation process, the insertion and expression of the new genetic trait, or even no metabolic changes were observed in the plants.
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 soy MON 87708 is substantially equivalent to conventional soy, and its consumption is safe for human and animal health. Regarding the environment, CTNBio concluded that MON 87708 soy is not a potential cause of significant environmental degradation, keeping with the biota the same relationship as that of conventional soy.
Molecular traddicional methods.
Yes
Yes
Yes
Yes
Yes
EN
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
