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Risk Assessment
Record information and status
Record ID
112297
Status
Published
Date of creation
2017-06-28 13:14 UTC (gutemberg.sousa@mctic.gov.br)
Date of publication
2017-08-01 20:07 UTC (dema@itamaraty.gov.br)

General Information
Country
  • Brazil
Title of risk assessment
Risk assessment of genetically modified soybeans Containing the event MON87751 - Technical Report 5398/17
Date of the risk assessment
2017-03-09
Competent National Authority(ies) responsible for the risk assessment
National Technical Biosafety Commission
Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 10 à 14
Brasília, DF
Brazil, CEP - 70610-200
Phone:(5561) 3411-5516
Fax:(5561) 3317-7475
Email:ctnbio@mct.gov.br
Url:National Technical Biosafety Comission
Risk assessment details
Living modified organism
MON-87751-7 - Insect resistant soybean
Monsanto Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths)
Scope of the risk assessment
  • LMOs for Contained use
  • LMOs for direct use as feed
  • LMOs for direct use as food
  • LMOs for Introduction into the environment
  • LMOs for processing
Risk assessment report / Summary
Methodology and points to consider
Potential adverse effects identified in the risk assessment
The studies carried out indicated that pleiotropic and epistatic effects were not observed in the morphological and agronomic character evaluation tests performed with soybean MON 87751 in Brazil in the harvest of 2013/2014. The agronomic characteristics of MON 87751 soybean were not altered in relation to Commercial varieties, except for the expression of the insect resistance characteristic, which was the objective of introducing the cry1A.105 and cry2Ab2 genes into the soybean genome.
Likelihood that the potential adverse effects will be realized
In Brazil soy GlycineMax is considered an exotic species, not being identified any native, wild or feral species that can spontaneously cross with it. There is also no center of genetic diversity of soybeans in Brazil, all the genetic variability of the species was introduced from centers of origin or genetic diversity and is stored in germplasm banks of public and private institutions. There is no evidence that soy escaped or dispersed from experimental areas, becoming an invader.
Possible consequences:
Soybean includes G. maxi cultivated soybean, the annual wild species G. soja, which is found in China, Taiwan, Japan, Korea and Russia. F1 hybrids of G. maxe G. soybean carry similar genomes and are fertile. Interspecific fertile hybrids formed by artificial crosses between G. maxi G. soja and G. maxe G. gracilis were easily obtained. Although the Hybridization between G. maxi members of the Subgenus Soja may occur, G. soybean is not found in South and North America, and gene transfer from soybean MON87751 is not expected to occur for these species. The transfer of the transgenes to native species of the subgenus Soja may occur, where these wild species are naturally present.
Estimation of the overall risk
The characteristic conferred by the introduction of the cry1A.105 and cry2Ab2 genes is not expected to provide any competitive advantage or greater aggressiveness to MON 87751 soybean, which would result in an invasive species. The insect resistance characteristic does not make the MON 87751 soybean a weed or invasive of natural habitats, since the reproductive and vegetative development characteristics of the soybean were not altered. The only advantage of soybeans MON 87751 is insect resistance.
Recommendation(s)
Although soybean is a species of self-fertilization, a low percentage of cross-fertilization may occur, and the frequency of crossing will depend on the genotype, distance, flowering synchrony, environmental conditions, presence of pollinators. Results of gene flow studies with genetically modified soybean tolerant to glyphosate and conventional soy were used to show the low gene flow rate in soybean culture and to support
Conclusion that the cry1A.105 and cry2Ab2 genes present in MON 87751 soybean also present a low frequency of gene flow because the reproductive characteristics do not differ between soybean MON 87751 and conventional soybean varieties
Need(s) for further information on specific issues of concern
Reports of significant adverse effects on some species of non-target organisms that are closely related to target species are found (Mendelsohn et al., 2003; Romeiset al., 2006b). On the other hand field studies with insect resistant crops that produce several types of Cry proteins have been
Conducted by industry and the academic community since the advent of these cultures and have demonstrated that they do not cause adverse effects on biodiversity, populations of tested natural enemies and other ecologically important non-target insects
Receiving environment(s) considered
The data demonstrate that the presence of the Cry1A.105 and Cry2Ab2 proteins in the original plant material of MON 87751 soybean or cultural remains deposited on the soil do not interfere in the physico-chemical composition of the soil samples studied in six representative sites of the culture of this culture .
LMO detection and identification methods proposed
molecualr traditional methods

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