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Risk Assessment
Record information and status
Record ID
112301
Status
Published
Date of creation
2017-06-19 13:58 UTC (gutemberg.sousa@mctic.gov.br)
Date of publication
2017-08-01 20:12 UTC (dema@itamaraty.gov.br)

General Information
Country
  • Brazil
Title of risk assessment
Risk assessment of the Commercial Soybean Release Events FG72 x A5547-127. Technical Report  4866/15
Date of the risk assessment
2015-12-10
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
Contact details of the main responsible risk assessor
Dr. Edivaldo Domingues Velini
President
National Technical Biosafety Comission (CTNBio)
Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 08 à 10
Brasília, DF
Brazil, CEP - 70610-200
Phone:(5561) 3411-5151
Fax:(5561) 3317-7475
Email:secretariactnbio@mct.gov.br
Url:National Technical Biosafety Comission
Risk assessment details
Living modified organism
MST-FGØ72-2 x ACS-GMØØ6-4 - Soybean modified for herbicide tolerance
Resistance to herbicides - Glufosinate, Glyphosate
Show detection method(s)
Scope of the risk assessment
  • LMOs for Contained use
  • LMOs for direct use as feed
  • LMOs for direct use as food
  • LMOs for processing
Risk assessment report / Summary
Methodology and points to consider
Potential adverse effects identified in the risk assessment
The safety of Event FG72 x A5547-127 was evaluated in several studies carried out in Brazil and Abroad, in order to demonstrate that the combination of the Events through traditional Not result in lineages significantly different from those from which they originate (Events Parental) and conventional varieties. Thus, the safety of soybean FG72 x A5547-127 is Demonstrated not only by the information previously presented for the Isolated Events, but also As, through analyzes that demonstrated the absence of any interaction between the present inserts In this lineage;
Likelihood that the potential adverse effects will be realized
According to data collected under field conditions in both Brazil and the United States,
The insertion of the 2mepsps genes, hppdPfw336, and pat, do not interfere with / alter environmental behavior Of genetically modified plants derived from Event FG72 x A5547-127. The new attributes,
Permitting the selective use of herbicides, do not introduce any competitive or Adaptive to the individual. The differentiated phenotype of the plants is only perceived under the management conditions
When using the herbicides Glyphosate, Isoxaflutole or Glufosinate of Ammonium, where
Only the weeds suffer the insults caused by the product.
Possible consequences:
Results obtained in studies conducted in Brazil and abroad, using Bioinformatics, tools of molecular biology, chemical, nutritional analyzes, as well as Phenotypic and agronomic evaluations indicate that the proteins encoded by the genes in question On different metabolic routes, on very specific substrates. Therefore, we do not expect That the joint expression of the proteins affects other attributes of the plant and does not Adverse reactions.
Estimation of the overall risk
In Brazil, trials under Planned Release in the Environment were conducted (CTNBio Process
N °. 01200.001109 / 2012-12) in the 2012/13 crop in four representative States for the cultivation of soybeans (SP, GO, RS and MT) with the objective of evaluating soybean development, reproduction and survival FG72 x A5547-127, as compared to the conventional non-GM variety. The characteristics evaluated In the phenological stages R2, R3-R4, R5-R6 and R6-R7 were: vigor of the crop, stand (number of Plants / plot), chlorophyll content in the leaves and height of the plants. The characteristics evaluated in the The pre-harvest period were: number of healthy pods, number of seedless pods and total green beans. The characteristics evaluated in the post-harvest period were: grain moisture, weight of 100 Seeds and productivity. In most comparisons, no differences were detected Significant. The significant differences observed between genetically modified soybean FG72 x A5547-127 and
The conventional variety were not repeated in all localities, demonstrating a possible Of environmental factors in the agronomic characteristics evaluated.
Recommendation(s)
As established in art. 1 of Law 11,460, of March 21, 2007, "are prohibited the research and the cultivation of genetically modified organisms in the indigenous lands and areas of conservation units", except in the areas of environmental protection
Need(s) for further information on specific issues of concern
The safety of PAT protein, encoded by homologous pat or bar genes (isolated from the bacteria Streptomyces viridochromogenes or Streptomyces hygroscopicus), has been extensively demonstrated and presented for the isolated events T25 (corn), LLCotton25 (cotton), A2704-12, A5547- 127 (soybean), as well as for the combined Events GHB614 x T304-40 x GHB119 and GHB614 x LLCotton25, approved for commercial use in Brazil. Safety approvals have already been granted for at least 43 distinct transformation events expressing the PAT protein of five plant species (soybean, maize, canola, beet, cotton) in different countries,
Receiving environment(s) considered
According to the results of the studies carried out in Brazil, and considering the internationally accepted criteria in the risk analysis process of genetically modified raw materials, it is possible to conclude that soybean FG72 x A5547-127 is as safe as its conventional equivalents.
LMO detection and identification methods proposed
molecular traditional methods

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