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Risk Assessment
Record information and status
Record ID
113499
Status
Published
Date of creation
2017-12-27 17:28 UTC (gutemberg.sousa@mctic.gov.br)
Date of publication
2018-06-15 13:37 UTC (dema@itamaraty.gov.br)

General Information
Country
  • Brazil
Title of risk assessment
Risk Assessment of NK603 x T25 maize tolerant to the herbicides glyphosate and glufosinate ammonium.
Date of the risk assessment
2015-03-05
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
Dra Maria Sueli Felipe Soares
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:msueliunb@gmail.com
Url:National Technical Biosafety Comission
Risk assessment details
Living modified organism
MON-ØØ6Ø3-6 x ACS-ZMØØ3-2 - Roundup Ready™ Liberty Link™ maize
Resistance to antibiotics - Ampicillin 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 CP4 EPSPS protein does not exhibit acute toxic effects in mammals. Results from acute oral toxicity studies in mice have demonstrated that the protein does not cause acute toxicity or adverse effects, even at high doses tested, much higher than those related to human exposure. The agronomic and phenotypic observations allowed to conclude that NK603 × T25 maize does not differ consistently from maize control. The data from the trials evaluated together show that NK603 × T25 maize does not impose a greater risk as a weed and does not result in a risk to the environment when compared to conventional maize.
Likelihood that the potential adverse effects will be realized
Even though it was concluded that there is no interaction between the CP4 EPSPS and PAT proteins, and these being not proteins with insecticidal activity against target pests, a survey of entomofauna was evaluated in the abundance of non-target organisms in field experiments conducted in Brazil harvest in five locations distributed in representative areas of maize crop in Brazil showed that there are no significant differences between genetically modified maize and conventional maize
Possible consequences:
It can be concluded that NK603 × T25 maize is so safe, substantially equivalent and has no greater potential to become a weed or cause adverse effects to human and animal health or any adverse environmental impacts when compared to conventional maize or to events already assessed as safe
Estimation of the overall risk
Gene flow rate evaluation was performed at various distances from the genetically modified pollen source in all four directions. Due to the slope of the terrain and prevailing winds, the dispersion of the pollen produced by the hybrid AG 6016 (yellow seeds) was decreasing from the right side of the quadrant to the left side, counterclockwise. However, the results show that the pollen dispersal frequency in the four quadrants was drastically reduced, with fertilization values close to zero being recorded from the distance of 7.2 meters from the pollen source.
Recommendation(s)
the distance of 25-40 meters between the genetically modified organism and the conventional organism is sufficient to keep the threshold below the 0.9% allowed by the European Commission in the case of labeling. It is important to emphasize that in Brazil, this limit for labeling is 1%, according to Decree No. 4,680, dated 04/24/2003, which regulates the right to information, guaranteed by Law No. 8,078, of 09/11/1990.
Need(s) for further information on specific issues of concern
NK603 × T25 maize provides Brazilian farmers with the possibility of using two herbicides with different modes of action in weed control and as a weed resistance management tool
Receiving environment(s) considered
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".
LMO detection and identification methods proposed
Molecular traditional methods

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