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Risk Assessment
Record information and status
Record ID
115243
Status
Published
Date of creation
2019-10-30 14:32 UTC (gutemberg.sousa@mctic.gov.br)
Date of publication
2019-10-30 14:58 UTC (dema@itamaraty.gov.br)

General Information
Country
  • Brazil
Title of risk assessment
Risk assessment of maize 87460 - Technical Report 5224/2019
Date of the risk assessment
2015-10-06
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
Monsanto do Brasil Ltda
Monsanto do Brasil Ltda
Geraldo Ubirajara Berger

Avenida das Nações Unidas, 12901 - Torre Norte - 7º andar
Sao Paulo, SP
Brazil, 04578-000
Phone:+55(11) 3383-8356
Fax:+55(11) 3383-8102 ; +55 (61) 3245-2523
Email:geraldo.u.berger@monsanto.com
Risk assessment details
Living modified organism
MON-8746Ø-4 - Droughtgard™ Maize
Resistance to antibiotics - Kanamycin Tolerance to abiotic stress - Cold / Heat, Drought
Show detection method(s)
Scope of the risk assessment
  • 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
This approval is exclusively for human and animal consumption. The characterization performed confirmed the safety of proteins for human and animal consumption. The evaluations included the following methodologies: 1) characterization of the functional and physicochemical properties of each protein; 2) quantification of protein expression in different plant tissues; 3) assessing the similarity of each protein to toxic or allergenic substances and other known biologically active substances that may have adverse effects on mammals; 4) evaluation of
protein digestibility in simulated gastrointestinal fluids; 5) documentation of the history of safe use and consumption of proteins or structural and functional counterparts that have no documented adverse effect on human or animal health; 6) evaluation of potential mammalian toxicity by forced protein administration (gavage) analysis. All evaluations indicated that CSPB and NPTII proteins are safe for human and animal consumption.
Likelihood that the potential adverse effects will be realized
These two proteins have no similarity to toxic, allergenic or other known anti-nutritional proteins. Furthermore, these proteins are rapidly digested in simulated gastric and intestinal fluids and none have acute toxicity in gavage administration evaluations, even at doses of several orders of magnitude above those
observed in the most conservative (high dose) exposure scenarios. Considering all the evaluations and analyzes, it is evident that dietary exposure of CSPB or NPTII proteins expressed in MON 87460 maize does not cause any risk to human or animal health.
Possible consequences:
A detailed evaluation of the centesimal and nutritional composition of MON 87460 maize compared to conventional control maize and conventional commercial hybrids confirmed that this maize is as
safe and nutritious as conventional corn. Samples were generated from six different locations in the United States in the 2006 vintage (10 years ago). The results of these additional analyzes
corroborated that MON 87460 maize is compositionally and nutritionally equivalent to conventional maize.
Estimation of the overall risk
The data presented above reinforces that feed and food produced from MON 87460 maize are as safe and nutritionally equivalent to those produced by conventional maize.
Recommendation(s)
MON 87460 maize is already approved in the following countries: United States, Australia and New Zealand, Canada, Colombia, Japan, China, South Korea, Mexico, Philippines, Taiwan, Singapore, South Africa, Vietnam and the European Union. The approval of MON 87460 maize in the European Union by the European Food Safety Authority (EFSA) is set out in Annex 1 to this document. So far there is not only one report of adverse effects of this corn on human and animal health, but also on the environment in those countries where it is approved.
Need(s) for further information on specific issues of concern
A detailed evaluation of the centesimal and nutritional composition of MON 87460 maize compared to conventional control maize and conventional commercial hybrids confirmed that this maize is as
safe and nutritious as conventional corn
Receiving environment(s) considered
The data set presented reinforces that feed and food produced from MON 87460 maize are as safe and nutritionally equivalent to those produced by conventional maize.
LMO detection and identification methods proposed
Molecular traditional methods

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