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Risk Assessment
Record information and status
Record ID
Date of creation
2011-09-08 12:11 UTC (gutemberg.sousa@mctic.gov.br)
Date of publication
2011-09-08 12:50 UTC (larissa.costa@itamaraty.gov.br)

General Information
  • Brazil
Title of risk assessment
Risk Assessment of MON 89034 x NK 603 maize
Date of the risk assessment
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
Url:National Technical Biosafety Comission
Contact details of the main responsible risk assessor
Dr Edilson Paiva
President of National Biosafety Commitie
Ministry Of Science and Technology (MCT)
SPO - Área 05 - Quadra 03 Bloco B - Térreo - Salas  08 a 10
Brasília , DF - CEP: 70610-200
Fones: (55)(61) 3411 5151 - FAX: (55)(61) 3317 7475
Brasilia, Brasília
Brazil, 70610-200
Risk assessment details
Living modified organism
MON-89Ø34-3 x MON-ØØ6Ø3-6 - Genuity® VT Double Pro™ Maize
Resistance to antibiotics - Kanamycin Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths) Resistance to herbicides - 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 introduction into the environment
    • commercial production
    • field trial
  • LMOs for processing
Risk assessment report / Summary
Methodology and points to consider
Potential adverse effects identified in the risk assessment
The proteins present in NK 603 x MON89034 maize have a history of safe use by the consumption of MON 89034 maize since 2008, and the NK603 maize since 2000. The MON 89034 x NK 603 maize is approved in Japan, North Korea, the Philippines, Taiwan, and the USA. Concerning the proteins expressed by MON 89034 x NK 603 maize, it is known that Cry proteins accumulate in the cytoplasm and which have selective toxicity for some species of lepidopteran insects, and their mechanism of action mediated by specific receptors on target organisms. The Cry1A.105 protein and Cry2Ab2 protein bind to these receptors located in the midgut of susceptible insects, leading to form pores that cause insect death. The EPSPS protein, accumulated in the chloroplast, catalyses a step in the shikimic acid pathway for biosynthesis of aromatic amino acids, being so essential to normal growth in plants and micro-organisms. The mechanism for glyphosate action is by forming a complex with the EPSPS enzyme, which regards to the natural substrate binding for the enzyme, blocking the biosynthetic pathway. The CP4 EPSPS enzyme is present in the MON 89034 x NK 603 maize, has low affinity for glyphosate compared to wild EPSPS proteins. Thus, when the MON 89034 x NK603 maize is treated with glyphosate, the CP4 EPSPS enzyme activity causes the plants to continue developing normally. In summary, the proteins expressed by transgene cp4 epsps and cry (and Cry1A.105 cry2Ab2) in MON 89034 x NK603 maize are accumulated in different cellular compartments. They act in different pathways and have different functions and not interactive functions. Studies with the proteins Cry1A.105, Cry2Ab2, and CP4 EPSPS show that these are rapidly digested in simulated gastric and intestinal fluids. This contributes to a low allergenic potential of these proteins, together with the fact they are present in MON 89034 x NK 603 maize in low quantities. Tests for acute oral toxicity and for sub-chronic oral toxicity indicated that the protein in question does not produce adverse effects in mammals. Bioinformatics analysis also demonstrated that the proteins Cry1A.105, Cry2Ab2, and CP4 EPSPS show no similarity in amino acid sequence with known allergenic and toxic proteins. The confirmation of presence and of integrity for DNA sequence introduced into MON 89034 x NK603 maize was carried out by using insert-specific identification by Southern blot analysis. The expression of proteins Cry1A.105, Cry2Ab2, and CP4 EPSPS occurs in all tissues of the plant because the promoters used to promote constitutive expression of these proteins. The expression levels of these proteins were determined in leaves, grain, and fodder, tissues relevant to assess the safety of MON 89034 x NK603 maize as human food and animal feed. The results show comparable levels of expression of proteins in the pyramided event and in their parents, with a low expression of these proteins in the grains and a higher expression in leaves, and were intermediate in fodder. During the analysis of agronomic traits in the phenotypic MON 89034 x NK 603 maize were not identified statistically significant differences concerning control maize for any parameter assessed. It was demonstrated also the effectiveness in controlling target pests and the presence of the trait to tolerate the herbicide glyphosate. Together, their results support the conclusion that, except by the specific characteristics of each introduced gene, the phenotype of GM maize has not changed and therefore the MON 89034 x NK 603 maize has no greater potential than conventional maize to become a weed. Chemical composition analyses were performed in grains and fodder of MON 89034 x NK 603 maize, comparing it to conventional control variety, which has similar genetic base, and seven varieties of conventional maize referenda. The samples used were generated in three locations, representative of the area of maize crop in Brazil, during the 2007/2008 harvest. All values of chemical composition on fodder and MON 89034 x NK 603 maize grains were within the range of values for isogenic control maize, or of commercial values found in the database of the composition of the ILSI-CCD. With this, we can say that the MON 89034 x NK 603 maize is substantially equivalent to conventional maize and therefore as safe, healthy, and nutritious as conventional maize. Besides the data provided by the company, CTNBio consulted independent scientific literature to assess the safety and the occurrence of any unexpected effect from the cross between these events. Given the above, it is concluded that the cultivation and consumption of MON 89034 x NK 603 maize is not potentially causer of significant environmental degradation or risk to human and animal health. For this reason, there are no restrictions on the use of maize and its derivatives. CTNBio determines that the monitoring post-commercial release should be conducted in commercial fields and not in experimental fields. The areas chosen to be monitored should not be isolated from the others, have borders or any situation that is out of business standard. Monitoring should be carried out in model comparison between the conventional system of cultivation and cropping system of GMOs, and the data collection done by sampling. Monitoring should be conducted in representative biomes of the main areas of cultivation of GMOs and, where possible, involve different types of producers. The monitoring should be conducted for at least five years. The reports presented should be detailed information about all activities in the pre-planting and planting on their implementation, with reports of activities conducted in the areas of monitoring during the crop cycle, about the activities of harvest and weather conditions. There should be monitoring of any injuries to human and animal health systems through the official notification of adverse effects, such as the SINEPS System (Adverse Event Reporting Related to Health Products) regulated by ANVISA. The analytical methods, results, and their interpretations must be developed in accordance with the principles of independence and transparency, subject to commercial confidentiality issues previously defined and justified as such. With regard to the gene cp4 epsps, which confers resistance to the herbicide, should be monitored: the nutritional status and health of GM plants, the chemical and physical attributes related to soil fertility and other basic soil characteristics, soil microbial diversity; the soil diaspore bank, the weed community, the development of herbicide resistance in weeds, the herbicide residues in soil, in grain and in aerial parts, and the gene flow. With respect to the genes Cry1A.105 and cry2Ab2, which confer resistance to insects, should be monitored: the impact on the target insects and on non-target insects, the impact on soil invertebrates of indicators, not belonging to the class Insecta, the residues of insecticidal proteins in decomposing organic matter, soil and waterways near the area of monitoring, the development of resistance among target insects and the gene flow of the two inserted genes.

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