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Risk Assessment
Record information and status
Record ID
104330
Status
Published
Date of creation
2012-10-31 15:44 UTC (hana_jirakova@env.cz)
Date of publication
2012-10-31 15:44 UTC (hana_jirakova@env.cz)

General Information
Country
  • Czech Republic
Title of risk assessment
Decision on a field trial with MON89034 x NK603 and MON89034 x MON88017 maize
Date of the risk assessment
2009-04-27
Competent National Authority(ies) responsible for the risk assessment
Ministry of the Environment
Vrsovicka 65
Prague
Czech Republic, 10010
Phone:+420 267 122 066
Fax:+420 267 310 013
Email:gmo@mzp.cz
Url:Ministry of the Environment of the Czech Republic
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)
MON-89Ø34-3 x MON-88Ø17-3 - Genuity® VT Triple Pro™ Maize
Resistance to diseases and pests - Insects - Coleoptera (beetles), Lepidoptera (butterflies and moths) Resistance to herbicides - Glyphosate
Show detection method(s)
Scope of the risk assessment
  • LMOs for Introduction into the environment
    • Field trial
Risk assessment report / Summary
Methodology and points to consider
Estimation of the overall risk
Analysis of the characteristics of MON 89034 x NK603 and MON 89034 x MON 88017 have shown that the risk of potential adverse effects on human and animal health or the environment, resulting from the planned deliberate release of these maize plants for field testing, is negligible:
· The risk of the introduced traits in MON 89034 × NK603 and in MON 89034 x MON 88017 to be the cause of any meaningful competitive advantage or disadvantage in natural environments is negligible. As for any other maize, the likelihood of MON 89034 × NK603 and MON 89034 x MON 88017 to spread into non-agricultural environments is negligible, as their persistence in agricultural habitats and their invasiveness into non-agricultural habitats are unaltered compared to conventional maize.
· There is no potential for gene transfer from MON 89034 x NK603 and from MON 89034 x MON 88017 to wild plant species in Europe and low to negligible likelihood for gene transfer to other maize crops. In the event that the introduced genes would outcross to another maize plant, its transfer would, in any case, have negligible consequences for the environment. Therefore, no risk management strategies are considered necessary. Nevertheless, measures will be taken to avoid hybridization with other maize plants and seed dissemination at harvest and during transportation (see Point E).
· As for the respective parental lines MON 89034, NK603 and MON 88017, MON 89034 x NK603 and MON 89034 x MON 88017 pose negligible risk for adverse environmental effects through their interaction with target organisms. By definition, the glyphosate tolerance trait has no direct or indirect interaction with any target organism. The insect-protection trait has activity only toward the larvae of particular target lepidopteran and coleopteran pests. Therefore, the effect of MON 89034 x NK603 and MON 89034 x MON 88017 on target organisms is limited to specific conditions in the field, spatially limited and short in duration.
· Based on the selectivity of the Cry1A.105 and Cry2Ab2 toxins (expressed in MON 89034 x NK603) and of the Cry3Bb1 toxin (expressed in MON 89034 x MON 88017) for certain lepidopteran and coleopteran pests, the well-characterised mode of action of the cry proteins and the confirmation through studies of no adverse effects found, the risk of an adverse effect on non-target organisms is considered negligible. Further, the potential exposure of non-target organisms to CP4 EPSPS proteins expressed in MON 89034 x NK603 and MON 89034 × MON 88017 presents no conceivable mechanism to cause adverse effects because of its properties. The ecological interactions with non-target organisms or the biochemical processes in soil are considered similar to the respective caused by conventional maize.
· Any occupational health aspects of handling MON 89034 x NK603 and MON 89034 x MON 88017 are not different from conventional maize, and these maize plants were shown not to cause any toxic or allergenic effects in man or animal health and to be as safe and nutritious as any other maize without any consequences for the feed/food chain.
· The environmental impact of the cultivation, management and harvesting techniques applied in the planned trials is considered no different from the farming practices for conventional maize.

It is actually expected that the production of MON 89034 x NK603 will positively impact current agronomic practices in maize and provide benefits to farmers and the environment. The benefits of planting this maize result, in one hand, from its lepidopteran-protection traits and include: 1) a reliable means to control the target lepidopteran maize pests; 2) control of target insects while maintaining beneficial species; 3) potential for reduced use of hazardous chemical insecticides and reduced applicator exposure to these products; 4) fit with integrated pest management (IPM) and sustainable agricultural systems; 5) potential for reduced mycotoxin levels in maize kernels; 6) no additional labour or machinery requirements, allowing both large and small growers to maximize hybrid yields and 7) reduced likelihood for lepidopteran insects to develop resistance to Bt proteins in the case of MON 89034 ´ NK603, since the combination of the Cry1A.105 and Cry2Ab2 insecticidal proteins in a single plant provides better insect control and offers an additional insect-resistance management tool.

Likewise, the glyphosate-tolerant trait in MON 89034 x NK603 and MON 89034 x MON 88017 enables the farmer to take advantage of the herbicides favourable environmental and safety properties (see Annex I listing of glyphosate under Council Directive 91/414/EEC). Glyphosate-tolerant maize benefits the farmer by providing (1) an additional broad-spectrum weed control option in maize, (2) a new herbicidal mode of action for in-season maize weed control, (3) increased flexibility to treat weeds on an "as needed" basis, (4) cost-effective weed control and (5) an excellent fit with reduced-tillage systems. In turn, a number of environmental benefits arise from the use of conservation tillage including improved soil quality, improved water infiltration, reductions in erosion and sedimentation of water resources, reduced runoff of nutrients and pesticides to surface water, improved wildlife habitat, increased carbon retention in the soil, reduced fuel use and encouragement of sustainable agricultural practices.

It is actually expected that the production of MON 89034 x MON 88017 will positively impact current agronomic practices in maize and provide benefits to farmers and the environment. The benefits of planting this maize result, in one hand, from its insect-protection traits and include: 1) a reliable means to control the target lepidopteran and coleopteran maize pests; 2) control of target insects while maintaining beneficial species; 3) potential for reduced use of hazardous chemical insecticides and reduced applicator exposure to these products; 4) fit with integrated pest management (IPM) and sustainable agricultural systems; 5) potential for reduced mycotoxin levels in maize kernels; 6) reduced likelihood for lepidopteran insects to develop resistance to Bt proteins and 7) no additional labour or machinery requirements, allowing both large and small growers to maximize hybrid yields.

Since no characteristics of MON 89034 × NK603 and MON 89034 x MON 88017 could be identified that may cause adverse effects on human health or the environment, no risk management strategies are considered necessary.
Recommendation(s)
In addition to the scheduled observations, the trial site will be checked regularly during the period of the deliberate release for potentially occurring, direct or indirect, adverse environmental effects. This will be done by visual inspection of the status of MON 89034 × NK603 and MON 89034 × MON 88017 crops and that of their receiving environment. In case any adverse environmental effects, linked to the deliberate release of MON 89034 × NK603 and MON 89034 × MON 88017 are observed during the period of release, these will be reported immediately to the Competent Authority.
The minimal isolation distance (200 m) from other maize crops, together with the eight rows of non transgenic maize surrounding the trials will prevent most of the possibility of hybridization with other maize plants.
The equipment, especially the experimental drill and combine, will be cleaned on the experimental site, thus preventing seed dissemination.
Although regrowth in the rotation crops is unlikely because of poor winter survival, the site will be sown with a crop different from maize the year following the planned trial.
Volunteer plants will be controlled by mechanical destruction or non-selective herbicides.
Seeds will be transported in sealed and labelled bags.
At the end of the field-testing campaign, a report will be made available by the notifier to the Competent Authority. This report will detail any unexpected adverse environmental effects observed during the general surveillance, if any, and further actions elicited as an effect of these findings, if applicable.
Receiving environment(s) considered
Czech Republic - South Moravia Region, Zlinsky Region
Additional Information
Additional Information
The field trial was officially finished in October 2011. The consent holder has submitted a final report on results of the deliberate release of given GMOs into the environment in the Czech Republic. The report is available at http://gmoinfo.jrc.ec.europa.eu/gmp_report.aspx?CurNot=B/CZ/09/03