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Évaluation des risques générée par un processus de réglementation
(RA)
last updated: 30 juil. 2015
Risk assessment of the genetically modified maize NK603 x MON810 and MON89034 x NK603
EN
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Autorité nationale compétente :Ministry of Environment, Department of environmental risks and biosafety ()Namestie L. Stura 1Bratislava,
812 35, SlovaquieTéléphone : +421 2 5956 2400, +421 905 669 515,Télécopieur : +421 2 5956 2508,E-mail : henrieta.cajkova@enviro.gov.sk, info@enviro.gov.sk,Site Web : http://www.minzp.sk/en/,
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MON-ØØ6Ø3-6 × MON-ØØ81Ø-6 - Roundup Ready™ YieldGard™ maize| Monsanto | Résistance aux maladies et aux parasites (Insectes, Chenille tisseuse (papillons et mites), Pyrale du maïs (Ostrinia nubilalis)), Résistance aux herbicides (Glyphosate)
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MON-89Ø34-3 × MON-ØØ6Ø3-6 - Genuity® VT Double Pro™ Maize| Résistance aux antibiotiques (Kanamycine), Résistance aux maladies et aux parasites (Insectes, Chenille tisseuse (papillons et mites)), Résistance aux herbicides (Glyphosate)
The insecticidal activity of proteins Cry1A.105 and Cry2Ab2 on the target insect larvae can affect the level of the population. Theoretically, it could indirectly impact on the population dynamics of organisms which interact with target pests.
To characterize the spectrum of insecticidal activity of proteins Cry1A.105 and Cry2Ab2 to agronomically important insect species from different genera, many biological feeding tests with pure proteins or lyophilized leaf tissue were done. The biotests were performed on representative harmful and non-harmful insect species of the five lines - Coleoptera, Lepidoptera, Hemiptera, Hymenoptera, Collembola.
Biologically significant insecticidal effect was observed only for the species of Lepidoptera.
The pollen from genetically modified maize can pollinate neighboring plants of another variety. Also the tolerance to target Lepidoptera and tolerance to glyphosate, which is further expressed in the offspring, is transeferred to this variety.
EN
To characterize the spectrum of insecticidal activity of proteins Cry1A.105 and Cry2Ab2 to agronomically important insect species from different genera, many biological feeding tests with pure proteins or lyophilized leaf tissue were done. The biotests were performed on representative harmful and non-harmful insect species of the five lines - Coleoptera, Lepidoptera, Hemiptera, Hymenoptera, Collembola.
Biologically significant insecticidal effect was observed only for the species of Lepidoptera.
The pollen from genetically modified maize can pollinate neighboring plants of another variety. Also the tolerance to target Lepidoptera and tolerance to glyphosate, which is further expressed in the offspring, is transeferred to this variety.
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 pests. Therefore, the effect of MON 89034 x NK603 and NK603 x MON 810 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 Cry1Ab toxin (expressed in NK603 x MON 810) for certain lepidopteran 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.
The majority of pollen of the GM maize remains at a short distance from the source, so the likelihood of transferring the inserted properties of GM maize on neighboring maize is low.
The proposed measures in the form of isolation distance and protective buffer strips that accompany the implementation of field trials, further significantly reduce the potential of this transfer.
As for any other maize, the likelihood of MON 89034 × NK603 and NK603 x MON 810 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.
EN
Based on the selectivity of the Cry1A.105 and Cry2Ab2 toxins (expressed in MON 89034 x NK603) and of the Cry1Ab toxin (expressed in NK603 x MON 810) for certain lepidopteran 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.
The majority of pollen of the GM maize remains at a short distance from the source, so the likelihood of transferring the inserted properties of GM maize on neighboring maize is low.
The proposed measures in the form of isolation distance and protective buffer strips that accompany the implementation of field trials, further significantly reduce the potential of this transfer.
As for any other maize, the likelihood of MON 89034 × NK603 and NK603 x MON 810 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.
Any occupational health aspects of handling MON 89034 x NK603 and NK603 x MON 810 are not different from conventional maize and these maize plants were shown not to cause any toxic or allergenic effects in human 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 trials is considered no different from the farming practices for conventional maize.
EN
The environmental impact of the cultivation, management and harvesting techniques applied in the trials is considered no different from the farming practices for conventional maize.
Analysis of the characteristics of MON 89034 x NK603 and NK603 x MON 810 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.
EN
The 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 NK603 × MON 810 crops and that of their receiving environment.
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.
Bolting plants will be controlled by mechanical destruction or non-selective herbicides.
Seeds will be transported in sealed and labelled bags.
EN
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.
Bolting plants will be controlled by mechanical destruction or non-selective herbicides.
Seeds will be transported in sealed and labelled bags.
FR
Field site in Borovce, near Piestany, Slovakia. The site is located in a geographic area where the maize is a common crop to grow. Environment of the field site is agriculturally used land.
Location of the field trial is not close to the protected areas.
MON 89034 x NK603 was first field tested for efficacy in Puerto Rico during the 2004/2005 winter season. Field trials were also conducted in U.S.A. and Argentina, where agronomic performance was assessed. In the E.U., MON 89034 x NK603 was field tested in Spain and France during 2007/2008. The results of the releases in these countries showed no evidence that MON 89034 x NK603 is likely to cause any adverse effects to human or animal health and the environment. Except for its protection against certain lepidopteran insects and its tolerance to glyphosate, MON 89034 x NK603 could not be distinguished from conventional maize.
Field trials with NK603 x MON 810 have been notified in the E.U. since the year 2000 in several countries such as Spain, France, Czech Republic and Germany. No adverse effects to human or animal health and the environment have been observed from the results of the release of NK603 x MON 810 in those countries. Additionally, post-release general surveillance from environments inside and outside the E.U. has shown that NK603 x MON 810 and its single trait parental lines, NK603 and MON 810, are unlikely to pose any risk of adverse effects to human or animal health or to the environment.
EN
Location of the field trial is not close to the protected areas.
MON 89034 x NK603 was first field tested for efficacy in Puerto Rico during the 2004/2005 winter season. Field trials were also conducted in U.S.A. and Argentina, where agronomic performance was assessed. In the E.U., MON 89034 x NK603 was field tested in Spain and France during 2007/2008. The results of the releases in these countries showed no evidence that MON 89034 x NK603 is likely to cause any adverse effects to human or animal health and the environment. Except for its protection against certain lepidopteran insects and its tolerance to glyphosate, MON 89034 x NK603 could not be distinguished from conventional maize.
Field trials with NK603 x MON 810 have been notified in the E.U. since the year 2000 in several countries such as Spain, France, Czech Republic and Germany. No adverse effects to human or animal health and the environment have been observed from the results of the release of NK603 x MON 810 in those countries. Additionally, post-release general surveillance from environments inside and outside the E.U. has shown that NK603 x MON 810 and its single trait parental lines, NK603 and MON 810, are unlikely to pose any risk of adverse effects to human or animal health or to the environment.
Event specific detection method
http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx
EN
http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx
The same field trial was implemented in the years 2009 - 2011. Both maize lines were grown during the duration of that former experimental release.
In the years 2012 - 2014, the maize MON89034 x NK603 was the only one cultivated, except for the last year of the experiment when any maize was sown. An English summary of the notification including the risk assessment of the notifier is available at the EU WebSNIF internet-page of Joint Research Centre under notification number B/SK/12/01 (http://gmoinfo.jrc.ec.europa.eu/gmp_report.aspx?CurNot=B/SK/12/01).
EN
In the years 2012 - 2014, the maize MON89034 x NK603 was the only one cultivated, except for the last year of the experiment when any maize was sown. An English summary of the notification including the risk assessment of the notifier is available at the EU WebSNIF internet-page of Joint Research Centre under notification number B/SK/12/01 (http://gmoinfo.jrc.ec.europa.eu/gmp_report.aspx?CurNot=B/SK/12/01).
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