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Notification report


General information

Notification Number
B/ES/06/03

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
07/11/2005

Title of the Project
Notification according to Directive 2001/18/EC, Part B, for the deliberate release of genetically modified maize MON 88017 x MON 810, tolerant to glyphosate and protected against certain Coleopteran and Lepidopteran insect pests.

Field trials program (2006-2009) for characterization and development of MON 88017 x MON 810 maize, which was produced by conventional breeding of two genetically modified parental inbred lines of maize, one being derived from transformation event MON 88017 (which is tolerant to glyphosate and protected against certain Coleopteran) and one derived from event MON 810 (which is protected from certain lepidopteran insect pests).


Proposed period of release:
01/01/2006 to 31/12/2006

Name of the Institute(s) or Company(ies)
Monsanto Europe, S.A., represented by Monsanto Agricultura España, S.L., ;


3. Is the same GMPt release planned elsewhere in the Community?
Yes:
Germany; Spain; France;

Has the same GMPt been notified elsewhere by the same notifier?
No

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
maizepoaceaezeazea maysmaysMON 88017 x MON 810 maize

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
MON 88017 x MON 810 hybrid maize consists in the combination, by conventional breeding, of two genetically modified parental inbred lines, derived from maize transformation events MON 88017 and MON 810, respectively.
MON 88017 x MON 810 expresses CP4 EPSPS protein, which imparts tolerance to glyphosate.
MON 88017 x MON 810 expresses Cry3Bb1 protein, which provides protection against certain coleopteran insects, including Corn Root Worm (Diabrotica virgifera). The insecticidal activity of the Cry3Bb1 protein is specific to coleopterans belonging to the chrysomelidae family.
MON 88017 x MON 810 also expresses the Cry1Ab protein, which provides the maize plant of protection from certain lepidopteran insects, including European Corn Borer (Ostrinia nubilalis) and pink borers (Sesamia spp.). The insecticidal activity of the Cry1Ab protein is specific to predation by the larvae of the targeted lepidopterans.


Genetic modification

3. Type of genetic modification:
Insertion; Other;
Other
MON 88017 x MON 810 was obtained by conventional breeding.

In case of insertion of genetic material, give the source and intended function of each constituent fragment of the region to be inserted:
Genetic modifications were solely used in the development of lines MON 88017 and MON 810.
MON 88017 x MON 810, obtained by conventional breeding, contains the following genetic elements:
- the cry3Bb1 gene from Bacillus thuringiensis subsp. kumamotoensis which confers protection against Corn Root Worm (Diabrotica virgifera);
- the cp4 epsps gene from Agrobacterium sp. strain CP4, which provides tolerance to ghyphosate herbicide;
- the cry1Ab gene from Bacillus thuringienses subsp. kurstaki which confers protection against European Corn Borer (Ostrinia nubilalis) and pink borers (Sesamia spp.)
These genes have been introduced with regulatory components necessary for expression in plant cells.


6. Brief description of the method used for the genetic modification:
MON 88017 x MON 810 was created using conventional breeding techniques. No additional genetic modification is used in the production of MON 88017 × MON 810 varieties. Instead, MON 88017 × MON 810 is produced by a conventional cross of MON 88017 and MON 810 inbred lines.
While MON 88017 × MON 810 results from conventional breeding, genetic modification was used in the development of MON 88017 and MON 810.
MON 88017 was produced by Agrobacterium-mediated transformation of immature embryos of maize tissue and MON 810 was genetically modified using a particle acceleration method.


7. If the recipient or parental plant is a forest tree species, describe ways and extent of dissemination and specific factors affecting dissemination:
Not applicable.

Experimental Release

1. Purpose of the release:
The aims of the release are:
1. to characterize MON 88017 x MON 810 maize under European crop conditions, including analysis for protein expression.
2. to evaluate the agronomic performance and equivalence of MON 88017 x MON 810 to non-GM maize.
3. to evaluate residues after applications with herbicides formulations based on glyphosate.


2. Geographical location of the site:
Toral de los Guzmanes (León)
Fuentes de Ropel (Zamora)
Amudévar (Huesca)
Grañén (Huesca)
Torres de Berrellén (Zaragoza)
Malpica de Tajo (Toledo)
Buñuel (Navarra)
Aranjuez (Madrid)


3. Size of the site (m2):
The total surface occupied by MON 88017 x MON 810 maize will be lower than:
Toral de los Guzmanes (León): 1.500 m2
Fuentes de Ropel (Zamora): 1.500 m2
Amudévar (Huesca): 1.500 m2
Grañén (Huesca): 1.500 m2
Torres de Berrellén (Zaragoza): 1.500 m2
Malpica de Tajo (Toledo): 1.500 m2
Buñuel (Navarra): 1.500 m2
Aranjuez (Madrid): 1.500 m2


4. Relevant data regarding previous releases carried out with the same GM-plant, if any, specifically related to the potential environmental and human health impacts from the release:
General surveillance from environments outside the E.U. has shown that MON 88017 x MON 810 and single-trait lines, MON 88017 and MON 810, are unlikely to pose any risk of adverse effects to human or animal health or to the environment.
The two insect-protection traits and the glyphosate tolerance trait present in MON 88017 x MON 810 are already present in three commercial products, MON 863, MON 810 and NK603, respectively, which have a safety commercial experience.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Analysis of the characteristics of MON 88017 x MON 810 maize, especially in comparison with extensive experience with cultivation of conventional maize within the E.U., has shown that the risk for potential adverse effects on human and animal health and the receiving environment, resulting from the planned field trials with MON 88017 x MON 810 maize, is negligible:
• The risk of the introduced traits in MON 88017 x MON 810 maize to be the cause of any meaningful competitive advantage or disadvantage in natural environments is negligible. As for any other maize, the likelihood of this maize to spread into non-agronomic environments is negligible, as its persistence in agricultural habitats and its invasiveness into natural habitats are unaltered compared to conventional maize.
• As for parental MON 88017 and MON 810, MON 88017 x MON 810 poses negligible risk for adverse environmental effects through its interaction with target organisms. The ecological interactions of MON 88017 × MON 810 with non-target organisms or soil processes are not different from conventional maize. Potential exposure of non-target organisms to CP4 EPSPS presents no conceivable mechanism to cause adverse effects because of its properties, and due to the highly selective insecticidal activity of the Cry3Bb1 and Cry1Ab proteins on targeted Coleopteran and Lepidopteran insect pests, respectively, also these proteins pose negligible risks to non-target organisms.
• Any occupational health aspects of handling MON 88017x MON 810 maize are not different from conventional maize, and this maize was shown to be as safe and as nutritious as any other maize.
• 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 commercial production of MON 88017 x MON 810 maize will positively impact current agronomic practices in maize and provide benefits to farmers and the environment.
Maize can hybridize with teosinte but these plants are not present in Europe. Measures will be taken to avoid hybridization with other maize plants and seed dissemination at harvest and during transportation (see E.)


Brief description of any measures taken for the management of risks:
In addition to the scheduled observations of phenotypic and agronomic parameters that form the basis of the planned research, 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 the MON 88017 x MON 810 crop and that of its receiving environment. In case any adverse environmental effects, linked to the deliberate release of MON 88017 x MON 810, are observed during the period of release, these will be reported immediately to the Competent Authority.
The spatial isolation distance (200 m) from other maize crops, or the separation of at least one month in flowering times, and the four 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.
After completion of harvest, the stalks will be chopped and then incorporated into the soil. Any shattered seed will be allowed to germinate. The resulting seedlings will be destroyed by soil incorporation. Maize cobs will be harvested by experimental-plot combine, or by hand.
Although regrowth in the rotation crops is unlikely because of poor winter survival, the site will be sown either with a crop different from maize or with experimental maize that will be destroyed and not used in any commercial, industrial or food application. Volunteer plants will be controlled by mechanical destruction or other non-selective herbicides.
Seeds will be transported in sealed and labelled bags.
At the end of the field-testing campaign, a report of will be made available by the notifier to the Competent Authority. This report will detail any unexpected adverse environmental effects that were observed during the general surveillance, if any, and further actions elicited as an effect of these findings, if applicable.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Not applicable.
However, any unanticipated adverse effects on human health or the environment would be reported immediately to the Competent Authority.


Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
23/03/2006 00:00:00
Remarks:
There are several Autonomous Communities as competent authorities for give the consent of these field trials:

- Castilla-La Mancha: 23/03/2006.
- Navarra: 04/04/2006.
- Aragón: 18/04/2006.
- Castilla y León: 16/05/2006.
- Madrid: 25/05/2006.