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Notification report


General information

Notification Number
B/FR/05/04/01

Member State to which the notification was sent
France

Date of acknowledgement from the Member State Competent Authority
11/03/2005

Title of the Project
Five year field trials programme (2005-2009) for development of genetically modified maize MON 88017 protected against Corn Root Worm (Diabrotica virgifera) and tolerant to glyphosate

Proposed period of release:
01/04/2005 to 31/12/2009

Name of the Institute(s) or Company(ies)
Monsanto Agriculture France S.A.S, ;


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

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 maysmays

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
MON 88017 that will be tested in these field trials is protected to certain Coleopteran insects, such as Corn Root Worm (Diabrotica virgifera) and is tolerant to glyphosate herbicide.

Genetic modification

3. Type of genetic modification:
Insertion;

In case of insertion of genetic material, give the source and intended function of each constituent fragment of the region to be inserted:
MON 88017 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.


6. Brief description of the method used for the genetic modification:
MON 88017 was produced by Agrobacterium-mediated transformation of immature embryos of maize tissue.

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 dissemination are:

1. to test the performance of weed control programmes with different rates/stages of glyphosate ;
2. to evaluate the agronomic performance (yield) of maize when sprayed with rates/stages of application of glyphosate and when planted in areas infested by targeted pests,
3. to produce vegetative plant material and grain in order to perform analyses of different parameters of the transformed maize ,
4. to conduct small demonstrative platforms,
5. to follow seeds selection trials and seed production for research,
6. to check equivalence to non-GM maize on agronomic parameters,
7. to check agronomic performances and compliance to DUS tests in order to get modified varieties registered,
8. to store, handle, process transgenic seeds in our seed plant.


2. Geographical location of the site:
The releases are planned at several locations in 2005 in Midi-Pyrénées

3. Size of the site (m2):
Each site will have a maximum of 5 000 m² sown with MON 88017 concerned by this application, the total area covered by the trial will be higher.

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:
Many field trials have already been conducted at several locations across maize growing regions in North and South Americas. No environmental problems were reported for these trials. Except for its protection against certain coleopteran insects and its tolerance to glyphosate herbicide, MON 88017 could not be distinguished from the non-genetically modified maize.

Insect-protection and glyphosate tolerance traits present in MON 88017 are already present in two commercial products, MON 863 and NK603, respectively.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Several generations of MON 88017 have been tested previously in different environments in North and South America. These experiments have demonstrated that the traits are inherited and the plants resemble the recipient plant in all respect differing only in its ability to be protected against Corn Root Worm and to be tolerant to glyphosate. Measures will be taken to avoid seed dissemination at harvest and during transportation (see E.). Maize can hybridize with teosinte (Zea mays ssp. Mexicana) but these plants are not present in Europe. The possibility of hybridization with other maize plants will be minimised by a spatial isolation distance of 200 meters form other cultivated maize. Some trials (efficacy especially) could be carried out without isolation. In this case, the trials will be destroyed before the flowering stage of the crop. Four rows of non transgenic maize (commercial hybrid) will surround all the trials and act as pollen trap.
All plant material that is not needed for the continuation of the programme will be destroyed and will not be used as food or fodder.


Brief description of any measures taken for the management of risks:
1. 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  MON 810 crop and that of its receiving environment.In case any adverse environmental effects, linked to the deliberate release of MON 88017, are observed during the period of release, these will be reported immediately to the Competent Authority.

2. The spatial isolation distance (200 m) from other maize crops and the four rows of non transgenic maize surrounding the trials will prevent most of the possibility of hybridisation with other maize plants. Some trials (efficacy especially) could be carried out without isolation. In this case, the trials will be destroyed before the flowering stage of the crop.

3. The equipment, especially the experimental drill and combine, will be cleaned on the experimental site, thus preventing seed dissemination.

4. 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.

5. Although regrouwth 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 the use of routinely used commercial antimonocotyledonous herbicides in this crop.

6. Seeds will be transported in sealed and labelled bags placed in a rigid container.


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
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European Commission administrative information

Consent given by the Member State Competent Authority:
Not known