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Notification report


General information

Notification Number
B/FR/06/03/01

Member State to which the notification was sent
France

Date of acknowledgement from the Member State Competent Authority
20/02/2006

Title of the Project
Application for the deliberate release of genetically modified MON-ØØ6Ø3-6xMON-ØØ81Ø-6 (NK603xMON810) maize

Proposed period of release:
01/04/2006 to 31/12/2009

Name of the Institute(s) or Company(ies)
Pioneer Genetique, Chemin de l'Enseigure
31840 Aussonne
France;


3. Is the same GMPt release planned elsewhere in the Community?
No

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 maysmaysexperimental varieties

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
The genetically modified NK603xMON810 maize varieties that will be tested in these field trials can tolerate the use of glyphosate herbicide for the weeding of maize field and are resistant to certain Lepidopteran insect pests such as the European corn borer (Ostrinia nubilalis). This maize was derived through traditional breeding methods between progeny of the genetically modified NK603 maize (from Monsanto), which is tolerant to glyphosate herbicide, and MON810 maize (from Monsanto), which is resistant to certain lepidopteran insects.

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:
The genes introduced in NK603xMON810 maize are the cp4epsps gene from Agrobacterium sp. strain CP4 that confers tolerance to glyphosate herbicide, like in NK603 maize, and the cry1Ab gene from Bacillus thuringiensis subsp. kurstaki that confers resistance to certain Lepidopteran insects such as Ostrinia nubilalis, like in MON810 maize, along with the regulatory components necessary for expression in maize plant:
- the cp4epsps gene, the P-ract1/ract1 intron + ctp2, the NOS 3’ terminator.
- the cp4epsps gene, the e35S promoter + Zmhsp70 + ctp2, the NOS 3’ terminator.
- the cry1Ab gene, the e35S promoter + Zmhsp70


6. Brief description of the method used for the genetic modification:
No genetic modification was applied to obtain the NK603xMON810 maize varieties directly: they were derived through traditional breeding methods between progeny of the genetically modified NK603 maize and MON810 maize.
NK603 maize and MON810 maize were genetically modified by Monsanto using the 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 purpose of the release is to collect data on the agronomic value and insect resistance of NK603xMON810 maize varieties and to observe the plant behavior, which could enable to collect morpho-physiological data.

2. Geographical location of the site:
The releases are planned at several locations in France within the following areas: Nord-Pas-de-Calais (Nord), Picardie (Aisne, Oise, Somme), Bourgogne (Saône et Loire), Rhône-Alpes (Ain, Isère, Drome), Centre (Eure et Loir, Loir et Cher, Indre, Indre et Loire, Loiret), Aquitaine (Landes, Lot et Garonne), Midi-Pyrénées (Haute-Garonne, Gers, Tarn, Tarn et Garonne), Languedoc-Roussillon (Aude).

3. Size of the site (m2):
Every year, there could have up to 12 sites of release, each sown with up to 5000 m² of genetically modified NK603xMON810 maize subject of this notification. Other GMOs may be planted on the same sites of release. Thus, the total trial surface for each site (all varieties and borders included) will be larger.

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 and no environmental problems were reported for these trials. The transgenic plants behaved as conventional maize. They were indistinguishable from the non-genetically modified maize plants except for showing tolerance to glyphosate herbicide and resistance to certain Lepidopteran insects such as the European Corn Borer, traits due to the genetic modifications.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
No risks to human and animal health or the environment from the deliberate release of genetically modified NK603xMON810 maize tolerant to glyphosate herbicide and resistant to certain Lepidopteran insects are expected, as per information contained in the Summary Notification Information Format of notification C/ES/04/01.

Brief description of any measures taken for the management of risks:
The shedding of pollen from the genetically modified plants will be controlled by maintaining a 200-meter isolation distance with any other non-experimental maize crop. In addition, the trial will be surrounded by four border rows of conventional maize of a similar relative maturity that will be also destroyed at the end of the release.
Seed dispersal of individual kernels does not generally occur. They are fixed on a cob and enclosed in many husks that protect the seeds from outside contact. When a few seeds need to be collected for analysis; this will be done by sampling the whole ear and unused seeds will be destroyed.
In case of any emergency, the trial could be stopped by application of a non-selective herbicide, other than glyphosate, or by mechanical destruction and incorporation into the soil.
At the end of the release, all remaining plant matter that has not been harvested for analyses will be destroyed by chopping and incorporating into the soil. No plant or plant product coming from the trials will enter the food or feed chains.
Volunteer maize will be monitored during the following year in order to ensure their destruction, if needed.
No commercial maize will be cultivated in the trial site the following year.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Not applicable to this release.

Final report
-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
19/05/2006 00:00:00
Remarks: