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Notification report


General information

Notification Number
B/FR/04/06/01-CON

Member State to which the notification was sent
France

Date of acknowledgement from the Member State Competent Authority
01/06/2004

Title of the Project
Testing of genetically modified maize resistant to certain Lepidopteran insects and tolerant to two herbicides.

Proposed period of release:
01/06/2004 to 31/12/2006

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


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 hybrids

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
The tested maize hybrids have been obtained by crossing 2 genetically modified inbreds : one inbred had an insert providing resistance to Lepidopteran insects and tolerance to glufosinate-ammonium (confidential information is provided in Annex 1) and the other inbred is carrying an insert for tolerance to glyphosate herbicide (confidential information is provided in Annex 1).

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 list of the genetic elements inserted in the parental lines is provided in Annex 1 (all are Confidential Business Information).

6. Brief description of the method used for the genetic modification:
No genetic modification was made on the tested hybrids: they were obtained by traditional crossing of two genetically modified parental lines. Each parental line was genetically modified using a particle acceleration method, using a "gene gun".

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 goal of the release is to evaluate the efficacy of different herbicides commercially used in rotational crops, to control genetically-modified maize plants tolerant to two herbicides and resistant to Lepidopteran insects that may occur as volunteers, in comparison with their efficacy on non genetically-modified maize checks.

2. Geographical location of the site:
The releases are planned at two locations in France in 2004, in Tarn et Garonne (Midi-Pyrénées).

3. Size of the site (m2):
In 2004, the trial planted at each site to simulate maize volunteers that may occur in a spring rotational crop will cover about 600m² (all varieties and borders included) of which 60m² will be planted with the transgenic plants concerned by this application; the trial planted at each site to simulate maize volunteers that may occur in a fall rotational crop will cover about 500m² (all varieties and borders included) of which 40m² will be planted with the transgenic plants concerned by this application.

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:
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 hybrids. They were indistinguishable from the non-genetically modified maize plants except for showing tolerance when the herbicides (glufosinate and glyphosate) have been applied as well as showing resistance to Lepidopteran insects such as European Corn Borer.

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 maize resistant to Lepidopteran insects and tolerant to glufosinate and glyphosate have been reported. This is based on the environmental risk assessment included in the notification.

Brief description of any measures taken for the management of risks:
If some genetically modified maize plants are able to develop until flowering, despite the herbicide treatments, the shedding of pollen from these genetically modified plants will be controlled by bagging the tassels before any pollen shed can occur. The bags will be maintained during all flowering time and discarded with the plants.
In any case, the trial will stopped before grain production.
In case of any emergency, the trial could be destroyed by mechanical destruction and incorporation into the soil.
At the end of the release, all remaining plant matter will be destroyed by chopping and incorporating into the soil.
Volunteer maize will be monitored during the following year, in order to ensure their destruction, if needed.


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

Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Not known