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Notification report


General information

Notification Number
B/FR/06/01/09

Member State to which the notification was sent
France

Date of acknowledgement from the Member State Competent Authority
12/12/2005

Title of the Project
Application for the deliberate release of genetically modified 1507x59122 (DAS-Ø15Ø7-1xDAS-59122-7) 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 1507x59122 maize varieties that will be tested in these field trials are resistant to certain Lepidopteran insects, such as European corn borer (Ostrinia nubilalis) and to certain Coleopteran insects, such as Western corn rootworm (Diabrotica virgifera virgifera), and tolerant to glufosinate-ammonium herbicide. This maize was derived through traditional breeding methods between progeny of the genetically modified 1507 maize and 59122 maize.

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 1507x59122 maize are the cry1F gene from Bacillus thuringiensis var. aizawai, providing resistance to certain Lepidopteran insects and the pat gene from Streptomyces viridochromogenes, introduced as a selectable marker, providing tolerance to glufosinate-ammonium herbicide, like in 1507 maize, and the cry34Ab1 and cry35Ab1 genes from Bacillus thuringiensis strain PS149B1, providing resistance to certain Coleopteran insects and the pat gene from Streptomyces viridochromogenes, introduced as a selectable marker, providing tolerance to glufosinate herbicide, like 59122 maize, along with their regulatory components necessary for expression in maize plant:
- the cry1F gene, the UBIZM1(2) promoter, the ORF25PolyA terminator.
- the pat gene, the CaMV35S promoter, the CaMV35S terminator.
- the cry34Ab1 gene, the UBIZM1(2) promoter, the PINII terminator.
- the cry35Ab1 gene, the Peroxidase promoter, the PINII terminator.
- the pat gene, the CaMV35S promoter, the CaMV35S terminator.


6. Brief description of the method used for the genetic modification:
No genetic modification was made on the 1507x59122 maize varieties directly: they were derived through traditional breeding methods between progeny of the genetically modified 1507 and 59122 maize.
1507 maize was genetically modified using a particle acceleration method. 59122 maize was genetically modified using Agrobacterium transformation 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 additional data on 1507x59122 maize. Studies will be carried out to observe the plant behavior and the expression of the genes introduced.

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 1507x59122 maize subject of this notification. Other genetically modified maize 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 across maize growing regions in North America, South America and Europe and no environmental problems were reported for these trials. The transgenic plants were indistinguishable from the non-genetically modified maize plants except for showing resistance to certain Lepidopteran insects such as European corn borer and certain Coleopteran insects, such as Western corn rootworm, and showing tolerance when glufosinate and glyphosate herbicides were applied, 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 1507x59122 maize, resistant to Lepidopteran and certain Coleopteran insects and tolerant to glufosinate herbicide, are expected, as per information contained in the environmental risk assessment included in the notification.

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 site 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 glufosinate, 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
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European Commission administrative information

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