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Notification report


General information

Notification Number
B/FR/06/12/02-CON

Member State to which the notification was sent
France

Date of acknowledgement from the Member State Competent Authority
10/11/2006

Title of the Project
Application for a multiyear program for the deliberate release of genetically modified maize DAS-Ø15Ø7-1, DAS-59122-7, DP-Ø9814Ø-6, DP-Ø9814Ø-6xDAS-Ø15Ø7-1,
DP-Ø9814Ø-6xDAS-Ø15Ø7-1xDAS-59122-7


Proposed period of release:
01/04/2007 to 31/12/2010

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 varieties

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
This deliberate release program concerns three genetically modified maize, DAS-Ø15Ø7-1 (referred to as 1507 maize), DAS-59122-7 (referred to as 59122 maize), DP-Ø9814Ø-6 (referred to as 98140 maize), and combinations of these maize obtained through traditional breeding methods, maize DP-Ø9814Ø-6xDAS-Ø15Ø7-1 (referred to as 98140x1507 maize) and DP-Ø9814Ø-6xDAS-Ø15Ø7-1xDAS-59122-7 (referred to as 98140x1507x59122 maize).
The genetically modified maize subject of this deliberate release program are resistant to certain Lepidopteran insects, such as European corn borer (Ostrinia nubilalis), and/or resistant to certain Coleopteran insects, such as Western corn rootworm (Diabrotica virgifera virgifera), and/or tolerant to certain herbicides, containing glyphosate and acetolactate synthase (ALS)-inhibiting herbicides such as sulfonylureas and/or glufosinate-ammonium (tolerance to glufosinate-ammonium in Europe is used only as a selectable marker).


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 1507 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, 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 genes introduced in 59122 maize are 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, along with their regulatory components necessary for expression in maize plant:
- 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.
· 98140 maize has been genetically modified by insertion of the glyphosate-N-acetyltransferase (gat4621) gene and a modified maize acetolactate synthase (zm-hra) gene, along with the necessary regulatory elements for gene expression in the maize plant (cf confidential Annex1). The gat4621 gene encodes the GAT4621 protein, which was derived from the soil bacterium Bacillus licheniformis, and confers tolerance to herbicides containing glyphosate. The zm-hra gene encodes the ZM-HRA protein and confers tolerance to a range of ALS-inhibiting herbicides such as sulfonylureas.
· 98140x1507 maize, obtained from traditional breeding methods between progeny of 98140 and 1507 maize, contains the genetic elements introduced in the two maize: the gat4621, zm-hra, cry1F and pat genes along with the regulatory elements for gene expression.
· 98140x1507x59122 maize, obtained from traditional breeding methods between progeny of 98140, 1507 and 59122 maize contains the genetic elements introduced in the three maize: the gat4621, zm-hra, cry1F, cry34Ab1, cry35Ab1 and pat genes along with the regulatory elements for gene expression.


6. Brief description of the method used for the genetic modification:
1507 maize was genetically modified using a particle acceleration method.
Both 59122 maize and 98140 maize were genetically modified using Agrobacterium transformation method.
No genetic modification was made on 98140x1507 and 98140x1507x59122 maize directly: they were derived through traditional breeding methods from progeny of the genetically modified 98140 and 1507 maize, or 98140, 1507 and 59122 maize, respectively.


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 deliberate release program is to collect additional data on these genetically modified maize. Studies will be carried out to evaluate the expression of the introduced genes and the composition, to observe the plant behavior, as well as the herbicide application effects and the control of maize volunteers with different herbicides.

2. Geographical location of the site:
In 2007, the release is planned at the following locations in France: Fronton (31), Condom (32), Ouzouer sous Bellegarde (45), Villeneuve sur Lot (47), Mansonville (82), Valvidienne (86).

3. Size of the site (m2):
Every year, there could have up to 12 sites of release, each sown with up to 1000 m² of 1507 maize, 1000 m² of 59122 maize, 7000 m² of 98140 maize, 5000 m² of 98140x1507 maize, 5000 m² of 98140x1507x59122 maize.

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, as well as South America and Europe depending on the maize, and no environmental problems were reported for these trials. The transgenic plants are indistinguishable from the non-genetically modified maize plants except for the traits due to the genetic modifications (resistance to target Lepidopteran insects such as European corn borer, and/or resistance to target Coleopteran insects, such as Western corn rootworm, and/or tolerance when glyphosate, ALS-inhibiting herbicides such as sulfonylureas and/or glufosinate were applied).
Moreover, 1507 and 59122 maize are no more regulated in the USA since 2001 and 2005, respectively, and thus are widely commercialized in the USA.


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 proposed deliberate release of 1507, 59122, 98140, 98140x1507, 98140x1507x59122 maize 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 pollen shed from the genetically modified plants will be controlled by maintaining a 200-meter isolation distance with any other commercial maize crop. As it is done for any trial with conventional maize, the trial site will be surrounded by agronomic border rows of conventional maize of a similar maturity. The agronomic border rows 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 by incorporation into the soil.
In case of an emergency, the trial could be destructively stopped by mechanical destruction or application of a herbicide other than glyphosate, ALS-inhibiting herbicides and glufosinate-ammonium, and incorporation into the soil by a deep ploughing.
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 by a deep ploughing. No plant or plant product coming from the trials will enter the food or feed chains.
After the release, the site will be visited regularly during the following year in order to ensure removal of maize volunteers, if any. Although volunteer maize cannot generally survive hard winter, maize volunteers, if any, will be monitored in order to ensure their destruction.
No commercial maize crop will be planted on the same area 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:
Not known