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Notification report


General information

Notification Number
B/FR/06/12/03

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;
MON-ØØ6Ø3-6 ;
DAS-Ø15Ø7-1xMON-ØØ6Ø3-6 ;
DAS-Ø15Ø7-1xDAS-59122-7;
DAS-59122-7xDAS-Ø15Ø7-1xMON-ØØ6Ø3-6;
MON-ØØ6Ø3-6xMON-ØØ81Ø-6


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 four genetically modified maize, DAS-Ø15Ø7-1 (referred to as 1507 maize), DAS-59122-7 (referred to as 59122 maize), MON-ØØ6Ø3-6 (referred to as NK603 maize), MON-ØØ81Ø-6 (referred to as MON810 maize) (whose cultivation has been approved in Europe in 1998), as well as combinations of these maize obtained through traditional breeding methods, maize DAS-Ø15Ø7-1xMON-ØØ6Ø3-6 (referred to as 1507xNK603 maize), DAS-Ø15Ø7-1xDAS-59122-7 (referred to as 1507x59122 maize), DAS-59122-7xDAS-Ø15Ø7-1xMON-ØØ6Ø3-6 (referred to as 59122x1507xNK603), MON-ØØ6Ø3-6xMON-ØØ81Ø-6 (referred to as NK603xMON810 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/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.
· NK603 maize, from Monsanto, has been genetically modified by the introduction of the cp4epsps gene, from Agrobacterium sp. strain CP4, that confers tolerance to glyphosate herbicide, 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 CaMV e35S promoter + Zmhsp70 + ctp2, the NOS 3’ terminator.
· MON810 maize, from Monsanto (whose cultivation has been authorized in Europe by Commission decision 98/294/EC), has been genetically modified by the introduction of the cry1Ab gene from Bacillus thuringiensis subsp. kurstaki that confers resistance to certain Lepidopteran insects such as Ostrinia nubilalis, along with the regulatory components necessary for expression in maize plant:
- The cry1Ab gene, the e35S promoter + Zmhsp70
· The maize 1507xNK603, 1507x59122, 59122x1507xNK603, NK603xMON810 have been obtained with traditional breeding methods from progeny of the individual genetically modified maize and contains the genetic elements introduced in these maize.


6. Brief description of the method used for the genetic modification:
1507 maize was genetically modified using a particle acceleration method.
Both NK603 maize and MON maize were genetically modified by Monsanto using a particle acceleration method.
59122 maize was genetically modified using Agrobacterium transformation method.
No genetic modification was made on 1507xNK603, 1507x59122, 59122x1507xNK603, NK603xMON810 maize directly: they were derived through traditional breeding methods from progeny of the genetically modified maize, 1507, 59122, NK603, MON810.


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, to observe the plant behavior, as well as the glyphosate herbicide application effects.

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 3000 m² of each genetically modified maize subject of the current 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:
Many field trials have already been conducted at several locations across maize growing regions in North America, as well as South America and Europe, 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 and/or glufosinate were applied).
Moreover 1507, 59122, NK603 and MON810 maize are no more regulated in the USA since 2001, 2005, 2000 and 1996, respectively and are thus widely commercialized in the USA, as well as the combinations 1507xNK603, 1507x59122, 59122x1507x.NK603, NK603xMON810.


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, NK603, 1507xNK603, 1507x59122, 59122x1507xNK603, NK603xMON810 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 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. 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 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
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European Commission administrative information

Consent given by the Member State Competent Authority:
Not known