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Notification report


General information

Notification Number
B/DE/06/179

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
15/10/2007

Title of the Project
Application for the deliberate release of genetically modified DAS-59122-7xDAS-Ø15Ø7-1xMON-ØØ6Ø3-6 (59122x1507xNK603) maize (4-year program).

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

Name of the Institute(s) or Company(ies)
Pioneer Hi-Bred Northern Europe Sales Division GmbH, ;


3. Is the same GMPt release planned elsewhere in the Community?
Yes:
Netherlands;

Has the same GMPt been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):
B/NL/06/06;

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
maizepoaceaezeazea maysmays

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
The genetically modified 59122x1507xNK603 maize varieties that will be tested in these field trials are resistant to certain Coleopteran insects, such as Western corn rootworm (Diabrotica virgifera virgifera), and certain Lepidopteran insects, such as European corn borer (Ostrinia nubilalis), and tolerant to glufosinate-ammonium and glyphosate herbicides. This maize was derived through traditional breeding methods between progeny of the genetically modified 59122 maize, 1507 maize and NK603 maize (from Monsanto).

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 59122x1507xNK603 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, like in 59122 maize, 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 cp4epsps gene from Agrobacterium sp. strain CP4 that confers tolerance to glyphosate herbicide, like in NK603 maize, 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.
- the cry1F gene, the UBIZM1(2) promoter, the ORF25PolyA terminator.
- the pat gene, the CaMV35S promoter, the CaMV35S terminator.
- the cp4epsps gene, the P-ract1/ract1 intron + ctp2, the nos transcript termination sequence.
- the cp4epsps gene, the CaMV e35S promoter + Zmhsp70 + ctp2, the nos transcript termination sequence.


6. Brief description of the method used for the genetic modification:
No genetic modification was made on the 59122x1507xNK603 maize varieties directly: they were derived through traditional breeding methods between progeny of the genetically modified 59122, 1507 and NK603 maize.
59122 maize was genetically modified using Agrobacterium transformation method. 1507 maize was genetically modified using a particle acceleration method. NK603 maize was genetically modified by Monsanto using a 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 evaluate the agronomic performances, the physiological behavior and the morphological aspects of 59122x1507xNK603 maize varieties, with and without glyphosate.

2. Geographical location of the site:
The release is planned at the following locations in Germany in 2007:
1. 01561 Zabeltitz / Uebigau
2. 01561 Zabeltitz / Krauschütz
3. 03149 Forst / Naundorf
4. 15320 Neutrebbin
5. 14641 Nauen / Ribbeck
6. 14641 Nauen / Bergerdamm


3. Size of the site (m2):
Each site could have up to 5000 m² sown with the genetically modified maize subject of this notification (59122x1507xNK603 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:
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 Coleopteran insects, such as Western corn rootworm, and certain Lepidopteran insects such as European corn borer and showing tolerance when glufosinate and glyphosate herbicides were applied, traits due to the genetic modifications.
59122x1507xNK603 maize is no more regulated in the USA since 2005, in Japan since 2006, and is widely cultivated since that dates. No adverse effects have been reported.


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 certain Coleopteran and Lepidopteran insects and tolerant to glufosinate and glyphosate herbicides 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 to any non-experimental maize crop. In addition, the trial site will be surrounded by four border rows of conventional maize of a similar 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 by incorporation into the soil.
In case of any emergency, the trial could be stopped by mechanical destruction, or by application of a non-selective herbicide, other than glufosinate and glyphosate, 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 deep ploughing. No plant or plant product coming from the trials will enter the food or feed chains.
After the release, the plot 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.
There will be no commercial maize grown on the same area of the field 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
20/04/2007 00:00:00
Remarks: