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Notification report


General information

Notification Number
B/DE/10/208

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
21/10/2009

Title of the Project
Notification for the deliberate release of genetically modified DP-Ø9814Ø-6xDAS-Ø15Ø7-1xDAS-59122-7, DP-Ø9814Ø-6xDAS-Ø15Ø7-1, DP-Ø9814Ø-6xDAS-59122-7, DAS-Ø15Ø7-1xDAS-59122-7 maize and the parental lines DAS-Ø15Ø7-1, DAS-59122-7, DP-Ø9814Ø-6 maize (Five-year program).

Proposed period of release:
01/04/2010 to 31/12/2014

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?
No

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

If yes, notification number(s):
B/CZ/08/01; B/DE/07/190; B/NL/07/09;

Other notifications
98140 maize: B/DE/07/190; B/NL/07/09; B/CZ/08/01

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:
This deliberate release program concerns the genetically modified maize DP-Ø9814Ø-6xDAS-Ø15Ø7-1xDAS-59122-7 (referred to as 98140x1507x59122), DP-Ø9814Ø-6xDAS-Ø15Ø7-1 (referred to as 98140x1507), DP-Ø9814Ø-6xDAS-59122-7 (referred to as 98140x59122), DAS-Ø15Ø7-1xDAS-59122-7 (referred to as 1507x59122), and the parental maize lines DAS-Ø15Ø7-1 (referred to as 1507), DAS-59122-7 (referred to as 59122), DP-Ø9814Ø-6 maize (referred to as 98140). 98140x1507x59122, 98140x1507, 98140x59122 and 1507x59122 maize have been obtained from traditional breeding methods between progeny of the genetically modified 98140 maize, and/or 1507 maize, and/or 59122 maize.

98140 maize is tolerant to glyphosate and a range of acetolactate synthase (ALS)-inhibiting herbicides such as sulfonylureas.
1507 maize is resistant to certain lepidopteran insect pests, such as European corn borer (Ostrinia nubilalis), and tolerant to glufosinate herbicide (trait introduced as a selectable marker).
59122 maize is resistant to certain coleopteran insect pests, such as Western corn rootworm (Diabrotica virgifera virgifera), and tolerant to glufosinate herbicide (trait introduced as a selectable marker).
98140x1507x59122 maize is tolerant to glyphosate and a range of ALS-inhibiting herbicides such as sulfonylureas, resistant against certain lepidopteran and certain coleopteran insect pests, and tolerant to glufosinate-ammonium herbicide (trait only used as a selectable marker).
98140x1507 maize is tolerant to glyphosate and a range of ALS-inhibiting herbicides such as sulfonylureas, resistant against certain lepidopteran insect pests, and tolerant to glufosinate-ammonium herbicide (trait only used as a selectable marker). 98140x59122 maize is tolerant to glyphosate and a range of ALS-inhibiting herbicides such as sulfonylureas, resistant against certain coleopteran insect pests, and tolerant to glufosinate-ammonium herbicide (trait only used as a selectable marker). 1507x59122 maize is resistant against certain lepidopteran and certain coleopteran insect pests, and tolerant to glufosinate-ammonium herbicide (trait only used 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:
• 98140 maize has been genetically modified by the insertion of the gat4621 gene, an optimized form of the gat gene from the soil bacterium Bacillus licheniformis, which confers tolerance to herbicides containing glyphosate, and the zm-hra gene, an optimized form of the endogenous als gene from Zea mays, which confers tolerance to a range of ALS-inhibiting herbicides such as sulfonylureas, along with the regulatory components necessary to drive their expression:
- The gat4621 gene, the ubiZm1 promoter, ubiZM1 5’UTR, the ubiZM1 intron, the pinII terminator.
- CaMV 35S enhancers
- The zm-hra gene, the zm-als promoter, the pinII terminator.
• 1507 maize has been genetically modified by the introduction of a plant-optimized cry1F gene from Bacillus thuringiensis var. aizawai, providing resistance to certain Lepidopteran insects and a plant-optimized pat gene from Streptomyces viridochromogenes, introduced as a selectable marker, providing tolerance to glufosinate-ammonium herbicide, along with the regulatory components necessary to drive their expression:
- The cry1F gene, the UBIZM1(2) promoter, the ORF25PolyA terminator.
- The pat gene, the CaMV35S promoter, the CaMV35S terminator.
• 59122 maize has been genetically modified by the introduction of maize-optimized cry34Ab1 and cry35Ab1 genes from Bacillus thuringiensis strain PS149B1, providing resistance to certain Coleopteran insects and a plant-optimized pat gene from Streptomyces viridochromogenes, introduced as a selectable marker, providing tolerance to glufosinate herbicide, along with the regulatory components necessary to drive their expression:
- 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 98140x1507, 98140x59122, 98140x1507x59122 and 1507x59122 maize have been obtained by traditional breeding methods from progeny of the genetically modified 98140 and/or 1507 and/or 59122 maize, and contain the genetic elements introduced in these corresponding maize.


6. Brief description of the method used for the genetic modification:
1507 maize was genetically modified using a particle acceleration method. 59122 maize and 98140 maize were genetically modified using Agrobacterium transformation method.
The 98140x1507, 98140x59122, 98140x1507x59122 and 1507x59122 maize have been obtained from traditional breeding methods between progeny of the genetically modified 98140 maize and/or 1507 maize and/or 59122 maize. No genetic modification other than those of these maize has been introduced in 98140x1507, 98140x59122, 98140x1507x59122 and 1507x59122 maize.


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 refine knowledge concerning the behavior in the environment and the agronomic performances of 98140x1507x59122, 98140x1507, 98140x59122, 1507x59122, 1507, 59122 and 98140 maize varieties, with and without applications of herbicides.

2. Geographical location of the site:
The release is planned at the following locations in Germany in 2010:
Land PLZ Ort/Ortsteil Gemarkung Flur Flurstück
Sachsen 01561 Zabeltitz Uebigau - 121
Sachsen-Anhalt 39393 Üplingen Ausleben 3 244
Bayern 97318 Kitzingen/Hohenfeld Hohenfeld - 224,225


3. Size of the site (m2):
The maximum area of release per site will be 5 ha in 2010 and 7 ha in the following years. At the site Kitzingen the size will be 1,5 ha in 2010 and 2,5 ha in the following years. The maximum area per event will be 2 ha at each site of release, every year.

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 experiments with 1507, 59122, 98140, 98140x1507, 98140x59122, 98140x1507x59122 and 1507x59122 maize have already been carried out throughout the maize growing regions of North America, South America and the European Union. No environmental problems were reported to date for these trials.
The 1507, 59122, 98140, 98140x1507, 98140x59122, 98140x1507x59122 and 1507x59122 maize plants performed as expected, with no evidence of any unintentional morphological or phenotypical characteristics. In particular, there was no evidence of enhanced weediness of the genetically modified maize. They were indistinguishable from the non-genetically modified maize plants except for being resistant against target insects and tolerant to herbicides, traits due to the genetic modifications.
Moreover, 1507 maize has been approved for commercial cultivation in the USA in 2001, Canada and Japan in 2002, Argentina in 2005, Brazil in 2008. 59122 maize has been approved for commercial cultivation in the USA and Canada in 2005, Japan in 2006. 1507x59122 maize is no more regulated in the USA and Canada since 2005, in Japan since 2006. These maize are widely cultivated and no adverse effects have been reported to our knowledge.


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 are expected from the deliberate release of 98140x1507x59122, 98140x1507, 98140x59122, 1507x59122, 1507, 59122 and 98140 maize resistant to certain Coleopteran and/or Lepidopteran insects and/or tolerant to herbicides, 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 sites will be surrounded by four agronomic border rows of conventional maize of a similar maturity that will be also destroyed at the end of the release.
Grains are fixed on a cob and enclosed in many husks that protect the seeds from outside contact. Thus seed dispersal of individual kernels is not likely to occur. 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. Alternatively, unused seeds may be disposed of by use in energy generation facility.
If needed, the trial could be stopped by mechanical destruction, or by application of a herbicide other than glyphosate, ALS-inhibiting herbicides and glufosinate, and incorporation into the soil by a deep ploughing, or disposed of by use in energy generation facilities.
At the end of the release, all remaining plant matter that has not been harvested for analyses will be destroyed by chopping and incorporation into the soil by a deep ploughing. Alternatively, it will be chopped and removed for use in energy generation facilities and disposed of in that way.
No plant or plant product coming from the trials will enter the food or feed chains.
Although volunteer maize cannot generally survive hard winter, the plot will be visited regularly during the year following the end of the release in order to monitor maize volunteers and if any, ensure their destruction prior to flowering.
In addition, no commercial maize crop will be 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:
In the frame of the multiyear trialing program, trials are planed to evaluate the impact of the cultivation of some of these maize on key non-target arthropod populations.

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Not known