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Notification report


General information

Notification Number
B/SK/08/01

Member State to which the notification was sent
Slovakia

Date of acknowledgement from the Member State Competent Authority
07/01/2008

Title of the Project
Monitoring of Key Non-Target Arthropods in Transgenic Maize Lines Containing Events DP-Ø9814Ø-6, DP-Ø9814Ø-6 × DAS-Ø15Ø7-1, and DP-Ø9814Ø-6 × DAS-Ø15Ø7-1 × DAS-59122-7

Proposed period of release:
15/04/2008 to 31/12/2011

Name of the Institute(s) or Company(ies)
Slovak Center of Agricultural Research, Research Institute of Plant Production;


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:
DP-Ø9814Ø-6 maize, referred to as 98140 maize hereafter, has been genetically modified so that it can tolerate application of herbicides containing glyphosate and a range of ALS-inhibiting herbicides such as sulfonylureas for the weeding of the maize crop.
DP-Ø9814Ø-6xDAS-Ø15Ø7-1 maize, referred to as 98140x1507 maize hereafter, is tolerant to herbicides containing glyphosate and a range of acetolactate synthase (ALS)-inhibiting herbicides such as sulfonylureas, resistant against certain lepidopteran insect pests, such as European corn borer (Ostrinia nubilalis), and tolerant to glufosinate-ammonium (trait introduced as a selectable marker). 98140x1507 maize has been obtained from traditional breeding methods between progeny of genetically modified 98140 maize and 1507 maize. No genetic modification other than those of these maize has been introduced in 98140x1507 maize.
DP-Ø9814Ø-6xDAS-Ø15Ø7-1xDAS-59122-7 maize, referred to as 98140x1507x59122 maize hereafter, is tolerant to herbicides containing glyphosate and a range of acetolactate synthase (ALS)-inhibiting herbicides such as sulfonylureas, resistant against certain lepidopteran insect pests, such as European corn borer (Ostrinia nubilalis), and certain coleopteran insect pests, such as Western corn rootworm (Diabrotica virgifera virgifera), and tolerant to glufosinate-ammonium (trait introduced as a selectable marker). 98140x1507x59122 maize has been obtained from traditional breeding methods between progeny of genetically modified 98140 maize, 1507 maize and 59122 maize. No new genetic modification has been introduced in 98140x1507x59122 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:
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.
- 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.
The 98140x1507 maize, obtained from traditional breeding methods between progeny of genetically modified 98140 and 1507 maize, contains the genetic elements introduced in 98140 maize and 1507 maize:
- the gat4621 gene derived from the soil bacterium Bacillus licheniformis, which confers tolerance to herbicides containing glyphosate, and the zm-hra gene, a modified maize acetolactate synthase gene which confers tolerance to a range of acetolactate synthase inhibiting herbicides, from 98140 maize,
- the cry1F gene from the soil bacterium Bacillus thuringiensis var. aizawai, providing resistance against certain Lepidopteran insects and the pat gene from the soil bacterium Streptomyces viridochromogenes, introduced as a selectable marker, providing tolerance to glufosinate-ammonium, from 1507 maize,
along with the necessary regulatory elements for gene expression in the maize plant. Thus:
- the gat4621 gene
- the zm-hra gene
- the cry1F gene, the UBIZM1(2) promoter, the ORF25PolyA terminator
- the pat gene, the CaMV35S promoter, the CaMV35S terminator
The 98140x1507x59122 maize, obtained from traditional breeding methods between progeny of genetically modified maize 98140, 1507 and 59122 maize, contains the genetic elements introduced in 98140 maize, 1507 maize and 59122 maize:
- the gat4621 gene derived from the soil bacterium Bacillus licheniformis, which confers tolerance to herbicides containing glyphosate, and the zm-hra gene, a modified maize acetolactate synthase gene which confers tolerance to a range of acetolactate synthase inhibiting herbicides, from 98140 maize,
- the cry1F gene from the soil bacterium Bacillus thuringiensis var. aizawai, providing resistance against certain Lepidopteran insects and the pat gene from the soil bacterium Streptomyces viridochromogenes, introduced as a selectable marker, providing tolerance to glufosinate-ammonium, from 1507 maize,
- the cry34Ab1 and cry35Ab1 genes from the soil bacterium Bacillus thuringiensis strain PS149B1, providing resistance against certain Coleopteran insects and the pat gene from the soil bacterium Streptomyces viridochromogenes, introduced as a selectable marker, providing tolerance to glufosinate-ammonium, from 59122 maize;
along with the necessary regulatory elements for gene expression in the maize plant. Thus:
- the gat4621 gene
- the zm-hra gene
- 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:
98140 maize was genetically modified using the Agrobacterium-mediated transformation method.
No genetic modification was made on 98140x1507 maize directly: it was obtained from traditional breeding methods between progeny of the genetically modified 98140 and 1507 maize. 98140 maize was genetically modified using Agrobacterium-mediated transformation method. 1507 maize was genetically modified using a particle acceleration method.
No genetic modification was made on 98140x1507x59122 maize directly: it was obtained from traditional breeding methods between progeny of the genetically modified 98140, 1507 and 59122 maize. 98140 maize and 59122 maize were genetically modified using Agrobacterium-mediated transformation method. 1507 maize was genetically modified 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:
organisms
The purpose of the release is to evaluate the impact of the cultivation of 98140 maize on key non-target arthropod populations in comparison with the cultivation of non-transgenic equivalent maize.
The purpose of the release is to evaluate the impact of the cultivation of 98140x1507 maize on key non-target arthropod populations in comparison with the cultivation of non-transgenic equivalent maize.
The purpose of the release is to evaluate the impact of the cultivation of 98140x1507x59122 maize on key non-target arthropod populations in comparison with the cultivation of non-transgenic equivalent maize.


2. Geographical location of the site:
Locations Borovce and Špačince (Slovak Republic)

3. Size of the site (m2):
Field trial site will have up to 100000 m2 (maximum), i.e. up to 50000 m2 (Borovce) + up to 50000 m2 (Špačince), including borders.

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 the European Union and no environmental problems were reported for these trials. The transgenic plants were 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 herbicides containing glyphosate, ALS-inhibiting herbicides such as sulfonylureas and/or glufosinate were applied).

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 98140, 98140x1507 and 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 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 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. If a few seeds need to be collected; this will be done by sampling the whole ear and unused seeds will be destroyed.
If needed, 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 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 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:
The purpose of the release is to evaluate the impact of the cultivation of 98140, 98140x1507 and 98140x1507x59122 maize on key non-target arthropod populations in comparison with the cultivation of non-transgenic equivalent maize.

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
30/04/2008 00:00:00
Remarks: