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Notification report


General information

Notification Number
B/HU/09/12/07/02


This notification has been withdrawn by the notifier
30/03/2010


Member State to which the notification was sent
Hungary

Date of acknowledgement from the Member State Competent Authority
07/12/2009

Title of the Project
Notification for the deliberate release of genetically modified 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)
Szent István University, Gödöllő;


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.

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.


6. Brief description of the method used for the genetic modification:
98140 maize was genetically modified using the Agrobacterium-mediated transformation method.

Experimental Release

1. Purpose of the release:
The purpose of the release is to evaluate the impact of the cultivation of 98140 maize on key non-target arthropod populations under Hungarian conditions.

2. Geographical location of the site:
The release is planned at Sóskút, plot number 0106 in Pest county, in Hungary.

3. Size of the site (m2):
There will be one site of release. The dissemination of genetically modified 98140 maize will cover up to 10 000 m2 at the site of release. This dissemination will be included in a field trial that will also contain non-genetically modified maize and other genetically modified maize described in other submitted applications.

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:
Pioneer began testing DP-Ø9814Ø maize, hereafter referred to as 98140 maize, in 2005. Since that date, many field trials have already been conducted throughout the maize growing region of the United States of America. Several field trials have also been carried out in Chile and Argentina since 2005, as well as in Canada since 2006. The 98140 maize has been in continuous nurseries (3 plantings per year) in Hawaii and Puerto Rico since 2005. Field trials have also been carried out in the European Union since 2007. According to the notifier, the transgenic plants appeared normal in all respects. They were indistinguishable from the non-genetically modified maize plants except for being tolerant to glyphosate and ALS-inhibiting herbicides such as sulfonylureas, traits due to the genetic modification.

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 98140 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:
Pollen flow from the genetically modified plants will be controlled by an isolation distance to non-experimental maize crop. In addition, the trial site will be surrounded by border rows of commercial maize of a similar maturity that will be also destroyed at the end of the release. All remaining plant matter that has not been harvested for analysis will be destroyed by chopping and incorporating into the soil.

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 maize in comparison with other maize on key non-target arthropod populations under Hungarian conditions.

Final report
-

European Commission administrative information

Consent given by the Member State Competent Authority:
No
01/01/1900 00:00:00
Remarks:
According to the request of the applicant in order to withdraw the original application, the competent authority terminated the procedure on 30/03/2010.