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Notification report


General information

Notification Number
B/HU/09/12/07/01

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 DAS-Ø15Ø7-1 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:
A new gene was introduced into the genetically modified DAS-Ø15Ø7-1 maize (referred to as 1507 maize) so that it can fight against the damages caused by certain Lepidopteran insect pests, such as European Corn Borer (Ostrinia nubilalis), Fall Armyworm (Spodoptera frugiperda), Corn Earworm (Helicoverpa zea) and Black Cutworm (Agrostis ipsilon). Tolerance to glufosinate-ammonium herbicide has been introduced as a selectable marker for the screening process.

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 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.


6. Brief description of the method used for the genetic modification:
The genetic modification has been done by the particle acceleration method using a "gene gun" to introduce, into maize cells, a linear DNA fragment containing the two genes along with their regulatory components necessary for expression.

Experimental Release

1. Purpose of the release:
The purpose of the release is to evaluate the impact of the cultivation of 1507 maize in comparison with other 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 1507 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 in the fields the genetically modified 1507 maize in late 1996. Many field trials with 1507 maize have been carried out in Europe since 1999. 1507 maize has been aprroved for commercial cultivation in the USA in 2001, in Canada and Japan in 2002, in Argentina in 2005, in Brazil in 2008 and is widely cultivated. Pioneer reported no environmental or health problems.

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 1507 maize resistant to certain Lepidopteran insects and tolerant to glufosinate herbicide 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 1507 maize in comparison with other maize on key non-target arthropod populations under Hungarian conditions.

Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Not known