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Notification report


General information

Notification Number
B/HU/05/02/1

Member State to which the notification was sent
Hungary

Date of acknowledgement from the Member State Competent Authority
17/02/2005

Title of the Project
Field trial program of genetically modified maize varieties resistant to certain Lepidopteran insects and tolerant to two herbicides (1507xNK603 maize)

Proposed period of release:
01/04/2005 to 31/12/2008

Name of the Institute(s) or Company(ies)
Pioneer Hi-Bred Hungary Ltd., ;


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:
The genetically modified 1507xNK603 maize varieties that will be tested in these field trials are resistant to certain Lepidopteran insects, such as the European corn borer (Ostrinia nubilalis) and can tolerate the use of glufosinate-ammonium and glyphosate herbicides for the weeding of maize field. This maize was derived through traditional breeding methods between progeny of the genetically modified 1507 maize, which is resistant to certain lepidopteran insects and tolerant to glufosinate herbicide, and NK603 maize (from Monsanto), which is tolerant to glyphosate herbicide.

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:
1507xNK603 maize contains the following genetic elements:
- the cry1F gene from Bacillus thuringiensis var. aizawai that confers resistance to certain Lepidopteran insects, such as Ostrinia nubilalis,
- the pat gene from Streptomyces viridochromogenes that confers tolerance to glufosinate-ammonium herbicide
- the cp4epsps genes from Agrobacterium sp. strain CP4 that confer tolerance to glyphosate herbicide.
All these genes have been introduced with only their regulatory components necessary for expression in maize plant.


6. Brief description of the method used for the genetic modification:
No genetic modification was made on the 1507xNK603 maize varieties directly: they were derived through traditional breeding methods between progeny of the genetically modified 1507 maize and NK603 maize.
1507 maize and NK603 maize (from Monsanto) were genetically modified using the 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:
Several types of trials will be carried out, such as trials for protein expression analyses, effects on non-target organisms, herbicide residue analyses, trials for elimination of maize volunteers in rotational crops, agronomic value and insect resistance, and other trials in view of registration on the National List of Hungary.

2. Geographical location of the site:
In 2005, the location of the release sites will be as follows:

Country Fejér:
Enying, Agrár Rt. B-2 tábla
Füle, Búzakalász Mezőgazdasági Szövetkezet, F-14 tábla

Country Pest:
Sóskút, Sóskút Fruct Gyümölcstermelő Kft, hrsz. 0106


3. Size of the site (m2):
Each trial site in 2005 will have up to 8000 m2 sown with the genetically modified plants, the total surface area taken up by the trials (all varieties and borders included) being higher. There will be up to 3 sites of release in 2005. In the following years, up to 6 field trials could be sown, each with up to 10000 m2 of the genetically modified plants.

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 and no environmental problems were reported for these trials. The transgenic plants behaved as conventional maize hybrids. They were indistinguishable from the non-genetically modified maize plants except for showing resistance to Lepidopteran insects such as European Corn Borer, as well as showing tolerance when glufosinate and glyphosate herbicides have been applied, traits due to the genetic modifications.

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 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 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 will be surrounded by four border rows of conventional maize of a similar relative 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.
In case of any emergency, the trial could be stopped by application of a non-selective herbicide, other than glufosinate and glyphosate, or by mechanical destruction and incorporation into the soil.
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.
Volunteer maize will be monitored during the following year in order to ensure their destruction, if needed.
No commercial maize will be cultivated in the trial site the following year.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Trials for effects on Non-Target Organisms:
The purpose of the release is to evaluate the impact of the cultivation of insect-resistant 1507xNK603 maize hybrids on key non-target arthropod populations, in comparison with the cultivation of non-transgenic equivalent maize hybrids treated with chemical insecticide and untreated.


Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Not known