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Notification report


General information

Notification Number
B/HU/05/12/2

Member State to which the notification was sent
Hungary

Date of acknowledgement from the Member State Competent Authority
19/12/2005

Title of the Project
Field trial program of genetically modified corn hybrids containing resistance to certain Coleopteran and Lepidopteran insects and tolerance to two herbicides.

Proposed period of release:
01/04/2006 to 31/12/2009

Name of the Institute(s) or Company(ies)
Dow AgroSciences Hungary Kft., ;


3. Is the same GMPt release planned elsewhere in the Community?
Yes:


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

If yes, notification number(s):
B/ES/04/16-CON; B/ES/05/12-CON; B/ES/05/17; B/FR/05/03/01; B/HU/05/01/4; B/PT/05/04;

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 59122x1507xNK603 (DAS-59122-7xDAS-Ø15Ø7-1xMON-ØØ60Ø3-6) maize varieties that will be tested in these field trials are resistant to certain Coleopteran insects, such as Western corn rootworm (Diabrotica virgifera virgifera), and certain Lepidopteran insects, such as 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 59122 maize, 1507 maize and NK603 maize (from Monsanto).

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:
59122x1507xNK603 maize contains the following genetic elements:
- the cry34Ab1 and cry35Ab1 genes from Bacillus thuringiensis strain PS149B1 that confer resistance to certain Coleopteran insects, such as Diabrotica virgifera virgifera, and the pat gene from Streptomyces viridochromogenes that confers tolerance to glufosinate-ammonium herbicide, from 59122 maize.
- the cry1F gene from Bacillus thuringiensis var. aizawai that confers resistance to certain Lepidopteran insects, such as Ostrinia nubilalis, and the pat gene from Streptomyces viridochromogenes that confers tolerance to glufosinate-ammonium herbicide, from 1507 maize.
- the cp4epsps genes from Agrobacterium sp. strain CP4 that confer tolerance to glyphosate herbicide, from NK603 maize.
All these genes have been introduced in the corresponding maize along with their regulatory components necessary for expression.


6. Brief description of the method used for the genetic modification:
No genetic modification was made on the 59122x1507xNK603 maize varieties directly: they were derived through traditional breeding methods between progeny of the genetically modified 59122, 1507 and NK603 maize.

59122 maize was genetically modified using Agrobacterium transformation method. 1507 maize was genetically modified using a particle acceleration method. NK603 maize was genetically modified by Monsanto 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:
For year 2006, the purpose of this application is to carry out, under European conditions, the evaluation of the selectivity of glyphosate and glufosinate herbicides on the 1507x59122xNK603 event.

2. Geographical location of the site:
In 2006, the locations of the release sites will be as follows:

1: DowAgroSciences Hungary Kft. Research Station to Szolnok, Vizpart krt. 32. (location); 0651/1 (log)
2: Outskirts of Biatorbágy / 0106 (location/log); Quatro Bt. (2462. Martonvásár, József Attila út. 9.)


3. Size of the site (m2):
Each of the 2 sites for 2006 will have 400 m2 sown with the particular genetically modified plants concerned by this application; the total surface area taken up by this trial (all varieties and borders) is about 1000 m².
In the following 4 years, 4 field trials/year considered, approximately 6400 m² of the particular genetically modified plants will be drilled all together.


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 Europe and no environmental problems were reported for these trials. The transgenic plants were indistinguishable from the non-genetically modified maize plants except for showing resistance to certain Coleopteran insects, such as Western corn rootworm, and certain Lepidopteran insects such as European corn borer and showing tolerance when glufosinate and glyphosate herbicides were 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 Coleopteran and 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 bagging, before the pollen shed, the tassels from the plants that will be self-pollinated and by detasselling the plants that will not be self-pollinated or by distance in excess of 500m.
Seed dispersal of individual kernels does not occur. They are fixed on a cob and enclosed in many husks that protect the seeds from outside contact.
For this trial, a few seeds will need to be collected for analysis. This will be done by sampling the whole ear and destroying the remaining ear and unused seeds.
It is important to store and handle research seed apart from other seed to eliminate possibilities of potential contamination. Packages of seed must be labelled properly to avoid mixing. During storage seed should be kept in a secure environment to avoid potential contamination, theft or vandalism. For shipping double containment of primary package (i.e. primary, secondary, tertiary) is required to ensure the containment of seed should a shipping container be compromised.
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 fallow winter period, an adapted herbicide treatment (other than glufosinate-ammonium and glyphosate herbicides) will be made in order to ensure destruction.
Waste from genetically-modified plants produced by the release will be destroyed by incorporation into the soil.
Both testing sites are defended and continuously controlled by fence and a security guard. The sites will be visited regularly for agronomic and experimentation needs and for protection. These visits will also enable plant development and the non-dispersal of material to be monitored.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
The purpose of this application is to carry out, under European conditions, the evaluation of the selectivity of glyphosate and glufosinate herbicides on the 1507x59122xNK603 event.

Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Not known