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Notification report


General information

Notification Number
B/HU/05/12/1

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 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 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:
For 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 1507 (x) NK603 event.

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


3. Size of the site (m2):
Each of the 2 sites for 2006 will have approx 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:
Experiments with 1507 (x) NK603 hybrids have been carried out since May 2004 in Spain, Canada, and the US. Corn line 1507 was approved by USDA in 2001 (petition 00-136-01p) and Corn line NK603 was approved by USDA in 1997 (petition 97-099-01p) both these lines have been planted throughout North America and have previously been field tested in Latin America as well as the EU. In these releases, no adverse effects on human health and the environment were observed.

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 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 and 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. 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.
The regular monitoring of the trials will enable immediate identification of any unwanted event or development.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
For 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 1507 (x) NK603 event.

Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Not known