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Notification report


General information

Notification Number
B/HU/07/05

Member State to which the notification was sent
Hungary

Date of acknowledgement from the Member State Competent Authority
15/01/2007

Title of the Project
Field trials program with genetically modified maize variety resistant to certain Coleopteran
insects.


Proposed period of release:
01/04/2007 to 30/11/2010

Name of the Institute(s) or Company(ies)
St. Stephen University, Gödöllő, Department of Plant Protection;


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 maysmays

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
Event MIR604 is a genetically modified (GM) maize developed to confer field protection against the Western Corn rootworm (WCR) (Diabrotica virgifera virgifera LeConte), and the Northern Corn rootworm (NCR) (D. longicornis barberi Smith and Lawrence) and other related coleopteran species. It also expresses a marker protein, PMI, that allows the plants to utilise
mannose as a carbon source, acting as a selectable marker.


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:
Event MIR604 is a genetically modified (GM) maize expressing two transgenes:
- A modified cry3A (mcry3A) gene encoding the mCry3A protein that confers
resistance to the Western Corn rootworm (WCR) (Diabrotica virgifera virgifera), the Northern Corn rootworm (NCR) (Diabrotica longicornis barberi, Smith and
Lawrence) and other related coleopteran pests of maize. This gene is under the
control of the promoter derived from maize metallothionein-like (MTL) gene that
provides root preferential expression and the termination sequence of the nopaline synthase (NOS) gene, isolated from Agrobacterium tumefaciens.
- the pmi (manA) gene from Escherichia coli, which encodes the enzyme PMI as a
selectable marker. PMI allows transformed corn cells to utilize mannose as a sole carbon source, while maize cells lacking the pmi gene fail to grow. The pmi gene is under the control of the ZmUbiIntron promoter derived from a maize ubiquitin gene together with the 1st intron of the gene and the termination sequence of the nopaline synthase (NOS) gene, isolated from Agrobacterium tumefaciens.


6. Brief description of the method used for the genetic modification:
Transformation of immature maize embryos using Agrobacterium tumefaciens LBA4404

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:
The purpose of the release is to investigate the potential effects of Event MIR604 maize cultivation on key non-target arthropods.

2. Geographical location of the site:
In 2007, the location of the release site will be as follows:

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


3. Size of the site (m2):
There will be only one site of release. The total trial site will be a maximum of 10,000 m2 of
which up to 4,000 m2 will be GM maize.


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 with Event MIR604 maize have been conducted to date. No biologically significant differences between Event MIR604 and near isogenic conventional maize were detected apart from tolerance to Diabrotica infestation. The genetically modified lines do not differ from the recipient plant in mode or rate of reproduction, dissemination or survivability of
the plant.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
An Environmental Risk Assessment has been conducted to evaluate the potential effects of the proposed release to the environment. The conclusion of this assessment is that effects to the environment arising from these small scale field trials maize can be considered negligible.

Brief description of any measures taken for the management of risks:
The experimental field trails will be conducted in areas where maize is not cultivated for the
production of seeds and measures will be taken to ensure temporal and spatial isolation:
• Distance to the nearest maize field will be no less than 500m;

• The trials will be surrounded by a border of no less than 6 rows of conventional maize
plants that will serve as pollen trap and that will reduce edge effects.
• Throughout the trials, the release plot will be visited regularly for observations and to
ensure that the appropriate action is taken to control weeds and diseases.
• The grain produced in the field trials will be harvested and destroyed. At the end of the
trials, any remaining plant material will be incorporated into the soil, as soon as the
agronomic and environmental conditions allow.
• All grain produced in these trials will be harvested and destroyed to minimise the chances
of volunteers appearing in subsequent seasons. However, the following year a crop other
than maize will be planted in the field, to ensure that any maize volunteers are easily
identified and destroyed.
• During the following season the trial site will be monitored for detection of maize
volunteers. Any volunteer plants will be destroyed.
• All the plants used in the releases (including the border rows) will be destroyed at the end of
the trial and will not be used as human food or animal feed
• In case of any emergency, the trial could be stopped by application of a herbicide, or by
mechanical destruction, and incorporation 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 these trials is to investigate the potential effects of Event MIR604 maize cultivation on key non-target arthropods in Europe.

Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Not known