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Notification report


General information

Notification Number
B/DE/04/161

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
19/10/2004

Title of the Project
Biosafety research of new transgenic Bt-maize varieties against the Western corn root worm Diabrotica virgifera: development and evaluation of monitoring methods

Proposed period of release:
01/04/2005 to 30/11/2007

Name of the Institute(s) or Company(ies)
Institute of Environmental Research (Biology V), Chair of Ecology, Ecotoxicology, Ecochemistry
Aachen University (RWTH), Worringerweg 1, D 52062 Aachen, Germany;


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:
beetle resistance; herbicide tolerance

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:
Genetic material - source - function
P-ract1 - Oryza sativa - promotor
CP4EPSPS - Agrobacterium - Glyphosate-tolerance
NOS 3’ - Agrobacterium - terminator
--------------------------------------------------------------------------------
P-e35S - Cauliflower mosaic virus - promotor
Cry3bb1 - Bacillus thuringiensis - insect resistance
tahsp17 3’ - Wheat heat shock protein - terminator


6. Brief description of the method used for the genetic modification:
A disarmed, binary transformation plasmid factor was used, designed for Agrobacterium mediated transformation to obtain the genetic modification of MON88017 Bt-maize. This leads to an expression of Cry3Bb1 protein and results in the insect resistance properties.

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:
Performance of a joined project (10 partners, granted be the Federal Ministry of Education and Research): Biosafety research of new transgenic Bt-maize varieties against the Western corn root worm Diabrotica virgifera: development and evaluation of monitoring methods.
Mon88017 Bt-maize will be investigated in a block designed experimental field in comparison to isogenic and two other non transgenic maize cultivars (each 8 replicates) in view of possible unexpected effects of Mon 88017 on non target organisms. Organisms in the soil (edaphon) and on the soil (epigaeon) and in the herbaceous layer (hypergaeon) will be investigated.


2. Geographical location of the site:
Schwarzenau, 97359 Schwarzach a. Main, Freistaat Bayern, Germany

3. Size of the site (m2):
10,400 m2 of MON88017 Bt maize ( sum of 8 plots in a block designed experimental field of 54,000 m2)

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:
not applicable

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
No impact by pollination is expected. This will be true because:
- Distance of 50 m to possible neighbour maize fields will be realized.
- 10 m surrounding cover of the experimental field with conventional maize.
- Additional 6 m of a surrounding way, additional 6 m of a surrounding hedge,
- 8 of Bt-maize plots will be partly protected by 24 plots of conventional maize,
- This Bt-maize cultivar is a late flowering cultivar (pollination asynchrony to other maize)
The experimental field will be watched and controlled during the whole investigation time because of the scientific activities (performance of experiments, collecting activities etc.)


Brief description of any measures taken for the management of risks:
See B. After each growing period the Bt-maize will be worked into the soil or will be inactivated in a biogas plant. In the following year, after termination of the experiments, no further maize will be planted and the field will be observed for maize plants. If any will arise it will be inactivated before flowering.

Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Mon88017 Bt-maize will be investigated in a block designed experimental field in comparison to isogenic and two other non transgenic maize cultivars (each 8 replicates) in view of possible unexpected effects of Mon 88017 on non target organisms. Organisms in the soil (edaphon) and on the soil (epigaeon) and in the herbaceous layer (hypergaeon) will be investigated. The aim is to get science based, statistically proper results of a possible adverse effect of Diabrotica-resistante Bt-maize on the maize field biosphere (ecological safety research) and to propose organisms for a monitoring, if any time necessary.

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
24/05/2005 00:00:00
Remarks: