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Notification report


General information

Notification Number
B/DE/07/194

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
12/11/2007

Title of the Project
Effects of stacked Bt-maize with ECB and WCR resistance genes on non-target organisms

Proposed period of release:
01/04/2008 to 31/10/2010

Name of the Institute(s) or Company(ies)
RWTH Aachen, D-52056 Aachen;


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 maysmaysMON 89034 x MON 88017

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
MON 89034 x MON 88017-maize was generated by crossing single-trait MON 89034 and MON 88017 inbred lines using traditional breeding methods.

Like MON 88017 parental maize, MON 89034 x MON 88017 expresses the CP4 EPSPS protein, derived from Agrobacterium sp. phylum CP4, which provides tolerance to the herbicidal active ingredient glyphosate. Moreover, like MON 88017 parental maize, MON 89034 x MON 88017 expresses a synthetic variant of the Cry3Bb1 protein, derived from Bacillus thuringiensis subsp. kumamotoensis, which provides protection against certain coleopteran insect pests, including members of the corn rootworm complex (Diabrotica spp., especially Western Corn Root Worm Diabrotica virgifera virgifera).

Like MON 89034 parental maize, MON 89034 x MON 88017 expresses a synthetic variant of the Cry2Ab2 protein, derived from Bacillus thuringiensis subsp. kurstaki, as well as the synthetic Cry1A.105 protein, which is a modified Cry1A protein from Bacillus thuringiensis. The expression of both proteins provides protection against certain lepidopteran insect pests (including European Corn Borer Ostrinia nubilalis).


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:
The genome of MON 89034 x MON 88017 contains two different inserts, one derived from parent MON 89034 and one derived from parent MON 88017.

Parent 1 (MON 89034):
Inserted element / source / function:
- cry1A.105 gene (synthetic) / modified Cry1A protein from Bacillus thuringiensis / resistance to Ostrinia nubilalis
- P-e35S / cauliflower mosaic virus / promoter
- L-Cab / Triticum aestivum / increase in efficiency of gene expression
- I-ract1 / Oryza sativa / increase in efficiency of gene expression
- T-hsp17 / Triticum aestivum / terminator sequence

- cry2Ab2 gene / Bacillus thuringiensis subsp. kurstaki / resistance to Ostrinia nubilalis
- P-35S / figwort mosaic virus / promoter
- I-hsp70 / Zea mays / increase in efficiency of gene expression
- TS-SSU-CTP / Zea mays / chloroplast transit peptide sequence
- T-nos / Agrobacterium tumefaciens / terminator sequence


Parent 2 (MON 88017):
Inserted element / source / function:
- cp4 epsps gene / Agrobacterium sp. phylum CP4 / glyphosate tolerance
- P-ract1 / Oryza sativa / promoter
- I-ract1 / Oryza sativa / increase in efficiency of gene expression
- CTP2 / Arabidopsis thaliana / chloroplast transit peptide sequence
- T-nos / Agrobacterium tumefaciens / terminator sequence

- cry3Bb1 gene / Bacillus thuringiensis subsp. kumamotoensis / resistance to Diabrotica virgifera virgifera
- P-e35S / cauliflower mosaic virus / promoter
- L-Cab / Triticum aestivum / increase in efficiency of gene expression
- I-ract1 / Oryza sativa / increase in efficiency of gene expression
- T-hsp70 / Triticum aestivum / terminator sequence


6. Brief description of the method used for the genetic modification:
The genetic modification of the maize MON 89034 is related to an Agrobacterium-mediated transformation of the plasmid vector PV-ZMIR245 into maize cells.

The genetic modification of the maize MON 88017 is related to an Agrobacterium-mediated transformation of the plasmid vector PV-ZMIR39 into maize cells.

MON 89034 x MON 88017-maize is the product of a conventional crossing of MON 89034-maize and MON 88017-maize.


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:
Biosafety research: Potential effects of stacked Bt-maize on non-target organisms

2. Geographical location of the site:
Germany, Lower Saxony, 38114 Braunschweig, Field station of the Friedrich-Loeffler-Institute

3. Size of the site (m2):
Release site 11200 m²

Whole sample area about 80000 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:
There have been no previous releases of the same GM-plant by Aachen University.

However, comparative assessments of the phenotypic and agronomic characteristics of both parental lines (MON 89034 and MON 88017) have been conducted based on field trials performed in the USA. The experience gathered from these plantings indicates that, except for the tolerance to glyphosate and the protection against target coleopteran and lepidopteran insect pests, there are no biologically significant differences in the reproductive capability, dissemination or survivability of MON 89034 or MON 88017 when compared to conventional maize.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Based on centuries of experience with conventional, domesticated maize in the EU, there is negligible capability for maize to be invasive of natural habitats or to persist in the agronomic environment without the aid of human intervention. The maize plant is known as a poor competitor, which outside cultivation has no significant impact on the environment. Compared to non-transgenic maize, any newly introduced characteristics in MON 89034 x MON 88017 are limited to the expression of the proteins CP4 EPSPS, Cry3Bb1, Cry2Ab2, and Cry1A.105. No increased selective advantage of MON 89034 x MON 88017 in natural habitats or the agronomic environment is expected, anyhow, the aim of the research project is to investigate the potential effects of the combined resistance genes. More precisely, the aim of the release is to quantify any possible effects of MON 89034 x MON 88017-maize on the environment. It could be expected that the new Bt-maize trait will be beneficial to the environment in maize-insect pest infected areas because chemical insecticide treatments could be avoided. As for safety the site is surrounded by a safety mantle of conventional maize (10 m) and additional 150 m security belt in which no maize will be planted (if any will be planted it will be deactivated by chopping and ensilaging and fermentation in a biogas plant).

Brief description of any measures taken for the management of risks:
The aim of the release trial is to monitor possible adverse effects of the new Bt-maize trait MON 89034 x MON 88017-maize on organisms in and on the soil (edaphon, epigaeic fauna) and the vegetation layer (hypergaeon). In a plot design the Bt-cultivar MON 89034 x MON 88017 will be compared with three conventional maize cultivars. In addition, contents of the Bt-toxins in the soil and the degradation behaviour will be studied. After finishing each year the whole maize material will be deactivated by chopping and ensilaging as well as fermentation in a biogas plant or working into the soil. An annual post monitoring of the site will be performed to watch/eliminate any surviving maize on the site, which will be replanted with other crops than maize.

Moreover, the following measures are planned:
- All trangenic material (seeds) will be stored in S1-areas and transported in closed containers.
- All agricultural machinery used for dealing with the transgenic material will be cleaned appropriately after use.
- There will be an isolation zone of 150 m around the release area where either no maize will be planted or, if maize is planted, it will be utilized in a biogas plant.
- A 10 m-buffer zone with conventional maize will surround the release area.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Field trials will be performed during three maize cultivation periods (2008-2010) from April to October with a maximum of 112000 transgenic maize plants on 8 plots (plot size 1400 m² each) distributed across a whole sample area of about 80000 m2

see E.


Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
14/05/2008 00:00:00
Remarks: