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Notification report


General information

Notification Number
B/DE/06/184


This notification has been withdrawn by the notifier
09/11/2007


Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
14/11/2006

Title of the Project
“Combined resistance genes in maize, effect neutral for the environment?”

Proposed period of release:
01/05/2007 to 30/10/2010

Name of the Institute(s) or Company(ies)
Fraunhofer Gesellschaft zur Förderung der angewandten Forschung e.V. (FhG), ;


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 88017 x MON 810 maize

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
MON 88017 × MON 810-maize was generated by crossing single-trait MON 88017 and MON 810 inbred lines using traditional breeding methods.

Like MON 88017 parental maize, MON 88017 x MON 810 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 88017 x MON 810 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.).

Like MON 810 parental maize, MON 88017 × MON 810 expresses a synthetic variant of the Cry1A(b) protein, derived from Bacillus thuringiensis subsp. kurstaki, which provides protection from certain lepidopteran insect pests (including European Corn Borer).


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 88017 x MON 810 contains two different inserts, one derived from parent MON 88017 and one derived from parent MON 810.

Parent 1 (MON 88017):
A copy of the gene cp4 epsps from Agrobacterium sp. phylum CP4, expressing a protein resulting in a tolerance against the herbicide glyphosate, under the control of the promoter (P-ract1) and intron (ract1-intron) of the actin gene from Oryza sativa as well as the terminator (NOS 3’) of the nopaline synthase gene from Agrobacterium tumefaciens. The coding sequence of the cp4 epsps gene was endued 5’-terminal with a DNA sequence coding for the N-terminal chloroplast transit peptide (CTP2) from Arabidopsis thaliana.
and
a copy of the gene cry3Bb1 from Bacillus thuringensis subsp. kumamotoensis, expressing a synthetic variant of Cry3Bb1 protein which protects maize from damage by larvae of the Western corn rootworm (Diabrotica virgifera virgifera), under the control of the 35S-promoter (P-e35S) from cauliflower mosaic virus and the intron (ract1-intron) of the actin gene from rice as well as a terminator (Tahsp17 3’) from wheat (wheat heat shock protein). The coding sequence of the cry3Bb1 gene was endued 5’-terminal with the sequence of the 5’ untranslated leader of the wheat chlorophyll a/b-binding protein.

Parent 2 (MON 810):
A copy of the gene cry1A(b) from Bacillus thuringensis subsp. kurstaki, expressing a synthetic variant of Cry1A(b) protein which protects maize from damage by larvae of the European corn borer (Ostrinia nubilalis), under the control the 35S-promoter with the duplicated enhancer region and 5’ untranslated region from cauliflower mosaic virus. The coding sequence of the cry1A(b) gene was endued 5’-terminal with the intron sequence from the maize hsp70 gene (heatshock protein) present to stabilize the level of gene transcription.


6. Brief description of the method used for the genetic modification:
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 810-maize has been generated using the particle gun method.

MON 88017 x MON 810-maize is the product of a conventional crossing of MON 88017-maize and MON 810-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:
Ecological safety research on MON 88017 x MON 810-maize.
Research on the possible effects of MON 88017 x MON 810-maize on organisms in and on the soil (edaphon, epigaeic fauna) and the vegetation layer (hypergaeon).


2. Geographical location of the site:
Germany, Free State of Bavaria, 97337 Dettelbach

3. Size of the site (m2):
Release site 10400 m²
Whole experimental field size about 60000 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:
The levels of the proteins CP4 EPSPS, Cry3Bb1 and Cry1A(b) were measured in various tissues collected from MON 88017 × MON 810 plants produced in three field trials in the USA during the 2002 growing season. Overall, the ranges across three sites for the CP4 EPSPS, Cry3Bb1 and Cry1Ab protein levels in MON 88017 × MON 810 were comparable to the corresponding ranges in both parent lines (either MON 88017 or MON 810).

Comparative assessments of the phenotypic and agronomic characteristics of both parent lines (MON 88017 and MON 810) have been conducted at multiple sites in the field. MON 88017 has been field tested since 2002 in the USA. MON 810 has been produced as a commercial product since 1997 in the USA and is also currently commercially produced in the EU. 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 88017 or MON 810 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 88017 x MON 810 are limited to the expression of the proteins CP4 EPSPS, Cry3Bb1 and Cry1A(b). No increased selective advantage of MON 88017 x MON 810 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 88017 x MON 810-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 (9 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 88017 x MON 810-maize on organisms in and on the soil (edaphon, epigaeic fauna) and the vegetation layer (hypergaeon). In a plot design (8 replicates each for statistic purpose) the Bt-cultivar MON 88017 x MON 810-maize will be compared with the isogenic control and a further conventional maize cultivar. 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 and fermentation in a biogas plant. An annual post monitoring of the site will be performed to watch/eliminate any surviving maize on the site, which will be planted with other crops than maize.

Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
See E.

Final report
-

European Commission administrative information

Consent given by the Member State Competent Authority:
No
01/01/1900 00:00:00
Remarks:
The application has been withdrawn by the notifier.