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Notification report


General information

Notification Number
B/DE/05/169

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
24/10/2005

Title of the Project
Notification according to Directive 2001/18/EC, Part B, for the deliberate release of MON 88017 × MON 810 maize and its parental lines for the use in field trials in Germany.

Proposed period of release:
01/01/2006 to 31/12/2010

Name of the Institute(s) or Company(ies)
Monsanto Company, Represented by Monsanto Agrar Deutschland GmbH;


3. Is the same GMPt release planned elsewhere in the Community?
Yes:
Spain; France;

Has the same GMPt been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):


Other notifications
In the E.U., EFSA/GMO/CZ/2006/33 (Food, feed, import and processing)
In the U.S., MON 88017, MON 810 and the combined trait product MON 88017 x MON 810 can be lawfully used for the full range of uses of traditional maize. The status of other pending regulatory reviews, which are currently in progress in numerous countries around the world, typically depend on the country and its local regulatory framework.


Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
maizepoaceaezeazea maysmaysMON88017 x MON810 and MON810

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
MON 88017 x MON 810 was obtained by conventional breeding, of two genetically modified parental inbred lines, one derived from MON 88017 and one derived from MON 810.
MON 88017 x MON 810 expresses:
CP4 EPSPS protein, which imparts tolerance to glyphosate;
Cry3Bb1 protein, which provides protection against certain coleopteran insects, including Corn Root Worm (Diabrotica virgifera);
Cry1Ab protein, which confers protection from certain lepidopteran insects, including European Corn Borer (Ostrinia nubilalis) and pink borers (Sesamia spp.).


Genetic modification

3. Type of genetic modification:
Insertion; Other;
Other
MON88017 × MON810 hybrid maize consists in the combination, by traditional breeding, of two genetically modified parental inbred lines, one derived from MON 88017 and one derived from MON 810, respectively.

In case of insertion of genetic material, give the source and intended function of each constituent fragment of the region to be inserted:
Genetic modifications were solely used in the development of MON 88017 and MON 810.
MON 88017 x MON 810, obtained by conventional breeding, contains the following genetic elements:
- the cp4 epsps gene from Agrobacterium sp. strain CP4, which provides tolerance to ghyphosate herbicide;
- the cry3Bb1 gene from Bacillus thuringiensis subsp. kumamotoensis which confers protection against Corn Root Worm (Diabrotica virgifera);
- the cry1Ab gene from Bacillus thuringienses subsp. kurstaki which confers protection against European Corn Borer (Ostrinia nubilalis) and pink borers (Sesamia spp.)
These genes have been introduced with regulatory components necessary for expression in plant cells.


6. Brief description of the method used for the genetic modification:
MON 88017 x MON 810 was obtained using conventional breeding techniques. No additional genetic modification is used in the production of MON 88017 × MON 810 varieties. Instead, MON 88017 × MON 810 is produced by a conventional cross of MON 88017 and MON 810 inbred lines.
While MON 88017 × MON 810 results from conventional breeding, genetic modification was used in the development of MON 88017 and MON 810.
MON 88017 was produced by Agrobacterium-mediated transformation of immature embryos of maize tissue and MON 810 was genetically modified using a 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:
MON 88017 × MON 810 maize and its parental lines will be planted in field trials for assessment of phenotypic characteristics and agronomic performance, and for variety trials.
The aims of the release are:
1. to characterize MON 88017 x MON 810 maize under European crop conditions, including analysis for protein expression.
2. to evaluate the agronomic performance and equivalence of MON 88017 x MON 810 to conventional maize.
3. to evaluate data after applications with herbicides formulations based on glyphosate.


2. Geographical location of the site:
The releases are planned at several German locations, which are representative for corn growing areas in Germany.

3. Size of the site (m2):
max. 10.000 m2 per site and year

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:
General surveillance from environments outside the E.U. has shown that MON 88017 x MON 810, MON 88017 and MON 810, are unlikely to pose any risk of adverse effects to human or animal health or to the environment.
The two insect-protection traits and the glyphosate tolerance trait expressed in MON 88017 x MON 810 are also present, alone or in combination, in the following commercial products: NK603, MON 863, MON 810, MON 863 x MON 810, MON 863 x NK603, NK603 x MON 810, MON 863 x MON 810 x NK603 which have a proven safety under commercial use.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Note especially if the introduced traits could directly or indirectly confer an increased selective advantage in natural environments; also explain any significant expected environmental benefits
Analysis of the characteristics of MON 88017 × MON 810 and its parental lines, especially in comparison with extensive experience with cultivation of conventional maize within the E.U., has shown that the risk for potential adverse effects on human and animal health and the receiving environment, resulting from the planned field trials with MON 88017 × MON 810, is consistently negligible:
The risk of the introduced traits in MON 88017 × MON 810 and its parental lines to be the cause of any meaningful competitive advantage or disadvantage in natural environments is negligible. Like for any other maize, the likelihood of this maize to spread into non-agronomic environments is negligible, as its persistence in agricultural habitats and its invasiveness into natural habitats are unaltered compared to conventional maize.
As for parental MON 88017 and MON 810, MON 88017 × MON 810 poses negligible risk for adverse environmental effects through its interaction with target organisms. The ecological interactions of MON 88017 × MON 810 with non-target organisms or soil processes are not different from conventional maize. Potential exposure of non-target organisms to CP4 EPSPS presents no conceivable mechanism to cause adverse effects because of its properties, and due to the specific insecticidal activity of the Cry3Bb1 and Cry1Ab proteins on targeted coleopteran and lepidopteran insect pests, respectively, also these proteins pose negligible risks to non-target organisms.
Any occupational health, safety, nutrition aspects of MON 88017 × MON 810 and its parental lines are not different from conventional maize.
The environmental impact of the cultivation, management and harvesting techniques applied in the planned trials is not considered to be different from the farming practices for traditional maize.
Measures will be taken to avoid seed dissemination at harvest and during transportation (see E.). The possibility of hybridization with other maize plants will be minimised by a spatial isolation zone from other cultivated maize. Additionally conventional maize will be planted around the trials and thus GM pollen flow will be minimised.


Brief description of any measures taken for the management of risks:
In addition to the scheduled observations of phenotypic and agronomic parameters that form the basis of the planned research, the trial site will be checked regularly during the period of the deliberate release for potentially occurring, direct or indirect, adverse environmental effects. This will be done by visual inspection of the status of the MON 88017 x MON 810 maize and its parental lines and of its receiving environment.
The spatial isolation distance from other maize crops and the conventional maize surrounding the trials will prevent most of the possibility of hybridisation with other maize plants.
The equipment, especially the experimental drill and combine, will be cleaned on the experimental site, thus preventing seed dissemination.
During harvest samples will be taken either by experimental-plot combine or by hand for further analysis.
Remaining plant material will be inactivated on the trial site for further degradation.
All important activities in the frame of the deliberate release will be reported as requested by regulation 2003/701/EU.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Not applicable.
However, any unanticipated adverse effects on human health or the environment would be reported immediately to the Competent Authority.


Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
19/05/2006 00:00:00
Remarks:
(No decision has yet been met for the trial site "Leingarten".)