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Notification report


General information

Notification Number
B/FR/05/04/02

Member State to which the notification was sent
France

Date of acknowledgement from the Member State Competent Authority
11/03/2005

Title of the Project
Five year field trials programme (2005-2009) for development of genetically modified maize MON 88017 x MON 810 protected against certain Coleopteran and Lepidopteran insects and tolerant to glyphosate herbicide.

Proposed period of release:
01/04/2005 to 31/12/2009

Name of the Institute(s) or Company(ies)
Monsanto Agriculture France S.A.S, ;


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 88017xMON 810

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
MON 88017 x MON 810 hybrid consists in the combination, by conventional breeding, of two genetically modified inbred lines, derived from maize transformation events MON 88017 and MON 810, respectively.

MON 88017 x MON 810 expresses Cry3Bb1 protein, which provides protection against certain coleopteran insects, including Corn Root Worm (Diabrotica virgifera). The insecticidal activity of the Cry3Bb1 protein is specific to coleopterans belonging to the chrysomelidae family.

MON 88017 x MON 810 expresses CP4 EPSPS protein, which imparts tolerance to glyphosate.

MON 88017 x MON 810 also expresses the Cry1Ab protein, which provides the maize plant of protection from certain lepidopteran insects, including European Corn Borer (Ostrinia nubilalis) and pink borers (Sesamia spp.). The insecticidal activity of the Cry1Ab protein is specific to predation by the larvae of the targeted lepidopterans.


Genetic modification

3. Type of genetic modification:
Insertion; Other;
Other
MON 88017 x MON 810 is obtained by conventional breeding techniques

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 lines MON 88017 and MON 810.
MON 88017 x MON 810, obtained by conventional breeding, contains the following genetic elements:
- the cry3Bb1 gene from Bacillus thuringiensis subsp. kumamotoensis which confers protection against Corn Root Worm (Diabrotica virgifera);
- the cp4 epsps gene from Agrobacterium sp. strain CP4, which provides tolerance to ghyphosate herbicide;
- the cry1Ab gene from Bacillus thuringienses subsp. kurstaki which confers protection against European Corn Borer (Ostrinia nubilalis) and pink borers (Sesamia spp.)


6. Brief description of the method used for the genetic modification:
MON 88017 x MON 810 was created 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.


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 aims of the dissemination are:
1. to test the performance of weed control programmes with different rates/stages of glyphosate;
2. to evaluate the agronomic performance (yield) of maize when sprayed with rates/stages of application of glyphosate and when planted in areas infested by targeted pests,
3. to produce vegetative plant material and grain in order to perform analyses of different parameters of the transformed maize ,
4. to conduct small demonstrative platforms,
5. to follow seeds selection trials and seed production for research,
6. to check equivalence to non-GM maize on agronomic parameters,
7. to check agronomic performances and compliance to DUS tests in order to get modified varieties registered,
8. to store, handle, process transgenic seeds in our seed plant.


2. Geographical location of the site:
The releases are planned at several locations in 2005 in France in Midi-Pyrénées.

3. Size of the site (m2):
Each site will have a maximum of 5 000 m² sown with MON 88017 x MON 810, the total trial surface for each site (including all varieties and borders) being larger.

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 and single-trait lines, 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 present in MON 88017 x MON 810 are already present in three commercial products, MON 863, MON 810 and NK603, respectively.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Analysis of the characteristics of MON 88017 × MON 810, 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 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 highly selective 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 aspects of handling MON 88017 × MON 810 are no different from conventional maize, and this maize was shown to be as safe and as nutritious as any other maize.
- The environmental impact of the cultivation, management and harvesting techniques applied in the planned trials is considered no different from the farming practices for conventional maize.

Measures will be taken to avoid seed dissemination at harvest and during transportation (see E.). Maize can hybridize with teosinte but these plants are not present in Europe. The possibility of hybridization with other maize plants will be minimised by a spatial isolation distance of 200 meters form other cultivated maize. Some trials (efficacy especially) could be carried out without isolation. In this case, the trials will be destroyed before the flowering stage of the crop. Four rows of non transgenic maize (commercial hybrid) will surround all the trials and act as pollen trap.


Brief description of any measures taken for the management of risks:
1. 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 crop and that of its receiving environment. In case any adverse environmental effects, linked to the deliberate release of MON 88017 × MON 810, are observed during the period of release, these will be reported immediately to the Competent Authority.

2. The spatial isolation distance (200 m) from other maize crops and the four rows of non transgenic maize surrounding the trials will prevent most of the possibility of hybridisation with other maize plants. Some trials (efficacy especially) could be carried out without isolation. In this case, the trials will be destroyed before the flowering stage of the crop.

3. The equipment, especially the experimental drill and combine, will be cleaned on the experimental site, thus preventing seed dissemination.

4. After completion of harvest, the stalks will be chopped and then incorporated into the soil. Any shattered seed will be allowed to germinate. The resulting seedlings will be destroyed by soil incorporation. Maize cobs will be harvested by experimental-plot combine, or by hand.

5. Although regrowth in the rotation crops is unlikely because of poor winter survival, the site will be sown either with a crop different from corn or with experimental corn that will be destroyed and not used in any commercial, industrial or food application. Volunteer plants will be controlled by the use of routinely used commercial antimonocotyledonous herbicides in this crop.

6. Seed will be transported in sealed and labelled bags placed in a rigid container.


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
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European Commission administrative information

Consent given by the Member State Competent Authority:
Not known