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Notification report


General information

Notification Number
B/FR/06/12/11

Member State to which the notification was sent
France

Date of acknowledgement from the Member State Competent Authority
10/11/2006

Title of the Project
One year field trials programme (2007) for the deliberate release of MON 88017 x MON 810 maize protected against certain coleopteran and lepidopteran insects and tolerant to glyphosate herbicide.

Proposed period of release:
01/04/2007 to 31/12/2007

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?
Yes:
Germany; Spain;

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

If yes, notification number(s):
B/DE/05/169; B/ES/06/03; B/FR/05/04/02; B/FR/06/01/03;

Other notifications
In addition, many field trials have already been conducted across maize growing regions in North and South America and other world area.

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
maizepoaceaezeazea maysmaysMON 88017 x MON 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 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
MON 88017 x MON 810 was obtained by conventional breeding

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:
While MON 88017 × MON 810 was produced by a conventional cross of MON 88017 and MON 810 inbred lines, 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:
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 residues after applications with herbicides formulations based on glyphosate.


2. Geographical location of the site:
The releases are planned at several locations in 2007 (Rhône-Alpes, Midi-Pyrénées, Aquitaine, Poitou-Charentes, Centre, Lorraine).

The trial locations for the campaign 2007 are shown in the table below :

Valvidienne (86)
Civaux (86)
Beux (57)
Allamont (54)
Moulotte (55)
Foameix-Ornel (55)
Yermenonville (28)
Poinville (28)
St Maurice de Gourdans (01)
Faramans (01)
Bourgoin-Jallieu (38)
Linxe (40)
Magescq (40)
Layrac (47)
Fronton (31)
Mauroux (32)
Serignac (82)
La Salvetat de Belmontet (82)
Monclar de Quercy (82)


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, 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 present, alone or in combination, in 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 safety commercial experience.


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 400 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 conventional 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 (400 m) from other maize crops and the four rows of conventional 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