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Notification report


General information

Notification Number
B/FR/06/12/09

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
Notification according to Directive 2001/18/EC, Part B, for the deliberate release of NK603 for the use in field trials in France

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; Denmark; Spain; Sweden; Czech Republic; Slovak Republic;

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

If yes, notification number(s):
B/DE/00/115; B/DE/03/148; B/ES/00/06; B/ES/01/05; B/ES/02/03; B/ES/04/17; B/ES/04/19; B/ES/06/06; B/ES/06/08; B/FR/00/03/05; B/FR/01/01/01; B/FR/04/02/02; B/FR/06/01/01; B/FR/99/04/06; B/IT/99/17;

Other notifications
B/FR/04/06

In addition, many field trials have already been conducted across maize growing regions in North and South America and other world area and NK603 has been commercially released for cultivation in the U.S.A. and Canada, since 2001


Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
maizepoaceaezeazea maysmays

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
The production of CP4 EPSPS proteins in NK603 confers to the maize plants the tolerance to glyphosate, which is the active ingredient of the agricultural herbicide Roundup®.

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 cp4 epsps coding region of interest was derived from the common soil-borne bacterium Agrobacterium sp. (strain CP4). Moreover, in each gene expression cassette, a 3’ nontranslated region of the nopaline synthase gene from A. tumefaciens was used (nos 3’), which ends transcription and directs polyadenylation of the mRNA. The cp4 epsps-coding sequence in each of the two cassettes in the NK603 insert is fused to a chloroplast transit peptide sequence (designated ctp2), of which the sequence is based on the CTP isolated from Arabidopsis thaliana EPSPS. The CTP directs the CP4 EPSPS enzymes to the chloroplast, the location of EPSPS in plants and the site of aromatic amino acid biosynthesis In the first gene cassette, the ctp2 cp4 epsps coding sequence is under the regulation of the rice actin promoter (P-ract1) and rice actin (ract1) intron, both of which were derived from Oryza sativa L. (rice). The coding region of the second cassette is under the regulation of the enhanced CaMV 35S promoter (e35S), derived from the cauliflower mosaic virus, and the Zm hsp70 (heat shock protein) intron derived from maize (Zea mays L.).

6. Brief description of the method used for the genetic modification:
NK603 was produced by the 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 proposed experiments are part of a programme based on progeny of NK603 plants containing the glyphosate-tolerance trait. The aims of the programme are:

1 - to test in the field the performance of weed control programmes with different rates/stages of application of Roundup herbicides
2 - to evaluate the agronomic performance (yield) of NK603 when a Roundup herbicide is applied at various rates/stages of application ,
3 - to produce vegetative plant material and grain in order to assess quality parameters of the genetically modified maize ;
4 - to conduct small demonstration platforms.
5 - to conduct characterization trials to get the variety registration (CTPS)
6 - to follow seeds selection trials and seed production for research.


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 NK603 concerned by this application, the total area covered by the trial will be higher.

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:
Multi-year field-testing in the E.U. (for the assessment of agronomic performance, phenotypic and morphological characteristics, yield, residues determination, protein expression and compositional analysis) and post-marketing experience in other world areas since 2001 provided no significant evidence that NK603 and its progeny would cause any adverse effects to human or animal health and the environment.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Analysis of the characteristics of NK603, especially in comparison with extensive experience with cultivation of traditional 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 NK603, is consistently negligible:
· The risk of the introduced trait in NK603 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 traditional maize. Moreover, there is no potential for gene transfer from NK603 to any wild plant species in Europe.
· Potential exposure of non-target organisms to CP4 EPSPS presents no conceivable mechanism to cause adverse effects because of its properties.
· Any occupational health aspects of handling NK603 are no different from traditional maize, and this maize was shown to be as safe and 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 traditional maize.
Since no characteristics of NK603 could be identified that may cause adverse effects on human health or the environment, no risk management strategies are considered necessary.
It is actually expected that the commercial production of NK603 will positively impact current agronomic practices in maize and provide benefits to farmers and the environment. The use of Roundup herbicides in maize enables the farmer to take advantage of the herbicide’s favourable environmental and safety properties (see Annex I listing of glyphosate under Council Directive 91/414/EEC). Glyphosate-tolerant maize benefits the farmer by providing (1) an additional broad-spectrum weed control option in maize, (2) a new herbicidal mode of action for in-season maize weed control, (3) increased flexibility to treat weeds on an “as needed” basis, (4) cost-effective weed control and (5) an excellent fit with reduced-tillage systems. In turn, a number of environmental benefits arise from the use of conservation tillage including improved soil quality, improved water infiltration, reductions in erosion and sedimentation of water resources, reduced runoff of nutrients and pesticides to surface water, improved wildlife habitat, increased carbon retention in the soil, reduced fuel use and encouragement of sustainable agricultural practices.


Brief description of any measures taken for the management of risks:
1. In addition to 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 NK603 crop and that of its receiving environment. In case any adverse environmental effects, linked to the deliberate release of NK603, 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 traditional maize surrounding the trials will prevent most of the possibility of hybridisation with other maize plants. Some trials (efficacy trials 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.

3. 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.

4. Although regrowth in the rotation crops is unlikely because of poor winter survival of maize, the site will be sown either with a crop different from maize or with experimental maize 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.

5. 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