Date of publication: January 16,
2006
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification number:
B/FR/06/01/01
Member State: France
Date of Acknowledgement: 12/12/2005
Title of the Project:
Five year field trials programme (2006-2010) for deliberate
release of the genetically modified maize Roundup Ready corn 2
(NK603) (glyphosate tolerance).
Proposed period of release From:01/04/2006
To:31/12/2010
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
4 - Has the same GMPt been notified elsewhere by the same
notifier?
Yes
If yes, notification number(s):
B/BE/00/WSP13; 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/FR/00/03/05;
B/FR/01/01/01; B/FR/04/02/02; B/FR/99/04/06; B/IT/02/01;
B/IT/99/17
Other notifications
Czech Republic 26OA/OER/GMO/02, Hungary 24.111/2/2003 and
12269/2004). In the E.U., NK603 has been planted for
field-testing at several locations since 1999
Genetically
modified plant
1. Complete name of the
recipient or parental plant(s)
|
Common Name
|
Family Name
|
Genus |
Species
|
Subspecies
|
Cultivar/breeding line
|
| maize
|
poaceae |
zea
|
zea
mays |
mays
|
|
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;
4. 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 maize plantscontaining the Roundup Ready ®
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
2 - to evaluate the agronomic performance (yield) of NK603 when
Roundup 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 trials will be carried out in the different French areas
of the maize crop cultivation, in order to cover various soil
and climatic conditions. In 2006, the administrative regions
planned are Pays de Loire, Poitou-Charente, Centre, Rhône-Alpes,
Midi-Pyrénées and Aquitaine. According to the trial location,
seeds with appropriate precocity will be used.
3. Size of the site (m2):
In 2006, each site would cover a maximum of total area of
10000 m² (pollinic barrier included); and the GMO surface will
not exceed 5000 m² per trial.
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:
Post-release general surveillance from environments inside
and outside the E.U. has shown that NK603 maize is unlikely to
pose any risk of adverse effects to human or animal health or to
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 maize, 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 maize, is consistently negligible:
- The risk of the introduced trait in NK603 maize 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 maize 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 maize 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.
It is actually expected that the commercial production of NK603
maize will positively impact current agronomic practices in
maize and provide benefits to farmers and the environment. The
use of Roundup 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). Roundup-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 maize 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 (200 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
-
European
Commission administrative information
Consent given by the Competent
Authority: Not Known |
