Date of publication: December 19,
2006
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification number:
B/FR/06/12/09
Member State
France
Date of Acknowledgement
10/11/2006 00:00:00
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 00:00:00 to 31/12/2007
00:00:00
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:
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 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;
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
-
European Commission administrative
information
Consent given by the Competent
Authority:
Not known |
