Deliberate release into the E.U.
environment of GMOs for any other purposes than placing on the market:
Field trials continuation to
advance in the evaluation, agronomic characterization and
development of corn varieties derived from NK603 line, tolerant
to glyphosate herbicide |
Date of publication: January 20,
2006
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification number:
B/ES/06/08 Member
State:Spain
Date of Acknowledgement:12/12/2005
Title of the Project:
Field trials continuation to advance in the evaluation,
agronomic characterization and development of corn varieties
derived from NK603 line, tolerant to glyphosate herbicide.
Proposed period of release From:01/02/2006
To:28/02/2007
Name of the Institute(s) or Company(ies): Monsanto
Europe, S.A., represented by Monsanto Agricultura España, S.L.;
3. Is the same GMPt release planned elsewhere in the
Community?
Yes: Germany; France
4 - Has the same GMPt been notified elsewhere by the same
notifier?
Yes
If yes, notification number(s):
-
Other notifications
C/ES/00/01 and C/ES/03/01 according to Dir 2001/18/EC and
EFSA-GMO-NL-2005-22 according to Regulation (EC) 1829/2003 on
Genetically Modified Food and Feed.
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
|
NK603
maize |
2. Description of the traits and characteristics which have
been introduced or modified, including marker genes and previous
modifications:
NK603 maize expresses CP4 EPSPS proteins, which impart
tolerance to glyphosate (N phosphonomethyl-glycine), the active
ingredient in the non-selective herbicide Roundup. EPSPS is an
enzyme involved in the shikimic acid pathway for aromatic amino
acid biosynthesis in plants and microorganisms. CP4 EPSPS
enzymes have been shown to have significantly reduced affinity
for glyphosate herbicide when compared with the wild-type maize
enzyme, and to retain catalytic activity in the presence of the
inhibitor glyphosate. Therefore, when maize plants expressing
the CP4 EPSPS proteins are treated with glyphosate, the plants
are unaffected since the continued action of the tolerant CP4
EPSPS enzymes provides for the plant’s need for aromatic amino
acids.
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:
Components of the inserted DNA fragment inherited from NK603
maize:
- First cp4 epsps gene cassette:
P-ract1/ ract1 intron: from Oryza sativa 1.4 Kb. Contains
promoter, transcription start site and first intron.
Ctp 2: from Arabidopsis thaliana. 0.2 Kb. Encodes chloroplast
transit peptide, which directs the CP4 EPSPS protein to the
chloroplast.
cp4 epsp: from Agrobacterium sp. strain CP4. 1.4 Kb. Encodes
glyphosate-tolerant CP4 EPSPS protein.
NOS 3’: from Agrobacterium tumefaciens. 0.3 Kb. Ends
transcription and directs polyadenylation of the mRNA.
- Second cp4 epsps gene cassette:
e35S: from Cauliflower mosaic virus. 0.6 Kb. Promoter.
Zmhsp70: from Zea mays L. 0.8 Kb. Stabilizes the level of gene
transcription.
Ctp 2: from Arabidopsis thaliana. 0.2 Kb. Encodes chloroplast
transit peptide, which directs the CP4 EPSPS protein to the
chloroplast.
cp4 epspsl214p: from Agrobacterium sp. strain CP4. 1.4 Kb.
Encodes glyphosate-tolerant CP4 EPSPS L214P protein.
NOS 3’: from Agrobacterium tumefaciens. 0.3 Kb. Ends
transcription and directs polyadenylation of the mRNA
6. Brief description of the method used for the genetic
modification:
NK603 parental maize lines 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 release has the aim to advance in the agronomic
characterization and development of corn varieties derived from
NK603 line, tolerant to glyphosate herbicide, for possible
commercialization and cultivation by Spanish farmers.
2. Geographical location of the site:
The selected sites are located in the following localities:
• Fuentes de Ropel (Zamora)
• Toral de los Guzmanes (León)
• La Vellés (Salamanca)
• Coreses (Zamora)
• Almudévar (Huesca)
• Grañén (Huesca)
• Epila (Zaragoza)
• Sádaba (Zaragoza)
• Malpica de Tajo (Toledo)
• Buñuel (Navarra)
• Ribaforada (Navarra)
• Aranjuez (Madrid)
3. Size of the site (m2):
The surface occupied in every site by NK603 maize will be
less than:
• Fuentes de Ropel (Zamora): 2.500 m2
• Toral de los Guzmanes (León): 2.500 m2
• La Vellés (Salamanca): 9.000 m2
• Coreses (Zamora): 1.700 m2
• Almudévar (Huesca): 1.500 m2
• Grañén (Huesca): 13.500 m2
• Epila (Zaragoza): 10.200 m2
• Sádaba (Zaragoza): 2.500 m2
• Malpica de Tajo (Toledo): 10.000 m2
• Buñuel (Navarra): 1.800 m2
• Ribaforada (Navarra): 1.000 m2
• Aranjuez (Madrid): 13.500 m2
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 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 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. As 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.
• 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 is no
different from traditional 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
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 glyphosate in maize enables the farmer to take advantage
of the herbicide’s favourable environmental and safety
properties. 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:
The environmental risk assessment has indicated that the
environmental risks of this maize is negligible. Therefore,
strategies for risk management for NK603 maize would be the same
as for traditional maize.
However, 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 NK603 maize crop
and the interaction with its receiving environment.
In case any adverse environmental effects, linked to the
deliberate release of NK603 maize, are observed during the
period of release, these will be reported immediately to the
Competent Authority.
At the end of the field-testing campaign, a report of will be
made available by the notifier to the Competent Authority. This
report will detail any unexpected adverse environmental effects
that were observed during the general surveillance, if any, and
further actions elicited as an effect of these findings, if
applicable.
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 |
|
|
|
