Deliberate release into the
environment of GMOs for any other purposes than placing on the
market:
Notification according to Directive
2001/18/EC, Part B, for the deliberate release of NK603 maize
for the use in field trials in Spain. |
Date of publication: December 22, 2004,
updated march 8, 2005
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification
report
General information
Notification Number: B/ES/04/19
Member State: Spain
Date of Acknowledgement:08/11/2004
Title of the Project:
Notification according to Directive 2001/18/EC, Part B, for
the deliberate release of NK603 maize for the use in field
trials in Spain.
This application is to advance in the evaluation and agronomic
characterization of promising hybrid maize varieties derived
from transformation event NK603 (which is tolerant to treatment
with glyphosate). The NK603 maize will be used in field trials.
Proposed period of release From:01/01/2005
To:31/12/2007
Name of the Institute(s) or Company(ies): Monsanto
Agricultura España S.L.;
3. Is the same GMPt release planned elsewhere in the
Community?
Yes: Germany; Spain; France; Italy
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
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: Contains promoter, transcription start
site and first intron, from Oryza sativa, (size 1.4Kb).
- Ctp 2 : Encodes chloroplast transit peptide, which directs the
CP4 EPSPS protein to the chloroplast, from Arabidopsis thaliana,
(size 0.2 Kb).
- cp4 epsps: Encodes glyphosate-tolerant CP4 EPSPS protein, from
Agrobacterium sp. strain CP4, (size 1.4 Kb).
- NOS 3’: Ends transcription and directs polyadenylation of the
mRNA, from Agrobacterium tumefaciens,(size 0.3Kb).
Second cp4 epsps gene cassette:
- e35S: Promoter, from Cauliflower mosaic virus, (size 0.6 Kb).
- Zmhsp70: Stabilizes the level of gene transcription, from Zea
mays L., (size 0.8 Kb).
- Ctp 2 : Encodes chloroplast transit peptide, which directs the
CP4 EPSPS protein to the chloroplast, from Arabidopsis thaliana,
(size 0.2 Kb).
- cp4 epsps l214: Encodes glyphosate-tolerant CP4 EPSPS L214P
protein(1) , from Agrobacterium sp. strain CP4, (size 1.4 Kb).
- NOS 3’: Ends transcription and directs polyadenylation of the
mRNA, from Agrobacterium tumefaciens, (size 0.3 Kb).
(1) The substitution of leucine by proline in the CP4 EPSPS
encoded by the second cp4 epsps gene in the NK603 insert is
indicated by the suffix L214P.
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 of maize varieties derived from transformation
event NK603 (which is tolerant to treatment with Roundup
herbicide containing glyphosate), has the purpose of advancing
in the evaluation and characterization of new maize varieties,
for possible variety Registration submission and cultivation by
Spanish farmers.
2. Geographical location of the site:
- Maribañez (Los Palacios y Villafranca, Sevilla)
- Fuente Palmera (Córdoba)
- Almudevar (Huesca)
- Huerto (Huesca)
- Estadilla ( Huesca)
- Torrijos (Toledo)
- Cisterniga (Valladolid)
- Fuentes de Ropel (Zamora)
- Guadiana del Caudillo (Badajoz)
- Buñuel (Navarra)
3. Size of the site (m2):
The total surface will be lower than 15.000 m2 (1 ha) and the
potential surface occupied in every site by NK603 maize will be:
- Maribañez (Los Palacios y Villafranca, Sevilla): 180 m2
- Fuente Palmera (Córdoba): 180 m2
- Almudevar (Huesca): 1.680 m2
- Huerto (Huesca): 1.680 m2
- Estadilla ( Huesca): 1.680 m2
- Torrijos (Toledo): 1.080 m2
- Cisterniga (Valladolid): 600 m2
- Fuentes de Ropel (Zamora): 600 m2
- Guadiana del Caudillo (Badajoz): 1.080 m2
- Buñuel (Navarra): 1.680 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 (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:
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. |
|
|
|
