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 x MON
810 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/04/18
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 x MON 810 maize for the use in
field trials in Spain.
This application under Directive 2001/18/EC, Part B is for
deliberate release of NK603 x MON 810 maize, comprising hybrid
maize varieties that are produced by traditional breeding of two
genetically modified parental inbred lines of maize, one being
derived from transformation event NK603 (which is tolerant to
treatment with Roundup herbicide containing glyphosate) and the
second one derived from event MON 810 (which is protected from
certain lepidopteran insect pests. NK603 x MON 810 maize will be
used in field trials.
Proposed period of release From:01/01/2005
To:31/12/2006
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/04/01
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
x MON 810 maize |
2. Description of the traits and characteristics which have
been introduced or modified, including marker genes and previous
modifications:
NK603 x MON 810 hybrid maize consists in the combination, by
traditional breeding, of two genetically modified parental
inbred lines, derived from maize transformation events NK603 and
MON 810, respectively.
NK603 x MON 810 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.
NK603 x MON 810 maize also expresses the Cry1A(b) protein, which
provides the maize plant of protection from certain lepidopteran
insect pests, including European Corn Borer (Ostrinia nubilalis)
and pink borers (Sesamia spp.). The insecticidal activity of the
Cry1A(b) protein is specific to predation by the larvae of the
targeted lepidoptera.
Genetic
modification
3. Type of genetic
modification:
Insertion; Other:
NK603 x MON 810 hybrid maize consists in the combination, by
traditional breeding, of two genetically modified parental
inbred lines, derived from maize transformation events NK603 and
MON 810, respectively. No additional genetic modification is
involved.
4. In case of insertion of genetic material, give the source
and intended function of each constituent fragment of the region
to be inserted:
NK603 × MON 810 maize results from a single conventional
cross of the inbred parental lines NK603 maize and MON 810
maize, homozygous in their respective inserted sequences.
By crossing NK603 and MON 810 maize, NK603 × MON 810 maize
inherits the inserted DNA fragments from both its parental
lines. The individual components and the function of the
inherited sequences are:
*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.
*Components of the inserted DNA fragment inherited from MON 810
maize:
- e35S: Promoter, from Cauliflower mosaic virus, (size 0.6 Kb).
- Zmhsp7: Stabilizes level of gene transcription, from Zea mays
L., (size 0.8 Kb).
- Cry1A(b): Encodes Cry1A(b) protein, which targets specific
lepidopteran insect pests, from Bacillus thuringiensis, (size
3.5 Kb).
6. Brief description of the method used for the genetic
modification:
NK603 x MON 810 hybrid maize was created using conventional
breeding techniques. No additional genetic modification is
utilised in the production of NK603 × MON 810 maize hybrid
varieties. Instead, NK603 × MON 810 hybrid maize is produced by
a single traditional cross of NK603 and MON 810 parental inbred
lines (homozygous for the respective introduced trait). F1
hybrid seed thereby inherits the introduced Roundup Ready trait
from NK603 maize, as well as the insect-protection trait from
MON 810 maize.
While NK603 × MON 810 hybrid maize results from traditional
breeding, genetic modification was used in the development of
the parental NK603 and MON 810 maize. These single trait
parental maize lines were 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 that are produced by
traditional breeding of two genetically modified parental inbred
lines of maize, one being derived from transformation event
NK603 (which is tolerant to treatment with Roundup herbicide
containing glyphosate) and the second one derived from event MON
810 (which is protected from certain lepidopteran insect pests),
has the aim to complete the information to allow their
inscription in the Spanish seed variety Registration, for
possible 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 10.000 m2 (1 ha) and the
potential surface occupied in every site by NK603 x MON 810
maize will be:
- Maribañez (Los Palacios y Villafranca, Sevilla): 500 m2
- Fuente Palmera (Córdoba): 500 m2
- Almudevar (Huesca): 480 m2
- Huerto (Huesca): 480 m2
- Estadilla ( Huesca): 480 m2
- Torrijos (Toledo): 400 m2
- Cisterniga (Valladolid): 80 m2
- Fuentes de Ropel (Zamora): 80 m2
- Guadiana del Caudillo (Badajoz): 400 m2
- Buñuel (Navarra): 480 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 x MON 810 maize and
its single-trait parental lines, NK603 and MON 810 maize, are
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 × MON 810 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 × MON 810 maize, is consistently
negligible:
•The risk of the introduced traits in NK603 × MON 810 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.
•As for parental MON 810 maize, NK603 × MON 810 maize poses
negligible risk for adverse environmental effects through its
interaction with target organisms. The ecological interactions
of NK603 × MON 810 maize with non-target organisms or soil
processes are not different from traditional maize. Potential
exposure of non-target organisms to CP4 EPSPS presents no
conceivable mechanism to cause adverse effects because of its
properties, and due to the highly selective insecticidal
activity of the Cry1A(b) protein on the larvae of specifically
targeted Lepidopteran insect pests, also this protein poses
negligible risks to non-target organisms.
•Any occupational health aspects of handling NK603 × MON 810
maize are 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
× MON 810 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. Other benefits of planting
this maize result from its insect-protection trait and include:
1) a reliable means to control the target Lepidopteran maize
pests; 2) control of target insects while maintaining beneficial
species; 3) reduced use and applicator exposure to chemical
insecticides; 4) fit with integrated pest management (IPM) and
sustainable agricultural systems; 5) potential for reduced
fumonisin mycotoxin levels in maize kernels; and 6) no
additional labour or machinery requirements, allowing both large
and small growers to maximize hybrid yields.
Brief description of any measures taken for the management of
risks:
The environmental risk assessment has indicated that the
environmental risks of this maize are negligible. Therefore,
strategies for risk management for NK603 × MON 810 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 x MON 810
maize crop and that of its receiving environment.
In case any adverse environmental effects, linked to the
deliberate release of NK603 × MON 810 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. |
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