Date of publication: January 16,
2006
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification number:
B/FR/06/01/04
Member State: France
Date of Acknowledgement: 12/12/2005
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 France (2006-2007-2008-2009-2010).
Proposed period of release From:01/04/2006
To:31/12/2010
Name of the Institute(s) or Company(ies): Monsanto
Company represented by Monsanto Agriculture France S.A.S;
3. Is the same GMPt release planned elsewhere in the
Community?
Yes: Germany; Spain; Italy
4 - Has the same GMPt been notified elsewhere by the same
notifier?
Yes
If yes, notification number(s):
B/DE/04/163; B/ES/04/18; B/ES/04/20; B/FR/04/02/01
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
|
NK603xMON810 |
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 maize
lines, 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 lepidopterans.
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 traditional breeding of
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 given in Tables 1 and 2.
Table 1. Components of the inserted DNA fragment inherited from
NK603
Genetic Element
Source Size (kb) Function
First cp4 epsps gene cassette
P-ract1/ ract1 intron Oryza sativa 1.4
Contains promoter, transcription start site and first intron.
Ctp 2 Arabidopsis thaliana 0.2
Encodes chloroplast transit peptide, which directs the CP4 EPSPS
protein to the chloroplast
cp4 epsps Agrobacterium sp. strain CP4 1.4
Encodes glyphosate-tolerant CP4 EPSPS protein
NOS 3’ Agrobacterium tumefaciens 0.3
Ends transcription and directs polyadenylation of the mRNA.
Second cp4 epsps gene cassette
e35S Cauliflower mosaic virus 0.6
Promoter
Zmhsp70 Zea mays L. 0.8
Stabilizes the level of gene transcription.
Ctp 2 Arabidopsis thaliana 0.2
Encodes chloroplast transit peptide, which directs the CP4 EPSPS
protein to the chloroplast
cp4 epsps l214p Agrobacterium sp. strain CP4 1.4
Encodes glyphosate-tolerant CP4 EPSPS L214P protein1
NOS 3’ Agrobacterium tumefaciens 0.3
Ends transcription and directs polyadenylation of the mRNA.
Table 2. Components of the inserted DNA fragment inherited from
MON 810
Genetic Element
Source Size (kb) Function
e35S Cauliflower mosaic virus 0.32
Promoter
Zmhsp70 Zea mays L. 0.8
Stabilizes level of gene transcription.
Cry1A(b) Bacillus thuringiensis 3.5
Encodes Cry1A(b) protein, which targets specific lepidopteran
insect pests
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 x MON 810 is created using conventional breeding
techniques. No additional genetic modification is utilised in
the production of NK603 × MON 810. Typically, NK603 × MON 810
hybrids are 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 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:
NK603 x MON 810 maize will be planted in field trials : the
proposed experiments are part of a 5 year field testing
programme.
The aims of the programme are :
1 - to confirm by qualitative and quantitative measurements
(yields) of the agronomic performance of NK603 × MON 810 maize,
2 - to study of the effectiveness of maize weeding programmes
involving different combinations of doses and stages of
application of ROUNDUP.
3 - to study the lepidopteran insect protection of maize plants,
4 - to verify in the fields the performance of NK603 × MON 810
hybrids with a view to their inclusion in the official varieties
catalogue,
5 - to follow seeds selection trials and seeds production for
research,
6 - to present plots for transgenic maize set up within the
framework of technical demonstration trials.
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 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. Moreover, there is
no potential for gene transfer from NK603 × MON 810 maize to any
wild plant species in Europe.
- 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 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.
Final report
-
European
Commission administrative information
Consent given by the Competent
Authority: Not Known |
