Date of publication: December 19,
2006
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification number:
B/FR/06/12/13
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 x MON
810 for the use in field trials in France (2007).
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/04/163; B/ES/04/18; B/ES/04/20;
B/ES/06/07; B/ES/06/09; B/FR/00/02/06-CON; B/FR/04/02/01;
B/FR/06/01/04;
Other notifications
In addition, many field trials have
already been conducted across maize growing regions in North and
South America and other world area and NK603 × MON 810 has been
commercially released for cultivation in the U.S.A., since 2002.
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 |
NK603 × MON 810 |
2. Description of the traits and
characteristics which have been introduced or modified,
including marker genes and previous modifications:
NK603 x MON 810 consists in the
combination, by traditional breeding, of two genetically
modified parental maize lines, NK603 and MON 810, respectively.
NK603 x MON 810 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-containing 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 also expresses the
Cry1Ab 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 Cry1Ab protein is specific to
predation by the larvae of the targeted lepidopterans.
Genetic modification
3. Type of genetic modification:
Insertion; Other;
Other
NK603 x MON 810 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.
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 results from
traditional breeding of NK603 and MON 810, homozygous in their
respective inserted sequences. By crossing NK603 and MON 810,
NK603 × MON 810 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
First cp4 epsps gene cassette
P-ract1/ ract1 intron : Oryza sativa : Contains promoter,
transcription start site and first intron.
Ctp 2 : Arabidopsis thaliana : Encodes chloroplast transit
peptide, which directs the CP4 EPSPS protein to the chloroplast
cp4 epsps : Agrobacterium sp. strain CP4 : Encodes
glyphosate-tolerant CP4 EPSPS protein
NOS 3’ : Agrobacterium tumefaciens : Ends transcription and
directs polyadenylation of the mRNA.
Second cp4 epsps gene cassette
e35S : Cauliflower mosaic virus : Promoter
Zmhsp70 : Zea mays L. : Stabilizes the level of gene
transcription.
Ctp 2 : Arabidopsis thaliana : Encodes chloroplast transit
peptide, which directs the CP4 EPSPS protein to the chloroplast
cp4 epsps l214p : Agrobacterium sp. strain CP4 : Encodes
glyphosate-tolerant CP4 EPSPS L214P protein1
NOS 3’ : Agrobacterium tumefaciens : Ends transcription and
directs polyadenylation of the mRNA.
Table 2. Components of the inserted DNA fragment inherited from
MON 810 Genetic
e35S : Cauliflower mosaic virus : Promoter
Zmhsp70 : Zea mays L. : Stabilizes level of gene transcription.
Cry1Ab : Bacillus thuringiensis : Encodes Cry1Ab protein, which
targets specific lepidopteran insect pests
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 glyphosate-tolerance trait from
NK603, as well as the lepidopteran-protection trait from MON
810. While NK603 × MON 810 results from traditional breeding,
genetic modification was used in the development of the parental
NK603 and MON 810. 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 will be planted in
field trials: the proposed experiments are part of a 1 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,
2 - to study of the effectiveness of maize weeding programmes
involving different combinations of doses and stages of
application of ROUNDUP herbicides.
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 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 x MON 810 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 2002
provided no significant evidence that NK603 × MON 810 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 × MON 810, especially in comparison with extensive
experience with cultivation of conventional 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, is
consistently negligible:
· The risk of the introduced traits in NK603 × MON 810 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 to any wild
plant species in Europe.
· As for parental MON 810 maize, NK603 × MON 810 poses
negligible risk for adverse environmental effects through its
interaction with target organisms. The ecological interactions
of NK603 × MON 810 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
Cry1Ab 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
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. Since no characteristics of NK603 × MON 810
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 × MON 810 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.
Other benefits of planting this maize result from its
lepidopteran-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)
potential for reduced use to hazardous chemical insecticides and
reduced applicator exposure to these products; 4) fit with
integrated pest management (IPM) and sustainable agricultural
systems; 5) potential for reduced 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 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 crop and that of its receiving
environment.In case any adverse environmental effects, linked to
the deliberate release of NK603 × MON 810, 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 |
