Date of publication: March 31,
2005
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification number: B/FR/05/04.02
Member State: France
Date of Acknowledgement: 11/03/2005
Title of the Project:
Five year field trials programme (2005-2009) for development
of genetically modified maize MON 88017 x MON 810 protected
against certain Coleopteran and Lepidopteran insects and
tolerant to glyphosate herbicide.
Proposed period of release From:01/04/2005
To:31/12/2009
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? No
4 - Has the same GMPt been notified elsewhere by the same
notifier? No
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
|
MON
88017xMON 810 |
2. Description of the traits and characteristics which have
been introduced or modified, including marker genes and previous
modifications:
MON 88017 x MON 810 hybrid consists in the combination, by
conventional breeding, of two genetically modified inbred lines,
derived from maize transformation events MON 88017 and MON 810,
respectively.
MON 88017 x MON 810 expresses Cry3Bb1 protein, which provides
protection against certain coleopteran insects, including Corn
Root Worm (Diabrotica virgifera). The insecticidal activity of
the Cry3Bb1 protein is specific to coleopterans belonging to the
chrysomelidae family.
MON 88017 x MON 810 expresses CP4 EPSPS protein, which imparts
tolerance to glyphosate.
MON 88017 x MON 810 also expresses the Cry1Ab protein, which
provides the maize plant of protection from certain lepidopteran
insects, 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:
MON 88017 x MON 810 is obtained by conventional breeding
techniques
4. In case of insertion of genetic material, give the source
and intended function of each constituent fragment of the region
to be inserted:
Genetic modifications were solely used in the development of
lines MON 88017 and MON 810.
MON 88017 x MON 810, obtained by conventional breeding, contains
the following genetic elements:
- the cry3Bb1 gene from Bacillus thuringiensis subsp.
kumamotoensis which confers protection against Corn Root Worm
(Diabrotica virgifera);
- the cp4 epsps gene from Agrobacterium sp. strain CP4, which
provides tolerance to ghyphosate herbicide;
- the cry1Ab gene from Bacillus thuringienses subsp. kurstaki
which confers protection against European Corn Borer (Ostrinia
nubilalis) and pink borers (Sesamia spp.)
6. Brief description of the method used for the genetic
modification:
MON 88017 x MON 810 was created using conventional breeding
techniques. No additional genetic modification is used in the
production of MON 88017 × MON 810 varieties. Instead, MON 88017
× MON 810 is produced by a conventional cross of MON 88017 and
MON 810 inbred lines.
While MON 88017 × MON 810 results from conventional breeding,
genetic modification was used in the development of MON 88017
and MON 810.
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 aims of the dissemination are:
1. to test the performance of weed control programmes with
different rates/stages of glyphosate;
2. to evaluate the agronomic performance (yield) of maize when
sprayed with rates/stages of application of glyphosate and when
planted in areas infested by targeted pests,
3. to produce vegetative plant material and grain in order to
perform analyses of different parameters of the transformed
maize ,
4. to conduct small demonstrative platforms,
5. to follow seeds selection trials and seed production for
research,
6. to check equivalence to non-GM maize on agronomic parameters,
7. to check agronomic performances and compliance to DUS tests
in order to get modified varieties registered,
8. to store, handle, process transgenic seeds in our seed plant.
2. Geographical location of the site:
The releases are planned at several locations in 2005 in
France in Midi-Pyrénées.
3. Size of the site (m2):
Each site will have a maximum of 5 000 m² sown with MON 88017
x MON 810, the total trial surface for each site (including all
varieties and borders) being larger.
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:
General surveillance from environments outside the E.U. has
shown that MON 88017 x MON 810 and single-trait lines, MON 88017
and MON 810, are unlikely to pose any risk of adverse effects to
human or animal health or to the environment.
The two insect-protection traits and the glyphosate tolerance
trait present in MON 88017 x MON 810 are already present in
three commercial products, MON 863, MON 810 and NK603,
respectively.
Environmental
Impact and Risk Management
Summary of the potential
environmental impact from the release of the GMPts:
Analysis of the characteristics of MON 88017 × 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 MON 88017 × MON 810, is consistently
negligible:
- The risk of the introduced traits in MON 88017 × 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 conventional maize.
- As for parental MON 88017 and MON 810, MON 88017 × MON 810
poses negligible risk for adverse environmental effects through
its interaction with target organisms. The ecological
interactions of MON 88017 × MON 810 with non-target organisms or
soil processes are not different from conventional 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 Cry3Bb1 and Cry1Ab proteins on targeted
Coleopteran and Lepidopteran insect pests, respectively, also
these proteins pose negligible risks to non-target organisms.
- Any occupational health aspects of handling MON 88017 × MON
810 are no different from conventional 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
conventional maize.
Measures will be taken to avoid seed dissemination at harvest
and during transportation (see E.). Maize can hybridize with
teosinte but these plants are not present in Europe. The
possibility of hybridization with other maize plants will be
minimised by a spatial isolation distance of 200 meters form
other cultivated maize. Some trials (efficacy especially) could
be carried out without isolation. In this case, the trials will
be destroyed before the flowering stage of the crop. Four rows
of non transgenic maize (commercial hybrid) will surround all
the trials and act as pollen trap.
Brief description of any measures taken for the management of
risks:
1. 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 MON 88017 x MON
810 crop and that of its receiving environment. In case any
adverse environmental effects, linked to the deliberate release
of MON 88017 × MON 810, are observed during the period of
release, these will be reported immediately to the Competent
Authority.
2. The spatial isolation distance (200 m) from other maize crops
and the four rows of non transgenic maize surrounding the trials
will prevent most of the possibility of hybridisation with other
maize plants. Some trials (efficacy especially) could be carried
out without isolation. In this case, the trials will be
destroyed before the flowering stage of the crop.
3. The equipment, especially the experimental drill and combine,
will be cleaned on the experimental site, thus preventing seed
dissemination.
4. After completion of harvest, the stalks will be chopped and
then incorporated into the soil. Any shattered seed will be
allowed to germinate. The resulting seedlings will be destroyed
by soil incorporation. Maize cobs will be harvested by
experimental-plot combine, or by hand.
5. Although regrowth in the rotation crops is unlikely because
of poor winter survival, the site will be sown either with a
crop different from corn or with experimental corn that will be
destroyed and not used in any commercial, industrial or food
application. Volunteer plants will be controlled by the use of
routinely used commercial antimonocotyledonous herbicides in
this crop.
6. Seed will be transported in sealed and labelled bags placed
in a rigid container.
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. |
