Date of publication: January 16,
2006
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification number:
B/FR/06/01/03
Member State: France
Date of Acknowledgement: 12/12/2005
Title of the Project:
Five year field trials programme (2006-2010) for the
deliberate release of MON 88017 x MON 810 maize protected
against certain coleopteran and lepidopteran insects and
tolerant to glyphosate herbicide.
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
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
|
MON88017xMON810 |
2. Description of the traits and characteristics which have
been introduced or modified, including marker genes and previous
modifications:
MON 88017 x MON 810 was obtained by conventional breeding, of
two genetically modified parental inbred lines, one derived from
MON 88017 and one derived from MON 810.
MON 88017 x MON 810 expresses:
- CP4 EPSPS protein, which imparts tolerance to glyphosate;
- Cry3Bb1 protein, which provides protection against certain
coleopteran insects, including Corn Root Worm (Diabrotica
virgifera);
- Cry1Ab protein, which confers protection from certain
lepidopteran insects, including European Corn Borer (Ostrinia
nubilalis) and pink borers (Sesamia spp.).
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
MON 88017 and MON 810.
MON 88017 x MON 810, obtained by conventional breeding, contains
the following genetic elements:
- the cp4 epsps gene from Agrobacterium sp. strain CP4, which
provides tolerance to ghyphosate herbicide;
- the cry3Bb1 gene from Bacillus thuringiensis subsp.
kumamotoensis which confers protection against Corn Root Worm
(Diabrotica virgifera);
- the cry1Ab gene from Bacillus thuringienses subsp. kurstaki
which confers protection against European Corn Borer (Ostrinia
nubilalis) and pink borers (Sesamia spp.)
These genes have been introduced with regulatory components
necessary for expression in plant cells.
6. Brief description of the method used for the genetic
modification:
MON 88017 x MON 810 was obtained 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.
MON 88017 was produced by Agrobacterium-mediated transformation
of immature embryos of maize tissue and MON 810 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 aims of the release are:
1. to characterize MON 88017 x MON 810 maize under European crop
conditions, including analysis for protein expression.
2. to evaluate the agronomic performance and equivalence of MON
88017 x MON 810 to conventional maize.
3. to evaluate residues after applications with herbicides
formulations based on glyphosate.
2. Geographical location of the site:
The releases are planned at several locations in 2006 in
France (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, 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 present, alone or in
combination, in commercial products, NK603, MON 863, MON 810,
MON 863 x MON 810, MON 863 x NK603, NK603 x MON 810, MON 863 x
MON 810 x NK603, which have a safety commercial experience.
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 conventional 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 conventional 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.
Final report
-
European
Commission administrative information
Consent given by the Competent
Authority: Not Known |
