Deliberate release into the E.U.
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
genetically modified maize MON 88017 x MON 810, tolerant to
glyphosate and protected against certain Coleopteran and
Lepidopteran insect pests |
Date of publication: January 20,
2006
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification number:
B/ES/06/03 Member
State:Spain
Date of Acknowledgement:07/11/2005
Title of the Project:
Notification according to Directive 2001/18/EC, Part B, for
the deliberate release of genetically modified maize MON 88017 x
MON 810, tolerant to glyphosate and protected against certain
Coleopteran and Lepidopteran insect pests.
Field trials program (2006-2009) for characterization and
development of MON 88017 x MON 810 maize, which was produced by
conventional breeding of two genetically modified parental
inbred lines of maize, one being derived from transformation
event MON 88017 (which is tolerant to glyphosate and protected
against certain Coleopteran) and one derived from event MON 810
(which is protected from certain lepidopteran insect pests).
Proposed period of release From:01/01/2006
To:31/12/2006
Name of the Institute(s) or Company(ies): Monsanto
Europe, S.A., represented by Monsanto Agricultura España, S.L.;
3. Is the same GMPt release planned elsewhere in the
Community?
Yes: Germany; Spain; France
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
88017 x MON 810 maize |
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 maize consists in the combination,
by conventional breeding, of two genetically modified parental
inbred lines, derived from maize transformation events MON 88017
and MON 810, respectively.
MON 88017 x MON 810 expresses CP4 EPSPS protein, which imparts
tolerance to glyphosate.
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 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 was obtained by conventional breeding.
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.)
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 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.
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 non-GM maize.
3. to evaluate residues after applications with herbicides
formulations based on glyphosate.
2. Geographical location of the site:
• Toral de los Guzmanes (León)
• Fuentes de Ropel (Zamora)
• Amudévar (Huesca)
• Grañén (Huesca)
• Epila (Zaragoza)
• Malpica de Tajo (Toledo)
• Buñuel (Navarra)
• Aranjuez (Madrid)
3. Size of the site (m2):
The total surface occupied by MON 88017 x MON 810 maize will
be lower than:
• Toral de los Guzmanes (León): 1.500 m2
• Fuentes de Ropel (Zamora): 1.500 m2
• Amudévar (Huesca): 1.500 m2
• Grañén (Huesca) : 1.500 m2
• Epila (Zaragoza) : 1.500 m2
• Malpica de Tajo (Toledo): 1.500 m2
• Buñuel (Navarra) : 1.500 m2
• Aranjuez (Madrid) : 1.500 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:
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, 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 x MON 810 maize,
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 x MON 810 maize, is negligible:
• The risk of the introduced traits in MON 88017 x MON 810 maize
to be the cause of any meaningful competitive advantage or
disadvantage in natural environments is negligible. As 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 x 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 88017x MON 810
maize are not 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.
It is actually expected that the commercial production of MON
88017 x MON 810 maize will positively impact current agronomic
practices in maize and provide benefits to farmers and the
environment.
Maize can hybridize with teosinte but these plants are not
present in Europe. Measures will be taken to avoid hybridization
with other maize plants and seed dissemination at harvest and
during transportation (see E.)
Brief description of any measures taken for the management of
risks:
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 x MON 810, are observed during the period of
release, these will be reported immediately to the Competent
Authority.
The spatial isolation distance (200 m) from other maize crops,
or the separation of at least one month in flowering times, and
the four rows of non transgenic maize, surrounding the trials,
will prevent most of the possibility of hybridization with other
maize plants.
The equipment, especially the experimental drill and combine,
will be cleaned on the experimental site, thus preventing seed
dissemination.
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.
Although regrowth in the rotation crops is unlikely because of
poor winter survival, the site will be sown either with a crop
different from maize or with experimental maize that will be
destroyed and not used in any commercial, industrial or food
application. Volunteer plants will be controlled by mechanical
destruction or other non-selective herbicides.
Seeds will be transported in sealed and labelled bags.
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 |
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