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, tolerant to glyphosate and
protected against Corn Root Worm (Diabrotica virgifera). Field
trials program (2006-2009) for characterization and development
of MON 88017 maize |
Date of publication: January 20,
2006
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification number:
B/ES/06/02 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,
tolerant to glyphosate and protected against Corn Root Worm
(Diabrotica virgifera). Field trials program (2006-2009) for
characterization and development of MON 88017 maize.
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 maize |
2. Description of the traits and characteristics which have
been introduced or modified, including marker genes and previous
modifications:
MON 88017 that will be tested in these field trials is
protected against certain Coleopteran insects, such as Corn Root
Worm (Diabrotica virgifera) and is tolerant to glyphosate
herbicide.
Genetic
modification
3. Type of genetic
modification:
Insertion;
4. In case of insertion of genetic material, give the source
and intended function of each constituent fragment of the region
to be inserted:
MON 88017 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.
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 was produced by Agrobacterium-mediated
transformation of immature embryos of maize tissue.
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 maize under European crop
conditions, including analysis for protein expression.
2.to evaluate the agronomic performance and equivalence of MON
88017 to non-GM maize.
3.to evaluate residues after applications with herbicide
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 maize in every site
will be less 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:
Many field trials have already been conducted at several
locations across maize growing regions in North and South
America. No environmental problems were reported for these
trials. Except for its protection against certain coleopteran
insects and its tolerance to glyphosate herbicide, MON 88017
could not be distinguished from the non-genetically modified
maize.
Insect-protection and glyphosate tolerance traits present in MON
88017 are already present in two commercial products, MON 863
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 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 maize, is negligible:
• The risk of the introduced trait in MON 88017 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.
• Potential exposure of non-target organisms to CP4 EPSPS
presents no conceivable mechanism to cause adverse effects
because of its properties. Due to the high selectivity of
Cry3Bb1 protein to certain Coleopteran insects and based on
studies with different species, the risk for non target
organisms is considered negligible. The ecological interactions
of MON 88017 maize with non target organisms or soil process are
considered similar to the respective caused by conventional corn
• Any occupational health aspects of handling MON 88017 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 maize will positively impact current agronomic practices
in maize and provide benefits to farmers and the environment.
The protection against D. virgifera would offer a new tool for
IPM and would reduce the reliance on chemical pesticides whereas
the use of glyphosate in maize would enable the farmer to take
advantage of the herbicide’s favorable environmental and safety
properties (see Annex I listing of glyphosate under Council
Directive 91/414/EEC) as well as facilitate adoption of
conservation tillage practice in corn production.
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 crop
and that of its receiving environment. In case any adverse
environmental effects, linked to the deliberate release of MON
88017, 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 labeled 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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