Date of publication: February 21,
2006
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification number: B/DE/05/169
Member State:Germany
Date of Acknowledgement:24/10/2005
Title of the Project:
Notification according to Directive 2001/18/EC, Part B, for
the deliberate release of MON 88017 × MON 810 maize and its
parental lines for the use in field trials in Germany.
Proposed period of release From:01/01/2006
To:31/12/2010
Name of the Institute(s) or Company(ies): Monsanto
Company;
3. Is the same GMPt release planned elsewhere in the
Community?
Yes: Spain; France
4 - Has the same GMPt been notified elsewhere by the same
notifier?
Yes
If yes, notification number(s):
-
Other notifications
In the E.U., EFSA/GMO/CZ/2006/33 (Food, feed, import and
processing) In the U.S., MON 88017, MON 810 and the combined
trait product MON 88017 x MON 810 can be lawfully used for the
full range of uses of traditional maize. The status of other
pending regulatory reviews, which are currently in progress in
numerous countries around the world, typically depend on the
country and its local regulatory framework.
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
|
MON88017 x MON810 and MON810 |
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:
MON88017 × MON810 hybrid maize consists in the combination,
by traditional breeding, of two genetically modified parental
inbred lines, one derived from MON 88017 and one derived from
MON 810, respectively.
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:
MON 88017 × MON 810 maize and its parental lines will be
planted in field trials for assessment of phenotypic
characteristics and agronomic performance, and for variety
trials.
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 data after applications with herbicides
formulations based on glyphosate.
2. Geographical location of the site:
The releases are planned at several German locations, which
are representative for corn growing areas in Germany.
3. Size of the site (m2):
max. 10.000 m2 per site and year
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 expressed in MON 88017 x MON 810 are also present, alone
or in combination, in the following 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 proven safety
under commercial use.
Environmental
Impact and Risk Management
Summary of the potential
environmental impact from the release of the GMPts:
Note especially if the introduced traits could directly or
indirectly confer an increased selective advantage in natural
environments; also explain any significant expected
environmental benefits
Analysis of the characteristics of MON 88017 × MON 810 and its
parental lines, 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 and its
parental lines 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 specific 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, safety, nutrition aspects of MON 88017
× MON 810 and its parental lines are not different from
conventional maize.
The environmental impact of the cultivation, management and
harvesting techniques applied in the planned trials is not
considered to be different from the farming practices for
traditional maize.
Measures will be taken to avoid seed dissemination at harvest
and during transportation (see E.). The possibility of
hybridization with other maize plants will be minimised by a
spatial isolation zone from other cultivated maize. Additionally
conventional maize will be planted around the trials and thus GM
pollen flow will be minimised.
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 maize and its parental lines and of its receiving
environment.
The spatial isolation distance from other maize crops and the
conventional maize surrounding the trials will prevent most of
the possibility of hybridisation with other maize plants.
The equipment, especially the experimental drill and combine,
will be cleaned on the experimental site, thus preventing seed
dissemination.
During harvest samples will be taken either by experimental-plot
combine or by hand for further analysis.
Remaining plant material will be inactivated on the trial site
for further degradation.
All important activities in the frame of the deliberate release
will be reported as requested by regulation 2003/701/EU.
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 |
