Deliberate release into the E.U.
environment of GMOs for any other purposes than placing on the
market:
Program of field agronomic trials and
registration trials with NK603xMON810 maize varieties tolerant
to glyphosate herbicide and resistant to certain lepidopteran
insects - Hungary - Pioneer Hi-Bred Hungary Ltd. |
Date of publication: February 16,
2005
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification
report
General information
Notification Number:
B/HU/05/01/3
Member State: Hungary
Date of Acknowledgement:03/02/2005
Title of the Project:
Program of field agronomic trials and registration trials
with NK603xMON810 maize varieties tolerant to glyphosate
herbicide and resistant to certain lepidopteran insects
Proposed period of release From:01/04/2005
To:31/12/2008
Name of the Institute(s) or Company(ies): Pioneer
Hi-Bred Hungary Ltd.;
3. Is the same GMPt release planned elsewhere in the
Community?
Not known
4 - Has the same GMPt been notified elsewhere by the same
notifier?
Yes
If yes, notification number(s):
B/FR/05/01.05
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
|
experimental varieties |
2. Description of the traits and characteristics which have
been introduced or modified, including marker genes and previous
modifications:
By traditional crossing of two genetically modified maize
inbred lines, one being tolerant to glyphosate herbicide (NK603
maize, the OECD unique identifier assigned is MON-00603-6), the
other one being resistant to certain Lepidopteran insects
(MON810 maize, the OECD unique identifier assigned is
MON-00810-6), the notifier obtained maize hybrids tolerant to
glyphosate herbicide and resistant to certain Lepidopteran
insects.
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:
The NK603xMON810 maize hybrids contain the genetic elements
introduced in their parental inbred lines. The NK603xMON810
maize hybrids are tolerant to herbicide ‘glyphosate’ due to the
introduction of cp4 epsps genes isolated from Agrobacterium sp.
strain CP4 (NK603 maize), and resistant to certain lepidopteran
insect pests due to the introduction of the cry1Ab gene isolated
from Bacillus thuringiensis subsp. kurstaki (MON810 maize)
6. Brief description of the method used for the genetic
modification:
The NK603xMON810 hybrids were obtained by the traditional
crossing of two genetically modified inbred lines: NK603 maize
and MON810 maize.
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 purpose of the release is to evaluate NK603xMON810 maize
hybrids tolerant to glyphosate herbicide and resistant to
certain lepidopteran insect pests. Two types of trials are
planned:
o trials to collect data on the agronomic value and insect
resistance of the transgenic maize,
o trials in view of registration (VCU; Value for Cultivation and
Use and DUS Distinctness, Uniformity, Stability) of the
transgenic hybrids on the National List of Hungary.
2. Geographical location of the site:
The National Institute For Agricultural Quality Control
(OMMI) is going to set in the trials in two counties in two
locations. The trials will be in county Fejér and Pest.
County Fejér:
Enying, Agrár Rt., B-2 tábla
County Pest:
Sóskút, Sóskút Fruct Gyümölcstermelo; Kft., hrsz. 0106
3. Size of the site (m2):
Each of the 2 sites for 2005 will have 110 m2 sown with the
genetically modified plants concerned by this application, the
total surface area taken up by this trial (all varieties and
borders included) is about 800 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 experiments have already been carried out, based on
current knowledge, and the expression products of the introduced
genes are not known to be toxic for human or potentially
allergenic.
NK603xMON810 maize has been commercially grown in the U.S.A
since 2002 and, to our knowledge, no harmful effects on human
health were reported.
In addition, in Europe, cultivation of MON810 maize has been
approved since 1998 (Commission decision of April 22, 1998, no
98/294/CE) and import of NK603 maize has been approved by
Commission decision of July 19, 2004 (no 2004/643/CE).
NK603xMON810 maize grain, containing the NK603 and MON810
inserts, is as safe and nutritious as traditional maize hybrids,
as stated in the SNIF relating to notification C/ES/04/01, which
is available on web site http://gmoinfo.jrc.it/.
Nonetheless, the grain that may be harvested from these trials
will not enter the food or the feed chain.
Environmental
Impact and Risk Management
Summary of the potential
environmental impact from the release of the GMPts:
An environmental risk assessment has been carried out by
Monsanto in accordance with Annex II of Directive 2001/18/EC
(notifications C/GB/02/M3/3 and C/ES/04/01).
As stated in the Summary Notification Information Format
relating to notification C/ES/04/01, available on website
http://gmoinfo.jrc.it/, analysis of the characteristics of
NK603xMON810 maize has shown that the likelihood of potential
adverse effects on human health and the environment in the
European Union, resulting from its cultivation and use as any
other maize, is consistently negligible. Therefore, the overall
environmental risk posed by the genetically modified plant is
also negligible, and strategies for risk management for
NK603xMON810 maize would be the same as for traditional maize,
as stated in the notification. However, an insect resistance
management (IRM) strategy will be developed in the context of
product stewardship for the placing on the market of
NK603xMON810 maize.
The overall environmental risk posed by the deliberate release
of the genetically modified plant is also negligible.
Brief description of any measures taken for the management of
risks:
Pollen flow from the genetically modified plants will be
controlled by a 200-meter isolation distance to commercial maize
crop. In addition, the trial will be surrounded by 4 border rows
of conventional maize of a similar relative maturity that will
be also destroyed at the end of the release.
Summary of foreseen field trial studies focused to gain new
data on environmental and human health impact from the release:
Not applicable to this release. |
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