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 NK603 maize varieties tolerant to
glyphosate herbicide - 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/05/01/2
Member State: Hungary
Date of Acknowledgement:
Title of the Project:
Program of field agronomic trials and registration trials
with NK603 maize varieties tolerant to glyphosate herbicide
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/05/01.03
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:
The NK603 maize varieties has been made tolerant to
glyphosate herbicide using Monsanto's event (NK603 maize; the
OECD unique identifieris MON-00603-6).
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:
NK603 maize has been genetically modified by the introduction
of the cp4epsps gene from Agrobacterium sp. strain CP4. The
cp4epsps gene encodes for an enzyme (CP4 EPSPS,
5-enolpyruvylshikimate-3 phosphate synthase) that is naturally
tolerant to glyphosate, the active ingredient of a
broad-spectrum herbicide.
6. Brief description of the method used for the genetic
modification:
NK603 maize, from Monsanto, has been modified by
incorporation of a restriction fragment of plasmid DNA into the
maize genome 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 purpose of the release is to evaluate genetically
modified maize varieties tolerant to glyphosate herbicide. Two
types of trials are planned:
- trials to collect data on the agronomic value and insect
resistance of the transgenic maize,
- 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:
Pioneer Hi-Bred Magyarország Kft. 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:
The placing on the US market of NK603 maize has been
authorized in September 2000 by the American regulatory
administrations and subsequently NK603 maize has been
commercialized in the USA, under the trade name Roundup Ready.
In addition, NK603 maize has already been approved for import in
Australia, Colombia, Korea, Japan, Mexico, the Philippines,
Russia and Taiwan, and has received authorization for
cultivation in Argentina, Bulgaria, Canada, Japan and South
Africa.
It has also been applied for import and for cultivation of NK603
maize varieties in the European Union (notifications C/ES/00/01
and C/ES/03/01, respectively submitted by Monsanto). The placing
on the market of NK603 maize for import and processing has been
authorized by the Commission of the European Communities for
feed use (Commission decision of 19 July 2004) and food use
(Press release of 26 October 2004).
Also, many field trials have been carried out in Europe. No
environmental problems were reported from these trials.
Environmental
Impact and Risk Management
Summary of the potential
environmental impact from the release of the GMPts:
Environmental impact of the NK603 maize as stated in the
notification:
1. Likelihood of the genetically modified plants becoming more
persistent than parent or recipient plants in an agricultural
habitat or more invasive in a natural habitat: maize is not
persistent in an agricultural habitat and the tested
transformation does not change this characteristic.
2. Selective advantages or disadvantages conferred to other
sexually compatible plant species, that could result in transfer
of genetic material from the genetically modified plant: there
are no sexually compatible species as far as maize is concerned
in Europe.
3. Other ecological impacts from the interaction of the
genetically modified plant and target organisms: there are no
organisms targeted by the genetic modification.
4. Potential effects on niche-reorganization: the genetically
modified plants have no invasive potential and no wild relative.
So no potential effects are expected on the plant environment.
5. Potential effects on non-target organisms: not applicable.
An environmental risk assessment has been carried out by
Monsanto in accordance with Annex II of Directive 2001/18/EC
(please see notification C/ES/03/01).
As stated in the Summary Notification Information Format for
C/ES/03/01, available on web site http://gmoinfo.jrc.it/,
analysis of the characteristics of NK603 maize has shown that
the likelihood of potential adverse effects on human health and
the environment in the European Union, resulting from its import
and use as any other maize, including the cultivation of NK603
maize varieties and the use of this maize in animal feed, is
consistently negligible. Therefore, the overall environmental
risk posed by the genetically modified plant is also negligible,
and strategies for risk management for NK603 maize would be the
same as for traditional maize.
Brief description of any measures taken for the management of
risks:
A 200 meter-isolation distance will be maintained between the
transgenic tested varieties and any other commercial maize crop.
In addition, the trial site 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.
Seed dispersal of individual kernels does not occur. They are
fixed on a cob and enclosed in many husks that protect the seeds
from outside contact.
For this trial, kernels might be collected for analysis needs.
This will be done by sampling the whole ear and destroying the
remaining ear and unused kernels.
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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