Date of publication: June 12,
2006
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification number:
B/PL/06/02-06
Member State:Poland
Date of Acknowledgement:27/02/2006
Title of the Project: Official variety testing of NK
603 Roundup Ready® corn hybrid for national list of variety
Proposed period of release From:15/04/2006
To:15/10/2010
Name of the Institute(s) or Company(ies): Monsanto
Polska Sp. z o.o.;
3. Is the same GMPt release planned elsewhere in the
Community?
No
4 - Has the same GMPt been notified elsewhere by the same
notifier?
Yes
If yes, notification number(s):
B/BE/00/WSP13; B/DE/00/115; B/DE/03/148; B/ES/00/06;
B/ES/01/05; B/ES/02/03; B/ES/04/17; B/ES/04/19; B/ES/06/06;
B/ES/06/08; B/FR/00/03/05; B/FR/01/01/01; B/FR/04/02/02;
B/FR/06/01/01; B/FR/99/04/06; B/IT/02/01; B/IT/99/17;
B/SE/05/9831
Other notifications
Other notifications: Czech Republic 26OA/OER/GMO/02, Hungary
24.111/2/2003 and 12269/2004). In 2003, NK603 maize is already
registered in several world areas outside the E.U., including
the U.S.A., Japan, Canada and Bulgaria for cultivation, and in
Mexico, Australia and Russia for import of grain for food
purposes. Since 2001, NK603 maize has been commercially released
for cultivation in the U.S.A. and Canada.
Genetically
modified plant
1. Complete name of the
recipient or parental plant(s)
|
Common Name
|
Family Name
|
Genus
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Species
|
Subspecies
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Cultivar/breeding line
|
|
maize |
poaceae |
zea |
zea mays |
mays |
line NK 603
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2. Description of the traits and characteristics which have
been introduced or modified, including marker genes and previous
modifications:
NK603 Roundup Ready maize was modified by incorporation of a
restriction fragment of plasmid DNA, designated as PV-ZMGT32L,
into the maize genome using a particle acceleration method
NK603 Roundup Ready maize was generated using a particle
acceleration transformation system and a gel-isolated MluI
fragment, PV ZMGT32L (Figure 1), containing a
5-enolpyruvyl¬shikimate-3-phosphate synthase (EPSPS) gene from
Agro¬bacterium sp. strain CP4 (CP4 EPSPS). The cp4 epsps gene
encodes a tolerant form of EPSPS, which confers glyphosate
(Roundup Ready®) tolerance to the plant
The expression of glyphosate-tolerant CP4 EPSPS proteins in
NK603 Roundup Ready® maize plants imparts tolerance to
glyphosate (N-phosphonomethyl-glycine), the active ingredient in
the non-selective, foliar-applied, broad-spectrum, post-emergent
herbicide Roundup Ready® 360 SL
EPSPS is an enzyme involved in the shikimic acid pathway for
aromatic amino acid biosynthesis in plants and micro-organisms.
CP4 EPSPS enzymes have been shown to have significantly reduced
affinity for glyphosate when compared with the wild-type maize
enzyme, and to retain catalytic activity in the presence of the
inhibitor glyphosate. Therefore, when maize plants expressing
the CP4 EPSPS proteins are treated with glyphosate, the plants
are unaffected since the continued action of the tolerant CP4
EPSPS enzymes provides for the plant’s need for aromatic amino
acids. The use of maize plants containing the Roundup Ready
genes for maize production enables the farmer to utilize Roundup
Ready® 360 SL herbicide for effective control of weeds during
the growing season and to take advantage of the favorable
environmental and safety characteristics of Roundup Ready® 360
SL.
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:
Genetic elements present in the MluI restriction fragment,
designated
PV-ZMGT32L, used for transformation:
cp4 epsps gene cassette (1)
P-ract1/ ract1 intron Oryza sativa 1.4, 5’ region of the rice
actin 1 gene containing the promoter, transcription start site
and first intron.
ctp 2 Arabidopsis thaliana 0.2 DNA sequence for chloroplast
transit peptide, isolated from Arabidopsis thaliana EPSPS,
present to direct the CP4 EPSPS protein to the chloroplast, the
site of aromatic amino acid synthesis.
cp4 epsps Agrobacterium sp. strain CP4 1.4 The DNA sequence for
CP4 EPSPS, isolated from Agrobacterium sp. strain CP4, which
imparts tolerance to glyphosate.
NOS 3’ Agrobacterium tumefaciens 0.3 A 3’ nontranslated region
of the nopaline synthase gene from Agrobacterium tumefaciens
T-DNA which ends transcription and directs polyadenylation of
the mRNA.
cp4 epsps gene cassette (2)
e35S Cauliflower mosaic virus 0.6 The cauliflower mosaic virus
(CaMV) promoter with the duplicated enhancer region.
Zmhsp70 Zea mays L. 0.8 Intron from the corn hsp70 gene
(heat-shock protein) present to stabilize the level of gene
transcription.
ctp 2 Arabidopsis thaliana 0.2 DNA sequence for chloroplast
transit peptide, isolated from Arabidopsis thaliana EPSPS,
present to direct the CP4 EPSPS protein to the chloroplast, the
site of aromatic amino acid synthesis.
cp4 epsps Agrobacterium sp. strain CP4 1.4 The DNA sequence for
CP4 EPSPS, isolated from Agrobacterium sp. strain CP4, which
imparts tolerance to glyphosate.
NOS 3’ Agrobacterium tumefaciens 0.3 A 3’ nontranslated region
of the nopaline synthase gene from Agrobacterium tumefaciens
T-DNA which ends transcription and directs polyadenylation of
the mRNA.
Genetic elements present in the PV-ZMGT32 plasmid backbone, but
not present in the MluI restriction fragment (PV-ZGMT32L) used
for transformation:
ori Escherichia coli 0.65 The origin of replication from the E.
coli high copy plasmid pUC119.
nptII Transposon Tn5 0.8 The gene for the enzyme neomycin
phosphotransferase type II. This enzyme confers resistance to
certain aminoglycoside antibiotics and thereby allows for
selection of bacteria containing the plasmid.
6. Brief description of the method used for the genetic
modification:
NK603 Roundup Ready maize was modified by incorporation of a
restriction fragment of plasmid DNA, designated as PV-ZMGT32L
(see question 17, Figure 1), into the maize genome using a
particle acceleration method
NK603 Roundup Ready maize was generated using a particle
acceleration transformation system and a gel-isolated MluI
fragment, PV ZMGT32L (Figure 1), containing a
5-enolpyruvyl¬shikimate-3-phosphate synthase (EPSPS) gene from
Agro¬bacterium sp. strain CP4 (CP4 EPSPS). The cp4 epsps gene
encodes a tolerant form of EPSPS, which confers glyphosate
(Roundup) tolerance to the plant.
Experimental
Release
1. Purpose of the
release:
The aim of this experimental release is to conduct the
official registration efficacy field trials for herbicide
Roundup Raedy®360 SL in Polish conditions
2. Geographical location of the site:
Winna Gora, Wielkopolskie Voivodeship
Wroclaw, Dolnoslaskie Voivodeship
3. Size of the site (m2):
Area of releasing will be precisely define in the methodology
of trials.
Herbicide testing according to EPPO guidance PP 1/50(2).
Area of releasing will cover 950 sqm and 900 sqm of buffer zone
for one localization.
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:
Multi-year field-testing and post-marketing experience
provided no significant evidence that grain and derived products
from NK603 Roundup Ready maize and its progeny are likely to
cause any adverse effects to human or animal health and the
environment.
Environmental
Impact and Risk Management
Summary of the potential
environmental impact from the release of the GMPts:
It is concluded that, like traditional maize, the likelihood
of unintended spreading of NK603 into non-agronomic environments
is negligible, as its persistence in agricultural habitats and
its invasiveness into natural habitats are unaltered compared to
traditional maize. In the highly unlikely event of the
establishment of a NK603 plant in the natural environment, the
glyphosate-tolerance trait would confer only a limited selective
advantage (tolerance to glyphosate-containing herbicides) of
short duration, narrow spatial extent and have negligible
consequences for the environment. Hence the risk for unintended
spreading of NK603 through increased weediness of this maize is
negligible.
As the risk is negligible, no risk management strategies are
considered applicable.
Characteristics of the GMHP which may cause an adverse effect:
Introduced glyphosate-tolerance trait
Potential consequence of the adverse effect, if it occurs:
Increased persistence or invasiveness, potentially resulting in
an invasive species spreading in the environment
Likelihood of occurrence of the potential adverse effect:
Negligible
Estimation of the risk posed by the characteristic of the GMHP:
Negligible
Risk Management strategy for the marketing of the GMHP: (not
applicable).
Brief description of any measures taken for the management of
risks:
No adverse effects of the GMHP have been identified (see
question 29). This indicates that a requirement for
case-specific post-release monitoring is not appropriate, which
is consistent with approvals granted in other world areas
NK603 maize has been commercialized alongside stewardship
programmes involving downstream stakeholders in the use of this
maize, in order to ensure the implementation of good
agricultural practice in its cultivation and to ensure a channel
of communication in the unlikely event that unanticipated
adverse effects might occur.
Even thoughapplicant will implement:
- strict control of use of seed for the foeld trials
- isolation distances
- possibility of trials cancellation in any moment
Summary of foreseen field trial studies focused to gain new
data on environmental and human health impact from the release:
N/A
Final report
-
European
Commission administrative information
Consent given by the
Competent Authority: Not Known
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