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Notification report


General information

Notification Number
B/PL/08/02-04

Member State to which the notification was sent
Poland

Date of acknowledgement from the Member State Competent Authority
21/03/2008

Title of the Project
Official variety testing of NK 603 Roundup Ready® corn hybrid for economical evaluation

Proposed period of release:
01/04/2008 to 30/11/2011

Name of the Institute(s) or Company(ies)
Plant Breeding and Acclimatization Institute, 05-870 Blonie, Poland
fax (48 22) 725 47 14,(48 22) 731 96 17
e-mail: postbox@ihar.edu.pl;


3. Is the same GMPt release planned elsewhere in the Community?
Not known

Has the same GMPt been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):


Other notifications
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

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
maizepoaceaezeazea maysmaysNK 603

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®
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® herbicide for effective control of weeds during the growing season and to take advantage of the favorable environmental and safety characteristics of Roundup Ready® .


Genetic modification

3. Type of genetic modification:
Insertion;

In case of insertion of genetic material, give the source and intended function of each constituent fragment of the region to be inserted:
Genetic Element Source Size (kb) Function
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 Element Source Size (kb) Function
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 check the economical and agricultural value of the 4 hybrids made from crossing of the inbreed line from Smolice with the transgenic Monsanto herbicide-tolerant variety NK 603

2. Geographical location of the site:
Poland:
Radzikow (mazowieckie);
Rogozewo (wielkopolskie);
Lagiewniki (dolnośląskie).


3. Size of the site (m2):
Area of releasing will be precisely define in the methodology of trials.
Area of releasing will cover 150 sqm 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.


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
- manual top-cutting
- possibility of trials cancellation in any moment


Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
21/05/2009 00:00:00
Remarks: