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Notification report


General information

Notification Number
B/CZ/07/02

Member State to which the notification was sent
Czech Republic

Date of acknowledgement from the Member State Competent Authority
19/01/2007

Title of the Project
Introduction of genetically modified maize NK603 (tolerant to glyphosate herbicides) into the environment

Proposed period of release:
10/04/2007 to 30/11/2009

Name of the Institute(s) or Company(ies)
Czech University of Agriculture in Prague, ;


3. Is the same GMPt release planned elsewhere in the Community?
No

Has the same GMPt been notified elsewhere by the same notifier?
No

Genetically modified plant

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

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
The expression of 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®.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.

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:
First cp4 epsps gene cassette:P-ract1/ ract1 intron from Oryza sativa (1.4 kb): Contains promoter, transcription start site and first intron.Ctp 2 from Arabidopsis thaliana (0.2): Encodes chloroplast transit peptide, which directs the CP4 EPSPS protein to the chloroplast.cp4 epsps from Agrobacterium sp. strain CP4 (1.4 kb): Encodes glyphosate-tolerant CP4 EPSPS proteinNOS 3’ from Agrobacterium tumefaciens (0.3 kb): Ends transcription and directs polyadenylation of the mRNA.Second cp4 epsps gene cassette:e35S from Cauliflower mosaic virus (0.6 kb): PromoterZmhsp70 from Zea mays L.: Stabilizes the level of gene transcription. Ctp 2 from Arabidopsis thaliana (0.2): Encodes chloroplast transit peptide, which directs the CP4 EPSPS protein to the chloroplast.cp4 epsps l214p from Agrobacterium sp. strain CP4 (1.4 kb): Encodes glyphosate-tolerant CP4 EPSPS L214P protein1NOS 3’ from Agrobacterium tumefaciens (0.3 kb): Ends transcription and directs polyadenylation of the mRNA.

6. Brief description of the method used for the genetic modification:
Transformation using particle acceleration technology with a MluI restriction fragment isolated from plasmid PV-ZMGT32L.

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:
Research purpose – test of effects on target organisms (weeds).

2. Geographical location of the site:
Prague, Suchdol, experimental field of the University

3. Size of the site (m2):
2500 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:
Post-release general surveillance from environments inside and outside the EU has shown that NK603 maize is unlikely to pose any risk of adverse effects to human or animal health or to the environment.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Analysis of the characteristics of NK603 especially in comparison with extensive experience with cultivation of traditional 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 NK603 maize, is consistently 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 traditional maize. The environmental impact of the cultivation, management and harvesting techniques applied in the planned trials is considered no different from the farming practices for traditional maize.

Brief description of any measures taken for the management of risks:
The environmental risk assessment has indicated that the environmental risks of this maize are negligible. Therefore, strategies for risk management for NK603 maize would be the same as for traditional maize. However, in addition to the scheduled observations of 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 effects. This will be done by visual inspection of the status of the NK603 maize crop and that of its receiving environment. In case any adverse environmental effects linked to the deliberate release of NK603 maize are observed during the period of release, these will be reported immediately to the Competent Authority. The field trial will be no less than 200 m from other unregulated maize fields, and will be surrounded by a border of conventional maize. The products from the trial may be used for analysis only and will not be used for human food or animal feed. Volunteer surveillance program will be implemented. The year following the planned trial, the site will be scouted for the presence of any maize volunteers that could contain the traits expressed in NK603, and any volunteer will be removed. The year following harvest of GM maize trial, maize will not be grown on the trial site.

Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Field trials will be carried out to study the effect of glyphosate application onto the weed spectrum. Different doses of active ingredience will be applied on plots and than the survival rate together with reproductive parameters of present weed species will be tested.

Final report
-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
11/05/2007 00:00:00
Remarks: