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Notification report


General information

Notification Number
B/SK/06/01

Member State to which the notification was sent
Slovakia

Date of acknowledgement from the Member State Competent Authority
21/12/2006

Title of the Project
Notification according to Directive 2001/18/EC, Part B, for the deliberate release of NK603 maize for the use in field trials in the Slovak Republic.

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

Name of the Institute(s) or Company(ies)
Monsanto Company represented by MONSANTO SLOVAKIA, Ltd, ;


3. Is the same GMPt release planned elsewhere in the Community?
Yes:
Germany; Denmark; Spain; France; Sweden; Czech Republic; Lithuania;

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

If yes, notification number(s):
B/ES/04/19; B/ES/06/06; B/ES/06/08; B/FR/06/01/01; B/SE/05/9831;

Other notifications
Czech Republic 26OA/OER/GMO/02

In addition, many field trials have already been conducted across maize growing regions in North and South America and other world areas and NK603 has been commercially released for cultivation in the U.S.A. and Canada, since 2001 and in Argentina since 2004.


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:
All genetic constituents within plasmid vector PV-ZMGT32 are completely known including the gene of interest, cp4 epsps, and its function. The agarose gel-isolated MluI restriction fragment of this plasmid vector, designated as PV ZMGT32L, which was actually utilized for transformation of NK603 Roundup Ready maize, contains only the cp4 epsps plant gene expression cassettes and does not contain the nptII selectable marker gene or origin of replication. The size, source and function of the genetic elements present in the vector PV ZMGT32L used for transformation are given below:
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 kb): 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 protein
NOS 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): Promoter
Zmhsp70 from Zea mays L. (0.8 kb): Stabilizes the level of gene transcription.
ctp 2 from Arabidopsis thaliana (0.2 kb): 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 protein
NOS 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:
NK603 maize was modified by insertion of a DNA fragment into the maize genome using a particle acceleration method.
The introduced DNA fragment consists of two adjacent plant gene expression cassettes each containing a single copy of the cp4 epsps gene. The introduced cp4 epsps gene encodes a tolerant form of EPSPS, which confers glyphosate tolerance to the plant. This gene was derived from a common soil-borne bacterium, Agrobacterium sp. strain CP4. The source vector, plasmid PV-ZMGT32, containing this fragment, was developed by Monsanto Company, St. Louis, Missouri.


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:
NK603 will be planted in field trials for assessment of weed treatment strategies in maize under Slovak conditions.

2. Geographical location of the site:
The releases are planned at four locations of the Research Institute of Production of Piestany:
Borovce
Spacince
Viglas - Pstrusa
Milhostov


3. Size of the site (m2):
16. 800 m2 is the size of the four planned locations for 2007

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 in the E.U. (see question A4) and post-marketing experience in other world areas since 2001 has shown that NK603 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 has shown that the risk of potential adverse effects on human health or the environment, resulting from the deliberate release of this maize for field testing, is consistently negligible.
NK603 is herbicide-tolerant and, as such, has no target organisms. The interaction between this maize and non-target organisms is not different from traditional maize. Like traditional maize, NK603 is not invasive into non-agronomic environments. No evidence of any harmful or undesirable effects has been brought forward from extensive field-testing and from commercial planting by the many farmers who have grown NK603 in North America since 2001.
The CP4 EPSPS proteins expressed in NK603 are member of a safe family of proteins, 5 enolpyruvylshikimate-3-phosphate synthase proteins, that are enzymes, known to be ubiquitous in nature, possess no toxicity, and confer no selective advantage to the plants, algae, fungi and micro-organisms that express them. In environments where selective pressure from Roundup applications is absent, the glyphosate-tolerance trait does not confer a selective advantage and would not be of direct competitive importance to wild plants, nor indirectly for wildlife interacting with those wild plants. In addition, NK603 is not a weedy plant and the likelihood is negligible for NK603 to volunteer or survive in natural habitats under European conditions. Within NK603 fields, NK603 plants have a selective advantage over the glyphosate-susceptible weeds under specific conditions in the field (i.e. following treatment with Roundup herbicide), which are predictable, spatially limited, short in duration, and with negligible consequences to natural environments. This advantage is limited to the agricultural field and the growing season of the NK603 crop, and is considered of negligible risk to the environment.
It is actually expected that the commercial production of NK603 will positively impact current agronomic practices in maize and provide benefits to farmers and the environment. The use of Roundup in maize enables the farmer to take advantage of the herbicide’s favourable environmental and safety properties (see Annex I listing of glyphosate under Council Directive 91/414/EEC). Roundup-tolerant maize benefits the farmer by providing (1) an additional broad-spectrum weed control option in maize, (2) a new herbicidal mode of action for in-season maize weed control, (3) increased flexibility to treat weeds on an “as needed” basis, (4) cost-effective weed control and (5) an excellent fit with reduced-tillage systems. In turn, a number of environmental benefits arise from the use of conservation tillage including improved soil quality, improved water infiltration, reductions in erosion and sedimentation of water resources, reduced runoff of nutrients and pesticides to surface water, improved wildlife habitat, increased carbon retention in the soil, reduced fuel use and encouragement of sustainable agricultural practices.


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 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 crop and that of its receiving environment.
In case any adverse environmental effects, linked to the deliberate release of NK603, are observed during the period of release, these will be reported immediately to the Competent Authority.
The field trials 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 trials may be used for analysis and will not be used for human food or animal feed.
Volunteer surveillance program will be implemented. The year following the planned trial, all sites 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 sites.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Not applicable.
However, any unanticipated adverse effects on human health or the environment would be reported immediately to the Competent Authority.


Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
14/05/2007 00:00:00
Remarks: