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Notification report


General information

Notification Number
B/RO/08/09

Member State to which the notification was sent
Romania

Date of acknowledgement from the Member State Competent Authority
14/02/2008

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 Romania

Proposed period of release:
01/04/2008 to 01/12/2010

Name of the Institute(s) or Company(ies)
Monsanto Europe, S.A., Represented by Monsanto Romania SRL, address: B-dul D. Pompei nr 9-9A, Builduing 24, 4th floor, district 2, postal code 020335, Bucharest, Telefone, Fax: 305 71 40/65;


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

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

If yes, notification number(s):
B/BE/00/WSP13; B/CZ/06/04; B/DE/00/115; B/DE/03/148; B/DK/07/01; B/DK/07/02; B/DK/07/03; B/DK/07/04; 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/ES/07/05; B/ES/07/07; B/FR/00/03/05; B/FR/01/01/01; B/FR/04/02/02; B/FR/06/01/01; B/FR/06/12/09; B/FR/99/04/06; B/IT/99/17; B/SE/05/9831; B/SK/06/01;

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 maysmaysNK603

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 need of 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:
P-ract1/ ract1 intron Oryza sativa 1.4 Contains promoter, transcription start site and first intron.
Ctp 2 Arabidopsis thaliana 0.2 Encodes chloroplast transit peptide, which directs the CP4 EPSPS protein to the chloroplast
cp4 epsps Agrobacterium sp. strain CP4 1.4 Encodes glyphosate-tolerant CP4 EPSPS protein
NOS 3’ Agrobacterium tumefaciens 0.3 Ends transcription and directs polyadenylation of the mRNA.
Second cp4 epsps gene cassette
e35S Cauliflower mosaic virus 0.6 Promoter
Zmhsp70 Zea mays L. 0.8 Stabilizes the level of gene transcription.
Ctp 2 Arabidopsis thaliana 0.2 Encodes chloroplast transit peptide, which directs the CP4 EPSPS protein to the chloroplast
cp4 epsps l214p Agrobacterium sp. strain CP4 1.4 Encodes glyphosate-tolerant CP4 EPSPS L214P protein1
NOS 3’ Agrobacterium tumefaciens 0.3 Ends transcription and directs polyadenylation of the mRNA.
1 The substitution of leucine by proline in the CP4 EPSPS encoded by the second cp4 epsps gene in the NK603 insert is indicated by the suffix L214P


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.


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 deliberate introduction in the environment consists in agronomical and phonotypical dates collection necessary for registering the varieties of corn NK 603 in Official Catalog of Varieties (5 locations), registering of herbicide ( 4 locations) and experimental field for selectivity/bio-efficiency Tudor Vladimirescu – county Braila ( one location)

2. Geographical location of the site:
ISTIS – 5 locations
Dalga -CL 44-25-28,93 / 27-02-24,12
Mircea Voda -BR 45-06-18,40 / 27-23-57,18
Rm.Sarat -BZ 45-23-31,37 / 27-04-17,99
Tecuci -GL 45-49-12,54 / 27-26-43,22
Traian -TL 45-01-36,84 / 28-13-30,68
Fundulea –CL 44-26-58,68 / 26-31-29,13
Bucuresti 44-30-46,52 / 26-17-11,91
Tudor Vladimirescu- BR 45-15-32,71 / 27-51-42,38


3. Size of the site (m2):
ISTIS – 5 hybrids in 5 locations
Dalga – county Calarasi – 100 m2 / hybrid = 500 m2
Mircea Voda – county Braila – 100 m2/ hybrid = 500 m2
Ramnicu Sarat – county Buzau – 100 m2 / hybrid= 500 m2
Tecuci – county Galati – 100 m2 / hybrid= 500 m2
Traian – county Tulcea – 100 m2 / hybrid = 500 m2
Fundulea – county Calarasi - 3 locations x 400 m2 = 1200 m2 + check lot 2ha ( in one of the location)
Bucuresti - one location -100 m2
Tudor Vladimirescu- county Braila - 15 replicates x 240 m2 = 3600 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:
Multi-year field-testing in the E.U. (see question A4) and post-marketing experience in other world areas since 2001 provided no significant evidence that NK603 could 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:
Note especially if the introduced traits could directly or indirectly confer an increased selective advantage in natural environments; also explain any significant expected environmental benefits

Analysis of the characteristics of NK603 has shown that the risk of potential adverse effects on human and animal health and the receiving environment, resulting from the deliberate release of this maize for field testing, is consistently negligible:
The risk of the introduced trait in NK603 maize to be the cause of any meaningful competitive advantage or disadvantage in natural environments is negligible. As 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 conventional maize.
NK603 maize is herbicide-tolerant and, as such, has no target organisms. Potential exposure of non-target organisms to CP4 EPSPS presents no conceivable mechanism to cause adverse effects because of its properties. The interaction between this maize and non-target organisms is not different from conventional maize. Therefore, the environmental risk of adverse effects on biochemical processes, caused by the interaction of NK603 with decomposers and interacting detritivores in the soil compartment, is negligible. Additionally, as CP4 EPSPS proteins belong to a well-known, safe class of EPSPS proteins that are commonly found in bacteria, fungi, algae and in all higher plants, soil microorganisms have historically been exposed to a diversity of naturally occurring EPSPS proteins.
Any occupational health aspects of handling NK603 maize are no different from conventional maize, and this maize was shown to be as safe and as nutritious as any other maize, without any consequences for the feed/food chain. The environmental impact of the cultivation, management and harvesting techniques applied in the planned trials is considered no different from the cultivation of any other maize.
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 glyphosate 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.
At the end of the field-testing campaign, a report of will be made available by the notifier to the Competent Authority. This report will detail any unexpected adverse environmental effects that were observed during the general surveillance, if any, and further actions elicited as an effect of these findings, if applicable.
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:
Not known