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Notification report


General information

Notification Number
B/RO/11/03

Member State to which the notification was sent
Romania

Date of acknowledgement from the Member State Competent Authority
19/01/2011

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:
01/04/2011 to 31/12/2015

Name of the Institute(s) or Company(ies)
Monsanto Europe, S.A., Represented by Monsanto Romania SRL, address: Bucharest North-street, no 10, Global City Business Park, Building O21, Floor 5, Voluntari, Ilfov County, Zip code 77190; Phone: 004 021 305 71 40; Fax: 004 021 305 71 65.;


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

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

If yes, notification number(s):
B/CZ/06/04; B/DE/00/115; B/DE/03/148; B/DE/06/185; B/DE/08/201; B/DK/07/01; B/DK/07/02; B/DK/07/03; B/DK/07/04; B/DK/08/01; B/DK/09/02; B/DK/09/03; B/DK/09/04; 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/ES/08/06; B/ES/08/09; B/ES/09/04; B/ES/09/12; B/ES/10/04; B/ES/10/09; 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/PT/09/01; B/RO/08/09; B/RO/09/19; B/RO/10/03; B/SE/05/9831; B/SK/06/01; B/SK/08/03 ;

Other notifications
Other notifications
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.

IM-07-008 (NL); 64453/2/2007 (HU); 02-06/2006 (PL); 02-01/2007 (PL).


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:
Summary of DNA components of the vector PV-ZMGT32L, used for transformation

cp4 epsps gene cassette (1)
- P-ract1/ract1 intron
Source: Oryza sativa Intended function: 5’ region of the rice actin 1 gene containing the promoter, transcription start site and first intron. (1.4 kb)

- ctp 2
Source: Arabidopsis thaliana Intended function: 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. (0.2 kb)

- cp4 epsps
Source: Agrobacterium sp. strain CP4 Intended function: The DNA sequence for CP4 EPSPS, isolated from Agrobacterium sp. strain CP4, which imparts tolerance to glyphosate. (1.4 kb)

- NOS 3’
Source: Agrobacterium tumefaciens Intended function: A 3’ nontranslated region of the nopaline synthase gene from Agrobacterium tumefaciens T-DNA which ends transcription and directs polyadenylation of the mRNA. (0.3 kb) cp4 epsps gene

second cassette

- e35S
Source: Cauliflower mosaic virus Intended function: The cauliflower mosaic virus (CaMV) promoter with the duplicated enhancer region. (0.6 kb)

- Zmhsp70
Source: Zea mays L. Intended function: Intron from the corn hsp70 gene (heat-shock protein) present to stabilize the level of gene transcription. (0.8 kb)

- ctp 2
Source: Arabidopsis thaliana Intended function: 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. (0.2 kb)

- cp4 epsps
Source: Agrobacterium sp. strain CP4 Intended function: The DNA sequence for CP4 EPSPS, isolated from Agrobacterium sp. strain CP4, which imparts tolerance to glyphosate. (1.4 kb)

- NOS 3’
Source: Agrobacterium tumefaciensIntended function: A 3’ nontranslated region of the nopaline synthase gene from Agrobacterium tumefaciens T-DNA which ends transcription and directs polyadenylation of the mRNA. (0.3 kb)


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 of NK603 is to perform comparative studies with samplings of NK603 versus the conventional maize in experimental fields for bioefficacy and selectivity assessments.

2. Geographical location of the site:
Mărculeşti - Călăraşi County
Dâlga – Călăraşi County
Mircea Vodă – Brăila County
Râmnicu Sărat – Buzău County
Tecuci – Galaţi County


3. Size of the site (m2):
Mărculeşti - Călăraşi County – 3000 m2
Dâlga – Călăraşi County - 5000 m2
Mircea Vodă – Brăila County - 2500 m2
Râmnicu Sărat – Buzău County - 2500 m2
Tecuci – Galaţi County - 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:
The results of several releases for 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 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:
NK603 maize was approved on 19 July 2004 for import, feed use and processing in the EU under Directive 2001/18/EC (Commission Decision 2004/643/EC). Food and food ingredients derived from NK603 were approved under Regulation (EC) No. 258/97 (Commission Decision 2005/448/EC) and existing feed materials, feed additives and food additives produced from NK603 were listed in the Community Register, according to Regulation (EC) No. 1829/2003 . An application for cultivation of varieties of NK603 in the European Union was submitted under Regulation (EC) No. 1829/2003 and EFSA adopted a favorable scientific opinion (published on 11 June 2009) concluding that NK603 is as safe as its conventional counterpart with respect to potential direct effects on human and animal health and the environment .
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 herbicides favorable 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 and the favorable scientific opinion adopted by EFSA concluded that NK603 is as safe as its conventional counterpart with respect to potential direct effects on human or animal health and the environment. Therefore, strategies for risk management for NK603 would be the same as for traditional maize.
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.
Seeds will be transported in sealed and labeled bags.
The equipment, especially the experimental drill and combine, will be cleaned on the experimental site, thus preventing seed dissemination.
Volunteer surveillance program will be implemented. The following two years after 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 by mechanical destruction or non-selective herbicides. Two years following harvest of GM maize trial, maize will not be grown on the trial sites.
At the end of the field-testing campaign, a report of will be made available by the notified 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.


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
16/05/2012 00:00:00
Remarks: