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Notification report


General information

Notification Number
B/RO/09/14

Member State to which the notification was sent
Romania

Date of acknowledgement from the Member State Competent Authority
23/03/2009

Title of the Project
Application for deliberate release into the environment of genetically modified insect resistant and herbicide tolerant Bt11xGA21 maize (Field Trials)

Proposed period of release:
01/04/2009 to 01/12/2014

Name of the Institute(s) or Company(ies)
Syngenta Agro SRL, Victoria Park
73-81 Bucureşti-Ploieşti Str.
Floor. 4, 013685
Bucharest, România
Tel: + 40 21 5281200
Fax: + 40 21 5281299;


3. Is the same GMPt release planned elsewhere in the Community?
Yes:
Spain; Slovak Republic;

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

If yes, notification number(s):
B/RO/08/05; B/SK/09/01;

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:
Bt11xGA21 maize described in this field trial application, has been produced by crossing genetically modified herbicide tolerant maize Event GA21 and genetically modified insect resistant maize Event Bt11 through traditional breeding techniques.

Bt11 maize is resistant to certain Lepidopteran species such as the insect corn borers (European Corn Borer (ECB), Ostrinia nubilalis, and Mediterranean Corn Borer, (MCB), Sesamia nonagrioides) and tolerant to herbicide products containing glufosinate (selection marker). GA21 maize contains a gene encoding a protein (mEPSPS) capable of conferring a herbicide tolerant characteristic.


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:
Bt11xGA21 maize described in this field trial application, has been produced by crossing genetically modified herbicide tolerant maize Event GA21 and genetically modified insect resistant maize Event Bt11 through traditional breeding techniques. No other changes have been made to produce Bt11xGA21 genetically modified maize.

Genetic material derived from Bt11 maize:

Promoter sequences: Promoter and intone sequences derived from the Cauliflower Mosaic virus and maize. The function of these sequences is to control expression of the herbicide and insect tolerance genes.
Insect tolerance gene: cry1Ab gene, which encodes a Cry1Ab protein that confers resistance to certain lepidopteran insect pests. The cry1Ab gene was originally cloned from Bacillus thuringiensis var. kurstaki HD-1.
Herbicide tolerance gene: Streptomyces viridochromogenes gene encoding the selectable marker PAT. PAT confers resistance to herbicides containing glufosinate
NOS terminator: Termination sequence of the nopaline synthase gene, isolated from Agrobacterium tumefaciens. The function of this sequence is to signal the termination of the herbicide and insect tolerant gene expression.

Genetic material derived from GA21 maize:

Promoter sequences: Promoter, intron and exon sequences derived from rice. The function of these sequences is to control expression of the herbicide tolerance gene.
Optimised transit peptide: N-terminal optimised transit peptide sequence constructed based on transit peptide sequences from maize and sunflower.

Herbicide tolerance gene: epsps (5-enolpyruvylshikimate-3-phosphate synthase) gene derived from maize. The function of the product of this gene is to confer tolerance to herbicide products containing glyphosate.
NOS terminator: Termination sequence of the nopaline synthase gene, isolated from Agrobacterium tumefaciens. The function of this sequence is to signal the termination of the herbicide tolerant gene expression.


6. Brief description of the method used for the genetic modification:
Bt11xGA21 maize described in this field trial application, has been produced by crossing genetically modified herbicide tolerant maize Event GA21 and genetically modified insect resistant maize Event Bt11 through traditional breeding techniques. No other changes have been made to produce Bt11xGA21 genetically modified maize.

Bt11 maize has been produced by transformation of Zea mays protoplasts and is genetically modified for insect resistance to certain Lepidopteran species. GA21 maize was produced via micro-projectile bombardment of maize suspension culture cells.


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:
Field trial release of Bt11xGA21 insect resistant and herbicide tolerant maize in Romania to be carried out with the objectives of registrating Bt11xGA21 maize varieties in the National Catalogue Of Varieties Of Agricultural Plant Species , gathering of necessary information regarding the agronomical performances and environmental compatibility of Bt11xGA21 maize varieties under geo-climatic conditions of Romania during 2009-2014. Another main objective of the field release in Romania is to assess the potential effects of event Bt11xGA21 on key non-target organisms when cultivated under European field conditions.

Testing of Bt11xGA21 insect resistant and herbicide tolerant maize varieties during 2009-2014 is also carried out for comparative analysis (sampling of silage, grain, fresh vegetable material and pollen) and for the study of gene expression of genetically modified and non-genetically modified, conventional hybrids.


2. Geographical location of the site:
In Romania, the field trials will be conducted at thirteen (13) different location sites (2009-2014).

a) within the ISTIS network of 6 (six) centres for variety testing named hereafter CTS – CTS Dîlga (Călăraşi county), CTS Râmnicu Sărat (Buzău county), CTS Tecuci (Galaţi county ), CTS Târgovişte (Dâmboviţa county), CTS Mircea Vodă (Brăila county) şi CTS Satu Mare ( Satu Mare county)
b) SCDA – Lovrin, Timis county
c) Cărpiniş - Timiş county, Grabaţ - Timiş county, Jimbolia – Timiş county, Peregu Mare – Arad county, Şeitin – Arad county and Nădlac - Arad county


3. Size of the site (m2):
The field trials will be carried out in thirteen different locations between 2009 and 2014. The trial area with genetically modified Bt11xGA21 plants will be maximum 5000 sqm/location for comparative analysis, gene expression analysis, gathering of agronomic data, for assessing the potential effects of Bt11xGA21 maize on key non-target organisms when cultivated under European field conditions in Romania and, finally for official registration trials. In 2009, three Bt11xGA21 maize hybrids will be tested. In the following years, Syngenta will carry out field trials in România with different Bt11xGA21 hybrids.

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:
Evidence from previous field trials carried out in the USA and Europe suggests that the genetically modified Bt11 and GA21 lines do not differ from the recipient plant with regards to the mode or rate of reproduction, dissemination or survivability.

Bt11 maize has been approved for commercial cultivation in the USA, Canada, Argentina, Japan, South Africa, Uruguay and Philippines. This maize is currently cultivated in the USA, Canada, Argentina, Japan, South Africa and Philippines with no adverse effects to the environment or on human health reported. Field trials with Bt11 genetically modified maize has been carried out in Romania beginning with 2007.

GA21 maize has been approved for commercial cultivation in the USA, Canada, Argentina, Brazil and Japan. This maize is currently cultivated in the USA, Canada and Argentina with no adverse effects to the environment or on human health reported. Field trials with GA21 genetically modified maize has been carried out in Romania beginning with 2006.

Field trials with Bt11xGA21 maize has been carried out in Romania beginning with 2008.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
An Environmental Risk Assessment study has been completed and submitted with the application. In summary, no immediate or delayed adverse effects as a result of the direct and indirect interaction of the genetically modified maize with the environment when compared to the non-modified maize have been identified.

Brief description of any measures taken for the management of risks:
•The experimental field trails will be conducted in areas where maize is not cultivated for the production of seeds;
• The isolation distance to other maize fields will be no less than 200 m;
• A minimum of 4 non-GM maize (conventional) rows will surround the field trials (buffer rows) to minimize pollen dispersal and act as a pollen trap;
•The plants growing in the buffer zone will not be used for human food or animal feed;
•Sowing and harvesting will be conducted under the supervision of Syngenta personnel trained on precaution measures;
•Carrying out regular visits to inspect field trails sites, making observations and verifying that adequate measures are applied for preventing pests and diseases;
•Harvesting and destroying of plant material remaining after sampling is complete;
•No seed products resulting from the field trails will be used as food or feed;
•After harvest Syngenta personnel will supervise the incorporation of any plant remains into the soil;
•The sites will be monitored for one year after the harvest and any volunteer maize appearing will be eliminated and destroyed using conventional herbicides or by mechanical mean before flowering. During this year, maize will not be grown on the trial sites.
•The following year no commercial maize cultivation will take place on the field trail location site.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
The field trials will allow the further assessment of this maize in the environment and under geo-climatic conditions of Romania.

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
02/06/2009 00:00:00
Remarks: