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Notification report


General information

Notification Number
B/RO/09/03

Member State to which the notification was sent
Romania

Date of acknowledgement from the Member State Competent Authority
27/02/2009

Title of the Project
Field trials with genetically modified insect resistant and herbicide tolerant Bt11xMIR162xMIR604xGA21 maize

Proposed period of release:
01/04/2009 to 01/12/2012

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:
Czech Republic;

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

If yes, notification number(s):
B/CZ/09/01;

Genetically modified plant

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

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
Bt11xMIR162xMIR604xGA21 maize described in this field trial application, has been produced by crossing genetically modified Bt11, MIR162, MIR604 insect resistant maize events and herbicide tolerant GA21 maize through traditional breeding techniques. There was no further genetic modification to produce the stack. Therefore, these maize plants produce the five traits present in Bt11, MIR162, MIR604 and GA21 maize plants through the production of:

1. a truncated Cry1Ab protein for control of certain lepidopteran pests.
2. a phosphinothricin acetyltransferase (PAT) protein that confers tolerance to herbicide products containing glufosinate ammonium.
3. a Vip3Aa20 protein for control of certain lepidopteran pests.
4. a phosphomannose isomerase (PMI) protein as a selectable marker. PMI allows transformed maize cells to utilize mannose as the only primary carbon source while maize cells lacking this protein fail to grow.
5. a modified Cry3A (mCry3A) protein for control of certain coleopteran pests.
6. a phosphomannose isomerase (MIR604 PMI) protein as a selectable marker. PMI is an enzyme that allows transformed corn cells to utilize mannose as the only primary carbon source while maize cells lacking this protein fail to grow.
7. a modified maize 5-enolpyruvylshikimate-3-phosphate synthase enzyme (mEPSPS) that confers tolerance to herbicide products containing glyphosate.


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:
Bt11xMIR162xMIR604xGA21 maize described in this field trial application, has been produced by crossing genetically modified Bt11, MIR162, MIR604 insect resistant maize events and herbicide tolerant GA21 maize through traditional breeding techniques.

Genetic material derived from Bt11 maize:

Promoter sequences: Promoter and intron 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 MIR162 maize:

Promoter sequences: Promoter sequences from Zea mays. Provides root-preferential expression in Zea mays.

Insect tolerance gene: A modified version of the native vip3Aa1 gene from Bacillus thuringiensis that confers resistance to certain lepidopteran insect pests. After insertion in the plant, the vip3Aa19 gene was designated vip3Aa20; the encoded protein was designated Vip3Aa20.

Selectable marker: E. coli pmi gene encoding the enzyme phosphomannose isomerase (PMI). Catalyzes the isomerization of mannose-6-phosphate to fructose-6-phosphate.

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 gene expression.

Genetic material derived from MIR604 maize:

Promoter sequences: Promoter sequences from Zea mays. Provides root-preferential expression in Zea mays.

Insect tolerance gene: encodes a modified cry3A gene from Bacillus thuringiensis subsp. kurstaki which confers tolerance to certain coleopteran insect pests.

Selectable marker: E. coli pmi gene encoding the enzyme phosphomannose isomerase (PMI). Catalyzes the isomerization of mannose-6-phosphate to fructose-6-phosphate.

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 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.

OpTimişed transit peptide: N-terminal opTimişed 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:
Bt11xMIR162xMIR604xGA21 maize described in this field trial application, has been produced by crossing genetically modified Bt11, MIR162, MIR604 insect resistant maize events and herbicide tolerant GA21 maize through traditional breeding techniques. There was no further genetic modification to produce the stack.

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 Bt11xMIR162xMIR604xGA21 insect resistant and herbicide tolerant maize in Romania (2009-2012) with the objectives of: registration of Bt11xMIR162xMIR604xGA21 maize varieties in the National Catalogue Of Varieties Of Agricultural Plant Species and, gathering of necessary information regarding the agronomical performances, environmental compatibility of Bt11xMIR162xMIR604xGA21 maize varieties under geo-climatic conditions of Romania and to assess the potential effects of Bt11xMIR162xMIR604xGA21 maize on key non-target organisms when cultivated under European field conditions.

Field trials with Bt11xMIR162xMIR604xGA21 insect resistant and herbicide tolerant maize varieties during 2009-2012 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 trial will be conducted at thirteen (13) different location sites (2009-2012).

a) within the ISTIS network of 6 (six) centres for variety testing named hereafter CTS (Official registration trials (6 CTS - CTS Dâlga, CTS Râmnicu Sărat, CTS Târgovişte, CTS Tecuci, CTS Mircea Vodă and CTS Satu Mare) and Testing under production conditions - CTS Dâlga, CTS Râmnicu Sărat and CTS Satu Mare;
b) within the Lovrin Agronomical Research and Development Station named hereafter SCDA Lovrin – Lovrin - Timiş county and in Petreşti - Satu Mare county, Cărpiniş - Timiş county, Grabaţ - Timiş county, Jimbolia - Timiş county, Peregu Mare –Arad county – Testing under production conditions
c) within the Lovrin Agronomical Research and Development Station named hereafter SCDA Lovrin – Lovrin - Timiş county and Nădlac, Arad county for the assessment of the potential effects of Bt11xMIR162xMIR604xGA21 maize on key non-target organisms.


3. Size of the site (m2):
The field trials will be carried out in Romania (2009-2012), in 13 different locations. The surface area planted with Bt11xMIR162xMIR604xGA21 genetically modified maize plants will be maximum 600 sqm/location (9 experimental field trials – 3 in ISTIS and 1 at SCDA Lovrin, Lovrin – Timiş county, in Petreşti - Satu Mare county, Cărpiniş - Timiş county, Grabaţ - Timiş county, Jimbolia - Timiş county, Peregu Mare –Arad county) for comparative analysis and gathering of agronomical data (Testing under production conditions). The field trial for assessing the potential effects of event Bt11xMIR162xMIR604xGA21 on key non-target organisms when cultivated under European field conditions will not exceed 7500 sqm/location (two locations – SCDA Lovrin, Lovrin – Timiş county and Nădlac – Arad county) planted with genetically modified plants. The field trial releases for registration of Bt11xMIR162xMIR604xGA21 maize varieties in the National Catalogue Of Varieties Of Agricultural Plant Species will not exceed 150sqm/location/hybrid (6 ISTIS locations). In 2009, Syngenta will carry out field trials with only one Bt11xMIR162xMIR604xGA21 maize variety.

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 in Europe suggests that the genetically modified Bt11, MIR162, MIR604 and GA21 lines do not differ from the recipient plant with regards to the mode or rate of reproduction, dissemination or survivability.

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. Furthermore, the trials are designed to assess the potential effects of Bt11xMIR162xMIR604xGA21 maize on key non-target organisms in Romania when cultivated under European field conditions.

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
07/05/2009 00:00:00
Remarks: