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Notification report


General information

Notification Number
B/RO/08/04

Member State to which the notification was sent
Romania

Date of acknowledgement from the Member State Competent Authority
12/02/2008

Title of the Project
Field trials with genetically modified insect resistant maize and herbicide tolerant Bt11xMIR604xGA21 maize

Proposed period of release:
01/04/2008 to 01/12/2011

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;

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

If yes, notification number(s):
B/ES/07/34;

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:
The maize Bt11xMIR604xGA21 stacked product described in this field application, has been produced by crossing genetically modified Bt11 and MIR604 insect resistant maize events and herbicide tolerant maize GA21 maize 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). Event MIR604 is expresses a modified Cry3A (mCry3A) protein that confers protection against the Western Corn rootworm (WCR) (Diabrotica virgifera virgifera, LeConte), the Northern Corn rootworm (NCR) (Diabrotica longicornis barberi, Smith and Lawrence) and related Diabrotica species. It also expresses a marker gene, pmi, that encodes the enzyme phosphomannose isomerase (PMI) allowing the plants to utilise mannose as a carbon source (selection marker). GA21 maize contains a gene (mepsps) encoding a protein 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:
The maize Bt11xMIR604xGA21 stacked product described in this field application, has been produced by crossing genetically modified Bt11 and MIR604 insect resistant maize events and herbicide tolerant maize GA21 maize through traditional breeding techniques.

Bt11 maize
Regulatory sequences: Promoter derived from cauliflower mosaic virus 35S gene and the first intron from maize alcohol dehydrogenase 1S gene. The function of these sequences is to ensure the constitutive expression and enhancement of cry1Ab gene expression in maize.

Insect resistance gene: Bt gene isolated from Bacillus thuringiensis subsp. kurstaki strain HD-1 encodes a truncated version of the full-length cryIAb gene which confers tolerance to certain lepidopteran species.

Glufosinate ammonium herbicide tolerant gene: pat gene (Phosphinothricin acetyl transferase) isolated from Streptomyces viridochromogenes encodes for a phosphinothricine acetyl-transferase enzyme which confers tolerance to glufosinate ammonium herbicides (selection marker gene, does not confer an important agronomic characteristic).

NOS terminator: Termination sequence of the nopaline synthase gene, isolated from Agrobacterium tumefaciens. The function of this sequence is to signal termination of transcription and polyadenylation of the ARNm.

MIR604 maize

MIR604 is a genetically modified (GM) maize expressing two transgenes:

1. A modified cry3A (mcry3A) gene encoding the mCry3A protein that confers resistance to the Western Corn rootworm (CRW) (Diabrotica virgifera virgifera) and other related coleopteran pests of maize like the Northern Corn rootworm (CRW) (Diabrotica longicornis barberi, Smith and Lawrence)
2. the pmi (manA) gene from Escherichia coli, which encodes the enzyme PMI as a selectable marker. PMI allows transformed corn cells to utilize mannose as a sole carbon source, while maize cells lacking the pmi gene fail to grow.

GA21 maize
Regulatory sequences: Promoter, intron and exon sequences derived from rice. The function of these sequences is to control expression of the herbicide tolerance gene.

Optimized transit peptide: N-terminal optimized 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 encoded by 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:
The maize Bt11xMIR604xGA21 stacked product described in this field application, has been produced by crossing genetically modified Bt11 and MIR604 insect resistant maize events and herbicide tolerant maize GA21 maize through traditional breeding techniques.

Bt11 maize has been produced by transformation of Zea mays protoplasts and is genetically modified for insect resistance to certain Lepidopteran species. Event MIR604 was produced using immature maize embryos derived from a proprietary Zea mays line, via Agrobacterium-mediated transformation.

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 as the recipient or parental plant is not a forest tree species.

Experimental Release

1. Purpose of the release:
Field trial release of Bt11xMIR604xGA21 insect resistant and herbicide tolerant maize within the Romanian State Institutue for Variety Testing and Registration (ISTIS) and Agricultural Research and Development Station Lovrin (SCDA Lovrin) with the objectives of registrating Bt11xMIR604xGA21 maize varieties in the Official Catalogue of agricultural plant varieties and, gathering of necessary information regarding the agronomical performances, environmental compatibility of this maize varieties under geo-climatic conditions of Romania during 2008-2011. The final objective of the field release in Romania is to assess the potential effects of Bt11xMIR604xGA21 maize on key non-target arthropods when cultivated under European field conditions.

Testing within the ISTIS network and SCDA Lovrin of Bt11xMIR604xGA21 insect resistant and herbicide tolerant maize varieties during 2008-2011 is also carried out for comparative analysis (sampling of silage, grain, fresh vegetable material and pollen) and for the study of gene expression of GM and non-GM, conventional hybrids.


2. Geographical location of the site:
In Romania, the field trial studies will be conducted at seven (7) different location sites (2008-2011).

a) within the ISTIS network of 5 (five) centres for variety testing named hereafter CTS (Official registration trials and Testing under production conditions)

b) within the Lovrin Agronomical Research and Development Station named hereafter SCDA Lovrin – Lovrin, Timis county (200 Principala Str., Lovrin) – two experimental field trial locations (Lovrin, Timis county and Petresti, Satu Mare county) – Testing under production conditions


3. Size of the site (m2):
The field trials will be carried out in Romania in seven (7) different locations between 2008-2010. The surface area planted with Bt11xMIR604xGA21 genetically modified maize plants will be maximum 300 sqm/location (4 experimental field trials – 2 in ISTIS and 2 in SCDA Lovrin) for comparative analysis and gathering of agronomical data (Testing under production conditions). The field trial for assessing the potential effects of event Bt11xMIR604xGA21 on key non-target arthropods when cultivated under European field conditions will not exceed 7500 sqm/location (one location – SCDA Lovrin) planted with GM plants. The field trial releases for registration of Bt11xMIR604xGA21 maize varieties in the Official Catalogue of agricultural plant varieties will not exceed 100sqm/location/hybrid (5 ISTIS locations). In 2008, Syngenta will carry out field trials with only one Bt11xMIR604xGA21 maize variety (NX44287WU).

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 Bt1, MIR604 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.

Event MIR604 has been evaluated by Syngenta in field trials in multiple locations in the North and South America and in Spain. No adverse effects on human health or the environment were reported. MIR604 maize is approved for import in the USA, Canada, Japan, Mexico, Australia, New Zealand and is approved for cultivation in the USA, Canada and Japan

GA21 maize has been approved for commercial cultivation in the USA, Canada, Argentina 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.


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 Bt11xMIR604xGA21 maize on key non-target arthropods in Romania when cultivated under European field conditions.

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Not known