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Notification report


General information

Notification Number
B/RO/07/02

Member State to which the notification was sent
Romania

Date of acknowledgement from the Member State Competent Authority
01/02/2007

Title of the Project
Field trials with genetically modified glyphosate tolerant maize event GA21 to be carried out between 2006 and 2009, according to authorization approval no. 14 of the 24th of May 2006

Proposed period of release:
15/03/2007 to 15/11/2016

Name of the Institute(s) or Company(ies)
Syngenta Agro SRL, 2A Johann Strauss Str.
2nd and 3rd Floor
District 2, 020312, Bucharest
On behalf of:
Syngenta Crop Protection AG, Basel Switzerland and all affiliated companies
Schwarzwaldallee 215, CH 4058 Basle, Switzerland;


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

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

If yes, notification number(s):
B/ES/06/04; B/FR/06/01/12;

Other notifications
Cezch Republic: 48097, 46093, 44975/ENV/GMO/05

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
maizepoaceaezeazea maysmaysVarious GA21

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
A gene encoding a protein that confers tolerance to 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:
Regulatory sequences: Promoter and the first intron of the actin 1 gene derived from rice. The function of these sequences is to ensure the constitutive expression of the epspsm gene in maize.

Optimized transit peptide: N-terminal optimized transit peptide sequence constructed based on transit peptide sequences from maize and sunflower. The function of this sequence is the guide the transit peptide to the chloroplast, the location where the synthesis of aromatic amino is carried out.

Herbicide tolerance gene: epsps (5-enolpyruvylshikimate-3-phosphate synthase) gene derived from genetically modified 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 termination of transcription and polyadenylation of the ARNm.


6. Brief description of the method used for the genetic modification:
Event GA21 was produced via microprojectile 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:
The objective of the field trail releases of GA21 genetically modified glyphosate tolerant maize, to be carried out between 2006 and 2009, is to gain further information relating to the agricultural performance and environmental compatibility of the event under European conditions and to produce maize for comparative analysis. They will also allow the further assessment, in time, of the event in the environment and geo-climatic conditions of Romania.

2. Geographical location of the site:
In Romania, the studies will be conducted at three different location sites:
1. Lovrin, Timiş county (Lovrin Agronomical Research and Development Station)
2. Dâlga, Călăraşi county (CTS Dâlga, ISTIS)
3. Râmnicu Sărat, Buzău county (CTS Râmnicu Sărat, ISTIS)


3. Size of the site (m2):
The trial surface area for the genetically modified maize plants cultivated at each of the 3 locations will not exceed more than 1188 sqm. The total area size of the whole trial/location is no more than 2600 sqm (including non GM maize representing the 8 border rows included).

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:
Results obtained from previous field trials in the USA, suggests that the genetically modified lines do not differ from the recipient plant with regards to the mode or rate of reproduction, dissemination or survivability. Event GA21 has been approved for commercial cultivation in the USA, Canada, Argentina and Japan. The event is currently cultivated in the USA and Canada with no adverse effects to the environment or on human health reported.

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 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 300 m;
- A minimum of 8 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;
- The field trial will be sown at least a week later so that flowering will not coincide with neighbouring conventional maize fields;
- Sowing and harvesting will be conducted by 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 the 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 trials have not been designed to specifically gain new data on the environment and human health impact of the release. They will allow the further assessment of the event in the environment and in the geo-climatic conditions of Romania.

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
23/04/2007 00:00:00
Remarks:
It also includes the import permit no. 2/23.04.2007