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Notification report


General information

Notification Number
B/RO/07/01

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
Deliberate release into the environment for field trial purpose in the State Institute for Variety Testing and Registration network for registration in the Official Catalogue of Varieties of genetically modified insect resistant Bt11 maize hybrids to be carried out between 2007 and 2010

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

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; Portugal;

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

If yes, notification number(s):
B/ES/00/04; B/ES/01/06; B/ES/02/04; B/ES/02/05; B/ES/02/14; B/ES/04/09; B/ES/05/21; B/ES/96/07-CON; B/ES/97/14; B/ES/98/02; B/ES/99/27-CON; B/FR/03/01/01; B/FR/03/03/02; B/FR/94/01/06/A; B/FR/95/01/03; B/FR/96/01/09; B/FR/97/11/14; B/FR/99/01/02; B/FR/99/02/09; B/IT/95/16; B/IT/96/13; B/IT/96/53; B/IT/97/19-CON; B/IT/98/39-CON; B/IT/99/20-CON; B/PT/98/01;

Other notifications
B/FR/95 12.04
B/FR/02 03 04


Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
maizepoaceaezeazea maysmaysBt11 maize hibrid NX3434Bt11 NX400BB

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
The Bt11 maize described in this application has been produced by transformation of Zea mays protoplasts and is insect resistant.
Bt11 maize is resistant to certain lepidoperan insects such as European Corn Borer and Mediterranean Corn Borer.


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:
Bt11 event:
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.


6. Brief description of the method used for the genetic modification:
The Bt11 maize described in this application has been produced by transformation of Zea mays protoplasts and is genetically modified for insect resistance to certain Lepidopteran species.

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 trails within ISTIS network of Bt11 genetically modified insect resistant maize, to be carried out between 2007 and 2010, to gain further information relating to the agronomical and phenotype performance and compatibility of this event under Romanian geo-climatic conditions.
The overall purpose of the trials is to register the Bt11 hybrids (NX3434Bt11(NX400BB) in the national Official Variety Catalogue.


2. Geographical location of the site:
The studies will be conducted in Romania, at the following ISTIS network field trial locations:

1. CTS Dâlga, judeţul Călăraşi
2. CTS Târgovişte, judeţul Dâmboviţa
3. CTS Râmnicu Sărat, judeţul Buzău
4. CTS Satu Mare, judeţul Satu Mare
5. CTS Luduş, judeţul Mureş


3. Size of the site (m2):
For each of the five locations, the experimental field (VAU test) with GM plants will have a maximum of 100 sqm/hybrid/location. The plots will have four rows and will be organized in 5 repetitions (100 plants/plot). The DUS test will be carried out in only one location on maximum 200 sqm (Bt11 and GM parental line). In total, the GM plants will be sown on maximum 700 sqm.

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 carried out in the USA suggest that the genetically modified 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 cultivation in the United States of America, Canada, Argentina, Japan, South Africa, Uruguay and Philippines. It has also been approved for human food and animal feed use in Switzerland, Australia, New Zealand, Korea, Taiwan, Russia, China and the European Union (EU). No environmental or human health negative impact has been reported during previous trials or during commercial cultivation of maize carrying the Bt11 trait.


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 this 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 four 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 by ISTIS 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;
-No seed products resulting from the field trails will be used as food or feed;
-After harvest, ISTIS 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.

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. 1/23.04.2007