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Notification report


General information

Notification Number
B/RO/08/03

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
Application for review of authorization conditions for the deliberate release into the environment of genetically modified insect resistant Bt11 maize
(Field Trials)


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; France; Italy; 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; B/RO/07/01;

Other notifications
France:
B/FR/95/12/04
B/FR/96/01/09/B
B/FR/02/03/04

Field trials with Bt11 maize have been performed in the EU since 1994 (Spain, France, Italy and Portugal). In Romania, field trials with one Bt11 maize hybrid have been carried out for official registration purposes (beginning with 2007). No environmental or human health negative impact has been reported from these trials

Bt11 maize has been previously approved for import, processing and feed use under Directive 90/220/EEC. Food and food ingredients derived from Bt11 maize have been also authorized pursuant to Article 5 of Regulation (EC) 258/97. Bt11 sweet maize has also been approved for food consumption in the framework of Regulation (EC) 258/97. The European Food Safety Authority (EFSA) adopted on 20th April 2005 its favorable opinion about the evaluation of the maize Bt11 for cultivation.


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:
Bt11 maize is tolerant to certain Lepidopteran species such as the insect corn borers (European Corn Borer (ECB), Ostrinia nubilalis, and Mediterranean Corn Borer, (MCB), Sesamia nonagrioides).

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

Experimental Release

1. Purpose of the release:
The objectives of the field trail releases of Bt11 genetically modified insect resistant maize, to be carried out between 2008 and 2011, 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 this GM maize in the environment and geo-climatic conditions of Romania.

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 seven different locations between 2008-2011. The trial area with GM Bt11 plants will be maximum 300 sqm/location (4 locations – 2 at ISTIS and 2 at SCDA Lovrin) for agronomical and comparative analysis (Testing under production conditions). The trial area with Bt11 GM plants will not exceed 100 sqm/location/hybrid for official registration trials (5 experimental trials – ISTIS). In 2008, two Bt11 maize hybrids will be tested (NX3434Bt11(NX400BB) and NX4529).

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 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.

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. Bt11 maize has received in 2007 a positive opinion for field trials from the Romanian Biosafety Commission.

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:
Not known