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Notification report


General information

Notification Number
B/ES/04/09

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
13/01/2004

Title of the Project
Agronomic Value trials Event Bt11.

Proposed period of release:
01/04/2004 to 30/11/2004

Name of the Institute(s) or Company(ies)
Syngenta Seeds SA, ;


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

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/03/14; 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/96/01/09; B/FR/97/11/14; B/FR/99/01/01; 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;

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
maizepoaceaezeazea maysmaysEvent Bt11and offspring derived.

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
Bt11 maize contains two genes introduced by genetic modification techniques:
- Glufosinate tolerance gene: pat (phosphinotricin acetyltransferase) under the control of the 35S promoter and the nos termination region.
- Insect resistance gene: cryIAb, under the control of the 35S promoter and the nos3' termination region.


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:
- pat gene, isolated from Streptomyces viridochromogenes, gene encodes the enzyme phosphinotrycin acetyltransferase, which catalyzes the conversion of glufosinate to herbicidally inactive product.

- cryIAb gene, isolated from Bacillus thuringiensis, encodes a Btk protein, which protects the plant from damage by lepidopteran pests.


6. Brief description of the method used for the genetic modification:
The initial parental transformation of the maize line was accomplished through the insertion of a fragment of the plasmid pZO1502. No DNA carrier was used.

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 purpose of the release is to test the agronomic value of Bt11 hybrids for Variety Registration.

2. Geographical location of the site:
Locations :

Comunidad Autónoma de Andalucía
Los Palacios (Sevilla)

Comunidad Autónoma de Aragón:
Quinto de Ebro (Zaragoza)
Sástago (Zaragoza)
Alforque (Zaragoza)
La Cartuja Baja (Zaragoza)

Comunidad Autónoma de Cataluña:
Lleida (Lleida)
Torres de Segre (Lleida)
L’Aldea (Tarragona)

Comunidad Autónoma de Extremadura:
Guareña (Badajoz)

Comunidad Foral de Navarra:
Cortes (Navarra)


3. Size of the site (m2):
- 1500 m2.

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:
Bt11 has been approved for cultivation, food and feed use in USA, Canada, Argentina and Japan. It has been approved for food and feed use in Switzerland and South Africa. In Australia /New Zealand has been approved for food.
Bt11 field maize has been approved for import for food and feed use in the EU under Directive 90/220 (Notification C/GB/96/M4/1). The European Scientific Committee for Food has also recently (SCF/CS/NF/DOS/14 ADD2 Final :17April 2002) concluded that “Bt11 sweet maize is as safe for human food use as its conventional counterparts.

No environmental or human health impact have been reported during any previous trial or during any commercial cultivation of maize carrying the Bt11 trait.

Hence, no such impact is expected from this trial either.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
It is the specific and intended effect of the modification, that the use of Bt11 maize would have an immediate, direct effect on the populations of target pests in the fields with Bt11 maize (Ostrinia nubilalis and Sesamia nonagroides). It is also possible that in areas where the use of Bt11 maize leads to a reduction in the use of insecticides, an increase in generalist predators such as carabids and spiders could occur resulting in an improved biological control of pest species (Head et al, 2001). In addition, reduced insect damage may result in a reduction in Fusarium fungal colonisation leading to an improvement in grain yield and quality.
A substantial number of field studies of non-target insect populations in Bt corn have been performed. To date no adverse effects of non-target invertebrates have been detected. (ABSJC, 2002)
In the EU, there are no indigenous species (non-target organisms), which rely exclusively on maize pests for survival as symbionts, predators or pathogens, it is highly unlikely that the reduction in numbers of ECB or MCB in the maize fields will affect the population levels of these non-target organisms.
Maize has no wild relatives in the EU so the potential for gene transfer to sexually compatible plant species, other than maize, in the EU is zero.
There is no evidence to suggest that intact gene transfer occurs from a plant species to micro-organisms in the field situation.


Brief description of any measures taken for the management of risks:
All the fields will be isolated 220 m from other maize fields and each will be surrounded by a border of 8 rows of conventional maize.

The products from the trials will not be used for human food or animal feed.

Plant material remaining after harvest will be ploughed into the soil.

The site will be monitored for one year after the release. During this year, commercial maize will not be grown on the trial site. Any volunteer maize appearing in the field will be eliminated before flowering.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
The trials have been designed to provide data for Variety Registration purpose.

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
05/03/2004 00:00:00
Remarks: