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Notification report


General information

Notification Number
B/ES/10/15

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
17/02/2010

Title of the Project
Field trials for the registration of commercial varieties of Bt11 maize (2010).

Proposed period of release:
01/04/2010 to 30/11/2010

Name of the Institute(s) or Company(ies)
Syngenta Seeds SAS, Syngenta Seeds SAS on behalf of Syngenta Crop Protection AG, Basel Switzerland and all affiliated companies;


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

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/06/05; B/ES/06/38; B/ES/07/33; B/ES/07/37; B/ES/08/28; B/ES/08/29; B/ES/09/38; B/ES/09/58 ; B/ES/96/07-CON; B/ES/97/14; B/ES/98/02; B/ES/99/27-CON; B/FR/02/03/04; 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/08/01; B/RO/07/01; B/RO/08/03; B/RO/09/11;

Other notifications
B/FR/95/12/04

Genetically modified plant

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

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 ammonium tolerance gene: pat (phosphinothricin-acetyl-transferase) 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:
- Regulatory sequences: Promoter and intron sequences derived from the Cauliflower Mosaic virus and maize. The function of these sequences is to control expression of the herbicide and insect tolerance genes.

- Insect tolerance gene: cry1Ab gene, which encodes a Cry1Ab protein that confers resistance to certain lepidopteran insect pests. The cry1Ab gene was originally cloned from Bacillus thuringiensis var. kurstaki HD-1.

- Herbicide tolerance gene: Streptomyces viridochromogenes gene encoding the selectable marker PAT. PAT confers resistance to herbicides containing glufosinate.

- 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 and insect tolerant gene expression.


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

Experimental Release

1. Purpose of the release:
The purpose of the liberation is to do trials for the application of inscription of Bt11 maize varieties in the Official Commercial Varieties Register, required by Law 3/2000, of January 7th.

2. Geographical location of the site:
- Andalucía: Los Palacios 14000 m2.

- Aragón:
Alforque: 17500 m2.
Alagón-1: 9000 m2.
Alagón-2: 10200 m2.
Alagón-3: 3500 m2.
Alagón-4: 11500 m2.
Esplús: 24200 m2.
Fraga-1: 9000 m2.
Pedrola: 13000 m2.
Sastago-1: 22500 m2.
Sastago-2: 10000 m2.
Sastago-3: 3000 m2.
Sastago-4: 10000 m2.

- Cataluña:
Alamús: 7000 m2.
La Granja: 20000 m2.


3. Size of the site (m2):
- Andalucía: Los Palacios 14000 m2.

- Aragón:
Alforque: 17500 m2.
Alagón-1: 9000 m2.
Alagón-2: 10200 m2.
Alagón-3: 3500 m2.
Alagón-4: 11500 m2.
Esplús: 24200 m2.
Fraga-1: 9000 m2.
Pedrola: 13000 m2.
Sastago-1: 22500 m2.
Sastago-2: 10000 m2.
Sastago-3: 3000 m2.
Sastago-4: 10000 m2.

- Cataluña:
Alamús: 7000 m2.
La Granja: 20000 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 maize has been approved for cultivation in the USA, Canada, Argentina, Japan, South Africa, Uruguay and the 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).

An application for the cultivation of Bt11 maize in the EU was submitted in May 1996 under the Environmental Release Directive 90/220/EEC (updated to Directive 2001/18/EC). This file is still pending. In relation to this application, the European Food Safety Authority (EFSA) adopted a favourable opinion on the Bt11 maize for cultivation on 20th April 20051 and confirmed it in November 2008.

Bt11 maize is approved for import, food and feed use in the EU under formerly Directive 90/220/EEC (EFSA website).

Field trials with Bt11 maize have been performed in the EU since 1994. No environmental or human health negative impact has been reported from these trials:

Spain: B/ES/96/07, B/ES/97/14, B/ES/98/02, B/ES/99/27, B/ES/00/04, B/ES/00/28, B/ES/01/06, B/ES/02/04, B/ES/02/04, B/ES/02/05, B/ES/02/14, B/ES/04/09, B/ES/05/21, B/ES/06/05, B/ES/06/38, B/ES/07/37, B/ES/07/32, B/ES/07/33, B/ES/08/29, B/ES/09/38, B/ES/09/58
France: B/FR/94 01.06/A, B/FR/95 01.03, B/FR/95 12.04, B/FR/96 01.09, B/FR/97 11.14, B/FR/99 01.02, B/FR/99 02 09, B/FR/02 03 04, B/FR/03 01 01, B/FR/03 03 02
Italy: B/IT/95/16, B/IT/96/13, B/IT/96/53, B/IT/97/19, B/IT/98/39, B/IT/99/20 Portugal: B/PT/98/1
Romania: B/RO/07/01, B/RO/08/03, B/RO/09/11

The results of these releases confirm the safety of the Bt11 hybrids for cultivation in Europe. No negative impact on the environment or human or animal health has been reported during previous trials or during commercial cultivation of maize carrying the Bt11 trait. Please see the final reports for the above mentioned field trials on the homepage of the Joint Research Centre (http://gmoinfo.jrc.ec.europa.eu/).


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. (ABSTC, 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 sowed at a distance of at least 200 m from commercial maize fields.

A border of at least 8 rows of conventional maize will be planted surrounding the GM maize field.

Seeds lots will be packed in sealed paper bags in facilities authorized to carry out confined release of GMOs; the bags will remain closed until planting. Each paper bag will be clearly labeled with a unique identifier code and an indication that it is containing GM seeds. The name of the event will be also mentioned. All the bags containing the seeds lots will be contained into a sealed and labeled box.

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

Plant material remaining after harvest will be ground and incorporated into the soil.

The sites will be monitored for one year after the release and any volunteer maize appearing will be eliminated before flowering. During the following planting season, commercial maize will not be grown on the trial sites.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
The only purpose of the liberation is to do preliminary trials for the application of inscription of Bt11 maize varieties in the Official Commercial Varieties Register, required by Law 3/2000, of January 7th, the legal regime of the protection of the vegetal obtainings, and Law 11/1971, of seeds and plants of breeding ground. However, if any unanticipated adverse effects on human health or the environment would be observed, it will be reported immediately to the Competent Authority.

Final report
-

European Commission administrative information

Consent given by the Member State Competent Authority:
No
09/04/2010 00:00:00
Remarks:
Withdrawn by the notifier.