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Notification report


General information

Notification Number
B/ES/08/29

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
05/02/2008

Title of the Project
Field trials of Bt11 maize (2008).

Proposed period of release:
01/03/2008 to 30/11/2008

Name of the Institute(s) or Company(ies)
Syngenta Seeds, S.A., 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/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
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 maysmaysEvent Bt11 and 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 ammonium tolerance gene: pat (phosphinothricin-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 phosphinothrycin acetyl transferase which catalyzes the conversion of glufosinate ammonium to an 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 liberation is the line multiplication and collect complementary data from Bt11 maize field performance.

2. Geographical location of the site:
See next point (3)

3. Size of the site (m2):
The potential surface occupied by Bt11 maize will be:

Cataluña:
- La Fuliola: 1 Ha
- Lleida-30: 0.15 Ha

Castilla-La Mancha:
- Almansa -509: 2,64 Ha
- Almansa-511: 2,5 Ha
- Carcelén: 2,79 Ha
- La Roda: 1,64 Ha


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:
The European Food Safety Authority (EFSA) adopted on 20th April 2005 its favourable opinion about the evaluation of the maize Bt11 for cultivation. This Opinion was published in The EFSA Journal (2005) 213, 1-33: Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the notification (Referente C/F/96/05.10) for the placing on the market of insect resistant genetically modified maize Bt11, for cultivation, feed and industrial processing, under Part C of Directive 2001/18/EC from Syngenta Seeds (Question No EFSA-Q-2004-012)Opinion adopted on 20 April 2005.
This Opinion can be consulted in the EFSA web site:
http://www.efsa.eu.int/science/gmo/gmo_opinions/922/gmo_opinion_ej213_bt11maize_
cultivation_en1.pdf
The Bt11 maize has been evaluated for its security by numerous authorities in the world. It has been approved for its culture and for its use for human and animal consumption in: U.S.A., Canada, Argentina, Japan, South Africa, Uruguay and Philippines. Exclusively for human and animal consumption it has been authorized in Switzerland, Australia, New Zealand, Korea, Taiwan, Russia, China and the European Union (E .U.)
The results confirm the safety of the culturing for the environment and the agronomic adjustment of the studied hybrids.
No environmental or human health negative impact has been reported during previous trials or during 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. (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.
No characteristics of Bt11 maize could be identified that may cause adverse effects on human health or the environment.


Brief description of any measures taken for the management of risks:
o The isolation measures are designed taking in consideration the purpose of line multiplication for these trials, where the presence of external maize pollen represents a severe threat for its development.
o Fields planted in Catalonia, which will be under hand pollinization will be sowed at a distance of at least 200 m from commercial maize fields and a border of at least 4 rows of non-GM maize will be planted surrounding the GM maize field.
o Fields at Castilla-La Mancha, which will be pollinated at real field production conditions, will be isolated from any other maize field by a distance of at least 400 m.
o Plant material remaining after harvest will be ploughed into the soil.
o The site will be monitored for one year after the release. During the following planting season, commercial maize will not be grown on the trial site. Any volunteer maize appearing in the field will be eliminated before flowering.
o In addition to the scheduled observations of agronomic parameters for the
Commercial Register evaluation, during the regular visits to the Field trials a
visual inspection will be carried out in order to detect any potential unanticipated adverse environmental effect. In case any adverse environmental effects, linked to the deliberate release of Bt11 maize, are observed during the period of release, these will be reported immediately to the Competent Authority.


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 with the only purpose of collecting data and seed
multiplication. 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:
Yes
20/02/2008 00:00:00
Remarks:
There are several Autonomous Communities as competent authorities for give the consent of these field trials:
- Castilla-La Mancha: 20/02/2008.
- Cataluña: 25/03/2008.