Date of publication: March 9,
2006
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification number: B/ES/06/38
Member State:Spain
Date of Acknowledgement:21/02/2006
Title of the Project:
Preliminary trials for the registration of commercial
varieties of Bt11 maize resistant to insects. Spain 2006.
Proposed period of release From:01/03/2006
To:30/11/2006
Name of the Institute(s) or Company(ies): Syngenta
Seeds SA;
3. Is the same GMPt release planned elsewhere in the
Community?
No
4 - 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/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
1. Complete name of the
recipient or parental plant(s)
|
Common Name
|
Family Name
|
Genus |
Species
|
Subspecies
|
Cultivar/breeding line
|
| maize
|
poaceae |
zea
|
zea
mays |
mays
|
Event
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 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;
4. 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 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.
Adicionally, a nursery for the observation of parentals will be
planted in Lleida.
2. Geographical location of the site:
ARAGON
Alforque (Zaragoza)
Fraga (Huesca)
Sástago (Zaragoza)
CATALONIA
Barbens (Lleida)
Bellpuig (Lleida)
Lleida (Lleida)
Torres de Segre (Lleida)
3. Size of the site (m2):
ARAGÓN
Alforque (Zaragoza): 2000 m2
Fraga (Huesca): 2000 m2
Sástago (Zaragoza): 2000 m2
CATALONIA
Barbens (Lleida): 2000 m2
Bellpuig (Lleida): 2000 m2
Lleida (Lleida): 3500 m2
Torres de Segre (Lleida): 2000 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:
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.
Brief description of any measures taken for the management of
risks:
-All the fields will be isolated by a distance of at least
220 m from other maize fields.
- All the fields will be surrounded by a border of 8 rows of
conventional maize.
- The grain harvested 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 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.
Adicionally, a nursery for the observation of parentals will be
planted in Lleida.
Final report
-
European
Commission administrative information
Consent given by the Competent
Authority: Not Known |
