Date of publication: February 5, 2004
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification
report
General information
Notification Number:
B/ES/04/09
Member State:Spain
Date of Acknowledgement:13/01/2004
Title of the Project:
Agronomic Value trials Event Bt11.
Proposed period of release From: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
4 - Has the same GMPt been notified elsewhere by the same
notifier?
Yes
If yes, notification number(s):
B/ES/96/07-CON; B/ES/97/14; B/ES/98/02; B/ES/99/27-CON;
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/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/FR/03/01/01; B/FR/03/03/02;
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
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 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;
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 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. |
