Date of publication: March 18,
2005
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification number: B/ES/05/21
Member State:Spain
Date of Acknowledgement:15/02/2005
Title of the Project: Field trials of maize resistant to
insects. Event Bt11Spain 2005-2006
Proposed period of release From:01/04/2005
To:30/11/2005
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/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/99/02/09;
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
C/FR/96/05/10 UK/C/96/M4/1 B/F/95/12.04 B/F/99/01 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 collect data of Bt11
maize varieties related to the technical inspection for the
inscription of commercial varieties, 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.
2. Geographical location of the site:
Alforque (Zaragoza)
L’Aldea (Tarragona)
Deltebre(Tarragona)
Lleida (Lleida)
Fraga (Huesca)
Fuentes de Andalucía (Sevilla)
Sástago (Zaragoza)
Torres de Segre (Lleida)
3. Size of the site (m2):
Alforque (Zaragoza) 2604 m2
L’Aldea (Tarragona) 2604 m2
Deltebre(Tarragona) 2604 m2
Lleida (Lleida) 2604 m2
Fraga (Huesca) 2604 m2
Fuentes de Andalucía (Sevilla) 2604 m2
Sástago (Zaragoza) 2604 m2
Torres de Segre (Lleida) 2604 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, Japan and South Africa. It has been
approved for food and feed use in Switzerland, Australia, New
Zealand, Phiilipines, Korea and European Union (E.U.)
The European Scientific Committee for Food has concluded "Bt11
sweet maize is as safe for human food use as its conventional
counterparts".
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:
o All the fields will be isolated by a distance of at least
220 m from other maize fields
o All the fields will be surrounded by a border of 8 rows of
conventional maize.
o The grain harvested from the trials will not be used for human
food or animal feed.
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 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 not been designed to gain data related to the
technical inspection of the maize hybrids destined to the
Commercial Registry of the Varieties |
