Date of publication: February 5, 2004
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification
report
General information
Notification Number:
B/ES/04/01
Member State:Spain
Date of Acknowledgement:08/01/2004
Title of the Project:
Testing of Coleopteran insect resistant as well as herbicide
tolerant maize hybrids.
Proposed period of release From:01/04/2004
To:15/12/2004
Name of the Institute(s) or Company(ies): PIONEER
HI-BRED SPAIN S.L.;
3. Is the same GMPt release planned elsewhere in the
Community?
No
4 - Has the same GMPt been notified elsewhere by the same
notifier?
No
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
|
Experimental hybrids. |
2. Description of the traits and characteristics which have
been introduced or modified, including marker genes and previous
modifications:
The genetically modified plants that will be tested in these
field trials have been modified for resistance to certain
Coleopteran insects by the insertion of two genes from Bacillus
thuringiensis and for glufosinate tolerance by the insertion of
a gene from Streptomyces viridochromogenes. (CBI, See Annex 1)
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:
The list of genetic elements inserted is given in Annex 1 as
this is to be considered as Confidential Business Information.
6. Brief description of the method used for the genetic
modification:
The genetic modification has been done using Agrobacterium
tumefaciens, strain LBA4404 to introduce the DNA into the maize
genome. The T-DNA on the Ti-plasmid has been replaced by the
construction containing the 3 genes along with the regulative
components necessary for expression.
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 goal of this release is to collect data on the
composition of different parts of the plant and on the
expression of the produced proteins in comparison with the
non-genetically modified equivalent hybrid, at different growth
stages.
This will be necessary to later apply for a marketing release of
these genetically modified plants in the European Community.
2. Geographical location of the site:
The release is planned at several locations in Spain in 2004:
- Andalucía: Los Palacios (Sevilla), Los Molares (Sevilla), Los
Rosales (Sevilla).
- Aragón: Montañana (Zaragoza) (2 locations), San Juan de
Morrifar (Zaragoza), Pastriz (Zaragoza), Barbastro (Huesca),
Tamarite de Litera (Huesca), Graus (Huesca).
- Castilla la Mancha: Albacete (3 locations)
- Castilla-León: Colinas de Trasmontes (Zamora), El Burgo Ranero
(León) (2 sitios)
- Cataluña: Vimbodí (Lérida), Tremp (Lérida), Alguaire (Lérida).
- Madrid: Fuentidueña de Tajo (Madrid), Villamarique de Tajo
(Madrid), Estremeda (Madrid).
- Navarra: Cortes (3 locations)
3. Size of the site (m2):
The trial at each site in 2004 will cover about 1.000 m2 (all
varieties and borders included) of which 110 m2 will be planted
with the transgenic plants concerned by this application.
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:
Pioneer began testing corn hybrids genetically modified with
this transformation event in 2001. The genetically modified corn
hybrids have been in continuous nurseries in Hawaii and Puerto
Rico. Since 2002, several field trials have been conducted
throughout the maize growing region of the United States of
America and in Chile. Field trails were also conducted in Europe
in 2003, in France and Bulgaria. No environmental problems were
reported for these trials. The transgenic plants behaved as
conventional maize. They were indistinguishable from the
non-genetically modified maize plants except for being insect
resistant and herbicide tolerant.
Environmental
Impact and Risk Management
Summary of the potential
environmental impact from the release of the GMPts:
The e.r.a. has not identified any risks to human and animal
health or the environment from the deliberate release of GM
maize containing resistance to certain Coleopteran insects and
tolerance to glufosinate ammonium. This is based on the
information contained in this notification and the following
concluding remarks:
- There is negligible likelihood for GM maize to become
environmentally persistent or invasive giving rise to any
weediness;
- Expression of the two insecticidal proteins and the herbicide
tolerance protein does not confer any selective advantage
outside the agricultural environment;
- There are no wild relatives of maize in the EU and the genetic
modification in maize does not introduce any selective
advantages to maize plants outside the heavily managed
agricultural environments;
- The deliberate release of genetically modified maize will
result in negligible immediate and/or delayed environmental
impact resulting from direct and indirect interactions of
genetically modified maize with non-target organisms;
- The genetic modification in maize does not introduce any new
compounds known to cause, or expected to cause, any potential
immediate and/or delayed effects on human health;
- The genetic modification in maize does not introduce any new
compounds known to cause, or expected to cause, any possible
immediate and/or delayed effects on animal health. Moreover, the
genetically modified maize obtained from these field releases
will not enter the feed/food chain.
- The genetic modification will not cause any possible immediate
and/or delayed effects on biogeochemical processes.
- The specific cultivation, management and harvesting techniques
used for the genetically modified maize are identical to those
used for other non- genetically modified maize.
- The potential reduction of the control of certain Coleopteran
insect pests if the target insect pests develop resistance to
the proteins as expressed in genetically modified maize has been
identified as the only potential risk resulting from the
interaction of genetically modified maize with target organisms.
Given the size of this deliberate release, the probability of
occurrence of such a phenomenon is negligible. However, if later
a release for placing on the market is to be envisaged, a
monitoring plan in order to minimize the development of insect
resistance to these proteins will be submitted.
Brief description of any measures taken for the management of
risks:
The shedding of pollen from the genetically modified plants
will be controlled by bagging, before the pollen shedding, the
tassels from the plants that will be self-pollinated and by
detasselling the plants that will not be self-pollinated.
Moreover, a 200m-isolation distance will be maintained to any
other commercial corn crop.
Seed dispersal of individual kernels does not generally occur.
They are fixed on a cob and enclosed in many husks that protect
the seeds from outside contact. For this trial, a few seeds will
need to be collected for analysis; this will be done by sampling
the whole ear and unused seeds will be destroyed.
In case of any emergency, the trial could be stopped by
application of a non-selective herbicide other than glufosinate
or by mechanical destruction and incorporation into the soil.
At the end of the release all remaining plant matter that has
not been harvested for analyses will be destroyed by chopping
and incorporating into the soil.
Volunteer maize will be monitored during the following year. An
herbicide treatment (other than glufosinate) will be used in
order to ensure destruction if needed.
Summary of foreseen field trial studies focused to gain new
data on environmental and human health impact from the release:
Not applicable to this release. |
