Date of publication: February 23,
2006
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification number: B/ES/06/30
Member State:Spain
Date of Acknowledgement:24/01/2006
Title of the Project:
Testing of genetically modified 59122 (DAS-59122-7)maize.
Proposed period of release From:01/04/2006
To:31/12/2009
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 varieties |
2. Description of the traits and characteristics which have
been introduced or modified, including marker genes and previous
modifications:
New genes were introduced into the genetically modified 59122
maize plants so that they can fight against the damages caused
by certain Coleopteran insect pests, such as Western corn
rootworm (Diabrotica virgifera virgifera). Tolerance to
glufosinate-ammonium herbicide has been introduced as a
selectable marker for the screening process.
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 genes introduced in 59122 maize are the cry34Ab1 and
cry35Ab1 genes from Bacillus thuringiensis strain PS149B1,
providing resistance to certain Coleopteran insects and the pat
gene from Streptomyces viridochromogenes, introduced as a
selectable marker, providing tolerance to glufosinate herbicide,
along with their regulatory components necessary for expression
in maize plant:
- the cry34Ab1 gene, the UBIZM1(2) promoter, the PINII
terminator.
- the cry35Ab1 gene, the Peroxidase promoter, the PINII
terminator.
- the pat gene, the CaMV35S promoter, the CaMV35S terminator.
6. Brief description of the method used for the genetic
modification:
59122 maize was genetically modified using Agrobacterium
transformation method.
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 the testing of genetically
modified 59122 maize varieties in view of collecting regulatory
data for registration on the National Catalogue of varieties.
2. Geographical location of the site:
The release is planned at the following locations in Spain in
2006:
- Andalucía: La Rinconada (Sevilla), Marchena (Sevilla)
- Aragón: Zuera (Zaragoza), Gelsa (Zaragoza), Gurrea de Gállego
(Huesca)
- Castilla-León: Toro (Zamora), Llamas de la Ribera (Leon),
Pelabravo (Salamanca)
- Cataluña: Alguaire (Lérida)
- Castilla la Mancha: Membrilla (Ciudad Real), Tarazona de la
Mancha (Albacete), Alpera (Albacete)
- Galícia: Santa Uxía de Ribeira (La Coruña), Mesía (La Coruña)
- Madrid: San Martín de la Vega (Madrid).
- Navarra: Cortes (Navarra)
3. Size of the site (m2):
In 2006, each site could have up to 1000 m² sown with the
genetically modified maize subject of this notification (59122
maize), the total trial surface (all varieties and borders
included) being larger.
In the following years, there could have up to 1000 m² of the
genetically modified maize subject of this notification (59122
maize) sown per site, the total trial surface at each site (all
varieties and borders included) being larger.
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:
Many field trials have already been conducted at several
locations since 2001 and 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 showing resistance to certain
Coleopteran insects, such as the Western corn rootworm, and
showing tolerance when glufosinate has been applied, traits due
to the genetic modification.
Environmental
Impact and Risk Management
Summary of the potential
environmental impact from the release of the GMPts:
No risks to human and animal health or the environment from
the deliberate release of genetically modified maize resistant
to certain Coleopteran insects and tolerant to glufosinate
herbicide are expected, as per information contained in the
environmental risk assessment and the following concluding
remarks:
- There is negligible likelihood for 59122 maize to become
environmentally persistent or invasive giving rise to any
weediness;
- Expression of Cry34Ab1, Cry35Ab1 and PAT proteins in 59122
maize 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 59122 maize does not introduce any selective
advantages to maize plants outside heavily managed agricultural
environments;
- The deliberate release of 59122 maize will result in
negligible immediate and/or delayed environmental impact
resulting from direct and indirect interactions of 59122 maize
with non-target organisms;
- The genetic modification in 59122 maize does not introduce any
new compounds known to cause, or expected to cause, any
potential immediate and/or delayed effects on human health.
Moreover, 59122 maize will not enter the food chain;
- The genetic modification in 59122 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,
59122 maize will not enter the feed chain;
- The genetic modification in 59122 maize will not cause any
possible immediate and/or delayed effects on biogeochemical
processes;
- The specific cultivation, management and harvesting techniques
used for the 59122 maize are identical to those used for
non-genetically modified maize, with the exception of the
herbicide regime and monitoring plan to be proposed for
commercial cultivation of 59122 maize;
- The potential reduction of the control of certain coleopteran
insect pests if the target insect pests develop resistance to
the Cry34Ab1 and Cry35Ab1 proteins as expressed in 59122 maize
has been identified as the only potential risk resulting from
the interaction of 59122 maize with target organisms. In the
case of the trials, the likelihood of the occurrence of this
potential identified adverse effect is negligible. The risk
posed by the target-insect resistance development is thus
negligible. However, an IRM strategy will be developed in the
context of product stewardship for the placing on the market of
59122 maize.
Brief description of any measures taken for the management of
risks:
The shedding of pollen from the genetically modified plants
will be controlled by maintaining a 200-meter isolation distance
with any other non-experimental maize crop. In addition, the
trial site will be surrounded by four border rows of
conventional maize of a similar relative maturity that will be
also destroyed at the end of the release.
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. When a few seeds 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. No plant or plant product
coming from the trials will enter the food or feed chains.
Volunteer maize will be monitored during the following year in
order to ensure their destruction, if needed.
No commercial maize will be cultivated in the trial site the
following year.
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.
Final report
-
European
Commission administrative information
Consent given by the Competent
Authority: Not Known |