Date of publication: February 23,
2006
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification number: B/ES/06/32
Member State:Spain
Date of Acknowledgement:24/01/2006
Title of the Project:
Testing of genetically modified 59122x1507xNK603
(DAS-59122-7xDAS-Ø15Ø7-1xMON-ØØ6Ø3-6) 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:
The genetically modified 59122x1507xNK603 maize varieties
that will be tested in these field trials are resistant to
certain Coleopteran insects, such as Western corn rootworm
(Diabrotica virgifera virgifera), and certain Lepidopteran
insects, such as European corn borer (Ostrinia nubilalis), and
tolerant to glufosinate-ammonium and glyphosate herbicides. This
maize was derived through traditional breeding methods between
progeny of the genetically modified 59122 maize, 1507 maize and
NK603 maize (from Monsanto).
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 59122x1507xNK603 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, like in 59122 maize, the cry1F gene from Bacillus
thuringiensis var. aizawai, providing resistance to certain
Lepidopteran insects and the pat gene from Streptomyces
viridochromogenes, introduced as a selectable marker, providing
tolerance to glufosinate-ammonium herbicide, like in 1507 maize,
and the cp4epsps gene from Agrobacterium sp. strain CP4 that
confers tolerance to glyphosate herbicide, like in NK603 maize,
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.
- the cry1F gene, the UBIZM1(2) promoter, the ORF25PolyA
terminator.
- the pat gene, the CaMV35S promoter, the CaMV35S terminator.
- the cp4epsps gene, the P-ract1/ract1 intron + ctp2, the NOS 3’
terminator.
- the cp4epsps gene, the CaMV e35S promoter + Zmhsp70 + ctp2,
the NOS 3’ terminator.
6. Brief description of the method used for the genetic
modification:
No genetic modification was made on the 59122x1507xNK603
maize varieties directly: they were derived through traditional
breeding methods between progeny of the genetically modified
59122, 1507 and NK603 maize.
59122 maize was genetically modified using Agrobacterium
transformation method. 1507 maize was genetically modified using
a particle acceleration method. NK603 maize was genetically
modified by Monsanto using a particle acceleration 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 59122x1507xNK603 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 1000m² sown with the
genetically modified maize subject of this notification
(59122x1507xNK603 maize), the total trial surface (all varieties
and borders included) being larger.
In the following years, there could have up to 1000m² of the
genetically modified maize subject of this notification
(59122x1507xNK603 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:
Field trials have already been conducted at several locations
across maize growing regions in North America, South America and
Europe and no environmental problems were reported for these
trials. The transgenic plants were indistinguishable from the
non-genetically modified maize plants except for showing
resistance to certain Coleopteran insects, such as Western corn
rootworm, and certain Lepidopteran insects such as European corn
borer and showing tolerance when glufosinate and glyphosate
herbicides were applied, traits due to the genetic
modifications.
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 and Lepidopteran insects and tolerant to
glufosinate and glyphosate herbicides are expected, as per
information contained in the environmental risk assessment and
the following concluding remarks.
- There is negligible likelihood for 59122x1507xNK603 maize to
become environmentally persistent or invasive giving rise to any
weediness;
- Expression of Cry34Ab1, Cry35Ab1, Cry1F, PAT and CP4 EPSPS
proteins in 59122x1507xNK603 maize does not confer any selective
advantage outside the agricultural environment;
- There are no wild relatives of maize in the EU and the
traditional breeding that led to 59122x1507xNK603 maize does not
introduce any selective advantages to maize plants outside
heavily managed agricultural environments;
- The deliberate release of 59122x1507xNK603 maize will result
in negligible immediate and/or delayed environmental impact
resulting from direct and indirect interactions of
59122x1507xNK603 maize with non-target organisms;
- The genetic modification in 59122x1507xNK603 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, 59122x1507xNK603 maize subject of the release
will not enter the food chain;
- The genetic modification in 59122x1507xNK603 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, 59122x1507xNK603 maize subject of the release
will not enter the feed chain;
- The 59122x1507xNK603 maize will not cause any possible
immediate and/or delayed effects on biogeochemical processes;
- The specific cultivation, management and harvesting techniques
used for the 59122x1507xNK603 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 59122x1507xNK603 maize;
- The potential reduction of the control of certain coleopteran
and lepidopteran insect pests if the target insect pests develop
resistance to the Cry34Ab1 and Cry35Ab1 or Cry1F proteins as
expressed in 59122x1507xNK603 maize has been identified as the
only potential risk resulting from the interaction of
59122x1507xNK603 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
59122x1507xNK603 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
and glyphosate, 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. An
herbicide treatment (other than glufosinate and glyphosate) will
be used in order to ensure destruction if needed.
There will be no commercial maize grown on the same field 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 |
