Date of publication: July 28, 2004
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification
report
General information
Notification Number:
B/FR/04/03/04-CON
Member State:France
Date of Acknowledgement:01/03/2004
Title of the Project: Testing of genetically modified
maize resistant to Lepidopteran insects as well as herbicide
tolerant.
Proposed period of release From:15/04/2004
To:15/12/2007
Name of the Institute(s) or Company(ies): Pioneer
Genetique Sarl;
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 and inbred lines |
2. Description of the traits and characteristics which have
been introduced or modified, including marker genes and previous
modifications:
The introduced genes are the cry1F gene from Bacillus
thuringiensis var. aizawai, providing resistance to certain
Lepidopteran insects and the pat gene from Streptomyces
viridochromogenes providing glufosinate-ammonium herbicide
tolerance.
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 the 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 by the particle
acceleration method using a "gene gun" to introduce, into maize
cells, a linear DNA fragment containing the two genes along with
their regulatory 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 on the one hand, to collect
agronomic data and data on insect resistance, on the other hand
to collect morpho-physiological data as well as data on proteins
expression and chemical composition, of the genetically modified
plants in comparison with the non-modified equivalent maize
plants.
2. Geographical location of the site:
The releases are planned at several locations in France in
2004 within the following areas: Aude, Haute-Garonne, Gers, Lot
et Garonne, Tarn et Garonne.
3. Size of the site (m2):
Each site will have up to 3000 m2 sown with the particular
genetically modified plants concerned by this application, the
total area covered by this trial (including all varieties and
borders) will be higher. There will be up to 10 field trials
sown each year.
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:
Since 1996, field trials have already been conducted in
several locations with this genetically modified maize 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 being insect resistant and herbicide tolerant.
A marketing release application for cultivation has been filed
under C/ES/01/01.
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 the
genetically modified (GM) maize containing resistance to certain
Lepidopteran insects and tolerance to glufosinate-ammonium. This
is based on the information contained in the notification and
the following concluding remarks:
- There is negligible likelihood for genetically modified maize
to become environmentally persistent or invasive giving rise to
any weediness;
- Expression of the insecticidal crystal protein 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 lepidopteran
insect pests if the target insect pests develop resistance to
the protein 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, an
insect resistance management (IRM) strategy will be developed in
the context of product stewardship when this genetically
modified maize is placed on the European market.
Brief description of any measures taken for the management of
risks:
The shedding of pollen from the genetically modified plants
will be controlled either by maintaining a 200-meter isolation
distance with any other commercial corn crop, or manually by
removing the tassels or bagging them before any pollen shed can
occur.
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.
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. |
