Date of publication: January 16,
2006
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification number:
B/SE/05/9831
Member State: Sweden
Date of Acknowledgement: 22/12/2005
Title of the Project:
Weed control strategies in Maize
Proposed period of release From:01/05/2006
To:31/10/2010
Name of the Institute(s) or Company(ies): Monsanto
Company;
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/BE/00/WSP13; B/ES/00/06; B/ES/01/05; B/FR/00/03/05;
B/FR/01/01/01; B/FR/99/04/06; B/IT/99/17
Other notifications
FB5-6786-01-115 In 2003, NK603 maize is already registered in
several world areas outside the E.U., including the U.S.A.,
Japan, Canada and Bulgaria for cultivation, and in Mexico,
Australia and Russia for import of grain for food purposes.
Since 2001, NK603 maize has been commercially released for
cultivation in the U.S.A. and Canada.
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
|
NK603
Rondup Ready Maize |
2. Description of the traits and characteristics which have
been introduced or modified, including marker genes and previous
modifications:
The expression of CP4 EPSPS proteins in NK603 Roundup Ready
maize plants imparts tolerance to glyphosate
(N-phosphonomethyl-glycine), the active ingredient in the
non-selective, foliar-applied, broad-spectrum, post-emergent
herbicide Roundup.
EPSPS is an enzyme involved in the shikimic acid pathway for
aromatic amino acid biosynthesis in plants and micro-organisms.
CP4 EPSPS enzymes have been shown to have significantly reduced
affinity for glyphosate when compared with the wild-type maize
enzyme, and to retain catalytic activity in the presence of the
inhibitor glyphosate. Therefore, when maize plants expressing
the CP4 EPSPS proteins are treated with glyphosate, the plants
are unaffected since the continued action of the tolerant CP4
EPSPS enzymes provides for the plant’s need for aromatic amino
acids. The use of maize plants containing the Roundup Ready
genes for maize production enables the farmer to utilise Roundup
herbicide for effective control of weeds during the growing
season and to take advantage of the favourable environmental and
safety characteristics of Roundup.
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:
All genetic constituents within plasmid vector PV-ZMGT32 are
completely known including the gene of interest, cp4 epsps, and
its function. The agarose gel-isolated MluI restriction fragment
of this plasmid vector, designated as PV ZMGT32L, which was
actually utilized for transformation of NK603 Roundup Ready
maize, contains only the cp4 epsps plant gene expression
cassettes and does not contain the nptII selectable marker gene
or origin of replication. The size, source and function of the
genetic elements present in the vector PV ZMGT32L used for
transformation are given below.
Summary of DNA components of the vector PV-ZMGT32L, used for
transformation
cp4 epsps gene cassette (1)
- P-ract1/ract1 intron
Source: Oryza sativa
Intended function: 5’ region of the rice actin 1 gene containing
the promoter, transcription start site and first intron. (1.4
kb)
- ctp 2
Source: Arabidopsis thaliana
Intended function: DNA sequence for chloroplast transit peptide,
isolated from Arabidopsis thaliana EPSPS, present to direct the
CP4 EPSPS protein to the chloroplast, the site of aromatic amino
acid synthesis. (0.2 kb)
- cp4 epsps
Source: Agrobacterium sp. strain CP4
Intended function: The DNA sequence for CP4 EPSPS, isolated from
Agrobacterium sp. strain CP4, which imparts tolerance to
glyphosate. (1.4 kb)
- NOS 3’
Source: Agrobacterium tumefaciens
Intended function: A 3’ nontranslated region of the nopaline
synthase gene from Agrobacterium tumefaciens T-DNA which ends
transcription and directs polyadenylation of the mRNA. (0.3 kb)
cp4 epsps gene cassette (2)
- e35S
Source: Cauliflower mosaic virus
Intended function: The cauliflower mosaic virus (CaMV) promoter
with the duplicated enhancer region. (0.6 kb)
- Zmhsp70
Source: Zea mays L.
Intended function: Intron from the corn hsp70 gene (heat-shock
protein) present to stabilize the level of gene transcription.
(0.8 kb)
- ctp 2
Source: Arabidopsis thaliana
Intended function: DNA sequence for chloroplast transit peptide,
isolated from Arabidopsis thaliana EPSPS, present to direct the
CP4 EPSPS protein to the chloroplast, the site of aromatic amino
acid synthesis. (0.2 kb)
- cp4 epsps
Source: Agrobacterium sp. strain CP4
Intended function: The DNA sequence for CP4 EPSPS, isolated from
Agrobacterium sp. strain CP4, which imparts tolerance to
glyphosate. (1.4 kb)
- NOS 3’
Source: Agrobacterium tumefaciens
Intended function: A 3’ nontranslated region of the nopaline
synthase gene from Agrobacterium tumefaciens T-DNA which ends
transcription and directs polyadenylation of the mRNA. (0.3 kb)
6. Brief description of the method used for the genetic
modification:
NK603 Roundup Ready maize was modified by insertion of a DNA
fragment into the maize genome using a particle acceleration
method.
The introduced DNA fragment consists of two adjacent plant gene
expression cassettes each containing a single copy of the cp4
epsps gene. The introduced cp4 epsps gene encodes a tolerant
form of EPSPS, which confers Roundup tolerance to the plant.
This gene was derived from a common soil-borne bacterium,
Agrobacterium sp. strain CP4. The source vector, plasmid
PV-ZMGT32, containing this fragment, was developed by Monsanto
Company, St. Louis, Missouri. This vector also contains an nptII
selectable marker gene, which allows selection of bacteria
containing the plasmid, and an origin of replication (ori)
necessary for replicating the plasmid in Escherichia coli.
However, the agarose gel-isolated MluI restriction fragment of
this plasmid vector, PV ZMGT32L, which was actually utilized for
transformation of NK603 Roundup Ready maize, contains only the
cp4 epsps plant gene expression cassettes and does not contain
the nptII selectable marker gene or origin of replication.
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:
Studies of different weed treatment strategies in Maize under
Swedish conditions.
2. Geographical location of the site:
Öland (Mörbylånga and Borgholm) and Skåne (Lomma and
Kristianstad).
3. Size of the site (m2):
20000 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:
Multi-year field-testing in the EU (see question A4) and
post-marketing experience in other world areas since 2001
provided no significant evidence that NK603 Roundup Ready maize
and its progeny would cause any adverse effects to human or
animal health and the environment.
Environmental
Impact and Risk Management
Summary of the potential
environmental impact from the release of the GMPts:
Analysis of the characteristics of NK603 maize has shown that
the risk of potential adverse effects on human health or the
environment, resulting from the deliberate release of this maize
for field testing, is consistently negligible.
NK603 maize is herbicide-tolerant and, as such, has no target
organisms. The interaction between this maize and non-target
organisms is not different from traditional maize. Like
traditional maize, NK603 maize is not invasive of natural
environments. No evidence of any harmful or undesirable effects
has been brought forward from extensive field-testing and from
commercial planting by the many farmers who have grown NK603
maize in North America since 2001.
The CP4 EPSPS proteins expressed in NK603 maize are member of a
safe family of proteins, 5 enolpyruvylshikimate-3-phosphate
synthase proteins, that are enzymes, known to be ubiquitous in
nature, possess no toxicity, and confer no selective advantage
to the plants, algae, fungi and micro-organisms that express
them. In environments where selective pressure from Roundup
applications is absent, the glyphosate-tolerance trait does not
confer a selective advantage and would not be of direct
competitive importance to wild plants, nor indirectly for
wildlife interacting with those wild plants. In addition, NK603
maize is not a weedy plant and the likelihood is negligible for
NK603 maize to volunteer or survive in natural habitats under
European conditions. Within NK603 maize fields, NK603 maize
plants have a selective advantage over the
glyphosate-susceptible weeds under specific conditions in the
field (i.e. following treatment with Roundup herbicide), which
are predictable, spatially limited, short in duration, and with
negligible consequences to natural environments. This advantage
is limited to the agricultural field and the growing season of
the NK603 maize crop, and is considered of negligible risk to
the environment.
Production of Roundup Ready maize in Europe is expected to
positively impact current agronomic practices in maize and
provide benefits to farmers and the environment. NK603 maize
enables the farmer to utilise Roundup herbicide for effective
control of weeds during the growing season and to take advantage
of the favourable environmental and safety characteristics of
Roundup (see Annex I listing of glyphosate under Council
Directive 91/414/EEC). NK603 Roundup Ready maize benefits the
farmer by providing: (1) an additional broad-spectrum weed
control option in maize, including difficult perennial weeds;
(2) a new herbicidal mode of action for in-season weed control
in maize, with a very favourable environmental and safety
profile; (3) increased flexibility to treat weeds on an "as
needed" basis; (4) increased flexibility with regard to weeds
growth stage; (5) the potential for herbicide use reduction in
many situations; (6) cost-effective weed control; (7) an
excellent fit with reduced-tillage systems. Conservation tillage
in turn yields a number of environmental benefits including
improved soil quality, improved water infiltration, reductions
in erosion and sedimentation of water resources, reduced runoff
of nutrients and pesticides to surface water, improved wildlife
habitat, increased carbon retention in the soil, reduced fuel
use and encouragement of sustainable agricultural practices.
Brief description of any measures taken for the management of
risks:
The environmental risk assessment has indicated that the
environmental risks of this maize are negligible. Therefore,
strategies for risk management for NK603 maize would be the same
as for traditional maize.
However, in addition to the scheduled observations of agronomic
parameters that form the basis of the planned research, the
trial site will be checked regularly during the period of the
deliberate release for potentially occurring, direct or
indirect, adverse effects. This will be done by visual
inspection of the status of the NK603 maize crop and that of its
receiving environment.
In case any adverse environmental effects, linked to the
deliberate release of NK603 maize, are observed during the
period of release, these will be reported immediately to the
Competent Authorithy.
At the end of the field-testing campaign, a report of will be
made available by the notifier to the Competent Authority. This
report will detail any unexpected adverse environmental effects
that were observed during the general surveillance, if any, and
further actions elicited as an effect of these findings, if
applicable.
Summary of foreseen field trial studies focused to gain new
data on environmental and human health impact from the release:
Not applicable.
However, any unanticipated adverse effects on human health or
the environment would be reported immediately to the Competent
Authority.
Final report
-
European
Commission administrative information
Consent given by the Competent
Authority: Not Known |
