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Notification report


General information

Notification Number
B/DK/07/02

Member State to which the notification was sent
Denmark

Date of acknowledgement from the Member State Competent Authority
05/01/2007

Title of the Project
Weed control strategies in maize

Proposed period of release:
01/04/2007 to 31/12/2011

Name of the Institute(s) or Company(ies)
Monsanto Company represented by
Monsanto Crop Sciences Danmark A/S, ;


3. Is the same GMPt release planned elsewhere in the Community?
Yes:
Germany; Spain; France; Sweden; Czech Republic; Lithuania; Slovak Republic;

Has the same GMPt been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):
B/DE/00/115; B/DE/03/148; B/ES/00/06; B/ES/01/05; B/ES/02/03; B/ES/04/17; B/ES/04/19; B/ES/06/06; B/ES/06/08; B/FR/00/03/05; B/FR/01/01/01; B/FR/04/02/02; B/FR/06/01/01; B/FR/99/04/06; B/IT/99/17; B/SE/05/9831;

Other notifications
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

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
maizepoaceaezeazea maysmaysNK603 Roundup Ready

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 nonselective, 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;

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 NK603Roundup 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:
-Efficacy and selectivity assessments of NK603 maize using Roundup® herbicide and other herbicide formulations.

2. Geographical location of the site:
The realease site is located in East Jutland.

3. Size of the site (m2):
Up to 2 ha per location and 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:
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 Member State Competent Authority:
Yes
30/03/2007 00:00:00
Remarks: