Date of publication: November 22,
2006
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification number:
B/CZ/06/04
Member State
Czech Republic
Date of Acknowledgement
16/11/2006 00:00:00
Title of the Project
Deliberate release of NK603 and
NK603 x MON 810 maize for the use in field trials in the Czech
Republic
Proposed period of release:
10/04/2007 00:00:00 to 30/11/2009
00:00:00
Name of the Institute(s) or Company(ies)
Monsanto Company, Represented by
MONSANTO CR s.r.o.;
3. Is the same GMPt release planned
elsewhere in the Community?
Yes:
Has the same GMPt been notified elsewhere
by the same notifier?
Yes
If yes, notification number(s):
B/BE/00/WSP13; B/DE/00/115;
B/DE/03/148; B/DE/04/163; B/ES/00/06; B/ES/01/05; B/ES/02/03;
B/ES/04/17; B/ES/04/18; B/ES/04/19; B/ES/04/20; B/ES/06/06;
B/ES/06/07; B/ES/06/08; B/ES/06/09; B/FR/00/02/06-CON;
B/FR/00/03/05; B/FR/01/01/01; B/FR/04/02/01; B/FR/04/02/02;
B/FR/06/01/01; B/FR/06/01/04; B/FR/99/04/06; B/IT/99/17;
B/SE/05/9831;
Other notifications
NK603 has been notified for
field-testing in the E.U. since 1999 (see Monsanto Part B
notification numbers)
Czech Republic 26OA/OER/GMO/02, Hungary 24.111/2/2003 and
12269/2004).
In addition, many field trials have already been conducted
across maize growing regions in North and South America and
other world areas and NK603 has been commercially released for
cultivation in the U.S.A. and Canada since 2001.
---------------------------
NK603 x MON810 has been notified for field-testing in the E.U.
since 2000 (See Notification numbers)
In addition, many field trials have already been conducted
across maize growing regions in North and South America and
other world areas and NK603 × MON 810 has been commercially
released for cultivation in the U.S.A., since 2002
Genetically modified plant
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, NK603 x MON810 |
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.NK603 x MON810 hybrid maize consists in
the combination, by traditional breeding, of two genetically
modified parental inbred lines, derived from maize
transformation events NK603 and MON 810, respectively.
NK603 x MON810 maize expresses CP4 EPSPS proteins, which impart
tolerance to glyphosate (N?phosphonomethyl-glycine), the active
ingredient in the non-selective herbicide Roundup. NK603 x
MON810 maize also expresses the Cry1Ab protein, which provides
the maize plant of protection from certain lepidopteran insect
pests, including European Corn Borer (Ostrinia nubilalis) and
pink borers (Sesamia spp.). The insecticidal activity of the
Cry1Ab protein is specific to predation by the larvae of the
targeted lepidopterans.
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:
NK603 x MON810 maize results from a
single conventional cross of the inbred parental lines NK603
maize and MON 810 maize, homozygous in their respective inserted
sequences. By crossing NK603 and MON 810 maize, NK603 x MON810
maize inherits the inserted DNA fragments from both its parental
lines. The individual components and the function of the
inherited sequences are given below.
NK603:First cp4 epsps gene cassette:P-ract1/ ract1 intron from
Oryza sativa (1.4 kb): Contains promoter, transcription start
site and first intron.Ctp 2 from Arabidopsis thaliana (0.2):
Encodes chloroplast transit peptide, which directs the CP4 EPSPS
protein to the chloroplast.cp4 epsps from Agrobacterium sp.
strain CP4 (1.4 kb): Encodes glyphosate-tolerant CP4 EPSPS
proteinNOS 3’ from Agrobacterium tumefaciens (0.3 kb): Ends
transcription and directs polyadenylation of the mRNA.Second cp4
epsps gene cassette:e35S from Cauliflower mosaic virus (0.6 kb):
PromoterZmhsp70 from Zea mays L.: Stabilizes the level of gene
transcription. Ctp 2 from Arabidopsis thaliana (0.2): Encodes
chloroplast transit peptide, which directs the CP4 EPSPS protein
to the chloroplast.cp4 epsps l214p from Agrobacterium sp. strain
CP4 (1.4 kb): Encodes glyphosate-tolerant CP4 EPSPS L214P
protein1NOS 3’ from Agrobacterium tumefaciens (0.3 kb): Ends
transcription and directs polyadenylation of the mRNA.
MON810:e35S from Cauliflower mosaic virus (0.32):
PromoterZmhsp70 from Zea mays L. (0.81): Stabilizes the level of
gene transcription. Cry1Ab from Bacillus thuringiensis (2.45
kb): Encodes Cry1A(b) protein, which targets specific
lepidopteran insect pests
6. Brief description of the method used
for the genetic modification:
NK603 x MON810 hybrid maize was created
using conventional breeding techniques. No additional genetic
modification is utilised in the production of NK603 x MON810
maize hybrid varieties. Instead, NK603 x MON810 hybrid maize is
produced by a single traditional cross of NK603 and MON 810
parental inbred lines (homozygous for the respective introduced
trait). F1 hybrid seed thereby inherits the introduced Roundup
Ready trait from NK603 maize, as well as the insect-protection
trait from MON 810 maize.While NK603 x MON810 hybrid maize
results from traditional breeding, genetic modification was used
in the development of the parental NK603 and MON 810 maize.
These single trait parental maize lines were genetically
modified 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:
NK603 x MON810 maize and the single
trait parent NK603 will be planted in field trials for
assessment of weed treatment strategies in maize under Czech
conditions
2. Geographical location of the site:
Four locations: Ivanovice na Hane,
region Jihomoravsky, Kromeriz, region Zlinsky, Nechanice, region
Kralovehradecky, Troubsko, region Jihomoravsky
3. Size of the site (m2):
16. 800 m2 is the size of the four
planned locations for 2007
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:
Post-release general surveillance from
environments inside and outside the E.U. has shown that NK603 x
MON810 maize and its single trait parental lines, NK603 and MON
810, are unlikely to pose any risk of adverse effects to human
or animal health or to 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 and NK603 x MON810 maize, especially in comparison with
extensive experience with cultivation of traditional maize
within the E.U., has shown that the risk for potential adverse
effects on human and animal health and the receiving
environment, resulting from the planned field trials with NK603
and NK603 x MON810 maize, is consistently negligible:The risk of
the introduced traits in NK603 x MON810 maize to be the cause of
any meaningful competitive advantage or disadvantage in natural
environments is negligible. Like for any other maize, the
likelihood of this maize to spread into non-agronomic
environments is negligible, as its persistence in agricultural
habitats and its invasiveness into natural habitats are
unaltered compared to traditional maize. Moreover, there is no
potential for gene transfer from NK603 x MON810 maize to any
wild plant species in Europe. As for parental MON 810 maize,
NK603 x MON810 maize poses negligible risk for adverse
environmental effects through its interaction with target
organisms. The ecological interactions of NK603 x MON810 maize
with non-target organisms or soil processes are not different
from traditional maize. Potential exposure of non-target
organisms to CP4 EPSPS presents no conceivable mechanism to
cause adverse effects because of its properties, and due to the
highly selective insecticidal activity of the Cry1Ab protein on
the larvae of specifically targeted Lepidopteran insect pests,
also this protein poses negligible risks to non-target
organisms.Any occupational health aspects of handling NK603 x
MON810 maize are no different from traditional maize, and this
maize was shown to be as safe and as nutritious as any other
maize.The environmental impact of the cultivation, management
and harvesting techniques applied in the planned trials is
considered no different from the farming practices for
traditional maize. It is actually expected that the commercial
production of NK603 x MON810 maize will positively impact
current agronomic practices in maize and provide benefits to
farmers and the environment. The use of Roundup in maize enables
the farmer to take advantage of the herbicide’s favourable
environmental and safety properties (see Annex I listing of
glyphosate under Council Directive 91/414/EEC). Roundup-tolerant
maize benefits the farmer by providing (1) an additional
broad-spectrum weed control option in maize, (2) a new
herbicidal mode of action for in-season maize weed control, (3)
increased flexibility to treat weeds on an “as needed” basis,
(4) cost-effective weed control and (5) an excellent fit with
reduced-tillage systems. In turn, a number of environmental
benefits arise from the use of conservation tillage 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.
Other benefits of planting this maize result from its
insect-protection trait and include: 1) a reliable means to
control the target Lepidopteran maize pests; 2) control of
target insects while maintaining beneficial species; 3) reduced
use and applicator exposure to chemical insecticides; 4) fit
with integrated pest management (IPM) and sustainable
agricultural systems; 5) potential for reduced fumonisin
mycotoxin levels in maize kernels; and 6) no additional labour
or machinery requirements, allowing both large and small growers
to maximize hybrid yields.
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
and NK603 x MON810 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 and NK603 x MON810 maize
crop and that of its receiving environment.In case any adverse
environmental effects, linked to the deliberate release of NK603
or NK603 x MON810 maize, are observed during the period of
release, these will be reported immediately to the Competent
Authority.The field trials will be no less than 200 m from other
unregulated maize fields, and will be surrounded by a border of
conventional maize. The products from the trials may be used for
analysis and will not be used for human food or animal feed.
Volunteer surveillance program will be implemented. The year
following the planned trial, all sites will be scouted for the
presence of any maize volunteers that could contain the traits
expressed in NK603 or NK603 x MON810, and any volunteer will be
removed. The year following harvest of GM maize trial, maize
will not be grown on the trial sites.
Summary of foreseen field trial studies
focused to gain new data on environmental and human health
impact from the release:
Not applicable
Final report
-
European Commission administrative
information
Consent given by the Competent Authority:
Not known
B/CZ/06/04
Member State
Czech Republic
Date of Acknowledgement
16/11/2006 00:00:00
Title of the Project
Deliberate release of NK603 and NK603 x
MON 810 maize for the use in field trials in the Czech Republic
Proposed period of release:
10/04/2007 00:00:00 to 30/11/2009
00:00:00
Name of the Institute(s) or Company(ies)
Monsanto Company, Represented by
MONSANTO CR s.r.o.;
3. Is the same GMPt release planned
elsewhere in the Community?
Yes:
Has the same GMPt been notified elsewhere
by the same notifier?
Yes
If yes, notification number(s):
B/BE/00/WSP13; B/DE/00/115;
B/DE/03/148; B/DE/04/163; B/ES/00/06; B/ES/01/05; B/ES/02/03;
B/ES/04/17; B/ES/04/18; B/ES/04/19; B/ES/04/20; B/ES/06/06;
B/ES/06/07; B/ES/06/08; B/ES/06/09; B/FR/00/02/06-CON;
B/FR/00/03/05; B/FR/01/01/01; B/FR/04/02/01; B/FR/04/02/02;
B/FR/06/01/01; B/FR/06/01/04; B/FR/99/04/06; B/IT/99/17;
B/SE/05/9831;
Other notifications
NK603 has been notified for
field-testing in the E.U. since 1999 (see Monsanto Part B
notification numbers)
Czech Republic 26OA/OER/GMO/02, Hungary 24.111/2/2003 and
12269/2004).
In addition, many field trials have already been conducted
across maize growing regions in North and South America and
other world areas and NK603 has been commercially released for
cultivation in the U.S.A. and Canada since 2001.
---------------------------
NK603 x MON810 has been notified for field-testing in the E.U.
since 2000 (See Notification numbers)
In addition, many field trials have already been conducted
across maize growing regions in North and South America and
other world areas and NK603 × MON 810 has been commercially
released for cultivation in the U.S.A., since 2002
Genetically modified plant
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, NK603 x MON810 |
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.NK603 x MON810 hybrid maize consists in
the combination, by traditional breeding, of two genetically
modified parental inbred lines, derived from maize
transformation events NK603 and MON 810, respectively.
NK603 x MON810 maize expresses CP4 EPSPS proteins, which impart
tolerance to glyphosate (N?phosphonomethyl-glycine), the active
ingredient in the non-selective herbicide Roundup. NK603 x
MON810 maize also expresses the Cry1Ab protein, which provides
the maize plant of protection from certain lepidopteran insect
pests, including European Corn Borer (Ostrinia nubilalis) and
pink borers (Sesamia spp.). The insecticidal activity of the
Cry1Ab protein is specific to predation by the larvae of the
targeted lepidopterans.
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:
NK603 x MON810 maize results from a
single conventional cross of the inbred parental lines NK603
maize and MON 810 maize, homozygous in their respective inserted
sequences. By crossing NK603 and MON 810 maize, NK603 x MON810
maize inherits the inserted DNA fragments from both its parental
lines. The individual components and the function of the
inherited sequences are given below.
NK603:First cp4 epsps gene cassette:P-ract1/ ract1 intron from
Oryza sativa (1.4 kb): Contains promoter, transcription start
site and first intron.Ctp 2 from Arabidopsis thaliana (0.2):
Encodes chloroplast transit peptide, which directs the CP4 EPSPS
protein to the chloroplast.cp4 epsps from Agrobacterium sp.
strain CP4 (1.4 kb): Encodes glyphosate-tolerant CP4 EPSPS
proteinNOS 3’ from Agrobacterium tumefaciens (0.3 kb): Ends
transcription and directs polyadenylation of the mRNA.Second cp4
epsps gene cassette:e35S from Cauliflower mosaic virus (0.6 kb):
PromoterZmhsp70 from Zea mays L.: Stabilizes the level of gene
transcription. Ctp 2 from Arabidopsis thaliana (0.2): Encodes
chloroplast transit peptide, which directs the CP4 EPSPS protein
to the chloroplast.cp4 epsps l214p from Agrobacterium sp. strain
CP4 (1.4 kb): Encodes glyphosate-tolerant CP4 EPSPS L214P
protein1NOS 3’ from Agrobacterium tumefaciens (0.3 kb): Ends
transcription and directs polyadenylation of the mRNA.
MON810:e35S from Cauliflower mosaic virus (0.32):
PromoterZmhsp70 from Zea mays L. (0.81): Stabilizes the level of
gene transcription. Cry1Ab from Bacillus thuringiensis (2.45
kb): Encodes Cry1A(b) protein, which targets specific
lepidopteran insect pests
6. Brief description of the method used
for the genetic modification:
NK603 x MON810 hybrid maize was created
using conventional breeding techniques. No additional genetic
modification is utilised in the production of NK603 x MON810
maize hybrid varieties. Instead, NK603 x MON810 hybrid maize is
produced by a single traditional cross of NK603 and MON 810
parental inbred lines (homozygous for the respective introduced
trait). F1 hybrid seed thereby inherits the introduced Roundup
Ready trait from NK603 maize, as well as the insect-protection
trait from MON 810 maize.While NK603 x MON810 hybrid maize
results from traditional breeding, genetic modification was used
in the development of the parental NK603 and MON 810 maize.
These single trait parental maize lines were genetically
modified 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:
NK603 x MON810 maize and the single
trait parent NK603 will be planted in field trials for
assessment of weed treatment strategies in maize under Czech
conditions
2. Geographical location of the site:
Four locations: Ivanovice na Hane,
region Jihomoravsky, Kromeriz, region Zlinsky, Nechanice, region
Kralovehradecky, Troubsko, region Jihomoravsky
3. Size of the site (m2):
16. 800 m2 is the size of the four
planned locations for 2007
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:
Post-release general surveillance from
environments inside and outside the E.U. has shown that NK603 x
MON810 maize and its single trait parental lines, NK603 and MON
810, are unlikely to pose any risk of adverse effects to human
or animal health or to 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 and NK603 x MON810 maize, especially in comparison with
extensive experience with cultivation of traditional maize
within the E.U., has shown that the risk for potential adverse
effects on human and animal health and the receiving
environment, resulting from the planned field trials with NK603
and NK603 x MON810 maize, is consistently negligible:The risk of
the introduced traits in NK603 x MON810 maize to be the cause of
any meaningful competitive advantage or disadvantage in natural
environments is negligible. Like for any other maize, the
likelihood of this maize to spread into non-agronomic
environments is negligible, as its persistence in agricultural
habitats and its invasiveness into natural habitats are
unaltered compared to traditional maize. Moreover, there is no
potential for gene transfer from NK603 x MON810 maize to any
wild plant species in Europe. As for parental MON 810 maize,
NK603 x MON810 maize poses negligible risk for adverse
environmental effects through its interaction with target
organisms. The ecological interactions of NK603 x MON810 maize
with non-target organisms or soil processes are not different
from traditional maize. Potential exposure of non-target
organisms to CP4 EPSPS presents no conceivable mechanism to
cause adverse effects because of its properties, and due to the
highly selective insecticidal activity of the Cry1Ab protein on
the larvae of specifically targeted Lepidopteran insect pests,
also this protein poses negligible risks to non-target
organisms.Any occupational health aspects of handling NK603 x
MON810 maize are no different from traditional maize, and this
maize was shown to be as safe and as nutritious as any other
maize.The environmental impact of the cultivation, management
and harvesting techniques applied in the planned trials is
considered no different from the farming practices for
traditional maize. It is actually expected that the commercial
production of NK603 x MON810 maize will positively impact
current agronomic practices in maize and provide benefits to
farmers and the environment. The use of Roundup in maize enables
the farmer to take advantage of the herbicide’s favourable
environmental and safety properties (see Annex I listing of
glyphosate under Council Directive 91/414/EEC). Roundup-tolerant
maize benefits the farmer by providing (1) an additional
broad-spectrum weed control option in maize, (2) a new
herbicidal mode of action for in-season maize weed control, (3)
increased flexibility to treat weeds on an “as needed” basis,
(4) cost-effective weed control and (5) an excellent fit with
reduced-tillage systems. In turn, a number of environmental
benefits arise from the use of conservation tillage 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.
Other benefits of planting this maize result from its
insect-protection trait and include: 1) a reliable means to
control the target Lepidopteran maize pests; 2) control of
target insects while maintaining beneficial species; 3) reduced
use and applicator exposure to chemical insecticides; 4) fit
with integrated pest management (IPM) and sustainable
agricultural systems; 5) potential for reduced fumonisin
mycotoxin levels in maize kernels; and 6) no additional labour
or machinery requirements, allowing both large and small growers
to maximize hybrid yields.
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
and NK603 x MON810 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 and NK603 x MON810 maize
crop and that of its receiving environment.In case any adverse
environmental effects, linked to the deliberate release of NK603
or NK603 x MON810 maize, are observed during the period of
release, these will be reported immediately to the Competent
Authority.The field trials will be no less than 200 m from other
unregulated maize fields, and will be surrounded by a border of
conventional maize. The products from the trials may be used for
analysis and will not be used for human food or animal feed.
Volunteer surveillance program will be implemented. The year
following the planned trial, all sites will be scouted for the
presence of any maize volunteers that could contain the traits
expressed in NK603 or NK603 x MON810, and any volunteer will be
removed. The year following harvest of GM maize trial, maize
will not be grown on the trial sites.
Summary of foreseen field trial studies
focused to gain new data on environmental and human health
impact from the release:
Not applicable
Final report
-
European Commission administrative
information
Consent given by the Competent Authority:
Not known |
