Date of publication: December 18,
2006
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification number:
B/FR/06//12/03
Member State
France
Date of Acknowledgement
10/11/2006 00:00:00
Title of the Project
Application for a multiyear program for
the deliberate release of genetically modified maize
DAS-Ø15Ø7-1; DAS-59122-7;
MON-ØØ6Ø3-6 ;
DAS-Ø15Ø7-1xMON-ØØ6Ø3-6 ;
DAS-Ø15Ø7-1xDAS-59122-7;
DAS-59122-7xDAS-Ø15Ø7-1xMON-ØØ6Ø3-6;
MON-ØØ6Ø3-6xMON-ØØ81Ø-6
Proposed period of release:
01/04/2007 00:00:00 to 31/12/2010
00:00:00
Name of the Institute(s) or
Company(ies)
Pioneer Genetique Sarl, Chemin de
l'Enseigure
31840 Aussonne;
3. Is the same GMPt release planned
elsewhere in the Community?
No
Has the same GMPt been notified
elsewhere by the same notifier?
No
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 |
experimental varieties |
2. Description of the traits and
characteristics which have been introduced or modified,
including marker genes and previous modifications:
This deliberate release program
concerns four genetically modified maize, DAS-Ø15Ø7-1 (referred
to as 1507 maize), DAS-59122-7 (referred to as 59122 maize),
MON-ØØ6Ø3-6 (referred to as NK603 maize), MON-ØØ81Ø-6 (referred
to as MON810 maize) (whose cultivation has been approved in
Europe in 1998), as well as combinations of these maize obtained
through traditional breeding methods, maize
DAS-Ø15Ø7-1xMON-ØØ6Ø3-6 (referred to as 1507xNK603 maize),
DAS-Ø15Ø7-1xDAS-59122-7 (referred to as 1507x59122 maize),
DAS-59122-7xDAS-Ø15Ø7-1xMON-ØØ6Ø3-6 (referred to as
59122x1507xNK603), MON-ØØ6Ø3-6xMON-ØØ81Ø-6 (referred to as
NK603xMON810 maize).
The genetically modified maize subject of this deliberate
release program are resistant to certain Lepidopteran insects,
such as European corn borer (Ostrinia nubilalis), and/or
resistant to certain Coleopteran insects, such as Western corn
rootworm (Diabrotica virgifera virgifera), and/or tolerant to
certain herbicides, containing glyphosate and/or
glufosinate-ammonium (tolerance to glufosinate-ammonium in
Europe is used only as a selectable marker).
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:
· The genes introduced in 1507 maize
are 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, along with their regulatory components necessary for
expression in maize plant:
- The cry1F gene, the UBIZM1(2) promoter, the ORF25PolyA
terminator.
- The pat gene, the CaMV35S promoter, the CaMV35S terminator.
· The genes introduced in 59122 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,
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.
· NK603 maize, from Monsanto, has been genetically modified by
the introduction of the cp4epsps gene, from Agrobacterium sp.
strain CP4, that confers tolerance to glyphosate herbicide,
along with the regulatory components necessary for expression in
maize plant:
- 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.
· MON810 maize, from Monsanto (whose cultivation has been
authorized in Europe by Commission decision 98/294/EC), has been
genetically modified by the introduction of the cry1Ab gene from
Bacillus thuringiensis subsp. kurstaki that confers resistance
to certain Lepidopteran insects such as Ostrinia nubilalis,
along with the regulatory components necessary for expression in
maize plant:
- The cry1Ab gene, the e35S promoter + Zmhsp70
· The maize 1507xNK603, 1507x59122, 59122x1507xNK603,
NK603xMON810 have been obtained with traditional breeding
methods from progeny of the individual genetically modified
maize and contains the genetic elements introduced in these
maize.
6. Brief description of the method
used for the genetic modification:
1507 maize was genetically modified
using a particle acceleration method.
Both NK603 maize and MON maize were genetically modified by
Monsanto using a particle acceleration method.
59122 maize was genetically modified using Agrobacterium
transformation method.
No genetic modification was made on 1507xNK603, 1507x59122,
59122x1507xNK603, NK603xMON810 maize directly: they were derived
through traditional breeding methods from progeny of the
genetically modified maize, 1507, 59122, NK603, MON810.
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 deliberate
release program is to collect additional data on these
genetically modified maize. Studies will be carried out to
evaluate the expression of the introduced genes, to observe the
plant behavior, as well as the glyphosate herbicide application
effects.
2. Geographical location of the site:
In 2007, the release is planned at
the following locations in France: Fronton (31), Condom (32),
Ouzouer sous Bellegarde (45), Villeneuve sur Lot (47),
Mansonville (82), Valvidienne (86).
3. Size of the site (m2):
Every year, there could have up to
12 sites of release, each sown with up to 3000 m² of each
genetically modified maize subject of the current application.
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:
Many field trials have already been
conducted at several locations across maize growing regions in
North America, as well as South America and Europe, and no
environmental problems were reported for these trials. The
transgenic plants are indistinguishable from the non-genetically
modified maize plants except for the traits due to the genetic
modifications (resistance to target Lepidopteran insects such as
European corn borer, and/or resistance to target Coleopteran
insects, such as Western corn rootworm, and/or tolerance when
glyphosate and/or glufosinate were applied).
Moreover 1507, 59122, NK603 and MON810 maize are no more
regulated in the USA since 2001, 2005, 2000 and 1996,
respectively and are thus widely commercialized in the USA, as
well as the combinations 1507xNK603, 1507x59122,
59122x1507x.NK603, NK603xMON810.
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 proposed deliberate release of 1507,
59122, NK603, 1507xNK603, 1507x59122, 59122x1507xNK603,
NK603xMON810 maize are expected, as per information contained in
the environmental risk assessment included in the notification.
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. As it is done for any trial with conventional maize,
the trial site will be surrounded by agronomic border rows of
conventional maize of a similar maturity. The agronomic border
rows 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 by incorporation into the
soil.
In case of an emergency, the trial could be destructively
stopped by mechanical destruction or application of a herbicide
other than glyphosate and glufosinate-ammonium, and
incorporation into the soil by a deep ploughing.
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 by a deep ploughing. No plant or
plant product coming from the trials will enter the food or feed
chains.
After the release, the site will be visited regularly during the
following year in order to ensure removal of maize volunteers,
if any. Although volunteer maize cannot generally survive hard
winter, maize volunteers, if any, will be monitored in order to
ensure their destruction.
No commercial maize crop will be planted on the same area 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 |