Date of publication: December 19,
2006
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification number:
B/FR/06/12/14
Member State
France
Date of Acknowledgement
10/11/2006 00:00:00
Title of the Project
Notification according to Directive
2001/18/EC, Part B, for the deliberate release of MON 89034 ×
MON 88017 for the use in field trials in France
Proposed period of release:
01/04/2007 00:00:00 to 31/12/2007
00:00:00
Name of the Institute(s) or
Company(ies)
Monsanto Agriculture France S.A.S, ;
3. Is the same GMPt release planned
elsewhere in the Community?
Yes:
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 |
MON 89034 × MON 88017 |
2. Description of the traits and
characteristics which have been introduced or modified,
including marker genes and previous modifications:
MON 89034 × MON 88017 consists in the
combination, by traditional breeding, of two genetically
modified parental inbred lines derived from MON 89034 and MON
88017.
· Like MON 89034, MON 89034 × MON 88017 produces the Cry1A.105
and Cry2Ab2 insecticidal proteins, which impart protection
against feeding damage caused by the European corn borer (ECB,
Ostrinia nubilalis) and other lepidopteran insect pests.
· Like MON 88017, MON 89034 × MON 88017 expresses the modified
Cry3Bb1 protein, derived from Bacillus thuringiensis subsp.
kumamotoensis. Expression of this protein provides protection
against certain coleopteran insect pests including members of
the corn rootworm (CRW) complex (Diabrotica spp.). In addition,
like MON 88017, MON 89034 × MON 88017 expresses the CP4 EPSPS
protein, derived from Agrobacterium sp. strain CP4, which
provides tolerance to glyphosate.
Genetic modification
3. Type of genetic modification:
Insertion; Other;
Other
MON 89034 × MON 88017 consists in the
combination, by traditional breeding, of two genetically
modified parental inbred lines derived from MON 89034 and MON
88017. No additional genetic modification is involved.
In case of insertion of genetic
material, give the source and intended function of each
constituent fragment of the region to be inserted:
MON 89034 x MON 88017 results form
traditional breeding of MON 89034 and MON 88017. The inserted
DNA fragments from both inbred parental lines are inherited in
MON 89034 x MON 88017. The individual components and the size,
source and function of these inherited DNA sequences are given
in Tables 1 and 2.
Table 1. Summary of the inserted DNA fragment inherited from MON
89034
B-Left Border : 239 bp DNA region from the B?Left Border region
remaining after integration
Pp-e35S : Modified promoter and leader for the cauliflower
mosaic virus (CaMV) 35S RNA containing the duplicated enhancer
region
L-Cab : 5' untranslated leader of the wheat chlorophyll
a/b?binding protein
I-Ract1: Intron from the rice actin gene
CS-cry1A.105 : Coding sequence for the Bacillus thuringiensis
Cry1A.105 protein
T-Hsp17 : 3' transcript termination sequence for wheat heat
shock protein 17.3, which ends transcription and directs
polyadenylation
P-FMV : Figwort Mosaic Virus 35S promoter
I-Hsp70 : First intron from the maize heat shock protein 70 gene
TS-SSU-CTP : DNA region containing the targeting sequence for
the transit peptide region of maize ribulose 1,5-bisphosphate
carboxylase small subunit and the first intron
CS-cry2Ab2 : Coding sequence for a Cry2Ab2 protein from Bacillus
thuringiensis. This coding sequence uses a modified codon usage.
T-nos : 3' transcript termination sequence of the nopaline
synthase (nos) coding sequence from Agrobacterium tumefaciens
which terminates transcription and directs polyadenylation
B-Left Border : 230 bp DNA region from the B-Left Border region
remaining after integration
Table 2. Summary of the inserted DNA fragment inherited from MON
88017
B-Left Border : Portion of the left border sequence from
Agrobacterium tumefaciens involved in transfer of T-DNA
P-Ract1 : Promoter from the rice actin gene
I-Ract1 : Intron from the rice actin gene
TS-CTP2 : DNA sequence coding for the N-teminal chloroplast
transit peptide
CS-cp4 epsps : DNA sequence coding for the native CP4 EPSPS
protein
T-nos : 3' nontranslated region of the nopaline synthase (nos)
coding sequence from Agrobacterium tumefaciens which terminates
transcription and directs polyadenylation
P-e35S : Promoter and leader for the cauliflower mosaic virus
(CaMV) 35S RNA containing the duplicated enhancer region
L-Cab : 5’ untranslated leader of the wheat chlorophyll
a/b-binding protein
I-Ract1 : Intron from the rice actin gene
CS-cry3Bb1 : DNA sequence coding for a synthetic variant of
Cry3Bb1 protein from Bacillus thuringiensis
T-Hsp17 : 3’ nontranslated region of the coding sequence for
wheat heat-shock protein 17.3, which ends transcription and
directs polyadenylation
B-Right Border : DNA region from Agrobacterium tumefaciens
containing the Right border sequence, used for transfer of the
T-DNA
6. Brief description of the method
used for the genetic modification:
While MON 89034 x MON 88017 results
from traditional breeding, genetic modification was used in the
development of the parental MON 89034 and MON 88017. These
parental maize lines were produced by Agrobacterium-mediated
transformation of maize cells.
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 aims of the programme are:
1- To confirm by qualitative and quantitative measurements
(yields) the agronomic performance of MON 89034 x MON 88017.
2- To sudy the effectiveness of maize weeding programmes
involving different combinaison
3- to characterize MON 89034 x MON 88017 under European crop
conditions, including analysis for protein expression.
2. Geographical location of the site:
The releases are planned at several
locations in 2007 (Rhône-Alpes, Midi-Pyrénées, Aquitaine,
Poitou-Charentes, Centre and Lorraine).
The trial locations for the campaign 2007 are shown in the table
below:
Valvidienne (86)
Civaux (86)
Beux (57)
Allamont (54)
Moulotte (55)
Foameix-Ornel (55)
Yermenonville (28)
Poinville (28)
St Maurice de Gourdans (01)
Faramans (01)
Bourgoin-Jallieu (38)
Linxe (40)
Magescq (40)
Layrac (47)
Fronton (31)
Mauroux (32)
Serignac (82)
La Salvetat de Belmontet (82)
Monclar de Quercy (82)
3. Size of the site (m2):
In 2007, the number of sites will not
exceed 26. Each site has a maximum of 5000 m2 sown with MON
89034 x MON 88017 The total area covered by the trial will be
higher.
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:
MON 89034 x MON 88017 was first field
tested for efficacy in Puerto Rico during the 2004/2005 winter
season. Field trials were also conducted in U.S.A. and
Argentina, where agronomic performance was assessed.
The results of the releases in these countries showed no
evidence that MON 89034 x MON 88017 is likely to cause any
adverse effects to human or animal health and the environment.
Except for its protection against certain lepidopteran and
coleopteran insects and its tolerance to glyohosate, MON 89034 x
MON 88017 could not be distinguished from conventional maize.
Environmental Impact and Risk
Management
Summary of the potential environmental
impact from the release of the GMPts:
Analysis of the characteristics of MON
89034 x MON 88017 has shown that the risk of potential adverse
effects on human and animal health or the environment, resulting
from the planned deliberate release of this maize for field
testing, is negligible:
· The risk of the introduced traits in MON 89034 × MON 88017 to
be the cause of any meaningful competitive advantage or
disadvantage in natural environments is negligible. As for any
other maize, the likelihood of this maize to spread into
non-agricultural environments is negligible, as its persistence
in agricultural habitats and its invasiveness into
non-agricultural habitats are unaltered compared to conventional
maize.
· There is no potential for gene transfer from MON 89034 x MON
88017 to wild plant species in Europe and low to negligible
likelihood for gene transfer to other maize crops. In the event
that the introduced genes would outcross to another maize plant,
its transfer would, in any case, have negligible consequences
for the environment. Therefore, no risk management strategies
are considered necessary. Nevertheless, measures will be taken
to avoid hybridization with other maize plants and seed
dissemination at harvest and during transportation (see Point
E).
· As for parental lines MON 89034 and MON 88017, MON 89034 x MON
88017 poses negligible risk for adverse environmental effects
through its interaction with target organisms. By definition,
the glyphosate tolerance trait has no direct or indirect
interaction with any target organism. The insect-protection
trait has activity only toward the larvae of particular target
lepidopterans and coleopterans, therefore the effect of MON
89034 x MON 88017 on target organisms is limited to specific
conditions in the field, spatially limited and short in
duration.
· Based on the selectivity of the Cry1A.105, Cry2Ab2 and Cry3Bb1
toxins for certain lepidopteran and coleopteran pests, their
well-characterised mode of action and the confirmation through
studies of no adverse effects found, the risk of an adverse
effect on non-target organisms is considered negligible. The
ecological interactions with non-target organisms or the
biochemical processes in soil are considered similar to the
respective caused by conventional maize.
· No occupational health aspects of handling MON 89034 x MON
88017 maize are different from conventional maize, and this
maize was shown not to cause any toxic or allergenic effects in
man or animal health and to be as safe and nutritious as any
other maize without any consequences for the feed/food chain.
· The environmental impact of the cultivation, management and
harvesting techniques applied in the planned trials is
considered no different from the farming practices for
conventional maize.
It is actually expected that the production of MON 89034 x MON
88017 will positively impact current agronomic practices in
maize and provide benefits to farmers and the environment. The
benefits of planting this maize result, in one hand, from its
insect-protection traits and include: 1) a reliable means to
control the target lepidopteran and coleopteran maize pests; 2)
control of target insects while maintaining beneficial species;
3) potential for reduced use of hazardous chemical insecticides
and reduced applicator exposure to these products; 4) fit with
integrated pest management (IPM) and sustainable agricultural
systems; 5) potential for reduced mycotoxin levels in maize
kernels; 6) reduced likelihood for lepidopteran insects to
develop resistance to Bt proteins and 7) no additional labour or
machinery requirements, allowing both large and small growers to
maximize hybrid yields. Likewise, the use of glyphosate-tolerant
maize enables the farmer to take advantage of the herbicides
favourable environmental and safety properties (see Annex I
listing of glyphosate under Council Directive 91/414/EEC).
Glyphosate-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.
Since no characteristics of MON 89034 × MON 88017 could be
identified that may cause adverse effects on human health or the
environment, no risk management strategies are considered
necessary.
Brief description of any measures
taken for the management of risks:
1. In addition to the scheduled
observations of phenotypic and agronomic parameters that form
the basis of the planned research, the trial sites will be
checked regularly during the period of the deliberate release
for potentially occurring, direct or indirect, adverse
environmental effects. This will be done by visual inspection of
the status of the MON 89034 x MON88017 crop and that of its
receiving environment. In case that adverse environmental
effects linked to the deliberate release of MON 89034 x MON
88017 are observed during the period of release, these will be
reported immediately to the Competent Authority.
2. The spatial isolation distance (400 m) from other maize crops
and the four rows of conventional maize surrounding the trials
will prevent the risk of hybridisation with other maize plants.
Some trials (efficacy especially) can be carried out without
isolation. In this case, the trials will be destroyed before the
flowering stage of the crop.
3. The equipment, especially the experimental drill and combine,
will be cleaned on the experimental site, thus preventing seed
dissemination.
4. After completion of harvest, the stalks will be chopped and
then incorporated into the soil. Any shattered seed will be
allowed to germinate. The resulting seedlings will be destroyed
by soil incorporation. Maize cobs will be harvested by
experimental-plot combine, or by hand.
5. Although regrowth in the rotation crops is unlikely because
of poor winter survival, the site will be sown either with a
crop different from maize or with experimental maize that will
be destroyed and not used in any commercial, industrial or food
application. Volunteer plants will be controlled with routinely
used commercial antimonocotyledonous herbicides in this crop.
6. Seeds will be transported in sealed and labelled bags placed
in a rigid container.
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 |