Date of publication: December 20,
2006
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification number:
B/ES/07/03
Member State
Spain
Date of Acknowledgement
28/11/2006 00:00:00
Title of the Project
Notification according to Directive
2001/18/EC, Part B, for the deliberate release of MON 89034 x
MON 88017 for the use in field trials in Spain.
Proposed period of release:
01/01/2007 00:00:00 to 28/02/2008
00:00:00
Name of the Institute(s) or
Company(ies)
Monsanto Europe, S.A., represented by
Monsanto Agricultura España, S.L., ;
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):
Other notifications
MON 89034 x MON 88017 was field tested
in several regions of North and South America, as described in
Section C.4. No environmental problems were reported for these
trials.
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 |
|
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 x 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.
Summary of the inserted DNA fragment inherited from MON 89034:
Genetic Element: Size (~kb). Function.
- B-Left Border: 0.24kb. 239 bp DNA region from the B Left
Border region remaining after integration.
- Pp-e35S: 0.30kb. Modified promoter and leader for the
cauliflower mosaic virus (CaMV) 35S RNA containing the
duplicated enhancer region.
- L-Cab: 0.06kb. 5' untranslated leader of the wheat chlorophyll
a/b binding protein.
- I-Ract1: 0.48kb. Intron from the rice actin gene.
- CS-cry1A.105: 3.53kb. Coding sequence for the Bacillus
thuringiensis Cry1A.105 protein.
- T-Hsp17: 0.21kb. 3' transcript termination sequence for wheat
heat shock protein 17.3, which ends transcription and directs
polyadenylation.
- P-FMV: 0.56kb. Figwort Mosaic Virus 35S promoter.
- I-Hsp70: 0.80kb. First intron from the maize heat shock
protein 70 gene.
- TS-SSU-CTP: 0.40kb. 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: 1.91kb. Coding sequence for a Cry2Ab2 protein from
Bacillus thuringiensis. This coding sequence uses a modified
codon usage.
- T-nos: 0.25kb. 3' transcript termination sequence of the
nopaline synthase (nos) coding sequence from Agrobacterium
tumefaciens which terminates transcription and directs
polyadenylation.
- B-Left Border: 0.23kb. 230 bp DNA region from the B Left
Border region remaining after integration.
Summary of the inserted DNA fragment inherited from MON 88017
Genetic element: Size (~kb). Function.
- B-Left Border: 0.02kb. Portion of the left border sequence
from Agrobacterium tumefaciens involved in transfer of T-DNA.
- P-Ract1: 0.93kb. Promoter from the rice actin gene.
- I-Ract1: 0.46kb. Intron from the rice actin gene.
- TS-CTP2: 0.23kb. DNA sequence coding for the N teminal
chloroplast transit peptide.
- CS-cp4 epsps: 1.37kb. DNA sequence coding for the native CP4
EPSPS protein.
- T-nos: 0.26kb. 3' nontranslated region of the nopaline
synthase (nos) coding sequence from Agrobacterium tumefaciens
which terminates transcription and directs polyadenylation.
- P-e35S: 0.61kb. Promoter and leader for the cauliflower mosaic
virus (CaMV) 35S RNA containing the duplicated enhancer region.
- L-Cab: 0.07kb. 5’ untranslated leader of the wheat chlorophyll
a/b binding protein.
- I-Ract1: 0.46kb. Intron from the rice actin gene.
- CS-cry3Bb1: 1.96kb. DNA sequence coding for a synthetic
variant of Cry3Bb1 protein from Bacillus thuringiensis.
- T-Hsp17: 0.23kb. 3’ nontranslated region of the coding
sequence for wheat heat-shock protein 17.3, which ends
transcription and directs polyadenylation.
- B-Right Border: 0.24kb. DNA region from Agrobacterium
tumefaciens containing the Right border sequence, used for
transfer of the T DNA.
B – border region
CS – coding sequence
I – intron
L – leader
P – promoter
Pp – modified promoter
T – transcript termination sequence
TS – targeting sequence
Cry2Ab2 refers to the protein expressed by MON 89034 x MON 88017
and MON 89034, unless otherwise stated
Cry3Bb1 refers to the protein expressed by MON 89034 x MON 88017
and MON 88017, unless otherwise stated
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 release are:
1. to characterize MON 89034 x MON 88017 maize under European
crop conditions, including analysis for protein expression.
2. to evaluate the agronomic performance and equivalence of MON
89034 x MON 88017 to conventional maize.
3. to evaluate residues after applications with herbicides
formulations based on glyphosate.
2. Geographical location of the site:
• Amudévar (Huesca)
• Grañén (Huesca)
• Tauste (Zaragoza)
• Ejea de los Caballeros (Zaragoza)
• Malpica de Tajo (Toledo)
• Albacete (Albacete)
• Porzuna (Ciudad Real)
• Fuentes de Ropel (Zamora)
• Toral de los Guzmanes (León)
• Coreses (Zamora)
• Ribaforada (Navarra)
• Buñuel (Navarra)
3. Size of the site (m2):
The total surface occupied by MON 89034
x MON 88017 maize in every site will be less than:
• Amudévar (Huesca): 300 m2
• Grañén (Huesca): 300 m2
• Tauste (Zaragoza): 300 m2
• Ejea de los Caballeros (Zaragoza): 300 m2
• Malpica de Tajo (Toledo): 300 m2
• Albacete (Albacete): 300 m2
• Porzuna (Ciudad Real): 300 m2
• Fuentes de Ropel (Zamora): 300 m2
• Toral de los Guzmanes (León): 300 m2
• Coreses (Zamora): 300 m2
• Ribaforada (Navarra): 300 m2
• Buñuel (Navarra): 300 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:
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 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:
In addition to the scheduled
observations of phenotypic and 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
environmental effects. This will be done by visual inspection of
the status of the MON 89034 x MON 88017 crop and that of its
receiving environment. In case any 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.
The spatial isolation distance (200 m) from other maize crops
and the four rows of non transgenic maize surrounding the trials
will prevent the risk of hybridization with other maize plants.
The equipment, especially the experimental drill and combine,
will be cleaned on the experimental site, thus preventing seed
dissemination.
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.
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 by mechanical
destruction or other non-selective herbicides.
Seeds will be transported in sealed and labeled bags.
At the end of the field-testing campaign, a report 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 |
