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Notification report


General information

Notification Number
B/DE/08/201

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
29/10/2008

Title of the Project
“Notification according to Directive 2001/18/EC, Part B, for the deliberate release of MON 89034 × MON 88017, MON 89034 × NK603 maize and their parental lines MON 89034, MON 88017, and NK603 for the use in field trials in Germany under simplified procedure”

Proposed period of release:
01/04/2009 to 31/10/2012

Name of the Institute(s) or Company(ies)
Monsanto Agrar Deutschland GmbH, on behalf of Monsanto Company;


3. Is the same GMPt release planned elsewhere in the Community?
Yes:
Spain; France; Slovak Republic; Romania;

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

If yes, notification number(s):
B/CZ/08/03; B/DE/04/161; B/DE/05/169; B/DE/06/185; B/DE/07/194; B/ES/06/02; B/ES/07/01; B/ES/07/02; B/ES/07/03; B/ES/07/04; B/ES/08/08; B/ES/08/11; B/ES/08/12; B/FR/05/04/01; B/FR/06/01/02; B/FR/06/12/08; B/FR/06/12/10; B/FR/06/12/12; B/FR/06/12/14; B/HU/06/11/6; B/HU/06/11/7; B/HU/06/11/8; B/RO/08/06; B/RO/08/07; B/RO/08/08; B/SK/08/02;

Other notifications
Other Notifications:

In addition to the planned release (see above), MON 89034 × MON 88017, MON 89034 × NK603 maize and their parental lines have already been tested across maize growing regions in North and South American field trials.


Genetically modified plant

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

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
MON 89034 × MON 88017, MON 89034 × NK603 maize were obtained by traditional breeding of two inbred lines, one derived from MON 89034, MON 88017 and from NK603. MON 89034 × MON 88017, MON 89034 × NK603 maize and their parental lines containing have been developed by Monsanto Company.
MON 89034 has been developed to produce the Cry1A.105 and the Cry2Ab2 proteins that confer protection against certain lepidopteran pests. The Cry1A.105 protein provides increased activity against fall armyworm (FAW, Spodoptera sp.) and black cutworm (BCW, Agrotis ipsilon) compared to Cry1Ab, produced in current product MON 810 (Ostrinia nubilalis and Sesamia spp.). The Cry2Ab2 protein provides improved control over Cry1Ab products from damage caused by corn earworm (CEW, Helicoverpa zea). MON 89034 was produced by Agrobacterium-mediated transformation of maize cells with plasmid vector PV-ZMIR245, that contains two separate T-DNAs (2 T-DNA system plasmid vector).
MON 88017 produces the CP4 EPSPS and the Cry3Bb1 proteins that confer tolerance to glyphosate and protection against certain coleopteran pests belonging to the Chrysomelidae family (Diabrotica spp.), respectively. MON 88017 was produced by Agrobacterium-mediated transformation of maize cells with plasmid vector PV-ZMIR39.
NK603 has been developed to produce the CP4 EPSPS and CP4 EPSPS L214P2 proteins that confer tolerance to glyphosate-containing herbicides. NK603 was generated by particle acceleration technology using the DNA fragment PV-ZMGT32L containing a 5-enolpyruvylshikimate-3-phosphate synthase gene (epsps) from Agrobacterium sp. strain CP4 (cp4 epsps).
As MON 89034 x MON 88017 and MON 89034 x NK603 inherit the introduced traits from their parental inbreds, they are protected from the targeted lepidopteran and/or coleopteran insect pests as well as tolerant to glyphosate.
MON 89034 × MON 88017, MON 89034 × NK603 maize and their parental lines enable the farmer to effectively control the targeted insect pests in maize, ensuring maximum realization of yield potential, while removing the environmental burden of the production, packaging, and transport of insecticides, previously used to control Diabrotica spp., Ostrinia nubilalis, and Sesamia spp. In addition, growers will have the ability to apply glyphosate over the top of maize for broad-spectrum weed control while using MON 89034 × MON 88017, MON 89034 × NK603, MON 88017 or NK603.


Genetic modification

3. Type of genetic modification:
Insertion; Other;
Other
MON 89034 x MON 88017 as well as MON 89034 x NK603 was produced by traditional breeding of the respective parental lines. The parental lines are genetically modified by insertion of genetic material.

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 contains the cry1A.105 gene which codes for a protein comprised of naturally occurring Cry1Ab, Cry1F, and Cry1Ac proteins from Bacillus thuringiensis, and the cry2Ab2 gene which codes for a variant of the Bacillus thuringiensis subsp. kurstaki Cry2Ab2 protein. These proteins provide protection against feeding damage caused by lepidopteran insect pests such as the European corn borer (ECB, Ostrinia nubilalis) and the corn earworm (CEW, Helicoverpa zea). A full description of the genetic elements in MON 89034, including the approximate size, source, and function is provided in Table 1.

MON 88017 contains the following genetic elements: a) the cry3Bb1 gene from Bacillus thuringiensis subsp. kumamotoensis which confers protection against Corn Root Worm (Diabrotica virgifera) and b) the cp4 epsps gene from Agrobacterium sp., strain CP4, which provides tolerance to ghyphosate herbicide. These genes have been introduced with regulatory components necessary for expression in plant cells. A full description of the genetic elements in MON 88017, including the approximate size, source, and function is provided in Table 2.

NK603: 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. A full description of the genetic elements in NK603, including the approximate size, source and function is provided in Table 3.

MON 89034 × MON 88017 and MON 89034 x NK603 result from traditional breeding of their parental lines, and no additional genetic modification was used to develop MON 89034 × MON 88017 and MON 89034 x NK603. MON 89034 × MON 88017 and MON 89034 x NK603 inherit the inserted DNA fragments from their respective inbred parental lines.


Table 1: Summary of the genetic elements inserted in MON 89034

Genetic Element (~ size): Function

B1-Left Border (0.24 kb):
239 bp DNA region from the B Left Border region remaining after integration

Pp2-e35S (0.30 kb):
Modified promoter and leader for the cauliflower mosaic virus (CaMV) 35S RNA containing the duplicated enhancer region

L3-Cab (0.06 kb):
5' untranslated leader of the wheat chlorophyll a/b binding protein

I4-Ract1 (0.48 kb):
Intron from the rice actin gene

CS5-cry1A.105 (3.53 kb):
Coding sequence for the Bacillus thuringiensis Cry1A.105 protein

T6-Hsp17 (0.21 kb):
3' transcript termination sequence for wheat heat shock protein 17.3, which ends transcription and directs polyadenylation

P-FMV (0.56 kb):
Figwort Mosaic Virus 35S promoter

I-Hsp70 (0.80 kb):
First intron from the maize heat shock protein 70 gene

TS7-SSU-CTP (0.40 kb):
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 (1.91 kb):
Coding sequence for a Cry2Ab2 protein from Bacillus thuringiensis. This coding sequence uses a modified codon usage.

T-nos (0.25 kb):
3' transcript termination sequence of the nopaline synthase (nos) coding sequence from Agrobacterium tumefaciens which terminates transcription and directs polyadenylation

B-Left Border (0.23 kb):
230 bp DNA region from the B Left Border region remaining after integration

1. B – border region, 2. Pp –modified promoter, 3. L – leader, 4. I – intron, 5. CS coding sequence, 6. T – transcript termination sequence, 7. P – promoter, 8. TS – targeting sequence, 9. Cry2Ab2 refers to the protein expressed by MON 89034, unless otherwise stated


Table 2: Summary of the genetic elements inserted in MON 88017

Genetic Element (~ size): Function

B-Left Border (0.02 kb):
Portion of the left border sequence from Agrobacterium tumefaciens involved in transfer of T-DNA

P-Ract1 (0.93 kb):
Promoter from the rice actin gene

I-Ract1 (0.46 kb):
Intron from the rice actin gene

TS-CTP2 (0.23 kb):
DNA sequence coding for the N teminal chloroplast transit peptide

CS-cp4 epsps (1.37 kb):
DNA sequence coding for the native CP4 EPSPS protein

T-nos (0.26 kb):
3' nontranslated region of the nopaline synthase (nos) coding sequence from Agrobacterium tumefaciens which terminates transcription and directs polyadenylation

P-e35S (0.61 kb):
Promoter and leader for the cauliflower mosaic virus (CaMV) 35S RNA containing the duplicated enhancer region

L-Cab (0.07 kb):
5’ untranslated leader of the wheat chlorophyll a/b binding protein

I-Ract1 (0.46 kb):
Intron from the rice actin gene

CS-cry3Bb1 (1.96 kb):
DNA sequence coding for a synthetic variant of Cry3Bb1 protein from Bacillus thuringiensis

T-Hsp17 (0.23 kb):
3’ nontranslated region of the coding sequence for wheat heat-shock protein 17.3, which ends transcription and directs polyadenylation

B-Right Border (0.24 kb):
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 ´ MON 88017 and MON 89034, unless otherwise stated. Cry3Bb1 refers to the protein expressed by MON 89034 ´ MON 88017 and MON 88017, unless otherwise stated.


Table 3: Summary of the genetic elements inserted in NK603

Genetic Elemen (~ size): Function

P1-Ract1/ I2-Ract1 (1.4 kb):
5’ region of the rice actin gene containing the promoter, transcription start site and first intron

TS3-CTP2 (0.2 kb):
DNA sequence coding for the N-teminal chloroplast transit peptide

CS4-cp4 epsps (1.4 kb):
DNA sequence coding for the native CP4 EPSPS protein

T5-nos (0.3 kb):
3' transcript termination sequence of the nopaline synthase (nos) coding sequence from Agrobacterium tumefaciens which terminates transcription and directs polyadenylation

P-e35S (0.6 kb):
Promoter and leader for the cauliflower mosaic virus (CaMV) 35S RNA containing the duplicated enhancer region

I-Hsp70 (0.8 kb):
Intron from the maize heat-shock protein 70 gene

TS-CTP2 (0.2 kb):
DNA sequence coding for the N-teminal chloroplast transit peptide

CS-cp4 epsps l214p (1.4 kb):
DNA sequence coding for the CP4 EPSPS L214P protein

T-nos (0.3 kb):
3' transcript termination sequence of the nopaline synthase (nos) coding sequence from Agrobacterium tumefaciens which terminates transcription and directs polyadenylation

1. P – promoter, 2. I – intron, 3. TS – targeting sequence, 4. CS – coding sequence, 5. T – transcript termination sequence


6. Brief description of the method used for the genetic modification:
MON 89034 maize was produced by Agrobacterium-mediated transformation of immature embryos of maize tissue.
MON 88017 maize was produced by Agrobacterium-mediated transformation of immature embryos of maize tissue.
NK603 maize was produced by insertion of a DNA fragment into the maize genome using a particle acceleration method.
MON 89034 × MON 88017 and MON 89034 x NK603 result from traditional breeding of their parental lines, and no additional genetic modification was used to develop MON 89034 × MON 88017 and MON 89034 x NK603. MON 89034 × MON 88017 and MON 89034 x NK603 inherit the inserted DNA fragments from their respective inbred parental lines.


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:
MON 89034 × MON 88017, MON 89034 × NK603 maize and their parental lines will be planted in field trials for assessment of phenotypic characteristics and agronomic performance in comparison with conventionel and/or transgenic lines.
In the field trials data will be achieved that will help in establishing guidelines on the appropriate use of glyphosate containg herbicides in MON 89034 × MON 88017, MON 89034 × NK603 and their parental lines.


2. Geographical location of the site:
Germany, Saxony-Anhalt, 39393 Ausleben (district Üplingen)

3. Size of the site (m2):
max. 10.000 m2 per site in 2009
max. 20.000 m2 per site and year from 2010 to 2012


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, MON 89034 x NK603 and their parental lines have been released for field-testing at several locations outside the EU. These field trials were conducted to produce material for the regulatory studies and to assess agronomic performance and characterization (efficacy, selectivity, yield assessment). The results of the release in these countries showed no evidence that MON 89034 x MON 88017, MON 89034 x NK603 and their parental lines are likely to 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 MON 89034 x MON 88017, MON 89034 x NK603 and their parental lines 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 x MON 88017, MON 89034 x NK603 and their parental lines 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, MON 89034 x NK603 and their parental lines to wild plant species in Europe. Due to the measures to be taken during the release (the site is surrounded by a 6 m safety mantle of conventional maize and an additional 50 m security belt in which no commercial maize will be planted) there is 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.
- As for parental lines MON 89034, MON 88017, and NK603, MON 89034  MON 88017 and MON 89034 x NK603 pose 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 traits have activity only towards the larvae of particular target pest, therefore the effect of MON 89034  MON 88017, MON 89034  NK603 and their parental lines on target organisms are 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.
- Any occupational health aspects of handling MON 89034 x MON 88017, MON 89034 x NK603 and their parental lines are not different from conventional maize, and were 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 use of MON 89034 x MON 88017, MON 89034 x NK603 and their parental lines will positively impact current agronomic practices in maize and provide benefits to farmers and the environment. The benefits of planting this maize result, on the 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 arises 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.
No characteristics of MON 89034 x MON 88017, MON 89034 x NK603 and their parental lines could be identified that may cause adverse effects on human health or the environment.


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 MON 89034 x MON 88017, MON 89034 x NK603 and their parental lines would be the same as for traditional maize.
Besides, after finishing each year the whole maize material will be deactivated by chopping and ensilaging as well as fermentation in a biogas plant or working into the soil. An annual post monitoring of the site will be performed to watch/eliminate any surviving maize on the site, which will be planted with other crops than maize.
Furthermore, the following measures are planned:
- All trangenic material (seeds) will be stored in S1-areas and transported in closed containers.
- All agricultural machinery used for dealing with the transgenic material will be cleaned appropriately after use.
- There will be an isolation zone of 50 m around the release area where either no maize will be planted or, if maize is planted, it will be deactivated.
- A 6 m-buffer zone with conventional maize will surround the release area.
Moreover, 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, MON 89034 x NK603 and their parental lines and that of its receiving environment.
In case any adverse environmental effects, linked to the deliberate release of MON 89034 x MON 88017, MON 89034 x NK603 and their parental lines, are observed during the period of release, these will be reported immediately to the Competent Authority.
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
12/05/2009 00:00:00
Remarks: