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Notification report


General information

Notification Number
B/ES/10/12

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
04/12/2009

Title of the Project
Field trials under official supervision with genetically modified maize MON 89034 x NK603 maize protected against certain lepidopteran insect pests and tolerant to glyphosate, for variety registration.

Proposed period of release:
01/02/2010 to 28/02/2011

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:
Germany; France; Czech Republic; Slovak Republic; Romania;

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

If yes, notification number(s):
B/ES/07/02; B/ES/08/12; B/ES/09/08; B/FR/06/12/08; B/RO/09/06;

Other notifications
MON 89034  NK603 has been tested as well 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 NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
maizepoaceaezeazea maysmaysMON 89034 x NK603

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
MON 89034 × NK603 consists in the combination, by traditional breeding, of two genetically modified parental inbred lines derived from MON 89034 and NK603.

- Like MON 89034, MON 89034 × NK603 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 NK603, MON 89034 × NK603 expresses the CP4 EPSPS proteins, derived from Agrobacterium sp. strain CP4, which provides tolerance to glyphosate.


Genetic modification

3. Type of genetic modification:
Insertion; Other;
Other
MON 89034 × NK603 consists in the combination, by traditional breeding, of two genetically modified parental inbred lines derived from MON 89034 and NK603. 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 NK603 results form traditional breeding of MON 89034 and NK603. The inserted DNA fragments from both inbred parental lines are inherited in MON 89034 x NK603.

Summary of the inserted DNA fragment inherited from MON 89034:

Genetic Element: Size (~kb). Function (Reference).

- 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.

B – border region
Pp –modified promoter
L - leader
I - intron
CS - coding sequence
T – transcript termination sequence
P – promoter
TS – targeting sequence
Cry2Ab2 refers to the protein expressed by MON 89034, unless otherwise stated


Summary of the inserted DNA fragment inherited from NK603:

Genetic Element: Size (kb). Function.

- P-Ract1/ I-Ract1: 1.4kb. 5’ region of the rice actin gene containing the promoter, transcription start site and first intron.

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

- CS-cp4 epsps: 1.4kb. DNA sequence coding for the native CP4 EPSPS protein.

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

- P-e35S: 0.6kb. Promoter and leader for the cauliflower mosaic virus (CaMV) 35S RNA (Odell et al., 1985) containing the duplicated enhancer region.

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

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

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

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

P –promoter
I intron
TS targeting sequence
CS – coding sequence
T– transcript termination sequence


6. Brief description of the method used for the genetic modification:
While MON 89034 x NK603 results from traditional breeding, genetic modification was used in the development of the parental MON 89034 and NK603. These parental maize lines were produced by Agrobacterium-mediated transformation of maize cells and particle acceleration transformation, respectively.

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 release of MON 89034 x NK603 genetically modified maize has the aim to collect regulatory data (DUS and Agronomic Value) for variety registration.

2. Geographical location of the site:
- Fuente Palmera (Córdoba).
- Aznalcázar (Sevilla).
- Lebrija (Sevilla).
- Utrera (Sevilla).
- Ejea de los Caballeros (Zaragoza).
- Grañén (Huesca).
- Tauste (Zaragoza).
- Calera y Chozas (Toledo).
- Daimiel (Ciudad Real).
- Olmedo (Valladolid).
- Dueñas (Palencia).
- Molacillos (Zamora).
- Coreses (Zamora).
- Alcarrás (Lleida).
- Valdetorres (Badajoz).


3. Size of the site (m2):
The total surface occupied by MON 89034 x NK603 maize in every site will be less than:
- Fuente Palmera (Córdoba): 1.000 m2.
- Aznalcázar (Sevilla): 1.000 m2.
- Lebrija (Sevilla): 1.000 m2.
- Utrera (Sevilla): 1.000 m2.
- Ejea de los Caballeros (Zaragoza): 1.000 m2.
- Grañén (Huesca): 1.000 m2.
- Tauste (Zaragoza): 1.000 m2.
- Calera y Chozas (Toledo): 1.000 m2.
- Daimiel (Ciudad Real): 1.000 m2.
- Olmedo (Valladolid): 1.000 m2.
- Dueñas (Palencia): 1.000 m2.
- Molacillos (Zamora): 1.000 m2.
- Coreses (Zamora): 1.000 m2.
- Alcarrás (Lleida): 1.000 m2.
- Valdetorres (Badajoz): 1.000 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 NK603 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. In the EU it has been released since 2007 for regulatory purposes (evaluate the performance in European environment, agronomic equivalence, protein expression and residues of glyphosate).

The results of the releases in these countries showed no evidence that MON 89034 x NK603 is likely to cause any adverse effects to human or animal health and the environment. Except for its protection against certain lepidopteran insects and its tolerance to glyphosate, MON 89034 x NK603 could not be distinguished from conventional maize.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
MON 89034 and NK603 maize have been individually approved in the EU for food and feed uses, import and processing. The application for the placing on the market of MON 89034 x NK603 maize for food and feed uses, import and processing (EFSA-GMO-NL-2007-38) has received the positive opinion of the EFSA GMO Panel, which concludes that maize MON89034 x NK603 is as safe and as nutritious as its non-GM counterpart and unlikely to have any adverse effect on human and animal health or on the environment in the context of its intended uses Analysis of the characteristics of MON 89034 x NK603 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 because:

- The risk of the introduced traits in MON 89034 × NK603 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 is unaltered compared to conventional maize.

- There is no potential for gene transfer from MON 89034 x NK603 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 NK603, MON 89034 x NK603 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. Therefore, the effect of MON 89034 x NK603 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 and Cry2Ab2 toxins for certain lepidopteran 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 NK603 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 NK603 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 lepidopteran-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) 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 × NK603 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 NK603 crop and that of its receiving environment. In case any adverse environmental effects, linked to the deliberate release of MON 89034 x NK603, 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.

Seeds will be transported in sealed and labeled bags, and their management for setting the trial will be done by qualified staff, informed about preventive measures to avoid any spill. The equipments, especially the experimental drill and combine, will be cleaned on the experimental site, thus preventing seed dissemination.

Plant products from trials will be only used for studies intended by this notification and will be destroyed at their end. After completion of harvest, the stalks will be chopped and then incorporated into the soil. Harvested grain not used in further analysis or studies will be destroyed by burying, grinding to no viable fractions, incineration or authorized dump.

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.

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 Member State Competent Authority:
Yes
09/03/2010 00:00:00
Remarks: