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Notification report


General information

Notification Number
B/ES/10/06

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
21/12/2009

Title of the Project
Notification according to Directive 2001/18/EC, Part B, for continuing the field testing of MON 89034 (maize protected against certain lepidopteran insect pests) in order to complete its agronomic characterization and development.

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:
France;

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

If yes, notification number(s):
B/DE/06/185; B/ES/07/01; B/ES/08/11; B/ES/09/07; B/FR/06/12/12; B/RO/08/07; B/SK/08/02;

Other notifications
In addition to these releases, many field trials have already been conducted across maize growing regions in 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

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
MON 89034 is protected against certain lepidopteran insect pests, such as European corn borer (ECB, Ostrinia nubilalis).

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:
MON 89034 contains the cry1A.105 gene which codes for protein Cry1A.105, belonging to the Cry1 type of 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).

Summary of the genetic elements inserted in 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.

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
* Analyses of the MON 89034 insert sequence revealed that the e35S promoter that regulates expression of the cry1A.105 coding sequence was modified: the Right Border sequence present in PV-ZMIR245 was replaced by the Left Border sequence. It is likely that this modification is the result of a crossover recombination event that occurred prior to the DNA being inserted into the genome.


6. Brief description of the method used for the genetic modification:
MON 89034 was produced by Agrobacterium-mediated transformation of immature embryos of maize tissue.

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 to continue the agronomic characterization and development of maize hybrids containing MON 89034 event and evaluate efficacy against certain lepidopteran pests.

2. Geographical location of the site:
The selected sites are located in the following localities:
- Grañén (Huesca).
- Ejea de los Caballeros (Zaragoza).
- Tauste (Zaragoza).
- Alcarrás (Lleida).


3. Size of the site (m2):
The total surface occupied by MON 89034 maize in every site will be less than:
- Grañén (Huesca): 1.500 m2.
- Ejea de los Caballeros (Zaragoza): 1.500 m2.
- Tauste (Zaragoza): 1.500 m2.
- Alcarrás (Lleida): 1.500 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 has been released for field-testing at several locations in the U.S.A. and Argentina since 2002. These field trials were conducted to produce material for the regulatory studies and to assess agronomic performance (efficacy, selectivity, yield assessment). It has also been tested in Canada in 2005 for agronomic characterization and evaluations. In the EU it has been released since32007 for regulatory purposes (evaluate the performance in European environment, the agronomic equivalence and protein expression).

The results of the release in these countries showed no evidence that MON 89034 is likely to cause any adverse effects to human or animal health and the environment. Except for its protection against certain lepidopteran insects, MON 89034 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 has shown that the risk of potential adverse effects on human health or the environment, resulting from the deliberate release of this maize for field testing, is negligible:

- The risk of the introduced trait in MON 89034 to be the cause of any meaningful competitive advantage or disadvantage in natural environments is negligible. The likelihood of unintended spreading of MON 89034 in the non-agricultural environments is negligible, as maize is neither persistent nor invasive and these parameters are unaltered when compared to conventional maize.

- There is no potential for gene transfer from MON 89034 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).

- The effect of MON 89034 on target organisms is limited to specific conditions in the field, spatially limited and short in duration. Therefore MON 89034 poses negligible risk for adverse environmental effects through its interaction with target organisms.

- It is actually expected that the planting of MON 89034 will provide important environmental benefits, relevant to the discussion on target organisms, including: 1) a reliable means to control specific lepidopteran maize pests while maintaining beneficial species; 2) potential for reduced use of hazardous chemical insecticides; 3) excellent fit with Integrated Pest Management and sustainable agricultural systems; 4) reduced likelihood for lepidopteran insects to develop resistance to Bt proteins; 5) potentially reduced levels of mycotoxins such as fumonisins 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.

- Based on the selectivity of the Cry1A.105 and the 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 are different from conventional maize. Additionally, 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 cultivation of any other maize.

Since no characteristics of MON 89034 could be identified that may cause adverse effects on human health or the environment, no risk management strategies are considered necessary. Additionaly it has to be considered that MON 89034 maize is approved in EU for food, feed, import and processing in accordance with Regulation (EC) No 1829/2003 (Commission Decision 2007/701/CE).


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 crop and that of its receiving environment. In case of any adverse environmental effects, linked to the deliberate release of MON 89034 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
23/03/2010 00:00:00
Remarks:
There are several Autonomous Communities as competent authorities for give the consent of these field trials:
- Cataluña: 23/03/2010.
- Aragón: 26/03/2010.