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Notification report


General information

Notification Number
B/RO/10/02

Member State to which the notification was sent
Romania

Date of acknowledgement from the Member State Competent Authority
22/02/2010

Title of the Project
Notification according to Directive 2001/18/EC, Part B, for the deliberate release of MON 89034 × NK603 for the use in field trials in Romania.

Proposed period of release:
01/04/2010 to 31/12/2015

Name of the Institute(s) or Company(ies)
Monsanto Europe, S.A., Represented by Monsanto Romania SRL, address: Bucharest North-street, no 10, Global City Business Park, Building O21, Floor 5, Voluntari, Ilfov County, Zip code 77190; Phone: 004 021 305 71 40; Fax: 004 021 305 71 65.;


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

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

If yes, notification number(s):
B/CZ/09/03; B/DE/06/185; B/DE/08/201; B/ES/07/02; B/ES/08/12; B/ES/09/08; B/FR/06/12/08; B/RO/09/06; B/SK/09/03;

Other notifications
Other:It has tested as well in several of North and South America.

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 × 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 89034xNK603. The individual components and the size, source and function of these inherited DNA sequences .

Summary of the inserted DNA fragment inherited from MON 89034:

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

B-Left Border: 0.24 Kb. 239 bp DNA region from the B-Left Border region remaining after integration.
Pp-e35S: 0.30 Kb. Modified promoter and leader for the cauliflower mosaic virus (CaMV) 35S RNA containing the duplicated enhancer region.
L-Cab: 0.06 kb. 5' untranslated leader of the wheat chlorophyll a/b-binding protein.
I-Ract1: 0.48 kb. Intron from the rice actin gene.
CS-cry1A.105: 3.53 kb. Coding sequence for the B. thuringiensis Cry1A.105 protein.
T-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.
TS-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 B. 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.

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 purpose of the deliberate introduction in the environment consists in collection of the agronomy and phenotype dates in experimental fields for selectivity/ bio-effiency and sampling regarding comparative study of MON 89034 x NK603 versus conventional corn .

2. Geographical location of the site:
Dalga – Calarasi county
Mircea Voda – Braila county
Ramnicu Sarat – Buzau county
Tecuci – Galati county
Troianu –Teleorman county
Peciu Nou –Timis county
Satu Mare – Satu Mare county
Arad – Arad County


3. Size of the site (m2):
Dalga – Calarasi county-2500 sq.m
Mircea Voda – Braila county-2500 sq.m
Ramnicu Sarat – Buzau county -2500 sq.m
Tecuci – Galati county-2500 sq.m
Troianu –Teleorman county -2500 sq.m
Peciu Nou –Timis county-2500 sq.m
Satu Mare – Satu Mare county-2500 sq.m
Arad- Arad County – 2500 sq.m


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.

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 × NK603 consists in the combination, by traditional breeding, of two genetically modified parental inbred lines derived from MON 89034 and NK603. MON 89034 and NK603 maize have been individually approved in the EU for food and feed uses, import and processing (see Commission Decision 2009/813/EC for MON 89034 and Commission Decisions 2004/643/EC and 2005/448/EC for NK603). The application for the placing on the market of MON 89034 × 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 × 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:
•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 are 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.
•Any occupational health aspects of handling MON 89034 x NK603 maize are not 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.


Brief description of any measures taken for the management of risks:
Besides 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 × NK603 crop and that of its receiving environment.
In case any adverse environmental effects, linked to the deliberate release of MON 89034 × NK603 are observed during the period of release, these will be reported immediately to the Competent Authority.
In order to prevent the possibility of hybridization with other maize plants, the following measures will be taken: the maize testing fields will be placed 200 meters away from other maize crops and will be surrounded by a buffer zone made of 4 rows of conventional maize; the batches will be set up so that there is a difference of at least one month between the blooming period of MON 89034 × NK603 and the conventional maize.
The equipment, especially the seeder and the combine harvester, will be cleaned on the experimental batch, thus preventing the dissemination of the seeds.
The destruction of the field trials will be done under the supervision of the National Environemntal Guard representatives.
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
03/05/2010 00:00:00
Remarks: