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Notification report


General information

Notification Number
B/RO/09/10

Member State to which the notification was sent
Romania

Date of acknowledgement from the Member State Competent Authority
17/03/2009

Title of the Project
Notification according to Directive 2001/18/ EC , Part B, for the deliberate release of NK603 x MON 810 maize for the use in field trials in Romania.

Proposed period of release:
01/04/2009 to 01/12/2012

Name of the Institute(s) or Company(ies)
EURALIS SEMINTE SRL, Represented by EURALIS SEMINTE SRL, adress: Splaiul Independentei, No.42-44, sector 5, Bucharest
Bucharest : Phone: +4074388019;


3. Is the same GMPt release planned elsewhere in the Community?
No

Has the same GMPt been notified elsewhere by the same notifier?
No

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:
NK603 x MON 810 consists in the combination, by traditional breeding, of two genetically modified parental inbred lines, derived from maize transformation events NK603 and MON 810, respectively.
NK603 x MON 810 expresses CP4 EPSPS proteins, which impart tolerance to glyphosate (N phosphonomethyl-glycine), the active ingredient in the non-selective herbicide Roundup. EPSPS is an enzyme involved in the shikimic acid pathway for aromatic amino acid biosynthesis in plants and microorganisms. CP4 EPSPS enzymes have been shown to have significantly reduced affinity for glyphosate herbicide when compared with the wild-type maize enzyme, and to retain catalytic activity in the presence of the inhibitor glyphosate. Therefore, when maize plants expressing the CP4 EPSPS proteins are treated with glyphosate, the plants are unaffected since the continued action of the tolerant CP4 EPSPS enzymes provides for the plant’s need for aromatic amino acids.
NK603 x MON 810 also expresses the Cry1Ab protein, which provides the maize plant of protection from certain lepidopteran insect pests, including European Corn Borer (Ostrinia nubilalis) and pink borers (Sesamia spp.). The insecticidal activity of the Cry1Ab protein is specific to predation by the larvae of the targeted lepidopterans.


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:
NK603 × MON 810 results from a single conventional cross of the inbred parental lines NK603 and MON 810, homozygous in their respective inserted sequences.
By crossing NK603 and MON 810, NK603 × MON 810 inherits the inserted DNA fragments from both its parental lines. The individual components and the function of the inherited sequences .
Summary of the inserted DNA fragment inherited from NK603:

Genetic Element: Size (kb). Function.
First cp4 epsps gene cassette
- 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.
Second cp4 epsps gene cassette
- 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

Summary of the inserted DNA fragment inherited from MON 810:

Genetic Element - Size (~kb) - Function (Reference)

-e35S - 0.32 - DNA sequence derived from cauliflower mosaic virus (CaMV) containing a portion of the CaMV promoter with the duplicated enhancer region and 5’ untranslated region
-Zmhsp70 - 0.81 - DNA sequence derived from maize containing the intron sequence from the maize hsp 70 gene (heat-shock protein) present to stabilize the level of gene transcription.
-CS-Cry1Ab - 2.45 - DNA sequence containing synthetic linker and a portion of the synthetic coding sequence for a variant of Cry1Ab1 protein from Bacillus thuringiensis subsp. kurstaki


6. Brief description of the method used for the genetic modification:
NK603 x MON 810 was created using conventional breeding techniques. No additional genetic modification is utilised in the production of NK603 × MON 810 varieties. Instead, NK603 × MON 810 is produced by a single traditional cross of NK603 and MON 810 parental inbred lines (homozygous for the respective introduced trait). F1 hybrid seed thereby inherits the introduced Roundup Ready trait from NK603, as well as the insect-protection trait from MON 810.
While NK603 × MON 810 results from traditional breeding, genetic modification was used in the development of the parental NK603 and MON 810. These single trait parental maize lines were genetically modified using a particle acceleration method.


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 for corn variety registration in the National Catalogue Of Varieties Of Agricultural Plant Species (5 locations), experimental fields for selectivity/ bio-efficiency and sampling regarding comparative study of NK603 x MON810 versus conventional corn in 5 locations: Dalga – Calarasi county, Mircea Voda – Braila county ,Ramnicu Sarat – Buzau county,Tecuci – Galati county ,Troianu – Teleorman county

2. Geographical location of the site:
Dalga - Calarasi county
Mircea Voda - Braila county
Ramnicu Sarat - Buzau county
Tecuci - Galati county
Troianu – Teleorman county


3. Size of the site (m2):
ISTIS – 5 locations:
Dalga – Calarasi county – 100 m2
Mircea Voda – Braila county – 100 m2
Ramnicu Sarat – Buzau county – 100 m2
Tecuci – Galati county – 100 m2
Troianu – Teleorman county – 100 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:
Post-release general surveillance from environments inside and outside the E.U. has shown that NK603 x MON 810 and its single-trait parental lines, NK603 and MON 810, are unlikely to pose any risk of adverse effects to human or animal health or to the environment.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Analysis of the characteristics of NK603 × MON 810, especially in comparison with extensive experience with cultivation of traditional maize within the E.U., has shown that the risk for potential adverse effects on human and animal health and the receiving environment, resulting from the planned field trials with NK603 × MON 810, is consistently negligible:
• The risk of the introduced traits in NK603 × MON 810 to be the cause of any meaningful competitive advantage or disadvantage in natural environments is negligible. Like for any other maize, the likelihood of this maize to spread into non-agronomic environments is negligible, as its persistence in agricultural habitats and its invasiveness into natural habitats are unaltered compared to traditional maize. Moreover, there is no potential for gene transfer from NK603 × MON 810 to any wild plant species in Europe.
• As for parental MON 810, NK603 × MON 810 poses negligible risk for adverse environmental effects through its interaction with target organisms. The ecological interactions of NK603 × MON 810 with non-target organisms or soil processes are not different from conventional maize. Potential exposure of non-target organisms to CP4 EPSPS presents no conceivable mechanism to cause adverse effects because of its properties, and due to the highly selective insecticidal activity of the Cry1Ab protein on the larvae of specifically targeted Lepidopteran insect pests, also this protein poses negligible risks to non-target organisms.
• Any occupational health aspects of handling NK603 × MON 810 are no different from traditional maize, and this maize was shown to be as safe and as nutritious as any other maize.
• 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 commercial production of NK603 × MON 810 will positively impact current agronomic practices in maize and provide benefits to farmers and the environment. The use of glyphosate in maize enables the farmer to take advantage of the herbicide’s 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. Other benefits of planting this maize result 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) reduced use and applicator exposure to chemical insecticides; 4) fit with integrated pest management (IPM) and sustainable agricultural systems; 5) potential for reduced fumonisin mycotoxin levels in maize kernels; and 6) no additional labour or machinery requirements, allowing both large and small growers to maximize hybrid yields.


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 NK603 × MON 810 would be the same as for traditional maize.
However, 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 NK603 x MON 810 crop and that of its receiving environment.
In case any adverse environmental effects, linked to the deliberate release of NK603 × MON 810 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
02/06/2009 00:00:00
Remarks: