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Notification report


General information

Notification Number
B/SK/10/04

Member State to which the notification was sent
Slovakia

Date of acknowledgement from the Member State Competent Authority
04/02/2010

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

Proposed period of release:
10/04/2010 to 30/11/2012

Name of the Institute(s) or Company(ies)
Crop Production Research Centre, Crop Production Research Centre – Research Institute of Plant Production Piešťany, Slovak Republic.;


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
potatosolanaceaesolanumsolanum tuberosumtuberosumNK603

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
The expression of CP4 EPSPS proteins in NK603 Roundup Ready maize plants imparts tolerance to glyphosate (N-phosphonomethyl-glycine), the active ingredient in the non-selective, foliar-applied, broad-spectrum, post-emergent herbicide Roundup®1.
EPSPS is an enzyme involved in the shikimic acid pathway for aromatic amino acid biosynthesis in plants and micro-organisms. CP4 EPSPS enzymes have been shown to have significantly reduced affinity for glyphosate 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.


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 contains the cp4 epsps gene from Agrobacterium sp. strain CP4, which provides tolerance to ghyphosate herbicide. This gene has been introduced with regulatory components necessary for expression in plant cells. A full description of the genetic elements in NK603, including the approximate size, source and function is provided in Table 1.

Table 1. Summary of genetic elements in the plasmid PV-BVGT08

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

TS3-CTP2 0.2 DNA sequence coding for the N-teminal
chloroplast transit peptide

CS4-cp4 epsps 1.4 DNA sequence coding for the native CP4 EPSPS protein

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

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

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

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

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

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

Legend:
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:
NK603 maize was modified by insertion of a DNA fragment into the maize genome
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 as the recipient or parental plant is not a forest tree species.

Experimental Release

1. Purpose of the release:
NK603 maize will be planted in field trials with the aim of assessing the following criteria: biological efficacy, characterization of introduced traits, compositional analysis, comparison with chemical insecticide strategies, evaluation of possible effects on non target organisms, breeding activities - testing of local germplasm with above mentioned characteristics of genetically modified maize, variety registration trials and assessment of weed treatment strategies in maize under Slovak conditions.

2. Geographical location of the site:
Locations in Gabčíkovo, Sokolce, Borovce, Špačince, Viglaš-Pstruša, Milhostov and Šaľa Hetmín (Slovak Republic).

3. Size of the site (m2):
189 500 m2 is the max. estimated size of all locations in 2010.

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 is 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:
NK603 maize was approved on 19 July 2004 for import, feed use and processing in the EU under Directive 2001/18/EC (Commission Decision 2004/643/EC). Food and food ingredients derived from NK603 were approved under Regulation (EC) No. 258/97 (Commission Decision 2005/448/EC) and existing feed materials, feed additives and food additives produced from NK603 were listed in the Community Register, according to Regulation (EC) No. 1829/20032. An application for cultivation of varieties of NK603 in the European Union was submitted under Regulation (EC) No. 1829/2003 and EFSA adopted a favourable scientific opinion (published on 11 June 2009) concluding that NK603 is as safe as its conventional counterpart with respect to potential direct effects on human and animal health and the environment3.
Analysis of the characteristics of NK603 has shown that the risk of potential adverse effects on human and animal health and the receiving environment, resulting from the deliberate release of this maize for field testing, is consistently negligible:
The risk of the introduced trait in NK603 maize 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-agronomic environments is negligible, as its persistence in agricultural habitats and its invasiveness into natural habitats are unaltered compared to conventional maize.
NK603 maize is herbicide-tolerant and, as such, has no target organisms. Potential exposure of non-target organisms to CP4 EPSPS presents no conceivable mechanism to cause adverse effects because of its properties. The interaction between this maize and non-target organisms is not different from conventional maize. Therefore, the environmental risk of adverse effects on biochemical processes, caused by the interaction of NK603 with decomposers and interacting detritivores in the soil compartment, is negligible. Additionally, as CP4 EPSPS proteins belong to a wellknown, safe class of EPSPS proteins that are commonly found in bacteria, fungi, algae and in all higher plants, soil microorganisms have historically been exposed to a diversity of naturally occurring EPSPS proteins.
Any occupational health aspects of handling NK603 maize are no different from conventional maize, and this maize was shown to be as safe and as 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. It is actually expected that the commercial production of NK603 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 herbicides favourable environmental and safety properties (see Annex I listing of glyphosate under Council Directive 91/414/EEC). Roundup-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) costeffective 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.

Remarks
2 http://ec.europa.eu/food/dyna/gm_register/gm_register_auth.cfm?pr_id=16
3 http://www.efsa.europa.eu/en/efsajournal/pub/1137.htm


Brief description of any measures taken for the management of risks:
The environmental risk assessment has indicated that the environmental risk of this maize is negligible and the favorable scientific opinion adopted by EFSA concluded that NK603 is as safe as its conventional counterpart with respect to potential direct effects on human and animal health and the environment. Therefore, strategies for risk management for NK603 maize would be the same as for traditional maize.
In addition to the scheduled observations, 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 NK603 crop and that of their receiving environment. In case any adverse environmental effects, linked to the deliberate release of NK603 are observed during the period of release, these will be reported immediately to the Competent Authority.
The minimal isolation distance (200 m) from other maize crops, together with the eight rows of non transgenic maize surrounding the trials will prevent most of the possibility of hybridization with other maize plants.
The equipment, especially the experimental drill and combine, will be cleaned on the experimental site, thus preventing seed dissemination.
Although regrowth in the rotation crops is unlikely because of poor winter survival, the site will be sown with a crop different from maize the year following the planned trial.
Volunteer plants will be controlled by mechanical destruction or non-selective herbicides.
Seeds will be transported in sealed and labelled bags.
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 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 effect on human health or environment would be reported immediately to Competent Authority.

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
16/04/2010 00:00:00
Remarks: