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Notification report


General information

Notification Number
B/ES/12/04

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
09/12/2011

Title of the Project
Notification according to Directive 2001/18/EC, Part B, for the deliberate release of glyphosate tolerant NK603 maize in Castilla y León (Spain).

Proposed period of release:
01/04/2012 to 30/11/2012

Name of the Institute(s) or Company(ies)
KWS SAAT AG, Represented by KWS Semillas Iberica.;


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 maysmaysNK603

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
NK603 maize expresses CP4 EPSPS proteins, which impart tolerance to glyphosate (Nphosphonomethyl-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.


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:
Genetic Element: Source. Size (kb). Function.

First cp4 epsps gene cassette

- P-ract1/ ract1 intron: Oryza sativa. 1.4kb. Contains promoter, transcription start site and first intron.

- Ctp 2: Arabidopsis thaliana. 0.2kb. Encodes chloroplast transit peptide, which directs the CP4 EPSPS protein to the chloroplast.

- cp4 epsps: Agrobacterium sp. strain CP4. 1.4kb. Encodes glyphosate-tolerant CP4 EPSPS protein.

- NOS 3’: Agrobacterium tumefaciens. 0.3kb. Ends transcription and directs polyadenylation of the mRNA.

Second cp4 epsps gene cassette

- e35S: Cauliflower mosaic virus. 0.6kb. Promoter.

- Zmhsp70: Zea mays L. 0.8kb. Stabilizes the level of gene transcription.

- Ctp 2: Arabidopsis thaliana. 0.2kb. Encodes chloroplast transit peptide, which directs the CP4 EPSPS protein to the chloroplast.

- cp4 epsps l214p: Agrobacterium sp. strain CP4. 1.4kb. Encodes glyphosate-tolerant CP4 EPSPS L214P protein*.

- NOS 3’: Agrobacterium tumefaciens. 0.3kb. Ends transcription and directs polyadenylation of the mRNA.


*The substitution of leucine by proline in the CP4 EPSPS encoded by the second cp4 epsps gene in the NK603 insert is indicated by the suffix L214P.


6. Brief description of the method used for the genetic modification:
NK603 parental maize line was 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:
Observation, crossing, selfing and data collection of NK603 maize lines resistant to Roundup Ready.

2. Geographical location of the site:
Castilla y León:
- Benavente (Zamora).
- Castrogonzalo (Zamora).
- Villanueva de Azoague (Zamora).
- Toro (Zamora).


3. Size of the site (m2):
The maximum surface occupied by the NK603 maize field trial will be: 5.000 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:
Post-release general surveillance from environments inside and outside the EU has shown that NK603 behavior is similar to the conventional maize so it 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. 1829/2003. An application for cultivation 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 environment.

Analysis of the characteristics of NK603 maize, especially in comparison with extensive experience with cultivation of traditional maize within the EU, 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 maize, is negligible because:

- The risk of the introduced trait in NK603 maize to be the cause of any meaningful competitive advantage or disadvantage in natural environments has not been found. 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 traditional maize.

- Potential exposure of non-target organisms to CP4 EPSPS presents no conceivable mechanism to cause adverse effects because of its properties.

- Any occupational health aspect of handling NK603 maize is 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 traditional maize.

It is actually expected that the commercial production of NK603 maize 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). 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) 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:
The environmental risk assessment has indicated that the environmental risk of this maize is no different from conventional maize 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 conventional maize.

In addition to the scheduled observations, the trial site will be inspected periodically 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 crop and that of its receiving environment. In case of any adverse environmental effects linked to the deliberate release of NK603, observed during the period of release, these will be reported immediately to the Competent Authority.

In order to minimize dispersion of pollen from the genetically-modified plants, a minimum distance of isolation of 200 m will be maintained from any other plot of land designated for corn cultivation. Moreover, the trial area will be surrounded by a boundary of eight rows of conventional corn.This boundary of conventional corn will be destroyed at the end of the release period.

Seeds will be transported in properly-closed and labelled containers which prevent dispersion into the environment. Sowing of genetically-modified corn will be carried out with a sowing machine for trials that is equipped with a self-cleaning system by which the left-over seed is collected and stored.

Once the sowing process is completed, the sowing equipment will be cleaned thoroughly on the release site to eliminate every possible seed residue and in this way avoid the dispersion or spread of genetically-modified seed. Any remaining and unused seed and all seed residues recovered during the cleaning process will be buried within the perimeters of the trial area.

The majority of the test crops will be harvested by hand – the corncobs shall be gathered in properly-closed and labelled containers. The rest of the trial area, including the boundaries, will be harvested by a combine harvester and the grain will be buried within the perimeters of the trial area. The plant remains located on the release site will be decayed, turned and incorporated into the ground with the aim of accelerating the natural process of biodegration.

No plant or product resulting from the trial period will use for animal or human consumption or for other purposes outside of that stated in this application.

Commercial corn will not be grown from the land which would be designated for the field trial during the year following the completion of the trial. Periodical inspections will be carried out on the release site during the year following the completion of the trial. Any possible regrowth will be destroyed before the flowering period begins.

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
23/03/2012 00:00:00
Remarks:
The competent authority for give the consent of these field trials is the Autonomous Community of Castilla y León.