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Notification report


General information

Notification Number
B/ES/13/09

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
21/11/2012

Title of the Project
Continuation of multiannual field trials, under official supervision, for registration of maize varieties containing NK603 x MON 810, genetically modified for tolerance to glyphosate and protected against corn borers.

Proposed period of release:
01/02/2013 to 28/12/2015

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:
Czech Republic; Romania;

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

If yes, notification number(s):
B/CZ/06/04; B/DE/04/163; B/ES/04/18; B/ES/04/20; B/ES/06/07; B/ES/06/09; B/ES/07/06; B/ES/08/07; B/ES/08/10; B/ES/09/05; B/ES/09/13; B/ES/10/05; B/ES/10/10; B/ES/11/06; B/ES/11/08; B/ES/12/06; B/ES/12/08; B/FR/00/02/06-CON; B/FR/04/02/01; B/FR/06/01/04; B/FR/06/12/13; B/RO/09/07; B/SK/09/03;

Other notifications
B/FR/08/01/05

27384/ENV/12 (CZ)
63925/1/2007

In addition, many field trials have already been conducted across maize growing regions in North and South America and other world areas. NK603 × MON 810 maize varieties have been planted commercially for the first time in 2002 in the US and Canada and from 2010 in Honduras, the Philippines, Argentina, Brazil, Colombia and South Africa. NK603 × MON 810 maize has also received regulatory approvals for import in several countries around the world, namely, Japan, Korea, Mexico, Taiwan and the EU.

C/ES/04/01 according to Dir 2001/18/EC, and EFSA-GMO-NL-2005-26 according to Regulation (EC) 1829/2003 on Genetically Modified Food and Feed.


Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
maizepoaceaezeazea maysmaysNK603 x MON 810 maize

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
NK603 x MON 810 hybrid maize consists in the combination, by traditional breeding, of two genetically modified parental inbred lines derived from maize transformation events NK603 and MON 810, respectively.

Like in NK603, NK603 x MON 810 maize 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.

Like in MON810, NK603 x MON 810 maize also expresses the Cry1A(b) protein, which provides the maize plant of protection from certain lepidopteran insect pests, including corn borers Ostrinia nubilalis and Sesamia spp. The insecticidal activity of the Cry1A(b) protein is specific to predation by the larvae of the targeted lepidopterans.


Genetic modification

3. Type of genetic modification:
Insertion; Other;
Other
NK603 x MON 810 hybrid maize consists in the combination, by traditional breeding, of two genetically modified parental inbred lines, derived from maize transformation events NK603 and MON 810, respectively. 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:
NK603 × MON 810 maize results from a single conventional cross of the inbred parental lines NK603 maize and MON 810 maize, homozygous in their respective inserted sequences.

By crossing NK603 and MON 810 maize, NK603 × MON 810 maize inherits the inserted DNA fragments from both its parental lines.

Components of the inserted DNA fragment inherited from NK603 maize:

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 protein1.

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


Components of the inserted DNA fragment inherited from MON 810 maize:

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

- e35S: Cauliflower mosaic virus. 0.32kb. Promoter.

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

- Cry1A(b): Bacillus thuringiensis. 2.45kb. Encodes Cry1A(b) protein, which targets specific lepidopteran insect pests.


6. Brief description of the method used for the genetic modification:
While NK603 x MON 810 hybrid maize results from traditional breeding, genetic modification was used in the development of the parental NK603 and MON 810 maize. 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 release of genetically modified maize NK603 x MON 810, tolerant to glyphosate and protected against corn borers, has the aim to collect regulatory data (DUS and Agronomic Value).

2. Geographical location of the site:
The selected sites are located in the following localities:
- Fuente Palmera (Córdoba)
- Dos Hermanas (Sevilla)
- Lebrija (Sevilla)
- Tauste (Zaragoza)
- Daimiel (Ciudad Real)
- Calera y Chozas (Toledo)
- Alcarrás (Lleida)
- Valdetorres (Badajoz)


3. Size of the site (m2):
The potential surface occupied in every site by NK603 x MON 810 maize will be less than:
- Fuente Palmera (Córdoba): 2.000 m²
- Dos Hermanas (Sevilla): 2.000 m²
- Lebrija (Sevilla): 2.000 m²
- Tauste (Zaragoza): 2.000 m²
- Daimiel (Ciudad Real): 2.000 m²
- Calera y Chozas (Toledo): 2.000 m²
- Alcarrás (Lleida): 2.000 m²
- Valdetorres (Badajoz): 2.000 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:
NK603 x MON 810 hybrids have been evaluated in field trials in EU since 2001. Many other trials have been performed in main maize growing areas of North and South America and other geographies.

Post-release general surveillance from environments inside and outside the EU has shown that NK603 x MON 810 maize is unlikely to pose any risk of adverse effects to human or animal health, or to the environment. NK603 x MON 810 can not be distinguished from the conventional maize with the exception of its protection against corn borer pests and glyphosate tolerance.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
NK603 × MON 810 maize for food, feed, import and processing is approved in EU in accordance with Regulation (EC) No 1829/2003 on GM food and feed (Commission Decision 2007/701/CE). NK603 and MON 810 single events have been approved separately for food, feed, import and processing. The submission for NK603 cultivation in the EU received the favourable opinion of the EFSA GMO Panel and MON 810 is approved for cultivation in EU since 1998.

Analysis of the characteristics of NK603 × MON 810 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 × MON 810 maize, is not different from the conventional corn crop:

- The risk of the introduced traits in NK603 × MON 810 maize 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 conventional maize.

- There is no risk of genetic transfer from NK603 x MON 810 to wild plants in EU. Likelihood of genetic transfer to other maize crops is low, and in case of such transference took place it will have negligible consequences for the environment. However field trials will be isolated to avoid cross-pollination and trial management will be carefully conducted in order to avoid any seed dispersal out of the test site (see E point).

- The ecological interactions of NK603 × MON 810 maize with non-target organisms or soil processes are not different from traditional 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 Cry1A(b) 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 maize are no different from traditional maize. Also, it has been demonstrated that this maize doesn´t cause any toxic or allergenic effects neither on humans or on animals 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 × MON 810 maize will positively impact current agronomic practices in maize and provide benefits to farmers and the environment. The use of Roundup 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 which provide a number of environmental benefits as improved soil quality, reductions in erosion and runoff of nutrients and pesticides to surface water, improved wildlife habitat, increased carbon retention in the soil and reduced fuel use.

Other benefits of planting this maize result from its insect-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) an option for reduced use and applicator exposure to non selective 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) less requirements of monitoring, machinery, etc, 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 risk of the experimental release with NK603 × MON 810 maize is no different from conventional maize. Therefore, strategies for risk management for NK603 maize would be the same as for traditional maize.

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 × MON 810 crop and that of its receiving environment. In case of any adverse environmental effects, linked to the deliberate release of NK603 x MON 810 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.

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
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European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
09/04/2013 00:00:00
Remarks: