Back

Notification report


General information

Notification Number
B/ES/04/20

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
08/11/2004

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 Spain.
This application is to advance in the evaluation and agronomic characterization of hybrid maize varieties derived from NK603 x MON 810 maize, that are produced by traditional breeding of two genetically modified parental inbred lines of maize, one being derived from transformation event NK603 (which is tolerant to treatment with Roundup herbicide containing glyphosate) and the second one derived from event MON 810 (which is protected from certain lepidopteran insect pests. NK603 x MON 810 maize will be used in field trials.


Proposed period of release:
01/01/2005 to 31/12/2007

Name of the Institute(s) or Company(ies)
Monsanto Agricultura España S.L., Avda. de Burgos, 17, 10ª
E-28036 Madrid
Spain;


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

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

If yes, notification number(s):


Other notifications
C/ES/04/01

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.
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.
NK603 x MON 810 maize also expresses the Cry1A(b) 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 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. The individual components and the function of the inherited sequences are:

* Components of the inserted DNA fragment inherited from NK603 maize:

First cp4 epsps gene cassette

- P-ract1/ ract1 intron: Contains promoter, transcription start site and first intron, from Oryza sativa, (size 1.4Kb).
- Ctp 2 : Encodes chloroplast transit peptide, which directs the CP4 EPSPS protein to the chloroplast, from Arabidopsis thaliana, (size 0.2 Kb).
- cp4 epsps: Encodes glyphosate-tolerant CP4 EPSPS protein, from Agrobacterium sp. strain CP4, (size 1.4 Kb).
- NOS 3’: Ends transcription and directs polyadenylation of the mRNA, from Agrobacterium tumefaciens,(size 0.3Kb).

Second cp4 epsps gene cassette

- e35S: Promoter, from Cauliflower mosaic virus, (size 0.6 Kb).
- Zmhsp70: Stabilizes the level of gene transcription, from Zea mays L., (size 0.8 Kb).
- Ctp 2 : Encodes chloroplast transit peptide, which directs the CP4 EPSPS protein to the chloroplast, from Arabidopsis thaliana, (size 0.2 Kb).
- cp4 epsps l214: Encodes glyphosate-tolerant CP4 EPSPS L214P protein(1) , from Agrobacterium sp. strain CP4, (size 1.4 Kb).
- NOS 3’: Ends transcription and directs polyadenylation of the mRNA, from Agrobacterium tumefaciens, (size 0.3 Kb).

(1) 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.

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

- e35S: Promoter, from Cauliflower mosaic virus, (size 0.6 Kb).
- Zmhsp7: Stabilizes level of gene transcription, from Zea mays L., (size 0.8 Kb).
- Cry1A(b): Encodes Cry1A(b) protein, which targets specific lepidopteran insect pests, from Bacillus thuringiensis, (size 3.5 Kb).


6. Brief description of the method used for the genetic modification:
NK603 x MON 810 hybrid maize was created using conventional breeding techniques. No additional genetic modification is utilised in the production of NK603 × MON 810 maize hybrid varieties. Instead, NK603 × MON 810 hybrid maize 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 maize, as well as the insect-protection trait from MON 810 maize.
While NK603 × 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 maize varieties that are produced by traditional breeding of two genetically modified parental inbred lines of maize, one being derived from transformation event NK603 (which is tolerant to treatment with Roundup herbicide containing glyphosate) and the second one derived from event MON 810 (which is protected from certain lepidopteran insect pests), has the aim to advance in the evaluation and characterization of NK603 x MON81 maize varieties, for possible submission to variety Registration and cultivation by Spanish farmers.

2. Geographical location of the site:
- Maribañez (Los Palacios y Villafranca, Sevilla)
- Fuente Palmera (Córdoba)
- Almudevar (Huesca)
- Huerto (Huesca)
- Estadilla ( Huesca)
- Torrijos (Toledo)
- Cisterniga (Valladolid)
- Fuentes de Ropel (Zamora)
- Guadiana del Caudillo (Badajoz)
- Buñuel (Navarra)


3. Size of the site (m2):
The total surface will be lower than 10.000 m2 (1 ha) and the potential surface occupied in every site by NK603 x MON 810 maize will be:

- Maribañez (Los Palacios y Villafranca, Sevilla): 600 m2
- Fuente Palmera (Córdoba): 600 m2
- Almudevar (Huesca): 780 m2
- Huerto (Huesca): 780 m2
- Estadilla ( Huesca): 780 m2
- Torrijos (Toledo): 600 m2
- Cisterniga (Valladolid): 180 m2
- Fuentes de Ropel (Zamora): 180 m2
- Guadiana del Caudillo (Badajoz): 600 m2
- Buñuel (Navarra): 780 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 maize and its single-trait parental lines, NK603 and MON 810 maize, 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 maize, 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 maize, is consistently negligible:
•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 traditional maize.
•As for parental MON 810 maize, NK603 × MON 810 maize poses negligible risk for adverse environmental effects through its interaction with target organisms. 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, 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 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 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) 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 maize 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 maize crop and that of its receiving environment.
In case any adverse environmental effects, linked to the deliberate release of NK603 × MON 810 maize, 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
15/02/2005 00:00:00
Remarks:
Consents given by the competent authorities of these Autonomous Communities:
- Castilla-La Mancha: 15/02/2005
- Extremadura: Denied
- Andalucía: Denied
- Navarra: 22/02/2005
- Aragón:21/03/2005