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Notification report


General information

Notification Number
B/ES/04/19

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 maize for the use in field trials in Spain.
This application is to advance in the evaluation and agronomic characterization of promising hybrid maize varieties derived from transformation event NK603 (which is tolerant to treatment with glyphosate). The NK603 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/00/01 and C/ES/03/01

Genetically modified plant

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

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 (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.

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:
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.


6. Brief description of the method used for the genetic modification:
NK603 parental maize lines 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:
The release of maize varieties derived from transformation event NK603 (which is tolerant to treatment with Roundup herbicide containing glyphosate), has the purpose of advancing in the evaluation and characterization of new maize varieties, for possible variety Registration submission 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 15.000 m2 (1 ha) and the potential surface occupied in every site by NK603 maize will be:

- Maribañez (Los Palacios y Villafranca, Sevilla): 180 m2
- Fuente Palmera (Córdoba): 180 m2
- Almudevar (Huesca): 1.680 m2
- Huerto (Huesca): 1.680 m2
- Estadilla ( Huesca): 1.680 m2
- Torrijos (Toledo): 1.080 m2
- Cisterniga (Valladolid): 600 m2
- Fuentes de Ropel (Zamora): 600 m2
- Guadiana del Caudillo (Badajoz): 1.080 m2
- Buñuel (Navarra): 1.680 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 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:
Analysis of the characteristics of NK603 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 maize, is 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 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 aspects 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 risks of this maize is negligible. Therefore, strategies for risk management for NK603 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 maize crop and the interaction with its receiving environment.
In case any adverse environmental effects, linked to the deliberate release of NK603 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