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Notification report


General information

Notification Number
B/ES/05/06-CON

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
21/01/2005

Title of the Project
Official trials for registration of maize varieties resistant to certain Lepidopteran insect pests.

Proposed period of release:
01/04/2005 to 30/11/2005

Name of the Institute(s) or Company(ies)
Dow AgroSciences, ;


3. Is the same GMPt release planned elsewhere in the Community?
Not known

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 maysmays

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
The cry1F(synpro) and pat genes were inserted into the maize genome to express the Cry1F and PAT proteins, aiming at conferring resistance to certain lepidopteran insect pests and tolerance to glufosinate ammonium herbicide into the maize plants.

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:
The genetic material in PHI8999A intended to be inserted into the maize genome contains a synthetic version of the cry1F and pat genes, along with the regulatory signals required for the transcription and the expression of these genes into the plant tissues.

The cry1F gene (1818 bp. Origin Bacillus thuringiensis subs. aizawai) is driven by the UbiZm1 promoter (1986 bp, origin zea maiz) followed by the transcription terminator sequence ORF25 PolyA (714 bp, origin Agrobacterium tumefasciens pTi15995). The function of the Cry1F protein in 1507 maize is to confer resistance against some lepidopteran insect pests including Sesamia spp.

The pat gene (552 bp; origin: Streptomyces viridochromogenes strain Tü494) is under the control of the CaMV35S promoter and terminator (554 y 204 bp, respectively; origin: mosaic cauliflower). The function of the PAT protein is to confer tolerance to maize 1507 against glufosinate ammonium herbicide.

See annex 1: List of genetic elements and brief description of the transformation method (Confidential Business Information)


6. Brief description of the method used for the genetic modification:
The genes were introduced into the maize genome by using the particle bombardment technique with the linear fragment containing the genes cry1F and pat genes along with the regulatory sequences for their expression (PHI8999A).

7. If the recipient or parental plant is a forest tree species, describe ways and extent of dissemination and specific factors affecting dissemination:
Not relevant.

Experimental Release

1. Purpose of the release:
The purpose of the release is to determine the field efficacy of the Cry1F and PAT proteins expressed in transgenic maize 1507 against some lepidopteran insect pests under natural infestation conditions. The Cry proteins are known to be very specific against certain lepidopteran insects and no effects on non-target organisms are expected.
No changes on survivability, weediness or dissemination were observed in the field trials performed during the years 2000 and 2001 in the US, Argentina, South Africa and Brazil when compared with conventional maize varieties as a consequence of the expression of Cry1F or PAT proteins in maize 1507.


2. Geographical location of the site:
Aragón:Zaragoza (2 locations), Luceni (Zaragoza),Lalueza (Huesca)
Castilla La Mancha: Oropesa (Toledo) (1 location)
Castilla León: Fuentesauco (Zaragoza) (1 location)
Andalucía: La Puebla del Rio (Sevilla) (1 location)
Cataluña: Bell-Lloc (Lleida) (1 location)
Navarra: Milagro(1 location)


3. Size of the site (m2):
Aragón: 6600 m2
Castilla la Mancha: 1500 m2
Castilla León: 3000 m2
Andalucía : 1500 m2
Cataluña: 1500 m2
Navarra: 2054 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:
During the field trials performed in the US, Argentina, Brazil, South Africa, no particular characteristics that could have a negative impact on the environment or human health were observed. Moreover, no significant differences between the maize 1507 and the conventional maize plants were detected.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
No maize sexual compatible species have been found in Spain. Additionally, the field trials will be isolated from any other maize field by at least 60 m. Maize has a long history of safe use and been extensively domesticated by humans. The genes introduced into the maize 1507, cry1F and pat have a very specific mode of action, the first one conferring resistance to some lepidopteran insect pests and the latter conferring tolerance to the ammonium glufosinate herbicide. With the adoption of this technology the insecticide will be localised within the transgenic plants, reducing the environmental impact to surrounding areas and the farmers will reduce fuel costs and soil compaction through a substantial reduction in the numbers of applications required to control insect pests.

Brief description of any measures taken for the management of risks:
The trials are going to be isolated from any other maize plot by a minimum distance of 60m. A non-GMO maize 4 row border will be planted and subsequently destroyed at the end of the experiment. Strict biosafety practices will be implemented according to the Junta de …. guidelines. The following year a different crop will be planted in these lots to facilitate the detection and destruction of any volunteer plant. All the plant products from these trials will be manually or chemically destroyed. Trained people will carry on the experiment and follow up closely. Regular monitoring visits will be implemented during the growing season to evaluate the performance and looking for any unintended effects and in the following season to control volunteers

Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
These field trials are implemented to assess the efficacy of the Cry1F protein expressed in maize 1507 against certain lepidopteran insect pests and the and PAT protein conferring tolerance against glufosinate ammonium herbicide. According to the results obtained in the trials, the commercial strategy will be drawn.

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
16/05/2005 00:00:00
Remarks: