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Notification report


General information

Notification Number
B/ES/03/38-CON

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
24/04/2003

Title of the Project
Field trials with glyphosate tolerant maize, following a three-year program frame (2002-2004).

Proposed period of release:
04/01/2003 to 30/11/2003

Name of the Institute(s) or Company(ies)
Bayer CropScience, S.L., Pol.Industrial el Plá, parcela 30
46290-Alcacer (Valencia) España;


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:
Tolerance to glyphosate herbicide

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 elements present in the plasmid restriction fragment used for transformation
(Confidential data are presented in an annex)
- 5' region of the rice actin 1 gene containing both the promoter and the first intron;
- Optimised transit peptide based on transit peptide sequences from maize and sunflower ribulose-1,5-bis phosphate carboxylase oxygenase (RuBisCo) genes;
- Modified EPSPS gene from maize, coding sequence of the Enolpyruvyl-Shikimate-3-Phosphate Synthase;
- Polyadenylation region from the nopalin synthase gene from A. Tumefaciens


6. Brief description of the method used for the genetic modification:
Microprojectile bombardment was used to deliver the plasmid restriction fragment used for transformation.

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 this study is to prepare genetic material (grains and vegetative parts) for:
1- Agronomic studies
2- Production of maize for compositional studies
3- Production of maize for food processing studies
4- Production of maize for poultry feeding studies
5- Production of maize for mammals feeding studies


2. Geographical location of the site:
For 2003 : 5 locations in Spain
Aragon: 2 locations
Castilla y Leon: 3 locations


3. Size of the site (m2):
For 2003: 5 locations in Spain
Aragon: 2 locations: 1 big location, with a total area = 47 000 m2 approx. and a GMO area = 24 510 m2, and 1 other locations, with a total area = 1824 m2 and a GMO area = 288 m2.
Castilla y Leon: 3 locations, with a total area = 1824 m2 and a GMO area = 288 m2 for each location


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:
Previous releases were carried out using plants derived from event H177 in 2002 under authorisation B/ES/02/01.
Official reports related to this campaign was sent to the Spanish authorities.
The material from the field trials was used only for experimental purposes or destroyed. As a consequence no human consumption occurred from these releases.
Trials located in the region of Zaragoza suffered from a hailstorm before flowering time. No impact on the environment was observed but the trials could no longer be used to generate reliable data. As a consequence, those trials were destroyed according to pre-established crop destruction plans. Local and national Spanish authorities were informed in due time allowing both notifier and authorities to correctly handle the destruction related operations.
Insect damage was observed in most of the trials, to both GM and non-GM plants, but in a range common for corn fields. Insecticide applications prevented any deleterious effects to the plants.
No other adverse effects, including no effects on the arthrofauna by the genetically modified maize plants of event H177, were observed.
Conclusion : No impact on either environmental or human health was observed.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Genetically modified maize has the same behaviour as conventional maize except for the characters encoded by the inserted genes.
Due to the measures taken in the trials and the lack of wild relatives of maize in Europe, we consider that gene transfer should not be possible, neither to other species nor to conventional maize.
However if a weed or a volunteer would receive the mEPSPS gene, this would not confer any selective advantage in the absence of glyphosate treatment.
The mEPSPS gene was evaluated by the Scientific Committee on Plants in September 2000. The whole text is available on http://europa.eu.int/comm/food/fs/sc/scp/out77_gmo_en.pdf
The maize GA21 event that contains the same mEPSPS gene is already released in the USA (APHIS Petition 97-099-01p).


Brief description of any measures taken for the management of risks:
The trials will be conducted with an isolation distance of 200 m from any other maize. The field trial sites will be surrounded with at least 4 rows of non-transgenic maize (pollen trap) which will be destroyed after flowering.
The products harvested from the field trials will be used for experimental purposes or destroyed.
Each site will be visited on a regular basis during the trial period.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
The proposed releases for 2003 in Spain under authorisation B/ES/02/01 are primarily planned to obtain material for compositional analyses and for animal feeding studies.
Other than coincidental agronomic and environmental observations, most of the related data will not be generated in field during the cropping season but testing facilities after sampling and analysis. Such a material collection also pertains to the 2002 trials in Spain and to those planned for 2003 in France under B/FR/01-06-02.


Final report
-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
23/05/2003 00:00:00
Remarks:
The competent authority for the consent of these field trials is Aragón.