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Notification report


General information

Notification Number
B/HU/05/01/1

Member State to which the notification was sent
Hungary

Date of acknowledgement from the Member State Competent Authority
01/02/2005

Title of the Project
Trial program for the testing of 1507 genetically modified maize varieties resistant to certain Lepidopteran insects and tolerant to glufosinate-ammonium herbicide

Proposed period of release:
01/04/2005 to 31/12/2008

Name of the Institute(s) or Company(ies)
Pioneer Hi-Bred Hungary Ltd., ;


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

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

If yes, notification number(s):
B/FR/05/01/02;

Genetically modified plant

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

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
New genes were introduced into the genetically modified maize plants so that they can fight against the damages caused by Lepidopteran insect pests and tolerate application of glufosinate-ammonium 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:
The 1507 maize has been modified by the insertion of the cry1F and pat genes. The cry1F gene, isolated from Bacillus thuringiensis var. aizawai, confers resistance to certain Lepidopteran insects at the larval stage of growth by producing the Cry1F insecticidal protein. The pat gene, isolated from Streptomyces viridochromogenes, confers tolerance to glufosinate-ammonium herbicide by producing the phosphinothricin acetyltransferase (PAT) protein.

6. Brief description of the method used for the genetic modification:
The particle acceleration method using a gene gun was used to introduce the cry1F and pat coding sequences and the necessary regulatory components into maize cells resulting in maize event 1507.

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 purpose of the release is to evaluate genetically modified maize varieties tolerant to glyphosate herbicide. Two types of trials are planned:

o trials to collect data on the agronomic value and insect resistance of the transgenic maize,

o trials in view of registration (VCU - Value for Cultivation and Use and DUS - Distinctness, Uniformity, Stability) of the transgenic hybrids on the National List of Hungary.


2. Geographical location of the site:
Pioneer Hi-Bred Magyarország Kft. is going to set in the trials in two counties in two locations. The trials will be in county Fejér and Pest.

County fejér:
- Enying, Agrár Rt. B-2 tábla
County Pest:
- Sóskút, Sóskút Fruct Gyümölcstermelo Kft., hrsz. 0106


3. Size of the site (m2):
Each of the 2 sites for 2005 will have 110 m2 sown with the genetically modified plants concerned by this application, the total surface area taken up by this trial (all varieties and borders included) is about 800 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:
The placing on the US market of 1507 maize has been authorized in October 2001 by the American regulatory administrations and 1507 maize has been commercialized in the USA under the trade name Herculex I Insect Protection.
A dossier for importing 1507 maize in Europe was submitted to the Competent Authority in the Netherlands in 2000 (Notification C/NL/00/10). In 2001, a novel food notification was also submitted to the Netherlands and the cultivation dossier of 1507 maize was submitted to Spain (Notification C/ES/01/01).
Many field trials with 1507 maize have been carried out in Europe since 1998.
To the notifier' s knowledge, no harmful effects on human health and the environment have been reported. Moreover, the harvest will not enter the food chain so there will be no effect on humans.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
An environmental risk assessment has been carried out by the notifier in accordance with Annex II of Directive 2001/18/EC.
The e.r.a. has not identified any risks to human and animal health or the environment from the deliberate release of 1507 maize.
The e.r.a. is based on the information contained in the notification and the following concluding remarks:
- There is negligible likelihood for 1507 maize to become environmentally persistent or invasive giving rise to any weediness;
- Expression of Cry1F and PAT proteins in 1507 does not confer any selective advantage outside the agricultural environment;
- There are no wild relatives of maize in the EU and the genetic modification in 1507 maize does not introduce any selective advantages to maize plants outside heavily managed agricultural environments;
- The deliberate release of 1507 maize will result in negligible immediate and/or delayed environmental impact resulting from direct and indirect interactions of 1507 maize with non-target organisms;
- The genetic modification in 1507 maize does not introduce any new compounds known to cause, or expected to cause, any potential immediate and/or delayed effects on human health;
- The genetic modification in 1507 maize does not introduce any new compounds known to cause, or expected to cause, any possible immediate and/or delayed effects on animal health. Moreover, 1507 maize will not enter the feed/food chain;
- The genetic modification in 1507 maize will not cause any possible immediate and/or delayed effects on biogeochemical processes;
- The specific cultivation, management and harvesting techniques used for the 1507 maize are identical to those used for non-genetically modified maize.
- The potential reduction of the control of certain lepidopteran insect pests if the target insect pests develop resistance to Cry1F protein as expressed in 1507 maize has been identified as the only potential risk resulting from the interaction of 1507 maize with target organisms. In the case of the trials, the likelihood of the occurrence of this potential identified adverse effect is negligible. The risk posed by the target-insect resistance development is thus negligible.
However, an IRM strategy will be proposed in the context of product stewardship for the market release of 1507 maize.


Brief description of any measures taken for the management of risks:
A 200 meter-isolation distance will be maintained between the transgenic tested varieties and any other commercial maize crop. In addition, the trial site will be surrounded by 4 border rows of conventional maize of a similar relative maturity that will be also destroyed at the end of the release.
Seed dispersal of individual kernels does not occur. They are fixed on a cob and enclosed in many husks that protect the seeds from outside contact.
For this trial, kernels might be collected for analysis needs. This will be done by sampling the whole ear and destroying the remaining ear and unused kernels.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Not applicable to this release.

Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Not known