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Notification report


General information

Notification Number
B/PL/05/02-01

Member State to which the notification was sent
Poland

Date of acknowledgement from the Member State Competent Authority
27/01/2005

Title of the Project
Trialing of 1507 maize varieties.

Proposed period of release:
01/04/2005 to 30/11/2007

Name of the Institute(s) or Company(ies)
Pioneer Hi-Bred Services GmbH, Przedstawicielstwo w Polsce
Swadzim, ul. Poznanska 16
62-080 Tarnowo Podg├│rne;


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 maysmaysF1 hybrids of X0842K HX1,LL line

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
The introduced genes are the cry1F gene from Bacillus thuringiensis var. aizawai, providing resistance to certain Lepidopteran insects and the pat gene from Streptomyces viridochromogenes providing glufosinate-ammonium herbicide tolerance.

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:
ubiZM1(2), Size in bp 1986, ubiquitin promoter (plus 5' untranslated region) from Zea mays (Christensen et al., 1992, PMB 18: 675-689).
cry1F, Size in bp 1818 synthetic version of truncated cry1F from Bacillus thuringiensis var. aizawai (plant-optimized) (Chambers et al., 1991).
ORF25PolyA, Size in bp 714, Terminator from Agrobacterium tumefaciens extrachromosomal plasmid pTi15955 (Barker et al., 1983).
CaMV 35S, Size in bp 554, 35S terminator from Cauliflower Mosaic Virus
pat 552 synthetic glufosinate-ammonium tolerance gene, based on a phosphinothricin acetyltransferase gene sequence from Streptomyces viridochromogenes (Eckes et al., 1989).
CaMV 35S, Size in bp 204, 35S terminator from Cauliflower Mosaic Virus (Pietrzak M. et al. (1986) Nucleic Acids Res. 14, 5857-5868).


6. Brief description of the method used for the genetic modification:
The genetic modification has been done by the particle acceleration method using a "gene gun" to introduce into maize cells, a linear DNA fragment containing the two genes along with their regulatory components necessary for expression.

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 goal of this release is the testing of hybrids in view of registration on the National List.

2. Geographical location of the site:
Voivodeship: dolnoslaskie, slaskie, wielkopolskie, wielkopolskie, malopolskie (west, south-west and south part of Poland)

3. Size of the site (m2):
Size of each 5 testing sites will include ca. 600 m2 and another ca. 400 m2 of souranding buffer zone. 1507 maize plots will cover 96 m2 at each of 5 locations.

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:
Since 1996 many field trials have already been conducted in several locations with this genetically modified maize and no environmental problems were reported for these trials. The transgenic plants behaved as conventional maize. They were indistinguishable from the non-genetically modified maize plants except for being insect resistant and herbicide tolerant, traits due to the genetic modification.
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 in 2000 (notification C/NL/00/10). In 2001, a novel food notification as well as a notification for the cultivation of 1507 maize (notification C/ES/01/01) were submitted.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
The e.r.a. has not identified any risks to human and animal health or the environment from the deliberate release of the genetically modified maize containing resistance to certain Lepidopteran insects and tolerance to glufosinate-ammonium. This is based on the information contained in the notification and the following concluding remarks:

- There is negligible likelihood for genetically modified maize to become environmentally persistent or invasive giving rise to any weediness;

- Expression of the insecticidal crystal protein and the herbicide tolerance protein 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 maize does not introduce any selective advantages to maize plants outside the heavily managed agricultural environments;

- The deliberate release of genetically modified maize will result in negligible immediate and/or delayed environmental impact resulting from direct and indirect interactions of genetically modified maize with non-target organisms;

- The genetic modification in 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 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, the genetically modified maize obtained from these field releases will not enter the feed/food chain.

- The genetic modification will not cause any possible immediate and/or delayed effects on biogeochemical processes.

- The specific cultivation, management and harvesting techniques used for the genetically modified maize are identical to those used for other non-genetically modified maize.

- The potential reduction of the control of certain lepidopteran insect pests if the target insect pests develop resistance to the protein as expressed in genetically modified maize has been identified as the only potential risk resulting from the interaction of genetically modified maize with target organisms. Given the size of this deliberate release, the probability of occurrence of such a phenomenon is negligible. However, an insect resistance management (IRM) strategy will be developed in the context of product stewardship when this genetically modified maize is placed on the European market.


Brief description of any measures taken for the management of risks:
The shedding of pollen from the genetically modified plants will be controlled by maintaining a 200-meter isolation distance with any commercial maize crop. Seed dispersal of individual kernels does not generally occur. They are fixed on a cob and enclosed in many husks that protect the seeds from outside contact. When a few seeds need to be collected for analysis; this will be done by sampling the whole ear and unused seeds will be destroyed.
In case of any emergency, the trial could be stopped by application of a non-selective herbicide other than glufosinate or by mechanical destruction and incorporation into the soil.
At the end of the release all remaining plant matter that has not been harvested for analyses will be destroyed by chopping and incorporating into the soil.


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:
Yes
04/08/2005 00:00:00
Remarks: