Notification report
General information

Genetically modified plant

1. Complete name of the recipient or parental plant(s)

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;

4. In case of insertion of genetic material, give the source and intended function of each constituent fragment of the region to be inserted:
The list of the genetic elements inserted is given in Annex 1 as this is to be considered as Confidential Business Information.

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 the release is the testing of genetically modified maize varieties in view of collecting regulatory data for registration on the National Catalogue.

2. Geographical location of the site:
The release is planned at one location in Spain in 2004:
- Andalucía: La Rinconada (Sevilla)

3. Size of the site (m2):
The trial at the site in 2004 will cover about 514 m² (all varieties and borders included) of which 90 m² will be planted with the transgenic plants concerned by this application.

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:
Pioneer began testing in the fields the genetically modified 1507 maize in late 1996. Since that time, it has been in continuous nurseries (3 plantings per year) in Hawaii and Puerto Rico. Several field trials have been conducted throughout the maize growing region of the United States since 1997 and in Europe since 1998. A marketing release application for cultivation has been filed under C/ES/01/01.
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.

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 (GM) 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, in the future.

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 other 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. For this trial, a few seeds will 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.
Volunteer maize will be monitored during the following year. An herbicide treatment (other than glufosinate) will be used in order to ensure destruction if needed.

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.