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Notification report


General information

Notification Number
B/HU/04/12

Member State to which the notification was sent
Hungary

Date of acknowledgement from the Member State Competent Authority
13/12/2004

Title of the Project
Field trial program of genetically modified corn hybrids containing resistance to certain Coleopteran and Lepidopteran insects and tolerance to two herbicides.

Proposed period of release:
01/04/2005 to 31/10/2008

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


3. Is the same GMPt release planned elsewhere in the Community?
No

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 maysmaysexperimental hybrid 1507x59122xNK603

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
These corn lines are described as follows: the first corn line - a conventional cross of two genetically modified maize lines (event DAS-01507-1 and event DAS-59122-7) resistant to certain Coleopteran and Lepidopteran insects and tolerant to glufosinate-ammonium herbicide (by the introduction of cry34Ab1, cry35Ab1, cry1F and pat genes) (event 1507x59122); the second corn line – a genetically modified maize line (event NK603) which is tolerant to glyphosate herbicides (by the introduction of cp4 epsps gene)(event NK603).These events are conventionally crossed together (hybrid event 1507x59122xNK603).

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 corn hybrid 1507x59122xNK603 obtained by traditional crossing of two genetically modified corn lines, 1507x59122 and NK603 contains

o the cry1F gene isolated from Bacillus thuringiensis for resistance to certain Lepidopteran insects,
o the cry34/35Ab1 gene isolated from Bacillus thuringiensis for resistance to certain Coleopteran insects,
o the pat gene from Streptomyces viridochromogenes for tolerance to glufosinate ammonium herbicide,
o the cp4epsps gene from Agrobacterium tumefaciens for tolerance to glyphosate herbicide.


6. Brief description of the method used for the genetic modification:
No new genetic modification has been implemented in the production of 1507 (x) NK603 (x) 59122 maize, since it was produced through a series of traditional breeding crosses between DAS-59122-7, DAS-01507-1, and NK603 maize.

DAS-01507-1 maize was obtained by insertion of an insert which contains the cry1F and pat coding into maize cells using the particle acceleration method.
NK603 maize has been genetically modified to express cp4 epsps gene.
DAS-59122-7 maize was genetically modified using the Agrobacterium mediated transformation method. The insert contains cry34Ab1, cry35Ab1 and pat genes.


7. If the recipient or parental plant is a forest tree species, describe ways and extent of dissemination and specific factors affecting dissemination:
-

Experimental Release

1. Purpose of the release:
The purpose of the trials is to collect data on the efficacy in controlling certain lepidopteran and coleopteran insect pests and on the expression of the proteins produced, in comparison with the non-genetically modified equivalent hybrid.

2. Geographical location of the site:
Locations in year 2005:
Biatorbágy; 01063
Herceghalom; 0293
Gyula; K0505/16-18
Szolnok; 0651/1

In the following 4 years, 4 field trials/year considered.


3. Size of the site (m2):
Each of the 4 sites for 2005 will have 400 m2 sown with the particular genetically modified plants concerned by this application; the total surface area taken up by this trial (all varieties and borders) is about 1000 m².

In the following 4 years, 4 field trials/year considered, approximately 6400 m² of the particular genetically modified plants will be drilled all together.


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:
-

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
(1) Potential environment effect arising from the release of GM organisms, if it differs from the similar release or distribution of the recipient or parental organism:
The possibility that the genetically modified plants become more persistent than parent or recipient plants in an agricultural area or more invasive in a natural habitat is low as maize is not persistent in an agricultural area and the tested transformation does not change this characteristic. There are no sexually compatible species for maize as far as maize is concerned in Europe therefore selective advantages or disadvantages conferred to other sexually compatible plant species, that could result from the transfer of genetic material of the genetically modified plant, are not possible.
Environmental effect of the GMHP and the target organisms, if it differs from the one of the recipient / parental organism(s)
The only target organisms of this genetically modified plant are certain Coleopteran and Lepidopteran insects sensitive to Bacillus thuringiensis protein. The only possible impact, with a very low probability, is that the target Coleopteran and Lepidopteran develop a resistance to either the Cry34/35 or Cry1F protein. If this happened, there would not be any developmental advantage gained by these insects, the only inconvenience would be that the genetically modified plants would not be effective against these Coleopteran or Lepidopteran pests.
In the light of current knowledge and existing experience with Bt maize products, a detailed proposal for an insect resistance management (IRM) strategy will be developed in the context of product stewardship when the GM maize is placed on the market.


(2) Potential environmental effect of the potential interactions with non-target organisms, if it differs from the one of the recipient / parental organism(s):

a) Effect on the biodiversity on the area of application:
The GM plants have no invasive potential and no wild relative. So no potential effects are expected on the plant environment.

b) Effect on the biodiversity on other natural environment:
The GM plants have no invasive potential and no wild relatives. So no potential effects are expected on the plant environment.

c) Effect of the pollinatants:
The proteins produced by the GM plants have not shown any animal toxicity except for the target insects.

d) Effect on the endangered animals:
The proteins produced by the GM plants have not shown any animal toxicity except for the target insects.


Brief description of any measures taken for the management of risks:
(1) Distance from other sexually compatible plant species, both wild relatives and cultivated crops:
There are no sexually compatible wild relative species likely to cross with corn in Europe. One of the following measures are planned by the notifier to aviod outcrossing with cultivated maize varieties: tassel bagging, detasseling or distance in excess of 500m.

(2) Any measures to minimize or prevent the dissemination of pollen or seeds:
The shedding of pollen from the genetically modified plants is planned to be controlled by bagging before the pollen shed, the plants which will not been self-pollinated will be detassled or a distance of 500 m will be used.
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, a few seeds will need to be collected for analysis. This will be done by sampling the whole ear and destroying the remaining ear and unused seeds.

(3) Specific instructions relating to storage and handling:
It is important to store and handle research seed apart from other seed to eliminate possibilities of potential contamination. Packages of seed must be labelled properly to avoid mixing. During storage seed should be kept in a secure environment to avoid potential contamination, theft or vandalism. For shipping double containment of primary package (i.e. primary, secondary, tertiary) is required to ensure the containment of seed should a shipping container be compromised.

(4)Description of post-release treatment methods for the site:
At the end of the release all remaining plant material that has not been harvested for analyses are planned to be destroyed by chopping and incorporating into the soil.
Volunteer maize will be monitored. During the fallow winter period, an adapted herbicide treatment (other than glufosinate-ammonium and glyphosate herbicides) will be made in order to ensure destruction.

(5) Description of post-release treatment methods for the genetically modified plant material including wastes:
Waste from genetically-modified plants produced by the release are planned to be destroyed by incorporation into the soil.

(6) Description of monitoring plans and techniques:
The sites will be visited regularly for agronomic and experimentation needs and for protection. These visits will also enable plant development and the non-dispersal of material to be monitored.

(7) Description of any emergency plans:
The regular monitoring of the trials will enable immediate identification of any unwanted event or development.
In case of an emergency the trial could be destructively stopped by application of an herbicide other than glufosinate and glyphosate or by mechanical destruction and incorporation into the soil.
Pollen flow from the genetically modified plants will be controlled, prior to pollen shed, by tassel bagging or detasselling. 500 m isolation distance from other corn fields.

(8) Measures to be taken in the case of an unintentional release or wrong use:
It is important to notify the proper authorities of misuse or loss of containment. Such cases will be addressed as soon as possible from knowledge of the incident. Areas in question will be remediated through immediate containment of spilt grain or destruction of the offending plants as necessary.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
The notifier does not plan to carry out field trials concerning the environmental and human health impacts of the GM maize.

Final report
-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known