Deliberate release into the E.U.
environment of GMOs for any other purposes than placing on the
market:
Trial program for the testing of 1507
genetically modified maize varieties resistant to certain
Lepidopteran insects and tolerant to glufosinate-ammonium
herbicide - Hungary - Pioneer Hi-Bred Hungary Ltd. |
Date of publication: February 16,
2005
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification
report
General information
Notification Number:
B/HU/05/01/1
Member State: Hungary
Date of Acknowledgement: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 From: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
4 - 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
1. Complete name of the
recipient or parental plant(s)
|
Common Name
|
Family Name
|
Genus |
Species
|
Subspecies
|
Cultivar/breeding line
|
| maize
|
poaceae |
zea
|
zea
mays |
mays
|
experimental 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;
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 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. |
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