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Country's Decision or any other Communication
Record information and status
Record ID
109232
Status
Published
Date of creation
2015-10-01 08:36 UTC (german_bch@bvl.bund.de)
Date of last update
2020-08-06 12:36 UTC (german_bch@bvl.bund.de)
Date of publication
2020-08-07 05:47 UTC (nina.opitz@bmel.bund.de)

This document is also available in the following languages:
General information
Country submitting the decision or communication
  • Germany
Competent National Authority(ies) responsible for the decision or communication
Federal Office of Consumer Protection and Food Safety
Mauerstrasse 39-42
Berlin
Germany, 10117
Phone:+49-(0)3018-445-6500
Fax:+49-(0)3018-445-6099
Email:german_bch@bvl.bund.de
Url:http://www.biosafety-bch.de (english language),BVL Homepage (English)
Title / Reference number of the decision or communication
6786-01-0200 (adv. 42010.0200); Decision regarding the deliberate release (field trial) of genetically modified barley (Hordeum vulgare L.) pYW210-9-(4001-4360) and pJH271-Beta-Glu-307, issued by the German Competent Authority
Date of the decision
2009-05-04
Is the decision taken prior to entry into force of the Protocol?
No
Jurisdiction
  • Germany
Is this an amendment to a previous decision / communication?
No
Decision or communication details
Subject(s) of the decision
  • Decision on LMOs for intentional introduction into the environment (according Article 10 or domestic regulatory framework)
Was the decision triggered by a request for a transboundary movement of LMOs into the country?
No
Does the decision apply to transboundary movements of LMO(s) into the country?
No
Importer’s or Applicant’s contact details
Justus-Liebig-Universität Gießen
Institut für Phytopathologie und Angewandte Zoologie
Justus-Liebig-Universität Gießen
Heinrich-Buff-Ring 26-32
Gießen, Hessen
Germany, 35392
Phone:+ 49 641 99-37490
Fax:+ 49 641 99-37499
Email:info@hrz.uni-giessen.de,Karl-Heinz.Kogel@agrar.uni-giessen.de,Andreas.Vilcinskas@agrar.uni-giessen.de
Url:http://www.uni-giessen.de/ipaz-alt/home.htm
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions
- If any new information on the cultivated LMOs emerges that might bear any risk for human health, animal health or the environment the national federal authority needs to be informed.

- A sign at the release site needs to indicate that at this site a field trial with genetically barley is conducted which is not approved as food or feed and that removal of plants by unauthorised persons is not permitted. The signs need to be put up in the time from sowing to harvest.

- Fertile plant material of the LMOs or material that is intended for sowing has to be transported and stored in closed and clearly labelled repositories at any time outside the release site. The label needs to distinctively describe the LMO and it needs to be noted that these LMOs and their offspring are unfit for consumption. Especially the loss of seeds needs to be avoided when seeds or seed-bearing components of the genetically modified barley lines are transported.

- Machines that have been in contact with the LMOs have to be cleaned after use on the release site to avoid unintended spread of seeds.

- To repel small mammals the field site has to be surrounded by a fine-meshed fence. Immediately after sowing and also immediately after start of ear emergence, a bird net has to be spanned over the barley to avoid feeding by birds and carryover.

- An isolation distance of 100 m is to be respected to other barley fields. Prior and during florescence of barley potential crossbreeding partners such as H. jubatum L. (foxtail barley), H. murinum L. (mouse barleye) and its subspecie H. murinum subsp. leporinum Arcang., H. secalinum Schreb. (meadow barley) und H. marinum Huds. (sea barley), Hordelymus europaeus (wood barley), Elymus spec. (wild rye) and cereals have to be removed within a radius of 35 m from the release site.

- Inspection of the release site on unexpected biological traits of the LMO and on disturbance by wildlife has to be accomplished weekly during the experimental release and sufficient risk measures have to be performed. Furthermore, particular attention needs to be given to reciprocal effects between LMO and other organisms - especially herbivores.

- Unused harvested barley seeds have to be inactivated, e.g. by burning. On the release site, remaining plant material needs to be devitalized by a non-selective herbicide and has to be shredded and worked into the soil to allow rotting after harvest. Thereby shelter crops have to be treated the same way as the LMOs. It is possible to dipose fertile plant material of the LMOs in a combustor outside of a laboratory if complete combustion is ensured and if the material is transported to the facility as described above.

- After completion of the field trial and during the next spring a shallow soil working has to be performed on the whole release site (including the sites of shelter crops). If necessary the release site needs to be sprinkled.

- After completion of the field trial an inspection of the release site for transgenic barley volunteers, their removal before florescence and disposal has to be accomplished every two weeks for one year. The inspection period has to be extended for another year if barley volunteers were observed.

- Localisation of the release site has to be ensured during inspection time.
Reasons
To comply with requirements of Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act): reduce possibility of GMO spread/establishment.
Does the decision involve field trials?
Yes
Does the decision involve commercial release?
No
LMO identification
Barley modified for increased fungal resistance
Justus-Liebig-Universität Gießen Resistance to diseases and pests - Fungi Resistance to herbicides - Glufosinate
Barley modified for increased (1,3-1,4)-β-glucan degradation
Justus-Liebig-Universität Gießen Changes in quality and/or metabolite content - Carbohydrates Resistance to herbicides - Glufosinate Selectable marker genes and reporter genes
Risk assessment
6786-01-0200 (adv. 42010.0200); Summary of the risk assessment of a deliberate release (field trial) of genetically modified barley (Hordeum vulgare L.) pYW210-9-(4001-4360) and pJH271-Beta-Glu-307, issued by the German Competent Authority
Barley modified for increased fungal resistance
Justus-Liebig-Universität Gießen

Resistance to diseases and pests - Fungi
Resistance to herbicides - Glufosinate
Barley modified for increased (1,3-1,4)-β-glucan degradation
Justus-Liebig-Universität Gießen

Changes in quality and/or metabolite content - Carbohydrates
Resistance to herbicides - Glufosinate
Selectable marker genes and reporter genes