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Country's Decision or any other Communication
Record information and status
Record ID
109237
Status
Published
Date of creation
2015-10-21 11:52 UTC (german_bch@bvl.bund.de)
Date of last update
2018-01-12 10:29 UTC (german_bch@bvl.bund.de)
Date of publication
2018-01-25 16:11 UTC (ursula.monnerjahn@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
6786-01-0210 (adv. 42010.0210); Decision regarding the deliberate release (field trial) of genetically modified tobacco (Nicotiana tabacum) Nt-pDK53 issued by the German Competent Authority
Date of the decision
2012-05-25
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
Universität Rostock
Agrobiotechnology - Faculty of Agricultural and Environmental Sciences
Justus-von-Liebig-Weg 6

Rostock, Mecklenburg-Vorpommern
Germany, 18059
Phone:+49 381 498 ext 3080
Fax:+49 381 498 ext 3082
Email:dekan.auf@uni-rostock.de
Url:Rostock University,Agrobiotechnology - Rostock University
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions
Some confinement measures:
- If any new information on the cultivated LMO emerges that might bear any risk for human health, animal health or the environment the national federal authority needs to be informed and sufficient risk measures have to be performed.
- Fertile plant material has to be transported and stored in closed and clearly labelled repositories at any time outside the release site and laboratory. The label needs to distinctively describe the LMO. During transport any loss and spillage of seeds shall be avoided.
- Transgenic and non transgenic tobacco plants have to be stored separately.
- Inspection of release site on unexpected biological traits of the LMO and reciprocal effects between LMO and other organisms has to be accomplished weekly during the experimental release and monthly after the experimental release and sufficient risk measures have to be performed.
- All machines in contact with LMO that have been used on the release site have to be thoroughly cleaned on the release site in order to minimize the possibility of unintended loss and spillage of seeds. LMO plant material from cleaned machines and not used LMO material has to be destroyed by heat inactivation on the release site.
- Crossing compatible tobacco plants, which flower within a distance of 100 m to the release sites should be treated as genetically modified tobacco plants.
- After completion of the field trial monthly inspection of release site and surrounding areas (5 m) for transgenic tobacco volunteers, their documentation and removal and disposal has to be accomplished for one year. The inspection period has to be extended for another year if potato volunteers were observed. No plant species must be cultivated on the release site that impairs the detection of transgenic tobacco volunteers.
- A sign indicating "Versuch mit gentechnisch veränderten Tabakpflanzen, die nicht als Lebensmittel oder Futtermittel zugelassen sind. Eine Entnahme durch Unbefugte ist nicht gestattet." (test with genetically modified potatoes, not authorized for use as food and feed, unauthorized removal is not permitted) has to be put up at the release site.

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
Tobacco modified for antibiotic resistance and GFP expression
Universität Rostock Resistance to antibiotics - Streptomycin Selectable marker genes and reporter genes
Risk assessment
6786-01-0210 (adv. 42010.0210); Summary of the risk assessment of a deliberate release (field trial) genetically modified tobacco (Nicotiana tabacum) Nt-pDK53 issued by the German Competent Authority
Tobacco modified for antibiotic resistance and GFP expression
Universität Rostock

Resistance to antibiotics - Streptomycin
Selectable marker genes and reporter genes
Additional Information
Additional Information
type of decision: field trial
LMO: Nt-pDK53
legal basis: Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act)
scope: test of field performance of LMO
authorization valid from 25/05/2012 to 31/12/2016
locations: experimental fields located in 2 different villages in Germany; for details see German LMO/GMO location register ( http://apps2.bvl.bund.de/stareg_web/localeSwitch.do?language=en&page=/showflaechen.do?)
size: max. 3000 m²/site/year; max. 1000 GMO/site/year