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Country's Decision or any other Communication
Record information and status
Record ID
103120
Status
Published
Date of creation
2012-02-20 13:52 UTC (german_bch@bvl.bund.de)
Date of last update
2017-05-23 14:48 UTC (german_bch@bvl.bund.de)
Date of publication
2017-07-13 15:43 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
6786-01-0176 (adv. 420101.1076; Decision regarding the deliberate release (field trial) of genetically modified potatoes (Solanum tuberosum, varieties Albatros and Desirée) VP60, PsbY-cyeI, 35SctxBSEK and 35S-nptII issued by the German Competent Authority"
Date of the decision
2005-11-21
Is the decision taken prior to entry into force of the Protocol?
No
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
- Fertile genetically modified plant material has to be stored in closed and clearly labelled repositories for transport and storage at any time outside the release site and laboratory. On the labels it needs to be noted that these potatoes are unfit for consumption. Remaining potato tubers have to be disposed by chopping, squeezing or autoclaving.
- To prevent entering of the release site by wild animals (including rabbits) a fence has to surround the release site.
- Inspection of the release site on unexpected biological traits of the LMO and reciprocal effects between LMO and other organism has to be accomplished weekly during the experimental release and monthly after the experimental release.
- Monthly inspection of the surrounding area [20 m] of the release site for transgenic potato volunteers and their removal and disposal.
- After completion of the field trial the soil needs to be loosen up to uncover remaining potato tubers in the field site which have to be removed and disposed.
- Machines that have been in contact with LMOs have to be cleaned after use.
- After completion of the field trial an inspection of the release site and the surrounding area for transgenic potato volunteers, their documentation and removal and disposal has to be accomplished monthly for one year. if volunteers were observed the inspection period has to be extended for another year. Thereby the release site must not be cultivated with plants impairing the detection of transgenic volunteers.
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
Potato modified for the expression of synthetic VP60 for vaccine production against RHDV
Universität Rostock Production of medical or pharmaceutical compounds (human or animal) - Vaccines Resistance to antibiotics - Kanamycin
Potato producing vaccine against cholera
Universität Rostock Production of medical or pharmaceutical compounds (human or animal) - Vaccines Resistance to antibiotics - Kanamycin
Show detection method(s)
Potato synthesizing cyanophycin biopolymer
Universität Rostock Resistance to antibiotics - Kanamycin Use in industrial applications
Show detection method(s)
Potato resistant to aminoglycoside antibiotics
Universität Rostock Resistance to antibiotics - Kanamycin
Show detection method(s)
Risk assessment
6786-01-0176; Summary of the risk assessment of a deliberate release (field trial) of genetically modified potatos (Solanum tuberosum, varieties Albatros and Desirée) VP60, PsbY-cyeI, 35SctxBSEK and 35S-nptII issued by the German Competent Authority
Potato modified for the expression of synthetic VP60 for vaccine production against RHDV
Universität Rostock

Production of medical or pharmaceutical compounds (human or animal) - Vaccines
Resistance to antibiotics - Kanamycin
Potato resistant to aminoglycoside antibiotics
Universität Rostock

Resistance to antibiotics - Kanamycin
Potato producing vaccine against cholera
Universität Rostock

Production of medical or pharmaceutical compounds (human or animal) - Vaccines
Resistance to antibiotics - Kanamycin
Potato synthesizing cyanophycin biopolymer
Universität Rostock

Resistance to antibiotics - Kanamycin
Use in industrial applications
Additional Information
Additional Information
type of decision: field trial
LMO: VP60, PsbY-cyeI, 35SctxBSEK and 35S-nptII
legal basis: Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act)
scope: test of field performance of LMO
authorization valid within the vegetation periods of the years 2006, 2007 and 2008
locations: One experimental field in Germany; for details see German LMO/GMO location register (http://apps2.bvl.bund.de/stareg_web/showflaechen.do)
size: Including the surrounding area the release site covers 5,378 m² that contain 28 agricultural holdings of 3 x 3.6 m² each. Approximately 5 plants/m² will be planted

- There is a Summary Notification Information Format available on the Internet (WebSNIF) for B/DE/05/176