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Country's Decision or any other Communication (DEC)
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BCH-DEC-DE-103569-3   |   PDF   |   Print   |  
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published: 01 Jun 2012 last updated: 31 Jul 2020
Amendment
No
General Information
6786-01-0160 (adv. 42010.0160); Decision regarding the deliberate release (field trial) of genetically modified potatoes (Solanum tuberosum, variety Albatros) pCB301-Kan-MaSpI-100xELP, pCB301-Kan-MaSpII-100xELP and pCB301-Kan-SO1-100xELP, issued by the German Competent Authority
EN
10 May 2005
No
Subject of the decision, notification, communication or declaration
  • Decision on LMOs for intentional introduction into the environment (according to Article 10 or domestic regulatory framework)
LMOs for intentional introduction into the environment
No
No
Yes
No
No
Result of the decision
Approval of the import and/or use of the LMO(s) with conditions
- 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 need to distinctively describe the LMO and it needs to be noted that this potato is unfit for consumption. All remaining fertile plant material has to be destroyed by disruption of the germination capacity.
- The release site needs to be labelled with signs indicating “test plant, unfit for consumption”.
- Inspection of the release site has to be accomplished weekly during the experimental release.
- During cultivation of transgenic potatoes, after appearance of the leaves, all potato lines have to be tested for the presence of the nptII gene by PCR-based methods. In the case of nptII detection the respective plants have to be removed from the release site and disposed.
- During the field trial the formation of fertile seeds has to be prohibiten by collecting blossoms and/or berries from the plants.
- If the release site is threatened by flooding sufficient risk measures have to be performed, e.g. through enclosing the release site with sandbags or through removal of the plants to prevent spreading of fertile plant material outside the release site by moving water.
- After completion of the field trial as well as in the following spring time, the first 20 cm of soil of the release site have to be loosening up; the release site must not be plough. Uncovered potatoes need to be collected manually and disposed by disruption of their germination capacity
- After completion of the field trial a monthly inspection of the release site for transgenic potato volunteers, their documentation and removal and disposal has to be accomplished during the growing season. The inspection period has to be extended for another year if potato volunteers were observed. The release site must not be cultivated with plants impairing the detection of transgenic volunteers. 
EN
To comply with requirements of Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act): reduce possibility of GMO spread/establishment.
EN
LMO identification & risk assessment
  • BCH-LMO-SCBD-100315-5 Living Modified Organism Potato modified to synthesise fusion spider silk/ elastin protein
    Resistance to antibiotics (Kanamycin), Use in industrial applications
  • BCH-LMO-SCBD-103555-2 Living Modified Organism Potato modified for the production of spider silk protein
    Production of medical or pharmaceutical compounds (human or animal), Resistance to antibiotics (Kanamycin), Use in industrial applications
  • BCH-LMO-SCBD-100316-4 Living Modified Organism Potato modified to synthesise fusion spider silk fragment/ elastin protein
    Resistance to antibiotics (Kanamycin), Use in industrial applications
  • BCH-RA-DE-103568-4 Risk Assessment generated by a regulatory process 6786-01-0160 (adv. 42010.0160); Summary of the risk assessment of a deliberate release (field trial) of genetically modified potatoes (Solanum tuberosum, variety Albatros)  transformed with plasmids pCB301-Kan-MaSpI-100xELP, pCB301-Kan-MaSpII-100xELP and pCB301-Kan-SO1-100xELP, issued by the German Competent Authority
    Potato modified to synthesise fusion spider silk/ elastin protein | Potato, SOLTU, Resistance to antibiotics, Use in industrial applications | Potato modified for the production of spider silk protein | Potato, SOLTU, Resistance to antibiotics, Production of medical or pharmaceutical compounds (human or animal), Use in industrial applications | Potato modified to synthesise fusion spider silk fragment/ elastin protein | Potato, SOLTU, Resistance to antibiotics, Use in industrial applications
Document on the decision, communication, notification or declaration
Additional Information
 type of decision: field trial
 LMO: Solanum tuberosum, variety Albatros pCB301-Kan-MaSpI-100xELP, pCB301-Kan-MaSpII-100xELP and pCB301-Kan-SO1-100xELP
 legal basis: Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act)
 scope: test of field performance of LMO
 authorization valid within the vegetation period of 2005
 locations: One experimental field located 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: 2000 m² with max. 2 plants per m²
- Related publications:
Fischer R, Schillberg S, Scheller J, Conrad U (2005) Molecular Farming Plant-Made Pharmaceuticals and Technical Proteins: Production of spider silk proteins in transgenic tobacco and potato, Wiley-VCH Verlag GmbH & Co. KGaA, p 171-181
EN