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Risk Assessment generated by a regulatory process (RA)
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BCH-RA-DE-109236-3   |   PDF   |   Print   |  
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published: 21 Oct 2015 last updated: 06 Aug 2020
General Information
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
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25 May 2012
Risk assessment details
  • Tobacco modified for antibiotic resistance and GFP expression
    | University of Rostock | Resistance to antibiotics (Streptomycin), Selectable marker genes and reporter genes
Methodology and points to consider
The execution of this field trial is not expected to have a negative impact on human or animal health, or on the environment.
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Adverse effects on human or animal health or on the environment are not expected.
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Two field sites in Germany, for details refer to the German LMO/GMO location register (http://apps2.bvl.bund.de/stareg_web/localeSwitch.do?language=en&page=/showflaechen.do?)
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construct-specific PCR-based method
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Additional information
deliberate release, no placing on the market.

crops are not intended to be used as food or feed.

The LMO carries the introduced genetic modification in the plastids exclusively. Accordingly, it is though that the genetic modification is not transferred to offspring by paternal but solely by maternal inheritance. Within the described field trial it is meant to test whether vertical gene transfer of the genetic modification occurs nevertheless. Therefore, the transplastomic tobacco plants are cultivated together with non-modified, male-sterile plants. The seeds of the non-modified plants will be grown and analyzed for resistance towards streptromycin and spectomycin and for GFP expression. By means of this field trial it is meant to test whether the described system is suitable as a confinement system for the development of LMO. The rate of paternal inheritance of plastids (paternal leakage) and of gene transfer from the plastome to the nuclear genome of the tobacco plants under cultivation conditions - including different climatic and soil conditions – is analyzed.
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Country's Decision or any other Communication Risk assessment 1