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Risk Assessment
Record information and status
Record ID
Date of creation
2015-10-21 11:51 UTC (german_bch@bvl.bund.de)
Date of last update
2020-08-06 12:45 UTC (german_bch@bvl.bund.de)
Date of publication
2020-08-07 05:48 UTC (nina.opitz@bmel.bund.de)

This document is also available in the following languages:
General Information
  • Germany
Title of 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
Date of the risk assessment
Competent National Authority(ies) responsible for the risk assessment
Federal Office of Consumer Protection and Food Safety
Mauerstrasse 39-42
Germany, 10117
Url:http://www.biosafety-bch.de (english language),BVL Homepage (English)
Risk assessment details
Methodology and points to consider
Potential adverse effects identified in the risk assessment
The execution of this field trial is not expected to have a negative impact on human or animal health, or on the environment.
Estimation of the overall risk
Adverse effects on human or animal health or on the environment are not expected.
Receiving environment(s) considered
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?)
LMO detection and identification methods proposed
construct-specific PCR-based method
Additional Information
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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