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Country's Decision or any other Communication
Record information and status
Record ID
111809
Status
Published
Date of creation
2017-02-03 09:52 UTC (german_bch@bvl.bund.de)
Date of last update
2017-04-18 12:55 UTC (german_bch@bvl.bund.de)
Date of publication
2017-07-13 11:47 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
6786-01-0071 (adv. 42010-0071); Decision regarding the risk assessment of a deliberate release (field trial) of genetically modified sinorhizobia (Sinorhizobium meliloti) L1 and L33, issued by the German Competent Authority
Date of the decision
1997-08-20
Is the decision taken prior to entry into force of the Protocol?
Yes
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
Uni Bielefeld
Universität Bielefeld
Universitätsstraße 25
33615 Bielefeld
Bielefeld
Germany, 33615
Phone:+49 521 106-00
Fax:+49 521 106-5844
Email:post@uni-bielefeld.de
Url:Bielefeld University
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions
Inspection of the release site on inconsistencies has to be conducted at least every second week.
Tools and shoes that were used on the release site and might have had contact with the LMO need to be cleaned on the field site.
The LMO has to be transported and stored in closed and clearly labelled repositories at any time outside the release site and laboratory. The identity of the transgenic material has to be clearly stated on the label.
No potential Sinorhizobium meliloti host plants must be planted 100 m around the field site. Naturally growing host plants in up to 20 m of the field site have to be tested regarding a potential spreading of the LMO. At the end of the vegetation period these potential host plants have to be removed with their root ball and analyzed for root nodules and the presence of LMO in the rhizosphere. If LMO are found, the monitored area has to be increased step wise up to 100 m from the release site.
If a spread of the LMO is detected, new germination of all host plants growing in that area has to be prevented and potentially newly emerging plants need to be removed.
After the field trial the alfalfa hostplants have to be treated to prevent germination in the following year. Eventually emerging alfalfa volunteers have to be removed in the following vegetation period. The titer of transgenic Sinorhizobium meliloti in the soil has to be analyzed for 2 years after the end of the field trial. The control period has to be extended for another year if the titer of transgenic S. meliloti does not decrease in the second year. If, contrary to the expectations, the titer of LMOs is constant or increasing, the authorities need to be informed and sufficient measures have to be taken to eliminate the LMO. If the titer of LMO is decreasing already during the release no measure for the removal have to be taken.
Reasons
To comply with requirements of Directive 90/220/EEC, 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
Sinorhizobium meliloti modified for the expression of a reporter gene
Uni Bielefeld Selectable marker genes and reporter genes
Sinorhizobium meliloti modified for the expression of a reporter gene and reduced growth
Uni Bielefeld Selectable marker genes and reporter genes
Risk assessment
6786-01-0071 (adv. 42010-0071) Summary of the risk assessment of a deliberate release (field trial) of genetically modified sinorhizobia (Sinorhizobium meliloti) L1 and L33, issued by the German Competent Authority
Sinorhizobium meliloti modified for the expression of a reporter gene
Uni Bielefeld

Selectable marker genes and reporter genes
Sinorhizobium meliloti modified for the expression of a reporter gene and reduced growth
Uni Bielefeld

Selectable marker genes and reporter genes
Additional Information
Additional Information
-   S. meliloti need a suitable host plant for proliferatoin. Here, the symbiotic interaction partener alfalfa (Medicago sativa) is used as a host plant.

-  type of decision: field trial
-  LMO: L1 and L33
-  legal basis: Directive 90/220/EEC, Gentechnikgesetz (German Gene Technology Act)
-  scope: test of field performance of LMO
-  authorization valid from 20 August 1997 to 31 December 1997
-  locations: 1 experimental field located in 1 village in Germany.
-  size: 630 m²/site/year;
-  max. 9,1 x 10^13  LMO/site/year

-  There is no Summary Notification Information Format available on the Internet (WebSNIF) for B/DE/97/41 

The decision on this deliberate release was made by the Robert Koch Institute (RKI).
The RKI was the competent national authority for the German Gene Technology Act before the competences were transferred to the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, BVL) on April 1st 2004. Deliberate releases that were authorized by the RKI prior to this date are now handled by the BVL.