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

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.

To comply with requirements of Directive 90/220/EEC, Gentechnikgesetz (German Gene Technology Act): reduce possibility of GMO spread/establishment.

-   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, for details refer to the German LMO/GMO location register ( https://apps2.bvl.bund.de/stareg_web/localeSwitch.do?language=en&page=/showflaechen.do?)
-  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.