Decisions related to genetic engineering operations and contained use facilities
Genetic engineering operations are carried out in facilities for contained use, predominantly in laboratories. The main objective of these activities is research. The containment level of the facilities for contained use corresponds to the hazard potential of the genetically modified organism (GMO). Dependent on the containment level, the installed technical and organisational safety measures minimise or prevent the contact between GMOs and the experimenter as well as the environment.
GMOs in contained use systems
Source: Gloger/BVL
The Federal Office of Consumer Protection and Food Safety (BVL) obtains information from the German Federal States (Bundesländer) on the number of genetic engineering operations and contained use facilities pertaining to the respective containment level. This information can be found here.
The websites of the individual Federal States, along with further information relating to genetic engineering operations and contained use facilities, can be accessed via the website of the “Bund/Länder-Arbeitsgemeinschaft Gentechnik” (LAG). LAG is a standing working group which promotes cooperation and coordination between the Federal States and the Federal Government as well as among the Federal States.
Procedure and opinions
Applications for, approvals for and notifications of genetic engineering operations and contained use facilities are processed by the Federal States in Germany. The respective procedure is determined by the containment level already mentioned (biosafety level 1 to biosafety level 4). For biosafety level 3 or 4 genetic engineering operations and contained use facilities the Central Committee on Biological Safety (ZKBS) has to be asked for an opinion.
The administrative office of the ZKBS is based at the BVL. Position statements of the ZKBS on risk assessments of microorganisms or assessments of safety measures can be accessed via the ZKBS website.
Further information on the procedure leading to the notification or authorisation of a genetic engineering operation or contained use facility can be found on the BVL website.
Notifications to the Biosafety Clearing-House (BCH) Central Portal
The BVL enters some of the position statements of the ZKBS on risk assessments into the databases of the Biosafety Clearing-House (BCH) Central Portal. This contributes to the international exchange of scientific information on GMOs. Entries to the BCH database can be viewed here.