The so-called revisions

The legal basis for monitoring is relatively rudimentary. The starting point is Section 25, Paragraph 1 of the Genetic Engineering Act (GenTG). According to this, the competent authorities must monitor the implementation of this law, the legal regulations issued pursuant to this law, the directly applicable legal acts of the European Communities and the European Union within the scope of this law, and the official orders and rulings based thereon. The obligated parties (Section 25, Paragraph 2 of the GenTG) and the authorities' powers (Section 25, Paragraph 3, Paragraphs 6 and 7 of the GenTG) are then regulated below. Further regulations on how such monitoring is to be carried out can be found neither in the GenTSV nor in the GenTVfV. The GenTSV merely regulates the safety requirements for genetic engineering work in genetic engineering facilities. The GenTVfV regulates the approval procedures and possible rights and obligations of the authorities in the approval procedures. The authorities' website, LAG-Gentechnik.de, also contains no further details regarding the revision. If necessary, reference can be made to Section 52 of the Federal Immission Control Act (BImSchG) and its interpretation for the monitoring of installations requiring emission control.

Overall, a system inspection cycle has developed that ranges from one to three years, depending on the system's security level. The following are monitored in particular:

• the operator’s obligations when operating genetic engineering facilities
• the project manager’s duties in managing genetic engineering work
• the implementation of the approval and order notices of the authority
• the safety equipment of genetic engineering facilities
• the risk assessment of genetic engineering work
• the identity of the genetically modified organisms and
• the records.

Typically, a report is prepared on the inspection. This inspection report is usually made available to the operator, the project manager, and the Federal Office for Biotechnology (BBS). Genetic engineering law does not specify a deadline for the completion of this inspection report. Nevertheless, the inspection report should be prepared and submitted promptly so that those responsible within the facility can address it and make any necessary changes.

This publication can also be found on the website of the law firm Dr. Kauch .