Draft of a law amending the Genetic Engineering Act in the consultation procedure
Dr. Petra KauchShare
Recall that in March 2015, the European Union amended the Deliberate Release Directive (Directive 2001/18/EC) with the so-called Opt-Out Directive (EU) 2015/412. Since then, the implementation of this directive has been a matter of debate between the federal and state governments in Germany. The federal government has now submitted a draft bill (Drs. 18/10459) to utilize the regulatory framework opened up by the amending directive for restrictions or prohibitions on the cultivation of genetically modified organisms (GMOs) in Germany. A consultation process was conducted for this purpose on January 16, 2017. At the same time, the draft submitted by the federal states (Drs. 18/664) was also the subject of this consultation process. In addition to some editorial changes, the draft initially contains, in Sections 16a-j of the Genetic Engineering Act, the provisions intended to incorporate the opt-out procedure into the Genetic Engineering Act. Genetic engineering facilities are generally not affected by these regulations. However, the legislature has also used the fourth amendment to the Genetic Engineering Act as an opportunity to make changes to Sections 2, 4, 5, and 6 (Principles), Section 9 (Authorization Procedures), and Sections 21 to 28 (Authorizations of the Authority). Genetic engineering facilities will also have to adapt to these changes in detail. Whether these changes will be incorporated into the law in their entirety cannot yet be conclusively assessed. The draft law has been referred back to committee in its entirety.