Proposed amendments to the GenTG

Since March, Directive (EU) 2015/412 amending the Deliberate Release Directive has been published (see AGCT-Gentechnik.report 03/2015 ). Since then, the federal government and the states have been wrangling over the implementation of this amended directive. What this means for laboratories is still largely unclear. According to initial information, "only those regulations for laboratory areas are to be adapted for which practice has long seen a need." Little has been learned so far about what these regulations are exactly. The legislative proposal from the states of Rhineland-Palatinate, Baden-Württemberg, Lower Saxony, North Rhine-Westphalia, and Schleswig-Holstein, which can be found in Federal Council document 713/15 (here GenTGE denotes a draft version), contains at least one approach.

Essentially, this draft law also deals with the amendment of Sections 16f) ff. of the GenTG, which directly concern the release of genetically modified organisms.

However, five minor changes are also proposed for laboratory operations:

Changes of a more editorial nature have been made with regard to the cooperation of the Commission with the committees (Section 4 (5) Sentence 1 GenTGE) and the carrying out of further genetic engineering work at the instigation of the authority (Section 9 (6) Sentence 2 GenTGE).

The amendment to Section 5, Sentence 1 of the GenTGE represents more than just an editorial change. According to this amendment, the commission's scope of work will in future include not only questions relating to genetic engineering, but also those relating to synthetic nucleic acids. This suggestion is certainly more than appropriate given the ZKBS's proximity to new issues in genetic engineering—in this case, synthetic biology. Furthermore, it reflects an alignment with the BiostoffV (Biomaterials Ordinance), which has also covered synthetic biology since 2013.

The amendment to Section 12, Paragraph 6 of the Genetic Engineering Act (GenTGE) would also be important. Under the current version, the competent authority can make the implementation of notified or registered genetic engineering work subject to conditions, impose time limits, or impose requirements. In the future, conditions should be possible not only regarding the work itself, but also regarding the operation of the notified or registered genetic engineering facility. This expands the scope of conditions to include facility-related aspects and is therefore likely to be of great importance.

We would like to expressly point out that these are proposed amendments by some of the federal states. The extent to which they will be incorporated into a coalition draft or later into parliamentary legislation remains to be seen. Should individual provisions be adopted, we will certainly revisit them once the relevant legal amendments have been made.

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