Genetic engineering work

According to the legal definition, genetic engineering work includes
- the production of genetically modified organisms and
- the propagation, storage, destruction or disposal as well as the internal transport of genetically modified organisms (Section 3 No. 2 GenTG)
The term "genetic engineering work" is problematic because, in the production of GMOs, there is no clear distinction between complete genetic engineering work and a mere experimental step within genetic engineering work. However, this distinction is of considerable importance for the question of whether a work falls under the term "further genetic engineering work" as independent genetic engineering work. If this is the case, a new authorization (notification, registration, or approval) is required. It therefore crucially depends on whether an experiment is considered independent work—and thus subject to its own authorization—or whether it is to be understood as part of a unified genetic engineering work—and thus covered by the initial authorization.
According to the Federal/State Working Group – LAG Genetic Engineering, genetic engineering work encompasses all work steps necessary to achieve a specific goal (project) that is more precisely defined in the individual case. The obligation to undergo a new approval procedure for an experiment as further genetic engineering work therefore depends largely on the prior approval decision. This determines the scope of the activity that is subsequently permitted without a new procedure. Therefore, it is recommended to exercise particular care when describing the experimental goal and the individual experimental steps in order to keep the paperwork to a minimum.

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