Genetic Engineering Safety Ordinance (GenTSV) new since 07.06.2019

At its meeting on June 7, 2019, the Federal Council largely approved the amendments to the GenTSV. The numerous changes had been requested by the committees and the State of Hesse.

In particular, the changes focused on the first-time introduction of regulations on so-called gene drive organisms in German genetic engineering law in Sections 10 and 11 of the Genetic Engineering Ordinance (GenTSV). If released, these organisms have the potential to pass on new traits, along with the blueprint for the genetic modification mechanism, to all offspring. The release of gene drive organisms therefore carries the risk of irreversibly altering or eradicating entire populations of plants and animals.

For this reason, gene drive organisms require special regulations for risk assessment and safety classification, as well as for protective measures for the affected organisms. For this purpose, gene drive organisms are assigned to safety level 3 (amended Sections 10 (5) Sentence 1 and 11 (6) Sentence 1 of the Genetic Engineering Ordinance). A downgrade to safety level 2 is possible through a correspondingly inserted exception and is at the discretion of the genetic engineering authority. This high safety classification is intended, in particular, to reliably prevent—and not just minimize—unintentional and improper release of gene drive organisms from genetic engineering facilities.

In this context, both the committees and the Federal Council advocate obtaining an opinion from the ZKBS on the safety classification of the planned genetic engineering work and on the necessary safety measures in each of the authorisation procedures required under Sections 10 and 11 of the GenTSV.

Section 12 (1) of the Genetic Engineering Ordinance (GenTSV) also requires genetic engineering work to be classified at safety level 3 for the production of highly potent toxins. An exception to the lower classification also exists here under Section 12 (3) in conjunction with Section 7 (1) of the Genetic Engineering Ordinance.

Contrary to the Federal Government's original draft regulation, the Genetic Engineering Authority is not obligated on an equal footing with the operator of the genetic engineering facility to implement practical measures in the event of a hazard during the operation of the facility. The Federal Council and its committees believe that the Genetic Engineering Authority lacks the necessary capacity to fulfill such an equal obligation. It is legally, personnel-wise, organizationally, and materially unable to do so. Furthermore, there is no sufficient reason for such an extension of liability.

Analogous to the provisions of the Radiation Protection Act, the future regulation of Section 28 Paragraph 3 GenTSV requires all project managers to participate in suitable training measures at appropriate intervals and to provide appropriate proof of participation.

The committees had previously supported changes to the fine provision in Section 33 of the Genetic Engineering Ordinance (GenTSV), which the Federal Council ultimately rejected. Finally, the Federal Council called on the Federal Government, particularly with regard to the legal standards for gene drive organisms, to go beyond the provisions now established in the new GenTSV and, while taking the precautionary principle into account, give particular emphasis to the protected interests of Section 1, Number 1 of the Genetic Engineering Act (GenTG), and in particular to nature conservation, in the future design of the requirements for the risk assessment and safety classification of gene drive organisms.