On June 7, 2019, the Federal Council spoke out in favour of tightening the safety requirements for laboratory experiments with gene drive organisms (GDO) in the Genetic Engineering Safety Ordinance. In addition, it also demands the development of GDO-specific safety measures and calls on the German government to give special weight to nature conservation.

Mosquitoes, flies and mice, but also plants can be modified by a new genetic engineering method called gene drive in such a way that they quickly and comprehensively spread a new trait and in wild populations. Through a special application of the so-called CRISPR-Cas technology, the genetic manipulation itself can be passed on and thus trigger a genetic chain reaction in nature that cannot be controlled in time or space. By releasing such gene drive organisms, entire populations or species in nature are to be genetically modified or even eradicated. Experiments with gene drive organisms in the laboratory involve the risk of experimental animals escaping. Even a few released GDOs could theoretically lead to the extinction of a species in nature.

After an alliance of NGOs (the AbL, BUND, GeN, IG-Saatgut, Testbiotech and Save Our Seeds) drew attention to this danger in an open letter, the federal states responsible for genetic engineering safety became active. At the plenary session of the Federal Council on June 7, 2019, the federal states responsible for the supervision of genetic engineering decided to set a safety level 3 (out of a possible four; the second more serious risk classification) for laboratory experiments with gene drive organisms for precautionary reasons. In an amendment to the Genetic Engineering Safety Ordinance, the federal government included GDOs in the ordinance for the first time and only provided for safety level 2 for laboratory experiments. In addition to this amendment, the federal states appealed to the federal government „to give special weight to the objects of protection under § 1 No. 1 of the Gene Technology Act and in particular to nature conservation in the future design of the specifications for the risk assessment and safety classification of gene drive organisms, over and above the regulations on gene drive organisms laid down in the Ordinance for the Reorganisation of the Law on Safety Levels and Safety Measures for Gene Technology Work in Gene Technology Facilities, taking into account the precautionary principle“.

Following the Federal Council’s decision, the Genetic Engineering Safety Ordinance has become operative and includes gene drive organisms in the regulation of genetic engineering law for the first time.
However, there is also a catch: after the automatic classification of gene drive organisms in safety level 3, the Central Commission carries out a case-by-case assessment for Biological Safety (ZKBS). Based on this assessment, the ZKBS can select a different safety level, including safety level 1, which assumes that the risk to the environment and human health posed by the explored GMOs is negligible and therefore does not require any special safety requirements.

For this reason, the Federal Council’s welcome decision was only the first, urgently required step. Since the Genetic Engineering Safety Ordinance is not yet designed to cover the risks posed by genetically modified organisms to biodiversity and the environment, the ZKBS and the federal states should draw up specific safety measures for this new class of genetically modified organisms as quickly as possible. In addition, the expert position on nature conservation issues within the ZKBS, which has been vacant for years, must now be filled quickly. We can no longer continue to perform safety classification and risk assessment of gene drive organisms without giving special weight to nature conservation.