Regulation of Gene Drive Organisms in Germany

In Germany, political discussion and regulation of gene drives is still in its infancy. The German government has yet to announce an official position on the evaluation and regulation of gene drive organisms.

Technology Safety Ordinance: Safety Standards for Gene Drive Research
In the summer of 2019, gene drive organisms were mentioned and regulated by German genetic engineering legislation for the first time. The Genetic Engineering Safety Ordinance (GenTSV) lays down safety standards for the handling of GMOs (Genetically Modified Organisms) in research laboratories.

Work with genetically modified organisms is assigned to one of four safety levels, depending on their risk potential for humans, animals and the environment. Safety level 1 applies to work without risk potential, while level 4 applies to work with high risk potential. Depending on the safety level, security measures of varying degrees of stringency must be observed during experiments.

According to the German Genetic Engineering Act (GenTG), the approval of a research project involving GMOs, its classification in a safety level and monitoring of the safety requirements is the responsibility of the state authorities. According to §10 paragraph 7 GenTG, these authorities are obliged to obtain an opinion from the Central Commission for Biological Safety (ZKBS) as a part of this process.

In the absence of uniform regulation by the Genetic Engineering Safety Ordinance, the ZKBS had set a safety level of 2 for work with gene drive systems in the laboratory in 2016, which will remain operative until the new version of the GenTSV comes into force on 01.03.2021.
In the revised genetic engineering safety ordinance, genetic engineering work with GDOs is assigned to safety level 3 as a precaution. This ensures that every research project with gene drives is reported to a supervisory authority and that an individual case-based risk assessment is carried out by the CCSDR before work begins. By amending Article 1, §11, paragraph 6, a further new regulation of the GenTSV stipulates that the CCSDR must also prescribe specific safety requirements for work with GDOs within the scope of its recommendations to the state authority, in order to reliably prevent the escape and reproduction of GDOs in natural populations. Specific requirements for gene drive systems cannot yet be derived from the existing legal criteria, even in the new version of the GenTSV. As part of the approval procedure, the authority can assign projects to different safety integrity levels on the basis of the risk assessment and specific safety standards.

These changes were decided on by the Federal Council in opposition to the proposal of the federal government, which provided for a fundamental classification of gene drives in safety integrity level 2. Environmental protection and agricultural organisations had drawn the attention of the federal states to the fact that such a classification would not do justice to the potential threat gene drives pose to biodiversity.

Positioning of the German Federal States
At its 9th conference in September 2018, the European network of the then 64 GMO-free regions of Europe, including 11 German federal states, adopted the Berlin Declaration, in which it called on national governments and the European Union to stop the release of gene drives in the European Union and to advocate for a moratorium on gene drives at international level, in the context of the CBD and the IUCN.

At the Conference of Agriculture Ministers (AMK) in September 2019, the agriculture ministers of the German federal states called on the federal government to put gene drive organisms back on the agenda of the Conference of the Parties to the UN Convention on Biological Diversity (CBD) and its Biosafety Protocol at COP 15 in China in October 2020 on the occasion of the upcoming six-month EU Council Presidency in the second half of 2020.

Positioning of the Ministry of the Environment
The Ministry of the Environment was critical of the application of gene drive technology in nature. In response to an open letter from environmental and nature conservation associations in the run-up to COP 14, a senior staff member of the ministry replied in September 2018 that the ministry would work to prevent the release of gene drive organisms in Germany and Europe as long as negative effects on the environment could not be excluded. Furthermore, the ministry would work to ensure that the precautionary principle be upheld in international negotiations within the framework of the CBD. It sees a great need for research and adaptation in the environmental risk assessment of gene drive organisms.

Political Process in the German Bundestag/Federal Parliament
The German Bundestag has commissioned its Office of Technology Assessment (TAB) to work on a cross-party basis to answer open ecological, ethical and regulatory questions concerning the risks and options for action as well as alternatives to gene drive technology in a technology assessment by the end of 2021. The report should aide the German Bundestag in settings its position on the topic.

Positioning of German Parties
At the request of an alliance of environmental and agricultural associations in spring 2019, the Social Democratic Party of Germany (SPD), Alliance 90/The Greens (Bündnis90/Die Grünen)and the Left (DIE LINKE) declared their support for an international moratorium on gene drives. The Christian Democratic Union of Germany (CDU/CSU) described this idea as worthy of consideration. The Free Democratic Party and the Alternative for Germany did not take a position on the issue.

Regarding the global Gene Drive Moratorium, the parties write:

CDU/CSU: ‘In the EU there are no applications for field trials with organisms modified by gene drives. There are also no known plans in this direction. Nevertheless, CDU and CSU are in favour of additional regulations or the necessity of a moratorium being examined‘.

SPD: ‘We advocate for an international moratorium on gene-drives because of the lack of knowledge, data and understanding of their potential impact on biodiversity‘.

Bündnis90/Die Grünen: ‘We advocate for a worldwide moratorium on the use of gene drives. This is necessary to comply with the precautionary principle and protect ecosystems.‘

DIE LINKE: ‘DIE LINKE advocates for […] an immediate moratorium against the release of GMOs in general and GMOs with gene drives in particular‘.

Research Project on Risk Assessment and Monitoring of Gene Drives on Behalf of the Federal Agency for Nature Conservation
Risk assessment and monitoring plans for the release of genetically modified organisms into the wild, including gene drive organisms, are based on European Union laws, principles, procedures and regulations. However, implementation, authorisation and monitoring are the responsibility of the EU member states. For this reason, the German Federal Agency for Nature Conservation (BfN), which is responsible for the environmental risk assessment of GMOs in Germany, initiated a research project at the end of 2018 to identify potential risks and fundamental challenges of gene drives before the first field experiments with GDO are carried out.

The research project, which is based at the University of Natural Resources and Applied Life Sciences, Vienna, is intended, among other things, to work out what new challenges gene drive technology poses for risk assessment and how the ecological consequences of gene drives can be recorded and evaluated. To this end, the extent to which gene drives can be confined in space and time and the role that computer-based modelling can play in the assessment of environmental risks will also be examined. In addition, the project will analyse how the monitoring of GMOs prescribed by the EU would need to be adapted for gene drives in order to be able to record and assess their environmental impact after release. Results of the project should be available in spring 2021.