Monitoring according to Section 16 c GenTG as an early warning system

Section 16c GenTG stipulates that operators who place products consisting of or containing genetically modified organisms on the market must continue to monitor them after the approval has been granted in order to determine any potential impacts on protected legal interests. This monitoring obligation applies without exception to the placing of products on the market, but not to releases. The aim of monitoring is to confirm that an assumption regarding the occurrence and effect of any harmful effects of a genetically modified organism or its use in the risk assessment is correct (case-specific monitoring) (No. 1) and to determine the occurrence of harmful effects of genetically modified organisms or their use on human health and the environment that were not foreseen in the risk assessment (general monitoring) (No. 2).
The publication by Weimann, Emmermacher, Klein, and Marburger, "Observation of Possible Environmental Impacts of Genetically Modified Plants: Monitoring as an Early Warning System to Avoid Environmental Damage?" (NuR 2010, pp. 229 ff.), explores the potential of monitoring as an early warning system to help prevent environmental damage. The authors address observations during cultivation to determine the harmful effects of genetically modified organisms on the environment. In this context, they address, among other things, genetic engineering law, scientific requirements for observing the ecological effects of genetically modified plants, and the evaluation of previous observations. The aspect of monitoring is explored in depth, primarily from the perspective of liability law and the question of the operator's public-law liability for environmental damage. Ultimately, the authors conclude that proper monitoring is required under Section 16c of the Genetic Engineering Act (GenTG) simply because the Act on the Prevention and Remediation of Environmental Damage (USchadG) imposes extensive information, prevention, and remediation obligations, and operators may also be liable for damages under civil law. For this reason, there is a strong financial incentive to prevent damage and thus to properly implement the monitoring obligation under Section 16c of the Genetic Engineering Act.
This result, however, considerably limits the noble approach that was associated with monitoring when it was introduced, if it ultimately cannot be implemented without the accompanying measures of tort law and liability.

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