Gene transfers into the environment

Global trade and climate change contribute to erase the bio-geographical boundaries separating the ecological niches of numerous species, favouring the emergence or re-emergence of crop pest or disease vector species. This report, commissioned by the Swiss Federal Ethics Committee on Non-Human Biotechnology (ECNH) will describe technologies implying the transfer of genetic material in the environment such as biological control, CRISPR-Cas9 and Wolbachia based technologies. It purposely focuses on technologies that are currently not used in Switzerland but that could be used in the future. The focus is set on potential future technologies. Every technology described is used somewhere in the world, enabling us to discuss biosafety concerns and provide an analysis of the regulation procedures mobilized to evaluate potential environmental risks.

A classical biological control case study focusing on risks associated with hybridization between introduced biological control agents and native species showed that the laws regulating releases of environment in the environment is suitable to ensure biosafety but that the environmental risk assessment procedure is incomplete. This case study revealed the need for an harmonized European environmental risk assessment and the need to integrate socio-economic aspects in environmental risk assessment procedures.

An analysis of a Wolbachia-based control strategy to control disease vectors showed that the Swiss laws regulating releases of organisms in the environment seems perfectly suitable to ensure biosafety. The environmental risk assessment scheme developed by Australian researchers seems to be adequate to evaluate the risks even if the technology is probably to new for evaluating its long-term appropriateness.

The chapters on the CRISPR/Cas9 technology that could be used to control disease vectors such as mosquitoes, herbicide resistant agricultural weeds or invasive alien plants highlighted the disruptive character of the technology, the need for more stringent biosafety measures in gene drive experiments compared to other genetic manipulations and potential gaps between law texts in force in certain countries and this rapidly evolving new technology. To overcome this problem, we encourage regulators to consider a product based regulation rather than a technology-based regulation.

To summarize, this works highlights the need to consider every case as a unique case necessitating a precise and thorough evaluation or expertise. We strongly encourage regulators to advocate for case-by-case environmental risk assessment.