Why is risk assessment important for gene drive? As gene drive technologies move closer to potential field evaluations, it is important that they be responsibly assessed to make sure they can be used safely and efficiently. The purpose of the risk assessment process is to identify potential pathways to harm that could lead to adverse health or environment impacts, and thus implement suitable measures that can eliminate or mitigate risks.
In collaboration with the Outreach Network for Gene Drive Research, the ISAAA SEAsia Center published a new policy brief entitled Risk Assessment for Gene Drive Organisms. The policy brief was developed following the Key Considerations for Risk Assessment of Gene Drive Technologies webinar, the second in the 2022 Gene Drive Webinar Series led by the Outreach Network for Gene Drive Research and the ISAAA SEAsia Center. It provides an overview of the appropriateness of current guidelines, best practices, and gaps in the processes through which gene drive technologies are being developed and assessed.
One of the key recommendations emerging from this document is for risk assessment processes to be science-based and consistent with the principle of case-by-case assessment, as there are many different types of gene drive constructs, for many different uses and contexts. A risk assessment should therefore be considered a living document that is likely to change as new evidence from testing or the scientific literature comes to light. Another point highlighted is that risk assessments should be inclusive, to ensure that a broad range of stakeholders are allowed to voice their concerns and contribute to the process.
The policy brief also provides a set of recommendations related to the regulation of gene drive research, which ultimately takes place at the national level. It suggests that national authorities turn to existing international risk assessment guidelines for LMOs to create and review national regulatory frameworks. Examples of international guidelines available include documents such as the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (CBD) and the WHO’s Guidance Framework for Testing of Genetically Modified Mosquitoes, amongst others. Although many countries already have strong regulatory frameworks, the brief highlights the need for investment in building biosafety expertise to increase other countries’ ability to take part in and benefit from innovative research.
Interested in learning more? Read the full policy brief here.