Closing the implementation gap: a harmonised EU framework for synthetic nucleic acid screening and customer...

Area of Science:

• Synthetic biology
• Biosecurity
• Molecular biology

Background:

• Synthetic nucleic acid technologies are crucial for research and biomanufacturing.
• Increased accessibility of these technologies presents significant dual-use biosecurity risks.
• Current voluntary biosecurity frameworks have systematic coverage gaps.

Purpose of the Study:

• To present a harmonized EU biosecurity screening framework.
• To evaluate Know Your Customer (KYC) verification and sequence screening against Sequences of Concern (SOC) as control mechanisms.
• To advocate for binding EU-level obligations to enhance biosecurity.

Main Methods:

• Analysis of existing voluntary biosecurity frameworks.
• Evaluation of KYC verification and SOC screening.
• Assessment of proposed EU Biotech Act I and ISO 20688-2:2024 standards.

Main Results:

• Existing voluntary frameworks are insufficient, leaving coverage gaps.
• Binding EU obligations, anchored to ISO 20688-2:2024, would address these gaps.
• The proposed framework is particularly relevant for smaller providers and benchtop devices.

Conclusions:

• Near-term EU action is critical to shape global synthetic biology governance.
• Harmonized biosecurity screening is essential to mitigate dual-use risks.
• Proactive regulatory measures can prevent future regulatory fragmentation.