Biosafety and Biosecurity for Synthetic Genomics

Customizable nucleic acid sequences and genomes are now available from commercially available sources and desktop synthesis devices are becoming more advanced, allowing for the creation of on-demand nucleic acids. The availability of synthetically produced, rapidly advancing technologies is raising concerns among biosecurity experts and policymakers. There is a fear that a nefarious actor could use these technologies to create known pathogens or use artificial intelligence to create even more dangerous agents. This special issue will focus on examining the potential risks posed by these devices and proposed mitigation efforts. It will review existing and forthcoming government policies to determine if there are gaps that still need to be addressed and consider the role of biosafety and biosecurity experts in the development of policies and guidance.

Contributions on specific areas may include but are not limited to the following topics:

• Introduction to the risks posed by ordering or synthesizing DNA and genetic material
• Institutional oversight strategies to review and approve synthetically produced nucleic acids
• Navigating risks and benefits of synthetic genomics research
• International biosafety perspectives on synthetic genome synthesis
• Comparing country and regional approaches to assessing and mitigating risk of genome synthesis technologies
• Recommended components of a biosafety training program for institutions conducting synthetic genomics
• Evidence-based risk assessment frameworks for reviewing synthetic nucleic acid sequences in research applications
• Centralized biological receiving programs and screening of biological materials
• A review of how DNA synthesis companies use algorithms to flag potentially risky sequences
• Software strategies to control desktop synthesis devices to reduce potential nefarious activities
• Possible administrative and engineering controls for desktop synthesis devices
• Methodologies to empirically validate security and safety measures for synthetic genomics
• Personnel reliability considerations in high-risk biological research programs
• Considerations for how artificial intelligence could influence future DNA synthesis
• Strategies used by companies to screen customers ordering genomic sequences
• Complying with export control rules when creating, handling and shipping synthetic nucleic acids
• A review of the 2010 U.S. Department of Health and Human Services guidance document titled, “Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA”
• A review of the biosafety and biosecurity implications of the “Screening Framework Guidance for Providers and Users of Synthetic Oligonucleotides”
• A comparison of the 2010 and proposed 2023 U.S. Government screening frameworks for synthetic genomics
• Understanding and anticipating the role of the NIH Guidelines for Research with Recombinant and Synthetic Nucleic Acid Molecules in desktop nucleic acid synthesis and commercially available nucleic acids
• Surveys of end-users to assess the real and perceived risks of nucleic acid synthesis technologies
• Nucleic acid synthesis concerns: Fear mongering or real risk?
• Engaging the biosafety community in the development of new regulation and risk-mitigation techniques
• Communication strategies for increasing awareness about the potential hazards of desktop synthesis devices and commercially available nucleic acids

Submissions will go through a double-blinded, expert peer-review process and published in the Special Issue on Biosafety and Biosecurity for Synthetic Genomics. The deadline for submissions to the special issue is December 1, 2023. Accepted articles may be published online ahead of print prior to the special issue being finalized.

Please refer to our Instructions for Authors before submitting your manuscript for consideration.  Please select “Special Issue on Biosafety and Biosecurity for Synthetic Genomics” for the manuscript type when submitting your manuscript.

If you have any questions or pre-submission queries, please contact David Gillum.