The Custom Synthetic Nucleic Acid Industry and Biosecurity: A Systems Analysis


Synthetic DNA can be used by researchers to acquire natural genes without the living source, enabling researchers to study the function of those genes without isolating them from a natural source. However, in the hands of a malicious actor, the technology could be used to acquire a harmful pathogen or toxin, creating a biosecurity risk. At the time our study was conducted in 2007, experts disagreed whether the risk warranted additional oversight of the custom, synthetic DNA industry (CSNA).


While some experts felt that industry posed a great biosecurity risk and therefore regulation was necessary, other experts held that the risk of misuse was low and that the potential harms of regulation, such as lost innovation or stunted economic growth, would outweigh the benefits. Among those calling for regulation, a range of oversight and governance mechanisms were proposed, including licensing customers, screening DNA sequences, or simply increased record-keeping. Gryphon conducted a three-month study to investigate the trade-offs associated with options for reducing the biosecurity risks associated with the CSNA industry. We developed recommendations  on how the federal government could best help secure the industry.


Gryphon’s recommendations were based on data gathered from a thorough review of the scientific literature as well as interviews with scientists who use CSNAs in their research and companies who produce CSNAs. Scientific literature was reviewed to understand how CSNAs could be misused, as well as the prevailing thoughts on biosecurity and the CSNA industry. Additionally, regulations, laws, and guidelines relevant to the oversight of the CSNA industry were reviewed. Interviews were conducted with users of synthetic DNA to understand how delays in ordering CSNA, and any financial costs associated with regulation, would affect their work. Interviews were also conducted with companies producing synthetic DNA—including interviews with all of the largest suppliers representing 85% of the total industry value. Following data collection, a variety of regulatory options were evaluated ranging from customer licensing to sequence screening.


Based on the data we collected, Gryphon developed several oversight options, highlighting the costs and benefits of each option, to inform policymakers on how to proceed. Each option was given ratings in a variety of categories such as burden to market, cost, and effectiveness for biosecurity, to allow our client to understand the trade-offs associated with each option. The Department of Health and Human Services (HHS) later developed our recommendations into official guidance to providers of synthetic DNA. The industry later formed a voluntary industry group, the International Gene Synthesis Consortium, who used the HHS guidelines as a starting point and developed further guidance with which all member companies must comply as a condition of joining the group.


The Custom Synthetic Nucleic Acid Industry and Biosecurity: A Systems Analysis report was released in December 2007 for The Department of Homeland Security: Science and Technology Directorate .