Abstract
INTRODUCTION: Synthetic DNA technology is rapidly emerging as a key driver of innovation in the fields of medicine, biotechnology, and more. But it also poses significant risk, particularly in lowering barriers to the production of dangerous pathogens and toxins. At present, oversight of this technology is voluntarily coordinated among synthetic DNA providers and stakeholders, and detailed understanding of security processes, infrastructures, and insights from these providers is imperative to understand how to best mitigate the inherent risks of this technology. OBJECTIVES: In this study, we aimed to determine the trends, outliers, strengths, and gaps in current DNA provider security practices through a broad survey of the gene synthesis field. METHODS: We interviewed synthetic DNA providers and stakeholders about their customer and sequence screening procedures. Respondents were divided into groups based on membership in the International Gene Synthesis Consortium, nationality, whether they were a new or established company, and whether they synthesize de novo DNA or not. We then performed meta-analysis and intergroup analysis to elucidate larger trends and points of variance. RESULTS: In total, we interviewed 18 companies. We found that synthetic DNA providers and stakeholders tend to operate under a "zero-trust model" for screenings and utilize common governmental and private resources to navigate international import/export policies. Major variabilities were identified in the sensitivity of screening, monitoring and evaluation practices, screening pipelines, and approaches to synthetic oligonucleotide screening. In addition, we identified a significant vulnerability of lacking awareness among providers of formal law enforcement reporting procedures. CONCLUSION: Collectively, we observed significant heterogeneity in security practice throughout the field, reflective of the current lack of codified oversight for DNA synthesis. The results presented in this study provide insight into the specifics, strengths, and shortcomings of current DNA provider security practices, and are important considerations for the biosecurity community in ongoing deliberations of if, when, and how to approach oversight of synthetic DNA technology.