DNA Synthesis and Biosecurity:
Lessons Learned and Options for the Future
Synthetic biology promises great scientific advances, but it also has the potential to pose unique biosecurity threats. It now is easier than ever to synthesize very long pieces of DNA from chemicals, potentially enabling a bioterrorist to build a toxin gene or an entire pathogenic virus. In 2007, the JCVI Policy Team released a report titled, “Synthetic Genomics: Options for Governance,” in which we proposed and evaluated a variety of options to address this biosecurity threat. A modified version of one of those options was later issued as Guidance for DNA synthesis companies by the US Department of Health and Human Services (HHS). In 2010, HHS released its “Screening Framework Guidance for Providers of Synthetic Double-stranded DNA,” which called on providers of double-stranded DNA to screen both customers and the DNA sequences ordered by those customers for potential biosecurity concerns.
This current report addresses two questions: 1) how well has the Guidance worked during its first five years? and 2) are changes to the Guidance needed to keep pace with anticipated developments in the field of DNA synthesis over the next five years?
We conclude that the Guidance has been reasonably successful in its first five years with a large majority of the industry in voluntary compliance. However, over the next five years, it will become more expensive for companies to adhere to the Guidance and more challenging for U.S. policy makers to maintain a high level of biosecurity screening. Declining costs for DNA synthesis and competition from international DNA providers (that might not practice biosecurity screening) will make following the Guidance increasingly burdensome for U.S. companies. Furthermore, decentralized methods of obtaining double-stranded DNA that are not addressed by the current Guidance may become more common, including the use of short, single-stranded DNA (“oligos”) and benchtop double-stranded DNA synthesizers.
We identify two options that policy makers could pursue to strengthen the Guidance over the next five years: 1) require federal grantees and contractors to purchase double-stranded DNA only from companies that comply with the Guidance, and 2) provide a curated database of “sequences of concern” for DNA providers to use for screening. We also consider ways in which the Guidance could be expanded to address oligos and benchtop synthesizers capable of making double-stranded DNA.
This report was funded by a grant from the Alfred P. Sloan Foundation and is the result of a 1.5-year process that included many conversations with industry representatives, stakeholders, and policy makers that culminated in a workshop held in Washington, D.C., on April 28, 2015. While many perspectives informed this report, the conclusions are solely those of the authors.