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Harmonizing biosecurity oversight for gene synthesis

Nature Biotechnology volume 28, pages 20–22 (2010)Cite this article

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To the Editor:

As highlighted in your December issue, commercial gene synthesis companies routinely sell long strands of made-to-order DNA to researchers around the world. Observers have long speculated that individuals, terrorist organizations and governments could potentially use this DNA to create pathogens and other biosecurity threats. Last November, two separate industry groups—the International Association Synthetic Biology (IASB) and the International Gene Synthesis Consortium (IGSC)—issued competing standards1,2 specifying the precautions that companies should take before they provide artificial DNA to customers. So far, roughly a dozen gene synthesis companies in the US, Europe and China have promised to follow one or the other of these standards. More recently, the US Department of Health and Human Services has similarly announced its own draft 'Framework Guidance' recommending steps that commercial gene synthesis providers should take to screen incoming orders3. Readers who follow private sector 'standards wars' will immediately recognize that the current situation is unstable and only one of these three standards is likely survive in the long term. Furthermore, the prevailing standard will almost certainly set security policy in this area for many years. As we explain below, the choices are profound. On the one hand, the US government's draft Guidance embraces an automated 'Best Match' approach that defines threats based on how closely they resemble the so-called Select Agent list. We argue that this procedure is clearly less capable (but also less expensive) than either private standard, both of which require human experts to investigate gene function any time a customer sequence resembles a pathogen or toxin found in government's enormously larger Genbank database. On the other hand, the two private standards—despite their strong substantive similarities—also present an important choice. This is because the IASB standard was developed openly in public meetings, whereas the IGSC standard was written behind closed doors by five large companies. For better or worse, the winning standard will almost certainly have a profound impact on future transparency both within the gene synthesis industry and in its dealings with the wider public.

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References

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  3. Department of Health and Human Services. Screening framework guidance for synthetic double-stranded DNA providers. Fed. Regist. 74, 62319–62327 <http://edocket.access.gpo.gov/2009/E9-28328.htm> (2009).

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  1. Entelechon GmbH, Regensburg, Germany

    Markus Fischer

  2. Goldman School of Public Policy, University of California, Berkeley, California, USA

    Stephen M Maurer

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  1. Markus Fischer
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Correspondence to Stephen M Maurer.

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Fischer, M., Maurer, S. Harmonizing biosecurity oversight for gene synthesis. Nat Biotechnol 28, 20–22 (2010). https://doi.org/10.1038/nbt0110-20

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