To the Editor — On 21 January, California took a major step to increase biosecurity in commercial gene synthesis, introducing legislation that requires all scientists purchasing gene synthesis products to use companies that perform screening on customers and the sequences they order. If enacted, this legislation would make it a competitive advantage for companies to take biosecurity seriously. Here, we argue that the US federal government and other governments should emulate California’s actions.
Assembly member Rudy Salas (assembly district 32) introduced the legislation, which requires not only that customers use companies that perform biosecurity screening but also that companies offering DNA synthesis services in California perform sequence screening1. These restrictions would make it harder for a potential nefarious actor to access genetic material for making pathogenic viruses de novo, such as smallpox, Ebola or influenza. The de novo synthesis of known pathogens, particularly small viruses, is listed as one of the most pressing biodefense risks by a 2018 report from the National Academies of Sciences, Engineering and Medicine2.
Many commercial gene synthesis companies already voluntarily screen customer orders to make sure that they are both selling to scientists working in regulated research institutions and not selling anything that could be potentially harmful. In 2010, the US Department of Health and Human Services issued voluntary guidance for companies, including steps to take if there is a sequence or customer of concern3.
Because it costs time and money to perform biosecurity screening, responsible companies that voluntarily take this step have until now been at a competitive business disadvantage4. The California legislation seeks to tackle this by requiring that all DNA synthesis companies undertake sequence screening, thus leveling the playing field. The California legislation also has a mechanism for eventually requiring screening of smaller gene synthesis products than the current Department of Health and Human Services guidance calls for, a necessary step to keep up with advances in biotechnology5.
Of course, there are limits to how much California can do by itself, as this legislation would apply only to California state funds and California gene synthesis companies. Although California is a biotech giant, with several gene synthesis companies, gene synthesis is international, with a global market valued at over $200 million in 2017 and projected growth to over $600 million by 2022 worldwide6.
It is time for the US federal government and other governments to put in place regulations that ensure DNA sequences of pathogenic agents do not fall into the wrong hands. It is no longer sufficient for voluntary participation in guidance to oversee a matter of national and international biosecurity. Governments around the world should follow California’s example by strengthening biosecurity rules that require synthetic DNA sequence screening.
AB-1966 Gene Synthesis Providers. Edn. 2019–2020 Regular Session https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201920200AB1966 (2020).
US National Academies of Sciences, Engineering and Medicine. Biodefense in the Age of Synthetic Biology (National Academies Press, 2018).
Department of Health and Human Services. Fed. Regist. 75, 62820–62832 (2010).
Carter, S. R. & Friedman, R. M. DNA Synthesis and Biosecurity: Lessons Learned and Options for the Future (J. Craig Venter Institute, 2015).
Kobokovich, A., West, R., Montague, M., Inglesby, T. & Gronvall, G. K. Health Secur. 17, 419–429 (2019).
Bergin, J. Synthetic Biology: Global Markets https://www.bccresearch.com/market-research/biotechnology/synthetic-biology-global-markets.html (BCC Research, 2018).
The authors declare no competing interests.
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West, R., Gronvall, G.K. California shows the way for biosecurity in commercial gene synthesis.
Nat Biotechnol (2020). https://doi.org/10.1038/s41587-020-0667-0