Scientists rely on gene synthesis technologies as a research tool for everything from basic research to vaccine development and drug target identification. Oligonucleotides, which are pieces of DNA about 15 to 30 base pairs long, are used in gene synthesis laboratories all over the world, along with DNA strands that may be thousands of bases long.
Ever since the inception of gene synthesis, there have been concerns about possible misuse of synthetic genes. Pathogens — particularly small viruses — could be assembled from scratch in a lab, evading the regulatory regimes the U.S. and many other nations have in place to control unauthorized access to dangerous pathogens. The National Academies of Sciences, Engineering, and Medicine listed the synthesis of known pathogens, particularly small viruses, as one of the most pressing biodefense risks in a 2018 report.
To be sure, progress has been made to reduce these risks. The Department of Health and Human Services published guidance in 2010 for commercial gene providers which included screening orders to ensure that unauthorized people weren’t ordering genetic material found in dangerous pathogens and screening customers to ensure that people weren’t paying for orders with cash or having them sent to P.O. boxes. Yet changes both in technologies and market conditions have reduced the effectiveness of these biosecurity protections, raising questions about whether the HHS guidance should be updated and what else can be done to increase biosecurity protections.
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Many commercial gene synthesis companies already voluntarily screen orders to ensure they are selling to scientists who work in regulated research institutions and comply with laws that govern the possession of dangerous pathogens. While research on dangerous viruses is essential for developing diagnostic tests, vaccines, and treatments, there is no reason unauthorized individuals should be able to buy the building blocks of such viruses and have them shipped to their addresses.
The U.S. and governments worldwide should take note of, and emulate, recent actions taken by California to increase biosecurity in laboratory research. In late August, Gov. Gavin Newsom signed into law Assembly Bill No. 1963, which requires California State University to develop systemwide guidance for buying gene synthesis products from companies that screen their orders to minimize the risk of misuse, and requests that the entire University of California system do the same. This will create a competitive advantage for companies that take biosecurity seriously. Widespread screening will make it more difficult for potential nefarious actors to access genetic material that could be used to construct pathogenic viruses, including smallpox, Ebola, or influenza, so this is an important step for biosecurity.
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Companies must expend both time and money to screen orders and customers. The California law is intended to start leveling the playing field for responsible companies, which are at a relative competitive disadvantage to international companies that do not screen orders or customers and which ship to U.S. laboratories. The gene synthesis industry is international, with a global market valued at more than $200 million in 2017 and projected to grow to $5.2 billion by 2027. Most of the larger companies belong to an organization called the International Gene Synthesis Consortium that requires companies to screen their orders, but screening is not universal.
While California is considered a biotech giant, and is home to several gene synthesis companies, there are limits to what this one state law can do. Screening orders for DNA or the customers making those orders cannot solve all the concerns about the potential development and use of biological weapons. But increasing and improving screening will make it more challenging for bad actors to take shortcuts to develop biological weapons.
The U.S. government and other governments must quickly adopt similar common-sense regulations to normalize the screening process and prevent gene synthesis products from falling into the wrong hands.
Gigi Kwik Gronvall is a senior scholar at the Johns Hopkins Center for Health Security and an associate professor in the Department of Environmental Health and Engineering at Johns Hopkins Bloomberg School of Public Health.
