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If you wanted to send some money to the government of North Korea, you’d find it pretty difficult. Banks are required to check who their customers are, and when they learn theirs is a foreign government subject to economic sanctions, they’ll decline to do business.
But what if you wanted to send DNA sequences for hazardous viruses to the government of North Korea? Weirdly enough, that’s easier to do.
No US or international law requires companies that print DNA sequences to check what exactly they’re selling or who they’re selling it to. Nearly all of the companies working in this exciting new field — called DNA synthesis — check anyway because they want their pioneering industry to transform medicine and science, not call down a catastrophe. “If there’s an order for Ebola that’s being ordered by the CDC in Atlanta, that’s great,” James Diggans, director of Data Science and Biosecurity for Twist Bioscience, told me. “But if we get an order for Ebola to be shipped to North Korea, we won’t do it.”
Twist and many of its competitors are in a voluntary association called the International Gene Synthesis Consortium (IGSC), which works to set out guidelines so that gene synthesis — a new technology that is making it vastly easier to do crucial medical research — can be cheaply available, even as biosecurity concerns are appropriately addressed.
But “many” doesn’t mean “all,” and there are a few companies cutting corners. Membership in the IGSC is entirely voluntary. “The vast majority of DNA synthesis companies are good actors, but there are some companies that are not good actors,” Emily Leproust, the CEO of Twist Bioscience, told me.
Screening properly costs money, and as DNA synthesis gets cheaper, the companies that cut corners can beat more legitimate actors on price. “As an industry, we’re driving down the cost to enable more research, which is a good outcome,” said Leproust, “but the more the cost goes down, the more companies that don’t screen are at a competitive advantage.”
For that reason, there’s been a push in the last few years to enshrine some of the principles that the IGSC operates by into law — or at absolute minimum, to state that US federal research dollars must go to organizations that are acting responsibly. There’s a need for “mandatory screening, not voluntary,” Mark Dybul, a professor of medicine at Georgetown University and a longtime public health expert, told me.
The rules needed are simple, he added: “Know your customer, know your order.” That is, know who is ordering — whether it’s a legitimate actor or a terrorist group or a state with a bioweapons program — and know what they’re ordering and whether it’s a pathogen that would be catastrophic if released.
This fall, Congress looks likely to address the state of DNA synthesis for the first time, and it’s critical they get this right.
Blazing progress in biotechnology
It’s hard to overstate how fast progress has happened in fundamental biology in recent decades. In particular, Ryan Morhard, director for Policy and Partnership at Ginkgo Bioworks, told me we’ve seen enormous improvements in our ability to “read, write, and edit DNA.”
“The promise here is enormous,” Dybul said.
Between 1990 and 2003, researchers sequenced the first whole human genome at a total cost of close to $3 billion. It was an enormous international undertaking, and while it only ended up sequencing around 92 percent of the human genome — due to the technology limits at the time — it represented a huge step forward in our ability to understand and work with DNA.
In the last three years, one institute sequenced more than 250,000 human genomes for release in order to advance our understanding of biology and medicine. Needless to say, it didn’t cost $3 billion each, or even $3 billion total. The cost of DNA sequencing has plummeted.
When the government tried to respond to the H1N1 flu pandemic in 2009, Morhard pointed out to me, “We manufactured and delivered 350 million vaccines. But 10 years later, [despite] 10 years of basic neglect of pandemic preparedness, we’re at 15 billion vaccines [for Covid-19]” in total.
Sequencing DNA is getting cheaper. Synthesizing DNA is getting cheaper. Hundreds of different avenues of medical research that used to be cost-prohibitive are now accessible as options. It’s fantastic news. But it risks leaving security and policy considerations behind the curve.
I’ve never before seen an industry like gene synthesis, where major actors are nearly uniform in requesting that the government put in place some regulation of their industry to prevent catastrophes on a nearly unfathomable scale. They emphasized, of course, that they wanted regulation that was limited in scope. But they wanted it to happen immediately. “If we don’t act quickly, the genie’s out of the bottle,” Dybul told me.
Will Congress act?
Enter the Securing Gene Synthesis Act, introduced this month in the Senate by Ed Markey (D-MA) and in the House by Rep. Anna Eshoo (CA-16).
It requires “gene synthesis providers or manufacturers of gene synthesis equipment to implement screening protocols to detect misuse of de novo gene synthesis products” — which, to be clear, is precisely what responsible actors are already doing. And it requires “any entity receiving Federal funds, or any Federal agency, which purchases de novo gene synthesis products from a gene synthesis provider or gene synthesis equipment from a manufacturer of gene synthesis equipment to purchase such products and equipment only if such providers or manufacturers are verified” to be in compliance with the screening requirements.
It’s a short, narrow, and well-targeted bill, and it represents a big step forward in congressional oversight of a transformative new technology.
But the act is only one of two ways Congress may take a look at regulating gene synthesis this fall. There have also been provisions inserted into the Senate’s version of the Pandemic and All-Hazards Preparedness Act (PAHPA) reauthorization addressing gene synthesis, though they are not nearly as well-targeted. Where the Securing Gene Synthesis Act requires providers to do screening, the proposal in PAHPA just directs the government to publish even more guidance and “conduct a landscape review.”
“The PAHPA section 405, we don’t think it goes far enough,” Leproust told me. “It does not mandate screening. It does not restrict federal R&D funds to companies that screen.” And because it mandates a new review of information that the government has actually just finished publishing a review of, “PAHPA may slow down HHS in pushing guidance out by a year, so Eshoo/Markey is the right approach.”
Or, even better, Congress could take the best of both of the proposals before them. PAHPA has one provision that some industry and nonprofit experts really liked: a proposal that the government create a database of agents of concern which DNA synthesis companies can consult for screening. “That’s something we’ve been asking the government for for more than 10 years,” Leproust said. “In the dream world, you’d take that database requirement, put it in Eshoo and Markey, and you’d have a bill that’s very good for the world.”
There’s a lot at stake. DNA synthesis companies have led the way in defining what responsibility in their industry looks like, and they are all acutely aware that the whole industry — or potentially even the whole world — could suffer if a single bad actor sells a dangerous pathogen. Getting this right in advance will let the blazing progress continue apace in one of our most exciting and vital industries.
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