Hey readers,
It's Kelsey Piper here.
In the past, if you were a researcher who wanted to study a specific strand of DNA or RNA, you’d have to go through the laborious process of coaxing some bacteria to produce it for you in the lab.
Not anymore: These days, you can send your DNA or RNA order off to a synthetic biology lab that can print those genetic sequences for you. It’s an incredible technology that pairs well with other exciting new biological technologies. The just-released next generation of Google’s AlphaFold AI makes it possible to predict how many DNA sequences will fold into proteins — synthetic biology will let us actually build the proteins we’ve identified as promising.
It’s hard to overstate the potential of synthetic biology. Medical innovation is slow and grinding, but as it gets cheaper to manufacture sequences of interest, incredible new things become possible. Add in AI and you have the ability to make biology faster, more powerful, and more personalized.
But there’s one possibility that has many leading companies in the synthetic biology space nervous: that their technology’s awesome potential could be turned toward destructive ends.
After all, the power to print any DNA or RNA sequence you want could in theory be used to reintroduce a dangerous extinct virus like smallpox to the world (though luckily for us, pox viruses are hard to assemble) or to manufacture an entirely novel pandemic-causing virus. It’s a classic dual-use technology: Synthetic DNA makes biological research much easier, but it would also make biological warfare much easier.
That’s why it’s so important that in an executive order last week, the Biden administration issued a new framework for synthetic biology that should make it safer and benefit the companies that are acting responsibly. The new policy didn’t get a lot of attention, but it has the potential to be a big deal — quietly reducing the risks of catastrophe while rewarding those companies that have approached their powerful new technology responsibly.
Doing synthetic biology right
Say North Korea, or a terrorist group, wants to dabble in biological warfare. Unfortunately, it would currently be possible for them to request a dangerous virus and get it shipped to them.
There’s a straightforward way to ensure this doesn’t happen: Companies that fulfill these requests can just check the orders they’re getting and make sure they’re not sending out anything on a short list of potential bioweapons. And while until now there has been very little regulation of synthetic biology companies, many of the leaders in the field were doing this voluntarily. Why go through the extra effort? Because they want to avoid a pandemic as much as the rest of us, and because they feared that a single malicious use would cause a generation of setbacks for a technology with the power to vastly transform our world for the better.
“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 last year. “But if we get an order for Ebola to be shipped to North Korea, we won’t do it.”
But not every DNA synthesis company checks where their orders are coming from or checks whether the sequence they’ve been asked to print is a dangerous one. You can save a little money by cutting corners, and some companies do.
For that reason, as I’ve written, leading synthetic biology companies have been in the unusual position of patiently asking the federal government to add some regulations. There’s a bill under consideration in Congress, the Securing Gene Synthesis Act, but it hasn’t moved forward.
The White House executive order from last week shores up some of these gaps. It encourages (though doesn’t require — that’d take an act of Congress) companies to adopt know-your-customer (check who is making an order) and know-your-order (check what they’re ordering and if it’s a dangerous restricted sequence) policies.
Crucially, it also directs everyone who orders synthetic DNA with federal research money to order from companies that follow these guidelines: “Federal research funding agencies will require recipients of federal R&D funds to procure synthetic nucleic acids only from providers that implement these best practices.”
That’s huge. The US federal government is by far the largest funder of biological research. If all of those research dollars will only go to compliant companies, firms in the space will have an enormous financial incentive to get compliant — fast.
A meaningful first step
Hopefully, Congress will continue working on this. Ideally, screening requirements would be mandatory, and Congress has also floated proposals to build a database of sequences of concern which DNA synthesis companies could consult. But while Congress figures out the best approach, this executive order should substantially shift the financial incentives surrounding screening all by itself.
I want to emphasize again that synthetic biology is awesome, and no one — not the White House, not Congress, not the biosecurity experts who’ve talked with me about synthesis screening — wants to slow it down. But some sensible regulations will both save lives and reward the companies that have been voluntarily doing the right thing for years now.
It’s a win for which the administration — and the many people who’ve worked tirelessly to establish synthetic DNA screening frameworks before a catastrophe instead of in response to one — deserves some celebration.
—Kelsey Piper, senior writer
