The U.S. Tightens Regulations on Synthetic DNA

Emily Mullin

The White House has issued new rules aimed at companies that manufacture synthetic DNA after years of warnings that a pathogen made with mail-order genetic material could accidentally or intentionally spark the next pandemic.

The rules, released on April 29, are the result of an executive order signed by President Joe Biden last fall to establish new standards for AI safety and security, including AI applied to biotechnology.

Artificially generated DNA allows researchers to do all sorts of things—develop diagnostic tests, make beneficial enzymes to eat up plastic, or engineer potent antibodies to treat disease—without having to extract natural sequences from organisms. Need to study a rare type of bacteria? Instead of going out into the field to collect a sample, its genetic sequence can simply be ordered from a DNA synthesis company instead.

Synthesizing DNA, a feasible process for years, has become simpler, less costly, and quicker due to the advent of technology that enables the “printing” of customized gene sequences. Presently, numerous firms across the globe produce and distribute synthetic nucleic acids on a large scale. And it’s getting possible to generate entirely new sequences that don’t exist in the natural world with the help of AI. These new sequences have the potential to harm humans and other life forms.

“As gene synthesis has improved and become more affordable, and as the number of companies and technologies facilitating nucleic acids synthesis grows, the ability to create organisms from scratch, particularly viruses, has emerged as a major concern,” says Tom Inglesby, an epidemiologist and the director of The Johns Hopkins Center for Health Security.

It’s plausible that a rogue individual might develop a harmful virus from scratch by ordering its genetic components and constructing them into a complete pathogen. In 2017, Canadian researchers announced that they had resurrected the extinct horsepox virus for $100,000 using DNA ordered by mail, suggesting that smallpox, a lethal disease eradicated in 1980, could be similarly recreated.

The recently introduced regulations are designed to avert such eventualities. DNA manufacturers are requested to scrutinize purchase orders for so-called sequences of concern and check the legitimacy of the customer. Sequences of concern are those that contribute to an organism’s toxicity or disease-causing ability. For the time being, these regulations only apply to scientists or businesses that receive federal funding. They are required to purchase synthetic nucleic acids from suppliers that adhere to these measures.

Inglesby says it’s still a “big step forward” since about three-quarters of the US customer base for synthetic DNA are federally funded entities. But it means that scientists or organizations with private sources of funding aren’t beholden to using companies with these screening procedures.

Many DNA providers already follow screening guidelines issued by the Department of Health and Human Services in 2010. About 80 percent of the industry has joined the International Gene Synthesis Consortium, which pledges to vet orders. But these measures are both voluntary, and not all companies comply.

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Kevin Flyangolts, founder and CEO of New York-based Aclid, a company that offers screening software to DNA providers, says he’s glad to see the White House taking action. “While the industry has done a pretty good job of putting some protocols in place, it’s by and large not consistent,” he says. Still, he hopes Congress will adopt formal legislation by requiring all DNA providers to screen orders.

Last year, a bipartisan group of legislators introduced the Securing Gene Synthesis Act to mandate screening more broadly, but the bill has yet to advance.

Emily Leproust, at the helm of Twist Bioscience, a DNA-synthesis firm out of San Francisco, endorses regulating the sector. She mentions, “We see that DNA serves a dual-purpose. It’s like dynamite; it can facilitate tunnel construction, but it can also harm individuals. Together, we must advocate for the ethical application of DNA.”

Twist began scrutinizing sequences and clients back in 2016, which is when they initially commenced business in nucleic acids. A few years back, the firm brought in specialist consultants to assess its oversight procedures. These experts made pretend customer identities and covertly placed orders for sequences that could cause concern.

The CEO declares that the firm effectively identified a number of these suspect orders. However, there were occasions when the team could not reach a consensus on whether the requested sequences were cause for alarm. This trial led to the adoption of new measures by Twist. For instance, they used to only inspect DNA sequences of 200 base pairs and above (a base pair is a combination of two DNA letters). Now, even those that are at least 50 base pairs are on their radar, preventing clients from sourcing smaller sequences to piece together.

Even though Twist has stiffened its inspection routines, Leproust remains concerned about some theoretical circumstances that are out of her hands. One scenario she fears is a government with nefarious intentions creating its own gene sequences. “The largest perceived risk is if a country decides to construct its own DNA synthesis capabilities,” she expounds. “It may be possible, given the substantial resources at a nation’s disposal.”

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