The White House has issued new rules targeting companies that make synthetic DNA, after years of warnings that a pathogen made with mail-order genetic material could accidentally or intentionally trigger the next pandemic.
The rules, released April 29, are the result of an executive order signed by President Joe Biden last fall establishing new standards for AI safety, including the application of AI in biotechnology.
Man-made DNA allows researchers to do everything from developing diagnostic tests to making useful enzymes to eat up plastic to developing effective antibodies to treat diseases without having to extract natural sequences from organisms. Do you need to study a rare species of bacteria? Instead of going into the field to collect a sample, the genetic sequence can simply be ordered from a DNA synthesis company.
Synthesizing DNA has been possible for decades, but in recent years it has become increasingly easier, cheaper and faster thanks to new technologies that can “print” custom gene sequences. Dozens of companies around the world now produce and ship synthetic nucleic acids in large quantities. And with AI, it becomes possible to create entirely new sequences that do not exist in nature – including ones that could pose a threat to humans or other living beings.
“There has been concern for some time that this will be possible as gene synthesis has become better and cheaper, more companies have been founded and more technologies streamline the synthesis of nucleic acids again produce organisms, especially viruses,” says Tom Inglesby, an epidemiologist and director of the Johns Hopkins Center for Health Security.
It’s conceivable that a malicious actor could create a dangerous virus from scratch by arranging its genetic building blocks and assembling them into a whole pathogen. In 2017, Canadian researchers announced that they had reconstructed the extinct horsepox virus for $100,000 using shipping DNA, raising the possibility that the same could be done with smallpox, a deadly disease eradicated in 1980.
The new rules are intended to prevent a similar scenario. It calls on DNA manufacturers to review orders to flag so-called sequences of concern and assess the legitimacy of customers. Consequences of concern are those that contribute to an organism’s toxicity or ability to cause disease. For now, the rules only apply to scientists or companies that receive federal funding: They must order synthetic nucleic acids from providers that implement these practices.
Inglesby says it’s still a “big step forward” since about three-quarters of the U.S. customer base for synthetic DNA are government-funded companies. However, this means that scientists or organizations with private funding sources are not obliged to commission companies to carry out these screening procedures.
Many DNA providers already follow the Department of Health’s 2010 screening guidelines. About 80 percent of the industry has joined the International Gene Synthesis Consortium, which is committed to compliance with testing mandates. However, these measures are both voluntary and not all companies adhere to them.