The White House has issued new rules targeting companies that make synthetic DNA after years of warnings that a pathogen made from mail-order genetic material could accidentally or intentionally cause the next pandemic.
The rules, released April 29are the result of an executive order signed by President Joe Biden last fall set new standards for AI safety, including AI applied to biotechnology.
Artificially generated DNA allows researchers to do all sorts of things—develop diagnostic tests, produce beneficial enzymes to consume plastic, or design powerful antibodies to treat diseases—without having to extract natural sequences from organisms. Do you need to study a rare type of bacteria? Instead of going out into the field to collect a sample, your 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 to do so thanks to new technology that can “print” custom genetic sequences. Now, dozens of companies around the world manufacture and ship synthetic nucleic acids en masse. And with AI, it is possible to create entirely new sequences that do not exist in nature, including those that could pose a threat to humans or other living beings.
“For some time the concern has been that as gene synthesis has become better and cheaper, and as more companies appear and more technologies streamline nucleic acid synthesis, it is possible de novo “They create organisms, particularly viruses,” says Tom Inglesby, an epidemiologist and director of the Johns Hopkins Center for Health Security.
It is conceivable that a bad actor could create a dangerous virus from scratch by arranging its genetic components and assembling them into a complete pathogen. In 2017, Canadian researchers revealed that they had reconstructed the extinct horsepox virus for $100,000 using mail-order DNA, raising the possibility that the same could be done with smallpox, a deadly disease that was eradicated in 1980.
The new rules aim to avoid a similar scenario. It asks DNA manufacturers to examine purchase orders to flag so-called sequences of concern and assess customer legitimacy. Sequences 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 funds: they must order synthetic nucleic acids from suppliers that implement these practices.
Inglesby says it’s still a “huge step forward,” as about three-quarters of the U.S. synthetic DNA customer base are federally funded entities. But it means that scientists or organizations with private funding sources are not required to use 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 undertakes to examine the orders. But both measures are voluntary and not all companies comply with them.
