Worried that bioterrorists will take advantage of the growing ease of creating risky pathogens in the lab, federal officials are beefing up guidelines for companies that sell nucleic acids such as DNA and RNA. The recommendations, released earlier this month, update the U.S. Department of Health and Human Services’s (HHS’s) 13-year-old guidance for screening orders to cover more forms of DNA and RNA, as well as new desktop devices for printing these molecular blueprints. Yet the guidelines will remain voluntary under HHS’s plan, disappointing some biosecurity experts.
Biologists seeking to synthesize genes commonly order nucleic acids as part of their research on infectious diseases, cell biology, cancer, and myriad other projects. In some cases, the requested DNA or RNA encodes components of risky viruses or bacteria. There’s long been concern that such orders aren’t scrutinized well enough.
The U.S. has strict regulations overseeing labs that work on 68 dangerous human, animal, and plant microbes and toxins known as “select agents.” And separate export regulations identify the select agents that require licenses before they can be shipped abroad.
But biologists have shown they can assemble full genomes for such pathogens and get them to reproduce in the lab. So in 2010, HHS issued guidelines recommending that synthetic DNA providers screen orders and block sales to unverified researchers if the requested sequences matched those of select agents on the federal lists. Although the guidelines are voluntary, biosecurity experts say most international companies follow them.
Now HHS is updating the guidelines because the current select agents “do not represent the entirety of the potential risks. The guidance seeks to more fully encompass the risks … that contribute to pathogenicity or toxicity in the definition of sequences of concern,” according to a notice published on 13 October in the Federal Register. The goal is to limit the ability of “individuals with ill intent” to use synthetic nucleic acids to construct harmful biological pathogens or toxins.
Among the guideline changes, HHS says that companies that provide synthetic nucleic acids should not only screen requested sequences against lists of regulated pathogens and toxins, but also look for sequences that could increase the toxicity or pathogenicity of organisms not on those lists. That could include, for example, DNA encoding a spider toxin or pieces of DNA that could be stitched together to encode a protein from a virus that infects peaches.
The screens should include even snippets as short as 50 nucleotides in length, because it’s become easier to splice them together. Nucleic acid providers should also screen their customers to verify that they are legitimate researchers and contact FBI and other authorities if they are unable to resolve any concerns that arise.
HHS is also recognizing that companies are now selling desktop devices that allow owners to print desired nucleic acid sequences on demand. In the first-ever attempt to oversee this burgeoning market, the agency calls on the firms to only sell such equipment to researchers they have verified as legitimate, and to design their machines so that they automatically screen sequences and authenticate users.
“I think the updated guidance is great,” says Sarah Carter, an independent biosecurity policy expert who recently co-led a report by the Nuclear Threat Initiative (NTI) calling for more stringent rules around the distribution of synthetic nucleic acids to minimize biosecurity risks. However, she argues the guidelines need more teeth. “We should be moving to a regulatory system in which DNA providers are required to perform biosecurity screening”—but that’s a step that would require action by Congress.
Kevin Esvelt, a biosecurity expert at the Massachusetts Institute of Technology, agrees that stringent regulations are needed, rather than the updated voluntary guidelines. “We have failed to take even the simplest of precautions to control access to synthetic DNA that a skilled individual could use to kill more people than would perish in an act of nuclear terrorism,” Esvelt says. “We’ve a long way to go.”
Carter notes that the NTI is working to create an international organization to codify similar guidelines globally. But for the foreseeable future, she acknowledges, those rules too would be voluntary.
