Amidst the growing threat of lab-created pathogens, U.S. officials have updated guidelines for firms selling nucleic acids like DNA and RNA. Released by the U.S. Department of Health and Human Services (HHS), these new directives expand on the 13-year-old advice to encompass various DNA and RNA forms and the emerging technology of desktop devices that print these molecular designs. However, despite the advancement, the guidelines continue to be non-mandatory, a point of contention among biosecurity professionals.
The Need for Tightened Monitoring
Researchers frequently order nucleic acids for diverse projects, including those focused on infectious diseases and cancer. These orders can sometimes contain DNA or RNA segments related to hazardous viruses or bacteria. Concerns have been raised over inadequate scrutiny of these orders, especially since some biologists have demonstrated their ability to recreate whole genomes of such pathogens in labs.
U.S. regulations are stringent about labs working on 68 perilous microbes and toxins, termed “select agents.” Although the 2010 guidelines encouraged synthetic DNA suppliers to screen orders and block sales to unconfirmed researchers, these directions were optional. Most global firms, however, did comply.
The New Age of Biosecurity Precautions
HHS’s updated guidelines aim to curb malicious intent, ensuring individuals cannot employ synthetic nucleic acids to create detrimental biological pathogens or toxins. HHS now advises companies to not only screen against known pathogens and toxins but also search for sequences that might amplify the harmfulness of organisms not on regulated lists. This could comprise DNA sequences resembling spider toxins or parts that could combine to form a virus protein.
Screening is advised for sequences even as short as 50 nucleotides since merging them has become simpler. Moreover, companies are urged to validate their customers as legitimate researchers and alert relevant authorities about any concerns.
A groundbreaking inclusion in the guidelines pertains to desktop devices which can print nucleic acid sequences. HHS recommends selling these only to authenticated researchers and ensuring that these devices come equipped with automated sequence screening and user authentication.
Expert Reactions and Future Directions
Sarah Carter, an independent biosecurity policy specialist, praised the updated guidelines, but echoed the sentiment that more stringent regulations are essential. Kevin Esvelt, a biosecurity expert, emphasizes the severity of the issue, suggesting the potential catastrophic outcomes if not managed adequately.
Sarah Carter also mentioned the Nuclear Threat Initiative (NTI) aims to establish a global organization endorsing similar guidelines, though these too will be non-binding for the time being.
