The White House has issued new rules targeting companies that manufacture synthetic DNA due to concerns about the potential for a pathogen created with mail-order genetic material to unintentionally or intentionally trigger a pandemic.
The rules, which were released on April 29, were prompted by an executive order signed by President Joe Biden last fall to set forth new standards for AI safety and security, particularly in the realm of AI applied to biotechnology.
Synthetic DNA enables researchers to perform a variety of tasks, such as developing diagnostic tests, creating enzymes to break down plastic, or engineering antibodies to combat disease, without needing to extract natural sequences from organisms. With the ability to order genetic sequences from DNA synthesis companies, researchers can study rare bacteria without having to collect samples directly from the field.
While DNA synthesis has been feasible for years, advancements in technology have made it easier, cheaper, and faster to print custom gene sequences. This has led to the proliferation of companies worldwide producing and distributing synthetic nucleic acids, with the added risk of AI being used to create novel sequences that could potentially be harmful.
The concern lies in the possibility of malicious actors creating dangerous viruses by ordering genetic components and assembling them into pathogens. In one instance, Canadian researchers reconstructed the extinct horsepox virus using mail-order DNA, raising concerns about the potential recreation of smallpox, a disease eradicated in 1980.
The new rules seek to mitigate this risk by requiring DNA manufacturers to screen purchase orders for sequences of concern that could contribute to toxicity or disease-causing ability. While currently applicable only to federally funded scientists or companies, the rules mandate that synthetic nucleic acids be ordered from providers implementing these screening practices.
Despite the limitations of the rules, which do not apply to privately funded entities, the implementation represents progress since a majority of US customers for synthetic DNA are federally funded. However, it highlights the need for greater oversight in the industry, as not all companies adhere to voluntary screening guidelines.
