In Short:
The White House has issued new rules for companies that make synthetic DNA to prevent the creation of dangerous pathogens. The rules were released as part of President Joe Biden’s executive order to establish safety standards for AI in biotechnology. With technology making gene synthesis easier, cheaper, and faster, there is concern that harmful organisms could be created. The rules require DNA manufacturers to screen orders for dangerous sequences and assess customer legitimacy. The rules currently only apply to federally funded scientists and companies.
White House Issues New Rules for Synthetic DNA Manufacturers
The White House has issued new rules aimed at companies that manufacture synthetic DNA after years of warnings that a pathogen made with mail-order genetic material could accidentally or intentionally spark the next pandemic.
Background
The rules, released on April 29, are the result of an executive order signed by President Joe Biden last fall to establish new standards for AI safety and security, including AI applied to biotechnology.
Importance of Artificially Generated DNA
Artificially generated DNA allows researchers to develop diagnostic tests, create beneficial enzymes, engineer potent antibodies, and study rare bacteria without having to extract natural sequences from organisms.
Synthesizing DNA has become easier, cheaper, and faster with new technology that can “print” custom gene sequences, enabling dozens of companies worldwide to make and ship synthetic nucleic acids.
Concerns and Regulations
The concern revolves around the potential misuse of synthetic DNA to create harmful organisms. The new rules require DNA manufacturers to screen purchase orders for sequences of concern and assess customer legitimacy.
These sequences of concern are those that contribute to an organism’s toxicity or ability to cause disease. The rules currently apply to scientists or companies receiving federal funding.
Impact and Compliance
While the new rules represent a significant step forward in preventing misuse of synthetic DNA, they only apply to federally funded entities. Private sources of funding are not mandated to use companies with screening procedures.
Many DNA providers already follow screening guidelines, but not all companies comply due to the voluntary nature of these measures. Approximately 80% of the industry has joined the International Gene Synthesis Consortium to vet orders.
