The White House recently imposed new regulations targeting companies involved in the production of synthetic DNA. The move comes after years of warnings that using genetic material obtained through mail-order could potentially lead to the unintentional or deliberate creation of a dangerous pathogen that could trigger a pandemic.
These guidelines, which were unveiled on April 29th and are the outcome of an executive order issued by President Joe Biden last autumn, are part of broader efforts to establish higher safety and security standards for artificial intelligence (AI), particularly in the field of biotechnology.
The ability to artificially manufacture DNA has allowed researchers to undertake various tasks such as creating diagnostic tests, developing enzymes to break down plastic, or designing powerful antibodies to combat diseases without having to extract genetic material from living organisms. With advancements in technology, the process of synthesizing DNA has become more accessible, affordable, and rapid, enabling numerous companies worldwide to produce and distribute large quantities of synthetic nucleic acids. Additionally, AI technology now allows for the creation of entirely novel genetic sequences, some of which could potentially pose risks to humans and other organisms.
Researchers have expressed concerns about the possibility of creating harmful organisms, including viruses, from scratch by ordering customized genetic material and assembling it into a pathogen. To address these concerns, the new regulations require DNA manufacturers to scrutinize purchase orders for potentially risky sequences and verify the legitimacy of customers. Specifically, sequences that raise concerns related to toxicity or disease-causing potential must be identified and assessed. These regulations are presently applicable only to scientists and organizations that receive funding from the federal government, mandating them to obtain synthetic nucleic acids from suppliers adhering to these screening protocols.
While this is considered a significant stride forward, as the majority of synthetic DNA customers in the United States are federally-funded entities, it does not extend to individuals or entities supported by private funding sources. Moreover, while many DNA providers already adhere to screening guidelines established by the Department of Health and Human Services in 2010, compliance with these standards remains voluntary, and not all companies in the industry follow these protocols.
In conclusion, the implementation of these new regulations is aimed at mitigating the potential risks associated with the misuse of synthetic DNA technology while fostering responsible practices among DNA manufacturers and researchers.
