The White House recently released new rules aimed at regulating companies that manufacture synthetic DNA. This initiative comes after years of warnings regarding the potential risks associated with creating pathogens using mail-order genetic material. The rules, which were issued on April 29th, are a direct result of an executive order signed by President Joe Biden last fall. The main goal is to establish new standards for AI safety and security, particularly in the field of biotechnology.
Synthetic DNA has opened up a world of possibilities for researchers. It allows them to develop diagnostic tests, create beneficial enzymes to break down plastic, and engineer potent antibodies to treat diseases. One of the major advantages of artificially generated DNA is that it eliminates the need to extract natural sequences from organisms. Instead, researchers can simply order the required genetic sequences from DNA synthesis companies.
While the ability to synthesize DNA has been around for decades, recent technological advancements have made this process easier, cheaper, and faster. Thanks to new technologies that can “print” custom gene sequences, dozens of companies worldwide now produce and distribute synthetic nucleic acids on a large scale. Furthermore, with the help of AI, it is now possible to create entirely new gene sequences that do not exist in nature. This poses a significant risk, as these new sequences could potentially be harmful to humans and other living organisms.
According to Tom Inglesby, an epidemiologist and director of the Johns Hopkins Center for Health Security, the main concern is the possibility of de novo creation of organisms using synthetic DNA. There is a fear that bad actors could exploit this technology to create dangerous viruses from scratch by ordering genetic building blocks and assembling them into pathogens. The reconstruction of the extinct horsepox virus by Canadian researchers in 2017 using mail-order DNA further highlighted the risks associated with this technology. This raises the alarm that similar tactics could be used to recreate deadly diseases such as smallpox, which was eradicated in 1980.
The new rules introduced by the White House aim to address these concerns and prevent such scenarios from occurring. One of the key aspects of the rules is the screening of purchase orders by DNA manufacturers to identify sequences of concern. These sequences are those that contribute to an organism’s toxicity or its ability to cause disease. The rules currently apply only to scientists or companies that receive federal funding, requiring them to order synthetic nucleic acids from providers that implement screening procedures. While this is a significant step forward, it does not cover scientists or organizations with private sources of funding, who are not obligated to use companies with these screening practices.
Many DNA providers already comply with screening guidelines issued by the Department of Health and Human Services in 2010. Additionally, approximately 80 percent of the industry has joined the International Gene Synthesis Consortium, which commits to vetting orders. However, these measures are voluntary, and not all companies adhere to them. This highlights the need for more comprehensive regulations and oversight to ensure the safe and responsible use of synthetic DNA technology.
The new rules for DNA synthesis safety are a critical step towards mitigating the risks associated with the rapid advancement of synthetic DNA technology. By implementing stringent screening procedures and guidelines, we can better protect against the potential misuse of this technology and safeguard public health and safety.
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