The White House recently released new regulations targeting companies involved in the production of synthetic DNA amid concerns that a pathogen created with genetic material acquired through the mail could potentially trigger a global pandemic. President Joe Biden signed an executive order last fall to set forth fresh guidelines for AI safety and security, encompassing AI applications in biotechnology. The ability to artificially generate DNA has revolutionized scientific research, enabling advancements such as the development of diagnostic tests, the creation of enzymes to break down plastic, and the engineering of potent antibodies to combat diseases.
Synthetic DNA offers researchers the flexibility to manipulate genetic sequences without the need to extract them from natural organisms. This has made it easier, cheaper, and faster to synthesize DNA sequences in recent years with advancements in technology that facilitate the creation of customized gene sequences. Various companies worldwide are now able to produce and distribute synthetic nucleic acids at scale, opening up possibilities to design entirely new gene sequences that do not exist in nature. However, this also raises concerns about the potential threats posed by such engineered sequences.
Tom Inglesby, an epidemiologist and director of the Johns Hopkins Center for Health Security, highlights the growing apprehension surrounding the misuse of gene synthesis technology to create harmful organisms, particularly viruses. The ease of access to genetic building blocks combined with advancements in AI is a cause for concern, as it could enable malicious actors to develop dangerous pathogens by assembling genetic components ordered from DNA synthesis companies. A notable case in 2017 involved Canadian researchers who reconstructed the extinct horsepox virus using mail-order DNA, demonstrating the feasibility of recreating deadly viruses like smallpox, which was eradicated in 1980.
To address these risks, the White House has introduced new rules aimed at DNA manufacturers to prevent the misuse of synthetic genetic material. The regulations require companies to screen purchase orders to identify sequences that could contribute to the toxicity or disease-causing potential of an organism. These flagged sequences, known as “sequences of concern,” are subject to scrutiny, and customers must be verified for legitimacy. While the rules currently apply only to entities receiving federal funding, the goal is to establish a framework for ensuring the responsible use of synthetic DNA in research and development activities.
While a significant portion of the US customer base for synthetic DNA is covered by the new regulations due to federal funding requirements, there are concerns about the oversight of entities with private sources of funding. Although many DNA providers comply with screening guidelines set forth by the Department of Health and Human Services and participate in initiatives like the International Gene Synthesis Consortium, these measures are voluntary and not universally adopted across the industry. This lack of mandatory compliance raises questions about the robustness of current practices in safeguarding against the potential misuse of synthetic DNA.
The emergence of synthetic DNA technologies has presented groundbreaking opportunities for scientific advancement. However, the risks associated with the misuse of these capabilities underscore the need for stringent regulations and industry-wide compliance measures. The new rules issued by the White House represent a step forward in addressing the concerns surrounding synthetic DNA manufacturing, but ongoing efforts are essential to ensure responsible and ethical practices in genetic research and biotechnology.