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Document Type

Article

Abstract

Biotechnology is advancing at an astonishing clip, but our safeguards are decades behind. Given new technologies and economies of scale, it is possible for nefarious actors to assemble deadly viruses from scratch using synthetic DNA ordered off the internet. The Select Agents statute helps to prevent malicious actors from acquiring dangerous pathogens, but the Department of Health and Human Services has interpreted it to not cover synthetic DNA. Recognizing the gap, HHS issued guidance recommending that gene synthesis companies verify their customers to ensure their legitimacy and screen genetic sequences for matches to pathogen sequences. Unsurprisingly, voluntary guidance has not inspired full adherence. I argue that HHS should require providers to screen the sequences they provide and that it has the statutory authority to do so. This would improve security and level the playing field. But it would not be enough. Private companies are not in the best position to perform background checks on their customers, and their economic incentives point the other way. I propose a novel license regime, where every buyer and seller of synthetic DNA and gene synthesis equipment would need to undergo a background check before transacting. In a world where biotechnology will only grow cheaper and easier to use, open access is untenable. Informed by experts at the frontlines of science, industry, and security, this article advances novel regulatory solutions to counter the risks posed by dual-use biotechnology. If the US wishes to protect its people and remain the leader in the field, it must control who can access the code of life and death.

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