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The Code of Life and Death
Braden R. Leach*
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.
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.
Introduction
We are living in a new biotechnological age. Better gene sequencing, synthesis, and assembly methods have given us previously unimaginable abilities to manipulate living organisms. Vaccine platforms have accelerated vaccine development, machine learning has revolutionized protein prediction and design, and gene drives may soon eradicate mosquitos that transmit deadly diseases. The emerging bioeconomy promises “innovative solutions in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security.”
A major part of this advance is the new field of synthetic biology, which aims to make life easier to manipulate “so that biological traits, functions, and products can be programmed like a computer.” By applying engineering principles to biology, we can redesign organisms to create biofuels, biomaterials, and cheaper pharmaceuticals. In 2012, the World Economic Forum ranked synthetic biology as the second key technology for the 21st century, right after informatics.
Given new techniques and economies of scale, business is booming. In the past twenty years, the cost of gene synthesis has fallen from hundreds of dollars per base pair to fractions of cents. Synthetic DNA generated more than $3.6 billion in 2021 and is modeled to reach around $10.6 billion by 2030. While the North American region currently has the largest revenue share, the Asia Pacific region is estimated to grow the fastest this decade.
The cheapest way to obtain DNA is to order gene-length sequences from a commercial gene synthesis company. A researcher could also start with short DNA or RNA sequences (called oligonucleotides, or oligos for short) and chemically stitch them together. Improvements in gene synthesizer machines will allow researchers to assemble longer and longer genetic sequences in-house.
New synthetic biology technology and techniques are destroying barriers to entry. Previously, DNA synthesis required university-level implements and expertise, but now “anyone with a laptop computer can access public DNA sequence databases on the Internet, access free DNA design software, and place an order for synthesized DNA for delivery.”
But like all technologies, biotechnology can be used for good or for ill. This is known as the dual-use problem.
A major part of this advance is the new field of synthetic biology, which aims to make life easier to manipulate “so that biological traits, functions, and products can be programmed like a computer.” By applying engineering principles to biology, we can redesign organisms to create biofuels, biomaterials, and cheaper pharmaceuticals. In 2012, the World Economic Forum ranked synthetic biology as the second key technology for the 21st century, right after informatics.
Given new techniques and economies of scale, business is booming. In the past twenty years, the cost of gene synthesis has fallen from hundreds of dollars per base pair to fractions of cents. Synthetic DNA generated more than $3.6 billion in 2021 and is modeled to reach around $10.6 billion by 2030. While the North American region currently has the largest revenue share, the Asia Pacific region is estimated to grow the fastest this decade.
The cheapest way to obtain DNA is to order gene-length sequences from a commercial gene synthesis company. A researcher could also start with short DNA or RNA sequences (called oligonucleotides, or oligos for short) and chemically stitch them together. Improvements in gene synthesizer machines will allow researchers to assemble longer and longer genetic sequences in-house.
New synthetic biology technology and techniques are destroying barriers to entry. Previously, DNA synthesis required university-level implements and expertise, but now “anyone with a laptop computer can access public DNA sequence databases on the Internet, access free DNA design software, and place an order for synthesized DNA for delivery.”
But like all technologies, biotechnology can be used for good or for ill. This is known as the dual-use problem.
References
* J.D. 2022, University of California, Berkeley, School of Law; Visiting Scholar at the Johns Hopkins Center for Health Security. I would like to thank Dr. Gigi Gronvall, Dr. Michael Montague, Dr. Richard Bruns, and Doni Bloomfield for sharing their insights. All views and mistakes are my own.
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Notre Dame Journal on Emerging Technologies ©2020