Extinction.

Synthetic biology is an emerging new technical field that aims to make biology easier to engineer and more amenable to rational design, so that biological traits, functions, and products can be programmed like a computer. The concept of engineering biology is not a new one, nor is synthetic biology the first instance in which biology has been declared engineerable.1 Stephane Leduc wrote about the concept in the early 1900s.2 In 1974, the renowned cancer biologist Waclaw Szybalski described then-current work on molecular biology as the “descriptive phase,” adding that the real challenge will begin “when we enter the synthetic biology phase of research in our field. We will then devise new control elements and add these new modules to the existing genomes or build up wholly new genomes.”3(p23) Though what is now termed synthetic biology is not wholly distinct from previous studies of genetic engineering, the ability to fruitfully accomplish bioengineering is much greater now than it has been at any other point in history. Thanks to advances in computing power; the ability to rapidly, reliably, and inexpensively synthesize long tracts of DNA; new tools to reliably edit genomes; an increased understanding of biological systems; and the enthusiasm of young scientists who want to enter the field, synthetic biology is a new field and a new phenomenon, which proponents believe could revolutionize medicine and manufacturing.4-7

Synthetic biology encompasses widely diverse aims, making it difficult to draw boundaries for the field. For example, synthetic biology applications have included making a synthetic version of an anti-malarial compound that is difficult to harvest from nature; synthesis of influenza vaccines that could be produced in a shorter time than by traditional methods; manufacturing standard biological parts that can be assembled into genetic machines, including measurement devices, inverters, or logic devices; investigations into how life emerged on earth through the development of protocells; the synthesis of a bacterial cell; and the development of cell factories to produce biofuels and other compounds.8,9 In addition to synthetic biology being its own discipline, it has also brought about new tools to manipulate the genomes of biological organisms, which are used by scientists in disparate fields and in a variety of biotechnology companies.

The field shows a great deal of promise. According to the US National Bioeconomy Blueprint (2012), synthetic biology and related biotechnologies “can allow Americans to live longer, healthier lives, reduce our dependence on oil, address key environmental challenges, transform manufacturing processes, and increase the productivity and scope of the agricultural sector while growing new jobs and industries.”10 However, the advent of synthetic biology also poses risks, which have generated a great deal of attention from national security experts and the US government since the inception of the field. The field is creating new tools for genetic manipulation of biological organisms and making them more accessible worldwide; these tools could be misused to make a biological weapon or inadvertently cause a consequential accident. Concerns about these risks have resulted in numerous US government actions over the past decade, including guidance for DNA synthesis companies to limit unauthorized production of pathogens; an examination of the ethical risks and regulatory challenges inherent in the synthetic biology field by the Presidential Commission for the Study of Bioethical Issues in 2010; an examination of the biosecurity risks by the National Science Advisory Board for Biosecurity, a federal advisory committee created to address issues related to biosecurity and dual-use research; an FBI “see something, say something” program to reach out to scientists at universities as well as amateur scientists to report on intentional misuse; and a recent moratorium on certain areas of influenza infectious disease research (so-called “gain of function research”) while the risks and benefits are analyzed by advisory committees to the US government.11-16

While concerns about the safety or deliberate misuse of synthetic biology are appropriate, these prospective scenarios do not span the full range of risks that the development of the synthetic biology field may pose to US national security. There is another scenario that would have serious negative consequences to US national security that should be considered by US policymakers and experts and should inspire action: that the United States may lose its competitive edge in synthetic biology and related technologies. While the synthetic biology field was pioneered in the United States, and the United States is currently the leader in these technologies, other nations are investing heavily in these technologies in hopes of capitalizing on the field's progress, boosting their economies, and leading the field. Some, like China, India, and the UK, have even developed specific synthetic biology roadmaps for development.17 At the same time as there is heavy investment in synthetic biology by other nations, there is mounting concern that the competitive position of US life sciences is diminishing.18,19

If the United States were to lose its competitive edge in synthetic biology and related technologies, there would be serious consequences for national security. Some negative effects would be strictly economic, resulting in a declining environment for businesses and workers to be productive in synthetic biology–related industries in the long term.20 This is important for national security because, as described in the US National Security Strategy (2015), “In addition to being a key measure of power and influence in its own right, [a strong economy] underwrites our military strength and diplomatic influence. A strong economy, combined with a prominent US presence in the global financial system, creates opportunities to advance our security.”21 Current forecasting would suggest that a loss of economic opportunities in synthetic biology could be immense: Fidelity Investments describes synthetic biology as “the defining technology of next century” for global investments.22 In 2012, the World Economic Forum ranked synthetic biology as the second key technology for the 21st century, after informatics.23 According to BCC research, a market analysis company, the synthetic biology market reached nearly $2.1 billion in 2012 and $2.7 billion in 2013. They expect the market to grow to $11.8 billion in 2018 with a compound annual growth rate of 34.4% over a 5-year period from 2013 to 2018.24

Losing competitiveness in synthetic biology could also limit specific security applications on the horizon that are essential for national defense. These include the development of medical countermeasures for responding to biological, chemical, or radiological weapons threats and new approaches to diagnostics. A US Department of Defense (DoD) report described how synthetic biology could bring major advances to the development of high-performance sensors, sensors for unusual signatures, clandestine sensing, and high-performance materials for national defense; these applications would not likely be available to DoD based on private sector funding alone.25 Synthetic biology may also offer the possibility for distributed manufacturing so that critical supply chains are less vulnerable to disruptions.