Imagine being able to use biological organisms as tiny machines to produce rare and complex chemicals faster and more efficiently with less waste, using a deliberate engineering process that enables molecular biology to make new and reliable commercial products. This is synthetic biology, which seeks to take the science of genetic engineering and apply it to industrial manufacturing in the fields of medicine, chemical manufacturing, fuel and power systems, and agriculture.Synthetic biology is a relatively recent technology whose future applications are being increasingly discussed within industry and academic circles. Like other technologies, it has potential dual-use (commercial and military) applications. As much as scientists and engineers are looking forward to creating new commercial processes and products with this capability, some experts are warning that synthetic biology could also lead to new military capabilities — specifically, new biological warfare agents and diseases that could be dangerous in the wrong hands. The John Hopkins Center for Health Security recently hosted a group exercise in which a bioengineered virus called “Clade X” was deliberately released by a violent extremist group, resulting in 150 million dead after 20 months. Loren Thompson of the Lexington Institute warns that synthetic biology could allow the development of “a super pathogen threatening the survival of large populations, and even civilization.” While these concerns may be premature, the U.S. government must consider the possibility that state and nonstate actors could misuse this emerging life science.The debate about the dual-use nature of nuclear, biological, and chemical technologies is not new. While nuclear physics have demonstrably improved power generation and health sciences, nuclear weapons have advanced states’ military capabilities and, in many cases, created proliferation challenges that are intertwined with commercial nuclear technologies. For decades, there were concerns that advances in chemical and biological sciences would result in the development of bioengineered viruses and novel chemical weapons. At the same time, industry has used these same technical advances to provide the general public with new household products and a broader selection of luxury services. Other dual-use technologies of concern include directed energy, commercial drones, and cyber systems. The challenge, in each case, is balancing the commercial growth of these technologies against the need to prevent them from being used against U.S. security interests.The National Academies of Science completed a study in June 2018 titled “Biodefense in the Age of Synthetic Biology” to investigate the potential manipulation of biological organisms to produce disease-causing agents or toxins, in response to a request by Deputy Assistant Secretary of Defense for Chemical and Biological Defense Dr. Chris Hassell. The study sought to address three questions: What are the security concerns relating to synthetic biology, how soon might these threats emerge, and what are the options to mitigate these concerns? The report offers a framework for assessing these questions, identifying the highest concerns to be re-creating known pathogenic viruses, making existing bacteria more dangerous, and making biochemicals through in situ synthesis (within the human body).The good news is that most of this technology is still largely beyond the capabilities of violent extremist organizations and limited to nation-states with sophisticated laboratories and good resources. The bad news is that the rapid rate of technological change creates significant uncertainty as to what potential weapon systems might eventually be developed and used against U.S. military forces. As the technology and the potential threats evolve, various U.S. government agencies — including the Departments of Defense, Health and Human Services, Homeland Security, Agriculture, and Commerce — will have interests regarding synthetic biology. How should the U.S. government articulate a strategy to guide the development of this new technology?The 2017 National Security Strategy does identify biothreats as an issue of concern. “Biological threats to the U.S. homeland — whether as the result of deliberate attack, accident, or a natural outbreak — are growing and require actions to address them at their source.” This general policy statement is not significantly different from the 2009 National Strategy for Countering Biological Threats. As such, it does not offer adequate guidance for addressing the dual-use challenges of synthetic biology. The British government just released a “Biological Security Strategy” that is much better developed than the 2009 U.S. strategy, but still makes the mistake of trying to address all biological threats under one rubric.The U.S. government should seek to articulate policy that encourages synthetic biology’s commercial growth while examining the potential development of biothreats. This is not an easy task. Good policy relies on clear definitions, defined roles and authorities, and assessments to ensure that the policy is making progress. If the U.S. government wants a robust, coordinated effort in this area, it must appreciate that it’s not merely a matter of getting the medical professionals to address this diverse set of biological threats — it’s also important to understand that there are multiple agencies with varying concerns. Addressing this new dual-use technology issue will require a delicate and deliberate approach rather than a general boilerplate strategy.Defining the ProblemSynthetic biology goes beyond genetic engineering. It has been described as a convergence of chemistry, biology, computer science, and engineering to create a standardized, automated construction of biological systems. While synthetic biology can involve the manipulation of biological material, the possibilities extend far beyond genetically modifying foods or animals; for instance, synthetic biology capabilities can be used to modify existing traits or introduce new ones into organisms to manufacture new products in a more consistent and less expensive way than traditional technologies allow. Many are familiar with the potential of 3-D printers (both commercial and defense applications). Consider the potential that could be unlocked by employing similar engineering methods that use biological and chemical materials at the nanometer-level to create jet fuels that don’t come from oil wells, batteries that run on bacteria, bricks that don’t require kilns, and more environmentally friendly industrial chemicals. Additionally, there are significant benefits that might be derived from synthetic biology in developing new medical countermeasures and diagnostics capabilities.Similar to the biotechnology boom of decades past, the challenge will be to develop U.S. government policy that does not overly hamper industry but allows for some degree of oversight against the dangers of misusing biotechnology. As noted in 2015 by an earlier National Academies of Sciences report, industry is well on its way to producing biobased products at lower costs, faster production speeds, and an increased production capacity. At the very least, a regulatory regime is required to ensure the safe commercialization of these new organisms, new chemical products, and new methodologies.The 2018 National Academies of Science report does a solid job of assessing concerns about making existing pathogens more dangerous, manufacturing chemicals and biochemicals in novel ways, and creating biological weapons that alter the human host. To be clear, there are significant hurdles that still need to be addressed before any nation could plausibly use this technology to develop new biological weapons. The framework offers policymakers insights on what to watch for as this new technology develops. The challenge is translating these observations into coherent and effective U.S. policy.While the National Security Strategy is correct to be concerned about the possible development of new and dangerous pathogens through synthetic biology, the greater national security challenge may come from the development of new commercial and military products in this field. This technology is certainly not limited to the United States. Other nations are eager to exploit the potential benefits of synthetic biology. China in particular is racing forward in this field, and its significant investments in U.S. pharmaceutical firms ought to be critically examined. As a parallel example, the U.S. military was concerned that fentanyl products might be weaponized to use against military or civilian populations, given their broad availability within the United States. There have been no domestic terrorism cases or military attacks using fentanyl agents, while there remains a significant role for fentanyls in the medical profession as analgesics.Developing a National PolicyThe 2017 National Defense Authorization Act directed the Departments of Defense, Health and Human Services, Homeland Security, and Agriculture to develop a new national biodefense strategy and implementation plan. The Trump administration has not yet released this plan, but if it is similar to other past national strategies addressing biological threats, it will be more of a general outline of the threat of biological organisms and less specific in its direction to executive agencies. While this approach may make sense to medical professionals, it does not allow the development of distinct policies within the areas of military operations, combating terrorism, and homeland security.The U.S. government’s approach to incident management is to mitigate deliberate and natural threats through an “all-hazard” response, allowing for the integration of diverse capabilities across the government within an accepted framework. But it is hard to determine how well the U.S. government addresses biological threats in particular. The 2009 National Strategy made the mistake of not distinguishing between natural disease outbreaks and bioterrorism incidents, and as a result, was not useful for guiding policy development. The United States cannot afford an attitude that assumes all biological threats are homogenous enough to address under one construct.Within the U.S. government, the terms biodefense, biosecurity, biosurety, and biosafety are often loosely used and not clearly defined when the general topic of “biothreats” comes up. These terms mean different things to different agencies. For instance, nonmedical personnel may be especially surprised to find out that biosurveillance is a system for monitoring not dangerous biological organisms, but rather the entire biological environment for hazards, including chemical, biological, and radiological, natural and man-made, and their effects on humans, animals, and plants. As a result of the failure to coordinate across agencies, the U.S. government wastes time and resources by creating duplicative programs, or worse yet, by ignoring obvious capability gaps.Developing a national strategy to exploit the potential commercial use of synthetic biology, while mitigating the impact of bad actors seeking to develop new and novel biological weapons, will take some adroit maneuvering. In seeking to minimize the impact on the commercial sector, the danger is that policymakers will have inadequate guidance on what and how to protect against both traditional and nontraditional biological threats. This is why the government should avoid a generalized policy approach that attempts to address all natural disease outbreaks and man-made biological threats, and instead clearly articulate its terms and objectives over the long term.