Editorial by BG (Ret.) William King

Why should we be concerned about Synthetic Biology: Isn’t it all done for the betterment of society and life in general?

Scientific advances in data analytics, decreased costs in synthesizing DNA, ease in use of automation, artificial intelligence, and nanotechnology over the past several decades have accelerated the ability to engineer existing organisms and to potentially create new novel ones not found in nature. Synthetic biology, which collectively refers to concepts, approaches, and tools that enable the modification or creation of biological organisms, is being pursued overwhelmingly and exponentially for beneficial purposes ranging from reducing the burden of disease to improving agricultural yields to remediating pollution. All great causes and worthy of the efforts and interests of our best scientists and budding STEM enthusiasts. Although the contributions synthetic biology can make in these and other areas hold great promise, it is also possible to imagine malicious uses that could threaten U.S. citizens and military personnel. Just imagine what those same advances are doing in terms of enhanced encapsulation that enabled new dissemination methods and undetectable delivery means or timed released activation or personalized medicine and gene therapies that could enable targeting of specific organs, systems, or ethnic groups, targeting of immune systems. Making informed decisions about how to address such concerns requires a realistic assessment of the capabilities that could be misused. To that end, the National Academies of Sciences, Engineering, and Medicine developed a framework to guide an assessment of the security concerns related to advances in synthetic biology, to assess the levels of concern warranted for such advances, and to identify options that could help mitigate those concerns.

To assist the U.S. Department of Defense’s Chemical and Biological Defense Program (CBDP), the National Academies of Sciences, Engineering, and Medicine appointed an ad hoc committee to address the changing nature of the biodefense threat in the age of synthetic biology. Specifically, the focus of the study was the manipulation of biological functions, systems, or microorganisms resulting in the production of disease-causing agents or toxins… Initially, the committee developed a strategic framework to guide an assessment of the potential security vulnerabilities related to advances in biology and biotechnology, with a particular emphasis on synthetic biology. The framework focused on how to address the following three questions: What are the possible security concerns with regard to synthetic biology that are on the horizon? What are the time frames of development of these concerns? What are our options for mitigating these potential concerns?

The committee used a strategic framework to generate an assessment of potential vulnerabilities posed by synthetic biology. Inputs to this assessment included information about the current threat, current program priorities and research, and an evaluation of the current landscape of science and technology. Conclusions and recommendations included a list and description of potential vulnerabilities posed by synthetic biology. An initial framework for assessing concerns was published in an interim report (National Academies of Sciences, Engineering, and Medicine, 2017). The study’s final report builds on and superseded that report. The report explored and envisioned potential misuses of synthetic biology, including concepts that are regularly discussed in open meetings. The potential misuses as they are discussed in the report are neither comprehensive nor enabling in the level of information and detail provided; they are included to illustrate the expanding mission of biodefense in the age of synthetic biology. Biotechnology in the age of synthetic biology expands the landscape of potential defense concerns. The U.S. Department of Defense (DoD) and its partnering agencies should continue to pursue ongoing and improve upon strategies for chemical and biological defense that include Pandemic Response and Preparedness; these strategies remain very relevant in the age of synthetic biology. DoD and its partners also need to have approaches to account for the broader capabilities enabled by synthetic biology, now and into the future.

The nation’s experience preparing for naturally occurring diseases provides a strong foundation for developing strategies to prevent and respond to emerging biologically-enabled threats, particularly those based on naturally occurring pathogens. But synthetic biology approaches also have the potential to be used in ways that could change the presentation of an attack, for example, by modifying the properties of existing microorganisms, using microorganisms to produce chemicals, or employing novel new or unexpected means to cause harm. It is valuable for the U.S. government to pay close attention to rapidly advancing fields such as synthetic biology, just as it did to advances in chemistry and physics during the Cold War era. However, approaches modeled after those taken to counter Cold War threats are not sufficient to address new biological and biologically enabled chemical weapons in the age of synthetic biology. The partners involved in the U.S. biodefense enterprise will need expanded strategies and approaches to account for the new capabilities enabled by advances in this field. It must also look to break down self-imposed barriers between communities of Biological Defense, Health Security, Agricultural Security, STEM-based academic recruiting and marketing, and the ever-growing public and private DITY Labs communities.

The Department of Defense and its interagency partners should use a framework in assessing synthetic biology capabilities and their implications. A framework is a valuable tool for parsing the changing biotechnology landscape. Using a framework facilitates the identification of bottlenecks and barriers, as well as efforts to monitor advances in technology and knowledge that change what is possible. A framework provides a mechanism for incorporating the necessary technical expertise into the assessment. A framework enables the participation of technical experts in synthetic biology and biotechnology along with experts in complementary areas (e.g., intelligence and public health). A framework like that developed by the National Academies of Sciences, Engineering, and Medicine report identifies the features of a synthetic biology–enabled capability that would increase or decrease the level of concern about a given capability being used for harm. This framework identifies factors to determine the relative levels of concern posed by advances in biotechnology. In addition to supporting the analysis conducted in their study, the framework is intended to aid others in their consideration of current and future synthetic biology capabilities. Specifically, the framework is designed to support uses including analyzing existing biotechnologies to evaluate the levels of concern warranted at present; understanding how various technologies or capabilities compare to, interact with, or complement each other; identifying key bottlenecks and barriers that, if removed, could lead to a change in the level of concern about a capability; evaluating the implications of new experimental results or new technologies; and horizon-scanning to predict or prepare for potential future areas of concern. Using a framework for assessing the implications of synthetic biology capabilities thus contributes to biodefense planning and facilitates consideration of expert opinions about specific synthetic biology-enabled capabilities or combinations of capabilities.

AUTHOR


BG(R) William King has served in a wide variety of command, leadership, and staff positions across numerous levels of the U.S. Army, Joint Task Forces, Regional Commands, and most recently as the Commanding General 20th CBRNE Command before retiring on 19 July 2017 with 30+ years of active duty US Army service. He joined Booz Allen Hamilton in 2017 as an Executive Advisor for the Joint Combatant Commands (JCC) Account and on 12 Oct 2018 was designated as an Industry CWMD Senior Fellow. Today he is a Principal/Director and is responsible for developing the market for Countering Weapons of Mass Destruction, assessing synchronization and integration, advising senior government clients, and serves as the Booz Allen market lead on challenges/opportunities, and providing strategic thinking for Chemical, Biological, Radiological, Nuclear, and Explosives (CBRNE) policies, modernization, capability and capacity development. BG(R) King’s expertise, honed through a series of multi-echelon capability and leadership positions, has prepared him to tackle the nation’s most complex CWMD challenges. He is a known luminary and clear leader in the field. He is widely recognized for his breadth of knowledge, experience, and depth of understanding of CWMD challenges. He is skilled at addressing complex problems, is intellectually agile, and is a recognized leader who inspires others and builds teams with ease.