The ongoing biotechnology revolution – particularly in the fields of genome sequencing, editing, and synthesis – has led to advancements and applications in the fields of medicine, agriculture, and environmental science. Naturally, the potential use of these technologies by those with malicious intent has brought up many questions and concerns. To begin to provide some answers and clarity, the US Department of Defense (DoD) asked the National Academies of Science, Engineering, and Medicine (NAS) to conduct a study regarding the potential concerns related to advances in synthetic biology. On Aug. 25, 2017, they published their initial report, “A Proposed Framework for Identifying Potential Biodefense Vulnerabilities Posed by Synthetic Biology.”
Synthetic biology is the use of biotechnology to predictably modify or create organisms or biological components. Synthetic biology is being used to design microbes that will seek and destroy tumors, build organisms to consume toxic chemicals in water or soil, and synthesize biofuels that would reduce our dependency on fossil fuels. However, in this golden age of biotechnology, the dual-use threat of synthetic biology has raised questions such as: what are the synthetic biology threats, their time frames, and options for mitigation? Some of these issues have been explored by our colleague Dr. Gigi Gronvall in her recent book, Synthetic Biology: Safety, Security, and Promise. Dr. Gronvall is also a contributor to the NAS report under consideration.
The NAS committee created a framework that seeks to answer these questions. It is important to note that the authors limited their analysis to threats that could potentially be used to directly target either human health or prevent military personnel from executing their missions. Modification of plants, animals, their associated pathogens, and organisms with an environmental effect (e.g., undermine agricultural productivity) were beyond the scope of their report. It would be interesting to see a future study that applies the guidelines in this report to synthetic biology threats that target the biosphere at large such as engineered insects, modification of bacterial and fungal species to produce chemicals on demand, and gene drives.
The framework breaks down synthetic biology technologies and applications into several broad categories. Within these categories various questions will be asked regarding specific technologies, potential actors who may use them, the feasibility of creating biological weapons, and options for mitigation.
Each synthetic biology technology and application was categorized in terms of the ways in which they enable the Design-Build-Test (DBT) cycle – which is an iterative design strategy that demonstrates the cyclical nature of practical synthetic biology from the designing of a prototype, to the building of said prototype, and finally testing to evaluate and improve its design.
Approaching synthetic biology in this manner allows the guiding principles of the framework to be applicable to not only the technology of today but of those in the future. However, some technologies may enable multiple aspects of the DBT cycle, and those will be of particular interest to the NAS committee during the second phase of this project. Additionally, the committee will examine the complex interplay that advancement in other fields may have on increased use or ease of access to synthetic biology technology.
The committee’s final report will further refine their initial framework with the input of those in the synthetic biology research community and provide insight as to what biosecurity concerns are most warranted and what the DoD can do to address the areas of greatest concern.