From genome editing to “hacking” the microbiome, advances in the life sciences and its associated technological revolution have already altered the biosecurity landscape, and will continue to do so. What does this new landscape look like, and how can policymakers and other stakeholders navigate this space? A new report by Stanford scholars David Relman and Megan Palmer along with George Mason University’s Jesse Kirkpatrick and Greg Koblentz assesses this emerging biosecurity landscape to help answer these questions and illustrates gaps in governance and regulation through the use of scenarios.

The report—the product of two years of workshops, issue briefs, and white papers authored by different participants—involved people from different organizations and backgrounds ranging from life sciences and medicine to social science and ethics. “The project process was just as important as the product,” said Palmer. “It was a truly interdisciplinary effort.”

Genome editing, including CRISPR, is disruptive to the biosecurity landscape, and it serves as an illustration of more general trends in the evolving landscape, the authors write. CRISPR technology does not exist in a vacuum—rather, it is enabled by, represents, and gives rise to a suite of technologies with potential benefits and that require new approaches to adaptive policy making and governance.

Scenarios illustrating governance gaps in in the report include:

• A reckless CRISPR user who develops and markets a probiotic created with genome editing that has serious unanticipated effects for consumers;
• An agricultural biotechnology firm conducting dual use genome editing research that lies outside current oversight, but nonetheless could have negative consequences for human health
• An intentional release of a gene drive organism from a lab, that while having limited physical harm, feeds a state-based misinformation campaign with large economic impacts
• An accidental release of a gene drive organism due to lack of awareness and uncertainty about the risk classifications and protocols for handling new technologies
• A terrorist group using commercial firms that lack strong customer and order screening to use genome editing to weaponize a nonpathogenic bacteria
• A state-sponsored program to develop biological weapons for new strategic uses, including covert assassination, using largely publicly available research
   

In each of these examples, the researchers play out a hypothetical situation exposing a number of security and governance gaps for policymakers and other stakeholders to address.

In the report, the authors conclude that genome editing has tremendous potential benefits and economic impacts. The authors note that the market for genome editing is expected to exceed $3.5 billion by 2019, but a security incident, safety lapse, reckless misadventure, or significant regulatory uncertainty could hurt growth. Increased reliance on the “bio-economy,” they write, means biosecurity is increasingly critical to economic security as well as human health.

Other key takeaways:

Genome editing has the potential to improve the human condition. Genome editing is poised to make major beneficial contributions to basic research, medicine, public health, agriculture, and manufacturing that could reduce suffering, strengthen food security, and protect the environment.

Genome editing is disruptive to the biosecurity landscape. The threat landscape has, and continues to expand to include new means of disrupting or manipulating biological systems and processes in humans, plants, and animals. Genome editing could be used to create new types of biological weapons. Further, technical advances will make misuse easier and more widespread.

CRISPR illuminates broader trends and the challenges of an evolving security landscape. An approach to biosecurity that accounts for these trends, and encompasses risks posed by deliberate, accidental, and reckless misuse, can help address the complex and evolving security landscape.

Technology must be taken seriously.  A thorough, informed, and accessible analysis of any emerging technology is crucial to considering the impact that it may have on the security landscape.

Key stakeholders must be engaged. Stakeholders in the genome editing field encompass a more diverse array of actors than those that have been involved so far in biosecurity discussions. These stakeholders range from international organizations to government agencies to universities, companies, lay communities writ large, and scientists.

Applied research is needed to create and implement innovative and effective policies. Applied research is necessary to continue the process of modifying existing governance measures, and testing and adapting new ones, as new genome editing technologies and applications are developed, new stakeholders emerge, and new pathways for misuse are identified.

Download the executive summary and full report at editingbiosecurity.org.