Accessibility issues

In relation to existing top-down governance measures for biosecurity, synthetic biology represents a promising yet potentially destabilizing advancement in the life sciences, one that could introduce new risks and regulatory challenges. In particular, a number of high-profile synthetic biology experiments, ranging from the de novo synthesis of poliovirus (Cello et al. 2002) to the recent synthesis of horsepox virus (Noyce et al. 2018), have raised concerns that the same techniques could be exploited to bypass regulatory controls (e.g. the United States, US, Select Agent Regulations) on lists of high-risk pathogens. Moreover, the possibility of synthesizing novel ‘taxonomically unclassified’ pathogens (NSABB 2006; Garfinkel et al. 2007) has led some to question the logic and utility of current ‘list-based’ approaches to regulation. Looking to the future, if synthetic biology does, in fact, ‘deskill’ the ‘art’ of biological engineering, new regulatory approaches could very well be essential because the tools of modern biology will be widely accessible to both responsible and malicious actors.

Claims about synthetic biology’s potential, like other emerging technologies, nonetheless tend to overstate its ‘enabling’ capacity. Likewise, the ease of producing biological weapons tends to be overstated. As a number of commentators note, biology is not yet easy to engineer (Jefferson et al. 2014) and, for the foreseeable future, the skills necessary to produce biological weapons are likely to remain only within the grasp of states (Piers Millet in Regalado 2016). However, the field’s emphasis on eliminating technical barriers and reducing the importance of tacit knowledge (Oye 2012) represents a powerful source of expectation for advocates and critics alike. For advocates, it represents the possible realization of modern biology’s full potential, one that could yield revolutionary advances in health, medicine, and industry in the twenty-first century. For critics, it represents a seemingly open-ended risk that requires exceptional precaution. For national governments, and international conventions responsible for establishing global biosecurity norms and obligations that are operationalized at the national level through legislation and other regulatory tools (McLeish and Nightingale 2007), a central question is how (if at all) does top-down biosecurity governance need to change in response to synthetic biology?

Regulatory considerations of this kind are both familiar and new (Hamilton 2015). In the 1970s, recombinant DNA technology similarly emerged as a source of significant and contrasting expectations, and questions were posed about the suitability of existing regulatory approaches in light of potentially novel risks. However, in the case of recombinant DNA technology, biosafety concerns – notably, concens about the possible unintended consequences of genetically modified organisms (GMOs) – were the primary focus of scientific deliberations at the Asilomar Conference and subsequent policy discussions. In the case of synthetic biology, a field that has emerged at a time of heightened concerns about (bio)terrorism, the possibility that synthetic biology could enable non-state actors to acquire (novel) biological agents that could be used as weapons has been an omnipresent source of concern. In 2009, synthetic biology came to the attention of the US Federal Bureau of Investigation (FBI) and in 2016 gene editing was listed as a potential weapon of mass destruction (WMD) by the US Intelligence Community (Ledford 2010; Clapper 2016).

To more fully understand the top-down governance challenges introduced by synthetic biology it is necessary to consider how synthetic biology’s novelties could disrupt or potentially undermine existing biosecurity regulations. In this chapter, we attempt to advance this discussion in several ways. First, we consider the scope and content of existing biosecurity regulations at the international and national levels. Second, we discuss several aspects of synthetic biology that present distinct regulatory challenges. Finally, we conclude with recommendations for strengthening current approaches to top-down biosecurity governance.

Taken together, we argue that although synthetic biology appears to be broadly (if indirectly) covered by existing international and national regulatory systems, several novelties underline the limitations of top-down governance approaches premised upon prohibiting access to specific ‘intrinsically dangerous’ scientific artifacts (McLeish and Nightingale 2007). Indeed, by some accounts, such restrictions may not only be ineffective, but may also make the world less safe. In an era of synthetic biology – characterized by technology convergence, increased access to bioengineering capabilities, and rapid growth in intangible life science knowledge – top-down governance must be increasingly adaptive, and hybrid forms of governance (incorporating a ‘mix’ of top-down and bottom-up approaches that leverage the self-governance potential of non-governmental actors) should be encouraged.