Policy on Synthetic Biology: Deliberation, Probability, and the Precautionary Paradox

Abstract

Synthetic biology is a cutting-edge area of research that holds the promise of unprecedented health benefits. However, in tandem with these large prospective benefits, synthetic biology projects entail a risk of catastrophic consequences whose severity may exceed that of most ordinary human undertakings. This is due to the peculiar nature of synthetic biology as a 'threshold technology' which opens doors to opportunities and applications that are essentially unpredictable. Fears about these potentially unstoppable consequences have led to declarations from civil society groups calling for the use of a precautionary principle to regulate the field. Moreover, the principle is prevalent in law and international agreements. Despite widespread political recognition of a need for caution, the precautionary principle has been extensively criticized as a guide for regulatory policy. We examine a central objection to the principle: that its application entails crippling inaction and incoherence, since whatever action one takes there is always a chance that some highly improbable cataclysm will occur. In response to this difficulty, which we call the 'precautionary paradox,' we outline a deliberative means for arriving at threshold of probability below which potential dangers can be disregarded. In addition, we describe a Bayesian mechanism with which to assign probabilities to harmful outcomes. We argue that these steps resolve the paradox. The rehabilitated PP can thus provide a viable policy option to confront the uncharted waters of synthetic biology research.

The value of bioethical research: A qualitative literature analysis of researchers’ statements

“…One example of this contribution is an article which discusses a paradox occurring regarding synthetic biology, namely, that the application of the precautionary principle can result in a situation where each way of action may result in catastrophic consequences. The authors declare that they present arguments which resolve this theoretical problem as a main contribution of their article [42].…”

Regulation of GM Organisms for Invasive Species Control

“…However, it is important to re-iterate that regulatory decision making should take into account the ecological consequences of applying/not applying control measures (including GD) when it comes to remediation of damage. A well-designed risk assessment helps to manage the tension between a desire for caution regarding the risk of intervention and worry about the risks of non-intervention (Wareham and Nardini, 2015). A historic example of intervention for the beneficial eradication of a disease is malaria in Europe (Box 2).…”

(Re‐)Designing Nature? An Overview and Outlook on the Ethical and Societal Challenges in Synthetic Biology

“…While it is implied that there must at least be an idea of the particular societal challenges which should have been addressed, [11] it seems to be perhaps one of the major lessons of at least the past two decades of biotechnological invention that there remains an inherent vagueness. [18][19][20][21][22][23] And third, emerging biotechnologies comprise a certain kind of ambiguity regarding the legal regimes, codes of conduct, and embedded beliefs and values which are linked to the practices, products, and outcomes of emerging biotechnologies. [3] Within the discourse on emerging biotechnologies, this inherent vagueness has been addressed along three important lines: a transformational potential, an embedded uncertainty, and last but not least an inherent ambiguity.…”

“…[13][14][15][16][17] Second, they involve uncertainty about the range of possible outcomes which have to be distinguished from quantifiable risks (in the sense that the range of outcomes and the likelihood of their occurrence is predictable to a specific degree). [18][19][20][21][22][23] And third, emerging biotechnologies comprise a certain kind of ambiguity regarding the legal regimes, codes of conduct, and embedded beliefs and values which are linked to the practices, products, and outcomes of emerging biotechnologies. [7] By understanding the conceptualization of SB as an emerging biotechnology, it is unsurprising that there is a broad and diverse scope of disciplines, approaches, and concepts pursuing the idea of SB.…”