S56 January-February 2018/HASTINGS CENTER REPORT M uch of the most substantive and in-depth ex- perience with formal CBA in the public poli- cy realm has occurred in the context of federal environmental regulation in the United States. This experience has many important lessons to teach in the realm of synthetic biology. Indeed, many of the dangers and pitfalls that arise when decision-makers use formal CBA to evaluate environmental regulation seem likely to arise in the synthetic biology context as well, sometimes in particularly troubling forms. Unfortunately, while in many instances these concerns may well point toward a rejection of formal CBA for synthetic biology, the expe- rience from environmental regulation turns out to be far less helpful in identifying alternative decision-making tools. Because the decisions that arise in the synthetic biology context have a fundamentally different struc- ture from decisions about environmental regulation, the most useful alternatives from that context do not map easily onto this new context. It may well be generally true that in the search for de- cision-making tools, we should not be looking for a sin- gle silver bullet that will work in all public policy realms. Perhaps, instead, different kinds of decision-making call for different tools. This may be true even within the realm of synthetic biology. I am not entirely sure what the “right” tool is for synthetic biology applications, or even whether a “right” tool exists. But at the end of this essay, I offer a few tentative thoughts about why scenario analysis—a strategic planning tool first developed in the context of military planning following World War II— might be one alternative worth considering. Lessons from Environmental Regulation A lthough it traces its roots to nineteenth-century France, 1 much of the theoretical and practical de- velopment of CBA as a tool for public policy decision- making, particularly of the formal, quantified brand most prevalent in the academic and policy literature to- day, has occurred in the United States in the context of environmental, health, and safety regulation. 2 Ironically, even though U.S. agencies expend substantial time and resources preparing ever more formal and elaborate CBAs of proposed regulations, in most instances, these documents do not, ostensibly at least, form the basis for decision. The obligation to prepare CBAs arises from a series of executive orders, dating back to the Reagan ad- ministration, that require agencies to demonstrate that benefits “justify” costs for “major” regulations (those costing the economy one hundred million dollars or more). 3 But an executive order, of course, cannot over- ride a statutory command. And only a small handful of U.S. environmental statutes actually make CBA the rule of decision. In most instances, Congress has directed agencies to use some alternative decision-making tool instead, most prominently (as discussed below) feasi- bility standards. 4 As a result, agencies are often put in the anomalous position of being required to conduct a formal CBA even though they are required to make the decision using an alternative tool. Nonetheless, agencies devote significant time and resources to these CBAs. And under the oversight of a staff of economists at the White House Office of Information and Regulatory Affairs, the brand of CBA practiced by U.S. agencies has become more and more formal, employing mathematical models as well as he- donic and contingent valuation studies (which attempt to price nonmarket goods) in increasingly elaborate at- Lessons from Environmental Regulation By Amy SINdEN Amy Sinden, “Lessons from Environmental Regulation,” Governance of Emerging Technologies: Aligning Policy Analysis with the Public’s Values, special report, Hastings Center Report 48, no. 1 (2018): S56-S64. DOI: 10.1002/hast.820