Decisions, Science, and Values: Crafting Regulatory Alternatives Analysis.

Emerging "prevention-based" approaches to chemical regulation seek to minimize the use of toxic chemicals by mandating or directly incentivizing the adoption of viable safer alternative chemicals or processes. California and Maine are beginning to implement such programs, requiring manufacturers of consumer products containing certain chemicals of concern to identify and evaluate potential safer alternatives. In the European Union, the REACH program imposes similar obligations on manufacturers of certain substances of very high concern. Effective prevention-based regulation requires regulatory alternatives analysis (RAA), a methodology for comparing and evaluating the regulated chemical or process and its alternatives across a range of relevant criteria. RAA has both public and private dimensions. To a significant degree, alternatives analysis is an aspect of product design; that is, the process by which private industry designs the goods it sells. Accordingly, an RAA method should reflect the attributes of well-crafted product design tools used by businesses. But RAA adds health and environmental objectives to the mix of concerns taken into account by the product designer. Moreover, as part of a prevention-based regulatory regime, it implicates important public values such as legitimacy, equity, public engagement, and accountability. Thus, an RAA should reflect both private standards and public values, and be evaluated against them. This article adopts that perspective, identifying an integrated set of design principles for RAA, and illustrating the application of those principles.