Shaping Nano Futures: Regulatory Definitions as Gatekeepers in the Pathway from Laboratory to Marketplace

Abstract

This poster illustrates the different regulatory paths a single nanomaterial (e.g., nanosilver) may take as it moves from the laboratory to commercial application, highlighting the impacts that varied government classifications have on the manner in which the nanomaterial ultimately enters the marketplace. In doing so, we illustrate how diverse regulatory rules and definitions can shape technological development, with long-embedded statutory or regulatory classifications often mattering more than the “scientific reality” of a given material. To demonstrate our point, we trace the selected nanomaterial through diverse potential regulatory routes depending on its perceived molecular composition, claims made about its impacts, or its intended use, showing the multiple “forks in the road” where government classifications can decide the material’s future path. At each fork, we show how statutory or regulatory classification or rules put in place often decades ago may determine the subsequent direction of the material, who (e.g., government or industry) is required to complete what actions for the material to move forward, and the likely capacity of either government or industry to fulfill their respective responsibilities. In doing so, this exercise sheds light on whether long-established regulatory rules and standards can be adapted to address the potentially unique challenges posed by new generations of nanoparticles and nanomaterials.