A Big Regulatory Tool-Box for a Small Technology

Abstract

There is little doubt that the development and commercialisation of nanotechnologies is challenging traditional state-based regulatory regimes. Yet governments currently appear to be taking a noninterventionist approach to directly regulating this emerging technology. This paper argues that a large regulatory toolbox is available for governing this small technology and that as nanotechnologies evolve, many regulatory advances are likely to occur outside of government. It notes the scientific uncertainties facing us as we contemplate nanotechnology regulatory matters and then examines the notion of regulation itself, suggesting new ways to frame our understanding of both regulation and the regulatory tools relevant to nanotechnologies. By drawing upon three different conceptual lenses of regulation, the paper articulates a wide range of potential regulatory tools at hand. It also focuses particularly on the ways various tools are currently being used or perhaps may be employed in the future. The strengths and weaknesses characterising these tools is examined as well as the different actors involved. The paper concludes that we will increasingly face debate over what is likely to work most effectively in regulating nano technologies, the legitimacy of these different potential approaches, and the speed at which these different regimes may be employed.

From Cradle-to-Grave at the Nanoscale: Gaps in U.S. Regulatory Oversight along the Nanomaterial Life Cycle

“…Such voluntary stewardship-based approaches have been only modestly effective in the past. − The failure of the EPA Nanomaterial Stewardship Program to collect ENM data voluntarily from industry illustrates this point with a lack of clear incentives for cooperation and perceived disadvantages to cooperating firms if competitors do not follow suit . To overcome these shortcomings, legal scholars have proposed multifaceted governance approaches utilizing a variety of legal, policy, and regulatory tools to address risks in a comprehensive manner. ,, The need is clear for innovative approaches to address novel ENM products and novel risks as nanotechnologies gain in complexity and ubiquity . However, without an effective top-down regulatory framework legally obligating producers to comply with information requests, voluntary programs are unlikely to provide regulators with the information they seek.…”

“…106 To overcome these shortcomings, legal scholars have proposed multifaceted governance approaches utilizing a variety of legal, policy, and regulatory tools to address risks in a comprehensive manner. 24,103,107 The need is clear for innovative approaches to address novel ENM products and novel risks as nanotechnologies gain in complexity and ubiquity. 108 However, without an effective top-down regulatory framework legally obligating producers to comply with information requests, voluntary programs are unlikely to provide regulators with the information they seek.…”

Governing risk, engaging publics and engendering trust: New horizons for law and social science?

“…Health-related research must now be conducted in an environment of strict control of personal data and where privacy impact assessments are expected to be a central feature of any governance framework (Laurie & Sethi, 2011;Information Commissioner's Office, 2012). Unfortunately, the preliminary nature of our understandings of the risks associated with many biosciences and biotechnologies introduces difficulties into all of these steps with the result that risk articulations are tentative and sound assessments are not yet within our grasp (Weisner et al, 2006;Handy and Shaw, 2007;Oberdörster et al, 2007;Bowman and Hodge, 2008). Law and legal institutions are face with profound dilemmas in such circumstances.…”

Governing Nanomedicine: Lessons from within, and for, the EU Medical Technology Regulatory Framework. Guest Editors Introduction

“…For the scientific community, nanotechnology or nanotechnologies are "about controlling matter at near atomic scales to produce unique or enhanced materials, products and devices" (Maynard et al 2006, 267), with the term nanoscience frequently used to describe the study of the phenomena at this scale (Royal Society and Royal Academy of Engineering 2004). What is important to note, however, is that nanotechnologies do not involve simply a uniform endeavour or field of innovation, but rather, as explained by Bowman and Hodge (2008), "a heterogeneous family of technologies and applications, unified by both scale and the exploitation of unique properties of elements and compounds that appear at the nanoscale" (195). At this scale, the physicochemical parameters of some engineered nanoparticles have been shown to display unique characteristics when compared to their to bulk counterparts, 4 which in turn gives rise to a number of diverse physicochemical properties relating to, for example, the material's physical and chemical characteristics (e.g., strength, solubility, and chemical reactivity) (Nel et al 2006;Oberdörster, Stone, and Donaldson 2007).…”