A New Soft Law Approach to Nanotechnology Oversight: A Voluntary Product Certification Scheme

Abstract

Regulatory oversight of nanotechnology is necessary yet problematic. The necessity of regulation, now or later, is driven by two related concerns. First, some nanotechnologies, if left unregulated, are likely to pose very real if currently unknowable risks of significant health or environmental damage. Second, public confidence in new technologies and in the regulatory agencies that govern them may be permanently damaged if injurious nanomaterials are released without adequate, or at least the perception of adequate, oversight. Of late, we have seen numerous proposals for “soft law” solutions, at least in the short term, as well as the implementation of some soft law mechanisms. None are based on the traditional command–and-control approach, under which government agencies enact detailed regulatory requirements enforced by the threat of penalty. Instead, all reflect a variety of voluntary, cooperative or partnership approaches. However, although these approaches have many advantages, none of the currently operational regimes has fully achieved two obvious and oft-cited goals of nanotechnology regulation: (1) broad industry participation, with sufficient data submission to aid regulators in risk assessments; and (2) reassurance of public stakeholders as to government’s role in regulating emerging technologies. This article therefore proposes another soft law option that may better achieve these goals. We propose a voluntary certification scheme under which companies that produce nanotechnology products may obtain a government-supervised certification for specific products if the firms subject those products to specified safety testing, data disclosure and risk management measures. Given differing national regulatory approaches, our proposal is designed primarily for the United States. However, there is nothing in the proposal that could not be adapted for use in other jurisdictions, indeed, nothing to prevent creation of an equivalent international scheme. Part II sets up the need for new approaches by explaining why regulation of nanotechnology is largely infeasible under traditional approaches. Part III summarizes the experience and promise of current soft law regimes, as well as some of their limitations. This Part also identifies some features of successful certification systems and discusses their relevance to a nanotechnology certification system. Part IV introduces our proposal for a voluntary safety testing certification scheme, and discusses the ways in which such a scheme might gain the trust of consumers and other relevant audiences. Part V considers the elements of the scheme in greater detail. The final section is a brief conclusion.