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

Abstract

I. INTRODUCTION II. THE FUTILE (NEAR TERM) QUEST FOR COMMAND--AND--CONTROL REGULATION A. Demand for Regulation B. Obstacles to Regulation III. THE LIMITS OF CURRENT SOFT LAW APPROACHES IV. A VOLUNTARY SAFETY TESTING CERTIFICATION SCHEME A. Background on Certification Programs B. The Role of Trust in Certification Programs 1. Dispositional and Situational Trust 2. Reputational Trust 3. Institutional or System Trust 4. Associational Trust 5. Trust and Certification Marks: Examples and Implications V. DESIGNING AND IMPLEMENTING A NANOTECHNOLOGY CERTIFICATION PROGRAM A. Requirements of a Nano Safety Testing Certification Program 1. Disclosure and Reporting 2. Premarket Toxicity Testing 3. Risk Management Practices 4. Post-market Surveillance B. Implementation of the Certification Program C. Limitations and Challenges of the Certification Program VI. CONCLUSION I. INTRODUCTION Regulatory oversight of is necessary yet problematic. The necessity of regulation 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. (1) 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. (2) Despite these considerations, regulation remains problematic. Most regulatory hurdles are currently insurmountable because we still not know exactly what nanotechnology means or encompasses, much less what concrete risks it may pose. Nanotechnology is a poorly defined, insufficiently understood set of diverse products, processes, and technologies that is not easily captured by any existing regulatory definition, model or system. This situation creates a problem for traditional regulatory tools. Government command-and-control regulations require, among many other things, clear definitions of what is to be regulated, understandable compliance requirements, and strong policy-based rationales to justify the regulation. (3) The impropriety, if not questionable legality, of employing traditional regulatory approaches, coupled with growing calls to do something, (4) has created an opportunity for new models of governance and oversight to emerge. (5) Of late, we have seen numerous short term proposals for (6) solutions and 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. (7) However, although these approaches have many advantages, none of the currently operational regimes has fully achieved two obvious and oft-cited goals of 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. (8) Therefore, this Article proposes another soft law option that may better achieve these goals. We propose a voluntary certification scheme under which companies that produce 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 or prevent the creation of an equivalent international scheme. …