A new soft law approach to nanotechnology oversight: a voluntary product certification scheme.

• Author: Marchant, Gary E.

1. 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 nanotechnology 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, nanotechnology regulation remains problematic. Most regulatory hurdles are currently insurmountable because we still do 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 nanotechnology governance and oversight to emerge. (5)

   Of late, we have seen numerous short term proposals for "soft law" (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 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. (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 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 or prevent the 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 Part is a brief conclusion.

   II.

   THE FUTILE (NEAR TERM) QUEST FOR COMMAND--AND--CONTROL REGULATION

   Many see a growing need for meaningful regulatory oversight of nanotechnology. (9) However, pressure for command-and-control regulation is frustrated by a number of obstacles. This Part addresses both the need for regulatory oversight and the impediments to traditional regulatory approaches.

   1. Demand for Regulation

      Nanotechnology involves the manipulation and use of materials at the nanoscale. The nanoscale ranges from approximately one to one hundred nanometers. At this size range, materials tend to exhibit different properties than they do at the bulk scale, usually including greater activity and reactivity. (10) The exploitation of these unique properties is fueling a frenzy of new products, processes and technologies. (11) These applications have the potential to provide enormous societal benefits, including improved cancer detection and treatment, cleaner energy, more efficient computers and electronic equipment, stronger and lighter structural materials, and yes, odor-free socks. Unfortunately, the same traits responsible for the many potential benefits of nanomaterials--especially their small size and dynamic properties-also create health and environmental risks, through the potential for nanomaterials to penetrate and react with biological systems.

      Current scientific evidence as to these risks is at best mixed. A few studies, some involving high exposures that may not be representative of human exposure levels, have induced toxic responses in animals. (12) Other studies, however, have produced relatively inert responses, suggesting the absence of significant health risks. (13) Whether these differences in result are based on errors in the studies, variances in the materials studied, or other phenomena, the perplexing bottom line is that there is currently no methodology for predicting which nanomaterials will produce a toxic response and which will not. Indeed, a specific nanomaterial may present significant variations in risk. For example, single-walled carbon nanotubes differ widely in terms of manufacturing method, coatings, size and other parameters; the limited available toxicology data indicate that these differences may produce dramatic variations in risk. (14) Traditional toxicological methods for extrapolating risks between related substances, most importantly quantitative structure activity relationships (QSAR), do not appear to work for nanomaterials for which hazard differences are largely determined by factors other than chemical structure, including size, surface area and surface chemistry.

      This highly ambiguous evidence leaves scientists and regulators in a position of toxicological purgatory, as explained by Kristen Kulinowski, director of the International Consortium on Nanotechnology (ICON): "We are in this awkward middle territory where we have just enough information to think there is an issue, but not enough information to really inform policymakers about what to do about it." (15) The highly uncertain and underdeveloped data sets on nanotechnology paralyze regulatory agencies under most existing statutes. The Toxic Substances Control Act (16) requires a finding of "unreasonable risk" while the Occupational Safety and Health Act (17) requires a finding of "significant risk" based on quantitative risk assessments. However, quantitative risk assessments are not currently available or feasible for nanotechnology exposures.

      Yet scientific uncertainty is seldom a reason for concerned actors to sit on their hands. Instead, as each new study suggesting a potential hazard from some nanomaterial is released, the number and urgency of calls for a substantive regulatory response increase. For example, in 2007 a coalition of forty-five nongovernmental organizations (NGOs) issued its "Principles for the Oversight of Nanotechnologies and Nanomaterials," calling for adoption of "a sui generis, nano-specific regulatory regime." (18) Even some industry representatives have recognized a need for more rigorous regulatory oversight. For example, one industry expert testified to Congress:

      [W]hat we want to avoid is for the trajectory of nanotechnology to follow that of genetically-modified organisms (GMOs), the most recent 'magic' technology. In the case of GMOs, deployment of applications outpaced attention to the environmental, health, and safety implications of the technology. Public concerns that arose because of this have significantly retarded the realization of GMO's great commercial potential. (19) Although it is unclear whether the GMO experience is as closely analogous to nanotechnology as this quotation suggests, many see a need for some regulatory response to the perceived dangers of nanotechnologies.

      These voices and many others, including legislators, insurers, investors, journalists and scholars, are creating growing momentum for nanotechnology regulation. (20) Such regulation could serve two valid purposes. First, it could reduce and manage the real risks that some nanotechnology products and processes are likely to create, benefiting public health, the environment and the long-term viability of the industry. Second, it could help build public confidence and trust in nanotechnology, an important secondary purpose of regulation.

   2. Obstacles to Regulation

      Unfortunately, and perhaps not surprisingly, regulation of nanotechnology is not as...