Disrupting Conventional Policy: The Three Faces of Nanotechnology

Technological innovation almost always comes at a price in terms, of environmental health. In large part, this equation can be traced to one of the fundamental differences between technological innovation and regulatory innovation. The former can often occur swiftly, coming from numerous diffuse sources within the market. The latter, with rare exceptions, moves slowly, flowing from centralized state, national or international sources. (1) Thus, regulatory response typically lags well beyond the introduction of new products and technology. Nanotechnology, defined for these purposes as the use, manipulation or control of materials at the nanometer scale, is yet another case in point. Nanomaterials already are present in hundreds of consumer and industrial applications, yet are subject to minimal regulation in the United States and elsewhere. Despite the paucity of comprehensive testing of nanomaterials, there is a growing body of evidence that exposure to some types of nanoparticles may pose significant health risks to workers and the general public. (2) The very properties that make engineered nanomaterials valuable--small size, large surface area and highly variable physical and chemical characteristics--both complicate our ability to monitor exposures to nanomaterials and increase the potential that some categories of nanomaterials will prove harmful. Notwithstanding the expected benefits of emerging nanotechnologies and nanomaterials, the hazards associated with them have lead to a cacophony of appeals for various types of regulatory response, ranging from a moratorium to industry self-regulation and virtually everything in between. With this background in mind, the UCLA Working Conference on Nanotechnology Regulatory Policy commissioned a series of papers to form the centerpiece of pragmatic discussion regarding the way forward. Commentators often characterize nanotechnology as disruptive, meaning it is a form of radical technological innovation that fundamentally challenges the existing product/technology market and leads to new competitive opportunities. (3) Yet this new technology is disruptive in three other significant ways as well. It presents difficult technical issues regarding toxicity testing and hazard assessment so central to conventional regulatory policy. Likewise, it highlights the limits of existing risk governance approaches in use in the United States and abroad, particularly with respect to the role of third parties and the general public in policymaking. Lastly, it strains an already overburdened--and some might say obsolete--regulatory system, raising calls for innovative approaches more suited to managing this strange new technology. The papers that follow deal thoughtfully with these three themes, providing useful background and provocative prescriptions for policymakers, industry and academia alike. THE NEED FOR A NEW TOXICOLOGY In The Scientific Basis for the Regulation of Nanoparticles: Challenging Paracelsus and Pare, Dr. Bernard Goldstein describes how the unique attributes of nanomaterials can turn commonly accepted laws of toxicology on their head. Consequently, he argues, conventional toxicity testing and assessment are neither protective nor cost-effective. He appeals for substantial investment in new approaches to toxicology, including new toxicological testing modalities, improved exposure assessment, and post-marketing surveillance of nanomaterials in products. Dr. Goldstein's emphasis on developing a new toxicology for nanotechnology is consistent with the growth of predictive toxicology more generally, (4) and with work currently underway at universities and other research centers. (5) Dr. Goldstein sees a direct link between the new toxicological science and regulatory policy, arguing that better science is required for appropriate risk management. He cautions against embracing the precautionary principle, concerned about the likelihood of incurring unreasonably high social costs. …