January 31, 2011 - While there is a consensus that nanotechnology, in addition to its vast potential, also poses significant health and environmental challenges, there is no consensus on how to address these challenges. In response, Timothy Malloy, a Professor of Law at UCLA, has published a paper in ACS Nano discussing regulation of nanotechnology. The paper outlines two standard approaches to regulation, hard-law and soft-law, and ways in which the proponents of each approach make their case. After analyzing each approach, Malloy makes the case for an alternative approach, which he calls iterative regulation.
Hard-law involves the conventional direct regulation of nanotechnology by bodies such as the Environmental Protection Agency, which sets out performance standards and uses monitoring and penalties to enforce those standards. Soft-law includes self-regulation by industries, and have no or limited legal force. Self-regulation is said to influence business behavior through three incentives - tort liability, stigma, and norms. Malloy contends that each of these incentives to self-regulate has limited influence on nanotechnology companies, and that direct regulation is a more effective policy.
Malloy envisions iterative regulation to be a three-fold approach. The first element involves identifying areas of regulatory concern based upon the existing and emerging scientific literature. The second element of iterative regulation concerns the implementation of regulations once areas of concern are identified. Because of a lack of detailed studies on the safe levels of many nanomaterials, Malloy advocates the use of industry best practices to shape policies. Regulators should identify successful industry best practices and then use their enforcement powers to ensure that those best practices are deployed throughout the industry. The third element is the continuing adjustment of regulation as new information regarding toxicity, exposure and safer alternatives and practices arises. Over time, this could lead to more conventional forms of direct regulation.
Professor Malloy is a faculty director of the UCLA Sustainable Technology and Policy Program, a joint undertaking of the School of Law and the School of Public Health. He is also on the Education and Outreach committee of the UC Center for the Environmental Implications of Nanotechnology (UC CEIN), a center established to ensure that nanotechnology is introduced in a responsible and environmentally compatible manner. UC CEIN, which is headquartered at CNSI, is funded by a cooperative agreement from the National Science Foundation and the Environmental Protection Agency.
Professor Malloy's paper is titled, "Nanotechnology Regulation: A Study in Claims Making," and can be read in full at ACS Nano.