The private dimension in the regulation of nanotechnologies: developments in the industrial chemicals sector.

• Author: Bowman, Diana M.

ABSTRACT

This Article examines the rise of self-regulation for nanotechnologies with particular attention to the initiatives within the industrial chemical sector. These initiatives may be viewed as a window into the evolution of nanotechnologies more broadly. The commercialization of nanotechnology-based products has taken place against a backdrop of regulators and risk assessors attempting to evaluate the adequacy of conventional risk assessment paradigms. These assessments aim to predict the potential risks of engineered nanoparticles (ENPs), including bio-persistent ENPs, which have increasingly found their way into a range of consumer products including, for example, personal care products. Such products have emerged despite concerns over the lack of risk assessment data. Notwithstanding current gaps in knowledge, one leading scientific commentator has stated that "there has been enough [research into risks] to reasonably conclude that there are some applications that will present problems." (1) In addition, our focus on this sector is due not only to the industry's earlier success with the Responsible Care program, but also to the transatlantic regulatory divergence that has recently occurred with the implementation of the REACH Regulation in the European Union. (2)

The industrial chemicals sector therefore presents an interesting case study in how different countries and regulatory cultures choose to approach similar problems of adequately regulating under existing regimes, and more challengingly, future nanotechnology-based products and processes. This is a crucial issue because the limited number of government and independent regulatory reviews that have been undertaken in the United Kingdom, the European Union, the United States and Australia suggest that, while for the most part these products and applications will fall under existing instruments, some gaps or weaknesses do exist. Recognition of current limitations in science and law has acted as a catalyst for industry to develop their own responses to ensure the responsible development of nanotechnologies. These proactive initiatives have included the development and implementation of risk governance and risk management frameworks, in addition to both individual and collective codes of conduct. Importantly, they do not seek to replace current regulatory requirements, but rather supplement them where the organisations perceive regulatory gaps. However, the vital question remains: can citizens and governments rely on the private sector to adequately regulate their own behaviour as they seek to maximise returns from their investments?

Drawing on these issues, this Article argues that credibility, transparency, independent oversight, and sanctions are pivotal components to any effective self-regulatory scheme and that they should be core elements of regulatory solutions and instruments being developed and utilised by the private sector.

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1. INTRODUCTION II. REGULATORY MODELS AND NANOTECHNOLOGIES III. THE EVOLUTION OF REGULATION FOR NANOTECHNOLOGIES IV. THE INDUSTRIAL CHEMICAL SECTOR -- A CASE STUDY IN THE REGULATION OF NANOTECHNOLOGIES V. CONCLUSION I

   INTRODUCTION

   Most aspects of contemporary life are affected by regulation to a greater or lesser degree. Regulation influences how people and societies eat, drink, travel, work, play and interrelate generally. This is true for less developed as well as advanced economies. The strategic importance of regulation in daily life is increasing rapidly in all countries around the world as the effects of globalisation and dynamic technological development grow in their extent and intensity, and national economies and societies become more interconnected and interdependent.

   Regulation has a ubiquitous effect on and in societies around the globe, and it is into this "Brave New Regulatory World" that nanotechnologies are entering. It is quite possible that the impacts of nanotechnologies may also have ubiquitous effects as this century develops. The technology promises to have a significant impact across all industry sectors, with some commentators suggesting that advancements are "likely to be at least as great as that of the Industrial Revolution." (3) While the nanotechnology "label" has emerged relatively recently, this heterogeneous family of technologies has already engendered a high degree of enthusiasm from both the public and private sectors alike, along with attendant lofty expectations.

   The strategic importance of nanotechnologies in the short-to-medium term has prompted government and industry alike to invest heavily in research and development (R&D) programs. A recent article by Andrew Maynard and David Rejeski of the Project on Emerging Nanotechnologies provides an insight into the current level of nanotech-funding around the world, with the authors noting that global public and private spending on R&D-related activities was in the vicinity of $18 billion U.S. dollars per year. (4) This can be compared to the levels of global funding in 2004, which Lux Research estimated to be in the ball-park of $10 billion U.S. dollars per year, with the greatest proportion of this funding being provided by the public sector at that time. (5) While both figures are somewhat speculative, the rapid increase in investment in R&D activates--some $8 billion U.S. dollars over five years--is suggestive of the increasing perceived importance of the technology to both the private and public sectors.

   Against this backdrop, it has been suggested that since 2005 private sector investment has equaled and subsequently surpassed that of the public sector. As this Article discusses, private sector actors have also have been prominent in the development of regulatory initiatives relating to nanotechnologies.

   Based on global R&D activities, it is not Surprising that the number of nanotechnology-based products has been purported to have increased dramatically over the last three or four years. (6) With engineered nanoparticles (ENPs) having already been incorporated into product categories ranging from cosmetics to therapeutic goods, paints, construction materials and food contact materials, the number of people already involved in the manufacture or transportation of ENPs, as well as those actively utilising these products is likely to be significant at this time. Industry experts have hypothesised that this trend will accelerate over the coming decade as the technologies mature, developers see new commercialisation opportunities, and consumer demand increases for new or improved products across industry sectors. (7) Predicted human and environmental benefits associated with many of the anticipated products are broad and include, for example, a so-called paradigm shift for the health care sector through nano-medicines. (8)

   Notwithstanding these benefits, there is increasing concern among members of the scientific community that the very properties that make ENPs attractive from a product and investment point of view may have the potential to give rise to unintended health and safety consequences. (9) For example, studies have shown that under specific experimentation parameters, certain types of carbon nanotubes display toxic and pathogenic behaviour. (10) Importantly however, the authors of these studies have, along with other commentators, noted a number of caveats in relation to these findings. (11) The Royal Commission on Environmental Pollution acknowledged, for example, that there are plausible concerns relating to the potential toxicity of some ENPs under certain conditions and consequently have called for directed research programs to address these uncertainties. (12)

   Even where adverse results have been demonstrated and reported, the authors of such studies have commented on the need for "further research" (13) and cautioned against the generalisation or extrapolation of researching findings from one specific type of ENP to other nanoscale particles. (14) Such statements have done little to placate the growing anxiety being voiced by some stakeholders including Friends of the Earth Australia (15) and the International Center for Technology Assessment (16) over the potential risks posed by certain aspects of nanotechnologies. A number of recent high profile reports and peer-reviewed articles within the scientific literature have not significantly lessened these concerns. (17)

   For the most part, however, it has been suggested that when ENPs are fixed or embedded into solid matrices or materials, the particles are unlikely to present a toxicological hazard to either humans or the environment because in this state they are unable to interact with biological systems and cause harm. (18) The majority of consumer products will incorporate fixed ENPs, and consequently pose little concern at this time. By contrast, free ENPs (i.e., those not within a matrix) have greater mobility and may interact with biological systems and processes and impact on human and environmental safety. Exposure to free ENPs appears most likely during the manufacturing and production of ENPs when in the dry form, during the handing and transportation phase (prior to the ENPs being fixed), and in certain types of consumer products, such as cosmetics. (19) It would appear that there is the potential for exposure to also occur upon the break down or recycling of products containing what were initially fixed ENPs. (20)

   The scaling up of global manufacturing of ENPs combined with questions over hazard and exposure has, unsurprisingly, resulted in a number of commentators questioning the ability of governments to adequately govern the technology. (21) Such concerns are not unique to nanotechnologies per se, with the Royal Commission on Environmental Pollution having eloquently reminded us that "the policy challenge posed by novel materials is a specific instance of the more general dilemma of how to govern the emergence of new...