2009 Working Conference on Nanotech Regulatory Policy
April 17, 2009
California NanoSystems Institute | UC CEIN | UCLA School of Law

Speakers and Commentators



Assemblyman Mike Feuer
Representing the 42nd Assembly District 		Special Lunch Speaker

Andrew Maynard
Chief Science Advisor to the Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars, Smithsonian Institute 		Overview of Science Issues Affecting Policy

Dr. Maynard will present an overview of the most critical challenges in producing the science needed for developing and implementing nanotech regulatory policy. Topics will include exposure monitoring, toxicity testing and the availability of standard reference materials.

Presentation

Bernard D. Goldstein, M.D.
University of Pittsburgh School of Public Health 		 

John Froines
Professor, Department of Environmental Sciences, University of California, Los Angeles Area of Expertise: Air Pollution, Public Health 		Commentator: Toxicology and Policy Short Panel

Dr. Diana M. Bowman Monash Centre for Regulatory Studies, Monash University, ABN
Dr. George Gilligan Senior Research Fellow, Department of Business Law and Taxation, Monash University, ABN 		Title: Self-regulation by industry: Sufficient to protect the consumer, the company and the technology?

Abstract: This paper examines the rise of civil regulation for nanotechnologies, and in doing so, pays particular attention to the initiatives within the industrial chemical sector, which may be viewed as a window on the evolution of nanotechnologies more broadly. The commercialisation 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, for example, personal care products. This is 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.'

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. The industrial chemicals sector therefore presents as an interesting case study in how different countries and regulatory cultures choose to approach similar problems of adequately regulating current, and more challengingly, future nanotechnology-based products and processes under existing regimes. 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 managements frameworks, and codes of conduct (both individual and collective). Importantly, they do not seek to replace current regulatory requirements, but rather supplement them where the organisations perceive regulatory gaps. However, can citizens and governments rely on the private sector to adequately regulate their own behaviour as they seek to maximize returns from their investments? Drawing on these issues this paper 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. The paper concludes by providing a number of specific recommendations on how the private sector can develop legitimate and effective regulatory programs that operate against, and within, the context of government regulation. Consideration is also given to the ways in which the public and private sectors may proactively co-operate in order to ensure the success of the technology.

Gary Marchant
Lincoln Professor of Emerging Technologies, Law & Ethics Sandra Day O.Connor College of Law, Arizona State University		 Title: Law Approaches to Nanotechnology Oversight

Abstract: This paper argues that traditional regulatory approaches are currently not feasible for nanotechnology, due to problems such as the lack of an enforceable definition of nanotechnology, the range and variety of nanotechnology applications and products, the enormous uncertainties about nanotechnology risks, the inability to accurately monitor nanotechnology discharges or exposures, and the unavailability of toxicological tools for categorizing or extrapolating nanotechnology risks. Nevertheless, some form of meaningful governmental oversight is necessary in order to both minimize potential risks and to instill public confidence in the technology. Accordingly, an oversight model is proposed that phases in a series of 'soft law' approaches that become increasingly hardened over time as new information becomes available. A variety of such soft law approaches are available, beginning with private standards and industry partnerships, which can evolve into programs with a greater governmental role such as a voluntary government certification program that would provide a government 'safety tested' certification for nanotechnology products that are tested in a specified battery of pre-market toxicological tests and are monitored with a post-marketing surveillance program. An additional advantage of these type of soft law approaches is that they may be more amenable to international adoption and harmonization. The soft law approaches that will be presented in this paper are part of a three-year project funded by the Department of Energy to generate new oversight models for nanotechnology, for which the author is a P.I.

Dr. Magali Delmas
Associate Professor of Management Institute of the Environment, University of California, Los Angeles, Area of Expertise: Business, Economics, Public Policy 		Commentator: Private Regulation of Nanotechnology Panel
Thomas R. Jacob
Government Affairs Manager, Western Region, Dupont Company 		Commentator: Private Regulation of Nanotechnology Panel

Douglas Kysar
Professor of Law, Yale Law School 		Title: Nanotechnology, Assurance Bonding, and Symmetric Humility

Abstract: To date, the turn toward market-based regulatory tools in the environmental, health, and safety context has tended to focus on taxes, tradable permits, and information disclosure rules, with comparatively little attention devoted to environmental assurance bonds. This paper will argue that environmental assurance bonding offers a particularly attractive regulatory approach for contexts - such as the present state of nanoscale science and engineering - in which both the risk and the benefit sides of the regulatory equation are characterized by great uncertainty. Historical examples and existing scholarly analyses of environmental assurance bonding will be reviewed, and the resulting lessons will be situated within the larger debate over economic cost-benefit balancing and precautionary approaches to environmental law and policy. In particular, the paper will argue that assurance bonding displays the virtue of symmetric humility, paying due heed to the dynamism and complexity both of sociolegal systems such as markets and of biophysical systems such as aquatic ecosystems.

Unlike typical cost-benefit approaches, environmental assurance bonding acknowledges uncertainty regarding the value, resilience, and replaceability of biophysical systems by assessing serious ex ante financial responsibility for the potential causation of environmental harm. At the same time - and in contrast to strict interpretations of the precautionary principle - environmental assurance bonding acknowledges the strength and dynamism of sociolegal systems by allowing market actors to proceed with potentially beneficial activities despite the existence of a credible risk of harm. Indeed, environmental assurance bonding actively marshals the decentralized decision making power of markets as a force for the development of knowledge regarding uncertain substances and activities. As such, the policy approach reflects a high degree of what has been called ecological rationality, approaching ill-posed regulatory problems with a pragmatic combination of respect for the power of markets and human technology, and caution before the complexities of nature.

Timothy Malloy,
Professor of Law, University of California, Los Angeles 		Commentator

David A. Dana
Associate Dean for Academic Affairs: Faculty and Research Professor of Law, Northwestern University 		Title: Limited Protection from Tort Liability and a Precautionary-Study Principle for Nanotechnology Products

Abstract: For products embodying nanotechnology, there is a powerful normative case for adherence to what I will call 'the precautionary-study principle' - a principle according to which the possible risks from products are at least explored if (in all likelihood) not really understood before their release to the marketplace, and possible risks are thereafter continually studied as the background science improves and any adverse effects of the products in the 'real world' may become observable with proper monitoring and analysis. In order to shift the status quo toward more adherence to a precautionary study principle, this Article will propose a legislative regime of limited protections from tort liability for nanotechnology product producers who engage in or financially support pre-market and post-market research regarding the possible adverse health and environmental effects from their products.

In response to the possible risk from nanotechnology products, some NGOS have called for a moratorium on the release of new nanotechnology products until their safety can be affirmatively demonstrated. In effect, the calls have been for the application of a strong form of the precautionary principle to nanotechnology products. For social welfare as well as pragmatic political reasons, the precautionary focus with regard to nanotechnology products should be consistent with the less demanding, more flexible precautionary-study principle. The question is how to move toward greater realization of a precautionary study principle.

The Article will use an economic model of industry research decisionmaking to frame a discussion of the current and potential role of tort liability in encouraging and deterring precautionary study of nanotechnology products. To the extent U.S. tort liability allows manufacturers to defend on the basis of a lack of knowledge of risk at the time of manufacture and sale, the tort system actively discourages precautionary study. Even to the extent that tort law does impose what is sometimes referred to as hindsight liability - liability for harms from products that have risks that were not understood until after they were marketed - the possibility of tort liability may discourage precautionary study: manufacturers may avoid study if, as may well be true in the nanotechnology context, they believe that that there is a very low probability that other, independent research will ever be undertaken that will causally link their products to adverse health effects.

The Article will then develop a proposal for limited tort protection for nanotechnology product manufacturers in return for their voluntary commitment to invest in pre-market and post-market study of possible adverse effects from their products. As long as such a proposal were wed to a commitment to bolster somewhat non-corporate, background basic research and included requirements of government supervision of research and strong public disclosure, it could result in greater voluntary investments in precautionary study. Moreover, to the extent precautionary study of any one product or products also sheds light on the possible effects of other products, there is likely to be a dynamic where the first participants in a voluntary program in effect draw in other participants to the point where significant industry participation is achieved.

Lee C. Paddock
Professor, The George Washington University Law School

Title: An Integrated Approach to Nanotechnology Governance

Abstract: Environmental and public health governance in the context of nanotechnologies present particularly difficult challenges because of the speed at which the technologies are developing and because of the wide range of technologies that are likely to include nanomaterials. In its study on Managing the Effects of Nanotechnology, the Woodrow Wilson Institute for Scholars pointed out that
[t]he rapid development of [nanotechnology] also means that government managers always will be operating with outdated information, and data about [nanotechnology] effects will lag behind commercial applications. Priorities for research and regulation will need to shift constantly. We have moved into a world which is.. dominated by rapid improvements in products, processes, and organizations, all moving at rates that exceed the ability of our traditional governing institutions to adapt or shape outcomes.1
The result is that effective environmental and public health governance will require the use of several governance tools. Traditional regulation must be part of the governance mix but the mix must also include a much more robust information disclosure regime, mechanisms for building public understanding of the risks and benefits of nanotechnology, a way that a broader range of the public can engage in the debate over nanotechnology management, a greater reliance on industry self-regulation programs such as the Environmental Defense - DuPont framework for 'Getting Nanotechnology Right,' and residual tort liability to help deter premature introduction of products that may be harmful.

1CLARENCE DAVIES, WOODROW WILSON INT.L CTR FOR SCHOLARS, PROJECT ON EMERGING NANOTECHNOLOGIES, MANAGING THE EFFECTS OF NANOTECHNOLOGY 9 (2006).

The paper will posit that an integrated system of governance is needed to identify and minimize the risk of adverse consequences from this rapidly growing set of technologies, to maintain public confidence in the industry, and to facilitate the development of important new technologies. The paper will first explore the problems posed for traditional regulation given the speed with which nanotechnologies are reaching the market and the diversity of technologies. It will then discuss the role and limitations of traditional regulation related to nanotechnologies including the role that regulation is anticipated to play in regulating nanotechnologies in the EU. The paper will examine four addition mechanisms that could, together, form an integrated system of governance. These four mechanisms are:
  • Information disclosure including the role that REACH type disclosures could play for nanotechnologies,
  • Public engagement including web-based mechanisms for providing credible information on nanotechnologies to the public and for the public to provide comments to regulators and members of the industry,
  • Self regulation systems that are reinforced by government recognition of the systems, and
  • Tort liability.
The paper will close with a discussion of the importance of viewing this approach as a 'system' of governance rather than a series of separate, uncoordinated approaches to nanotechnology governance.

Dr. Oren Perez
Faculty of Law, Bar- Ilan University, Ramat-Gan, Israel 		Title: Nano-politics and Precautionary Science: Nano-Technology as an Experiment in Precautionary Regulation

Abstract: Nano-technology presents regulators with a difficult challenge. Nano materials and nano-processes involve deep uncertainties regarding health and environmental risks, potential benefits reflecting the embryonic state of the underlying science. These uncertainties are exacerbated by the fact that nano-technology is not a uniform domain, but in fact encompasses a broad range of technologies and products, including bionanotechnology, supramolecular chemistry, nanostructured materials, self-assembly nano processes.

Given these uncertainties there has been various calls to use the precautionary principle ("PP") as a governing principle in the regulation of Nano-technology. Thus, for example, the Intergovernmental Forum on Chemical Safety (IFCS) recommended in September 2008 that the precautionary principle be used 'as one of the general principles of risk management' in the regulation of Manufactured Nanomaterials. A recent joint statement by several environmental NGOs notes similarly that 'The Precautionary Principle must be applied to nanotechnologies because scientific research to-date suggests that exposure to at least some nanomaterials, nanodevices, or the products of nanobiotechnology is likely to result in serious harm to human health and the environment.'

The PP, as this paper will seek to demonstrate remains . despite more than two decades of legal experimentation - an extremely vague principle, susceptible to conflicting interpretations. Thus, for example, there is indeterminacy regarding the type and magnitude of harm necessary to invoke the principle, the probability of harm in which such invocation will be justified and the level of costs (or foregone benefits) that society should be willing to incur in order to avert certain dangers. The different interpretations of the PP also seem to reflect differing opinions about the capacity of science to generate absolute predictions . of both safety and risks (disregarding Hume's famous challenge of inductive reasoning). The deep fluidity of this principle questions its usefulness as a guide for regulating Nano-technology.

Hilary Godwin
Professor, Environmental Health Sciences, Associate Dean for Academic Programs, School of Public Health, University of California, Los Angeles 		Commentator

Sean Hecht
Lecturer in Law
Executive Director, Environmental Law Center
UCLA School of Law 		Moderator