Jan 19, 2007
Regulating nanotechnology - meeting the challenge
The anticipated rapid emergence of nanotechnology brings significant regulatory challenges for environmental protection. A lack of regulation will undermine public confidence in the emerging technology. But on the other hand, an inappropriate regulatory burden could restrict the development of socially beneficial products and applications.
There has been little debate as to how the regulation of nanotechnology should appear. Law has long been at the interface between science, technology and regulation, so it's uncontroversial to suggest that such regulation is likely to be adopted in the form of law - whether national or international.
In devising regulatory systems for nanotech, it's essential to take important aspects of the technology into account. The regulatory response to nanotechnology should be official, international, flexible and innovative. To avoid the costly and long-running trade disputes seen in the genetically modified foods arena - where individual governments are able to proceed with the development of technologies under their own rules - will require an internationally-harmonized approach.
An international approach would benefit private firms that are developing and investing in nanotechnology and operate multinationally. Developing countries might also gain from an international framework as it could perhaps help them overcome any lack of resources and expertise to adopt their own national regulations.
One regulatory tool that could meet these requirements is an international framework convention (IFC) for nanotechnology.
But there's a problem with creating a nanotechnology IFC: international environmental law is influenced by a range of non-legal factors. The likelihood of achieving an effective measure will, to a large extent, depend on a scientific consensus about the emerging technology, increased public concern and the likelihood of short-term political benefits. That said, there are a number of factors that would play against the development of a nanotech IFC, such as the lack of an appropriate international forum for negotiating the convention, and the nature of arrangements for dealing with non-compliance. Of all these factors, both for and against the adoption of an IFC, the impact of science and the economic costs will be particularly influential.
The strong concern of states to ensure that their economic interests are taken into account in the development and application of environmental law has been matched by an equally firm view that environmental regulations should only be adopted where there is compelling scientific evidence that action is required to prevent environmental damage. The place of science in international environmental decision-making has been the subject of vigorous debate, largely focusing around competing claims concerning the lawfulness of the use of, and international trade in, modified foodstuffs, including genetically modified organisms.
In large part, the issues surrounding scientific considerations have been driven by differences of perspective between the United States and the European Union, with the former strongly in favour of decision-making which is based on "hard science" and strictly limiting the circumstances in which restrictions may be permitted in the face of uncertainty as to consequences. The contrary position - adopted by the European Union - would allow decision-makers a greater "margin of appreciation" in the face of scientific uncertainty. The tension in the two approaches has not been resolved at the level of international legislation, and will fall to international adjudicators to determine on a case-by-case basis.
The scientific uncertainty surrounding nanotechnology will influence the development of any proposed IFC. However, by limiting the IFC to being largely institutional and procedural in nature, with few substantive requirements or commitments, most of the reluctance brought about by scientific uncertainty can be overcome. The United Nations Framework Convention on Climate Change (UNFCCC) and the General Agreement on Tariffs and Trade (GATT) both started out on a similar basis with broad principles. Through the establishment of negotiating fora they then evolved into more effective, respected and powerful agreements. There is no reason why an IFC for nanotechnology could not develop along the same lines.
Where technical uncertainties exist, procedures will need to be put in place for developing, sharing and assessing scientific information. By putting institutions in place through an IFC, this would provide for a process of negotiating the substantive requirements once science has identified the real risks requiring regulation. When the scientific evidence becomes stronger, protocols could be adopted under an IFC since it would have cleared away many of the preliminary and institutional issues.
To provide credibility to the regulated parties and the public, there must be an official government role in assessing scientific information to inform the regulation of nanotechnology. However, this does not exclude the potential role that private institutions can play. The governments of Australia, Japan, the United Kingdom and the United States have independently come to the conclusion that some form of voluntary industry product stewardship programme is likely to be the most effective at this early stage of nanotechnology development. An IFC on nanotechnology could implement a legitimate and uniform transnational industry product stewardship programme to replace the current patchwork of different national programmes and provide greater consistency, effectiveness and certainty, especially for multinational companies.
To summarize, there is much promise in an IFC for nanotechnology, structured to address the specific characteristics and regulatory challenges associated with this emerging technology. The time for talking is now. The safe, equitable and successful worldwide development of nanotechnology will depend on establishing an adaptive, innovative and international regulatory framework before any problems arise and before faith and trust in the technology is needlessly lost.
About the author
Paul Collins is Environmental Law solicitor at Bond Pearce, Bristol, UK.