www.h20technologies.com

www.h20technologies.com

We are seeing an explosion of interest in and information about nanotechnology, its uses and its risks.  The law has yet to develop in this field.  I am pleased to start the conversation in this blog on the legal issues that are beginning to emerge about nanotechnology.  My entries will focus on efforts to determine what risks the new technologies may pose to consumers and the population in general.  My expertise in the area of toxic tort law is uniquely suited to examining the emerging health concerns from the viewpoint of anticipated litigation.  My co-blogger, Eric Laury, Widener Law ’11, will focus on the legal issues involving the development and use of the technologies, including intellectual property matters.  This blog is not intended to be a news source, though it will provide some links to stories in the news that bear upon our commentary.  Rather, we intend to analyze and question the developments as they emerge, and to place them in a legal context that will be useful for attorneys, regulators, and other legal observers.  We hope that our observations will begin the discussion and debate over the legal ramifications of nanotechnology.

Every week, numerous developments are reported in the media, but I will give my attention here to just one of them.  On March 25, 2010, the President’s Council of Advisors on Science and Technology (P-CAST) issued its report on the Third Assessment of the National Nanotechnology Initiative.  Among many other things, P-CAST calls for “clear principles” for identifying the environmental, health, and safety risks of nanotechnology.  To implement this, the report recommends further development of the existing cross-agency strategic plan to link research activities and information sharing and suggests that “member agencies increase coordinated efforts to overcome barriers to effective, sustainable, and responsible commercialization of nanotechnology.”

This is vague, suitably so for the first steps toward regulation.  One might question, however, the laissez-faire approach that it supports.  To start the discussion on examining the risks of nanotechnology, it is worthwhile to consider how the Government might regulate the products of these technologies.  What would regulation of the health and environmental impacts of nanotechnology look like?  One possibility is the current P-CAST proposal – interagency exchange of information with an individual directing interagency coordination efforts.  Another model would be the creation of an umbrella agency to manage nanotechnology, including the health, environmental, and safety risks of products using the technology.  This concept would take all nanotechnology-related matters away from other agencies – which, presumably, have at least some experience with handling new technologies – and place them within the authority of the new agency.  Another model might be creating a Department of Science and Technology along the lines of the Department of Homeland Security, though determining which agencies – or which parts of which agencies – would fall within the authority of a new Department would be problematic.  Finally, we could leave well enough alone and let existing agencies regulate individual uses of nanotechnology as they arise.  Under this incremental approach, for example, the FDA could regulate medical uses of nanotechnology on a use-by-use basis.

We need to think now about regulating nanotechnology and about what structure that regulation should take.  The history of toxic tort litigation is strewn with products that were allowed on the market with little or no health and safety regulation.  The result was massive health risks, seemingly endless litigation, and studies done too long after the fact.  Just consider the course of asbestos litigation.

www.whitehouse.gov/sites/default/files/microsites/ostp/pcast-nano-report.pdf