The regulation of nanotechnologiesproducts and processes which incorporate extremely small particles ( a nanometer is one billionth of a meter, and nanoparticles are usually described as those between 1 and 100 nanometers) has popped into public visibility in the last year or so. Both federal and state governments have been promoting these technologies in a big way over the last several yearsthe multiple federal agencies that are part of the National Nanotechnology Initiative (NNI) have been spending close to a billion dollars a year to research and promote these technologies, and states have been avidly chasing the firms which do the research and produce the products. Products have been moving out of the lab and into the marketplace at an increasingly rapid rateinventories maintained by the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars currently list over 300 products incorporating these particles and thats almost certainly on the low side.

All of this development has happened without much attention to the consequences of large scale use of these products, particularly in the short run. Beginning with a book by futurist Eric Drexler in 1986 and continuing through a widely cited article by Bill Joy and Michael Crichtons book Prey, there have been vivid dystopian scenarios of self-replicating nanobots covering the earth with grey goo which could annihilate the biosphere. More prosaically, there appears to have been little systematic effort to assess the environmental and health risks associated with nanoparticles. Recent reports by the British Royal Society and a distinguished largely American group which published an article in Nature a couple of months ago have noted this lack of attention. There is at least some evidence that these risks are not trivial substances which are not reactive at larger scales may be so at nanoscale, but other factors besides size also come into play. The Nature article calls for a fifteen year research program to reduce the current uncertainty about the consequences of widespread use of these products.

The immediate question is what we do in the meantime. There have been calls for a moratorium on nanotechnological products until risks are better understood, but this seems unlikely to materialize. Federal regulatory agencies such as the FDA and EPA are beginning to regulate nanoproducts under their existing statutesthe EPA just announced a couple of months ago that that manufacturers of products which use nanosilver products to kill bacteria in such products as washing machines and shoe liners must now submit data showing these products have no adverse environmental or public health impact. How readily nanoproducts can be regulated under existing law isnt really clear—some commentators have noted regulatory holes in the statutes authorizing federal action, which were written before nanomaterials came on the scene. Given the holes in the science and in the law, it may be a while before we have a coherent federal regulatory framework in place. Its not difficult to imagine a scenario in which legal challenges limit federal agencies ability to regulate nanoproducts and Congress is reluctant to support expanded funding for risk research, increases in the budgets of regulatory agencies, or changes in regulatory legislation.

Given this potentially slow pace in Washington, it wouldnt be surprising if the first serious attempts to regulate nanotechnologies come from state or even local governments. In fact, its already started—Berkeley, California has recently adopted an ordinance which requires users of nanomaterials to file an inventory and safety plan similar to those required for users of hazardous materials. This isnt the first time local governments have acted to regulate cutting edge technologysince the late 1970s, for example, anybody wishing to use recombinant DNA within the borders of Cambridge, Massachusetts has been required to secure a permit from the city health department that covers a wide range of biosafety issues. States typically have broad constitutional powers to protect the public health, and there may be fewer legal obstacles to state or local action than to federal. Even if federal action proceeds relatively rapidly, individual states or localities may wish to adopt additional health and environmental protection requirements for nanoproducts, and its far from clear that these would be pre-empted or invalidated in any way by federal regulatory action.

The major determinant of the future of nanoregulation in this country is likely to be political. The Cambridge ordinance had its origins in a rancorous spat between the city and Harvard in which the university basically blew off residents concerns. Similar conflicts over nanotechnology products are a real possibility. While grey goo scenarios are implausible, the real scientific uncertainty about how safe nanoproducts are, as well as the increased activism around these issues by environmental groups, may make some communities cautious about the conditions under which they allow research or manufacturing using these materials within their borders. Public opinion polls show considerable distrust of the ability of industry to regulate itself and support for governmental regulation of nanoproducts. Nanotech industry groups claim to get this, and have promoted responsible development of nanotechnology with appropriate acknowledgement of risks and uncertainties. What this means in particular circumstances, however, is still very much an open question.

– Jim Fossett, AMBI/Rockefeller Institute Federalism and Bioethics Initiative
(With thanks to Summer Johnson)

Labels: nanotechnology, state bioethics