Small Is the New Big: Eye On Nanotechnology Regulations In The U.S. And EU

In past issues, we have discussed the growing use of nanotechnology in a wide array of consumer, medical, food and industrial products.1 Among other things, we've noted that the incorporation of nanoparticles ó which may be as small as several molecules ó into such products has led to expressions of concern by scientists and regulators about the safety of such novel substances, particularly when used in products intended for human consumption. Nanotechnology is one of the fastest growing commercial technologies ó one eventually expected to cut a very wide swath across the global economy ó and many public agencies and academic institutions are launching comprehensive efforts to understand its benefits and potential risks. Recently, both the U.S. FDA and the European Union have issued reports concerning nanotechnology and product safety. Both bodies largely conclude that private industry must consider the special risks of nanotechnology in complying with existing regulatory requirements ó even though official nanotechnology-specific regulatory regimes are likely a long way off.

FDA Nanotechnology Task Force Report

In 2006, the FDA commissioned a Nanotechnology Task Force to look into a wide range of nanotechnology issues falling within the FDA's regulatory ambit. Following public hearings, "Nanotechnology: A Report of the U.S. Food and Drug Administration Nanotechnology Task Force" was issued on July 25,2007 ("Report").2 The Task Force was appointed partly in response to vocal calls for FDA regulation of nanomaterials by public interest groups, such as the International Center for Technology Assessment.

No Call ó Yetó For Product Labeling

The FDA Nanotechnology Task Force largely concluded tható for now ó current FDA regulatory and rule-making authority is sufficient to address health risks that may emerge from nanotechnology- based products. Notably, in light of the limits of current science, it specifically declined to recommend the adoption of any new labeling rules requiring identification of the presence of nanoscale materials.

Because the current science does not support a finding that classes of products with nanoscale materials necessarily present greater safety concerns than classes of products without nanoscale materials, the Task Force does not believe there is a basis for saying that, as a general matter, a product containing nanoscale materials must be labeled as such. Therefore the Task Force is not recommending that the agency require such labeling at this time.

Report at 35 (emphasis added).

Scientific State of the Art Still Too Immature for Consensus Building

In reaching its conclusions, the Task Force stressed the current lack of scientific and regulatory consensus both as to what constitutes a "nanoparticle"and how to determine whether "nanomaterials" might implicate special health concerns. More to the point, it concludes:

Identifying...