The year 2006 saw a dramatic increase in the use of nanotechnology as well the governmental action to oversee that use. Interestingly, the only new nanotechnology-specific regulatory requirement adopted in 2006 occurred at the local level. Looking forward to 2007, it is anticipated that both the use of this technology and increased government oversight – at the federal, state or local level – will continue.

In October 2006, the US Environmental Protection Agency (EPA) announced a variety of opportunities for public involvement in EPA’s anticipated stewardship program for nanoscale materials. EPA intends to launch this stewardship program during the later part of 2007 and will seek input from the public regarding the design and development of that program throughout the coming year. EPA’s outreach will include public meetings and workshops on topics such as risk-management practices and material characterization as well as the development of policy documents describing EPA’s thinking on the regulation of nanoscale materials under the Toxic Substances Control Act (TSCA).

Asserting its authority to regulate nanoscale pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA officials announced in late November 2006 the agency’s intent to regulate nanoscale silver used to kill bacteria in products as diverse as washing machines, food storage containers and clothing fibers. Several products incorporating silver ions have been registered as pesticides by EPA.

The Food and Drug Administration (FDA) took action in August 2006 to establish a nanotechnology task force, charged with determining regulatory approaches that encourage the continued development of innovative, safe and effective FDA-regulated products that use nanotechnology materials. FDA also held a public meeting on October 10, 2006, on nanotechnology as it relates to FDA-regulated products. The purpose of the meeting was to help FDA further its understanding of developments in nanotechnology materials that pertain to FDA-regulated products.

At the local level, on December 12, 2006, the city council of Berkeley, California, amended that city’s community right-to-know ordinance to require facilities that manufacture or use manufactured nanoparticles (defined as a particle with one axis less than 100 nanometers in length) to report all known toxicology of these materials as well as how the facility “will safely handle, monitor, contain, dispose, track inventory, prevent releases and mitigate such materials.” Although no businesses in Berkeley are currently known to manufacture or use nanomaterials, the ordinance’s chilling effect on future businesses remains to be seen. Activists see this action by the Berkeley city council as a model for similar regulation of the technology in other cities and states across the country.

Arent Fox is monitoring regulatory developments relating to nanotechnology for our clients and friends involved in this technology. If you have any questions about this update, or if you would like additional information about nanotechnology regulatory compliance in general , please contact Rachel Lattimore or anyone in the Life Sciences practice.