It had to happen sooner or later. And it’s happening now. A coalition of nonprofit consumer safety and environmental groups brought an action on December 21 in federal district court in California against the Food and Drug Administration (FDA). The action seeks an order for declaratory and injunctive relief under the Administrative Procedure Act to require the FDA to respond to a petition filed with the FDA in 2006 which sought action by the agency to assure the safety of the public exposed to nanomaterials, particularly sunscreen products. The requested relief is detailed on pages 3-4 of the petition. The lawsuit is International Center for Technology Assessment v. Hamburg (N.D. Calif., CV 11-6592).
The coalition includes the International Center for Technology Assessment (ICTA) as lead plaintiff for Friends of the Earth, Greenpeace, Food and Water Watch, the Center for Environmental Health, the Action Group on Erosion, Technology and Concentration (ETC Group), the Institute for Agricultural and Trade Policy, and several other groups.
Among other things, the petition detailed the status of research on and knowledge of the risks of nanomaterials, both relating to consumer products and the environment. This information included studies that have indicated some of the ways that engineered nanoparticles may harm living cells through new channels of exposure. Moreover, in 2007, the FDA’s own Nanotechnology Task Force issued a report recommending that the FDA issue guidance to manufacturers using nanomaterials and take steps to improve scientific knowledge of nanotechnology.
In the weeks to come, we will be anticipating the response from the FDA, which may very well insist that it has undertaken the efforts sought by the petitioners. There are several other legal strategies that the FDA could employ, including claiming the lack of legal authority to put into place some or all of the relief sought in the petition or the need for interagency coordination.
The greatest significance of this lawsuit is that it puts nanotechnology into the courts. This may be the first time, but it certainly won’t be the last time.
The 80-page petition is available at
http://www.icta.org/doc/Nano%20FDA%20petition%20final.pdf
The 2007 Nanotechnology Task Force report is available at
