Nanotechnology Regulatory Outlook for 2010

January 8, 2010
by MICHAEL NINES
Client Alert Newsletter Forecast 2010

Nanotechnology or "intentionally produced nanomaterials" includes objects between 1 and 100 nanometers. Nanotechnology manipulates matter for particular applications, and includes the engineering of particles by certain chemical and/or physical processes to create materials with specific properties not displayed in their larger scale counterparts. To date, nanomaterials can be found in over 500 consumer products. By 2015, it is estimated that consumer products with nanotechnology applications will value $1 trillion on the world market. Some of the same special properties that make nanomaterials useful are also properties that may pose hazards to humans and the environment under specific conditions. Multiple agencies in the federal, state, and international communities have studied the potential effects from nanomaterials in the environment. Specifically, the U.S. Environmental Protection Agency ("EPA") has played a leading role in funding research and setting research directions to develop environmental applications for, and understand the potential human health and environment implications of nanotechnology. EPA has stated that it will review nanotechnology products and processes as they are introduced under the product review requirements of the Toxic Substances Control Act ("TSCA"), the Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA"), and the Clean Air Act. EPA had previously launched a collaborative process to design a Nanoscale Materials Stewardship Program ("NMSP") under TSCA, to complement and support its efforts on new and existing nanomaterials. The EPA's NMSP ended in December 2009, with the release of the much anticipated interim report, with a final report due in 2010. Although the NMSP provided EPA with useful information regarding a limited number of nanoscale materials in commerce, significant gaps in environmental health and safety information remain. To address these information gaps, EPA is taking action on existing nanoscale materials under TSCA.

On February 19, 2010, EPA announced that it will be developing a Significant New Use Rule ("SNUR") under section 5(a)(2) of TSCA to ensure that nanomaterials receive appropriate regulatory review. The SNUR would require persons who intend to manufacture, import, or process certain nanoscale materials for an activity that is designated as a significant new use to submit a Significant New Use Notice to EPA at least 90 days before commencing that activity. The SNUR would identify existing uses of nanomaterials based on information previously submitted under the agency's voluntary NMSP and other information.

As part of EPA's efforts to ensure a more comprehensive understanding of nanomaterials already in commerce, EPA is also developing proposed rules under TSCA section 8(a) to require the submission of additional information, and under TSCA section 4 to require testing for nanomaterials of particular interest, which are already in commerce. This information would help EPA determine whether additional risk management actions for certain nanoscale materials are needed to protect human health and the environment. EPA anticipates proposing these rules by the end of 2010.