The US Environmental Protection Agency (EPA) recently published for public comment a draft of the long-awaited document regarding when nanoscale materials will be considered new chemical substances under the Toxic Substances Control Act (TSCA). EPA's Nanotechnology Guidance will be published in the Federal Register as well.
Nanotechnology has already produced significant advances in new products and holds the promise of many more innovations by developing machines or materials at the nanoscale. However, a significant concern has been expressed by certain environmental groups, professors, and the EPA over potential new health and environmental risks from the materials produced that have new characteristics and new potential harms to people and other organisms. Nano-size materiels, for example, may pass directly through the skin or into internal cells for example, and may cause harms not seen before.
On October 18, 2006, EPA invited stakeholders to participate in the design, development, and implementation of a Nanoscale Materials Stewardship Program (NMSP) under the Toxic Substances Control Act (TSCA). NM SP is a voluntary program intended to complement and support EPA’s new and existing chemical programs under TSCA and was designed to develop a firmer scientific foundation for regulatory decisions by encouraging the development of key scientific information and appropriate risk management practices for nanoscale chemical substances (‘‘nanoscale materials’’).
As part of this process, EPA is announcing the availability of two draft documents for public review and comment: ‘‘TSCA Inventory Status of Nanoscale Substances—General Approach’’ and ‘‘Concept Paper for the Nanoscale Materials Stewardship Program under TSCA.’’ The first document describes EPA’s current thinking regarding whether a nanoscale material is a ‘‘new’’ or ‘‘existing’’ chemical substance under TSCA. The second document describes the Agency’s general approach, issues, and considerations for NMSP and is intended to serve as a starting point for continuing work with stakeholders on the detailed design of NMSP.
EPA is seeking to address the potential risks and regulation of nanoscale materials in the context of existing statutes, rather than seeking amendments to existing laws or passage of new statutes. The success of this program would diminish any interest of Congress in passing new laws to govern the health and safety issues that may be associated with nanotechnology.