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The EPA May Take a Close Look at Regulating Nano-Particles in Antimicrobial Articles and Devices

By Lawrence E. Culleen and Ronald D. Lee
January 03, 2007

Nano-scale materials are said to have unique and potentially valuable properties in comparison to the same materials that exist naturally in larger than nano-scales, which can include greater tensile strength, enhanced electrical conductivity, and the ability to contribute to new chemical synthesis pathways. (Note: Nanotechnology is the science of manipulating materials at the atomic and molecular level to develop new or enhanced materials and products. A nanometer is one billionth of a meter in length and particles that have been specifically configured in the range of 100 nanometers or less in length for use in commercial applications often are described as being within the construct of 'nano-scale' ' although no uniform definition of 'nano-scale' has been reached.) These unique properties may lead to advances in industrial chemistry, engineering, biological, agricultural and medical applications. The U.S. Government's spending alone on nanotechnology research is said to exceed $1 billion annually, and the Government of China has recently announced that nanotechnology is one of 16 key technologies for which it will increase research and development spending over the next 15 years. As Chinese companies increasingly design, develop, and manufacture products based on nanotechnology, and export these products to the United States, they will confront and need to understand the emerging perspectives and concerns of U.S. government regulators who are struggling to reckon with perhaps hundreds of products employing nanotechnology that reportedly are already on the market and perhaps thousands more products soon to come on the market. U.S. Federal agencies are working independently, and occasionally in concert, to try to identify appropriate policies and practices to monitor and respond to this apparently sweeping new market development. See, e.g., National Science and Technology Council effort known as the National Nanotechnology Initiative. www.nano.gov/html/about/home_about.html.

The Environmental Protection Agency (EPA) offers a case study of a federal agency whose own position on nanotechnology (including the position of the Office of Pesticide Programs) is still very

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