Nanotechnology and TSCA

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If you've read Michael Crichton's book, "Prey," you are familiar with self-replicating products of nano-technology that turn on their human creators and engage in acts of violence and revenge. GE now is running a television ad featuring a nerdy "nanotechnology scientist." The book and the ad typify common misconceptions about nanotechnology ," that it is both scary and nerdy.

This column briefly summarizes the concept of nanotechnology and one topic that Chemical Processing readers should consider early on ," the potential regulation of nanosubstances under the Toxic Substances Control Act (TSCA).

What is nanotechnology?

Nanotechnology, often referred to as molecular manufacturing, focuses on the design and production of goods such as electrical circuits and mechanical devices at the molecular level of matter. Los Alamos National Laboratory describes nanotechnology as "the creation of functional materials, devices, and systems, through control of matter on the nanometer (1 to 100 nm) length scale and the exploitation of real properties and phenomena developed at that scale." To help visualize something in nano terms, consider that a nanometer is one ten-thousandth the diameter of a human hair.

While nanotechnology sounds futuristic, products of nanotechnology are not uncommon. Today, some of its many commercial applications include tennis racket frames, apparel, and computer hard drives.

One key reason that nanotechnology is the source of great scientific research and commercial enthusiasm is that manipulating matter at the nano level can alter the physical properties of a chemical without changing the chemical's composition. Many believe that the nano-scale manipulation of matter is critical to biological systems, and holds tremendous potential for medical applications, particularly in the area of medicinal delivery systems. Scientists envision designing machines that will travel through the human circulatory system attacking cancer cells, and repairing damaged tissue.

TSCA's application

Much thought now is being given to whether and, if so, how to regulate molecular manufacturing and whether new laws are needed to prevent precisely the type of killer molecules described so vividly in "Prey." Interesting issues arise in connection with the application of TSCA to nanosubstances and nanochemicals. TSCA regulates any organic or inorganic substance of a particular molecular identity, including ," (i) any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature and (ii) any element or uncombined radical." EPA states: "TSCA defines chemical substance' broadly and in terms that cover microorganisms as well as traditional chemicals."

With TSCA Section 4-7,Congress has given EPA broad regulatory tools to regulate the manufacture, production and disposal of chemical substances that EPA determines pose an unreasonable risk to human health or the environment. EPA also has the authority, before a final TSCA Section 6 rule can be published, to seize chemical substances or mixtures that it determines will present an unreasonable risk of serious and widespread injury to health and the environment.

In addition, TSCA authorizes EPA to regulate "new uses" of existing chemicals through Significant New Use Rules or SNURs. This authority would appear to have particular relevance to products of molecular manufacturing. For example, a carbon nanotube is a honeycomb lattice rolled into a cylinder and consists entirely of carbon atoms. Carbon is a distinct chemical substance listed on the TSCA Inventory. While the carbon's chemical composition is unchanged in a nanotube, its physical properties dramatically change.

The astonishing growth of molecular manufacturing will challenge the federal government to ensure that products of nanotechnology are safe, predictable and efficacious. Nano- substances may or may not be new chemicals for TSCA purposes, and substances re-engineered at the molecular level, like carbon nanotubes, may or may not fall into the category of TSCA "new uses". However, industry must work closely with EPA and other federal agencies, including FDA and the National Toxicology Program, which is conducting research on ultra-fine particulates, to ensure that all the issues raised by this new and promising technology are framed, discussed and resolved in a way that is scientifically defensible and that makes business sense.

For an interesting discussion paper on this subject, click here.

Lynn Bergeson is a founding shareholder of Bergeson & Campbell, P.C., a Washington, D.C. , based law firm. The views expressed herein are solely those of the author.

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