FDLI: Nanotechnology Risk Management Policies Needed Now

Companies that manufacture products containing nanomaterials immediately must institute high-quality risk management and product stewardship measures to limit potential liability exposure in the future, assert attorneys Jesse Ash, Anthony Klapper and James Wood.

In their Food and Drug Law Institute (FDLI) Insighter article, these attorneys, part of a team of more than two dozen involved in nanotechnology issues at the law firm of Reed Smith, note that while there has not been a single lawsuit filed where someone claimed injury because they were exposed to engineered nanomaterials, many scientists are raising questions regarding the manufacturing of nanomaterials and its effects on workforces, researchers and consumers.

"For example," they write, "some scientists wonder whether engineered nanomaterials will become the next asbestos."

The attorneys point out that a recent study indicated that certain types of carbon nanotubes, graphite-based structures commonly used in nanotechnology applications, both resemble and behave like asbestos fibers. Because they are as light as plastic and stronger than steel, carbon nanotubes will likely see use in a variety of new applications, including medical nanodevices. Based on toxicity studies, scientists found that inhaling long, thin multi-walled carbon nanotubes had the potential to cause lung disorders similar to those caused by exposure to asbestos.

Because there are many unanswered questions regarding risk, it is essential that companies follow the principles of good product stewardship activities and good risk management strategies in the design and manufacturing of products made with engineered nanomaterials, the authors conclude.

The issue of nanotechnology and risk management will be explored at FDLI's 2nd Annual Conference on Nanotechnology Law, Regulation and Policy, Feb. 18-19, in Washington, D.C., where six top officials of the Food and Drug Administration will answer questions about how the new administration intends to regulate nanotechnology products.

Visit http://www.fdli.org for more information.
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