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Posted: February 3, 2009
Reducing nanotechnology liability exposure when risks are unknown
(Nanowerk News) In their Insighter article (pdf download, 256 KB) on the Food and Drug Law Institute's website (www.fdli.org), Ash, Klapper and Wood, part of a team of more than two dozen attorneys 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.
They write that, "for example, the plaintiffs’ bar likely took note of a recent study showing 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. While this conclusion is alarming, the authors of this study
were quick to point out that additional research will be required to fully answer whether carbon nanotubes
truly are pathogenetic in humans. Regardless, the “carbon nanotube” story is an important one for companies
to stay on top of and monitor. And so too are developments in the story about the toxicological properties of
nanosized silver, a substance used in some medical devices to prevent infections.
"The plaintiffs’ bar is also monitoring activities at FDA. In May 2006, a coalition of environmental
NGOs filed a petition asking the FDA to, among other things, force manufacturers of sunscreens that use
nanoparticles to cease production and to recall their products. The petition discusses at length the possibly
increased toxic properties of nanomaterials, citing to various scholarly articles and reports. FDA has not
formally responded to this particular petition, but has held several public meetings on nanotechnology risks
during the past three years.
"Whether the studies on carbon nanotubes or the public petitions simply mark the beginning of
private lawsuits is unknown. Certainly if the science on nanomaterials more conclusively raises human
health concerns, the risk of litigation increases dramatically. 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. Core questions that affect whether a company has followed such principles include:
Has the company designed the product with safety in mind?
Has the company educated its workers and consumers about known exposure risks?
Has the company tracked what scientists, regulators and other members of industry are saying and doing about the product’s risk and ways to reduce that risk?
Has the company itself evaluated, or collaborated with others to evaluate, risks that are still
Are the company’s public pronouncements about the risks associated with its products consistent
with its own internal evaluations and assessments of its products?
Has the company taken affirmative steps to implement recommended controls to reduce exposures?
Has the company taken steps to monitor the health of its workforce and its consumers that are
exposed to its product?
These issue will be thoroughly explored at FDLI's 2nd Annual Conference on Nanotechnology Law, Regulation and Policy, February 18-19, 2009, in Washington, D.C., and discussed in a book to be published by FDLI February 17, Nanotechnology & FDA-Regulated Products: The Essential Guide. At the conference, six top officials of the Food and Drug Administration will answer questions about how the new Administration intends to regulate nanotechnology products.