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April 5th, 2010
The Editor interviews John R. Bashaw , Partner in the New Haven office, William S. Rogers, Jr., Partner in the Boston office and Joseph Clark , Counsel in the Florham Park, New Jersey office of Day Pitney LLP.
Editor: Please discuss the recently published EPA Significant New Use Rule (SNUR) under the Toxic Substances Control Act for multi-walled carbon nanotubes.
Rogers: Before the EPA announcement in January, 2010 concerning the proposed SNUR, a series of studies was done beginning in the United Kingdom with a study led by Poland, et al. (2008). That study involved the injection of multi-walled nanotubes into the abdomen of mice, the mucosal lining of which is identical to the mesothelium of the pleura or chest. The injection directly into the abdomen was intended to simulate exposure of the mesothelium in the chest due to inhalation exposure. Approximately 90 days later they examined the biological changes who had taken place as a result of exposure of the abdominal mesolthelial lining to the carbon nanotubes. They reportedly found evidence of inflammation that was consistent with the type of inflammation that had traditionally been recognized in people who had inhalation exposure to asbestos fibers and who later developed mesothelioma. They did not find actual mesothelioma in the mice, but rather what were thought to be precursors to such cancers. The result of publication of these findings was an alarmist reaction that carbon nanotubes posed a danger to humans analogous to that of asbestos fibers. This became headline news.
The problem with the study was that the mice were exposed to massive doses of nanotubes by injection, which is not a natural or likely cause of human exposure. The test methodologies were a poor analog for what likely human exposure would be in any setting. Many commentators criticized the study's findings and suggested that its conclusions about a potential relationship between carbon nanotubes and asbestos fibers was flawed because it rested largely on their shape similarity (long and thin); however, for the last two years there has been talk in the popular media about whether the risks associated with all nanomaterials are akin to those associated with asbestos fibers. The only similarities between carbon nanotubes and asbestos fibers is their long aspect ratio, unlike other nanomaterials. There has been more focus on carbon nanotube toxicity than on other nanomaterial substances, which has percolated up to the EPA. EPA has now decided to treat carbon nanotubes separately from other nano-objects.
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