NEWARK, N.J., May 21, 2012 /PRNewswire/ -- Federal regulators want to launch a series of in-depth studies into the risks of nanotechnology and nano-scale materials. While some in the industry might want to resist this research, forward-thinking companies ought to see it as an opportunity to safeguard the future of the field, writes LeClairRyan attorney James A. Kosch in a May 15 column posted on CorporateComplianceInsights.com.
"The FDA suggests that companies manufacturing and selling such products should meet and confer with the agency to start sharing information and develop this research," writes Kosch, a Newark-based shareholder in the national law firm's Tort Defense Practice and a director of the New Jersey State Bar Association's environmental law section. "Such collaboration is hardly the norm in the regulatory sphere. This approach is a sound one by a regulatory agency, and responsible companies should heed the invitation."
In the piece ("Under The Electron Microscope: Agencies Take A Closer Look At Nano Tech"), the veteran environmental attorney describes two new regulatory guidelines, published by the FDA in April, that aim to chart a path toward clearing up some of the uncertainty around nanotech, which has applications in industries ranging from food, pharmaceutical and health & beauty care products, to textiles, building materials, computers and sporting goods. "The chemical and physical properties of materials at the nano scale can differ significantly from those at the macroscopic scale," Kosch writes, "and today the ultimate effects of 'the smallest of the small' on human health and/or the environment are simply not well studied or known."
For example, the public continues to be confused about whether sunscreens that use nano-scale titanium dioxide cause health problems over the long term. This is partly because of mixed messages in the media, Kosch writes, noting that one health and wellness website describes titanium dioxide as a threat to human DNA, while other authorities insist it is perfectly safe.
And there are regulatory uncertainties as well. "Should silver nano materials, when dispersed into the environment as bactericides and micro biocides, be subject to regulation under FIFRA [The Federal Insecticide, Fungicide and Rodenticide Act]?" Kosch asks. "To date, in fact, most regulation of nano materials has focused on the question of whether these products are covered by the existing regulatory regime. If not, new regulations are required."
New FDA guidances highlight recent research into how nano materials may be absorbed into the body and affect health, but they also note that exactly how exposure to nano materials might affect cells or systems requires much further study. "The FDA has not called for wide-scale bans or restrictions, but rather a collaborative recommendation that studies be conducted of nano materials used in FDA-regulated consumer products or food substances," Kosch writes. "This would include more study (up to and including clinical studies) of the effects of nano materials, including toxicity testing at various exposure levels; dose studies in vitro and in vivo, and further examination of dermal modes of exposure such as dermal penetration, irritation and sensitization."
While these technologies are the smallest of the small, their potential benefits are large indeed. And this is precisely why forward-thinking firms should help the government embark on this research, the attorney writes. "Futurists may fret about the likes of nano robots running wild, but so far there are no Three Mile Islands or Love Canals marring the history of this field," Kosch concludes. "Nor are nano technologies being stymied by draconian regulations. By acting in good faith and collaborating with these agencies, the industry could help keep it that way."
Founded in 1988, LeClairRyan provides business counsel and client representation in corporate law and high-stakes litigation. With offices in California, Connecticut, Massachusetts, Michigan, New Jersey, New York, Pennsylvania, Virginia and Washington, D.C., the firm has approximately 350 attorneys representing a wide variety of clients throughout the nation. For more information about LeClairRyan, visit www.leclairryan.com.
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James A. Kosch