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George Kimbrell is sweating the small stuff. As staff attorney for the International Center for Technology Assessment, he has filed the first official challenge to the government’s lack of regulation of nanotechnology � a very tiny process creating some very big concerns, he asserts. The ubiquitous technology is used in countless products, from sunscreens that millions of consumers slather on every day to clothing, toothpaste, cooking oil, vitamins, furniture, pots, pans and much more. And for Kimbrell, a former clerk for the 9th U.S. Circuit Court of Appeals, what happens to those minuscule particles as they get absorbed into the human body is the great unknown. “I’m scared,” he said. Last month, the U.S. Food and Drug Administration (FDA) issued a report by its nanotechnology task force formed after the International Center for Technology Assessment (ICTA) filed its petition last year. The report, which stated that it was not a formal response to the petition, said that nanoscale materials could be used in most product types regulated by the FDA. It also recommended that the agency develop guidance for manufacturers and researchers. An FDA press release issued when the report was published said that the “uncertain nature of nanotechnology” and the rapid development of nanoscale materials in FDA-regulated products highlighted the need for transparent, consistent and predictable regulation. The FDA declined an interview on the matter. A spokeswoman for the agency noted that in November it had filed an interim response to the ICTA petition, stating that it needed more time to fully respond to the “complicated issues” in the petition. The spokeswoman said that the agency “can’t predict” when it will fully respond. Falling short Kimbrell asserts that last month’s report falls far short of addressing the kind of regulation his group and other consumer advocate organizations would like to see. He also continues to wait for an answer to the ICTA’s petition, asserting that safety measures are lagging behind the technology. The government should know more about nanotechnology and the potential ramifications of its use in consumer goods, said Lynn Bergeson, a partner at Washington-based Bergeson & Campbell, which represents several midsized and large companies that develop and use the technology. But demanding more regulation from the FDA at this point is a “knee-jerk reaction,” she said. “There is a need for more information that would inform the judgment of the decision-makers within FDA as well as the [Environmental Protection Agency],” Bergeson said. She added that the FDA’s report last month was a “disappointment” to consumer groups that were expecting more definitive answers. “On many of the issues it more or less punted,” she said. Part of the reason the technology has not garnered attention from regulators � and consumers � may be due to a lack of understanding about it. An applied science, nanotechnology involves the reconfiguring of molecular structures on a scale that is one-billionth of a meter, or a nanometer. The re-engineering can turn something as thin as a human hair into a substance stronger than a steel bridge. One of the most common applications includes the use of titanium dioxide nanoparticles in sunscreen, cosmetics and some food products. Manufacturers also use silver nanoparticles in food packaging, clothing, disinfectants and household appliances, and they use zinc oxide nanoparticles in sunscreens and cosmetics, surface coatings, paints and outdoor furniture varnishes. In its May 2006 petition, the ICTA was the lead party joined by seven other consumer and environmental groups, including Greenpeace International, the Center for Environmental Health and Friends of the Earth. The action asserts that the FDA has failed to regulate nanomaterials as a health threat. Specifically, it calls for the agency to regulate nanoproducts that fall under its general purview. It also asks the agency to pay special attention to nanosunscreens. Both prongs call for the FDA to research and regulate the toxicity of such products as they relate to human health and to the environment. Those wanting more research and regulation point to scientific studies that they say are a cause for alarm. In 2004, a study conducted by an environmental scientist from Southern Methodist University found that a spherical form of carbon, engineered by nanotechnology and used in the manufacture of computer processors, pharmaceuticals, fuel cells and more, caused extensive brain and liver damage in fish. The study, reported by the New York Times in March 2004, created concern among scientists and environmentalists, with some calling for a moratorium on nanotechnology and others advising to proceed cautiously. Kimbrell says that even though just 4% of $1.4 billion in federal funds for nanotech research is set aside for safety studies, the few that are out there “pop up red flags.” The FDA’s report issued last month recommended that the agency give guidance to manufacturers about what information they should provide to it. The report also said that the FDA should determine the information it needs to better regulate nanotechnology, and that it should evaluate the adequacy of current testing to assess the safety, effectiveness and quality of nanoscale materials. From the manufacturers’ perspective, safeguards are already in place to protect the public. “Under existing law, companies are required to substantiate the safety of all products before they are marketed,” said Elizabeth Anderson, general counsel for the Cosmetic, Toiletry and Fragrance Association, responding by e-mail. “These companies have developed comprehensive approaches to safety assessment to ensure the safety of all products, including those with and without nanoparticles,” she said.

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