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COUNTERPOINT: First EPA Regulation of Nanotechnology?

JCM: My reading is EPA’s new position on Samsung’s washing machine has little to do with the alleged "nanoness" of the silver ion particles released by the machine. Rather, EPA is focused on the claimed antimicrobial properties of the material. Whether or not the silver ions are truly "nano" is not determinative. Under EPA’s current thinking they would still be subject to FIFRA even if they were/are "full sized." Further, EPA has not even determined whether or not the washing machine truly uses nanotechnology, and has stated that such a finding is unnecessary for its ruling. Finally, EPA has made it clear that it evaluates all products on a case-by-case basis, and appears reluctant to make a categorical statement about all products containing nano-silver. Thus, while EPA’s upcoming notice to be published in the Federal Register will be of great interest, my guess is that it will not use the Samsung issue as a reason for treating nanomaterials any differently from the way it treats other microbial killing materials.

First EPA Regulation Of Nanotechnology?

Rick Weiss reported in yesterday’s Washington Post that the EPA plans to regulate silver nanomaterials used in consumer products as "germ-killing" agents:

The decision — which will affect the marketing of high-tech odor-destroying shoe liners, food-storage containers, air fresheners, washing machines and a wide range of other products that contain tiny bacteria-killing particles of silver — marks a significant reversal in federal policy. * * *

Under the new determination, first reported on Tuesday by the Daily Environment Report, a Washington publication, and confirmed yesterday by the EPA, any company wishing to sell a product that it claims will kill germs by the release of nanotech silver or related technology will first have to provide scientific evidence that the product does not pose an environmental risk.

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Report by Former FDA Official Urges Greater Regulation of Nanoindustry

An October report authored by Michael R. Taylor, Esq., former FDA Deputy Commissioner for Policy (1991-1994) may not be warmly received by all nanomanufacturers. Taylor’s report focuses on what he sees as FDA’s three primary purposes in relation to nanotechnology: (1) ensure product safety; (2) foster innovation; and (3) maintain public confidence in nanoproducts.  Taylor analyzes existing FDA pre-market review and post-market monitoring powers over nanotechnology products and finds several insufficiencies. Continue Reading

Survey Results Indicate Some North American Nanocompanies are Implementing EHS Strategies

On November 13, 2006, the International Council for Nanotechnology (ICON) published its recent survey results: “A Review of Current Practices in the Nanotechnology Industry.”  While the authors of the study admit the size of their survey was too small to provide statistically significant results, the article, nonetheless, provided insightful information on current global nanotechnology environmental, health, and safety practices (EHS).

The data presented regarding North American participants in the survey was particularly interesting.  Of 25 North American respondents, 21 offered their employees broad EHS training, while 18 offered nano-specific EHS programs. This training was most often in a classroom setting conducted by internal sources, using existing scientific literature as sources of health and safety information.  Beyond nano-related EHS training, the survey found that 19 of the North American respondents used fume hoods to contain possible nano-particle exposure; 16 used glove boxes; 13 used clean rooms; 12 used separate HVAC systems; 6 used closed piping systems; 7 used biological safety cabinets; and 5 used air pressure differentials.  Finally, 4 of the North American entities conducted their own nano-toxicology testing.

A lack of definitive scientific information regarding the potential health risks of nanotechnology was pointed to as the biggest hindrance to the further development of nano-EHS training and control.

 

Review: Nanotechnology: What You Need to Know on the Law, Regulation, and Science Policy Front

On November 16, 2006, the American Bar Association held their second of eight teleconferences concerning the regulation of nanomaterials.  The teleconference, moderated by Lynn L. Bergeson, entitled Nanotechnology: What You Need to Know on the Law, Regulation, and Science Policy Front , consisted of a three member panel, representing three different regulatory perspectives.  The panel members were: Jennifer Sass, Ph.D., Natural Resources Defense Council, Jim Alwood, U.S. Environmental Protection Agency, and William P. Gulledge, American Chemistry Council. Continue Reading

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