Christian Science Monitor Endorses Maynard Proposal
The Christian Science Monitor dedicated its editorial yesterday to the issue of nanotechnology safety, and endorsed the proposal set forth in November's Nature by fourteen scholars to discuss what lead author, Professor Andrew Maynard, termed the five "grand challenges" of nanotechnology safety.
Citing a Lux Research study, the CSM editorial indicated that by 2014, manufacturers will sell $2.6 trillion dollars' worth of products that use nanotechnology. After praising EPA's decision to regulate "nanosilver," a decision that we have reported on at length here, CSM endorsed the Maynard proposal:
They include developing ways to detect nanomaterials in the air and water, learning how the shape of nanomaterials affects their toxicity, creating accurate models for predicting how nanomaterials act in the human body and the environment, and finding ways to engineer nanomaterials so that they are safe by design.
Both the chairman and ranking minority member of the House Science Committee have endorsed the paper and urged the White House and federal agencies to put together a plan to fund the scientists' recommendations in the fiscal 2008 budget.
The need to act is urgent. Otherwise the enormous benefits of nanotech risk falling victim to safety issues that could - and should - have been confronted already.
Berkeley City Council to Consider Nanotechnology Regulation
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.
UPDATE: First EPA Regulation of Nanotechnology?
Since first being reported in the Washington Post, and relayed here, more information concerning EPA's proposed regulation of nanosilver under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) has been uncovered.
Continue Reading...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.
Continue Reading...Report by Former FDA Official Urges Greater Regulation of Nanoindustry
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
Scientists Present "Five Grand Challenges" Regarding Future Nano-EHS Research
Earlier today, two top nanoscientists -- Dr. Andrew Maynard, Chief Science Advisor, Project on Emerging Nanotechnologies, Woodrow Wilson Center and Dr. Sally S. Tinkle, Assistant to the Deputy Director, National Institute of Environmental Health Sciences, National Institutes of Health -- made a presentation at the Woodrow Wilson International Scholar Center announcing their new article appearing in November 2006 issue of Nature.
Maynard said that the article was the result of intense collaboration between 14 top nano-experts from numerous scientific disciplines who came together to create a 10-to-15 year framework for assessing the potential health risks posed by nano-technology.
Continue Reading...Environmental Law Alert
AUTHORED BY MICHAEL HEINTZ
Nanomaterials are becoming an increasing part of everyday life. Even now, man-made materials that measure one ten-thousandth the diameter of a human hair are found in products from computer chips and pesticides to stain-resistant fabrics and shampoo. As such, the U.S. Environmental Protection Agency is beginning to study the scientific properties of engineered nanomaterials to determine whether they should be regulated under the environmental statutes.
The cross-governmental National Nanotechnology Initiative, a partnership among several governmental agencies focused on research and sharing information about nanomaterials, states that to be nanotechnology, three factors must be met. The technology must 1) involve “an understanding and control of matter at dimensions of roughly 1 to 100 nanometers” (a nanometer is one-billionth of a meter); 2) “encompass nanoscale science, engineering, and technology”; and 3) involve “imaging, measuring, modeling and manipulating matter at this length scale.” Nanomaterials, thus, are purposefully engineered materials that measure between 1 and 100 nanometers. Interest is increasing in nanomaterials because their physical properties are governed by the laws of quantum mechanics, which produces “dramatic changes in [their] mechanical, optical, chemical, and electronic properties.”
Ball State Professor Urges Caution in Using Nano-Based Building Materials
A Ball State University architecture professor recently urged building designers and builders to keep themselves informed of the possible health risks of using nanoparticles in building materials. Dr. George Elvin pointed to commercially available nano-based water filters, HVAC filters, and cleaning products and coatings as possibly permitting exposure to nanoparticles. Dr. Elvin indicated that the health risks of such exposure are not currently known, but believes "[b]uildings will undoubtedly be one of our prime areas of contact with nanoparticles both inhaled and absorbed through the skin." In particular, he cited the potential that countertops, handrails, door pulls, and cabinets might incorporate nanoparticles as a possible source of exposure. He also pointed out that the International Conference of Building Officials and the American Society for Testing and Materials are still working on methodoligies for dealing with and regulating nanotechnology. Dr. Elvin's nanotechnology blog can be found at: www.nanotechbuzz.com.
"Risks in architectural applications of nanotechnology," November 9, 2006, www.nanowerk.com/spotlight'spotid=1007.php
Nanoparticles Used as a Topical Drug Delivery Device
PR Newswire US, November 14, 2006, “Pharmos Completes Phase 1 Study of Topical Diclofenac NanoEmulsion Cream; Data Indicate Positive results Achieved on Safety, Tolerability and Pharmacokinetics.”
NIOSH to Test Certified Respirators
The National Institute of Occupational Health and Saftety's (NIOSH)National Personal Protective Technology Laboratory (NPPTL) at NIOSH recently announced it intent to test currently certified repirators to determine whether they protect wearers against nanoparticle inhalation. The NIOSH testing follows up on a University of Minnesota study pointing to the effecacy electrostatically charged filters in screening out nano-sized particles. NPPTL also intends to conduct tests to determine whether nanoparticles will penetrate approved personal protective clothing. Along with its announcement, NPPTL also noted that there are currently no specific exposure limits for nanoparticles, and that the decision to wear repirators is left to professional judgment.
Inside OSHA, November 13, 2006, Vol. 13 No.23.
Insurance Expert Addresses Nanotechnology
The insurance industry makes a great effort to research and identify potential liability trends. In a recent Orlando Sentinel article, a commercial insurance expert expressed concern that the explosive growth of nanotechnology could have unintended health consequences, and if it proves harmful, “lawsuits will fly.” Frank Coyne -- CEO of Insurance Services Office Inc. -- addressed this issue as part of his recent presentation at the ISO Tech 2006 conference in Kissimmee, Florida.
Rice Professor Urges Responsible Development of Nano-Water Filtration Applications
Professor M.R. Wiesner at Rice University recently suggested the industry and research community use caution in developing water filtration applications using nanotechnology. While Weisner suggested it "would be naïve to imagine that technology will evolve without risks to our health and environment,” he found that "preliminary results suggest that the fabrication of nanomaterials entails risks that are less than or comparable to those associated with many current industrial activities such as silicon waiver production.” Wiesner also concluded that nanoparticle mobility in groundwater depends on type of nanomaterial involved -- fullerene-based nanoparticles move through a porous medium more rapidly and to a greater extent than colloidal-based nanoparticles.
M.R. Wiesner, "Responsible development of nanotechnologies for water and wastewater treatment," Water Science & Technology, Vol. 53 No. 3 pp 45–51 (2006 ).
Inhalation Toxicology Publishes New Nanoparticle Study
A recent paper published in Inhalation Toxicology suggests that reliance on ultrafine particle inhalation animal studies for nanoparticle health and safety purposes may be appropriate due to the lack of existing studies on nanoengineered particles. The article referenced several existing health and safety studies concerning nanoparticles, and noted their sometimes differing and conflicting conclusions. Specifically, the authors studied rat exposure to three types of ultrafine particle exposure in lab rats, and then applied a quantitative risk assessment model for "estimating human-equivalent exposure using rat does-response data." The paper concluded by stating more research and study are necessary to determine whether this methodology can be successfully modified to apply to nanoparticle exposure.
Kuempel, E. D., et al., “Lung Dosimetry and Risk Assessment of Nanoparticles: Evaluating and Extending Current Models in Rats and Humans,” Inhalation Toxicology, 18:717-724 (2006)
Press Release -- International Association Of Nanotechnology
2386 Fair Oaks Boulevard, Sacramento, CA 95825
1750 Montgomery Street, San Francisco, CA 94111
Tel. 916-529-4119, Toll Free 1-800-766-6008
Fax. 916-244-7029
Email: info@ianano.org
Web site: http://www.ianano.org
Press Release Press contact: Diana Rudé, Director, Government Relations
November 7, 2006 (916) 529-4119
San Francisco. The International Association of Nanotechnology (IANANO) sponsored a panel discussion on environmental health and safety at its 3rd International Congress of Nanotechnology (ICNT), held on October 30 - November 2, 2006 in San Francisco. IANANO convened the panel in recognition of the current information gap concerning the potential health risks associated with nanotechnology.
Speakers on the panel included two product liability attorneys - John C. Monica, Jr. of Porter Wright Morris & Arthur LLP, Cleveland, Ohio, and Antony Klapper of Reed Smith LLP, Washington, D.C.; and Dr. Justin Teeguarden, Senior Research Scientist, from the Pacific Northwest National Laboratory, Richland, Washington and Matthew Hull, principal Investigator from Luna Innovations, Inc, Blacksburg, Virginia.
Continue Reading...
Review: "Nanotechnology and the FDA," in Nanotechnology Law & Business
In the September 2006 edition of Nanotechnology Law & Business, two (2) employees of FDA’s Center for Drug Evaluation and Research (“CDER”) -- Nakissa Sadrieh and Parvaneh Espandiari -- published “Nanotechnology and the FDA: What Are the Scientific and Regulatory Considerations for Products Containing Nanomaterials?”
The article begins with a disclaimer that the authors’ views and opinions are not necessarily those of FDA, and then narrows its specific focus to nano-products regulated by FDA’s Center for Drug Evaluation and Research (‘CDER’) – primarily new drugs and/or drug delivery systems.