Nanowerk Article on Dermal Penetration
Nanowerk just published a very good Spotlight article on dermal penetration issues: "Nanoparticle penetration of human skin – a double-edged sword." The author does a nice job balancing the two sides to this contentious issue. Recommended reading.
Berkeley Issues Nano-Disclosure Guidelines
We previously discussed Berkeley, California's nanoparticle hazardous materials ordinance on a couple of occasions and also published a paper on this topic in last February's edition of Nature Nanotechnology. Berkeley has since issued new Disclosure Guidelines implementing the ordinance. The Guidelines partially address our concerns, yet also impose more stringent requirements on Berkeley's nanotechnology community than the ordinance itself. The filing deadline under the Guidelines is June 1, 2007.
The ordinance's operative provisions are contained in a single sentence: "All facilities that manufacture or use manufactured nanoparticles shall submit a separate written disclosure of the current toxicology, to the extent known, and how the facility will safely handle, monitor, contain, dispose, track inventory, prevent release and mitigate such materials." The Guidelines, however, contain three pages of over 30 specific requirements, creating even further difficulties.
Here are some highlights:
Toxicology Reporting Requirements. On the positive side, the Guidelines make it clear that the City is only seeking published information and data. On the negative side, the City wants five types of toxicity data: (i) inhalation, (ii) dermal, (iii) oral, (iv) mutagenicity/genotoxicity, and (v) reproductive. This comprehensive data simply does not exist for any nanomaterial. Fortunately, the Guidelines allow reporting businesses to indicate such "information is not available" in instances where none has been published. We have previosuly discussed the legal implications with making such a written admission yet continuing to develop and market products containing nanomaterials. To compound matters, the Guidelines also take the following hard-line position: "If an exposure potential is present but insufficient toxicological information is available, a precautionary approach should be taken which assumes that the material is toxic." Because comprehensive toxicity data is not available across the broad range called for by Berkeley, arguably most if not all nanomaterials will be treated as "toxic" under the City's approach. The legal ramifications created by the City's presumption are problematic to say the least.
Control Banding. As a method to "contain costs for reporting," the Guidelines mandate that reporting entities use a "system of prioritizing high-risk activities into [four] control bands:" (i) low potential toxicity and no exposure pathways; (ii) moderate potential toxicity and exposure pathways; (iii) high potential for toxicity and possible exposure pathways; and (iv) unknown toxicity and exposure pathways. The last category requires the highest level of control measures. Setting aside the issue of whether the City even had legal authority to implement this control banding experiment, the methodology seems to fail from the outset. Because the toxicity of most nanomaterials is largely unknown -- especially across all five of the specific categories identified by the City -- virtually all nanomaterials are all going to fall into the City's last category and require the highest levels of control. This is also in keeping with the City's position that in such instances "a precautionary approach should be taken which assumes the material is toxic."
Costs. Based on an initial reading of the Guidelines, nanocompanies will need to retain several types of experts to comply with the ordinance: (i) nanotoxicologist qualified to address each of the five areas identified by the City; (ii) nano-industrial hygienist qualified to conduct a control banding review and also create and implement an occupational and environmental protection plan; (iii) nanochemist qualified to identify the physicochemical properties of the nanoscale materials; and (iv) legal counsel to pull all of this together. Further, given differing frequent sub-specializations, multiple experts may be needed in each category. Regardless of the number and types of experts employed, complying with the ordinance and Guidelines is not an inexpensive proposition.
Confidentiality. The Guidelines allow a reporting company to label a nanomaterial as a "trade secret" under California Health and Safety Code Section 25538, but still require submission of the information to the City. The City then determines whether or not the information is truly a trade secret. While this approach is headed in the right direction, the state statute needs some polishing to fit the City's specific needs. Additionally, simply referencing the statute in the Disclosure Guidelines in passing is insufficient to make the statute's protection's part of Berkeley's municipal law in this specific context.
There are many more issues presented by the Guidelines that warrant discussion which we will undoubtedly address in upcoming seminars and presentations. We will post these materials here as they are developed. Finally, despite the deficiencies we perceive with Berkeley's ordinance and now its Guidelines, it is apparent that the City is at least trying to address some of the industry concerns raised after the fact. It is incumbent upon the industry to make sure its voice is heard in Berkeley and in other cities across the country considering such ordinances.
Former FDA Official Calls for Increased FDA Nanotech Authority
By Tim Cahill:
The April 20, 2007 edition of FDA Week reports that the former deputy commissioner in the FDA's policy office, Michael Taylor, repeated his call for Congress to grant FDA enhanced regulatory authority with respect to products that utilize nanotechnology, particularly cosmetics, dietary supplements, and foods.
Mr. Taylor believes that FDA should have the authority to force companies to disclose information about the nanotechnology they use in these products so the agency can better monitor the associated risks. Mr. Taylor made this assertion while speaking at a Food and Drug Law Institute conference on April 12th, and he initially raised this issue in a report he wrote last October for the Wilson Center's Project on Nanotechnology entitled "Regulating the Products of Nanotechnology: Does FDA Have the Tools It Needs?"
Symposium: "Risk Assessment for Nanomaterials: Current Developments and Trends"
Intertox, Massachusetts Toxic Use Reduction Institute, and Cambridge Public Health Department, are sponsoring a full day continuing education course "Risk Assessment for Nanomaterials: Current Developments and Trends" on May 29, 2007 at MIT.
Speakers include: T. Earles, Office of Science and Technology Policy, White House; M. Ellenbecker (Mass Toxic Use Reduction Institute); K. Kulinowski, International Council on Nanotechnology, Rice University ; J. Steevens (Army Corps of Engineers); J. Isaacs (Northeastern University) ;V. Murashov, NIOSH; M. Hull (Luna Innovation) and I. Linkov (Intertox) ; S. Lipson (City of Cambridge); J. Monica (Porter Wright) ; and L. Sheremeta (National Nanotech Institute, Canada) .
An online registration form for the symposium can be found here.
Another Environmental Fish Study
Late last year a Japanese researcher continued a line of environmental research into the potential adverse environmental effects of manufactured nanoparticles on a species of small fish, their eggs, and hatch-lings. The study exposed Medaka fish and their offspring to latex nanospheres in various sizes and at various water salinity levels. The fluorescent particles ranged in size from 39.4 nanometers to 42,000 nanometers in diameter and exposure times varied.
The study presented some interesting findings:
· Adult Medaka were dissected after exposure to 39.4 nm particles at 10 mg/l for 7 days and certain organs were then examined under a microscope. The liver, intestines, gonads, gills, kidney, ovary, testis and brains of the fish all exhibited nanoparticle uptake. No mortality was experience in this test.
· Medaka eggs were exposed to 39.4 nm particles under the same conditions. Nanoparticle uptake was observed in the eggs’ oil droplets, envelopes, and yolks following that order of accumulation. Larvae spawned from the eggs showed nanoparticle accumulation in the yolk and gallbladder, but not the liver. No mortality was observed in this test either.
· Additional Medaka eggs were also exposed for 3 days to 39.4 to 42,000 nm particles. Of all the various sizes of particles used, 474 nm particles were adsorbed and accumulated most by the eggs. Larger and smaller particles showed less adsorption and accumulation.
· Increasing levels of water salinity increased nanoparticle adsorption by the Medaka eggs.
· Increasing levels of water salinity also increased mortality. There was no mortality at lower salinity levels, but all of the fish died at high salinity levels.
The researcher concluded nanoparticles entered the Medaka through the membrane of the gills and/or intestine, then entered the bloodstream, and were transported and deposited into various organs. The olfactory neuron migration route as previously theorized in other fish experiments was ruled out. Moreover, the researcher found “[s]alinity may affect the bioavailability of nanoparticles to penetrate membranes.” He theorized, the potential toxicity of nanoparticles is complex and “depends on multiple physicochemical and environmental factors” such as particle size, chemical composition, surface structure, solubility shape and aggregation. He concluded with the familiar refrain that more studies are needed in this area, and advocated a precautionary approach: “until more is known about the environmental effects of nanomaterials, the release of manufactured nanomaterial into the environment must be avoided as far as possible.”
S. Kashiwada, “Distribution of Nanoparticles in the See-through Medaka (Oryzias latipes),” Environmental Health Perspectives Vol. 114, No. 11, Nov. 2006.
Nanotechnology in the Workplace
The Director of NIOSH’s Education and Information Division co-authored an informative paper regarding the use of nanotechnology in the workplace that was published in the January edition of Environmental Health Perspectives. The paper’s goal was to address the ethical issues surrounding worker health and safety related to the use of nanotechnology in the workplace. This paper identified five primary ethical issues in this area:
• Identification and communication of hazards and risks;
• Understanding and acceptance of risks by workers;
• Implementation of controls;
• Medical screening; and
• Investment in toxicological and exposure control research.
EPA's Stewardship Program in Jeopardy?
Information out of Europe suggests that the U.S. EPA's Nanoscale Materials Stewardship Program, when finally launched, may not be as successful as the Agency hopes.
A similar program in the United Kingdom, the Voluntary Reporting Scheme for Engineered Nanoscale Materials, administered by the Department for Environment, Food & Rural Affairs (DEFRA), has received lukewarm responses at-best.
Continue Reading...Environmental Defense Not "Green" Enough According to New Coalition
As we previously posted here, DuPont and Environmental Defense recently published the first draft of their risk assessment framework for nanotechnology. We commended the effort for its inclusive nature and focus on immediate EHS issues surrounding the use of nanotechnology.
However, a new coalition calling itself the "Civil Society-Labor Coalition" (CSLC) recently published an open letter to the nanotechnology community condemning the DuPont/Environmental Defense effort as mere "public relations." CSLC also "strongly object[ed] to any process in which broad public particpation in government oversight of nanotech policy is usurped by industry and its allies." CSLC further condemned all "voluntary regulatory" approaches to EHS issues in general as "delaying tactics."
Unfortunately, CSLC's open letter contains no substantive criticism or suggestions, making it hard to embrace. CSLC's members missed a chance to advance their position(s) on nanotechnology EHS issues in a credible way. The "labor" portion of CSLC in particular could have used the opportunity to provide constructive guidance on what they believe are the major EHS issues confronting their member workers. We encourage CSLC to join the "meaningful and open discussion" regarding these issues that it advocates in its open letter.
CSLC claims the following members: AFL-CIO; Beyond Pesticides; Brazilian Research Network in Nanotechnology; Society and Environment; Center for Environmental Health; Center for Food Safety; Corporate Watch; Edmonds Institute; ETC Group; Friends of the Earth Australia; Friends of the Earth Europe; Friends of the Earth United States; Greenpeace; Institute for Agriculture and Trade Policy; International Center for Technology Assessment; International Union of Food, Argricultural, Hotel, Restaurant, Catering, Tobacco and Allied Workers' Associations; Natural Resources Defense Council; Sciencecorps; Silicon Valley Toxics Coalition; Third World Network; and the United Steelworkers of America.
Columbus, Ohio Gets Nanotech!!
The Ohio Department of Development recently announced a significant financial incentive that it awarded to Zyvex Performance Materials, Inc., a "leading nano-technology company providing tools and instrumentation to the semi-conductor and research and education markets." The incentive, a 60%, 5-year tax cut on real property improvements, allows Zyvex to relocate its headquarters to Columbus along the new State Route 315 Technology Corridor. The move is expected to generate approximately 100 jobs in Central Ohio.
In addition to its semi-conductor work, Zyvex "was the first to provide carbon nanotube (CNT) powered products to the marketplace," and "Zyvex's performance materials serve customers in the aerospace, defense, automotive, and energy markets while its patent technology has been incorporated with customers who are sporting goods manufacturers."
The new facility will be used for administration, research, development, and limited manufacturing.
Come Hell Or High Water
Despite absolutely awful weather forcing the cancellation of literally hundreds of flights into New York City, the NanoBusiness Alliance managed to pack a couple of good-sized ballrooms at the Marriott Marquis on Times Square for its sixth annual conference. Such great attendance under these conditions is a true testimony to the determined entrepreneurial spirit of the participants. Informative presentations ran the gamut from literal start-up companies to Fortune 20 international corporations. All of the speakers and attendees were brought together by a common vision of how nanotechnology is transforming business as we know it.
Particularly interesting was a presentation by Lisa Farmen, President and COO of Crystal Clear Technologies, Inc. (CCT). Ms. Farmen's company uses proprietary absorptive nanomaterials to purify water. The technology is inexpensive, renewable, and able to remove high levels of heavy metals from water and contain them in a easy to recycle residue that is also safe to dispose of in ordinary landfills. The technology produces no waste-water, and a small amount of the nanomaterial can be used to purify hundreds of thousands of gallons of water. The most interesting thing about Ms. Farmer's company and its technology is that its business prospects are immense, yet at the same time it is targeting a most basic human need -- inexpensive, clean drinking water. Ms. Farmer indicated CCT expects to complete initial sales to the U.S. military in 2007.
Beyond the top-rate presentations, the conference's organizers should also be commended for pulling together such a premier event. The conference received live national television coverage on CNBC's Squawk Box news program and was also widely reported in the print and online press. The entire nano-industry benefits from such a well-put-together event.
Cellular Response to Nanoparticles
Three pharmacologists from McGill University recently published a paper concerning in vitro biological cell reponse to various types of internalized nanoparticles. Despite its hyperbolic title, the study makes some interesting observations.
First, the paper finds that no categorical conclusions can be drawn from existing testing data and much more research is necessary in this area. At the center of this lack of data, the articled notes several of the many variables affecting cellular response: "Depending on the kind of nanoparticles, the type of cells, the duration of exposure, the concentration of nanoparticles and the conditions under which cell-nanoparticle interaction takes place, different cells will either 'tolerate' nanoparticles or succumb to their 'attack.'" Given these variables and the relative adolescence of nanotechnology, it is easy to understand why is is difficult to draw overall conclusions from existing data.
Continue Reading...The Week(s) In Nanotechnology
Ed. note: every Friday (more or less) Nanotechnology Law Report's David Fischer will look back at the week’s news and analysis of nano related issues. If you have something you’d like to bring to our attention, email him.
- The Washington Post reports that researchers at Purdue University have found that bacteria are "not to be harmed when the soil they live in becomes contaminated with 'buckyballs' -- microscopic spheres of carbon that are being manufactured in increasing quantities for a variety of applications."
- Electronics Weekly reports that the "James Watt Nanofabrication Centre at Glasgow University was opened last week with a funding boost for a research project on compound semiconductor III-V Mosfets."
- The Ottawa Citizen reports that the director of the federal government's new National Institute for Nanotechnology wants Canada to "make a serious effort to examine the safety of nano-products, and consider whether the country needs new laws to govern them" because "unless the issue is carefully studied and explained to the public, the new technology and its economic benefits may suffer from the same kind of public backlash that greeted the arrival of genetically modified foods a decade ago."
- The public radio show "Marketplace" recently had a story Britain's Council of Science and Technology calling for "a closer look at a growing and lucrative science: nanotechnology." You can read the transcript here or listen to it here.
- Nanopublic has a very interesting and lengthy look at changes in labeling following the EPA's nanosilver announcement last year.
- Rice University has a Q&A with National Science Foundation senior advisor for nanotechnology - and key architect of the National Nanotechnology Initiative - Mike Roco (via Nanodot).
- Nanodot comments on delays in acquiring nanotechnology patents.
- Nanotechbuzz is looking for a nanotech blogger - and they pay too!
Sackler Lecture
The National Academy of Sciences held this year’s Sackler Lecture yesterday at which Dr. George Whitesides presented “Nanoscience and Nanotechnology: A Portrait in Early Adolescence.” The lecture was part of the larger two-day Sackler Colloquium on Nanomaterials in Biology and Medicine: Promises and Perils in which 16 distinguished speakers participated. Despite his towering scientific credentials, Dr. Whitesides explained relatively complicated nanotechnology issues in a very uncomplicated and direct manner that made the lecture particularly interesting. From a policy standpoint, Dr. Whitesides’s most interesting observation was that “first order” issues concerning nanotechnology -- such as EHS concerns in manufacturing and the environment -- are not the largest potential risks posed to society by nanotechnology. He views existing science as being well equipped to address these potential concerns. Rather, the largest societal issue from Dr. Whitesides’s perspective is the potential loss of privacy that may result from the inevitably increasing information technology capabilities enabled by nanotechnology. Dr. Whitesides also opined that while he believes nanotechnology has and will provide very important and dramatic changes in a variety of disciplines, it remains to be seen whether or not it will indeed be “revolutionary” under traditional understanding.
NANOTaxi and Texas Team Win Idea to Product Competition
Last week I had the pleasure of being a judge for the Nano Idea to Product Competition that took place as part of Nano Nexus 2007 at Oak Ridge National Laboratory in Tennessee. Fifteen teams of students from various universities across the country presented business proposals for some great new and innovative nanotechnology product ideas. The winner received $25,000 in seed money for their project. Judging the competition was very hard. Every team in my group of contestants was very good and all of the judges had a difficult time deciding who came out on top. A team from the University of Texas at Austin earned the winning spot in our round and ultimately won the competition with their NANOTaxi drug delivery platform. The product is an extremely targeted disease-responsive nano-drug delivery system. It consists of a biodegradable nanocylinder with a disease responsive lid that acts as a sensor and dissolves to release a drug only in the presence of a large quantity of specific enzymes found only inside diseased cells. Not only was the product creative and innovative, the presenters did an excellent job making their pitch and also at fielding our various questions. You can see a photograph of the winning team and read another blogger's take on the competition here.
As for the conference itself, Nano Nexus 2007 was exceedingly well-planned and organized. The facilities were excellent and everyone was very hospitable. The speakers were also top-rate. With all of the mega nano-conferences taking place this year, it was also nice to attend this one with a specific venture focus.
