The Journal of Consumer Policy is an academic journal, publisher by Springer, that, as the title implies, focuses on consumer issues. The editors have issued a call for papers for a special issue, "Nanotechnologies and the Consumer". For more information on submitting a manuscript, please take a look here.
In the June 24, 2009 federal register, the U.S. Environmental Protection Agency (EPA) issued two proposed Significant New Use Rules (SNUR) under Section 5(a) of the Toxic Substances Control Act (TSCA) for multi-walled and single walled carbon nanotubes. The SNURs followed up on the EPA's prior September 2008 consent orders entered into with Thomas Swan & Co. Ltd. (Swan) for two of its Elicarb carbon nanotube products.
Under TSCA, the prior September 2008 consent orders were only binding on Swan. "Consequently, after signing a Section 5(e) Consent Order, EPA generally promulgates a Significant New Use Rule (SNUR) that mimics the Consent Order to bind all other manufacturers and processors to the terms and conditions contained in the Consent Order. The SNUR requires that manufacturers, importers and processors of certain substances notify EPA at least 90 days before beginning any activity that EPA has designated as a "significant new use. These new use designations are typically those activities prohibited by the Section 5(e) Consent Order."
Under the terms of the Septmeber 2008 consent orders which are incorporated into the new proposed SNURs, significant new uses of multi-walled and singled-walled carbon nanotubes are deemed to occur when employees do not “use gloves impervious to nanoscale particles and chemical protective clothing;” and/or fail to “use a NIOSH-approved full-face respirator with an N-100 cartridge while exposed by inhalation in the work area.”
Thus, the new proposed SNURs require these same conditions.
Manufacturers should also be aware that the EPA considers carbon nanotubes new chemical substances requiring full PMN notice, registration, and approval under Section 5 of TSCA, and has initiated at least one recent enforcement action against a carbon nanotube manufacturer who has failed to properly register its products.
How to regulate nanomaterials, nanotechnologies, and nanoindustries has become and will continue to be for the foreseeable future a major focus of US and European regulatory agencies, legislatures on local and national levels and of NGOs.
This Fall in London, from 10-11 September, US and European regulators and researchers from NGOs such as the Woodrow Wilson Center's Project on Emerging Nanotechnologies, the London School of Economics, (a tidbit for the trivia buffs: Among the London School of Economics better know alumni, one Michael Philip Jagger, aka Mick Jagger) etc will meet and present a collaborative report and other papers. Attendance at the conference is by invitation only and e-mails should be addressed to nanotech@lse.ac.uk attention Ms. Carmen Gayson. For more information, look here.
The Woodrow Wilson Center's Project on Emerging Nanotechnologies is also presenting a meeting and webcast in connection with the conference on September 23, 2009. For more information, take a look here.
In a recent speech to the IFT International Nanoscience Conference, Dr. Annette McCarthy of the FDA, is quoted as saying "We believe that the regulatory authority is sufficient to address nanotechnology. But there are further questions we need to address".
J. Clarence Davies, currently with the Woodrow Wilson International Center project on Emerging Nanotechnologies, might agree with the latter part of that statement, but certainly not with the former.
In the recently published "Oversight of Next Generation Nanotechnology", Davies looks at existing regulatory agencies that would have oversight of nanoproducts and finds them lacking:
The current oversight system was designed to deal with the problems of steam engine technology in the context of a pre-computer economy. . , ,
It was based on assumptions that most programs are local, that programs can be segmented and isolated from each other, that technology changes slowly and that all the important problems have been identified. All of these concepts are no longer valid. . . . The antiquated conceptual basis of the system has been made more evident by the massive erosion of money and manpower from a system that always suffered from inadequate resources.
The inadequacy of the current system to deal with new technologies is obvious. Especially in the United States, regulatory oversight has always been somewhat deficient, and over the past 30 years it has been allowed to deteriorate to the point where only major changes can rescue it. On both sides of the Atlantic, extreme free market ideologies have contributed to the erosion of oversight. Furthermore, there has been a failure to anticipate and analyze the new technologies that are being created and commercialized at an ever-increasing rate.
Mr. Davies offers what some might see as a radical solution, dissolving such agencies as EPA, CPSC, etc, and creating a new cabinet level Department of Environmental and Consumer Protection, which would have the authority to and be tasked with product and technology regulation, pollution control, etc.
No one will, I think, disagree with Davies observations on the current state of US regulatory agencies. Decades of decreasing budgets, decreasing staff, and the dominance of a political ideology that viewed government regulation of anything as evil effectively rendered agencies such as CPSC impotent and unable to perform their duties. This impotence extended to other agencies as well- we have only to look at the near collapse of the economy to see that agencies charged with regulating economic matters failed as well. With a change in administrations and public outrage the various failures of regulatory agencies, those agencies are finally beginning to see an increase in their budgets, manpower and authority.
Certainly also, one cannot disagree with Davies assertion that the agencies that he focuses on were designed to regulate products created by 19th and early 20th century technologies and industries and are in need of a review and updating. However, one has to wonder if Davies proposal of tearing the regulatory structure down and starting over is a practical solution.
Davies assumes that a new Department of Environmental and Consumer Protection's budget would equal the combined total of the budgets of the agencies and departments it would be replacing. Given the way that the federal budget process operates, that's an assumption that is unlikely to happen. Further, it's also unlikely that moving agencies from one department to another and merging agencies to create an new department would be a smooth and easy process. Each one would have it's own particular office culture which might create friction among personnel. Also, aside from the lobbying of various interest groups to contend with, Congressional Committees and Subcommittees that have budgetary control might not be willing to give that control and power up.
Having said this, Davies report does serve as a starting point for a long overdue discussion of needed changes in regulatory agencies that have and will have responsibility for regulation of nanotechnology and nanoindustry. As Davies points out early on in the report, the purposes of regulation are to safeguard the public and create conditions that allow for the safe growth of, in this case, nanoindustry, something that I think most of us reading and writing on this blog want to see.
Perhaps the most overlooked issue when examining potential nano-related environmental, health, and safety concerns is whether there is any true likelihood of exposure in reasonably foreseeable use scenarios. While there should continue to be extensive toxicity testing for certain nanoscale materials, the most interesting research (from my perspective) relates to potential workplace and/or condumer exposure in realistic settings. We examine two studies along these lines below.
C. Su-Jung et al., "Control of Airborne Nanoparticles Releases During Compounding of Polymer Nanocomposites," 3 Nano: Brief Reports and Reviews 4, 301 - 309 (2008).
This study was conducted by researchers at the National Science Foundation-funded Center for High-Rate Nanomanufacturing at the University of Massachusetts at Lowell. The scientists examined potential nanoparticle release related to the twin-screw extruder compounding of polymer nanocomposites. The test was conducted because "commercial compounding (mixing) of nanocomposites is typically achieved by feeding the nanoparticles and polymer into a twin-screw extruder, the airborne particles associated with nanoparticles reinforcing agents are of particular concern, as they can readily enter the body through inhalation."
The nanoparticles in question were nano aluminum oxide particles acquired from Nanophase Technologies in commercially available form. The particles were spherical in shape and ranged from 27 to 53 nm in diameter. They were also specifically "engineered to form agglomerates with a nominal size of 200 nm."
Regarding the test itself, the scientists fed 2.3kg of polymer pellets and 0.16 kg of nano-alumina particles into a twin-screw extruder for processing and then measured potential nanoparticle release through two measurement techniques: (i) TSI Fast Mobility Particle Spectrometer for real time measurement; and (ii) personal air sampling using a special filter media designed to catch nanoparticles.
The study concluded that "[t]he twin-screw extrusion process for compounding polymer nanocomposites tends to break up nanoparticle aggregates and mechanically disperse particles thoroughly during the extrusion process." The study also found that "[nano]particle diffusion was enhanced by . . . poorly-performing local and general exhaust systems."
Interestingly, for part of the test the scientists applied a nominal engineering control by covering the open top of the extruder feeding tube throat with aluminum foil which they found "dramatically reduced" nanoparticle measurements. They also found that consistently cleaning the lab after each use "reduced laboratory background nanoparticle concentration."
D. Bello et al., "Exposure to nanoscale particles and fibres during machining of hybrid advanced composite containing carbon nanotubes," 11 J. Nanopart Res 231 - 249 (2009).
The researchers in this study investigated whether and to what extent airborne nanoparticles were generated by wet and dry cutting of two hybrid carbon nanotube composites. The dry cutting method employed a diamond coated band saw. The wet cutting was performed using a diamond grit rotary cutting wheel with water lubricating the cutting surfaces during the process. Because the scientists were interested in potential "worst case" scenarios, no vacuum or emission controls were used in tests.
The researchers found that wet cutting did not produce airborne nanoparticle emissions above background levels, but that dry cutting "generated statistically significant quantities of nanoscale and fine particles as compared to background (p<0.05), regardless of the composite type, . . . as expected."
Interestingly, the study also found that "CNTs, either individual or in bundles, were not observed in extensive microscopy of collected samples" for either wet or dry tests.
We will continue to track down and summarize these types of potential exposure studies. Right now, they are few and far between.
The Investor Environmental Health Network (IEHN) claims to represents 20 investment organizations with $22 billion under management that are seeking to ensure that the companies they invest in are taking appropriate steps to reduce risks associated with the toxic chemicals used in their products. IEHN's ultimate objective is to use "public policy work regarding investor rights and disclosure, as well as dialog and shareholder resolutions, [to address] the risks and opportunities associated with toxic chemicals and safer alternatives in products." IEHN previously issued a report on the use of nanotechnology in cosmetics in February 2007.
IEHN's new report -- "Bridging the Credibility Gap: Eight Corporate Liability Accounting Loopholes that Regulators Must Close," Investor Environmental Health Network, 2009 -- focuses on corporate disclosure issues surrounding the commercialization of nanoscale materials. IEHN identifies eight "loopholes" that it believes companies and regulators must close to protect shareholder value.
IEHN's eight purported "loopholes" are:
1. Shortsightedness: Failing to make a full accounting of potential risks and liability be focusing solely on short term issues.
2. Concealed Science: "Concealing emergency science that forewarns of potential liabilities in the future."
3. The Known Minimum: Basing business decisions on low end risk assessments rather than true case "worst case" scenarios.
4. Privileging Secrecy: Using the attorney client privilege to shield against public disclosure of potential liability.
5. Inconsistent Estimates: Providing different risk estimates to insurers on the one hand, and investors on the other.
6. Hidden Assumptions: "Using hidden assumptions to minimize estimates of liability.
7. Missing Benchmarks: Failing to benchmark a company's potential liability against its competitors in the same business facing similar liability issues.
8. Risk-Free Proxies: Failing to allow shareholders to place EHS questions on annual proxy ballots.
These purported "loopholes" are not exclusive to nanotechnology. IEHN hypothetically compares the potential corporate liability of companies using nanoscale materials to the ruin faced by companies involved in asbestos manufacturing from the 1930s forward. Basically, IEHN argues that failing to close these eight identified "loopholes" destroyed the asbestos industry and the same thing might happen to the nanomaterials industry if it does not act differently.
There's been a sort of a medical theme running through this week's entries, so, to close out medical week, we turn to an article by David Peters et al, advanced published on PNAS website, "Targeting atherosclerosis by using modular, multifunctional micelles". Much as other nanoparticles may be targeted at tumors (see "Targeting Tumors"), so micelles may be targeted at plaque in blood vessels.
As the article describes, lab mice fed a high fat diet were treated for plaque formation using micelles with peptides that would seek out and attach themselves at the weakest point of the plaque, delivering anticoagulants to reduce the formations. The results of the experiments
Micelles coated with the CREKA peptide were able to specifically target diseased vasculature in ApoE-null mice. . . . micelles targeted with the CREKA peptide present a potentially useful approach to targeting atherosclerotic plaques.
. . . the CREKA micelle platform may be useful in reducing the clotting tendency in plaques and could potentially also reduce the risk of thrombus formation on plaque rupture. Also the targeting makes it possible to lower the dose, which should reduce the risk of bleeding complications.
This study, along with earlier ones on targeting nanoparticles to seek out tumors to more effectively deliver chemotherapy treatments, seems to indicate that the best use of nanoparticles in medicine is as delivery systems.
And for anyone below a certain age who didn't get the reference in the title, take a look here. Ah, Lennon and McCartney. They just don't write them like this anymore.
Inside U.S. Trade reports three interesting nano-regulatory developments: (i) the "EPA has signaled that it may soon decide to regulate nano-silver as a pesticide under " FIFRA; (ii) the "EPA may rule favorably on some points" raised in the 2008 citizen's petition filed by 14 advocacy groups seeking more restrictive regulation of nanoscale silver; and (iii) Congresswoman Kathy DahlKemper (D-Pa) on the House Science and Technology Committee "is pursuing a Cosmetics Safety Bill that would require registration of cosmetics containing nanomaterials."
EurActiv.com (EU News, Policy Positions, and EU Actions on line) published an article on June 15, 2009 entitled "Nanotech claims 'dropped' for fear of consumer recoil."
The article reported on a nanotechnology conference which took place in Brussels during the week of June 10 at which a scientist from the Woodrow Wilson International Center for Scholars' Project on Emerging Nanotechnologies maintained that some of the current environmental, health, and safety controversy accompanying certain nanoscale materials is not grounded in scientific fact, but has nonetheless led some manufacturers to remove "nano" from their product labels and advertising. He further stated that "we have seen some companies drop the 'nano' claim while continuing to use nanotechnology. This suggests nanotechnology is going underground."
Providing a counterpoint, the Director of the European Nanotechnology Industries Association said that "[v]arying definitions [of nanotechnology] leads to claims that the industry is not open to information. But nobody is lying and nobody is misleading the public or authorities. Let's agree on what we're talking about and work together to inform consumers."
Mark your calendar for the one-day conference “NanoBiotech 2009” set for October 19, 2009 which is being co-sponsored by Rensselaer Polytechnic Institute (Troy, NY) and Bawa Biotechnology Consulting LLC (Ashburn, VA). This is the sixth in a series of international conferences they have conducted dating back to 2003 on the converging areas of nanotechnology and biotechnology.
From the conference's website: "The conference will feature 20+ speakers, including 2 keynotes and a networking luncheon. All presentations (20-30 minute Power Points) will be fast-paced, focused and will rely upon extensive color graphics and animations to reach the diverse audience. Raffle drawings will be held throughout the day."
You can find the agenda from last year's highly recommended conference here.
The Danville (Virginia) Register & Bee newspaper reported on June 9 that the U.S. Department of Education is funding a week-long training program for high school and middle school teachers to teach them about "the creation, measurement, manipulation and use of objects at the nanoscale." The course will be offered at the University of Virginia in July. Food, lodging, and tuition is covered for teachers who take the class.
For more information, contact Laura Holloway at (434) 766-6772 or laura.holloway@ialr.org.
The June 10, 2009 edition of AME Info - Company News (Dubai) reports that Samsung is launching a new line of anti-bacterial keyboards for its laptop computers using embedded nanoscale silver particles to kill germs and bacteria. Other computer keyboard manufacturers have marketed similar products in the past. The article stated that the keyboard kills 99% of all bacteria within 24 hours.
Also, for anyone interested, my daughter's fifth grade science fair project "tested" the effectiveness of another manufacturer's nanosilver computer keyboard. :)
Advanced Ceramics Report (ACR) recently ran an article about a Swiss-based nanotoxicity experiment using cerium oxide nanoparticles. According to the article, the researchers selected cerium oxide for the test because it is heavily used in the semiconductor industry as an abrasive to etch computer chips. The scientists simulated aerosol exposure of lung epithelial cells by spraying the particles on cells for 10, 20, and 30 minute intervals. "The longer the cultures were sprayed . . . the more nanoparticles were deposited on the lung cells. The scientists observed that the cells did not die. However, the permeability of the cell layer increased." Additionally, the cells apparently produced a precursor indication of potential oxidative stress.
ACR, June 1, 2009, "Cerium oxide nanoparticles toxicity on lungs examined."
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Springer recently published Nanomaterials: Risks and Benefits which is part of the North Atlantic Treaty Organization's Science for Peace and Security Series. The 460 page text was edited by Igor Linkov and Jeffery Steevens and contains 34 articles divided into 5 sections:
The full table of contents can be seen here. I co-authored an article in the Policy and Regulatory Aspects section entitled Considerations for Implementation of Manufactured Nanomaterial Policy and Governance for those readers who might be interested.
As has been discussed on this blog and in other forums, nanoparticles are increasingly being used in an ever increasing variety of products and industries, and, as has been discussed here and elsewhere, there has been a corresponding rise in concern about exposure to nanoparticles and the possible toxic effects such exposure could result in.
The Journal of Molecular Cell Biology last week published, on their website, an article by Chenggang Li et al, "PAMAM Nanoparticles Promote Acute Lung Injury by Inducing Autophagic Cell Death Through the Akt-TSC2-mTOR Signaling Pathway", which examined the toxicity of a particular type of nanoparticle, the Starburst Polyamidoamine dendrimer (PAMAN), a nanoparticle that that pharmaceutical industry has shown a great deal on interest in, and how PAMAM causes cell death to occur.
This study and its results will add to the growing body of research which should lead to discussions and establishment of safety protocols for the nanoindustry , protocols that will keep workers and consumers from unnecessary harm and allow the nanoindustry to grown and develop.
For decades after it was discovered, penicillin was used to combat bacteria and, eventually, almost every other disease, whether it was the appropriate treatment or not. Over time and over use of penicillin and its successor drugs, resistant strains of bacteria began to appear, to the point where, now, many strains of bacteria are almost completely drug resistant.
According to a recent article posted to the Australian Broadcasting Corporation (ABC) site, nanosilver might become the 21st century's penicillin, being widely used in the medical field, but also in consumer products, such as combs, hair dryers, men's socks, and underwear.
Some of this overuse of nanosilver is probably due to companies simply following trends and wanting to appear cutting edge or it may be due to marketing efforts that fall into the "All New!" category. Other companies may be adding nanosilver as part of a genuine effort to improve their products and make them healthier, although how much healthier underwear is with nanosilver as opposed to underwear without is a debate probably best left to others.
While a total ban on the sale of products containing nanosilver, which groups such as Friends of the Earth propose is unlikely, (and frankly seems more like simplistic fear mongering than anything else), regulations on the amount of nanosilver in consumer products, based on the results of reputable studies and tests on the effects on humans and bacteria of prolonged exposure to nanosilver particles are needed.
Personally, I'd start by regulating the amount of silver nanoparticles in men's underwear.
Earlier this week, the International Council on Nanotechnology (ICON) at Rice University launched GoodNanoGuide, a website devoted to safety protocols for handling nanomaterials. The site has a "Basic" section for those who are just beginning to deal with nanomaterials, an "Intermediate" one for those with some knowledge but in need of more, and an "Advanced" section for the more experienced. At each level, there are links that are focused on specific topics, such as protecting workers using nanomaterials in an industrial setting.
The site is easy to navigate and provides much needed information. It's well worth taking a look at , whatever level one happens to be at.
For another short article about GoodNanoGuide, please look here.
Much of the funding and research in nanobiotechnology has been directed at applying nanotechnology toward treating human illnesses and injuries. Dr. Edward Corredor and his collegues looked at something else: plants.
The possibility of targeting the movement of nanoparticles to specific sites of an organism paves the way for the use of nanobiotechnology in the treatment of plant diseases that affect specific parts of a plant. . . .
Recently, our group has applied carbon-coated iron nanoparticles to pumpkin plants in order to develop tools for the directed release of chemicals into plant organs susceptible to infection by pathogens that spefically attack them. . . .
The aim of this work was to analyse the penetration and movement of nanoparticles into plant cells, and the capacity of a magnetic field to retain them in spefic part of the plant.
Dr. Corredo et al's recent article in BMC Plant Biology, "Nanoparticle Penetration and Transport in Living Pumpkin Plants: In situ Subcellular Identification", presents the results of their experiments with pumpkin plants. What the experiments showed was
Only the cells containing the nanoparticle agglomerates exhibited more dense cytoplasms. . . .This fact suggested that the penetration of nanoparticles through the tissues did not damage them.
The presence of nanoparticles in epidermal cells after the application by spraying is of special interest. As stated before, one of the main drawbacks of other methods is that they cannot be employed for agronomic purposes. The method used in this work resembles the procedures which would be used by breeders and coordinators of phytosanitary control, employing both large scale and hand-on spraying to leaf surfaces. The fact that nanoparticles passed through the epidermal cell walls opens up the possible application of these nanotechnology tools for agronomical purposes.
In short, carbon coated nanoparticles could be used to target plant diseases and treat specific areas of the plant, much as the last entry on this site discussed using targeted nanoparticles to treat tumours in the human body. Similarily, magets would be used to guide the nanoparticles to where the diseased area is. It's easy to see how this would benefit farmers: less of their crop would be lost to plant diseases, yielding a higher return on their investment in the form of larger harvests of healthier crops.
Large scale use of targeted nanoparticles is probably a long way down the road, for reasons presented in this article
. . . in order to make the system suitable for agronomical purposes, methodological improvements would need to be made.
And for reasons that are not discussed in the article: (1) the regulatory process, (2) the opposition to wide spread use that would come from various social-political groups, such as Friends of the Earth, which would play out in the media and could create a climate of fear and rejection, such as happened here and in Europe with genetically modified foods, and (3) more testing that would need to be done to see if the nanoparticles would remain in the plants when they are harvested and how such accumulations might affect human or animal health.
Granted, those do lie outside the focus of this article, but they are factors that will need to be considered if the articles results are to become part of the future commericalization of nanobiotechnology.
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