Nanosoccer, sure. But How Big is the Trophey?

Its Friday of a short week, so of course we're getting a little goofy.  We ran across this story this morning and couldn't resist passing it on.  The National Institute of Standards and Technology (NIST) is hosting a nanosoccer tournament, of sorts.

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DEFRA Voluntary Reporting

The United Kingdom's Department of Food, Environment, and Rural Affairs (DEFRA) has released its Sixth Quarterly Report concerning the response to its Voluntary Reporting Scheme for Manufactured Nanomaterials (VRS), and the news is not good. Continue Reading...

Nanotechnology Law Report May 2008

Nanotechnology Law Report May 2008
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Kavli Recipients Named

Updating an earlier post on the new award for nanotechnology, the Kavli Prize, the first set of recipients has been named.  Remember, the award is for "transforming human knowledge in the fields of nanoscience, neuroscience and astrophysics."  The recipients were named earlier today, and there are seven total. Continue Reading...

GAO Report on Nanotech Guidance

Sorry for coming a little late to the party on this one, it slipped past us until recently.  Back in March the Government Accountability Office, the agency that investigates tax dollar spending for Congress, released a report entitled "Nanotechnology: Better Guidance Is Needed to Ensure Accurate Reporting of Federal Research Focused on Environmental, Health, and Safety Risks." Continue Reading...

Some Legal Considerations Regarding the Carbon Nanotube Asbestos Analogy, Circa 2005

Given all of the press this week regarding the Poland et al. letter in Nature Nanotechnology and the and Takagi et al. paper in the Journal of Toxicology -- both of which discuss alleged "asbestos-like" effects of carbon nanotubes in mice-studies, we thought readers might be interested in an excerpt from our 2005 paper "Preparing for Future Health Litigation" published in Nanotechnology Law & Business.

Carbon nanotubes have already been compared to asbestos. The asbestos litigation crisis provides a useful case study to explain the importance of keeping products liability law in mind from the beginning of a product’s life cycle to the end. The Rand Institute for Civil Justice has estimated that as of the end of 2002, approximately (i) 730,000 people had filed asbestos related lawsuits; (ii) 8,400 entities had been named as defendants in those lawsuits; and (iii) a total of approximately $70 billion had been spent defending those lawsuits and compensating those with alleged injuries. Of that $70 billion, approximately $21 billion was spent on actual defense costs, while another approximately $49 billion went to plaintiffs and their attorneys. (Approximately $19 billion went to the plaintiffs’ attorneys, while $30 billion went to the actual claimants themselves). And it is not over: due to the decades-long latency period of alleged asbestos related diseases, most experts estimate that only 75 percent of the final number of asbestos claimants have come forward.

Asbestos litigation began in 1966 when Claude Tomplait filed the first asbestos products liability suit against 11 manufacturers of asbestos products after he was diagnosed with asbestosis. He lost his case, but three years later, a coworker, Clarence Borel, sued and won nearly $80,000 from the manufacturers of asbestos products that purportedly caused him injury. The “asbestos litigation crisis” began in earnest in 1974 when attorney Steven Kazan filed, and ultimately won, a civil suit against the Johns-Manville Corporation on behalf of an employee who developed asbestosis after working in the company’s Pittsburg, California plant for 29 years. In 1981, the California Supreme Court upheld an award of damages against Johns-Mansville – damages that would ordinarily be foreclosed due to the state’s workers compensation laws. Specifically, attorney Kazan and his associates alleged that internal memoranda and letters showed that the manufacturers of asbestos had conspired to suppress knowledge of the hazardous effects of asbestos on human health as early as the 1930s."

In addition, as the body of scientific knowledge regarding negative alleged health consequences of asbestos exposure grew, trial lawyers sought out and found huge populations of workers and others that allegedly suffered significant occupational exposure to asbestos, despite having never worked in an asbestos factory. As time went on, asbestos litigation widened to include plaintiffs allegedly exposed to asbestos in construction jobs, power plants, oil refineries, shipyards and more. This “widening” trend continues to this day. According to the same Rand survey, claims by these workers have been increasing at a far greater pace than those by workers in “traditional” industries. (17% to 22% faster pace). In fact, the trial lawyers have begun a new strategy to further increase the number of asbestos claimants: suits on behalf of persons potentially exposed to asbestos, but who have not actually yet taken ill. It is unclear how the courts will come out on this issue.

The pattern of mass tort litigation showcased in the asbestos litigation has important implications for the nanotechnology industry. The pattern of lawsuits in the asbestos context may repeat in this area: first, those plaintiffs with the greatest and most direct exposure to nanotechnology products will sue. Then, after the trial lawyers have “skimmed the cream” off the top of the claimant pool, they will search for new theories of liabilities to allow more claimants to sue more and more corporations, including corporations very “remote” from the source of the alleged injury.

Asbestos litigation left nothing short of economic devastation in its wake for the companies that manufactured or otherwise used asbestos. While the trial lawyers argued that those companies who allegedly conspired to cover up the dangers associated with asbestos “deserved” to be bankrupted, it is also true that an even greater number of defendants who were only remotely involved in manufacturing the product met the same fate. Indeed, products liability is a strict liability cause of action, meaning that good intentions, lack of negligence, and best efforts are largely irrelevant. If a nanotech product is found to be defective and causes an injury to someone, the manufacturer and distributor of that product are presumptively liable.

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Swiss Food Retailer's Code of Conduct

Switzerland's food retailers association, IG DHS, has released a Code of Conduct for food and packaging suppliers with regards to nanotechnology usage in their products.  The Code is fallout from earlier criticism, and is aimed at avoiding similar public backlash, over the use of genetically modified food in Switzerland.

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Unraveling Nanotechnology Standards

One of my "go to" nano news sources, Nanowerk, posted an interesting story last week concerning the competing standards that are emerging with regards to the technical side of nanotechnology.  The article outlines the various scientific standards that are developing, and the lack of any one overarching, or governing, standard. Continue Reading...

Fullerene Environmental Study Finds No Impact on Microbial Communities

Three Purdue researchers recently published the results of a NSF sponsored study on the environmental effects of fullerenes on microbial communities in digestor sludge samples taken from the Greater Lafayette Wastewater Treatment Plant.

L. Nyberg, et al., "Assessing the Impact of Nanomaterials on Anaerobic Microbial Communities," 42 Environ Sci. Technol. 6, at 1938-1943 (2008).

The researchers hypothesized that the release of fullerenes into wastewater discharge is likely to occur as nanotechnology is commercialized.  Further, because anaerobic sludge at wastewater treatment facilities contains a host of important living organisms, the group believes that "microbial communities in anaerobic digestors are excellent sentinel communities for evaluation of the effects of" fullerenes.

The study measured methanogenesis [methane production] of sludge samples exposed to fullerenes for several weeks (up to 89 days).  "Gas production data showed no toxicity due to any fullerene treatment.  Nor was biodegradation of C60 indicated by an increase in gas formation."

Despite these positive results, the scientists cautioned that "[l]ong-term studies of microbial communities will be required to determine the overall environmental impact of fullerenes. The time frame for evolution of biodegradation of a new chemical in anaerobic systems may be particularly long, so it is too early to conclude that microbial ecosystems and biogeochemical cycles will be unaffected by C60."

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No Nano Regs in the EU?

Rumors from "across the pond" indicate that a forthcoming official recommendation to the European Union will be that nano-specific regulations are not needed in the EU. Continue Reading...

House Committee Passes NNI Reauthorization

On May 7, 2008 the House Committee on Science and Technology unanimously approved H.R. 5940, the National Nanotechnology Initiative Amendments Act of 2008.  The bill now moves onto the full House, and then Senate for full consideration.  As stated by the Committee, "H.R. 5940, does not substantially alter NNI, but makes adjustments to some of the priorities of the program and strengthens one of the core components – environmental and safety research."

The full text of the bill can be found here, and we now wait to see what the full House will do with the bill.  However, the fact that H.R. 5940 is receiving bi-partisan support in committee, and was referred back to the full House so quickly (the bill was originally introduced on May 1, 2008), is positive for future action.

ICON's "Good Practices Wiki"

Our friends at Rice University's International Council on Nanotechnology (ICON) is proposing an idea that will essentially take the idea of "best practices" straight to the stakeholders in the form of a living document that is continually updated.  Through using a "wiki," ICON proposes creating a set of "good practices" that companies can update along the way with their own ideas and suggestions. Continue Reading...

EPA Sued Over Nanoscale Silver

On May 1, 2008, a group of 14 NGOs sued the EPA asking the agency to issue new rules regulating products containing nanoscale silver particles. The NGOs are: The International Center for Technology Assessment; The Center for Food Safety; Beyond Pesticides; Friends of the Earth; Greenpeace; The Action Group on Erosion, Technology and Concentration; Center for Environmental Health; Silicon Valley Toxics Coalition; Institute for Agriculture and Trade Policy; Clean Production Action; Food & Water Watch; Loka Institute; The Center for the Study of Responsive Law; and Consumers Union.

 

The petition points to the consumer product inventory published on the Project on Emerging Nanotechnologies website of the Woodrow Wilson International Center for Scholars which identifies approximately 260 products purporting to contain or use nanoscale silver.  Petitioners claim the EPA has failed to adequately regulate these and other similar products.

 

In support of its call for new regulation, the petition takes the petition that while the specific long-term health effects of human and environmental exposure to nanoscale silver particles are still being studied, scientific studies “indicate that nanosilver materials pose serious risks to human health and the environment.”  According to the petitioners, some of these studies allegedly show:

 

  • Nanoscale silver is more toxic than other nanoscale metals.  Braydich-Stolle, et al., In Vitro Cyctotoxicity of Nanoparticles in Mammalian Germline Stem Cells, 88(2): Toxicological Sciences 412-419 (2005)

 

  • Nanoscale silver exhibits “effective antibacterial action” at much lower levels than silver ions.  Lok, et al., Proteomic analyses of the mode of antibacterial action of silver nanoparticles, 5 J. Protean Res. 916-924 (2007).

 

  • Nanoscale silver produces reactive oxygen species, which can result in toxic oxidative stress.  Hussain, et al., In vitro toxicity of nanoparticles in BRL 3A rat liver cells, 19 Toxicology in Vitro 975-983 (2005).

 

  • Nanoscale silver is toxic to mammalian liver cells.  Hussain, et al., In vitro toxicity of nanoparticles in BRL 3A rat liver cells, 19 Toxicology in Vitro 975-983 (2005).

 

  • Nanoscale silver is toxic to mammalian stem cells.  Braydich-Stolle, et al., In Vitro Cyctotoxicity of Nanoparticles in Mammalian Germline Stem Cells, 88(2): Toxicological Sciences 412-419 (2005)

 

  • Nanoscale silver is toxic to mammalian brain cells.  Hussain, et al., In vitro toxicity of nanoparticles in BRL 3A rat liver cells, 19 Toxicology in Vitro 975-983 (2005).

 

  • Mammalian cell function abnormalities result from contact with nanoscale silver. Hussain, et al., In vitro toxicity of nanoparticles in BRL 3A rat liver cells, 19 Toxicology in Vitro 975-983 (2005).

 

  • Inhaled nanoscale silver may be transported throughout the body and into the kidney, brain, and heart.  Health and Safety Laboratory, Health and Safety Executive NewsAlert Service, December 2006 at p. 26.

 

  • Nanoscale silver penetrates cell membranes agglomerates in cell cytoplasm.  Skebo, et al., Assessment of Metal Nanoparticle Agglomeration, Uptake, and Interaction Using High-Illuminating System, 26 International Journal of Toxicology 135 (2007).

 

  • Nanoscale silver causes embryonic contamination in Zebrafish.  Lee, et al., In Vivo Imaging of Transport and Biocompatibility of Single Silver nanoparticles in Early Development of Zebrafish Embryos, 1 ACS NANO 133, 141 (2007).

 

Because of these alleged risks, as well as others claimed in the petition, Petitioners ask EPA to take a litany of specific actions, including:

 

  1. Classify nanoscale silver as a new pesticide (or new use of an existing pesticide) and require detailed product registration and data submissions under the Federal Insecticide Fungicide and Rodenticide Act (FIFRA).

 

  1. Analyze the potential EHS risks of nanoscale silver under FIFRA, the Food Quality Protection Act (FQPA), the Endangered Species Act (ESA), and the National Environmental Policy Act (NEPA).

 

  1. Take action against unregistered products containing nanoscale silver including issuing stop sale and/or removal orders.

 

Finally, the petition appears to be driven by the EPA’s September 2007 public notice that it intends to regulate silver ion generators as pesticides under FIFRA.  Petitioners do not believe that the notice went far enough in addressing potential nanoscale silver issues:

 

In the FR notice no mention is given to the rest of the existing fleet of nano-silver products (besides the “ion generating” equipment) or any proposed action by the agency regarding it, contrary to the reports of the quotes from EPA officials in the November 2006 announcement.  Nowhere does the notice request information about such products or in any way solicit comment from interested parties or the public on the regulation of nano-silver products.

 

 

 

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