Nanotechnology Lawyer & Attorney : Porter Wright Morris & Arthur : Nanotechnology Law Report - Germanium nanobead image provided by UT-Battelle, which manages Oak Ridge National Laboratory for the Department of Energy

The May 3, 2011 edition of Chemistry World carried an interesting article by James Urqhart -- Titanate cigarette filter -- regarding several Chinese researchers who have developed a cigarette filter which employs nanoscale TiO2 which supposedly filters out harmful tobacco smoke constituents.  One of the researchers claims that "[a] great range of harmful compounds including tar, nicotine, ammonia, hydrogen cyanide, selected carbonyls and phenolic compounds can be reduced efficiently." 

The article also maintains that the researchers are "confident that titanate nanomaterials used in filters do not pose a health risk to smokers by inhalation" because "TiO2 is already widely used in consumer products including sunscreens, cosmetics and food."  Readers can judge the strength or weakness of this logic for themselves.

The article draws to mind Kent cigarettes with Micronite filters which were manufactured in the early to mid 1950s.  Believe it or not, these particular Kent cigarettes utilized crocidolite asbestos in their filters because of its unique filtering properties.  Readers can imagine the health-related lawsuits and judgments that followed.

Despite their unique filtering properties, mixing tobacco and engineered nanoscale materials in cigarette in this litigation environment is probably a bad idea.

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Earlier this month, the Reuters news service (now part of Thomson Reuters) carried an article by Richard A. Liroff, "Nanomaterials: Why Your Company Should Sweat the Small Stuff", primarily aimed at management executives at companies using or contemplating using nanomaterials in their products or manufacturing processes.

Noting that nanomaterials present "the potential to yield extraordinary health, environmental, and other global social benefits", Liroff also notes, as with asbestos, the potential for nanomaterials to have "novel toxicity risks". Pointing out that regulatory agencies in Canada, California, and the EU are basically at the beginning stages of issuing regulations;  EPA is noted for having initiated "a handful of regulatory actions" but since most of these actions featured voluntary compliance rather than mandatory, their success rate is noted as "poor".

Mr. Liroff points out that corporate management will

need to exercise especially demanding due diligence to make sure you're not taking on liabilities that you and your shareholders will come to regret.

With that in mind, Mr. Liroff poses several questions, largely focusing on suppliers of nanomaterials, that management should keep in mind while performing their due diligence and long term planning, including planning for the worst case scenario.

It's important that management and shareholders ask these questions and heed the warnings

about the unknown and under-researched hazards of nanomaterials . . . . If these misgivings go unheeded, that would be tragic on multiple counts. Not only because the potential benefits from the burgeoning forms of nanotechnologies will founder and be lost on the shoals of public mistrust and rejection, but also because companies and their shareholders will see corporate financial values vaporize in the face of closed markets and possible litigation.

Liroff raised the specter of asbestos in this article and it's important to learn from what happened - and is still happening, since litigation over the effects of asbestosis is still being filed, decades after asbestos was used in factories and consumer products - to avoid exposure to possible litigation and the lose of their investment by shareholders.

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The April issue of Environmental Health Perspectives carried an interesting article by Charles W. Schmidt,  "Nanotechnology Related Environment, Health, and Safety Research: Examining the National Strategy". The article looks at what could be a disturbing development, that

Experts in nanotoxicity and risk assessment have become increasingly polarized, represented on one side by the National Research Council (NRC) and on the other by the National Nanotechnology Initiative (NNI).

Schmidt's article notes that this polarization began after the Nanotechnology Environmental And Health Implications (NEHI) Working Group, part of NNI, released Strategy for Nanotechnology Related Environmental Health and Safety Research in February 2008. The report presented the then Bush Administration's agenda for studying nanoparticle hazards and was developed and written after "extensive consultations with regulatory agencies, research organizations, the business community and non-governmental organizations". The report reflected the concerns of the established stakeholders in nanotechnology.

In February 2009, an NRC assembled panel released its own report

. . .  describing what it calls serious short comings in the strategy document. According to the NRC panel . . . the strategy exposes weaknesses in the government's understanding of potential nanotechnology risks today and doesnot adequately address how they will be assessed in the future.

. . . NRC panelists would like to see a National Health based Strategy for nanotechnology research with defined goals, milestones, and mechanisms for assessing progress. . . . The need isn't just to insure the safety of nano-enabled products, but also to avert a public backlash against the technology, which could grow if health risks aren't seen as adequately addressed.

. . . The NNI strategy document - NRC panelists claim - is simply a compendium of federally funded projects without any unifying vision or sense of shared purpose.

An advance copy of the NRC report leaked out to the press in December 2008, leading NNI to post a rebuttal on its website , presenting the strategy document not an implementation plan, "But rather a higher-level description of the inter-agency approach to nanotechnology related EHS research."

One can only hope that the growing divide can be bridged. Both sides have much to contribute to the future growth of nanotechnology and a split into opposing camps serves neither side very well.

The final part of this article turns toward a different, in many ways more worrisome, topic. In January 2008, the EPA launched its nanoscale materials voluntary stewardship program, which urged companies to report information to EPA about their use, manufacture, import, etc of nanoparticles; according to the article, as of January 2009, only 29 companies had responded.

While companies might fear that their trade secrets might be revealed to competitors, it is more likely that what companies are afraid of are potential product liability lawsuits, legitimate or not, that would keep them in court for years (the shadow of asbestos again) and giving information to groups that would use the general public lack of understanding of nanotechnology - to most people, this is still science fiction - to create a climate of fear. At this stage in its development, the nanoindustry might be compared to the nuclear industry from 1950 until the mid-1980s. For the general public in that period, nuclear power was a mysterious thing beyond the non-scientist's ability to understand. For most people, nuclear energy meant only one thing: the power to destroy, personified in the form of Godzilla. Interest groups opposed to the further development of nuclear energy were able to use companies involved in the construction and running of nuclear power plants unwillingness to provide the public with information to create an effective climate of fear and opposition to the point where the industry nearly shut down after 3 Mile Island and Chernobyl.

To avoid this fate

. . .  nanoparticle toxicity data need to be made more widely available to insure public support for the technology.

rather than burying the information in annual reports or SEC filings, such as a 10K or a 10Q, which, while they are great sources of information, are also usually great cures for insomnia.

In an age of calls for greater transparency in both government and business, one can only hope that the nanoindustry will seize the moment and release more information in a form and language that the general public can understand. As someone once observed, sunshine is the best disinfectant.

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The April issue of Environmental Health Perspectives carries a short article summarizing a seminar at the 2009 AAAS Annual Meeting titled "Driving Beyond Our Nano-Headlights?". In the summary, there is a brief reference to work done by Vanesa Sanchez, a graduate student at Brown University. The results of her experiment are rather alarming.

Ms. Sanchez work showed that

very low doses of CNTs . . . appeared to cause lesions known as granulomas similar to what occurs with asbestos fibers. Moreover, the CNTs formed a cage-like structure that . . .  might promote granuloma formation.

It is too bad that the summary didn't give more space to a study that could have a profound effect on future nanomanufacturing facilities and possible future governmental regulation of the nano-industry.

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For those who are interested, below is the abstract of our new article published in the Fall edition of Nanotechnology Law & Business.   You can find the full edition here: www.nanolabweb.com

A Nano-Mesothelioma False Alarm

In May 2008, a scientific study (the “Poland Study”) was published in Nature Nanotechnology—which sparked a rash of popular media claims that like asbestos, exposure to carbon nanotubes may cause mesothelioma. In this article, a team led by lawyer John Monica evaluates the Poland Study in a potential litigation context to determine its significance, if any, in legally establishing that the inhalation of multiwalled carbon nanotubes (“MWCNTs”) causes mesothelioma. After first considering the reliability of the Poland Study's design and execution, they conclude that it would not be admissible in a court of law because it fails Daubert standards. Specifically, they argue that: (i) the design and execution of the Poland Study are not generally accepted in the scientific community for the purposes offered; (ii) in order to reach the conclusion that inhalation of MWCNTs may cause mesothelioma, an expert would have to use the Poland Study in such a manner as to extrapolate from an accepted premise to an unfounded conclusion; and, (iii) the Study's authors failed to adequately account for obvious alternative explanations (confounders), including surface chemistry, sample contamination, sample commingling, spontaneous formation of granulomas, and possible mouse colony infections.

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There have been a number of articles published since May 20 regarding a possible link between carbon nanotubes and the development of precursors of mesothelioma because of a recent letter published in Nature Nanotechnology.

C. Poland, et al., "Carbon nanotubes introduced into the abdominal cavity of mice show asbestos-like pathology in a pilot study," Nature Nanotechnology, May 20, 2008.

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