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

When I was growing up, one of the local tv channels in Baltimore, after football season was over, devoted Sunday afternoons to running old movies. One of those films was Fantastic Voyage, a fairly slick 1966 sf film. The plot of the movie revolved around a submarine and its crew being shrunk to the point where they could be injected into a human vein with the mission of finding and dissolving a blood clot lodged in the brain of a scientist defecting from an unnamed Iron Curtain nation.

The plot and acting ranged from the thoroughly absurd to the god awful bad, but the special effects were top of the line for that period of film making (okay, the scene of Donald Pleasance' villain being devoured by a white blood cell that looks more like slowly poured soap bubbles is a hoot and a half, but it worked . . . sort of.) The image that stays in the mind is of the sub just gliding through the blood steam.

Fantastic Voyage leapt up from the depths of my memories while I was reading "How to Build Nanotech Motors" , by Thomas E. Mallouk and Ayusman Sen and published in the May issue of Scientific American briefly reviews nanocar experiments and focuses on two problems with nanocars: (1) how to power them and (2) how to steer them. The article discusses progress made in developing "motors" to power the nanomobile and controlling its direction via the manipulation of magnetic fields.

Mallouk and Sen's vision of the future of the nanocar is more one of nanotrucks, carrying cargoes of drugs to areas of the human body where no ordinary delivery system can reach. For example, anticancer medications could be carried directly to the site of the tumor and delivered without affecting the surrounding healthy cells, much as the crew of the sub reached their blood clot and dissolved it without damaging the other brain cells. This is one area of nanomedicine that I think everyone hopes will reach its full potential.

As for Fantastic Voyage,  the producers and director of Independence Day are working on a remake, scheduled to come out in 2010. If its anything like the remake of Godzilla, do yourself a favour and watch the original.

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Nanotechnology Law & Business latest issue carries their top ten list of

individuals with substantial expertise in environmental, health and safety issues related to engineered nanomaterials. We expect these individuals to play leading roles in nanotechnology law and business.

Among those individuals is John Monica, a partner at Porter Wright . Congratulations John, well earned and much deserved.

The issue of Nanotechnology Law & Business is available online here ; articles are available only by subscription or purchase. For those with access to Westlaw, the journal is available that way as well (the database is NANOLB). The latest issue has not been upload to Westlaw as of this morning.

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 Rep. MIke Honda of California has been noted as a major supporter of nanotechnology in the US House of Representives. Judging from this recent article  about Rep. Daniel Lipinski of Illinois, Rep. Honda has some company ( although you wish Rep. Lipinski had expressed his support just a little differently).

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We've mentioned Luca Escoffier on this forum before, and he's even done a guest post previously.  Well, now he needs YOUR help.  He's in the process of accumulating data for his thesis addressing nanomedicine patents, and would appreciate assistance with a survey.  His message is:

"Luca Escoffier is a visiting scholar at the University of Washington School of Law. He specializes in intellectual property and he has recently posted a questionnaire for his thesis on the patenting and evaluation of nanotech innovations with a specific focus on medical applications.

All those interested in filling in the questionnaire can find the on-line version at:

http://www.surveymonkey.com/s.aspx?sm=HAFIWLnBfgYN2i1Xhft9SQ_3d_3d

and

http://www.surveymonkey.com/s.aspx?sm=X6hPb3QwxX43RTN4DMM6nQ_3d_3d

The second part of the questionnaire is fundamental (i.e. question 10) as it is where the authorization to use your answers is required.

For further info you can contact him at: lucae@u.washington.edu.”

He thanks your for your support.

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Larry Marsh is a columnist for the Kansas City Star. Judging from his recent article, "Stem Cells and Nanosurgery May Change What it Means to be Human", Mr. Marsh has either read or seen some really REALLY bad science fiction.

According to Mr. Marsh

Nanotechnology, which is just beginning to make its debut, may change what it means to be human.

Apparently nanosurgical techniques will accomplish this by speeding up the process of replacing damaged or aged body parts, such as knees or hips. Oh, and somewhere along the line, the human mind will merge with Google. Sorry Yahoo.

Having undergone surgery to replace a shoulder and having gone through the intial period of having to learn to accept that the replacement was part of me, I can understand Mr. Marsh's somewhat strained point, but knee and hip replacement surgeries have been around for sometime now and not too many people have reported not feeling human.

However, its his next idea that makes one step too many:

 What if nanosurgery ultimately allows us to transfer the mind out of the brain into silicon in a stainless steel model?

I don't know about anyone else, but I have two images that leap into my mind after reading that:

1) Spock's Brain, which anyone who has sat through it will painfully admit was probably the single worst ST:OS episode ever written

and

2) "The Colossus of New York". For anyone who hasn't seen it, "Colossus" is a much underrated film from the golden age of SF movies, the 1950's and is still the only film I know of where the film score uses a single piano and the music is based on Schoenberg's 12 tone system.

Marsh ends his article by suggesting that those of us who are growing older might want to consider placing an advance order with Microsoft for that new stainless steel body. Considering all the problems Microsoft had with Vista, you might want to wait until they get all the bugs worked out first.

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Nanotechnology Law Report -- Spring 2009

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The last issue of Nanotechnology Law & Business had an interesting article on nanotechnology regulation and patent issues in China:  D. Liu, Nanotechnology in China: Regulations and Patents, Nanotechnology Law & Business, (Winter 2008).  The author is a Lecturer in Law at Newcastle Law School in the U.K.  For Nanolawreport readers, the article contains useful information regarding commercial applications, research and development, environmental health and safety, and regulation of nanoscale materials in China.

Commercial Applications

Professor Liu notes that the OECD "reports that about 1,000 enterprises presently engage in nanotechnology in China. . . . Nanoproducts consist mainly of 'nanoscale powders of oxides, metals, carbon nanotubes, fullerenes, their diverse derivatives, and applications of them such as those for coatings, fibers, fabric, papers, ceramics, catalysts, and nanomedicine, etc.' "

"[N]anoscience and nanotechnology are one of the four major fields of science research in China’s medium and long-term plans for development. In the 2001-05 period, China invested U.S.$400 million in nanotechnology. In 2005, China’s investment in nanotech research was U.S.$250 million, second only to investment in the U.S. In 2006, the amount was U.S.$160 million.

Environment, Health, and Safety

"During the period of 2003-2006, 10% of the [Chinese government's] investment in nanotechnology [was] allocated [to environmental, health, and safety research].  The National Center for Nanoscience and Technology ('NCNST'), affiliated with the Chinese Academy of Sciences ('CAS') engages research on bio-safety such as cellular toxic effects of artificial nano-materials as mass produced in China. Toxicology studies on nanomaterials intended for medicines are being conducted by CAS, Beijing University and the Chinese Academy of Medical Sciences and other institutions." 

Regulation

"In 2004, the National Bureau of the State Food and Drug Administration ('SFDA') issued a regulation classifying 'nanometer silver antibiotic device for women’s use. . . as a Class II medical device.'   It is said that '[c]urrently, there are some 10 products made with nanometer level metal materials that have been registered and sold in the market as Class II medical devices.'  Then, SFDA issued a new regulation in 2006 to replace the previous regulation.  Under the new regulations, 'medical devices made with nanometer biological materials (for example medical instruments made with nanometer metal silver material) will be classified as Class III medical devices, and be subject to the administration of the relevant regulations of Class III medical devices.' ”

Research and Development 

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Sara Goodman's article "Researchers Look to Make 'Messy' Nanotech Production 'Clean and Green'" takes a look at the work of Dr. James Hutchison of the University of Oregon and others at the Safer Nanomaterials and Nanomanufacturing Initiative to find "greener methods and techniques to manufacture nanomaterials and reduce or eliminate the waste streams that are the result of what David Rejeski of the Project on Emerging Nanotechnologies refers to as "the brown production infrastructure".

Along with that goal is hope of making nanoproduction methods more efficent and economical, thus saving manufacturers a different form of green or whatever colours the pound, ruble, franc, etc happen to be.

As the article points out, no one is sure how nanomaterials will interact with the larger environment outside the manufacturing facility, whether they will break down with no harm or act like a version of plastics and similar materials that last for long periods of time and leave lasting damage in their wake.

Nanomanufacturing is still very much in its infancy at this time and is still flexible enough that it can look at adopting greener methods, particularly if those methods can reduce expenses. One can only hope that the industry seizes what may be a fleeting opportunity to make changes that will benefit everyone.

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Earlier this week, the Financial Times published "Nanotechnology: Plans for the next stage in humanity's development". The title is somewhat misleading, since what it examines is the Russian government's plans to develop nanotechnology into a "a locomotive for creating an innovation economy in the country as a whole"  after the oil that has fueled it's growth up to now runs out.  While the first half of the article looks briefly at Russia's past involvement in developing nanotechnology, the second half focuses on Rusnano, the state corporation that's been set up and "charged with stimulating development, creating and strengthening infrastructure and realizing projects in nanotechnology and the nanoindustry."

You have to wonder which other commodity based economies will follow the Russian lead.

Oh, and if anyone is wondering about this entry's title, take a look here. 

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A high-profile occupational health and safety attorney was interviewed yesterday on ABC Local Radio in Australia regarding potential workplace safety risks accompanying exposure to certain nanoscale materials in some circumstances.

The reporter conducting the interview evidently led off the radio report by stating that "[t]o one of the nation's leading work safety lawyers, the nanotechnology industry represents a ticking time bomb." 

Not good . . .

The attorney apparently then advised that "employers at the moment may be unaware of the extent of the potential liability sometime down the track.   . . . We could be facing another epidemic in our industrial history of people, large groups of people, displaying latent symptoms from current exposures that are taking place at the moment. . . . We just don't have a clue as to what the long-term impact of the use of that technology will have.  . . . . You can see the dilemma here.  It's not necessarily that the zinc product using nanotechnology is necessarily harmful, we just simply don't know."

Personally, I would not jump from "we don't know" to "ticking time bomb" and/or "epidemic."  Readers can find the transcript from the radio program here.

We recently posted about concerns voiced by Australian labor unions regarding potential workplace exposure to nanoscale materials.  The ABC Radio Australia interview will no doubt add more fuel to this fire.

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The European Trade Union Confederation adopted a "Resolution on Nanotechnologies and Nanomaterials" in June of 2008. At the recent "Working and Living with Nanotechnologies" conference earlier this month, ETUC presented this resolution and a powerpoint that both summarized and expanded on issues raised by the resolution.

The resolution takes a very positive approach to nanotechnology, anticipating a massive increase in the total number of people employed in nanomanufacturing in Europe. More importantly, it looks at how to minimize potential worker exposure to manufactured nanoparticles and reduce the possible adverse effects of such exposure. In addition, the resolution calls for changes in product labelling and for national registers of nanoproducts to aid the consumer in deciding if they want to purchase a product.

On the whole, this is a moderately toned document that corporations in both Europe and the US presently involved in the commercialization of nanotechnologies and nanomaterials should take a look at and consider.

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An April 2009 article in Environmental Health Perspectives (EHP) highlights the ongoing dispute over the federal government's nano-related environmental, health, and safety (EHS) research strategy. 

Regular readers will recall that the National Nanotechnology Initiative (NNI) published a 2008 document entitled “Strategy for Nanotechnology-Related Environmental, Health, and Safety Research” that outlined about 250 ongoing federal nano-research projects, identified EHS research gaps, and prioritized future EHS research needs.  The EHP artilce explains that in February 2009, the National Research Council published its review of the NNI document which was very critical (to put it mildly), and the NNI then posted its rebuttal to the NRC on its own website.   All three documents are well worth reading.  Exactly where federally-funded nano-related EHS research in the U.S. is headed (and regulation for that matter) presents complex political as well as scientific issues.

The EHS article also contains interesting quotes from three prominent scientists:

Jim Willis (EPA OPPT): Speaking about the response thus far to EPA’s Nanoscale Stewardship Program, Willis stated: “On the one hand, we thought it was pretty good responsiveness for a volunteer program,” he says. “On the other, we know there are hundreds of other nanomaterials that weren’t reported. And that indicates clearly that we need to do more if we want to get a better handle on what’s being produced, at what levels, and how humans are being exposed.”

Sally Tinkle (National Science and Technology Council): “There is still concern over exposure to nanoparticles at the end of the products’ life cycles, even if companies design the product to be completely safe for the immediate user. Once [a nano-enabled item] is thrown out and begins to decompose or degrade—or it begins to break down from day-to-day use—the particles can be released into the environment. Care needs to be taken to control the exposure throughout the product life cycle.”

Günter Oberdörster (University of Rochester): “I think there’s a certain amount of hype surrounding the toxicity issues,” he says. “However, until we know better, we should be careful and avoid exposure. You can do a lot of in vitro testing at high doses and identify a hazard, but you need the necessary exposure for a risk to be present.”

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Yesterday, Safenano and Defra, UK Government Department for Food & Rural Affairs, released EMERGNANO, the first global review of environmental, health, and safety studies examining the risks of nanotechnology exposure (essentially a study of the ongoing studies).  The review examined more than 250, from approximately 670, studies in the context of the 18 Research Objectives defined by the UK's Nanotechnology Research Coordination Group.  The project's goal was to conduct "a detailed review and analysis of research carried out worldwide on Environment, Health and Safety aspects of engineered nanoparticles, including issues relating to hazard, exposure and risk assessment and regulation, and made an assessment of how far 18 of the [Research Objectives] have been met and which gaps still remain to be filled."

Providing comprehensive reviews and analyses of EHS research to determine exposure risks is another important step in determining the potential risks of engineered nanomaterials.  This review is also likely to help fame future research studies in terms of effectiveness and need.

The full EMERGNANO report is available here.  In addition, a condensed version is also available as well as commentary by EMERGNANO authors.

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The Organization for Economic Cooperation and Development recently established an online database of environmental, health, and safety studies and projects related to nanotechnology.  The database currently contains information on 690 projects and also provides links to the International Council on Nanotechnology’s nanoEHS Virtual Journal and the National Institute for Occupational Safety and Health’s Nanoparticle Information library (currently inactive).

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The Australian Council of Trade Unions (ACTU) was created in 1927 and claims to represent the interests of 2 million workers. The ACTU published a Fact Sheet earlier this month explaining why its members are (or should be) concerned about nanotechnology. The ACTU begins by highlighting the asbestos/carbon nanotube analogy featured in the Donaldson article appearing in Nature Nanotechnology last summer (which we previously addressed here), as well as other studies regarding possible translocation concerns.  The ACTU’s main point is that existing regulations are insufficient:  “Regulators…rely on regulations that weren’t designed to protect workers against nano sized materials.”   Among other recommendations, the ACTU calls for the treatment of all nanoscale chemicals as “new chemicals” under Australia’s equivalent to the Toxic Substances Control Act, mandatory product labeling, establishment of a country-wide nanoscale material manufacturer registry, creation of new nano-specific exposure standards, and nano-worker health monitoring.

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In order to evaluate the possible health risks of occupational exposure to carbon nanotubes, the National Institute for Occupational Safety and Health (NIOSH) recently published a notice in the federal register requesting the submission of the following types of information from the public regarding carbon nanotubes:

• Data from published and unpublished in vitro and in vivo toxicity studies;
• Information regarding possible adverse health effects observed in workers exposed to carbon nanotubes;
• Identification of workplaces using carbon nanotubes and information regarding potential exposure scenarios, exposure data, and exposure control measures used in such locations; and
• Identification of products containing carbon nanotubes.

NIOSH notes that “[e]stimates of the number of workers potentially exposed to [carbon nanotubes] are unavailable due to limited exposure data and its relatively recent introduction into domestic commerce. The toxic nature of [single-walled carbon nanotubes] and [multi-walled carbon nanotubes] in humans is not known.”

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The American Chemical Society held a "What is Nano?" video contest and announced the winner yesterday.  The San Francisco Chronicle also has a short article about the winners of the contest. The winner? "The Nano Song", basically a song and dance number about nanotechnology using hand puppets. Its worth a giggle or two (or three or four). The cast and crew well deserved their win.

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