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

Nanotechnology: Science, Innovation, and Opportunity, compiled by Lynn E. Foster and published by Prentice Hall, is an excellent introduction into the world of nanotechnology and the possibilities it brings.  The book is a collection of 20 chapters written by different authors, all experts in their field, on the major topics concerning nanotechnology.  It begins with general discussions on the possibilities of nanotechnology, like thoughts on energy independence by Richard Smalley, for which the Smalley Institute at Rice University is named.  It then moves to identifying those involved with research, development, and funding of nanotechnology, such as the role of venture capitalists and university technology transfer.  Following that is a series of chapters on specific applications of nanotechnology, such as drug delivery systems and bio-nano-information fusion.  Finally, the book concludes with a transcript of the presentation "Infinitesimal Machinery" that Richard Feynman gave, rather prophetically, to the NASA Jet Propulsion Laboratory in 1983.

While Nanotechnology focuses on increasingly technical subjects as it progresses, the book is an easy to read glimpse into industries that nanotechnology is impacting.  Its broad coverage is supplemented by notes and references at the end of each chapter, providing readers an opportunity to delve deeper individual subjects.  For anyone looking to learn more about nanotechnology, its applications, and implications, Nanotechnology, is an excellent primer, and will hold the attention of both the casual reader and those studying this new technology alike.

Finally, I would be remiss if I didn't take this opportunity to introduce you to one other option for reading about nanotechnology.  As an indicator as to how this field is beginning to take off, you can now find Nanotechnology for Dummies at your local bookstore.  Like other books in the "for Dummies" series, Nanotechnology for Dummies, by Richard Booker and Earl Boysen, is designed to be a straight-forward and easy introduction into nanotechnology.  While I have not read the book in its entirety, I see it as a solid reference when a quick tutorial on individual topics is needed.  And with the inclusion of the occasional one-liner and cartoon, its also entertaining.

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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 MUST SEE - literally - post of the week is NanoBot's posting of The Office clip about killer nanorobots.
• Speaking of robots, Advanced Nanotechnology reports on a new class of soft-bodied robots; on how insect sized robots will fight; and on Singapore's urban warfare robot challenge.
• The Washington Post reported on the ETC Group's contest to design a nanotechnology warning sign.
• Nanodot takes issue with this contest and the top three symbols.
• Nanotechnology Law Report's John Monica on why workers are NOT canaries in the nanotechnology coal mines.
• Nanoscale Views wants to know what is the most powerful idea in condensed matter physics?  (and make sure to read the comments).
• Nanotech Buzz is disappointed that the president did not mention nanotechnology in the state of the union speech.
• Soft Machines on the possibility of putting a pharmaceutical nanofactory inside a body.
• Microanalysis answers readers' question.  And it's funny too.
• Although it may not be small enough to qualify as nanotechnology, it involves coffee and donuts, two of the greatest things in the world.  A North Carolina molecular scientist "has developed a way to add caffeine to baked goods" such as donuts.  Proof that there is a god, perhaps?

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As discussed on this site, here and here, an idea was presented concerning liability caps on the nanotechnology industry.  Professor David M. Berube, in an article appearing in the journal Nanotechnology Law & Business, suggests that the federal government should cap liability of nanoparticle industries in an attempt to spur development.

Now, Inside OSHA reports that Congress is considering the concepts put forth by Professor Berube.  The report has the attention of Senator Mark Pryor (D-AR), chairman of the subcommittee overseeing product safety and the insurance industry.  While Senator Pryor's office has not commented on the report, inside sources confirm that he is reviewing it.

MEH:  As John and I discussed, final enactment of such limits may be premature given the infancy of the nano-industry.  While a liability cap may help develop nano related businesses, it raises questions concerning how lawmakers are treating workplace safety and the message sent to the public at-large.  While Congress should consider all feasible alternatives in developing legislation, especially for nanotechnology, legislation limiting liability should be thoroughly considered before acting.

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North Carolina State and Rice University researchers recently published the results of their in vivo skin penetration experiments using fullerenes on pig skin. The researchers tested fullerene penetration on stationary skin and skin that was flexed for an hour or an hour and a half. They found the longer the skin was flexed, the greater and deeper the particle uptake. Additionally, they found greater uptake 24 hours after flexion than that measured eight hours after flexion. N Monteiro-Riviere, et al., Nano Letters, American Chemical Society, January 10, 2007.

It is interesting to compare the Cosmetic, Toiletry and Fragrance Association's October 10, 2006 "Nanotechnology White Paper: The Use of Nanotechnology in Personal Care Products," (maintaining scientific evidence confirms a lack of dermal absorption of nanoparticles), as well as recent efforts by the Pharmos Corporation to develop a dermal drug delivery nano-emulsion. 

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I am pleased to announce that John Monica will be speaking on "The Possible Adverse Consequences of Pre-emptive Nanotechnology Regulation" at the two-day conference and workshop, Regulations for Nanotechnology in Consumer Products, February 8-9, 2007, Washington Marriott, Washington, D.C.  This conference is aimed at those interested in doing more than simply scratching the surface of nanotechnology regulatory concerns.  A copy of the preliminary agenda can be found here.

Speakers will include:

• Dr. Linda Katz, M.P.H., Director, Office of Cosmetics and Colors, FDA, US
• David Rejeski, Director, Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars, US
• Dr. Peter Hatto, Chairman International Standards Committee (ISO)TC229 Nanotechnologies, Director of Research, UK
• George Kimbrell, Staff Attorney, THE INTERNATIONAL CENTER FOR TECHNOLOGY ASSESMENT, US
• Dr. Christoph Meili, CEO, THE INNOVATION SOCIETY, Switzerland
• Christopher Murray, Manager, Nanoscale Materials and Devices, IBM, US
• Ruben Serrato, Managing Editor, NANOTECHNOLOGY LAW & BUSINESS and Venture Partner, TEL VENTURE CAPITAL, US
• Dr. Kristen M Kulinowski, Executive Director for Education and Public Policy, Center for Biological and Environmental Nanotechnology, Director, International Council on Nanotechnology (ICON), Rice University, US
• Dr. Brent Segal, Co-Founder and CEO, NANTERO, US
• Dr. Sandy Weinberg, VP Regulations, Tikvah Therapeutics, US
• Dr. Justin Teeguarden, Senior Research Scientist, PACIFIC NORTHWEST NATIONAL LABORATORY, US
• Alan Gotcher, CEO, ALTAIRNANO, US
• Matt Hull, Principal Investigator, LUNA INNOVATIONS INC, US
• Dr. Annette Santamaria, Senior Manager, ENVlRON INTERNATIONAL CORPORATION, US
• Alissa Havens, Communications Director, DITTUS COMMUNICATIONS, US
  

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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. 

There was no Week In Review last week (let's blame the three day weekend, shall we?), so this week we a have special double-stuffed, two week review.  Let's get started:

• News.com reports on the National Nanotechnology Coordination Office's January 4, 2007 public meeting; NanoHype blogs about the meeting too.
• Voting is open in the 2006 Nanoart competition.
• The 2nd Meeting of the OECD Working Party on Manufactured Nanomaterials will take place in Berlin/Germany, on April 25-27, 2007.
• Check out this fasciinating article about Purdue's University's Birck Nanotechnology Center (and note that "[o]utside funding for research throughout the park has totaled $84 million since July 1, 2005, and the pace is accelerating").
• A consumer study from Rice University's Center for Biological and Environmental Nanotechnology (CBEN), University College London (UCL) and the London Business School reveals that consumers rate nanotechnology "safer than some commonplace, everyday products, including herbicides, chemical disinfectants and food preservatives."
• Advanced Nanotechnology discusses the structure of gold nanoclusters, bacteria that is resistant to artificial skin, and the world's fastest optical chip.
• Nanodot draws our attention to an open source nanotechnology textbook and the U.S. National Academy of Engineering's Grand Challenge.
• Nanotechbuzz on Brian Eno, Darwin, biotechnology and nanotechnology (all in one short post) and on a nanotechnology patent litigation dispute.
• Finally, congratulations to Home Depot co-founder Bernie Marcus, the Forbes/Wolfe 2006 Nanotech Person of the Year.

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For us non-scientists, a useful rule of thumb in inhalation toxicology is the finer the substance, the greater the possibility for adverse health effects -- and vice versa. Preliminary studies indicate this may hold true for nanoparticles which have been shown to have fewer potential adverse health effects when they occur in cluster form (aggregates and/or agglomerates).  In the "good news" department, scientists studying aerosol dispersion of nanoparticles have found they tend to cling together when dispersed into the environment.  Curious scientists ask logical follow up questions:  What happens to these nanoclusters if they somehow make it into the lung? Do they react with the body and end up breaking back down into smaller (and theoretically more toxic) sizes?

A new study by four German researchers makes some in-roads on these questions. M. Maier, et al., “Does lung surfactant promote disaggregation of nanostructured titanium dioxide?,” Journal of Occupational and Environmental Medicine, Vol. 48, No. 12 (December 2006). 

Maier looked at the theoretical interaction between the primary substance found in lung wall lubricant/fluid -- dipalmitoyl phosphatidylcholine (DPPC) -- and titanium dioxide nanoclusters to determine whether DPPC facilitates their breakdown into smaller sizes. Apparently, it does not. The researchers conducted two tests to reach this conclusion.  The first used computer simulation to determine that the DCCP did not have enough energy to break the bonds between individual nanoparticles in the clusters.  In the second test, the researchers exposed titanium dioxide nanoclusters to a simulated biological lung fluid containing DPPC.  The test results showed no disaggregation in the clusters from exposure to increasing amounts of DPPC, nor did it show any time dependent disaggregation.

The authors “conclude that DPPC only covers [titanium dioxide] aggregates and agglomerates instead of splitting them, i.e., lung surfactant does not promote the disaggregation of [titanium dioxide] agglomerates and aggregates."

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The American Public Health Association (APHA) recently held its 134th annual meeting in Boston, Massachusetts, at which it adopted policies addressing 22 important public health issues, including nanotechnology.  APHA's key policy recommendations are:

• Increase federal funding for nano-related EHS research to $100 million.
• Encourage the voluntary participation by nanomanufacturers in the (i) collection of nano-related safety data and (ii) prevention of human and environmental exposure unless positive information exists to show it is safe.
• Have federal agencies (i) require the collection and submission of workplace and environmental safety data by nanotechnology businesses/manufacturers; (ii) recommend interim risk management measures; and (iii) "assure the education, health and safety of workers, consumers and the general public through promulgation of protective standards and regulations."

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MEH:  Having read the same article, I agree with John that a national fund, similar to that of the Superfund that is limping along under CERCLA, is premature, and perhaps even unnecessary.  However, the idea of offering nanotechnology insurance, I think, has merit from an environmental protection standpoint.  Environmental contamination insurance is now available when purchasing a piece of property that could be contaminated.  Similarly, why couldn't insurance be offered to protect against "nanotechnology contamination?"  The goal should be to remediate any nanomaterial contamination, if it happens, as quickly as possible.  Admittedly, there are hurdles to overcome before a company may offer such a policy, and even then, it may not be cost effective to do so.  However, given the types of insurance policies that are available today, the option of purchasing a policy addressing nanomaterials is not something that should be dismissed quickly.  As John points out, this is a new and emerging field in which much is still to be learned.  No idea should be shelved out of hand.

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     In a recent article published by the Washington Legal Foundation, the attorney-author asks: “Is It Time to Consider a Nanotechnology Liability Protection Plan?” In answer to this question, the author advocates the establishment of a Nanotechnology Insurance Fund (“NIF”) with two principle purposes: “1) provide an exclusive source of compensation for people such as consumers or workers who claim, and can prove, injury from nanoparticles and 2) pay for any required environmental cleanup and restoration costs.” He also suggests the NIF could be used to fund nano-related EHS research. Finally, he believes this proposal “is a better solution for potential nanotechnology liability problems than years of tedious and expensive litigation followed by large and bankrupting settlements or judgments.” Nanotechnology: Don’t Delay Liability Risk Assessments and Solutions, Washington Legal Foundation, Vol. 21 No. 37 (Dec. 8, 2006).

     JCM: The author’s proposal seems premature. The nanotechnology industry is still in its infancy and no nano-related EHS lawsuits have yet been filed. The potential adverse health and environmental effects of nanoparticles are undetermined. Top nanotechnology scientists indicate basic research regarding the EHS effects of certain nanoparticles may not be completed until 2012 or later. See Safe handling of nanotechnology, Nature, Volume 444 Number 7117 pp. 243-400 (November 16, 2006). Simply put, while initial scientific research urges caution, it is too early to even remotely suggest the nano-industry will someday find itself in near bankruptcy from EHS litigation.

     Further, establishing a NIF would send the wrong message to the public, essentially conceding catastrophic personal injuries and/or environmental problems are a foreseeable likelihood. Why else would manufacturers establish a recovery fund? The larger question will then become why are nanomanufacturers are proceeding to market their products to the public if they belief such a high level of exposure is possible? The establishment of a NIF will also be an invitation to plaintiffs' attorneys to “find” clients with alleged injuries so they can partake of the fund and recover large contingent fees. If there are no nano-related EHS lawsuits pending before the fund it established, there will be thousands filed shortly thereafter.

     Rather than rushing to establish a NIF, each nanomanufacturer should take responsibility for the EHS implications of its own products consistent with existing products liability law and government regulation.

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Orthopedic implant failure often results from poor bone adhesion and/or infection. Purdue University recently conducted an in vitro study to determine whether nanotechnology might be used to reduce both of these risks. Purdue scientists compared the adhesive properties of nanoscale versus microscale samples of ZnO and TiO2 to staph cells and osteoblasts (bone-forming cells). ZnO was selected because of its antimicrobial properties and TiO2 was selected because it typically forms on titanium implants in the body. The researchers found that – as compared to their microscale counterparts – nanoscale ZnO and TiO2 led to reduced staph cell adhesion and increased osteoblast adhesion. The implication is that staph is less likely to form on titanium medical implants incorporating nanoscale ZnO, while bone adhesion improves at the same time. Obviously this is only a very preliminary study, but it should be of great interest to manufacturers of orthopedic implants.  G. Colon, et al., "Increased osteoblast and decreased staphyloccocus epidermidis functions on nanophase ZnO and TiO2," Journal of Biomedical Materials Research Part A, 2006;78(3):595-604.

For a hypothetical health and safety related scenario using nanotechnology in this context see “Preparing for Future Health Litigation: The Application of Products Liability Law to Nanotechnology,” Nanotechnology Law & Business, February 2006, www.nanolabweb.com.

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The American Industrial Hygiene Assocation has identified nanotechnology safety as among its members' top concerns for 2007, according to this report in Occupational Hazards.   AIHA identified nanotechnology as an OSHA concern and characterized the concern this way:

Nanotechnology – The increased use of nanotechnology for consumer products raises concerns that a clearer understanding is needed to accurately assess the occupational health and safety risks posed by working with this new technology. AIHA supports increased research into the possible hazards involved with nanotechnology.

Moreover, AIHA's 2007 annual AIHce conference will feature a panel on nanotechnology -- it will be interesting to see what, if any, recommendations come out of the conference about nanomaterial handling.

Given Berkeley, California's recent decision to regulate occupational and other exposure to nanomaterials through its hazardous materials ordinance, and recent Congressional and other pressures to regulate nanotechnology, it's good to see organizations like AIHA taking a look at nanotechnology regulatory issues.  As John argued here, we need a scientifically-based, rational regulatory approach to nanomaterial safety;  the sooner such an approach is taken, the better.  The last thing this industry needs is a highly public "scare" -- such as the Magic Nano scare last year -- to pique the interest of the trial lawyers.

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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.

• John Monica comments on David Berube's article “Regulating Nanoscience: A Proposal and Response to Clarence J. Davies," in Nanotechnology Law & Business.
• Project on Emerging Nanotechnologies chief scientist Andrew Maynard testifies before a government committee on nanotechnology today and calls for, among other things "a robust, top-down research plan that can be implemented by the U.S. government and used for collaborations with industry and with researchers in other countries."
• Advanced Nanotechnology reports on better optical films for solar cells and optical chips.
• Nanodot congratulates Fraser Stoddart who has been knighted for “services to chemistry and molecular nanotechnology" (as does Nanotech Buzz).
• Nanotech Buzz on a nano-enabled battery that powers a car at speeds of 100+ mph.

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University of South Carolina professor David Berube recently published “Regulating Nanoscience: A Proposal and Response to Clarence J. Davies," in Nanotechnology Law & Business, Vol. 3, Issue 4 (Dec. 2006). Professor Berube responds to Mr. Davies’ 2006 Woodrow Wilson article calling for a comprehensive reexamination of current regulatory regimes relevant to nanotechnology. Professor Berube, argues public perception is unlikely to be influenced by regulation, and a comprehensive regulatory scheme “would tend to be self defeating at this juncture.” As an alternative, Professor Berube suggests voluntary regulation of nanoproducts, and then “let market mechanism allocate risk.” Professor Berube’s “liability [plus] regime would involve the insurance industry and would be enforced by the courts in the form of lawsuits." Professor Berube further suggests “the liability regime advocated here avoids the resolution of the new versus existing materials problem for this determination will be removed from the regulatory hearing and conference process to the courtroom; thus, determinations can be resolved on a case-by-case basis.”

While figuring out how and to what extent to regulate nanotechnology is a very complicated issue, abdicating any part of that process to the litigation and/or insurance coverage process is not the answer. First, relying on litigation or even insurance coverage presupposes an alleged loss or injury. Catastrophic punitive damages have been awarded when companies purportedly ignore potential product risks and take the approach of letting their lawyers and insurance companies sort it out. Second, turning important scientific determinations over to the litigation process is unlikely to produce the results advocated by Professor Berube.  Judges and juries are frequently overburdened and are not equipped to analyze complicated scientific questions. Further, even the best scientists sometimes make poor testifying witnesses and may not stand up to cross-examination under the adversarial process. Additionally, there are razor sharp attorneys who can make “white” look “black,” and vice versa – regardless of the actual “scientific truth.” Simply put, nanotechnology decisions are too important to be determined on a “case-by-case” basis in a forum not designed for this process.  Additionally, the old adage that “justice is blind,” does not mean two courts will reach the same decision when presented with the same issue. Inconsistency between jurisdictions is frequently lamented in our profession which would be a further hindrance to this nascent industry.

Given the options, we advocate the reverse – to the extent possible, remove the decision making process from courtrooms (or keep it out) and put it into regulatory hearing and conference rooms. Despite the downsides, the industry is much more likely to get workable and scientifically based results.

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