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

A National Nanotechnology Innovation Summit to mark the 10th anniversary of the National Nanotechnology Initiative (NNI) will be held December 8-10, 2010 at the Gaylord National Hotel & Convention Center in National Harbor, MD. The Nano Science and Technology Institute (NTSI) will join with the White House Office of Science & Technology (OSTP), the Nanotechnology Coordination Office (NNCO) and the National Venture Capital Association (NCVA) to organize the event. Launched in 2001, the NNI is a federal program which serves as the coordinating body for 25 federal agencies which conduct nanotechnology research and development. The Summit will be a forum for the nation’s top nanotechnology researchers, investors, policy makers, and developers to join in recognition of the NNI’s efforts in the field over the past ten years. More information and registration details are available at: http://www.nsti.org/events/NNI  

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This article originally appeared on the National Nanomanufacturing Network's InterNano website earlier today. It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

Maxine Savitz[1] and Ed Penhoe[2] provided a recent presentation summarizing the highlights of the President’s Council of Advisors on Science and Technology (PCAST)[3] report on the status of the US National Nanotechnology Initiative (NNI) at a public meeting held at the National Academics on March 12, 2010.

Ms. Savitz provided a brief review at the beginning of the presentation regarding how, when, and why NNI was formed; its history from 2000 - 2010; and some of the participants in the PCAST review process. Participants included representatives from DuPont, IBM, A123 Systems, Nanocomp Technologies, Rice, Harvard, Caltech, Sandia National Labs, and the Woodrow Wilson Institute. Ms Savitz also explained that the group held two prior working meetings to solicit input from government agencies, the legislative and executive branches, as well as outside stakeholders. Finally, she explained that PCAST’s report has three major thematic areas: NNI program management; NNI output and work product; and NNI environmental, health, and safety programs and strategies.

Ed Penhoet then provided an update regarding NNI’s continued successes. He noted that the US is currently the world leader in nanotechnology and commercialization, but that other nations are gaining fast -- particularly in Asia and Europe. He further noted that NNI has had a substantial impact on the US nanotechnology industry over the past ten years, which can be seen in the larger number of nanotechnology patents filed, nano-related publications, and nano-related products hitting the commercial market during that period.

Mr. Penhoet further explained that while NNI is being effectively managed, there is still room for some improvement and greater coordination.

For an example, Mr. Penhoet pointed out that there is a lack of basic underlying data from which to analyze the economics of nano-related research, development, and commercialization in the US. Thus, it is difficult to precisely quantify the economic effectiveness of the NNI in measurable terms.

As another example, Mr. Penhoet also mentioned the need to identify and understand potential nano-related risks -- both for purposes of fundamental science, and also to provide a clear regulatory environment and path for commercialization. While undoubtedly a significant portion of PCAST’s written report touches on these issues, the topic was only briefly mentioned in passing during the presentation.

Mr. Penhoet then spent the majority of his presentation explaining the five major recommendations embodied in PCAST’s written report:

• Increase NNI funding for manufacturing research while maintaining support for basic research.
• Strengthen the NNCO, the NNI coordinating entity, with additional funds and a broader mandate.
• Require that metrics be developed to track benefits of nanotechnology such as job creation.
• Develop a cross agency strategy that links EHS research and knowledge gaps and decision making needs.
• Expedite the citizenship review process for those receiving advanced degrees in science and engineering.

The presentation closed with comments by several PCAST members regarding (i) potential methods for developing the underlying economic data needed to properly evaluate nano-related job creation and return on investment; and (ii) potential methods for increasing retention rates of foreign students obtaining advanced nano-related degrees in the US by reducing and/or streamlining citizenship restrictions.

PCAST voted to accept and approve the report after it is amended to reflect the comments discussed during the presentation.

References
[1] Director of the Washington Advisory Group, an LECG Company. Ms. Savitz is the former Deputy Assistant Secretary for Conservation, US Department of Energy. Prior to her DOE service, she was program manager for Research Applied to National Needs at the National Science Foundation. Following her government service, she served in executive positions in the private sector, including: President of Lighting Research Institute, assistant to the vice president for engineering at The Garrett Corporation, and General Manager of Allied Signal Ceramic Components. She recently retired from the position of General Manager for Technology Partnerships at Honeywell.

[2]President of the Gordon and Betty Moore Foundation. Mr. Penhoet is the former dean of the School of Public Health at the University of California, Berkeley, prior to which he cofounded and managed the Chiron Corporation. Prior that he was a faculty member of the Biochemistry Department of U.C. Berkeley. Mr. Penhot currently serves as the vice chairman of the Independent Citizen’s Oversight Committee which oversees the California Institute for Regenerative Medicine created by the passage of Proposition 71, the stem cell initiative.

[3] http://www.whitehouse.gov/administration/eop/ostp/pcast.

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New Edition of Nanotechnology Law Report

Inside you will find:

• EPA Considering New Approach to Nanoscale Materials Under TSCA
• EPA May Issue Mandatory Data Collection Rule for Nanoscale Materials Under TSCA
• EPA Takes Aim at Antimicrobial Products Under FIFRA
• EPA Unveils New Principles for Chemical Management Reform
• EPA Report on the Use of Nanoscale TiO2 in Water and Sunscreens
• EPA Withdraws Carbon Nanotube SNURs
• Press Release: New Contributing Editor for InterNano
• Virginia CLE presentation: “Insurance, Nanotechnology, and Risk”
• Nanoparticles and Deaths in the People’s Republic
• Sweating the Small Stuff
• Soil Association Cites China Deaths in Renewed Call for Moratorium on Nanotechnology Commercialization
• Nanotechnology Legislation in the 111th Congress
• Mapping Nano
• Flight of the Nanobees

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The National Nanomanufacuring Network (NNN) at the University of Massachusetts, Amherst just published its October newsletter which you can find here.  There is a nice article by Barbara Beck and Chris Long from Gradient regarding the recent Song nanoparticle study from China which was my first contributing editor piece for NNN's InterNano.  Please read the newsletter and follow NNN's valuable work.

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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 Project on Emerging Nanotechnologies, via Nanowerk, is reporting that Canada will announce, in February, that it will release a national regulation aimed at requiring the submission of the "use of engineered nanomaterials" by manufacturers and users.  "The information gathered under the requirement will be used to evaluate the risks of engineered nanomaterials and will help to develop appropriate safety measures to protect human health and the environment."  No further information is available concerning the nature of the regulation, the eventual scope, release date, and no statement is readily available directly from Environment Canada.

However, this announcement does follow on the heels of both US EPA's interim report on the Nanoscale Materials Stewardship Program, and the 2007 announcement by Environment Canada concerning nanomaterials' treatment under Canada's New Substance Program.

Should Canada release a national regulation concerning the tracking and reporting of nanomaterials for use by the government in developing additional health and safety regulations, that will be a significant step (perhaps more than a step?) towards the full regulation of nanomaterials.  To this point, only isolated state and local governments have made binding regulations with regard to nanotechnologies, while all national governments have remained aware, but mostly disengaged on the question of regulation.  Case in point, Canada, the United States, and the United Kingdom have all studied nanomaterials, or sought voluntary data submission, but none have regulated nanotechnology coast-to-coast.  This could be the first signal that national governments are becoming more comfortable with nanotechnology and believe they can begin putting reasonable requirements in place.  Or, this could signal that national governments are beginning to crack under increased calls for action and are putting requirements in place in order to answer the growing list of critics.  Without knowing the details of Canada's plan, we won't know for sure until its ultimate release and effective date.  February starts next week, so we should know soon enough.

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