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One industry group we have not yet mentioned is the European Nanotechnology Trade Alliance (ENTA).  It is about time we corrected that error.  ENTA is a trade association for companies operating in Europe (or subject to European regulation) that promotes "the benefits of nanotechnology" and attempts to mitigate "regulatory and reputational risk for the whole industry" by interfacing "with the public, the media, government and political bodies actively involved in determining regulatory framework."

Among other things, ENTA holds regular policy meetings in Brussels.  According to the website:

These policy meetings focus on a variety of issues facing Industry such as: REACH; Risk assessment and protocols for industry; Environmental, health, life cycle analysis and safety issues; Harmonization and standardization; Marketing of nanotechnology enabled products; Protection of intellectual property; Technology transfer; Workers and consumers issues; Media and public perception; Scenario planning, roadmaps and strategy; [and] Standardisation.

The next meeting is on March 14.  Here is a Draft Agenda and a list of Confirmed Participants.

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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 BIG news of the week was the EPA's release of its white paper on nanotechnology and related regulatory issues yesterday.  As the white paper is 132 pages - and available online - next week's big news will be analysis of the white paper.
• Advanced Nanotechnology celebrates its 1000th post by looking at Better Nanoscale Membranes.  (Ed. note: this blog will celebrate it's 1000th post with a good bottle of single malt).
• The St. Petersburg Times reports on Dermazone Solutions which "produces nano-based skin creams, sunscreens and other "cosmeceuticals" under the brands Celazome and Kara Vita."
• Nanotechnology Law Report's John Monica was interviewed by The Rose Sheet about Berkeley's nanotechnology regulation.
• Nanodot looks at  Microsoft's Vista operating program and concludes that it will harm nanotechnology.
• Nanoscale Views has a lengthy look at quantum computing and asks "are we there yet?"  And Scott Aaronson at Shtetl-Optimized takes The Economist to task for its reporting on quantum computing.
• Responsible Nanotechnology has a fascinating post on how each of the top ten results from a google search for nanotechnology define "nanotechnology."

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Nanotechnology Law Report's own John Monica was recently interviewed by Melina Vissat, the news editor of “The Rose Sheet,” published by FDC Reports and formally known as the Toiletries, Fragrances & Skin Care on-line trade report.  The interview was a followup to John's recent presentation on the perils of preemptive nanotechnology litigation at a recent conference regarding the regulation of nanotechnology in consumer products, in Washington, D.C.  Ms. Vissat’s interview is below the fold.

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The long-awaited final White Paper from the United States Environmental Protection Agency (EPA) on nanotechnology and related regulatory issues was finally issued today.  According to the Federal Register notice, the 132-page document, available here, covers "a basic description of nanotechnology, why EPA is interested in it, potential environmental benefits...,risk assessment issues..., and a discussion of responsible agency development of nanotechnology and the Agency's statutory mandates."

It is this last topic that is particularly interesting to the regulated community.  More will be posted here when the White Paper is fully reviewed and considered.

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After reading Virginia’s twin nanotechnology bills, we searched and located the below-listed statutory definitions of "nanotechnology."

Arkansas: “‘Nanotechnology’ means the materials and systems whose structures and components exhibit novel and significantly improved physical, chemical, and biological properties, phenomena, and processes due to their nanoscale size.”  A.C.A. §15-4-2103(5); and

Oklahoma:  “‘Nanotechnology' means technology development at the molecular range (1 nm to 100 nm) to create and use structures, and systems, that have novel properties because of their small size.”   74 Okl St. Ann. §5060.4(12).

Additionally, Michigan uses the term in the following statute:

Michigan:  “'Advanced automotive manufacturing, and materials technology' means any technology that involves /or more of the following . . . “nanotechnology, including materials, devices, or systems at the atomic, molecular, or macromolecular level with a scale measured in nanometers.”  M.C.L.A. 206.30 -125.2088a.

And don't forget about Berkeley's recent ordinance which contains the following language:

"All manufactured nanoparticles defined as a particle with one axis less than 100 nanometers in length . . "

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If adopted, Virginia House Bill No. 1939 would establish a "Virginia Technology, Nanotechnology, and Biotechnology Investment Fund” to provide up to $500,000 in grant money to small nanotechnology start up companies with 25 or fewer employees seeking to locate in Virginia. The bill is sponsored by Harry R. Purkey of Virginia Beach, and is currently in the appropriations process.   The bill defines “nanotechnology” as “technology, research, and development at the atomic, molecular, or macromolecular levels, in the 1 – 100 nanometer range, to create and use structures, devices, and systems that have novel properties and to integrate such structures, devices, and systems into large material components, systems, and architectures.”  The bill's sister legislation – Virginia House Bill No. 2275 – would establish the “Virginia Nanotechnology Authority,” which would (among other things) administer the fund.  Bill 2275 defines “nanotechnology” as “the manipulation of particles at the less-than-100-nanometer scale.”

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In late September, the National Nanotechnology Initiative (NNI) released its priorities for risk research needs.  The report has come back to the forefront of nano discussions because the NNI held meetings in January to allow other interested parties to comment on it.  While the report is being widely criticized for either taking too long to develop, or for failing to prioritize research needs and strategies any more than listing areas where researchers lack knowledge, the report shows how much education is still needed. 

However, when the report and the associated criticisms are put into a larger context, a recurring theme begins to appear.  In light of the recent movement for regulating nanotechnology and nanomaterials, including the ordinance enacted by Berkeley, a similar ordinance being considered by Cambridge, MA, and most recently, the U.N. report calling for "swift action" concerning nanotechnology regulation, recently discussed by Patrick, here, there is a growing disconnect between nanotechnology knowledge and nanotechnology regulation.  While a precautionary principle is appropriate for new technologies that are not yet fully understood, there must be a logical connection between the risks posed by nanotechnology and the resulting regulatory efforts.  To charge ahead with regulation, without an understanding of the technology being regulated, more harm than good may result.  Like most intersections between industry and law, there must be a balance between allowing industry and science to develop products in a responsible manner without overburdening a budding sector with regulations that do not understand the nature of the area and the risks posed.  To that end, researchers and regulators need to keep communicating with each other openly and honestly about discoveries and political movements.

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The 2007 United Nations Environment Program "GEO Year Book 2007" report was recently released, which explicitly calls for nanotechnology regulation on a global scale.   The abstract to the Year Book contains this overview:

The emerging scientific and policy challenges of nanotechnology are examined from an environmental perspective. Nanotechnology will bring environmental benefits but it is vital that we adopt appropriate assessment and legislative process to address the unique challenges presented by nanomaterials and their life cycles.

The AP provides more background in a February 5th report from Nairobi, the site of this year's Global Ministerial Environment Forum, where this report was unveiled.  More from the report:

In its annual report of the global environment, the U.N.'s Environment Program said ''swift action'' was needed by policy makers to properly evaluate the new science of nanotechnology.

Although nanotechnology could transform electronics, energy industries and medicine, more research is needed to identify environmental, health and socio-economic hazards, Achim Steiner, who heads UNEP, said in the 87-page report.

The UN is calling for cooperation between the nanotechnology industry and government, and also cooperation between developed nations and developing nations, in formulating a regulatory response to potential EHS nanomaterial concerns.  On that note, the National Science Foundation's proposed 2008 budget includes a $29 million request for a Program Component Area entitled "Societal Dimensions:  Environmental Health & Safety (EHS)." 

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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.  This week brings another 2 week review.

• Degussa, a specialty chemical company, has established a website that it hopes will encourage debate about the opportunities and risks of nanotechnology.  This writer is always glad to see companies being pro-active in communicating with the general public about nanotechnology.
• Speaking of communication, Dietram A. Scheufele at nanopublic has an excellent post on scientists' obligations to communicate to the public.
• Purdue University researchers "have shown how to create a new class of tiny sensors for applications ranging from environmental protection to pharmaceutical preservation."
• The UN Environmental Programme argues that "tighter regulation and control is needed to ensure the safety of nanotechnology."
• As Patrick Lewis reported in this weblog, Cambridge, Massachusetts is considering Berkeley-like nanotechnology regulation.
• The San Francisco Exploratorium recently launched SmallTalk, a monthly podcast on nano issues hosted by Stephanie Chasteen of the Exploratorium’s Teacher Institute.
• Michael Heintz reviews Lynn Foster's Nanotechnology: Science, Innovation, and Opportunity.
• At Nanohype, David Berube reviews and does not recommend both Robert Blaunstein's NANOTECHNOLOGY: The Plastics of the 21st Century? and Gleiche, Hoofschulz, & Lenhert's Nanotechnology In Consumer Products.
• At blog~nano, Rocky Rawstern reviews the year 2057.
• Pearl Chin has a fascinating article at Nanotechnology Now about investing in nanotechnology and nanotechnology IPOs.
• Advanced Nanotechnology reports on current and future port security.
• Nanodot reports that China is rapidly gaining in nanotechnology competition and on how Sun is profiting from nanotechnology R&D.
• Soft Machines discusses a near-term nanotechnology application: nanosensors.
• Steven Currall, a visiting professor of entrepreneurship and faculty co-director of the Institute of Technology at London Business School and professor of Enterprise & the Management of Innovation at University College London, has an op-ed in Business Week in which he "debunks" the nanotech myths.
• Finally, we wish a fond farewell and best of luck to George Elvin who will no longer be blogging at NanotechBuzz  in order to focus exclusively on his work as director of the Green Technology Forum.

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By Alan R. Malasky:

As reported recently in a variety of publications (e.g., Inside OSHA, Inside Green Business, and the Risk Policy Report), possible approaches to limit liability for accidental releases of nanomaterials are currently being reviewed by key members of the Senate Commerce Committee. According to sources, the review is being spearheaded by Senator Mark Pryor (D. AR), the chairman of the Senate subcommittee having jurisdiction over consumer affairs, product safety and insurance industry issues. 

This congressional interest is occurring precisely at the time that the nanotechnology industry stands poised at the threshold of significant technological advances. Some or all of those advances, however, could be stymied or substantially delayed by the possibility of major product liability litigation. At the same time, federal agencies, particularly the EPA, are looking into the potential risks associated with the unique properties found in nanomaterials, and are examining whether, and if so, what, regulatory changes may be necessary to address those risks. 

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John Monica, Michael Heintz and I have recently had an article published in the magazine Nature Nanotechnology (Vol. 2, No. 2, pp. 68-70 (Feb. 2007)) entitled "The Perils of Preemptive Regulation."  The full text of the article is available here (subscription required).  The lede/abstract of the article is:

In its rush to introduce new regulations about the handling of nanomaterials, the city of Berkeley in California has made mistakes that should not be repeated elsewhere.

In it, we analyze and critique the approach that Berkeley, California has taken in its quest to become the first American jurisdiction to regulate nanomaterials.  In particular, we question whether a "reporting requirement" that forces nanotechnology companies to do comprehensive literature reviews of environmental, health and safety ("EHS") literature pertaining to nanomaterials on an annual basis will significantly advance nanotechnology safety.  We also wonder whether the de facto characterization of nanomaterials as "hazardous" by the city of Berkeley will invite unmeritorious litigation.  That sort of litigation might well cripple this industry and hamper efforts to research, develop, and commercialize this potentially revolutionary new technology. 

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On the heels of Berkeley, California's decision last December to impose regulations on nanotechnology businesses, the Boston suburb of Cambridge, Mass -- home to MIT and my alma mater, Harvard -- is now looking at nanotechnology regulation.  According to the linked article from the Boston Globe, it appears that the Cambridge City Council is aware of the potential for stifling nanotechnology innovation with regulation:

We hope that nanotech is going to be a big part of new industry in Cambridge," said council member Henrietta Davis. But Davis said the city should make sure that nano-based businesses ply their trade safely. "It's not my intention to stifle it," she said. "It's more to be proactive."

This concept of "proactive" regulation, on which my co-blogger John Monica will be speaking this week, raises the question of how well government regulators can strike the balance between the need for innovation and the need of safety in the absence of good information about the probability and magnitude of risks associated with a given activity.  On that note, I am glad that Cambridge has decided to explicitly bring industry representatives to the table when deciding whether to impose nano regulations:

Igor Linkov, managing scientist at Intertox Inc., a technology consulting firm in Brookline, said there is some evidence that nanoparticles could pose health risks. He cited a study that found that rats developed scar tissue when liquid mixed with carbon nanoparticles was sprayed into their lungs. But Linkov said far more research is needed before jumping to conclusions about the safety of nanoparticles.

"We know that some nanomaterials, at some point during their life cycle, may pose risks," said Linkov. "We really cannot quantify how high the risk is."

On Jan. 8, the Cambridge City Council voted to ask Lipson to study the nanotechnology regulation enacted in Berkeley last year, and recommend a similar statute for Cambridge. * * * The City Council ordered Lipson to study the Berkeley law and determine whether it makes sense to draw up a similar statute.

We at the Nanotechnology Law Report will continue to follow these developments.

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By Drew Bergman:

The ABA Section of Environment, Energy, and Resources held a teleconference on January 16, 2007 on The Clean Air Act and Nanotechnology. The first presenter (Ann Klee of Crowell & Moring) discussed the National Nanotechnology Initiative, a federal research and development program comprising 25 federal agencies to coordinate multi-agency efforts in nanotechnology, including the U.S. Environmental Protection Agency. The Initiative has published a report entitled "Environmental, Health, and Safety Research Needs for Engineered Nanoscale Material" that summarizes ongoing nanotechnology research needs. The report can be found on the Initiative's website at http://www.nano.gov/.

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