Nanotechnology Law Report : 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

Our friends at Nanodialog.eu will now be publishing summaries of select nanolawreport blogs in Polish.  Here's an example:

NOWOSCI The Nanotechnology Education Act  Pełny artykuł zamieszczony  1 lutego, 2010, w Nanotechnology Law Report przez Robert Oszakiewski : http://www.nanolawreport.com/2010/02/articles/the-nanotechnology-education-act/ 06.03.2010. Streszczenie i tłumaczenie: Ewa Lockard Końcem stycznia 2010, dwóch kongresmanów amerykańskich: David Wu i Daniel Lipinski, zaproponowali wprowadzenie ustawy (The Nanotechnology Education Act), której celem byłoby stworzenie pogramu dotacji wspomagających wprowadzenie i ulepszenie programów i infrastruktur związanych z nauczaniem nanotechnologii. Dotacje obejmowałyby zarówno szkoły średnie, college, uczelnie jak i nieformalne centra technologiczne. Fundusze byłyby przeznaczone na: zakup sprzętu i oprogramowania, zatrudnienie nauczycieli włącznie ze szkoleniami dla nauczycieli nanotechnologii. Zmieniony ( 06.03.2010. ) Czytaj całość…

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Readers may be interested in learning that my 2009 book "Nanotechnology Law" is now online. You can find it on Westlaw as Nanotechnology Law (NANOTECH). 

The Westlaw version is very helpful because you can now electronically search for any nano-related legal topic and let your computer do all the work -- it even provides links to the footnotes.

As another shameless plug, "Nanotechnology Law" is the only comprehensive legal text on nanotechnology currently on the market and weighs in at 1006 pages.  (All the better reason to use the Westlaw search function).

Finally, I am in the process of updating the book for the 2010 edition.  Thus, if there is anything important from 2009 that you would like to see analyzed in the 2010 edition -- please let me know and I will see what I can do.

JCM

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Last September we predicted that sometime in 2010 EPA would reverse its "distinct molecular identity" approach to determining when and whether nanoscale materials are considered New Chemical Substances requiring premanufacturing notice and approval under the Toxic Substances Control Act (TSCA).   We have been advising clients accordingly. 

Inside EPA is now reporting that "EPA toxics chief Steve Owens" . . . "is expected to announce the shift Feb. 5."

Thus, tomorrow should be an interesting day in nano-regulatory-land.  We will provide our readers with a detailed analysis should EPA in fact reverse itself on this important issue.  Stay tuned . . .

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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. 

In late December 2009, California’s Department of Toxic Substances Control (DTSC) received the first response¹ to its January 22, 2009 information request regarding carbon nanotubes². The original request targeted 26 purported California manufacturers and/or importers of carbon nanotubes³.

It asked for information regarding analytical test methods, environmental fate and transport, and other relevant environmental, health, and safety information. The request was issued by DTSC under authority granted by California's Health and Safety Code 699, Sections 57018-57020. Stanford University was the first entity to respond to the six specific questions contained in DTSC’s request:

1.  What is the value chain for your company? For example, in what products are your carbon nanotubes used by others? In what quantities? Who are your major customers?

2.  What sampling, detection and measurement methods are you using to monitor (detect and measure) the presence of your chemical in the workplace and the environment? Provide a full description of all required sampling, detection, measurement and verification methodologies. Provide full QA/QC protocol.

3.  What is your knowledge about the current and projected presence of your chemical in the environment that results from manufacturing, distribution, use, and end-of-life disposal?

4.  What is your knowledge about the safety of your chemical in terms of occupational safety, public health and the environment?

5.  What methods are you using to protect workers in the research, development and manufacturing environment

6.  When released, does your material constitute a hazardous waste under California Health & Safety Code provisions? Are discarded off-spec materials a hazardous waste? Once discarded are the carbon nanotubes you produce a hazardous waste? What are your waste handling practices for carbon nanotubes?

Stanford’s response was thoughtful, yet very basic. The University confirmed that it follows standard laboratory safety procedures, has implemented most of the nanosafety guidelines issued by the National Institute for Occupational Safety and Health (NIOSH), and that it treats nano-waste as “hazardous waste” for disposal purposes. A summary of Stanford’s answers follows.

In response to DTSC’s first “value chain” question, Stanford responded that it has identified 16 of its laboratories that are working with carbon nanotubes. Research topics include medical applications, electronics, energy storage, fuel production, fundamental physics, and material science research. To support its “value chain” answer, Stanford attached five research papers resulting from its laboratories’ activities.

Regarding DTSC’s second “monitoring” question, Stanford answered that because there are only minimal risks of exposure and release of carbon nanotubes in its laboratories, it has not yet developed or implemented any quantitative sampling or detection methods. The University also advised that it was working with NIOSH to conduct a possible site visit of its facilities in 2010 to potentially address these issues.

Responding to DTSC’s third question concerning the “projected presence” of carbon nanotubes in the environment which may result from Stanford’s activities, the University answered that there could conceivably be (i) accidental releases and spills, (ii) routine releases from laboratory handling, and (iii) the presence of carbon nanotubes in its laboratory waste stream. Importantly, Stanford indicated that the combined use of carbon nanotubes in all of its laboratories only amounts to approximately 16 grams per year and that its nano-waste stream is treated as “hazardous waste.”

Regarding DTSC’s fourth question concerning Stanford’s knowledge of the possible environmental, health, and safety effects of its carbon nanotubes, the University responded that it takes “a precautionary, but reasonable approach” and uses good laboratory safety practices when working with nanoscale materials. Additionally, Stanford maintained that one the articles attached to its submission supports the position that carbon nanotubes are cleared from the body without adverse health effects. Finally, Stanford indicated that it closely follows the nano-EHS literature posted on NIOSH’s website, as well as the comprehensive nano-EHS website of the International Council on Nanotechnology at Rice University.

In response to DTSC’s fifth question concerning the nano-specific workplace safety measures implemented by Stanford, the University responded that (i) it follows a standard chemical hygiene plan created and implemented under existing California law, (ii) has implemented its “General Principles and Practices for Working Safely with Engineered Nanomaterials,” and (iii) has created a standard operation procedure template for use by its nano-laboratories “to assist in determining the [appropriate] levels and types of controls” which should be used in each laboratory working with nanoscale materials. Stanford’s “General Principles” document⁴ can be found on its website and basically summarizes the key points from NIOSH’s “Approaches to Safe Nanotechnology” document⁵ in a condensed bullet point format.

Finally, regarding DTSC’s sixth “hazardous waste” question, Stanford largely mooted the question by explaining that it treats its carbon nanotube waste stream as “hazardous waste,” whether or not such material actually constitutes “hazardous waste” from a scientific and/or regulatory perspective.

On the whole, Stanford put considerable effort into its response to DTSC’s information request, but it contained no “earth shattering” revelations. The University appears to be following state of the art procedures for working safely with carbon nanotubes. More importantly, there was little information in Stanford’s response that the State did not already know or could have learned with a simple telephone call. Of course, all of this begs the question of whether a formal data call in was even necessary in the first place and/or whether California is squandering its rapidly diminishing capital on this project. At the very least, the data call in should have contained a minimum threshold requirement in order to weed out minimal users and to prevent them from having to engage in the time consuming process which Stanford went through.

References:

1. Stanford University CNT Submittal Letter
2. DTSC January 22, 2009, Information Request Regarding Carbon Nanotubes
3. DTSC Carbon Nanotube Contact List
4. Stanford's General Principles Document
5. NIOSH's Approaches to Safe Nanotechnology

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Our readers might be interested in seeing an article published by BNA's Toxics Law Report which was published on December 3, 2009 -- "Nanotechnology: The Next Battleground for Mass Torts?"  The article by a prominent California attorney and one of his Chicago-based associates is primarily a summary of our prior October 2008 article: "A Nano-Mesothelioma False Alarm" with a few added procedural suggestions for defense attorneys.  Glad to see someone out there is reading.  :)

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Earlier today, an IEEE blogger commented on a nanosilver article we previously re-published on this cite.   The original article was written by the Silver Nanotechnology Working Group and was first published on the University of Massachusetts, Amherst's InterNano website (where I am Contibuting Editor for Environmental, Health and Safety and Regulation). 

Dexter Johnson comments on the Nanoclast blog of IEEE's Spectrum website:

"In what must come as a blow to NGOs around the world it turns out that the material that has fueled much of their indignation about nanotechnology, nanosilver, has not only been 'rationally manufactured, regulated, and used commercially for over a century with no significant adverse environmental, health, and safety effects', but also the EPA has specifically been looking at nanosilver as far back as the 1950s."

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This article was written by John C. Monica, Jr. and Dr. Diana Bowman and originally appeared on the National Nanomanufacturing Network's InterNano website earlier today.  It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

Dr. Bowman is a Senior Research Fellow in the School for Population Health at the University of Melbourne and a Visiting Research Fellow in the Department of International and European Law, KU Leuven. Dr. Bowman is also a co-editor, along with Matthew Hull, of the book “Nanotechnology Environmental Health and Safety: Risks, Regulation and Management,” (Elsevier, 2010).

In November 2009, the Australian Government’s Department of Health and Aging (DHA) published a public discussion paper —“Proposal for Regulatory Reform of Industrial Nanomaterials”—in relation to the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), which provides a national system of notification and assessment of industrial chemicals. For the purpose of the scheme, “industrial chemicals” include chemical entities found in, for example, many plastics and paints. And, unlike many jurisdictions, those chemicals found in cosmetic products. The paper provides concrete recommendations for the regulation of both “new” nanoscale chemical substances and “existing” chemical substances in nanoscale formulations, while thoughtfully considering legitimate business needs.

Regarding “new” nanoscale chemical substances, the paper notes that—by legal definition—these substances are those which are not already listed on the Australian Inventory of Chemical Substances and as such are subject to existing regulatory requirements. The paper also notes that several permitting exemptions currently exist for certain uses of chemicals already on the Inventory. As an initial nano-regulatory step, the paper recommends excluding “new” nanoscale materials not already on the Inventory from regulatory low volume exemptions, “thereby shifting a post-market audit activity to a pre-market assessment (i.e. new nanomaterials to be assessed under permit or certification categories prior to commercialization).” The suggestion is not unduly punitive, and a similar approach is already in use by the US EPA.

Additionally, the paper recommends modifying the Research and Development exemption for “new” chemical substances to require annual reporting of nanoscale materials produced in quantities exceeding 100 grams per year. While the paper could benefit from some explanation of why this specific threshold was selected, the idea of providing basic information on nanoscale materials used in sufficient quantities for research and development is not onerous.

The main rationale for these modifications is that the “uncertainty surrounding the hazards, exposure, and risk assessment methodologies . . . means that the determination of ‘no unreasonable risk’ or ‘non-hazardous’, both of which are prerequisites to a range of exemptions, is not expected to be straightforward,” and the accompanying need for a case-by-case approach to the responsible development of nanoscale chemical substances.

Regarding “existing” nanoscale chemical substances, the paper recommends that the Australian Government consider following up on their somewhat disappointing voluntary data call-ins under the NICNAS scheme (held in 2006 and 2008) with a study on “the feasibility of a mandatory notification and assessment program.” Such a program would be designed to establish a database of “existing” nanoscale chemicals in use in Australia and increase public confidence in regulatory oversight efforts. U.S. EPA is also considering a mandatory data call-in for nanoscale materials, while California has already issued a mandatory data call-in for carbon nanotubes and is targeting several additional nanoscale materials.

Australia’s DHA’s recommendations are well-balanced. Business and commercialization needs are recognized even though human and environmental, health, and safety regulatory needs are given priority. However, the paper largely ignores the most difficult topic in this space—whether nanoscale versions of “existing” chemicals already on the Australian Inventory of Chemical Substances should be considered “new” chemical substances for regulatory purposes, as suggested by Ludlow, Bowman, and Hodge in their review of Australia’s regulatory framework for nanotechnology, thus triggering pre-market approval requirements prior to commercialization. This issue has been argued back and forth in the US, the EU and other jurisdictions for quite some time, and it is unlikely that Australia will be able to avoid similar strong debate. It is perhaps the biggest issue facing regulators seeking to modify Australia’s industrial chemical legislative framework to fully cover both “new” and “existing” nanoscale materials.

Beyond the substantive regulatory changes noted above, the paper does an excellent job of explaining what “industrial nanomaterials” are, their current regulatory status in Australia, and national and international regulatory activities for nanoscale materials. Moreover, the paper is written in sharp, clear language. It provides lots of key questions for stakeholders to consider when thinking about these issues, as well as surveys and questionnaires encouraging feedback and input. The Australian Government is also sponsoring public consultation activities in most of the country’s larger metropolitan areas to explains the paper to stakeholders first-hand and to solicit additional input.

References

National Industrial Chemical Notification and Assessment Scheme (Department of Health and Aging, Australian Government). Proposal for Regulatory Reform of Industrial Nanomaterials. Public Discussion Paper. November 2009. Available from NICNAS. http://www.nicnas.gov.au/Current_Issues/Nanotechnology/Stakeholder_Consultation.asp

Ludlow K, Bowman DM, and Hodge GA. 2007. A Reveiw of Possible Impacts of Nanotechnology on Australia'a Regulatory Framework. Monash Centre for Regulatory Studies, Monash University, Melbourn.
 

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This article was contributed by Dr. Rosalinda Volpe, Executive Director, Silver Nanotechnology Working Group (SNWG) and originally appeared on the National Nanomanufacturing Network's InterNano website earlier today.  It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

On November 3 – 6, 2009 the US Environmental Protection Agency (EPA) held a Scientific Advisory Panel (SAP) meeting in Arlington, Virginia to discuss the “Evaluation of Hazard and Exposure Associated with Nanosilver and Other Nanometal Oxide Pesticide Products.”[1] The meeting was well attended. Over seventy-five people from industry, regulatory, public interest, and academic sectors attended the meeting over three days. EPA received presentations and comments from the SAP panel members during the course of the meeting, as well as six presentations during the Public Comment period, and also received over 560 written comments which can be found on EPA’s website.

One group—The Silver Nanotechnology Working Group (SNWG)[2] —made a detailed presentation[3] to EPA supporting a fundamental regulatory consideration previously overlooked by many in attendance: nanosilver has been rationally manufactured, regulated, and used commercially for over a century with no significant adverse environmental, health, and safety effects. SNWG explained that nanosilver—often called by other names such as "colloidal silver" or "millimicron silver"—has been used in a wide range of consumer applications such as swimming pool treatments and drinking water filters with an established record under FIFRA of regulated and safe use dating as far back as the 1950’s. Thus, SNWG believes that nanosilver is not a “new” material requiring some type of special regulation and EPA needs to look beyond general conceptions of nano terminology and consider the broader established regulatory record of nanoscale silver products within the Agency. Simply put, SNWG believes that calls for treatment of nanosilver as a new material requiring development of expensive new test regimes and discriminatory regulation are difficult to justify.

Moreover, SNWG explained at the meeting that a detailed look at the history of silver within EPA shows that the toxicological studies that form the center of EPA’s existing general hazard limits for silver are derived from historical data from nanoscale silver materials and not conventional (bulk) silver as is often mistakenly assumed. For example, SNWG’s careful examination of EPA’s public registration database[4] for silver over a period of 6 decades revealed:

• The very first registered silver product was a colloidal nanosilver algaecide product that has been safely used by millions of consumers for over 50 years (registered since 1954).
• Every EPA silver registration between 1970 and 1990 was either a colloidal nanosilver or nanosilver-composite product.
• The very first NON-nanosilver product registered by EPA was not registered until 1994.
• An overall analysis reveals that today over 50% of all EPA registered silver products are in fact based on nanoscale silver.

Based on its analysis, SNWG took the formal position that EPA has a range of existing regulatory structures that have successfully addressed silver materials across the size spectrum for over 5 decades. Additionally, EPA has not any incidents of significance on the Agency’s formal incident reporting database (EPA OPP IDS) – indicating that thorough monitoring of real-life use supports the safety of these products.

The SWNG congratulated EPA for its record of successful monitoring and risk management for these materials despite different terminologies being used throughout this time period. Indeed, SNWG pointed out that with nanosilver there is perhaps more historical data and evidence of safe use than for many other regulatory materials, and the EPA has the opportunity to assess nanosilver products with confidence given this long history of safe use under existing EPA regulatons.

The SNWG is hopeful that the EPA and the other meeting attendees will examine SNWG’s position and supporting information in more detail to confirm that nanosilver has been successfully regulated for decades. If sufficient consideration is given, SNWG believes that EPA will conclude that there is no need to “fix” a regulatory process that is not “broken,” but has worked exceedingly well for decades in the case of nanosilver.

References

1.  EPA Scientific Advisory Panel meeting, Arlington VA (November 3 - 6, 2009).

2.  SNWG is an industry effort intended to foster the collection of data on silver nanotechnology in order to advance the science and public understanding of the beneficial uses of silver nanoparticles in a wide-range of consumer and industrial products.

3.  SNWG “Evaluation of Hazard and Exposure Associated with Nanosilver and Other Nanometal Oxide Pesticide Products”, Presentation to Scientific Advisory Panel (November 4th, 2009).

4.  NPIRS Public.

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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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This article was originally published by the National Nanomanufacturing Network's "InterNano" project (www.internano.com).  It is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

A recent study published in the well-known medical journal, the European Respiratory Journal, has been receiving significant publicity as the authors have claimed their findings support an apparent linkage between workplace exposures to nanoparticles and severe respiratory disease. Specifically, in this study, investigators at China's Capital University of Medical Science related unusual and progressive lung disease in seven Chinese workers, two of whom died, to nanoparticle exposures in a print plant where a polyacrylic ester paste containing nanoparticles was used. This linkage was made by the study investigators despite a general lack of exposure data for the workers. 
 

The complete review is after the jump . . .

Reviewed by Christopher M. Long, Sc.D., and Barbara D. Beck, Ph.D., DABT, FATS, Gradient

• Song Y, Li X, Du X. 2009. Exposure to nanoparticles is related to pleural effusion, pulmonary fibrosis and granuloma. Eur Respir J. 34(3):559-67.  DOI:10.1183/09031936.00178308.

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We have previously reported on a study by Arizona State researchers looking into the potential release of nanosilver particles from odor-killing socks during theoretical wash cycles.  A new study from Switzerland examines the issue in further detail.

L. Geranio, et al., "The Behavior of Silver Nanotextiles during Washing," Environ. Sci. Technol. (Sept. 2009).

Three authors from the Swiss Federal Laboratories for Materials Testing and Research conducted the study with the aim of determining "the amount and the form of Ag released during washing from nine fabrics with different ways of silver incorporation into or onto the fibers."  The study generally found that when washed at low pH levels, there was little dissolution of nanoparticles from the textiles being tested.  However, the researchers theorized that the use of bleach "can greatly accelerate the dissolution of Ag."  The percentage of total silver emitted during one wash cycle for the fabrics varied between 1% and 45%.  Almost 75% of the silver released was greater than 450 nm in diameter. 

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Nanotechnology Law & Business just published our new article on the EPA's recent treatment of nanoscale materials under the Toxic Substances Control Act.  An abstract for the article is below and you can find a copy of the article itself here.

Abstract: This article provides a summary of recent (2008-2009) regulatory efforts by the U.S. Environmental Protection Agency under the Toxic Substances Control Act concerning nanoscale materials. These efforts include entering into two consent orders with a manufacturer of carbon nanotubes; issuing four significant new use rules for two siloxane-based nanoparticles and two carbon nanotubes (and then withdrawing the latter two); intimating that new testing and data collection rules will be implemented for certain nanoscale materials; and proposing and/or requiring acute toxicity rat inhalation testing regimes in certain instances. The authors explain these developments in detail and then provide some initial strategic and legal considerations for businesses attempting to navigate this emerging regulatory thicket.

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Our friends at AZoNano (www.AZoNano.com) recently sent us this full page, color, sunscreen advertisement from the September 16, 2009 Weekend Australian Magazine.  The sunscreen in question, called "Invisible Zinc," claims to use an invisible film of zinc oxide to provide UVA and UVB skin protection to its users.  Our readers will quickly note the prominent disclaimer appearing in the upper right hand corner of the page -- "*Micronised (Not Nano)."  It's the first I've seen.  If you know of others, please forward them to me if you get a chance.

It appears that the anti-nano sunscreen publicity occurring over the past few years is now taking root in demonstrable ways.

Author's note:  Technology is truly decreasing the size of our world.  AZoNano's CEO -- Dr. Ian Birkby -- found this "Invisible Zinc" advertisement in Australia where he lives, and then wrote about it on Twitter.  I picked up his tweet and asked for a copy, which he kindly emailed to me.  Now nanolawreport readers from various countries can also read about the advertisement.  Dr. Birkby is @Birkers on Twitter, while I am @nanolaw.  Hope to hear from you soon.

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There are often developments in the nano legal world that do not fit into our traditional Nanotechnology Law Report format, yet might be of interest to some of our readers. You can now find these short postings and other musings on twitter.com/nanolaw  .

Additionally, you can find me on linkedin under "John Monica," as well as on our new "Nano EHS Forum".  Please feel free to link in or to join our new discussion group.

Happy networking!

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A much valued contributor from CyberRegs provided us with the following information from the Federal Register that may be of interest to readers:

There will be a 4-day consultation meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review a set of scientific issues related to the assessment of hazard and exposure associated with nanosilver and other nanometal pesticide products.

DATES: The consultation meeting will be held on November 3 - 6, 2009, from approximately 8:30 a.m. to 5:00 p.m. The consultation meeting will be held at the Environmental Protection Agency, Conference Center, Lobby Level, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA 22202.

Comments. The Agency encourages that written comments be submitted by October 20, 2009 and requests for oral comments be submitted by October 27, 2009. Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

FOR FURTHER INFORMATION CONTACT: Joseph E. Bailey, DFO, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-2045; fax number: (202) 564-8382; e-mail address:
bailey.joseph@epa.gov.

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For anyone interested, I am presenting my recently approved Virginia CLE presentation "Insurance, Nanotechnology, and Risk" in mid-September to a national intellectual property law firm based here in D.C.  The presentation covers issues related to the alleged environmental, health, and safety (EHS) risks accompanying certain nanoscale materials from the perspective of both the insured and insurer. Particular emphasis is placed on (i) insurer approaches to EHS risk and uncertainty, (ii) the first commercial insurance exclusion for nanotechnology in the US, (iii) industry reaction to certain recent adverse EHS studies concerning carbon nanotubes, and (iv) three initial steps nano-related businesses should consider when dealing with these issues. The PowerPoint was originally presented at the Nanotechnology Health and Safety Forum in Seattle in June 2009, and the National Nanotechnology Initiative also asked for it to be presented at the opening plenary for its October 2009 workshop on "Nanomaterials and the Environment & Instrumentation."  I anticipate additional presentations of the CLE in D.C. and Virginia over the upcoming months.  Please let me know if you have any interest in attending one of the future sessions and I will try to hook you up for some free CLE credit.

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Earlier today, the Guardian printed a letter from the Soil Association criticizing the paper's nanotechnology supplement appearing last Thursday.  The letter cites the Song study from China as more evidence supporting its call for a moratorium on nanoscale materials along with "nano-free" standards, which we have previously covered.  Key statements from the letter follow:

"Seven women working in a factory [in China] where nanoparticles were used in paint fell ill with serious lung disease and two died. Researchers . . . found nanoparticles deep in the lungs of the women . . . A chemical in the paint, the patients' lung tissue and the liquid surrounding the lungs were all found to contain nanoparticles."

"There should be an immediate freeze on the commercial release of nanomaterials until there is a sound body of scientific research into all the health impacts."

The letter does not attempt to explain any of the severe criticism the Song article has received by most main stream scientists, and is a good example of bad science put to a questionable use.

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For anyone who might be interested, I will be speaking on nano-related insurance issues at the opening plenary of the National Nanotechnology Initiative's upcoming Oct. 6 -7 conference and workshop on Nanomaterials and the Environment & Instrumentation.  The draft agenda for the conference can be found here, and the plenary is also supposed to be broadcast on the web.  I will post the information for the simulcast as we get closer to the conference date.  Cost, location, and registration info. is here.

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For anyone interested, here is the index to my new book "Nanotechnology Law."  You can find the book on Amazon.

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Last Friday, EPA's Office of Research and Development announced in the Federal Register a 45 day comment period for its new draft case study on the use of nanoscale TiO2 in water and sunscreens:

"Nanomaterial Case Studies: Nanoscale Titanium Dioxide in Water Treatment and in Topical Sunscreen"

FR 74,146 at 38188 (July 31, 2009).  The report focuses on two specific applications of nanoscale titanium dioxide (nano-TiO2): (i) as an agent for removing arsenic from drinking water, and (ii) as an active ingredient in topical sunscreen. The draft report is divided into five chapters:

1. Introduction
2. Life Cycle Stages
3. Fate and Transport
4. Exposure - Dose Characterization
5. Characterization of Effects

The report is formidable in length, scope, and detail.  For those looking for some quick highlights, the report provides a great series of summaries of the existing TiO2 environmental, health, and safety literature.  For example:

• Table 4-4 presents an overview of approximately 25 existing TiO2 skin absorption/penetration studies dating back to 1997;

• Table 5-3 provides a summary of nano-TiO2 ecological effects; and

• Tables 5-4 through 5-6 provide a summary of health effects of nano-TiO2 particles in mammalian animal models via dermal, oral, and respiratory exposure routes.

EPA notes that the "document is not intended to serve as a basis for risk management decision in the near term on these specific uses of nano-TiO2."  Rather, its focus is on developing necessary data for "future assessment efforts." Specifically, the "document is a starting point to determine what is known and what needs to be known about selected nanomaterials as part of a process to identify and prioritize research to inform future assessments of the potential ecological and health implications of these materials."

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Readers may interested in learning that EPA issued a clarification today regarding its single-walled and multi-walled carbon nanotube SNURs previously issued in June 2009. EPA's announcement follows.  Stay tuned . . .

Good afternoon.  On June 24, 2009, the U.S. EPA issued final Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA) for 23 new chemicals, including two carbon nanotubes (nanoscale materials) (http://www.epa.gov/fedrgstr/EPA-TOX/2009/June/Day-24/t14780.pdf).  The SNURs will allow the commercialization of these specific carbon nanotubes under limited conditions to protect against unreasonable risks to human health and the environment.  

The SNURs require companies to notify EPA at least 90 days before manufacture, import, or processing of the specific carbon nanotubes for any activity not meeting the conditions specified in the rules at 40 C.F.R. 721.10155  and 40 C.F.R. 721.10156.

Upon reviewing the rules some stakeholders have asked EPA whether these SNURs apply to all variants of carbon nanotubes. This is not the case. These SNURs only apply to the specific carbon nanotubes that were the subject of the premanufacture notices (PMNs) submitted under Section 5 of TSCA and not to any other carbon nanotubes.  Other carbon nanotubes must be notified through EPA's New Chemicals Program.   The U.S. EPA strongly encourages all manufacturers and importers of nanoscale materials that are intended for commercial use to consult with the Agency in advance of production or importation.

If you have any questions, please contact:

Zofia Kosim (202-564-8733) or kosim.zofia@epa.gov
Jim Alwood (202-564-8974) or alwood.jim@epa.gov
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David E. Giamporcaro
Industry and Small Business Liaison
Environmental Assistance Division
Office of Pollution Prevention and Toxics
U.S. Environmental Protection Agency
East Building
1200 Pennsylvania Avenue, N.W. (MC7408M)
Washington, D.C. 20460
Phone: (202)564-8107
Fax: (202)564-8813

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Zurich North America recently published the June 2009 edition of its Industry Insight online magazine which focuses exclusively on nanotechnology issues. The magazine contains four informative articles which are well worth reading:

• "At the leading edge: Zurich's thought leadership on nanotechnology;"
• "No small thing: The enormous potential of nano;"
• "The kings of small things: The regulatory environment for nanotechnology development;" and
• "Large risks from small things? Myth and reality of nano-risks."

Our readers may be particularly interested in the "leading edge" article in which Zurich describes its nanotechnology emerging risk activities dating back to 2006. The article discusses Zurich's involvement in ANSI's TAG to ISO/TC 229 Nanotechnologies standards and nomenclature group; its ongoing efforts to make sure its voice is heard in the ongoing regulatory debate surrounding certain nanoscale materials; and the formation of a new Zurich Nanotechnology Exposure Protocol™ (ZNEP™).

As Zurich explains, its new ZNEP™ is a risk assessment protocol designed to understand potential nano-related insurance risks:

"By working closely with corporate customers, collecting data on the specific nano-particles they were using, learning about the specific applications where they're employed, and then combining this information, Zurich could form a global overview of nanotechnology and its various facets of risk. Such an activity would not only be a very good way to protect is business, but it could form a basis for providing risk management advice to its customers going forward."

Zurich is working with Seattle-based Intertox to implement its ZNEP™, which it also hopes will dramatically shorten the lag time between discovery of new nanotechnology-based inventions and their insurability.  Readers may also recall that Zurich's Director of Emerging Issues recently spoke on insurance issues at the very well-attended Nanotechnology Health and Safety Forum in Seattle, Washington.

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Here is the Summer 2009 edition of Nanotechnology Law Report.  The newsletter contains the below-listed articles (and more):

• EPA Issues Significant New Use Rules for Carbon Nanotubes
• Are Nanoparticles Released by Cutting or Compounding Nano-Composites?
• Annual Nano TiO2 Production Estimated at 44,000 Metric Tons
• Are Nano Consumer Products Headed Underground?
• Oversight of Next Generation Nanotechnology
• Regulating Nanotechnologies
• More Interesting Nano-Regulatory Developments
• Nano Tug of War
• Pumpkins & Nanoparticles
• Green Nano
• NanoBiotech 2009
• Take two silver nanoparticles and call me in the morning
• International Approaches to the Regulatory Governance of Nanotechnology
• ETUC Resolution on Nanotechnologies and Nanomaterials
• Private Spending on Nano Exceeds Government Spending
• EMERGNANO Released

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Chubb Insurance is hosting a one-day nanotechnology insurance conference on October 13, 2009 in North Branch, New Jersey:

"Nanotechnology: What is the Best Safety and Risk Management Approach?" 

From the conference website:

"This conference brings together prominent nanotechnology speakers who will review nanotechnology background, health and safety, and potential insurance and liability issues. Current risk assessment and 'best practice' controls will be shared, helping attendees better recognize and manage potential nanotechnology risks. A nanotechnology toolkit will be provided to help attendees stay abreast of critical developments in this dynamic field."

Speakers include: Charles Geraci (NIOSH), Charles Kingdollar (General Reinsurance Corp.); John Monica (Porter Wright); Susan Berry (DRS Technologies); Ganesh Skandan (NEI Corp.); William Barr (Chubb); Erik Olsen (Chubb); and Louise Vallee (Chubb).

More from the conference website:

Emerging risks require new risk management practices. Nanotechnology applications have outpaced safety and health research. The big challenge is trying to figure out a risk management roadmap when there is a scientific and regulatory abyss with the potential for future litigation looming in the distance. Companies that delay nanotechnology innovation awaiting safety consensus or regulations risk falling behind the competition. While these tiny materials and processes are big business, many risk managers and insurance buyers haven’t fully considered potential risks to employees, consumers and the environment, resulting in workers compensation, product liability and environmental liability exposures. Company risk managers and insurance buyers would value and benefit from knowledgeable broker and agent guidance. Application and control strategies considered now may have far-reaching future implications.

Nano insurance issues have received a lot of renewed interest lately.  This should be a great conference on the topic and is open to the public.  Hope to see you there.

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Nanotechnology Law & Business just published its new edition.  For those who might be interested, Volume 6.2 contains an article I co-authored with several nano-friends entitled: "Nano Risk Governance: Current Developments and Future Perspectives."  You can find the article here.  An abstract follows.

As with many new technologies, developing a framework for making risk management decisions for nanotechnology is a challenge. Risk assessment has been proposed as the foundation for many regulatory frameworks for nanomaterials. Although the traditional risk assessment paradigm successfully used by the scientific community since the early 1980s may be generally applicable, its application to nanotechnology requires a significant information base. The authors’ experience supporting federal agencies in the United States, Canada, and the European Union—as well as state agencies in Massachusetts and New York and cities such as Berkeley and Cambridge—suggests that nanomaterial regulatory frameworks could be built upon existing regulatory approaches with the addition of a more rigorous and transparent method for integrating technical information and expert judgment. The authors argue that the current focus on studying the amount of risk acceptable for a specific technology or material should be shifted toward comparative assessment of available alternatives, and the use of science and policy to identify alternative nanotechnologies and opportunities for risk reduction and innovation. This approach involves the use of both quantitative and qualitative decision analysis tools, offering roadmaps for assessing different information sources and making policy decisions. Two representative methods presented are the Alternatives Assessment method and the Multi-Criteria Decision Analysis method.

Igor Linkov, U.S. Army
F. Kyle Satterstrom, Harvard University
John C. Monica Jr., Porter Wright Morris & Arthur LLP
Steffen Foss Hansen, Technical University of Denmark
Thomas A. Davis, University of Montreal

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 "Nanotechnology Law" by John Monica was just published this week by West/Thomson/Reuters, the world's leading legal publisher. The book is the first comprehensive legal text on nanotechnology and weighs in at a healthy 900 pages. The table of contents is here. The book is divided into ten informative chapters:

• Nanotechnology Introduction
• National Nanotechnology Initiative and Federal Development Efforts
• Potential Nano-Related Environmental, Health, and Safety Concerns
• Nanotechnology Environmental Regulatory Issues
• Nano-Related Food and Drug Regulatory Issues
• Nanoscale Materials in the Workplace
• Nano-Consumer Products and Insurance Issues
• Municipal, Regional, and State Development and Regulation of Nanotechnology
• Nanotechnology Standards and Nomenclature
• Nano-Intellectual Property Landscape

More information can be found here.

 

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In the June 24, 2009 federal register, the U.S. Environmental Protection Agency (EPA) issued two proposed Significant New Use Rules (SNUR) under Section 5(a) of the Toxic Substances Control Act (TSCA) for multi-walled and single walled carbon nanotubes.  The SNURs followed up on the EPA's prior September 2008 consent orders entered into with Thomas Swan & Co. Ltd. (Swan) for two of its Elicarb carbon nanotube products.

Under TSCA, the prior September 2008 consent orders were only binding on Swan.  "Consequently, after signing a Section 5(e) Consent Order, EPA generally promulgates a Significant New Use Rule (SNUR) that mimics the Consent Order to bind all other manufacturers and processors to the terms and conditions contained in the Consent Order.  The SNUR requires that manufacturers, importers and processors of certain substances notify EPA at least 90 days before beginning any activity that EPA has designated as a "significant new use. These new use designations are typically those activities prohibited by the Section 5(e) Consent Order."

Under the terms of the Septmeber 2008 consent orders which are incorporated into the new proposed SNURs, significant new uses of multi-walled and singled-walled carbon nanotubes are deemed to occur when employees do not “use gloves impervious to nanoscale particles and chemical protective clothing;” and/or fail to “use a NIOSH-approved full-face respirator with an N-100 cartridge while exposed by inhalation in the work area.”

Thus, the new proposed SNURs require these same conditions.

Manufacturers should also be aware that the EPA considers carbon nanotubes new chemical substances requiring full PMN notice, registration, and approval under Section 5 of TSCA, and has initiated at least one recent enforcement action against a carbon nanotube manufacturer who has failed to properly register its products.

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Perhaps the most overlooked issue when examining potential nano-related environmental, health, and safety concerns is whether there is any true likelihood of exposure in reasonably foreseeable use scenarios.  While there should continue to be extensive toxicity testing for certain nanoscale materials, the most interesting research (from my perspective) relates to potential workplace and/or condumer exposure in realistic settings.  We examine two studies along these lines below.

C. Su-Jung et al., "Control of Airborne Nanoparticles Releases During Compounding of Polymer Nanocomposites," 3 Nano: Brief Reports and Reviews 4, 301 - 309 (2008).

This study was conducted by researchers at the National Science Foundation-funded Center for High-Rate Nanomanufacturing at the University of Massachusetts at Lowell.  The scientists examined potential nanoparticle release related to the twin-screw extruder compounding of polymer nanocomposites.  The test was conducted because "commercial compounding (mixing) of nanocomposites is typically achieved by feeding the nanoparticles and polymer into a twin-screw extruder, the airborne particles associated with nanoparticles reinforcing agents are of particular concern, as they can readily enter the body through inhalation."

The nanoparticles in question were nano aluminum oxide particles acquired from Nanophase Technologies in commercially available form.  The particles were spherical in shape and ranged from 27 to 53 nm in diameter.  They were also specifically "engineered to form agglomerates with a nominal size of 200 nm."

Regarding the test itself, the scientists fed 2.3kg of polymer pellets and 0.16 kg of nano-alumina particles into a twin-screw extruder for processing and then measured potential nanoparticle release through two measurement techniques: (i) TSI Fast Mobility Particle Spectrometer for real time measurement; and (ii) personal air sampling using a special filter media designed to catch nanoparticles. 

The study concluded that "[t]he twin-screw extrusion process for compounding polymer nanocomposites tends to break up nanoparticle aggregates and mechanically disperse particles thoroughly during the extrusion process."  The study also found that "[nano]particle diffusion was enhanced by . . . poorly-performing local and general exhaust systems."

Interestingly, for part of the test the scientists applied a nominal engineering control by covering the open top of the extruder feeding tube throat with aluminum foil which they found "dramatically reduced" nanoparticle measurements.  They also found that consistently cleaning the lab after each use "reduced laboratory background nanoparticle concentration."

D. Bello et al., "Exposure to nanoscale particles and fibres during machining of hybrid advanced composite containing carbon nanotubes," 11 J. Nanopart Res 231 - 249 (2009).

The researchers in this study investigated whether and to what extent airborne nanoparticles were generated by wet and dry cutting of two hybrid carbon nanotube composites.  The dry cutting method employed a diamond coated band saw.  The wet cutting was performed using a diamond grit rotary cutting wheel with water lubricating the cutting surfaces during the process.  Because the scientists were interested in potential "worst case" scenarios, no vacuum or emission controls were used in tests.

The researchers found that wet cutting did not produce airborne nanoparticle emissions above background levels, but that dry cutting "generated statistically significant quantities of nanoscale and fine particles as compared to background (p<0.05), regardless of the composite type, . . . as expected."

Interestingly, the study also found that "CNTs, either individual or in bundles, were not observed in extensive microscopy of collected samples" for either wet or dry tests.

We will continue to track down and summarize these types of potential exposure studies.  Right now, they are few and far between.

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The Investor Environmental Health Network (IEHN) claims to represents 20 investment organizations with $22 billion under management that are seeking to ensure that the companies they invest in are taking appropriate steps to reduce risks associated with the toxic chemicals used in their products.  IEHN's ultimate objective is to use "public policy work regarding investor rights and disclosure, as well as dialog and shareholder resolutions, [to address] the risks and opportunities associated with toxic chemicals and safer alternatives in products." IEHN previously issued a report on the use of nanotechnology in cosmetics in February 2007. 

IEHN's new report -- "Bridging the Credibility Gap: Eight Corporate Liability Accounting Loopholes that Regulators Must Close," Investor Environmental Health Network, 2009 -- focuses on corporate disclosure issues surrounding the commercialization of nanoscale materials. IEHN identifies eight "loopholes" that it believes companies and regulators must close to protect shareholder value.

IEHN's eight purported "loopholes" are:

1. Shortsightedness: Failing to make a full accounting of potential risks and liability be focusing solely on short term issues.

2. Concealed Science: "Concealing emergency science that forewarns of potential liabilities in the future."

3. The Known Minimum: Basing business decisions on low end risk assessments rather than true case "worst case" scenarios.

4. Privileging Secrecy: Using the attorney client privilege to shield against public disclosure of potential liability.

5. Inconsistent Estimates: Providing different risk estimates to insurers on the one hand, and investors on the other.

6. Hidden Assumptions: "Using hidden assumptions to minimize estimates of liability.

7. Missing Benchmarks: Failing to benchmark a company's potential liability against its competitors in the same business facing similar liability issues.

8. Risk-Free Proxies: Failing to allow shareholders to place EHS questions on annual proxy ballots.

These purported  "loopholes" are not exclusive to nanotechnology.  IEHN hypothetically compares the potential corporate liability of companies using nanoscale materials to the ruin faced by companies involved in asbestos manufacturing from the 1930s forward. Basically, IEHN argues that failing to close these eight identified "loopholes" destroyed the asbestos industry and the same thing might happen to the nanomaterials industry if it does not act differently.

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Inside U.S. Trade reports three interesting nano-regulatory developments: (i) the "EPA has signaled that it may soon decide to regulate nano-silver as a pesticide under " FIFRA; (ii) the "EPA may rule favorably on some points" raised in the 2008 citizen's petition filed by 14 advocacy groups seeking more restrictive regulation of nanoscale silver; and (iii) Congresswoman Kathy DahlKemper (D-Pa) on the House Science and Technology Committee "is pursuing a Cosmetics Safety Bill that would require registration of cosmetics containing nanomaterials."

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EurActiv.com (EU News, Policy Positions, and EU Actions on line) published an article on June 15, 2009 entitled "Nanotech claims 'dropped' for fear of consumer recoil." 

The article reported on a nanotechnology conference which took place in Brussels during the week of June 10 at which a scientist from the Woodrow Wilson International Center for Scholars' Project on Emerging Nanotechnologies maintained that some of the current environmental, health, and safety controversy accompanying certain nanoscale materials is not grounded in scientific fact, but has nonetheless led some manufacturers to remove "nano" from their product labels and advertising. He further stated that "we have seen some companies drop the 'nano' claim while continuing to use nanotechnology. This suggests nanotechnology is going underground."

Providing a counterpoint, the Director of the European Nanotechnology Industries Association said that "[v]arying definitions [of nanotechnology] leads to claims that the industry is not open to information. But nobody is lying and nobody is misleading the public or authorities. Let's agree on what we're talking about and work together to inform consumers."

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Mark your calendar for the one-day conference “NanoBiotech 2009” set for October 19, 2009 which is being co-sponsored by Rensselaer Polytechnic Institute (Troy, NY) and Bawa Biotechnology Consulting LLC (Ashburn, VA). This is the sixth in a series of international conferences they have conducted dating back to 2003 on the converging areas of nanotechnology and biotechnology.

From the conference's website: "The conference will feature 20+ speakers, including 2 keynotes and a networking luncheon. All presentations (20-30 minute Power Points) will be fast-paced, focused and will rely upon extensive color graphics and animations to reach the diverse audience. Raffle drawings will be held throughout the day."

You can find the agenda from last year's highly recommended conference here.
 

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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 Nanotechnology Health and Safety Forum which is being sponsored by Battelle, Porter Wright, University of Washington, University of Oregon, Oregon State University, and several others is taking place on June 8 - 9, 2009 at the Edgewater Hotel in Seattle, Washington.

Keynote speakers include: Dr. Leroy Hood, Co-Founder of the Institute for Systems Biology; Dr. Kenneth Dawson, Director of the Centre for BioNano Interactions; Dr. Justin Teeguarden Senior Research Scientist at Pacific Northwest National Laboratory and recent co-author of the NRC's assessment of the NNI's EHS research strategy; Dr. Vladimir Murashov from NIOSH; Dr. Saber Hussain from the Air Force Research Laboratory; former U.S. Congressman George Nethercutt; and Dr. Robert Tanguay from Oregon State University.

The program has 4 units:  Framing the Unknown; nanoEHS Perspective; Insurance, Nanotechnology, and Risk; and Nanotechnology: The Next Ten Years.

I will be speaking on the Insurance, Nanotechnology, and Risk panel on the second day of the conference along with Steve Knutson from Zurich North America; Walter Andrews from Hunton & Williams; and William E. Barr from Chubb Insurance.

You can sign up for the conference here.  Hope to see you there.

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Nanotechnology Law Report -- Spring 2009

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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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"Nanotechnology: Considering the Complex Ethical, Legal, and Societal Issues with the Parameters of Human Performance", by Linda MacDonald and Jeanann S. Boyce and published in Nanoethics 2: 265-275 (2008)  (available at http://ieet.org/index.php/IEET/print/2945) is one of the more thought provoking articles that look at the potential impacts of nanotechnology on law and society. It is certainly an ambitious article:

". . . we examine both the positive and negative aspects of the ethical, legal, and societal implications of using nanotechnology for human enhancement"

Human enhancement, for these authors, covers a very broad spectrum, from possible use in the treatment of cancer to "restoring lost functions of limbs, senses and brain function". (Unfortunately, at least for me, that part brings to mind two images, the nanites that appeared in a few late series episodes of Mystery Science Theatre 3000 and the nanoprobes used by the Borg on Star Trek: TNG.

In a suprisingly short section discussing the negative aspects of nanotechnology in general and nanomedicine in particular, the authors do little more than list what they refer to as the perils ranging from "neurnaowarfare" to economic upheaval.

The authors note that other articles have called for baning nanotechnology research and development, but note that this is unlikely to happen for two reasons:

1) "There is far too much money at stake." As someone once noted, money changes everything. Assuming that the economy and Wall Street return to normal, the stocks of nanotech and nanomanufacturing companies might attract the attention and dollars of investors.

2) "Such a ban would push research underground where it could not be regulated".

While noting that "much of the focus in the legal area . . . has been on intellectual property, the preservation of property rights, patent law", the authors turn to a discussion of an extreme possibility - using nano medicine to "enhance" the human body, putting forth the proposition that someone could reach a point where they are no longer totally human. While this might make for an interesting topic in a philosophy seminar or a good science fiction story (you wonder what Philip K. Dick could have done with that idea) it doesnot get a real development in this article.

The authors do make recommendations on how the law should deal with nanotechnology, ranging from a "continuing dialogue" between "lawmakers, scientists, ethicists, economists" to the creation of specialized science courts.

While, as I said earlier, this is a thought provoking article, it suffers from being too short. A longer article or monograph might have allowed for a fuller discussion of the ideas the authors raise. Still, it is worth a read.

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Battelle Memorial Institute, the University of Washington, and the University of Oregon are co-sponsoring the international Nanotechnology Health and Safety Forum (NHSF) in Seattle, Washington on June 8 - 9, 2009.  The NHSF is coinciding with the first world-wide meeting of the International Organization for Standardization (ISO) TC 229 -- Nanotechnologies being held in the United States, and will take place at the Bell Harbor International Conference Center.

Topics covered at the NHSF will include:

• The EHS Progress Report: today's status and tomorrow's next steps
• International Standards: developing a timeline & milestones
• Navigating Regulations: encouraging dialogue between Europe, Asia, and the U.S.
• Safety Guidelines: state of the science and recommended occupational safety guidelines for working with nanomaterials
• Managing Risk: the insurance industry perspective
• What's New: current activities of innovative nano-manufacturers

I have been invited to speak on the insurance/managing risk panel along with speakers from Riddell Williams, Hunton & Williams, Zurich North America, and Chubb Insurance:

The availability of insurance for entities using nanotechnology is critical to the further development and application of nanomaterials in industry. Yet the widening use of nanotechnology (while toxicology remains to be determined) is a central concern for the global insurance industry. Insurance, Nanotechnology, and Risk addresses the prospects for managing nano risk through the perspectives of a Silicon Valley loss control specialist, a major international underwriter, and liability / coverage counsel.

This should be a great conference with an international focus; plus Seattle in June is going to be a lot of fun. Hope to see you there.

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Steffen Foss Hansen is a Ph.D. candidate at the Technical University of Denmark's Department of Environmental Engineering.    Here is a link to his well-written Ph.D. thesis -- "Regulation and Risk Assessment of Nanomaterials -- Too Little, Too Late?" 

Dr. Hansen's thesis investigates whether existing environmental, health, and safety regulations and risk assessment techniques are adequate for nanotechnology and provides "some recommendations on how to govern nanotechnologies."   While I don't always agree with Dr. Hansen on nano-related EHS issues, there is no doubt that his work is detailed, thorough, and thought provoking.  Read it.  :)

As an aside, I also had the pleasure of contributing with Dr. Hansen and others on a nanogovernance book chapter this past year which might be of interest to Nanolawreport readers:

Considerations for Implementation of Manufactured Nanomaterial Policy and Governance, NANOMATERIALS RISKS AND BENEFITS, NATO Science for Peace and Security Series C: Environmental Security, (Igor Linkov and Jeffery Steevens eds., Springer 2008).

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SPEECH OF
HON. MICHAEL M. HONDA
OF CALIFORNIA
IN THE HOUSE OF REPRESENTATIVES
TUESDAY, FEBRUARY 3, 2009

Mr. HONDA. Madam Speaker, I rise today to discuss the introduction of the Nanotechnology Advancement and New Opportunities (NANO) Act.

The NANO Act is a comprehensive bill to promote the development and responsible stewardship of nanotechnology in the United States. The legislation draws upon the work of the Blue Ribbon Task Force on Nanotechnology, a panel of California nanotechnology experts with backgrounds in established industry, startup companies, consulting groups, non-profits, academia, government, medical research, and venture capital that I convened with during 2005.

Nanotechnology has the potential to create entirely new industries and radically transform the basis of competition in other fields, and I am proud of my work with former Science Committee Chairman Sherry Boehlert on the Nanotechnology Research and Development Act of 2003 to foster research in this area.

But one of the things I have heard from experts in the field is that while the United States is a leader in nanotechnology research, our foreign competitors are focusing more resources and effort on the commercialization of those research results than we are.

In its report Thinking Big About Thinking Small, which can be found on my website, the Blue Ribbon Task Force on Nanotechnology made a series of recommendations for ways that the nation can promote the development and commercialization of nanotechnology. The NANO Act includes a number of these recommendations.

In addition, the bill addresses concerns that have been raised about whether the federal government is doing enough to address potential health and safety risks associated With nanotechnology. The NANO Act requires the development of a nanotechnology research strategy that establishes research priorities for the federal government and industry that will ensure the development and responsible stewardship of nanotechnology. This strategy will help to resolve the uncertainty that is one of the major obstacles to the commercialization of nanotechnology--uncertainty about what the risks might be and uncertainty about how the Federal government might regulate nanotechnology in the future.

The NANO Act also includes a number of provisions to create partnerships, raise awareness, and implement strategic policies to resolve obstacles and promote nanotechnology. It will: create a public-private investment partnership to address the nanotechnology commercialization gap; establish a tax credit for investment in nanotechnology firms; authorize a grant program to support the establishment and development of nanotechnology incubators; establish a Nanoscale Science and Engineering Center for ``nano-CAD'' tools; establish grant programs for nanotechnology research to address specific challenges in the areas of energy, environment, homeland security, and health; establish a tax credit for nanotechnology education and training program expenses; establish a grant program to support the development of curriculum materials for interdisciplinary nanotechnology courses at higher education institutions; direct NSF to establish a program to encourage manufacturing companies to enter into partnerships with occupational training centers for the development of training to support nanotechnology manufacturing; and call for the development of a strategy for increasing interaction on nanotechnology interests between DOE national labs and the informal science education community.

I look forward to working with Science and Technology Committee Chairman Gordon to incorporate these provisions as his committee works to reauthorize the Nation's nanotechnology research and development program.
 

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Earlier today, the EPA published an interim status report regarding its Nanoscale Materials Stewardship Program.  A final report is expected in early 2010.

Nanoscale Materials Stewardship Program, Interim Report, January 2009, U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics.

At the outset, EPA notes that "[t]he findings and conclusions [of the] report should not be construed or interpreted to represent any Agency regulatory or statutory guidance or statement of official Agency policy."   Several companies submitting NMSP data should be relieved by this disclaimer, as EPA identified 18 nanoscale materials in NMSP submissions which may be considered new chemical substances under TSCA and subject to premanufacturing notice requirements.  Whether EPA takes any enforcement steps in this regard remains to be seen.

Getting to the highlights of the report, EPA concludes that the NMSP has (thus far) produce mixed results:

• "In the aggregate, the NMSP has sufficiently advanced EPA’s knowledge and understanding to enable the Agency to take further steps towards evaluating and, where appropriate, mitigating potential risks to health and the environment."
• "It appears that nearly two-thirds of the chemical substances from which commercially available nanoscale materials are based were not reported under the Basic Program."
• "It appears that approximately 90% of the different nanoscale materials that are likely to be commercially available were not reported under the Basic Program."
• "The low rate of engagement in the In-Depth Program suggests that most companies are not inclined to voluntarily test their nanoscale materials."

EPA's overall conclusion is that:

"[T]he NMSP can be considered successful. However, a number of the environmental health and safety data gaps the Agency hoped to fill through the NMSP still exist. EPA is considering how to best use testing and information gathering authorities under the [TSCA] to help address those gaps."

My own view is that response to the NMSP has been lukewarm, at best.

Analysis of Current Submissions

As of December 8, 2008 information under the Basic Program has been submitted by 29 companies/associations, covering 123 nanoscale materials.  Seven additional companies have also committed to submitting data under the Basic Program at a future date.  The In-Depth Program has commitments from four companies thus far.   Additionally, the American Chemistry Council (ACC) has expressed an interest in coordinating In-Depth data submissions. 

A chart from the interim report breaking down Basic Program submissions by material type follows.  Nanoscale metals and metal oxides predominate.  Many materials are still in the research and development stage.

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This article, which appeared in the Nov. 17, 2008 issue of Pesticide & Toxic Chemical News, Volume 37, No. 3, was reproduced with permission from Agra Informa. Further use of this article is prohibited without the express written permission of the publisher. For more information about Pesticide & Toxic Chemical News, Food Chemical News or other Agra Informa publications, go to: www.foodregulation.com .

EPA earlier this month announced it is promulgating significant new use rules (SNURs) under TSCA for two nanomaterials — siloxane modified silica nanoparticles and siloxane modified alumina nanoparticles — that were subject to premanufacture notices (PMNs). Some stakeholders view the move as a further sign that EPA is willing to use its authority to regulate nanomaterials, although to what extent remains uncertain.

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Nanotechnology Law and Business was kind enough to let us post a PDF of "A Nano-Mesothelioma False Alarm" here after several readers requested a copy. 

Please be sure to visit the journal to see the rest of this issue's articles:

• Grading of Fullerene Nanotubes for Composite Applications
• Next Generation Carbon Fiber
• Patenting Graphene: Opportunities and Challenges
• Oxonica v. Neuftec: Nanoparticle Fuel Additive Litigation in the United Kingdom
• Mediating the Uncertainty and Abstraction of Nanotechnology Promotion and Control: “Late” Lessons from Other “Early Warnings” in History
• The Implications of Recent Nanomaterials Toxicity Studies for the Nanotech Community
• A Nano-Mesothelioma False Alarm
• Convergence of Cleantech and Nanotech and the Benefits to the Nanotech Sector
• French and European Community Law on the Nanometric Forms of Chemical Substances: Questions About How the Law Handles Uncertain Risks
• The Validity of European Nanotechnology Patents in Germany
• Book Review of Nanotechnology & Society: Current and Emerging Ethical Issues
• Top Ten Ways Nanotech Will Impact Cleantech
• Updates

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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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The U.S. Environmental Protection Agency's Office of Inspector General (OIG) "helps the Agency protect the environment in a more efficient and cost effective manner.  [It] consist[s] of auditors, program analysts, investigators, and others with extensive expertise" who are tasked with evaluating EPA's ability to deliver on key Agency policies.  Risk Policy Report ran an article yesterday (October 14, 2008) indicating that EPA's OIG intended to assess EPA's nanotechnology efforts in FY 2009.  We tracked down the underlying document which is attached here.  Specifically, EPA OIG intends to conduct an "[a]ssessment of EPA's Efforts to Monitor, Evaluate, and Act on Threats from the Production, Use and Disposal of Nanotechnology Products/Nanomaterials."
 

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This fifth and final article in a series on standards for the nanotechnology community contributed by ANSI explains the development of specifications that will look at raw nanomaterials in terms of their use in a variety of applications.

By 2007, the development of international guidelines for nanotechnology was well underway within the International Organization for Standardization (ISO). Each of the projects of ISO Technical Committee (TC) 229, Nanotechnologies, had been categorized into one of the TC’s working groups: WG 1, Terminology and Nomenclature, WG 2, Measurement and Characterization, or WG 3, Health, Safety, and Environment.

But when the Standardization Administration of China (SAC), China’s national standards body, submitted two new work item proposals in October 2007, TC 229 members recognized that the proposed areas of technical activity – addressing specifications for nanomaterials in terms of possible applications – did not fit easily into any of the existing WGs.

Material specifications had already been identified as a priority area in the TC 229 business plan, which was based on the results of a 2006 survey, “ISO TC 229 Nanotechnologies Survey of Standardization Needs.” Some aspects of the SAC-proposed work items, however, fell under the scope of each of the WGs and yet other parts of the proposals didn’t fit into any of the groups.

In response to these newly identified needs, a new working group on Material Specifications (WG 4) was formed in early 2008.

Leadership and Work Items for WG 4

Given their important role in the creation of WG 4, China holds the convenorship of the group through SAC and Professor Limin Wang. The scope of the group is still being drafted with the help of several international stakeholders, including many from the United States. This scope, once established, will serve as a roadmap for how to further the efforts of the WG.

TC 229/WG 4 currently has three work items in development to examine raw materials in terms of their purpose in a variety of uses. The first two of these are the original SAC-submitted work items that sparked the formation of WG 4, and are currently being led by SAC:

• Nano TiO2 (Titanium Dioxide) specifies the characteristics and measurement methods for engineered nanoscale titanium dioxide (powder form). The material has numerous industrial applications, including use in sunblock, certain fibers and plastics, paints, printing ink, coatings, ceramics, and catalysts and catalyst carriers.

• Nano CaCO3 (Calcium Carbonate) specifies the characteristics and measurement methods for engineered nanoscale calcium carbonate (powder form). Industrial applications for this material include fillers in rubbers, plastics, coatings, paint, and printing ink.

Each of these work items will be divided into two parts: characterization of measurement and methods; and use of the nanoscale material in applications.

The third work item under WG 4 is being led by BSI British Standards, the national standards body for the United Kingdom:

• Guide to specifying nanomaterials will provide guidance on the preparation of comprehensive technical specifications for manufactured nanomaterials in order to ensure the delivery of a product that behaves in a reproducible manner.

Impact on Industry

As the standards developed under WG 4 can be used in industrial applications and consumer products from paint and coatings to textiles and sunblock, they will have a tremendous impact on manufacturers in a wide variety of industries, both in the U.S. and abroad. Interested stakeholders are encouraged to provide input that can help to formulate the strategy for WG 4.

U.S. involvement in ISO/TC 229 and its Working Groups begins with the U.S. Technical Advisory Group (TAG) to ISO/TC 229, administered by the American National Standards Institute (ANSI). Led by Clayton Teague, director of the National Nanotechnology Coordination Office, the TAG is organized into Working Groups that mirror their efforts on the scope of each TC 229 WG.

The mirror group for WG 4 is led by Dr. David S. Ensor, of RTI International.

“American industry has a rare opportunity to shape the content of these very early stage working draft standards and influence the strategic direction of WG 4,” said Dr. Ensor.

How to Participate

Participation in the U.S. TAG to ISO/TC 229 WG 4 is open to all nationally interested stakeholders. The TAG actively seeks participants who have expert knowledge in all aspects of nanotechnology material specifications.

“I encourage interested organizations to participate in the U.S. TAG and help develop U.S. positions to guide the deliberations of our experts to WG 4,” Dr. Ensor added. “We expect WG 4 will likely become an important ISO/TC 229 activity with time because it will eventually build on the standards developed by the other working groups.”

To join the ANSI-accredited U.S. TAG for ISO/TC 229 or any of its WGs, contact Heather Benko (hbenko@ansi.org; 212.642.4912).

For more information on the U.S. TAG for ISO/TC 229, visit http://www.ansi.org/isotc229tag.
 

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Earlier today, Continental Western Insurance Group issued what appears to be one of the first nano-specific commercial insurance exclusions in the United States.  Although Continental originally posted the exclusion and two supporting documents on its website, the materials were removed after BNA published an article about the exclusion this morning. We managed to print out the material before it was taken down and we provide links to it in this article.

Regular readers will recall that we have been covering nano-related insurance coverage issues for some time.  Prior posts are here, here, here, here, here, and here. 

A summary of each of Continental's three documents follows:

Background on Nanotubes

Continental's "Background on Nanotubes" document explains the policy behind its exclusion:
"The intent of this exclusion is to remove coverage for the, as of yet, unknown and unknowable risks created by products and processes that involve nanotubes. The exclusion is being added to make you and your customers explicitly aware of our intent not to cover injury and/or damage arising from nanotubes, as used in products and processes…"

The primary reason for the exclusion appears to be recent reports comparing carbon nanotubes to asbestos. You can find information about the press coverage of the May 2008 articles comparing multi-walled carbon nanotubes to asbestos here. Another factor in Continental's decision appears to be the often cited nano consumer product inventory published by the Project on Emerging Nanotechnologies. 

Based on the asbestos analogy and PEN's product database, Continental concludes that it "would not be prudent for us to knowingly provide coverage for risks that are, as of yet, unknown and unquantifiable. We are all too aware of what happened to companies involved with asbestos-related exposure in the past, and see this as a very similar issue."

Notice to Policyholders

Continental's draft Notice to Policyholders makes it clear that it covers most of Continental's insurance groups, including: Acadia Insurance Company; Continental Western Insurance Company; Fireman's Insurance Company of Washington, D.C.; and Union Insurance Company. The notice references the actual exclusion which is attached and explains that this "endorsement excludes bodily injury, property damage, and personal and advertising injury related to the exposure of nanotubes and nanotechnology in any form. This include the use of, contact with, existence of, presence of, proliferation of, discharge of, dispersal of, seepage of, migration of, release of, escape of, or exposure to nanotubes or nanotechnology."

Nanotubes and Nanotechnology Exclusion

The exclusion itself reiterates that this "endorsement excludes bodily injury, property damage, and personal and advertising injury related to the exposure of nanotubes and nanotechnology in any form. This include the use of, contact with, existence of, presence of, proliferation of, discharge of, dispersal of, seepage of, migration of, release of, escape of, or exposure to nanotubes or nanotechnology." 

It further contains specific exclusions for "existence, storage, handling, or transportation of 'nanotubes' or 'nanotechnology'…any manufacturing processes or products including same, and any losses arising from lawsuits related to 'nanotubes' and/or 'nanotechnology.'"

The exclusion defines "nanotubes" as "hollow cylinders of carbon atoms or carbon fibers or any type or form of "nanotechnology" which contains remarkable strength and electrical properties used in any products, goods, or materials.  "Nanotechnology" is defined as "engineering at a molecular or atomic level." 

Both definitions are vague. For example, a hollow carbon fiber fishing rod that makes no claim to contain nanoscale materials would still technically be included in the definition of 'nanotubes" because it is a hollow cylinder made of carbon atoms. Similarly, attempting to entirely exclude "nanotechnology" is unworkable because it is really just science on an extremely small scale.

Rather than excluding all "nanotechnology," Continental more likely meant to exclude all nanoscale materials. Even then, such a blanket exclusion would be extremely broad because many nanoscale materials have not been shown to pose any environmental, health, or safety risks. Further, even within the category of carbon nanotubes, recent researchers' warnings about potential EHS risks have been largely confined to long, thin, needle-like carbon nanotubes, while excluding other varieties.

Stay tuned.  We will attempt to find out what happened to Continental's documents and will continue to monitor nano-related insurance coverage issues.
 

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Late last month, the Woodrow Wilson International Center for Scholar's Project on Emerging Nanotechnologies (PEN) published a paper on the ability of the U.S. Consumer Product Safety Commission (CPSC) to deal with possible environmental, health, and safety risks potentially posed by the use of some nanoscale materials in certain consumer products.

 E. Marla Felcher, "The Consumer Product Safety Commission and Nanotechnology," Project on Emerging Nanotechnologies, PEN 14, August 2008.

 The article begins with an analysis of PEN’s online consumer nanoproduct inventory which is used to support the author’s claims that "nanotechnology-enabled products" have made their way into every category of product under the CPSC's jurisdiction. Of the 60 products on PEN’s website, the author claims that "all of them are available for purchase by consumers," and approximately "half of nanotechnology consumer products currently on the market would fall under CPSC's jurisdiction." She notes that "[e]very day, new nanoengineered products make their way into stores’ shelves, among them kids’ pants, teddy bears, baby bottles, pacifiers, teething rings, plastic food storage containers, socks, chopsticks, humidifiers, mobile phones, computer processors and tennis rackets."

In a loaded rhetorical follow-up question the author asks: "Is it safe for an infant to spend hours each day sucking on a nano-enhanced pacifier?" The question does more to cement the author’s predilection against the use of nanoscale materials in consumer products than it does to present readers with a true quandary. Moreover, while PEN’s online inventory is a great tool, the author fails to take into account that many of the products on the site have never been commercialized, or have long been taken off the market. Such an analysis would provide a helpful balance to the article’s "pending emergency" tone.

Getting beyond initial issues, the author’s key concerns appear to have less to do with potential nano-specific product risks than with CPSC foundational issues. The author’s primary complaint appears to be that the CPSC has no premarket testing authority. She also believes that there is "[a]mple evidence" that companies do not do premarket testing or self-report hazards and defects -- a conclusion many dispute.

In keeping with her general approach, the author lists "Five Generic Weaknesses in CPSC's Product Oversight Capacity:" 1. "CPSC's Data Collection System is Not Nano Ready;" 2. "CPSC has Limited Ability to Tell the Public About Health Hazards Associated with Nanoproducts;" 3. "CPSC Has Limited Ability to Get Recalled Nanoproducts Out of Use;" 4. "CPSC Lacks Sufficient Enforcement Staff to Identify Manufacturers That Fail to Report Nanoproduct Hazards;" and 5. "CPSC Does Not Have Sufficient Authority to Promulgate Mandatory Safety Standards for Nanoproducts."

While some of these points are valid, they are not nano-specific. In fact, this section of the article would suffer little if the prefix "nano" and the term "nanotechnology" were eliminated from the text. (Try it.) The same could be said for several of the prior papers published by PEN in which the authors’ complaints and cautions appear more related to broader governance issues than to nano-specific difficulties.

To get to the heart of the paper, most readers will want to flip to the last section where the author lists several recommendations to correct the problems she perceives with the CPSC.

The author recommends that the CPSC should: 1. "Build the agency’s nanotechnology base and expertise;" 2. Identify companies making "nanoproducts and request that they submit research studies, risk assessment data and any information they hold that will enable CPSC scientists to assess the safety of nanoproducts;" (Although she notes that the Consumer Product Safety Act provides sufficient authority to accomplish this recommendation); 3. "Coordinate with other health and safety agencies, and combine efforts to evaluate the risks associated with nanoproducts;" and 4. "Convene a CHAP to evaluate the health and safety risks associated with nanoproducts currently on the market that are intended for use by children."

The author’s second CPSC recommendation is the most interesting and could benefit from further development. If the Consumer Product Safety Act provides sufficient authority to allow the CPSC to ask companies making nanoproducts to submit safety and risk assessment data (as the author suggest), that should go a long way to satisfying the author’s nano-information gathering concerns. The potential civil liability facing companies marketing nanoproducts without first collecting such data after it has been specifically requested by the CPSC would act as a hefty deterrent to the potential misconduct she fears.

The author also recommends two Congressional remedies:

1. "Amend the Consumer Product Safety Act to give CPSC the authority to require manufacturers to identify the presence of nanomaterials in their products;" and 2. "Adopt Section II of the Consumer Products Safety Act Bill recommended to Congress by the NCPS in its 1970 Field Report." This would give the CPSC the ability to promulgate "safety standards for any 'new' consumer products" . . . "where there exists a lack of information adequate to determine the safety of such product in use by consumers."

It is hard to argue against the author’s first Congressional recommendation. Collecting more information is a good thing as long as the requirements are not onerous and the CPSC actually has the ability to process and use the data productively. Although mentioned in the "Foreword," left out of the author’s Congressional "should do" list is more CPSC funding specifically dedicated to nanotechnology safety issues. Arguably, many of the author’s issues with the CPSC could be diminished with additional funding, staff, and resources to more fully address nanotechnology issues.

All in all, the paper is well worth reading as long as PEN’s and the author’s predispositions are kept in mind.

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This fourth article in a series contibuted by ANSI on standards for the nanotechnology community addresses the development of specifications for measurement, characterization, and test methods that will provide a common reference point for material manufacturers and their customers.

Measurement and characterization standards fly under the radar, affecting our lives in innumerable ways – from the number of miles driven to work to the paper loaded in the office printer. To imagine daily activities without these concepts would be nearly impossible, but that is exactly the challenge faced by scientists and manufacturers in the nanotechnology community.

For the growing number of industries that work with or are affected by nano-materials, consistent and globally accepted methods for testing, measurement, and characterization will provide a common reference point. By establishing a baseline to determine the starting properties of materials, these standards can facilitate meaningful comparisons of manufacturing and research results from different organizations and labs, and help to form a basis for the measurement of additional material properties.

When the American National Standards Institute (ANSI) Nanotechnology Standards Panel (NSP) first convened in September of 2004 to discuss priority recommendations for nanotechnology standardization, participants earmarked metrology, methods of analysis, and test methods as areas needing urgent attention. In particular, guidelines for particle size and shape, as well as particle number and distribution, were considered critical.

These needs are being addressed by the International Organization for Standardization (ISO) through its Technical Committee (TC) 229, Nanotechnologies, Working Group (WG) 2, Measurement and Characterization. Convened by Japan under the Japanese Industrial Standards Committee (JISC), WG 2 focuses on the development of standards for consistent descriptions, assessment, and test methods for nanotechnologies, taking into consideration the need for metrology and reference materials.

U.S. participation in ISO/TC 229 WG 2

U.S. participation in ISO/TC 229 and its Working Groups is centered in the U.S. Technical Advisory Group (TAG) to ISO/TC 229, chaired by Clayton Teague, director of the National Nanotechnology Coordination Office. The TAG, which is administered by ANSI, is organized into Working Groups that mirror their efforts on the scope of each TC 229 WG.

The U.S. mirror group for WG 2 is led by Dr. Ray Tsui of Motorola. The TAG WG plays an important role in establishing ANSI’s positions on the issues addressed in the group with the help of experts from the industry, government, and academia.

Several other U.S. organizations actively participate in the both the international and domestic WG 2 work efforts, including the National Institute of Standards and Technology (NIST) and the National Aeronautics and Space Administration (NASA), as well as Honeywell, Hyperion Catalysis, and others.

Guidance Documents in Progress

Representative of its efforts over the past three years, WG 2 is currently developing 10 work items; most involve single-walled or multi-walled carbon nanotubes, and how to characterize them using specific instrumentation methods. Four of these work items are led or co-led by the United States:

• ISO/Approved Work Item (AWI) Technical Specification (TS) 10797, Nanotubes – Use of transmission electron microscopy in walled carbon nanotubes (co-led by the U.S. and Japan)

• ISO/AWI TS 10798, Nanotubes – Scanning electron microscopy and energy dispersive X-ray analysis in the characterization of single walled carbon nanotubes (led by the U.S.)

• ISO/New Work Item Proposal (NP) TS 10812, Nanotechnologies – Use of Raman spectroscopy in the characterization of single-walled carbon nanotubes (led by the U.S.)

• ISO/AWI TS 11308, Nanotechnologies – Use of thermo gravimetric analysis in the purity evaluation of single-walled nanotubes (co-led by the U.S. and Korea)

“The activities in WG 2 are strongly coupled to the other efforts within ISO/TC 229,” said Dr. Tsui. “The work of WG 1, Terminology and Nomenclature, defines the materials being measured, while the output from WG2 provides important information regarding intrinsic material properties and measurement methods that can be used by WG 3, Health, Safety, and Environment, and WG 4, Material Specifications.”

This overlap is apparent in one work item that is currently in the domain of WG 3: Guidance on physico-chemical characterization of engineered nano-objects for toxicologic assessment. This document, being developed under U.S. leadership, will serve as a reference for characterizing nano-objects to be used in toxicology testing. WG 3 is presently creating toxicology guidelines as they relate to health and safety; WG 2 may join the effort to assist in the development of methods used to characterize toxicity.

Getting Involved in ISO/TC 229 WG 2

Participation in the U.S. TAG ISO/TC 229 Working Group is open to all nationally interested stakeholders. The TAG actively seeks participants who have expert knowledge in all aspects of nanotechnology measurement and characterization. To join the ANSI-accredited U.S. TAG for ISO/TC 229 or any of its WGs, contact Heather Benko (hbenko@ansi.org; 212.642.4912).

For more information on the U.S. TAG for ISO/TC 229, visit http://www.ansi.org/isotc229tag.

Stay Tuned: The next article in this series will introduce ISO/TC 229/WG 4, Material Specifications.

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This article was authored and contributed by Terrence F. Smith, Director of Government Affairs, Cambridge Chamber of Commerce.

The report of the Nanomaterials Advisory Committee was on the agenda at the July 28 meeting of the Cambridge City Council. The Council’s actions bode well for continued manufacturing, processing, research and development using nanotechnology in Cambridge. The Council accepted the report of the Nanomaterials Advisory Committee with little comment and placed the report on file.

The discussion was brief. Councillor Davis, who filed the original order, said she was satisfied with the report. City Manager Healy stated that the report is balanced and the next steps will provide the City with a better idea of who does what in Cambridge. He also said that the LEPC has prepared the survey recommended in the report. Councillor Murphy said that the report reflects on the strengths of the Cambridge Public Health Department and the ability of the City to bring together “World Class” experts on the Nanomaterials Advisory Committee.

There was a question about nanomaterials getting into the City water supply. The Manager stated that he did not know whether it is possible to test for nano, as the City had done for pharmaceutical products several months ago, but would look into it. It should be noted that Massachusetts strictly regulates industrial wastewater. The Council took no formal action regarding this request but this issue may come up again.

If readers wish to view the discussion, the video of the meeting should be posted later this week on the City of Cambridge website at http://www.cambridgema.gov/council-archive.cfm. The discussion took place beginning around 8:15 p.m. which would be about 2 hours and 45 minutes into the meeting.

Terrence F. Smith
Director of Government Affairs
Cambridge Chamber of Commerce
859 Massachusetts Ave.
Cambridge, MA 02139
Phone: 617-876-4213
tsmith@cambridgechamber.org

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Cambridge, Massachusetts Nanotechnology Advisory Committee
Recommends Registration of Engineered Nanoscale Materials

Deadline for Similar Voluntary Registration Program by U.S. EPA Closes  

Washington, D.C. – July 28, 2008 – Porter Wright attorney John C. Monica, Jr., served as part of the Nanotechnology Advisory Committee of Cambridge, Massachusetts (NAC), which, after a year of deliberation and information gathering, recommended that the City require the registration of engineered nanoscale materials within city limits. The Cambridge City Counsel is set to adopt those recommendations at a meeting scheduled for tomorrow. Cambridge – host to approximately one dozen nanotechnology-related businesses – is just the second U.S. city (behind Berkeley, California) to require registration of nanomaterials.

“Interest in regulating nanotechnology has increased in recent years due to the recognition that certain materials may take on new and unexpected properties when they are engineered at the nanoscale,” said Monica, a partner in the Washington, D.C. office of Porter Wright Morris & Arthur, LLP and a recognized national authority on nanotechnology product liability and environmental health and safety issues. “The City of Cambridge has approached nanotechnology in a very deliberate, considered manner and appears poised to take steps that promote public safety without stifling nanoscale innovation,” he continued.

The NAC – comprised of citizens, scientists, industrial hygienists, university faculty, nano-businesses, and private environmental consulting firms – also recommended that Cambridge’s City Counsel act to assist businesses with updates to health and safety plans for workers; educate the public; track health and safety developments; and monitor regulatory initiatives in other jurisdictions.

The City’s steps follow closely on the heels of the July 28, 2008 deadline for the first phase of the United States Environmental Protection Agency’s (EPA’s) voluntary registration program – the Nanoscale Materials Stewardship Program (NMSP). NMSP asked companies to report voluntarily to EPA existing data concerning nanoscale materials’ uses, hazards, exposure levels, and risk-management practices. To date, about 20 companies have provided or promised to provide information.

For more information regarding nanotechnology-related legal issues, visit www.nanolawreport.com.

Porter Wright Morris & Arthur LLP is a nationally recognized law firm with more than 250 lawyers in its offices in Washington, D.C.; Cincinnati, Cleveland, Columbus, and Dayton, Ohio; and Naples, Florida. Porter Wright provides counsel to a worldwide base of clients.

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As Mike Heintz reported earlier today, the Woodrow Wilson International Center for Scholars' Project on Emerging Nanotechnologies issued a report yesterday providing some guidance regarding where it believes the next administration should start with the issue of nanotechnology regulation next January.

J. Clarence Davies, "Nanotechnology Oversight: An Agenda for the New Administration," Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, PEN 13, July 2008.

Among other suggestions, Mr. Davies advocates enacting new nano-specific legislation in the following areas.

TSCA: Mr. Davies offers specific legislative language for amending TSCA "to make clear that nanomaterials are covered as new substances." Other changes he suggests: "remove the catch-22 that requires EPA to show that a new chemical poses a risk before the agency can obtain enough information to determine whether it actually poses a risk;" "remove the conditions and requirements that guarantee that EPA can never regulate an existing substance;" and narrow TSCA’s confidential business information and data sharing provisions.

FFDCA: Mr. Davies argues the FFDCA should be amended to require submission and review by FDA of cosmetic active ingredient registration information.  He further maintains that "FDA should also be authorized to forbid marketing of any cosmetic containing an ingredient that is not safe or for which adequate test data are not available," and that applicable FDA laws should be altered "to make clear where and how to draw the line between a drug and a cosmetic."  Mr. Davies additionally recommends requiring premarket safety testing on food and cosmetic ingredients incorporating nanoscale materials, and increased post-marketing surveillance and reporting.

DSHEA: Mr. Davies calls for amending DSHEA so that it does not prohibit "FDA from imposing testing or approval on dietary supplements (vitamins, herbs, etc.) and placing the burden of proof on FDA to provide that a supplement is safe."

Other recommendations by Mr. Davies beyond long-term regulatory action are:

Research: dramatically increase federal nano-related EHS research funding (FY 2009 - $100 million; FY 2010 - $150 million), require a federal peer-reviewed EHS research plan; strengthen NNI; encourage separation of NNI promotional and oversight functions; and establish a Nanotechnology Effects Institute.

Regulatory Coordination: establish an interagency group devoted solely to nanotechnology regulation; develop a nanotechnology plan within each agency; and improve intergovernmental coordination.

Resource Requirements: increase regulatory agency budgets and staffing.

EPA: define nanomaterials as "new" chemical substances and/or "significant new uses" of existing chemical substances under TSCA; promulgate a new compulsory information collection rule under TSCA Section 8; expand regulation of anti-microbials under federal pesticide law; promote "green" technology; and evaluate the application of other EPA statutes to nanotechnology.

FDA: establish criteria for determining which nanomaterials are "new" for regulatory purposes; collect information on safety testing, forthcoming products and adverse effects; regulate cosmetics and dietary supplements.

OSHA: communicate to workers and firms about nanotechnology; use existing OSHA regulations to deal with nanoparticles; issue OSHA standards for nanomaterials.

CPSC: hire new staff to study nanotechnology exposure; create a chronic hazard advisory panel for nanotechnology products posing significant exposure risks.

Voluntary Efforts: use the DuPont-Environmental Defense framework as a basis for analyzing nanotechnology risks; issue a nanotechnology handbook for small businesses.

Public Involvement: give the public more information about nanotechnology; obtain the public's views about nanotechnology; convene a stakeholder dialogue.

Mr. Davies concludes his article with an interesting analogy: "[N]anotechnology comes in a treasure chest of riches and a Pandora's box of evils. The challenge of the new century and to the new administration is to use the treasure while keeping shut the lid on the Pandora's box."

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This Article Was Authored and Contributed by the American National Standards Intititute

This second article in a series on nanotechnology standardization introduces the international working group that, under US leadership, is creating the standards needed to support the health, safety, and environmental aspects of nanotechnology.

In the post-war era of the late 1940s, global leaders of government and industry formed a central body to “facilitate the international coordination and unification of industrial standards.” Twenty-six member nations came together in 1947 to form the International Organization for Standardization (ISO). 

ISO and its national member bodies – including the American National Standards Institute (ANSI) – are constantly evolving to meet changing demands. Today, ISO is addressing issues such as industrialization, the advancement of information technologies, quality, the environment, and the health and safety of workers and consumers. Today, roughly one of every twenty ISO standards addresses issues pertaining to health, safety or the environment.

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With all of the interest in nanosilver generated by the recent EPA petition filed by the International Center for Technology Assessment, I thought I would post some background material on EHS issues surrounding silver.  A couple of disclaimers: the material is not comprehensive, and you might see parts of it again in "Nanotechnology Law and Policy" which should be published by Thomson-West legal publishers sometime in 2009 (if I can keep pace with the production schedule).

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While it's not really related to legal issues, it certainly is a captivating idea.  The Guardian reports that a University of Washington Scientist is developing a contact lens LED display that uses nanoscale circuits.  If it works, the lenses may be powered by either solar or radio-frequency power transmission, and could be theoretically used to superimpose text messages, direction indicators, or even close captioning on the eye itself.  Bio-compatibility is an issue.  If the idea seems futuristic, readers may recall Arnold Schwarzenegger's Terminator character had this same set up way back in 1984.   Hmm . . . it seems to me that there were some fairly recent papers on potential ocular uptake of nanoscale materials a while back.  We will track this down over the next week or so.  Stay tuned . . .

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The Woodrow Wilson International Center for Scholars' Project on Emerging Nanotechnologies (PEN) recently published a short pamphlet intended to steer "nano firms" down the path towards commercial prosperity.

D. Lekas, "How to Reduce Your Firm's Risk and Increase Revenues Related to Nanotechnology," Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars, PEN Brief No. 4, April 2008.

PEN's "8 Step Program for Small Firms" is:  1. focus on the bottom line; 2. become or develop a champion within your firm; 3. incorporate life cycle thinking and operations and product development; 4. seek information and assistance on EHS implementation; 5. follow best practices for worker health and safety precautions; 6. prepare for potential nano-specific regulations; 7. increase educational efforts; and 8. seek continued improvement.

The new pamphlet is somewhat superficial and lacks the detail provided in PEN's numerous regulatory papers.  Additionally, regular readers will note that steps 3-6 in particular have been advocated by PEN in one form or another since its inception.  However, two of our friends received nice plugs under step 6 where PEN suggests that "[t]o keep up with the latest developments, firms may wish to subscribe to various listservs, including . . . www.nanoregnews.com . . . [and] . . . www.smalltimes.com."

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Mark your calendar for the one-day conference “NanoBiotech 2008” set for September 15, 2008 which is being co-sponsored by Rensselaer Polytechnic Institute (Troy, NY) and Bawa Biotechnology Consulting LLC (Ashburn, VA).  This is the fifth in a series of international conferences they have conducted dating back to 2003 on the converging areas of nanotechnology and biotechnology. 

From the conference's website:  "The conference will feature 20+ speakers, including 2 keynotes and a networking luncheon. All presentations (20-30 minute Power Points) will be fast-paced, focused and will rely upon extensive color graphics and animations to reach the diverse audience. Raffle drawings will be held throughout the day." 

You can find the agenda from last year's highly recommended conference here.

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This Article Was Authored and Contributed by the American National Standards Intititute

As the nanotechnology industry evolves, the need for globally relevant standards – from particle properties and terminology to health, safety, and the environment – is becoming increasingly apparent. This article, the first in a series, introduces how the U.S. is influencing nano-related standards on the international scene.

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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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MIT's Technology Review just published its list of Top Ten Emerging Technologies for 2008.  One of the top ten items is NanoRadio.  TR's description of NanoRadio begins with: 

If you own a sleek iPod Nano, you've got nothing on Alex Zettl. The physicist at the University of California, Berkeley, and his colleagues have come up with a nanoscale radio, in which the key circuitry consists of a single carbon nanotube.

Absolutely fascinating -- and especially so since this technology could be considered one of the first true "nano-machines."  As an aside, nanotechnology-related technologies have made the "TR10" for each of the past three years -- 2007 (Nanohealing), 2006 (Nanomedicine and Nanobiomechanics), and 2005 (quantum wires).

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This morning's New York Times features an editorial discussing Peter Barton Hutt's before the House subcommittee responsible for FDA oversight.  Mr. Hutt warned that the FDA was "barely hanging on by its fingertips;"  others testifying before the subcommittee suggested the agency lacked funds and staffing to do its job:

In a hearing before a House Energy and Commerce subcommittee, members of the agency’s own scientific advisory board outlined the F.D.A.’s many weaknesses. It lacks scientists who understand rapidly emerging technologies — including genomics and nanotechnology — relevant to product safety. The agency is further hobbled by a high turnover rate of scientists, a decrepit information technology system, a weak organizational structure, and a shrinking inspection force.

That said, FDA has been researching nanotechnology issues for some time -- it formed its Nanotechnology Task Force in August 2006.   Still, it's interesting that nanotechnology safety issues have even found their way to the editorial page of the New York Times.

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Nanotechnology was among the many hot topics discussed at this year's World Economic Forum in Davos, Switzerland.  Among the five conceptual pillars for this year's Forum was the topic: "Exploring Nature's New Frontiers," which is described here.  It's a nice concept, I believe, because it highlights the diverse areas -- everything from global climate change to disease eradication -- in which nanotechnology and other emerging technologies may play a role. 

In addition, as reported by Nanowerk, the World Economic Forum-founded "Global Risk Network" released its 2008 annual report [1.6mb pdf] that described nanotechnology risk as a "Core Risk."  Unsurprisingly, the driver for characterizing nanotechnology as a "Core Risk" appeared to be the still-preliminary state of the research into nanotechnology safety:

The report notes that studies reveal health impairment due to exposure to widely used nanoparticles (paint, cosmetics, healthcare). The primary impacts of a potential problem would be on public health, with secondary impacts on investment in a range of nanotechnologies.

It also states that increasing human exposure to nanotechnology will increase severity should an event occur, but this has to be balanced against the multiple opportunities created by nanotechnology.

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Back in October, we reported on a $314,000 grant three Arizona State University professors received from DOE to study nanotechnology regulation.  It seems that grant has already begun to bear fruit, as Nanowerk reports one of the grant recipients - law professor Doug Sylvester - will be teaching a two-hour interdisciplinary class in the Spring entitled "Nanotechnology And The Law."  Professor Sylvester describes the import of his class:

“It’s not just about the law, it’s about our lives,” says Sylvester, a College of Law professor and faculty fellow in the College’s Center for the Study of Law, Science, & Technology. “For the first time in history, we know something is coming that carries great potential and possible grave danger. The technology will revolutionize much of how we live in the world. The question becomes, how, as a society, can we prepare ourselves to best promote the benefits and prevent the risks?”

Professor Sylvester's course will be geared toward public policy, bioengineering, medicine, law and other students, and, according to the Nanowerk article, the class is designed to encourage students to collaborate to find ways of using public policy and regulation to balance the potential threat nanotechnology may pose to the environment against the need to develop the technology. 

I look forward to seeing what research comes out of this grant and out of this course.

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Environmental Science & Technology recently released an editorial discussing nanotechnology safety issues and, more importantly, the recent debate over whether EPA should regulate nanoscale materials as new chemicals under TSCA.  The editorial succinctly sets forth EPA's position, as expressed by Jim Willis, EPA's Chemical Control Division Director, on the TSCA issue this way: 

In an EPA document, TSCA Inventory Status of Nanoscale Substances—General Approach, released on July 12, the agency explained why it could not group all nanomaterials as new substances solely on the basis of size. This is because the definition of a new chemical under TSCA is based on only molecular structure or identity. If a nanomaterial contains the same molecules as a chemical already in the TSCA inventory, it is an existing chemical, says Willis. And almost all nanomaterials being researched and manufactured today are chemically identical to existing chemicals in the TSCA inventory. Thus, EPA has no authority to regulate them. Carbon nanotubes and fullerenes, for example, are made of carbon, an existing chemical in the inventory.

h/t to TGDaily.com.

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NorTech just announced the winners of its 2007 Innovation Award at its Summit in Westlake, Ohio.  Crain's Cleveland has the story here.  Among the winners was one local nanotechnology company, NanoMimetics, Inc., which according to Crain's develops and commercializes nanocoatings for medical and industrial applications.  Congratulations to all!

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Andrew Maynard of the Project on Emerging Nanotechnologies at the Woodrow Wilson Institute testified on October 31st before the House Science Committee.  PEN's press release is here and the full text of Maynard's remarks are here.  In his testimony, Maynard advocated six steps to improve nanotechnology safety and criticized what he believed was a lack of coordination and focus on environmental, health & safety issues. 

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SmallTimes's September/October print edition just recently hit newsstands.   Featured in that magazine is our own John Monica's article entitled  "Ramping up the EPA's Nanoscale Material Stewardship Program."  (Co-blogger Michael Heintz has previously blogged about this program here and here.) 

The issue also contains a great article by Lynn Bergeson -- "The EPA's Toxic Substances Control Act: What you must know," and another by Barbara Goode -- "Framing the DuPont/ED Nano Risk Framework."

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Researchers at Rice University successfully utilized a near-infrared flourescent imaging technique to detect individual carbon nanotubes in fruit flies.  The study, reported here and here, involved an experiment where the researchers fed fruit fly larvae a diet that contained carbon nanotubes.  The flies were then shot with a laser, which excited the nanotubes and allowed them to be viewed using a flourescent technique.   The good news is that the fruit flies apparently survived to adulthood just as well as fruit flies in the control group, and apparently weighed the same as the controls, too.  The study's conclusions about the bioaccumulation of the nanotubes in the fruit flies are interesting:

When the researchers removed and examined tissues from the flies, they found the near-infrared microscope allowed them to see and identify individual nanotubes inside the tissue specimens. The highest concentration of nanotubes was found in the dorsal vessel, which is analogous to a main blood vessel in a mammal. Lesser concentrations were found in the brain, ventral nerve cord, salivary glands, trachea and fat. Based on their assays, the team estimates that only about one in 100 million nanotubes passed through the gut wall and became incorporated into the flies' organs. 

I don't know enough about the anatomy of a fruit fly to fully grasp the significance of these findings, but I find it hopeful that only a tiny fraction of the nanotubes accumulated in the flies' organs, and also find it hopeful that the flies were apparently not harmed by the nanotubes' presence.  One of the researchers quoted in the report, Dr. Bruce Weisman, is a well-known nanotechnology researcher at Rice.

Update:

Thanks to Youtube, we can see a six second video of the carbon nanotubes "lit up" inside the fruit flies here. 

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According to this recent article in the Jerusalem Post, the European Union is the top public financier of nanotechnology:

With €1.4 billion allocated to 550 projects in the field of nanosciences and nanotechnology, the EU's 6th Research Framework Program accounts for one-third of total public funding for nanotechnology and is the world's largest single funding agency worldwide for this field.

The article notes, however, that private funding for nanotechnology research in Europe lags the U.S. and Japan.

The Europeans appear to be taking an integrated approach to nanotechnology safety, by investing €28 million in safety research as part of each of its programs.  Much like in the U.S., European regulators are also exploring whether the EC's environmental, health and safety laws require change to deal with these issues:

The European Commission is currently undertaking a review of existing legislation to see whether the current regulatory framework appropriately addresses health, safety and environmental risks. Moreover, it has taken steps to establish an observatory to provide decision-makers with dynamic assessments of scientific and market developments.

It looks like the U.S. might be moving faster on nanotechnology regulatory issues, so I will be interested to see whether the Europeans take our lead or chart their own course.  So far, they seem to be taking a sensible approach to the problem.  I especially like the integration of safety research into their primary research grants (which, among other benefits, reduces the likelihood that scientists will overstate the results of safety issues in an effort to attract more funding) and the inclusion of private industry in the regulatory process.

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In the ever growing world of nanotechnology information and research, and new system was launched earlier this week.  SAFENANO is attempting to become "the UK's premier resource on nanotechnology hazard and risk."  It is managed by the United Kingdom's Institute for Occupational Medicine located in Edinburgh, Scotland.

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Small Times is reporting that the National Nanotechnology Coordination Office at NNI is requesting public comment, until September 17, 2007, on its proposed  "Prioritization of Environmental, Health and Safety Research Needs for Engineered Nanoscale Materials:  An Interim Document For Public Comment." 

According to the Small Times article,

"The comment period is an opportunity for public input into the prioritization of research and information needs related to environmental, health, and safety aspects of nanomaterials," groups note, adding that the research priorities will be an important part of the NNI EHS research strategy, which will be used by the Federal agencies to support research within their mission areas.

The NNCO established 25 research priorities.  However, to make the list more manageable, it broke the 25 priorities into five broad categories.  Overall, I like the approach the government is taking on these research priorities.  They are asking the right questions about (1) how engineered nanomaterials interact with biological systems and the environment, (2) how to measure exposure to nanomaterials -- both in workers and to the general public, and (3) what impact nanomaterial exposure has on health.  The report also calls for risk management to be a research priority.

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By: Tim Cahill and Michael Heintz:

FDA Week reported on July 6, 2007 that the FDA's Internal Nanotechnology Task Force is close to issuing its first report and is going to recommend that the agency not create "regulatory policies" for nanomaterials.  Instead, the task force is likely recommending that FDA create guidelines for "best practices."  The Task Force report will also likely urge FDA to work with academia and the National Nanotechnology Initiative to gather more information about nanotechnology risks and benefits. 

FDA Week also observes that an agency official stated as early as 2005 that the agency would not regulate products containing nanotechnologies any different than conventional products, and "The agency does not regulate the technology as a separate entity so products such as drugs or medical devices that employ nanotechnology are scrutinized while cosmetics are not. "  The Task Force report will also likely urge FDA to work with academia and the National Nanotechnology Initiative to gather more information about nanotechnology risks and benefits.

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One downside to our focus on the safety of nanomaterials is that it can cause us to lose focus on the potential upsides of nanotechnology in the environmental, health and safety arena.  CORDIS is reporting on a study funded by the European Parliament's Scientific Technology Options Assessment ("STOA") committee which looked into whether nanomaterials could serve as substitutes for hazardous materials.

In particular, the study focused on two areas where nanotechnology is already making inroads --  coatings and catalysts:

Two areas where nanotechnology is already making inroads as a substitute for hazardous chemicals are coatings and catalysts. Coatings can create anti-adhesive surfaces which resist things sticking to them, such as dirt, or have biocidal properties to prevent living organisms from sticking to them.

Nanoparticles are also widely used in catalysts, although the authors point out that research in this field was already on the nanoscale, and so it is not clear to what extent future developments could be attributed to nanotechnologies.

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As reported by AzoNano.com, the EPA recently announced the award of two grants, collectively worth $600,000, to researchers at Oregon State University to study the human health impacts of nanomaterials.  The pair of studies look like the first step toward nanotechnology regulation.  According to the AzoNano article, the first study is a survey of common manufactured nanomaterials to understand their interaction with biological processes.  The second study looks specifically at how manufactured nanomaterials may "damage or kill cells:"

Dr. Alan Bakalinsky is studying the relationship between specific characteristics of nanoparticles, like shape and structure, and their effects on cells. The work is expected to lead to the development of safety guidelines for industrial and environmental exposure to nanomaterials. "We're trying to identify specific structures in manufactured nanoparticles that might cause damage to cells," said Bakalinsky. "If we can determine which shapes and structures are most dangerous to cell function, it should be possible to design the materials to avoid those shapes and minimize the risk of damage."

Both Oregon State researchers, Drs. Bakalinsky and Tanguay, look to be relatively new to the nanotechnology field.  Bakalinsky is a food science researcher and Tanguay is a molecular toxicologist. 

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Several sources are reporting that the Russian Government has created a state agency to oversee nanotechnology issues.  Nanowerk reports that the new government body "will ensure interaction between government, business and scientists in the implementation of the state policy in the spheres of nanotechnology and nano-industry."  And, the lower house of the Russian Parliament is considering legislation that would form Russia's first nanotechnology based company.

Additionally, Small Times reports  that Russian and American interests are collaborating for nanotechnology research and development as well as helping Russian counterparts present new technologies and discoveries while assisting with patent and other intellectual property protections.

This is just another example of how wide reaching nanotechnology is becoming.  Beyond the Russians more fully engaging in the sector, it appears that nanotech is helping to further thaw diplomatic relations between the United States and Russia.

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Nanotechnology Now reports that Small Times has named  the University of Albany's College of Nanoscale Science and Engineering ("CNSE") as the nation's top-ranked college for nanotechnology and microtechnology.  Rounding out the top-ten:

CNSE's ranking as number one in the world placed it ahead of Cornell University (2), the University of Michigan (3), the University of Illinois at Urbana-Champaign (4), Penn State University (5), Arizona State University (6), the University of Washington (7), North Carolina State University (8), the University of Maryland (9), Rice University (10), Rutgers University (11) and Stanford University (12), among others. CNSE also received top-10 rankings from its peers in three areas: nano commercialization, micro commercialization and micro research.

Congratulations to Albany!  I am glad to see that more and more universities are establishing nanotechnology as a separate program, although I'm not familiar with any other universities with actual schools or colleges dedicated to nanotechnology.  Of course, the Patent & Trademark Office still does not recognize materials science as a field of study that qualifies one to take the patent bar -- but that is a different subject for a different day.

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The Woodrow Wilson Center released a study entitled "EPA and Nanotechnology:  Oversight for the 21st Century," authored by a former high-level EPA administrator, J. Clarence Davies.  Mr. Davies argues that EPA oversight and regulation of nanotechnology is "urgently" needed.  The Wilson Center has the full text of the report available here.

The report is summarized in this Science Daily article.  The article notes the reaction from the Wilson Center's Project on Emerging Nanotechnologies:

"This new report seeks to encourage EPA, Congress, and others to create an intelligent oversight approach that empowers EPA and promotes investment and innovation in new nanotechnology products and processes," said David Rejeski, director of the Project on Emerging Nanotechnologies at the Wilson Center (PEN). "As both the chair and ranking minority member of the U.S. House of Representatives Committee on Science and Technology stated last year, 'Nanotechnology is an area of research that could add billions of dollars to the U.S. economy, but that won't happen if it is shrouded in uncertainty about its [environmental, health and safety] consequences.' "

The Science Daily article also summarizes the approach Davies recommends.  Specifically, it appears that Davies is focusing on creating an industry-EPA partnership to study the toxicity of nanotechnologies and creating an inter-agency coordinating group (possibly involving FDA and OSHA) to oversee nanotechnology regulation.   The eventual goal, it seems, is to amend the Toxic Substances Control Act (TSCA) to expand EPA's power to regulate the area.  It is promising that Davies' proposal involves significant industry cooperation in the development of any standards.  One must hope that any actual regulations or amendments to the TSCA that come from this type of approach are properly balanced to encourage innovation and America's entrepreneurial spirit while significantly mitigating any significant risk of harm from the use of nanomaterials.

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By Laurie N. Jacques:

The Supreme Court’s decision in KSR v. Teleflex makes it easier to show that an invention is obvious. This case is likely to result in changes in the nanotechnology field and elsewhere, including:

?For patent applicants, fewer – but perhaps more valuable – allowed patents.
?For patent owners, a greater risk to patent claims that are challenged based on obviousness.
?For patent licensees, another factor to consider when evaluating existing license agreements in view of Medimmune v. Genentech.

Here’s what happened:

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The Woodrow Wilson International Center for Scholars's Project on Emerging Nanotechnologies and The Pew Charitable Trusts created a map powered by Google Maps showing the location and types of nanotechnology appearing in the United States.  The map is interactive and searchable, providing both a broad-based look at where and what kind of nanotech is developing as well as point specific operations.

First impressions show the bulk of nanotechnology located on the coasts, however, note an increased nanotech presence in the Midwest/Great Lakes region.  Not surprisingly, the focus is on materials and electronics as the industries of choice.

Oh, and its fun to play with.

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A new nanotechnology-focused publication has just announced its own launch.  The Journal of Nano Education is "a peer-reviewed international journal that aims to provide the most complete and reliable source of information on current developments in nanoscale science, technology, engineering, and medical education," and is now accepting submissions for publication.  In addition to publishing materials from undergraduate and graduate research, the journal will also cover topics at the K-12 levels.  The Journal is targeting "various aspects of teaching and learning of nanoscale science, technology, engineering, and medicine."

The creation of another journal just shows how the field is growing.  The new twist here is the coverage of all levels of nano-education.  The Journal will be available via the Internet.

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By Tim Cahill:

The April 20, 2007 edition of FDA Week reports that the former deputy commissioner in the FDA's policy office, Michael Taylor, repeated his call for Congress to grant FDA enhanced regulatory authority with respect to products that utilize nanotechnology, particularly cosmetics, dietary supplements, and foods.

Mr. Taylor believes that FDA should have the authority to force companies to disclose information about the nanotechnology they use in these products so the agency can better monitor the associated risks. Mr. Taylor made this assertion while speaking at a Food and Drug Law Institute conference on April 12th, and he initially raised this issue in a report he wrote last October for the Wilson Center's Project on Nanotechnology entitled "Regulating the Products of Nanotechnology: Does FDA Have the Tools It Needs?"

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The Ohio Department of Development recently announced a significant financial incentive that it awarded to Zyvex Performance Materials, Inc., a "leading nano-technology company providing tools and instrumentation to the semi-conductor and research and education markets."  The incentive, a 60%, 5-year tax cut on real property improvements, allows Zyvex to relocate its headquarters to Columbus along the new State Route 315 Technology Corridor.  The move is expected to generate approximately 100 jobs in Central Ohio.

In addition to its semi-conductor work, Zyvex "was the first to provide carbon nanotube (CNT) powered products to the marketplace," and "Zyvex's performance materials serve customers in the aerospace, defense, automotive, and energy markets while its patent technology has been incorporated with customers who are sporting goods manufacturers."

The new facility will be used for administration, research, development, and limited manufacturing.

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Michael Heintz, of the Nanotechnology Law Report, and JD Gibbs, of ENVIRON, will be co-presenting on nanotechnology issues at the upcoming Ohio Chemistry Technology Council annual conference on March 19.  JD will discuss the technical aspects of nanotechnology, and Michael will discuss regulatory developments in nanotechnology, including the EPA White Paper, Berkeley ordinance, and TSCA inventory reviews. 

The presentation is part of the larger "regulatory forum" session conducted by the environmental attorneys from Porter Wright, and is always one of the most well attended events of the conference.  For more information on attending the conference, see here.

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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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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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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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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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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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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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According to a December 21, 2006 press release, both outgoing House Science Committee Chairman Sherwood Boehlert (R-NY) and incoming Chairman Bart Gordon (D-NT) urged the Bush administration "to establish a research agenda with clear priorities to ensure a greater understanding of the potential environmental, health, and safety risks associated with nanotechnology."  

I suspect that in 2007, the new Congress may well push a nanotechnology safety initiative.  Nanotechnology safety issues are increasingly being publicly discussed, especially given Berkeley's new regulations and NIOSH's recent interest in occupational nanotechnology safety.  Andrew Maynard's proposal, discussed in Nature in connection with the National Nanotechnology Initiative, so far looks to be the most comprehensive public proposal -- the press release expressly references it.   We previously reported on Maynard's proposal here and here. 

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By, Jaime T. Landrum:

As the impact of nanotechnology grows, more companies are considering the utilization of nanotech products and processes in the workplace. Questions regarding nanotechnology's effect on the American worker, however, come side-by-side with these business decisions. As reported at Occupational Hazards, The National Institute for Occupational Safety and Health (NIOSH) is expected to issue guidance for employers facing these problems.

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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 event this week was the International Conference on Nanotechnology Occupational and Environmental Health & Safety in Cincinnati, Ohio.  Nanotechnology Law Report's John Monica filed two reports (one, two) and Nanotechbuzz's George Elvin filed one too.
• Nanopublic on why red milk is one nano product that will not work.
• Nanodot previews a new book by German physicist Jürgen Altmann of Dortmund University on military nanotechnology; it sounds very interesting (Responsible Nanotechnology also posts about this book).
• Nanotechbuzz on nanotechnology and toothpaste and nanotechnology and molecular computers.
• Nanotechnology Law Report's Patrick Lewis examines consumer attitudes towards nanotechnology and Michael Heintz on the Berkley City Council's consideration of code amendments to require additional reporting by companies which produce or use nanotechnology.
• The ASTM International Committee on Nanotechnology approved its first standard: Terminology of Nanotechnology.

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Rice University's Center for Biological and Environmental Nanotechnology, together with researchers from University College London and the London Business School, released the results of a major consumer research study that sought to measure public perceptions of the risks & benefits of nanotechnology.  As reported in PhysOrg,

The largest and most comprehensive survey of public perceptions of nanotechnology products finds that U.S. consumers are willing to use specific nano-containing products – even if there are health and safety risks – when the potential benefits are high. The study also finds that U.S. consumers rate nanotechnology as less risky than everyday technologies like herbicides, chemical disinfectants, handguns and food preservatives.

The study also found that American consumers did take nanotechnology's possible health risks into consideration when evaluating whether they would purchase products containing nanotechnology:

One survey polled consumers about how likely they would be to use four specific, nano-containing products: a drug, skin lotion, automobile tires and refrigerator gas coolant. This is the first large-scale study to experimentally gauge the public's reaction to specific, nano-containing products, and [Professor Steven] Currall said the use of scenarios about plausible, specific products yielded results that challenge the assumption that the public focuses narrowly on risk.

"It was clear that people were thinking about more than risk," he said. "The average consumer is pretty shrewd when it comes to balancing risks against benefits, and we found that the greater the potential benefits, the more risks people are willing to tolerate."

Their findings were published in the journal Nature Nanotechnology.  You can access the full article here (subscription required). 

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At this morning's session of the International Conference on Nanotechnology Occupational & Environmental Health & Safety in Cincinnati, Ohio, Daniel Japuntich, Division Scientist at 3M, presented "Filtration and Respirators: Current Knowledge."  Japuntich shared 3M's research findings indicating HEPA respirator materials are effective in filtering nanoparticles down to three (3) nanometers in size. 

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At today’s session of the International Conference on Nanotechnology Occupational & Environmental Health & Safety in Cincinnati, Ohio, Altairnano President and CEO -- Alan Gotcher -- and Health Safety and Environment Facilitator -- Tabitha Maher -- both gave presentations regarding Altairnano’s environmental, health, and safety (EHS) efforts centered around the company’s use of nanomaterials.

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The December 4, 2006 on-line edition of the Proceedings of the National Academy of Sciences is set  to publish findings from a recent in vivo animal study researching the possible health effects of SWCNTs deliberately injected into the bloodstream.  Scientists at Rice University and the University of Texas are said to have found that carbon nanotubes are filtered from the bloodstream by the liver over one hour after injection.  The scientists are also said to have sampled tissue from various locations in the test animals and apparently found SWCNT deposits in the liver, and trace amounts in the kidney -- both of which were expected.  Preliminary reports believe the study supports the conclusion that there are no immediate adverse health effects from SWCNTs injected into the bloodstream.  Look for more information about this study in upcoming posts.

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JCM: My reading is EPA's new position on Samsung's washing machine has little to do with the alleged "nanoness" of the silver ion particles released by the machine. Rather, EPA is focused on the claimed antimicrobial properties of the material. Whether or not the silver ions are truly "nano" is not determinative. Under EPA's current thinking they would still be subject to FIFRA even if they were/are "full sized." Further, EPA has not even determined whether or not the washing machine truly uses nanotechnology, and has stated that such a finding is unnecessary for its ruling. Finally, EPA has made it clear that it evaluates all products on a case-by-case basis, and appears reluctant to make a categorical statement about all products containing nano-silver. Thus, while EPA's upcoming notice to be published in the Federal Register will be of great interest, my guess is that it will not use the Samsung issue as a reason for treating nanomaterials any differently from the way it treats other microbial killing materials.

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Since first being reported in the Washington Post, and relayed here, more information concerning EPA's proposed regulation of nanosilver under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) has been uncovered.

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Rick Weiss reported in yesterday's Washington Post that the EPA plans to regulate silver nanomaterials used in consumer products as "germ-killing" agents:

The decision -- which will affect the marketing of high-tech odor-destroying shoe liners, food-storage containers, air fresheners, washing machines and a wide range of other products that contain tiny bacteria-killing particles of silver -- marks a significant reversal in federal policy. * * *

Under the new determination, first reported on Tuesday by the Daily Environment Report, a Washington publication, and confirmed yesterday by the EPA, any company wishing to sell a product that it claims will kill germs by the release of nanotech silver or related technology will first have to provide scientific evidence that the product does not pose an environmental risk.

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In the September 2006 edition of Nanotechnology Law & Business, two (2) employees of FDA’s Center for Drug Evaluation and Research (“CDER”) -- Nakissa Sadrieh and Parvaneh Espandiari -- published “Nanotechnology and the FDA: What Are the Scientific and Regulatory Considerations for Products Containing Nanomaterials?”

The article begins with a disclaimer that the authors’ views and opinions are not necessarily those of FDA, and then narrows its specific focus to nano-products regulated by FDA’s Center for Drug Evaluation and Research (‘CDER’) – primarily new drugs and/or drug delivery systems.

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