Nanodialog.eu -- Nanotechnology Law Report Reaches Poland
Our friends at Nanodialog.eu will now be publishing summaries of select nanolawreport blogs in Polish. Here's an example:
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"Nanotechnology Law" -- Now Online
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
EPA to Reverse Position on 'Existing' Nanomaterials
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 . . .
Analysis: "Stanford University Responds to California's DTSC Data Call-In for Carbon Nanotubes"
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:
- Stanford University CNT Submittal Letter
- DTSC January 22, 2009, Information Request Regarding Carbon Nanotubes
- DTSC Carbon Nanotube Contact List
- Stanford's General Principles Document
- NIOSH's Approaches to Safe Nanotechnology
Article: "Nanotechnology: The Next Battleground for Mass Torts?"
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. :)
IEEE Blogger Comments on Nanosilver Article
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."
Australia Considers Proposal for Nano-Regulatory Reform
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.
New Edition of Nanotechnology Law Report
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
New National Nanomanufacturing Network Newsletter
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.
Study of Chinese Print Workers Claims to Provide the First Human Evidence of the Clinical Toxicity of Long-term Nanoparticle Exposures
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
While there are cellular and laboratory animal studies that suggest the enhanced toxicity of some engineered nanoparticles (ENP) relative to larger sized particles of the same chemical composition (e.g., carbon nanotubes versus graphite, nano-sized titanium dioxide versus conventional titanium dioxide), there remains no direct human evidence of the health risks posed by ENP. The absence of any epidemiology or medical case studies examining potential ENP exposures and adverse health effects among either workers or consumers is likely a result of several factors. These factors include the fairly recent intensification in ENP manufacturing and commercial application, as well as the fact that relatively small amounts are typically manufactured and handled. The Song et al. (2009) study is a medical case report that claims to provide the first human evidence of "nanomaterial-related disease" following long-term nanoparticle exposure.
This study attributed unusual and progressive lung disease in seven Chinese workers, two of whom died of respiratory failure, to workplace nanoparticle exposures in a print plant where a polyacrylic ester paste containing nanoparticles was sprayed onto a polystyrene substrate, with subsequent heat-curing. For 5 to 13-month durations, all seven employees worked in the same department of the print plant, specifically, in a room with little to no ventilation due to the failure of the mechanical ventilation system. Lacking any measurement data of actual worker exposures, study investigators concluded, based on the detection of 30-nm nanoparticles in the paste material as well as in accumulated dust in the workplace, that these workers were exposed to polyacrylate nanoparticles. Reporting the presence of similarly-sized nanoparticles in the chest fluid and lung cells of the diseased workers, Song et al. highlighted the emerging body of nanotoxicological evidence from animal and in vitro studies to support their conclusion that the observed health effects were due to polyacrylate nanoparticle exposures.
While highly tragic and certain to create a stir among regulators, the media, and the general public, it is important to recognize that this study does more to highlight the critical need to follow well-established industrial hygiene practices than to provide direct evidence in humans of any unique health risks posed by ENPs. This study has several key limitations, including a general lack of information on the exposures experienced by the workers. Given the spraying of a chemical paste and the heating of a plastic material in an enclosed space lacking any mechanical ventilation, it is clear that these workers were exposed to a complex cocktail of chemicals and fumes, in addition to any nanoparticle exposures.
Based on the identification of nanoparticles in the paste, in accumulated dust in the workplace, and in lung tissues and cells of the workers, it is likely that these workers were exposed to nanoparticles in their workplace. However, Song et al. do not provide the necessary materials characterization data to demonstrate that the observed nanoparticles are indeed engineered nanoparticles (i.e., nanoscale particles intentionally created to have nano properties) and to confirm that the nanoparticles observed in the paint paste are the same nanoparticles identified in the workplace dust and in biological samples. Incidental nanoparticles are ubiquitous in indoor and outdoor air from a variety of anthropogenic and natural sources (engine exhaust, metal fumes, secondary organic aerosols), and characterization data are thus needed to confirm that the nanoparticles observed in the dust and in biological samples are indeed polyacrylate nanoparticles.
Given the lack of chemical analysis of the nanoparticles and the workers’ co-exposures to a variety of other toxic substances, it remains highly uncertain to what extent workplace nanoparticle exposures, compared to other workplace exposures, may have contributed to the observed health effects. Further, toxicological evidence cited by the investigators as linking ENP such as carbon nanotubes and zinc oxide with toxic responses in animals and cell cultures is of dubious relevance to polyacrylate nanoparticles, which are unlikely to exhibit similar biological activity due to important differences in toxicologically-relevant properties, in particular chemical composition. Scientific evidence is quite clear that toxicological properties differ greatly among different nanoparticles.
Regardless of the actual role of nanoparticles in the observed health effects, there are important lessons that can be learned from this study. In particular, given the limited knowledge regarding the health and safety risks posed by ENPs, it is imperative that best management practices for workplace exposures be followed to control and minimize potential exposures. It is clear that occasional use of cotton gauze masks, as reported by Song et al. for the Chinese workers, is not an adequate practice for controlling workplace exposures. Fortunately, a number of good resources are available for identifying state-of-the-art nano practices, including the ICON GoodNanoGuide . This study also highlights the critical need for robust exposure assessments to support health effects studies, providing data to characterize key nanoparticle properties and to differentiate ENPs from incidental nanoparticles.
In summary, this study highlights the importance of continued vigilance for any signs of ENP-related illnesses in exposed human populations. However, it lacks the essential materials characterization, exposure, and toxicity data for both the ENP and the other chemicals to which the workers were exposed. Thus, the study is not supportive of the authors' conclusions that ENP exposures underlie the observed health effects among the Chinese workers and that these findings are of relevance to all commercially available ENPs.
Another Nano-Silver Sock Study
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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New Article: Examples of Recent EPA Regulation of Nanoscale Materials Under the Toxic Substances Control Act
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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The "Not Nano" Sunscreen
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.
Nano Networking and Nano EHS Forum
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!
EPA Scientific Advisory Panel to Discuss Nanoscale Silver at Public Meeting
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.
Virginia CLE presentation: "Insurance, Nanotechnology, and Risk"
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.
Soil Association Cites Alleged Deaths in Renewed Call for Moritorium on Nanotechnology Commercialization
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.
Nanotechnology Insurance Issues
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.
Index to New Book -- "Nanotechnology Law"
EPA to Issue Mandatory Data Collection Rule for Nanoscale Materials Under TSCA
Eight months after EPA's interim report on industry participation (or lack thereof) in its Nanoscale Materials Stewardship Program, EPA's Toxic Substances Control Act's ("TSCA") Interagency Testing Committee ("ITC") published a report in today's Federal Register mentioning that EPA intends to issue a new mandatory data collection rule for nanoscale materials under TSCA Section 8(a):
"EPA intends to develop a proposed TSCA section 8(a) rule to obtain information on the production, uses, and exposures of existing nanoscale materials. EPA has indicated that it will ensure that the chemicals where there is ITC interest as described in this unit are either included in that action or are otherwise new chemical substances subject to premanufacture notifications (PMN) reporting under TSCA. EPA also intends to develop a proposed TSCA section 4 rule to develop needed environmental, health, and safety data."
Among other things, TSCA section 8(a) allows EPA to issue a rule requiring the mandatory submission of data regarding:
(A) The common or trade name, the chemical identity, and the
molecular structure of each chemical substance or mixture for which
such a report is required.
(B) The categories or proposed categories of use of each such
substance or mixture.
(C) The total amount of each such substance and mixture
manufactured or processed, reasonable estimates of the total amount
to be manufactured or processed, the amount manufactured or
processed for each of its categories of use, and reasonable
estimates of the amount to be manufactured or processed for each of
its categories of use or proposed categories of use.
(D) A description of the byproducts resulting from the
manufacture, processing, use, or disposal of each such substance or
mixture.
(E) All existing data concerning the environmental and health
effects of such substance or mixture.
(F) The number of individuals exposed, and reasonable estimates
of the number who will be exposed, to such substance or mixture in
their places of employment and the duration of such exposure.
(G) . . . the manner or method of its disposal, and in any
subsequent report on such substance or mixture, any change in such
manner or method.
Some of the nanoscale materials prompting ITC's interest appear to be: fullerenes; titanium oxide nanowires; titanium oxide nanoparticles; nano zinc oxide; nanosilver; silica; quartz; cerium oxide; indium tin oxide; dendrimers; single-walled carbon nanotubes; multi-walled carbon nanotubes; carbon nanofibers; Se and Cd quantum dots; nanoceramic particles; and nanoclays.
EPA Report on the Use of Nanoscale TiO2 in Water and Sunscreens
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:
- Introduction
- Life Cycle Stages
- Fate and Transport
- Exposure - Dose Characterization
- 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."
EPA Issues Clarification Regarding Carbon Nanotube SNURs
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
Zurich Insurance Unveils New Nanotechnology Exposure Protocol
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.
New Edition of Nanotechnology Law Report
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
Nano Insurance Conference
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.
"Nano Risk Governance: Current Developments and Future Perspectives"
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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
"Nanotechnology Law" Published by West/Thomson/Reuters
"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.
Private Spending on Nano Exceeds Government Spending for First Time
Chemical Business NewsBase recently published an article comparing global private funding to government funding for nanotechnology research, development, and commercialization. The article cites Lux Research figures indicating that private funding for nanotechnology reached $9.6 billion in 2008, while government investment was $8.6 billion. According to the article, this was the first year that private spending exceeded public spending. Lux also estimates that nanotechnology-enabled products will constitute a $3.1 trillion market by 2015.
It is interesting to remember that a decade ago, advocates for dramatically increased federal funding of nanotechnology efforts argued that once nanotechnology is firmly established as a field of commerce, federal investment would be dwarfed by private research and development which was estimated would be 10% of ultimate sales revenues. Advocates of the National Nanotechnology Initiative took the position that the federal government should stimulate and support basic nanotechnology research until such time as private commercialization takes root at this level. Annual global government research, development, and commercialization was then estimated at a mere $432 million.
EPA Issues Significant New Use Rules for Multi-Walled and Single-Walled Carbon Nanotubes
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.
Are Nanoparticles Released by Compounding or the Cutting of Nano-Composites?
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.
Investor Environmental Health Network Publishes New Nano Corporate Responsibility Paper
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.
Interesting Nano-Regulatory Developments
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."
Are Nano Consumer Products Headed Underground?
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."
NanoBiotech 2009
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.
Nanotechnology Health and Safety Forum -- June 8 - 9, 2009
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.
Australian Occupational Health and Safety Attorney Warns of Potential Nano-EHS "Epidemic"
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.
"Regulation and Risk Assessment of Nanomaterials -- Too Little, Too Late?"
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:
Representative Honda Introduces Nanotechnology Advancement and Opportunities Act
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.
"nano" The Magazine for Small Science
Our readers might be interested in this month's edition of nano magazine which features a short article entitled "Asbestos Repeated? Assessing Risk in Nanotube Technologies." The article discusses the recent Poland/Donaldson paper published in nature nanotechnology that has been getting so much attention. Beyond the article, this much recommended magazine is published in the UK and features articles on international nanotechnology research, development, and commercialization. You can download a copy of the magazine here. Be sure to sign up for future editions by emailing subs@nanomagazine.co.uk.
Has Nano Gone to the Dogs?
Because its Friday, and I just got back from an extended trip, I'm probably not a serious as I should be today (the caffeine is probably part of the equation too). However, imagine my surprise this morning when I read about a company called "Nano Pet Products, LLC." It didn't take long, but nano seems to have gone to the dogs.
Nano Pet Products is marketing a line of dog beds and apparel touted as "the most technologically advanced dog bed on the market. Using the performance fabric finishes NanoSphere® and ActiveSilver®, these beds stay clean and kill bacteria naturally, standing up to the wear and tear of the most active dog." The "Dog Gone Smart Bed" and "Dog Gone Smart Wear" is being debuted at the Global Pet Expo in San Diego, wrapping up today.
There is no further information available on what "NanoSphere" or "ActiveSilver" is other than both are "based on nanotechnology." Does this mean we should add our pets to the list of "family" members we should be concerned about exposing nanotechnology to (much like nano-based sunscreens?). As you can see, my dog Simon loves his bed, nanotechnology or not, so maybe these guys are onto something?
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Caveat Emptor: All That is Nano May Not Be So
An interesting item came across my desk this morning. A co-worker, while on the treadmill at the gym saw an add for "nanoSLIM" the "enormously powerful, impossibly small" dietary weight-loss supplement. It is billed as a once per day supplement that is smaller than anything else available. However, after purchasing a package of nanoSLIM, I noticed a couple of curious things.
First, nanoSLIM claims to use nanotechnology in its manufacturing process and features the trademarked and patent pending "Nano-Diffuse" technology. While nanoSLIM does not define Nano Diffuse technology, other products that use this proprietary method describe it as, "Nano-Diffuse is a high tech process of micro-pulverizing the amino acid particles to a range of 2 to 50 microns in size using ultrasonic pneumatic machinery." Other products that use Nano-Diffuse include Muscle Tech Nitro-Tech and SleepMD.
Second, on the nanoSLIM box, the manufactures state, "the key ingredients in nanoSLIM are pulverized into micron-sized particles." And prominently featured at the words "Nanotechnology at Work."
However, I would caution readers to something you have probably already seen: nano and micro are not the same. This brings to light a growing problem in the nano world--the use of "nano" as a marketing tool when nano really isn't involved (does everyone remember Magic Nano?). Because these kinds of supplements are not tightly regulated by the Food & Drug Administration, just about anything goes. While I'm not familiar with the technology being put to use, it sure feels like there is no nanotechnology here and the "nano" is used to draw attention to the product (which seems to be working given I purchased the second to last box on the shelf).
Oh, one other thing. The warning on the box reads in part: "Not intended for use by persons under 18. Do not use if pregnant or nursing. Consult a medical doctor before use if you have been treated for, or diagnosed with, or have a family history of, any medical condition including (but not limited to) diabetes, or if you are using any prescription or over-the-counter drug."
Caveat emptor, indeed.
The Rise of "Nanoethics"
With all of the talk about new discoveries and advancements in nanotechnology, a new topic of discussion is coming to the surface. The idea of nanoethics, "understanding of the risks and benefits of nanotechnology among scientists, policy makers and the general public," is being more widely discussed as the field grows and progresses.
A previous post on nanoethics appears here, and I'm seeing more and more discussion as the idea becomes part of the agenda.
We've already heard from The Nanoethics Group, and seen the journal NanoEthics, (no direct relation, I'm told), and now comes an anthology collection of 40 authors, Nanoethics: The Ethical and Social Implications of Nanotechnology, that "gives the reader an introduction to and basic foundation in nanotechnology and nanoethics, and then delves into near-, mid-, and far-term issues. "
While there is the expected crossover between these three items, authors from one will certainly appear in another's publication, the increasing volume with which nanoethics is being discussed is noteworthy.
Responsible development of both the technology and any accompanying regulation cannot be made in a vacuum. Consideration of the wider societal impacts, both positive and negative, is critical in order to have worthwhile discussions. The ends of the spectrum have already been voiced: a complete lack of regulation on the developing science until more is known on the one hand, and a total moratorium on technological advancement until the risks are sufficiently understood and accounted for on the other. While I can't speak for my co-authors, I believe the answer lies somewhere in the middle. As to the second argument, the proverbial genie is out of the bottle--scientific advancement cannot be stopped at this stage. R&D labs, universities, and private companies will continue to research and learn about nanotechnology. As to the first argument, a complete disregard for the potential hazards that may develop is, at best, irresponsible.
We've not heard the last of the nanoethics discussion, and quite the contrary, I think we're just hearing the beginning. But that's just my opinion, I'd be curious to know what you think.
Nanotechnology: A New Weapon in the Battle Against Counterfeit Goods
Counterfeiting is widespread because it is lucrative and often difficult to detect. Nanowerk highlights the use of nanotechnology in the battle against counterfeit goods. Nanoencryption provides a new option for distinguishing between genuine and counterfeit goods, particularly pharmaceuticals.
Drug counterfeiting is particularly problematic because it compromises patient safety in addition to causing monetary losses and erosion of brand value. The Center for Medicine in the Public Interest estimates that counterfeit drug sales are growing at an annual rate of about 13% – nearly the twice the growth rate of genuine pharmaceutical products – and could reach $75 billion by 2010.
Anti-counterfeiting strategies rely heavily on supply chain monitoring and control, which may include the use of specially printed labels and radio frequency identification (RFID) tags to identify products at the package level. These labels and tags are readily visible to counterfeiters who can then try to circumvent or replicate them. More importantly, their use is limited to tracking of package, not the package contents.As the Nanowerk article explains, nanoencryption offers advantages in identification and monitoring of pharmaceutical products. Individual tablets of other unit doses may be tagged, not just the package that holds them and the tags are invisible to the naked eye. Authentication is quick and does not destroy the tablet so the tablet can be used later as evidence in a civil or criminal action. Nanoencryption also may be useful in authenticating other frequently counterfeited items such as currency, auto and aircraft parts, software, and luxury goods.
Where Science and Law Meet
The Nano Science and Technology Institute recently published an article, "Where Science and Law Meet," concerning the implications nanotechnology is having on intellectual property law. As one would expect, patents are being filed for nanotechnology products in increasing numbers. Given the complexities of both patent law and nanotechnology, there are unique implications when the two meet. The article provides a good discussion on developments in intellectual property law.
Carbon Nanotubes Can "Swim"
Researchers at the Georgia Institute of Technology (Georgia Tech) have discovered that multi walled carbon nanotubes will remain suspended in water for a month or longer when combined with other organic materials. The January issue of the journal Environmental Science & Technology , will fully report the findings by Assistant Professor Jaehong Kim, Professor Joseph Hughes, researcher John Fortner, and graduate student Hoon Hyung. However, the initial conclusion from the experiments is that multi walled carbon nanotubes are easily dispersed throughout the environment due to their extended suspension in river water. The nanotubes interacted with the organic material found in water from the Suwannee River, and as a result, remained suspended in the water. As reported by Georgia Tech, "Carbon nanotubes, which can be single- or multiwalled, are cylindrical carbon structures with novel properties that make them potentially useful in a wide variety of applications including electronics, composites, optics and pharmaceuticals."
This, of course, adds to the body of science regulators are looking to as the try to develop sound policy for governing nanotechnology. Check back for updates as the full report on the experiment is released.
Nanotechnology Law Report: The Week In Review
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.
Standardization: ASTM Releases "Terminology for Nanotechnology"
For those of you who have been paying close attention to nanotechnology issues, be them regulatory or otherwise, you've noticed that there does not seem to be any one standard for nanotechnology terms, including "nanotechnology." While various organizations and agencies, such as the United States Environmental Protection Agency, American Bar Association, and Rice University, among others, have all provided somewhat similar definitions for "nanotechnology" and related terms, ASTM International (formerly the American Society for Testing and Materials) recently released its Standard for nanotechnology related terms.
ASTM, International, by its own description is, "one of the largest voluntary standards development organizations in the world-a trusted source for technical standards for materials, products, systems, and services. Known for their high technical quality and market relevancy, ASTM International standards have an important role in the information infrastructure that guides design, manufacturing and trade in the global economy." ASTM, International develops many of the standard testing methods and procedures for scientific processes, and they have now created standard definitions for nanotechnology.
Standard E 2456-06 is a collection of definitions and terminology that should help to alleviate some of the confusion inherent in many organizations using slightly different definitions for nanotechnology related terms. Because it is copyrighted material, it cannot be reproduced or linked here (the standard can be purchased at the above link). However, terms addressed by the Standard include: nano, naoparticle, nanotechnology, and nanoscale.
This release by ASTM, International is important because that organization is heavily relied upon for developing and maintaining many of the world's scientific standards and procedures. The fact that they have now developed, what we hope to be, standardized definitions in the nanotechnology arena, helps to alleviate any confusion surrounding what is properly within the field of nanotechnology, and what is not. This, in turn, frees up those working in the field to turn their attention to the substantive issues at hand. While not binding on any organization or agency, the Standard reflects an attempt by several scientific organizations, including the American Institute of Chemical Engineers, NSF, International, the National Institute of Advanced Industrial Science and Technology, the Institute of Electrical and Electronics Engineers, the American Society of Mechanical Engineers, and the Semiconductor Equipment and Materials International to reach a consensus concerning the scope of nanotechnology.
UPDATE: Berkeley City Council to Consider Nanotechnology Regulation
On December 5, 2006 the Berkeley, California City Council began considering two municipal code amendments directly addressing manufactured nanoparticles. As reported here earlier, the ordinance will amend two portions of the Berkeley Municipal Code, sections 15.12.040 and 15.12.050, to include reporting requirements for manufactured nanoparticles. Those required to report are all "facilities" who produce or use manufactured nanoparticles. The amendments call for written disclosure of "the current toxicology of the materials reported, to the extent known,and how the facility will safely handle, monitor, contain, dispose, tract inventory, prevent releases, and mitigate such materials." The amendment further defines nanoparticles subject to disclosure as those "with one axis less than 100 nanometers in length." If passed, after the required subsequent readings by Council and a vote, this will be the first known regulation aimed specifically at manufactured nanoparticles by a local government.
Nanotech Helping to Clean Water
Given all the news recently about possible environmental regulation of nanotechnology, the potential benefits of these new discoveries sometimes gets lost in the shuffle. However, Rice University reported on November 16, 2006 that nanotechnology research shows promise in removing arsenic from drinking water. Recent experiments conducted by the Center for Biological and Environmental Technology at Rice University resulted in arsenic removal from drinking water through the use of nano-sized rust particles. The experiments are significant in that arsenic removal technology, as it currently exists, is both expensive and complicated because it uses high pressure pumps and needs electricity. Researchers at Rice discovered that "nanorust," iron oxide particles, could be removed from water in the presence of a weak magnetic field. In some instances, small, handheld magnets were enough to create the necessary magnetic force. Researchers previously thought that given the size of the nanorust, only large electromagnets would remove the particles from water. Iron oxide binds to arsenic extremely well, and such binding does not appear to impact the magnetic properties of the nanorust. This technology shows promise for areas of the world that do not have reliable electricity or funding, such as Southeast Asia, and who need to remove high levels of naturally occurring arsenic from their water supplies. This discovery may make it possible to decontaminate drinking water on a household scale without the use of electricity.
