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

Readers may be interested in learning about a new subscription website devoted to nanoscale carbon -- CNT Report. 

CNT Report is dedicated to bringing its readers the most recent news concerning important issues affecting nanoscale carbon research, development, and commercialization.  CNT Report closely covers all forms of nanoscale carbon in development on the global stage, including CNTs, graphene, fullerenes, specialty fibers, and all else in-between.  CNT Report's primary focus is on new scientific research developments, practical applications, finance, legal and regulatory issues, and general commercialization.   CNT Report publishes news in several broad categories including: Business, Commercialization,  Finance & Deals, Insurance, Intellectual Property, International Laws & Regulations, Policy, Standards, States, Science, Applications, Current Research, and Environmental, Health and Safety.

CNT Report also accepts press releases, research results, financial news, or any other news item related to nanoscale carbon which it then makes available to all of its subscribers.  CNT Report welcomes timely contributions from its readers and makes sure that their articles receive proper attribution and credit.

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Here is an advance copy of a new multi-walled carbon nanotube significant new use rule being published tomorrow in the federal register.  It applies only to the specific carbon nanotubes that were the subject of PMN P-08-199, and binds anyone who intends to manufacture, import, or process the specific chemical substance.  It is largely consistent with past SNURs and Consent Orders for other CNTs.  For those wondering, "processors" and "processing" is broadly defined under TSCA.  It has been used in the past to include repackaging for commercial purposes, using the material in the manufacturing of new mixtures, and/or the production of articles using the substance.

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The NanoSafety Consortium for Carbon just submitted a proposed toxicity testing agreement to EPA under Section 4 of the Toxic Substances Control Act covering a range of nanoscale materials including multi-walled carbon nanotubes, double-walled carbon nanotubes, single-walled carbon nanotubes, and graphene. 

Key elements for the curious:

• The chemical substances to be tested may include representative (i) purified multi-walled carbon nanotubes ranging from 4 to 600 nanometers in diameter and less than 30 micrometers in length; (ii) purified double-walled carbon nanotubes ranging from 1.5 to 4 nanometers in diameter and less than 5 micrometers in length; (iii) purified single-walled carbon nanotubes ranging from .7 to 2 nanometers in diameter and less than 30 micrometers in length; and (iv) purified graphene nanoplatelets in flake/sheet form ranging from .5 nanometers to 100 nanometers thick. All test materials will be purified by the National Institute of Standards and Technology to be at least 99 percent pure. Final test materials will be approved by the EPA and will be selected to adequately represent the constituency of the final signatories to the testing agreement.

• The characteristic for which testing will be conducted is subchronic inhalation toxicity in rodents, or such other toxicity testing as may be approved by EPA to achieve the intent and purpose of the testing agreement. As appropriate, consideration will be given to using in vivo instillation rather than inhalation test methods. Test data will be developed under standards based on TSCA test guidelines in 40 CFR parts 796, 797, and 798, Organization for Economic Cooperation and Development (OECD) test guidelines, or other suitable test methodologies.  Specifically, the signatories will conduct a 90 day inhalation toxicity study in rats with a post exposure observation period of up to 3 months, including broncholaveolar lavage fluid analysis (OPPTS 870.3465 or OECD 413), or such other testing as may be approved by the EPA to achieve the intent and purpose of the testing agreement. Testing guidelines will be modified to account for nanoscale properties of the materials being tested. Such modifications are subject to EPA approval and will be incorporated into the below-referenced study plan.

If EPA decides to pursue the proposed testing agreement, it will initiate a six-month negotiation and comment period which will open to the public pursuant to 40 C.F.R. § 790.28.

Stay tuned.

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“The New Steel? Enabling the Carbon Nanomaterials Revolution: Markets, Metrology, Safety, and Scale-up” is a workshop to be held on February 28th and March 1st, 2011, at NIST’s Gaithersburg, Maryland facility. NIST has assembled an outstanding roster of speakers from industry, academia and government to address the full spectrum of issues, including a special panel on EH&S.

If you can join the workshop, please register before the registry is filled! Remember that this will be a true workshop and participants are encouraged to actively share their views and perspectives over the two days, and also to provide if possible before the workshop commences a brief (2-page) white paper on one of the three breakout session topics, listed below, to help seed the discussions. If you prepare a white paper, please send it to TheNewSteel@nist.gov

The three topic areas for the workshop breakout sessions:

• Technology Challenges and Barriers for Carbon-based Nanomaterials
• EH&S – From Regulation to the Marketplace
• Measurement Issues and Grand Challenges

NIST contact information is below if you have any questions or would like to receive more information regarding the workshop.

J. Alexander Liddle, Group Leader
Nanofabrication Research Group
Center for Nanoscale Science and Technology
National Institute of Standards and Technology
Bldg. 216 Rm. B153
100 Bureau Drive, Stop 6203
Gaithersburg, MD 20899-6203
tel: 301 975 6050
fax: 301 975 5314
liddle@nist.gov
http://cnst.nist.gov
 

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UNIDYM ANNOUNCES ALLIANCE WITH SAMSUNG ELECTRONICS

Sunnyvale, CA - December 8, 2010 - Unidym, Inc., a majority owned subsidiary of Arrowhead Research Corporation (NASDAQ: ARWR), announced today that it has completed IP cooperation and license agreements with Samsung Electronics Co., Ltd. ("Samsung"). Under the agreements:

1. Unidym licensed to Samsung patents covering CNT materials, including fundamental patents on CNT compositions of matter, synthesis of CNTs, processing of CNTs, ink formulations, and transparent conductive films.

2. Unidym transferred certain patent rights to Samsung, primarily related to electronic devices incorporating CNTs. Samsung granted back to Unidym licenses to sell products under the transferred patent rights.

3. Unidym and Samsung will continue to work together to develop and commercialize CNT-based products.

"This is an important development in carbon-based electronics," said Mark Tilley, President and CEO of Unidym. "We have worked with Samsung Electronics for several years, and we are now looking forward to this next phase in our relationship. We expect Samsung's investment in this alliance and ongoing IP cooperation with Unidym will open the market for printable carbon electronics."

About Samsung Electronics Co., Ltd.

Samsung Electronics Co., Ltd. is a global leader in semiconductor, telecommunication, digital media and digital convergence technologies with 2009 consolidated sales of US$116.8 billion. Employing approximately 174,000 people in 193 offices across 66 countries, the company consists of eight independently operated business units: Visual Display, Mobile Communications, Telecommunication Systems, Digital Appliances, IT Solutions, Digital Imaging, Semiconductor and LCD. Recognized as one of the fastest growing global brands, Samsung Electronics is a leading producer of digital TVs, memory chips, mobile phones and TFT-LCDs. For more information, please visit www.samsung.com <http://www.samsung.com> .

About Unidym, Inc.

Unidym is a leader in carbon nanotube-based transparent, conductive films (TCFs) for the electronics industry. TCFs are a critical component in devices such as touch panels, displays, and thin-film solar cells. For example, both touch panels and LCDs typically employ two TCF layers per device. Unidym's TCFs offer substantial advantages over the incumbent technology, indium-based metal oxides, including: improved durability, lower processing costs, and lower overall cost structure. For more information, visit: http://www.unidym.com <http://www.unidym.com> .
 

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

In late November, the National Institute for Occupational Safety and Health (NIOSH) published a Current Intelligence Bulletin entitled "Occupational Exposure to Carbon Nanotubes and Nanofibers." The document is not an official "agency determination or policy," and was released solely by NIOSH for peer-review and comment. NIOSH's carbon nanotube recommended exposure limit (CNT REL) is set at 7 μg/m 3 for these preliminary purposes.

The old saying that "a picture is worth a thousand words" is once again proved by the document's cover image which is a remarkable "field emission micrograph of a multi-walled carbon nanotube…penetrating the pleura of the lung." The finely detailed image of a CNT penetrating a lung membrane should cause any reader to stop and closely consider the document's recommendations.

The document begins by noting that while there are no scientific reports of "adverse health effects in workers producing or using carbon nanotubes…or carbon nanofibers," NIOSH is concerned because some studies have shown that the potential for worker exposure exists. Additionally, some in vivo studies have shown adverse reactions to carbon nanotubes in rodents -- including pulmonary inflammation and fibrosis. Further, some in vitro and in vivo studies have led researchers to theorize that inhalation of certain carbon nanotubes in large doses may potentially cause asbestos-type exposure effects.

NIOSH explains that the scientific basis for its CNT REL is an extrapolation from subchronic in vivo toxicity studies in rodents. "The REL is based on the available subchronic and short-term animal dose-response data of early-stage fibrotic and inflammatory lung response to CNT exposure. Benchmark dose (BMD) estimates from the animal data (and the 95% lower confidence limit estimates of the BMD) have been extrapolated to humans by accounting for species differences in alveolar lung surface area. Working lifetime exposure concentration have been calculated based on estimates of either the deposited or retained alveolar lung dose of CNT assuming an 8-hour time-weighted average (TWA) work shift exposure during a 40-hour work week, 50 weeks per year, for 45 years."

However, because a risk of adverse lung effects may occur even below the 7 μg/m 3 CNT REL, NIOSH further recommends reducing airborne levels of nanoscale carbon to as low as possible. Additionally, NIOSH recognizes that the REL is based on a mass dose metric which might not be appropriate for nanoscale materials because "a mass-based sampling method may not be sufficiently sensitive to detect all [carbon nanotubes] and [carbon nanofiber] structures in the air at low mass concentrations." Accordingly, NIOSH recommends additional research to determine the most appropriate dose metric.

The CNT REL is not provided in isolation, NIOSH also recommends that employers and workers follow the detailed workplace safety measures outlined in its comprehensive guidance document, "Approaches to Safe Nanotechnology: Managing the Health and Safety Concerns Associated with Engineered Nanomaterials." To this end, NIOSH provides summary information outlining the basic measures explained in its "Approaches" document.

Another notable feature of the document is its position regarding worker medical screening and surveillance. NIOSH concludes "that workers occupationally exposed to [carbon nanotubes] and [carbon nanofiber] may be at risk of adverse respiratory effects. These workers may benefit from inclusion in a medical screening program recommended as a prudent means to help protect their health." This last quasi-recommendation alters NIOSH's prior position that "[t]he current body of evidence about the possible health risks of occupational exposure to engineered nanoparticles is quite small. Insufficient scientific and medical evidence now exists to recommend the specific medical screening of workers potentially exposed to engineered nanoparticles."

The document closes by listing 15 scientific research needs to "assist NIOSH in evaluating the occupational safety and health concerns of working with [carbon nanotubes] and [carbon nanofiber]."

Finally, for those keeping track, in 2005, NIOSH proposed a REL for ultrafine TiO2 (essentially nanoscale TiO2) of .1 μg/m 3. Bayer Material Sciences previously set a worker exposure limit for its multi-walled carbon nanotube products (BayTubes) at .05 mg/m 3 in 2009. Similarly, NIOSH's REL for carbon black is 3.5 mg/m 3, and OSHA's permissible exposure limit for respirable synthetic graphite is 5 mg/m 3.

Sources:

National Institute for Occupational Safety and Health, Current Intelligence Bulletin, "Occupational Exposure to Carbon Nanotubes and Nanofibers," p. 3, available at http://www.cdc.gov/niosh/docket/review/docket161A/pdfs/carbonNanotubeCIB_PublicReviewOfDraft.pdf (last visited Dec. 9, 2010).

National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Department of Health and Human Services, Approaches to Safe Nanotechnology: Managing the Health and Safety Concerns Associated with Engineered Nanomaterials (2009) available at http://www.cdc.gov/niosh/docs/2009-125/pdfs/2009-125.pdf.
 

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My new Nanotechnology Law & Business article -- "An Industry Driven Approach to EHS Issues: 'The NanoSafety Consortium for Carbon'" -- can be found here.  The abstract follows.

The NanoSafety Consortium for Carbon (NCC) is an industry-driven group formed to proactively address potential environmental, health, safety, and regulatory concerns related to the commercia-lization of its members’ nanoscale carbon products. NCC was formed to take advantage of an offer by the EPA for a consortium of companies to providing testing regarding carbon nanotube toxicity. This article provides background on NCC’s activities, purpose, and goals.

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In the Federal Register for Friday 09/17/2010, the Environmental Protection Agency (EPA), acting under the authority granted to it under section 5(a)(2) of the TSCA, issued as a final rule Significant New Use Rules (SNURS) affecting two chemical substances identified as generic multi-walled and single-walled carbon nanotubes (MWCNTs and SWCNTs respectively). These SNURs are applicable to manufacturers, importers, and processors, who will be required to notify EPA at least 90 days in advance if they intend to use these substances "for a use that is designated as a significant new use by this final rule. . . . EPA believes that this action is necessary because these chemical substances may be hazardous to human health and the environment".

This final rule is the culmination of a process that has taken over a year. EPA had issued a direct final rule in the Federal Register issue of 06/24/2009. This direct final rule affected several chemical substances, including the MWCNTs and the SWCNTs, that had been the subject of various consent decrees issued by EPA. The language of the final rule affecting the MWCNTs read as follows:

Sec.  721.10155  Multi-walled carbon nanotubes (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as multi-
walled carbon nanotubes (PMN P-08-177) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec. 
721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(5) (National
Institute for Occupational Safety and Health (NIOSH)-approved air-
purifying, tight-fitting full-face respirator equipped with N100
filters), (a)(6)(i), and (c).
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80 (j) and (q).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 
721.125 (a), (b), (c), (d), (e), and (i) are applicable to
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to this section.
 

The language affecting SWCNTs is the same.

Following receipt of a notice to file adverse comments, EPA withdrew the SNURs affecting MWCNTs and SWCNTs on  08/21/2009. A proposed final rule was published in the Federal Register on 11/06/2009. This proposed rule retained the language of the original direct rule while also adding new language regarding the release of the MWCNTs and SWCNTs into water. The added language is italicized and bolded below.

Sec.  721.10155  Multi-walled carbon nanotubes (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as multi-
walled carbon nanotubes (PMN P-08-177) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec. 
721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(5) (National
Institute for Occupational Safety and Health (NIOSH)-approved air-
purifying, tight-fitting full-face respirator equipped with N100
filters), (a)(6)(i), and (c).
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80 (k) and (q).
    (iii) Release to water. Requirements as specified in Sec.  721.90
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 
721.125 (a), (b), (c), (d), (e), (i), and (k) are applicable to
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to this section.
 

Again, the language for SWCNTs was the same.

After receiving and reviewing comments submitted by the public about the proposed rule, EPA added more new language clarifying that the requirements of the rule didnot apply after the substances had been cured, incorporated or embedded into a polymer matrix that had been cured or is a solid that will not undergo anymore chemical processing.  Again, the added language is italicized and bolded below.

Sec.  721.10155  Multi-walled carbon nanotubes (generic).

    (a) Chemical substance and significant new uses subject to
reporting--(1) The chemical substance identified generically as multi-
walled carbon nanotubes (PMN P-08-177) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section. The requirements of this rule do not apply to
quantities of the chemical substance after it has been completely
reacted (cured); incorporated or embedded into a polymer matrix that
itself has been reacted (cured); or embedded in a permanent solid
polymer form that is not intended to undergo further processing except
for mechanical processing.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec. 
721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(5) (National
Institute for Occupational Safety and Health (NIOSH)-approved air-
purifying, tightfitting full-face respirator equipped with N100
filters), (a)(6)(i), and (c).
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k) and (q).
    (iii) Release to water. Requirements as specified in Sec. 
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 
721.125(a), (b), (c), (d), (e), (i), and (k) are applicable to
manufacturers, importers, and processors of this chemical substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to this section.
 

EPA has issued these final SNURs to achieve four objectives:

EPA will receive notice of any person's intent to
manufacture, import, or process a listed chemical substance for the
described significant new use before that activity begins.
    EPA will have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing,
importing, or processing a listed chemical substance for the described
significant new use.
    EPA will be able to regulate prospective manufacturers,
importers, or processors of a listed chemical substance before the
described significant new use of that chemical substance occurs,
provided that regulation is warranted pursuant to TSCA sections 5(e),
5(f), 6, or 7.
    EPA will ensure that all manufacturers, importers, and
processors of the same chemical substance that is subject to a TSCA
section 5(e) consent order are subject to similar requirements.
 

In the review of the comments received in response to the proposed final rule, EPA specifies that these SNURs apply only to "the specific CNTs that were the subject of PMNs P-08-177 P-08-328. . . . EPA acknowledges that CNTs made by different manufacturers and processes may be considered different substances for purposes of reporting new chemical substances under TSCA. EPA will make this determination on a case-by-case basis." Other comments filed focused on what the commenters contend is the near impossibility of achieving 100% filtration of CNTs from the waste streams produced by manufacturing or processing of these substances and discharged into U.S. waters.

This rule comes into effect on 10/18/2010. To read the comments submitted and supporting materials, please go here.

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On July 20, 2010, David Hwang of Lux Research gave a webinar entitled: "Lux Research Nanomaterials: The Rise of MWNTs: Oversupply Hides Real Opportunities."

Mr. Hwang’s presentation identified the top global producers of multi-walled carbon nanotubes (MWCNTs), explained why commercialization over the past 25 years has been relatively "anemic," and made some predictions for where the market is heading in the next decade. He explained that while total sales of MWCNTs were under $100 million for 2008, the market is predicted to grow to approximately 2389 tons by 2020.

Two major forces slowing past commercialization included (i) a "you first" mentality by which companies wanted to see others take the first successful steps towards commercialization before they joined the trend, and (ii) regulatory risks inherent in the development of any new technology -- a commercialization bottleneck related to the potential environmental, health, and safety (EHS) impacts of certain carbon nanotubes.  (Regular readers will note that this is a recurring theme in our articles).

Mr. Hwang further explained that he believes the market for MWCNTs is currently in a transition phase, and that an oversupply will exist until 2017.  He commented that total sales in 2009 equaled $75 million and would increase to $513 million by 2020.   Mr. Hwang then covered four specific markets that are leading the commercialization for MWCNTs and provided 2009 versus 2020 material usage estimates:

Mr. Hwang closed with some further trends he saw forthcoming in the next decade which included market consolidation and a shakeout of smaller manufacturers, as well as a "crackdown" through EHS regulation of MWCNTs over the next two years.  Regarding the later point, he indicated that companies which proactively addressed EHS issues would have a competitive advantage over the long run.

You can find a link to the webinar here. 

http://bit.ly/dcrrHD.

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The Members of the European Union’s (“EU”) Environment Committee (“MEPs”) recently voted in favor of proposed amendments to the EU’s Restriction of Hazardous Substances Directive, first passed in 2002, banning the use of nanosilver and long multi-walled carbon nanotubes in electrical and electronic products. The legislators also approved language requiring that any electrical or electronic materials containing nanomaterials should be labeled as such and that manufacturers who use nanomaterials would be required to provide the European Commission with safety data on any materials used. Commentators have noted that the MEPs’ definition of nanomaterials is unclear and the current interpretation could require labeling for every electronic product, such as every transistor in a computer chip. A vote on the proposal is expected in October.

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The NanoSafety Consortium for Carbon has recently posted a bibliography of in vivo tox studies on its website.  The bibliography is (obviously) a work in progress.  We would greatly appreciate it if our readers would bring to our attention any pertinent articles that are not already on the bibliography.  The articles will be used to inform and guide our attempt in crafting a representative toxicity testing regime with US EPA.  Many thanks in advance for your input.

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Just a quick plug for our new NanoSafety Consortium for Carbon which was recently launched to address potential EHS issues concerning its members' products.  You can learn more about the consortium at: www.nanosafetyconsortium.com.

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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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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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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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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
--------------------------------------------------------------------
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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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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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 April issue of Environmental Health Perspectives carries a short article summarizing a seminar at the 2009 AAAS Annual Meeting titled "Driving Beyond Our Nano-Headlights?". In the summary, there is a brief reference to work done by Vanesa Sanchez, a graduate student at Brown University. The results of her experiment are rather alarming.

Ms. Sanchez work showed that

very low doses of CNTs . . . appeared to cause lesions known as granulomas similar to what occurs with asbestos fibers. Moreover, the CNTs formed a cage-like structure that . . .  might promote granuloma formation.

It is too bad that the summary didn't give more space to a study that could have a profound effect on future nanomanufacturing facilities and possible future governmental regulation of the nano-industry.

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On January 22, 2009, California's Department of Toxic Substances Control (DTSC) sent a formal request to several California manufacturers and/or importers of carbon nanotubes seeking information regarding analytical test methods, environmental fate and transport, and other relevant environmental, health, and safety information regarding carbon nanotubes.  The request was issued by DTSC under its authority granted under California's Health and Safety Code 699, Sections 57018-57020.

DTSC asked manufacturers to answer the following questions:

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?

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.

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?

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

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

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?

Recipients have one year to supply the requested information.

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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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The EC's 2006 Registration, Evaluation, Authorisation and Registration of Chemicals ("REACH") regulations place "the responsibility for the management of the risks of [chemical] substances with. . .[the companies that] manufacture, import, place on the market or use [the] substances in the context of their professional activities."  Guidance on Registration, Guidance for the Implementation of REACH, European Chemicals Agency, Version 1.3, May 2008, at p. 12.  

To this end, REACH requires companies manufacturing or importing chemical substances in quantities greater than one ton per year to register those substances before they "can be manufactured, imported or placed on the market."  As part of these requirements, "manufacturers and importers need to collect or generate data on the substances and assess how risks to human health and environment can be controlled by applying suitable risk management measures."  This can often be an expensive and time consuming process.

Providing some relief in certain circumstances, Article 2(7)(a) of Regulation (EC) No 1907/2006 provides that certain substances are exempt from registration under REACH because "sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties." These substances are listed in REACH Annex IV.

On October 8, 2008, the EC removed carbon and graphite from Annex IV "due to the fact that the concerned Einecs and/or CAS numbers are used to identify forms of carbon or graphite at the nano-scale, which do not meet the criteria for inclusion in" Annex IV.   We first posted on this possibility last June.

Commission Regulation (EC) NO 987/2008 of 8 October 2008 Amending Regulation (EC) No 1907/2006 of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes IV and V.

This decision is consistent with the U.S. Environmental Protection Agency's reasoning that nanoscale substances with new molecular identities -- such as fullerenes and carbon nanotubes -- are considered new chemical substances for purposes of premanufacturing notice submissions under the Toxic Substances Control Act.
 

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Last month we reported on a press release by Thomas Swan & Co. Ltd. of the United Kingdom indicating the company had recently entered into a PMN consent order with the EPA under the Toxic Substances Control Act (“TSCA”) concerning one of its multi-walled carbon nanotube (MWCNT) products. Barring an unusual coincidence, it appears that EPA has recently published a redacted version of the Swan Consent order here.

The order makes it clear that the PMN was submitted pursuant to § 5(a)(1) of TSCA, and that it covers a MWCNT product. Additionally, the consent order places several requirements on the manufacturer. Specifically, the manufacturer is required to:

1. Deliver 1 gram of the MWCNTs to EPA with a copy of MSDS for the product;
2. Conduct “90 day inhalation toxicity study in rats with a post exposure; observation period of up to 3 months, including bronchoalveolar lavage fluid (“BALF”) analysis (OPPTS 870.3465 or OECD 413);
3. Submit material characterization data within six months (see below);
4. Ensure employees “use gloves impervious to nanoscale particles and chemical protective clothing;” and
5. Ensure employees “use a NIOSH-approved full-face respirator with an N-100 cartridge while exposed by inhalation in the work area.”

Regarding the second requirement, the consent order also provides the manufacturer with an opportunity to submit toxicity testing data under the Agency’s new Nanoscale Material Stewardship Program as an alternative to the 90 day mouse inhalation test: “If, for example, a consortium of companies commit to testing a representative set of MWCNT for subchronic mammalian toxicity, EPA may consider waiving the triggered testing requirement. EPA would be willing to facilitate the process in coordination with other ongoing health effects testing for MWCNT nationally and internationally. EPA would consider accepting the results of such testing in lieu of triggered testing in this order.”
 

Regarding material characterization information, EPA is requiring the manufacturer to submit the following within six months:

• Type of multi-walled carbon nanotube (concentric cylinders or scrolled tubes; number of walls/tubes);
• Configuration of nanotube ends (e.g., open, capped);
• Description of any branching;
• Width/diameter of inner most wall/tube (average and range);
• Carbon unit cell ring size and connectivity;
• Alignment of nanotube along long axis (straight, bent, buckled);
• Hexagonal array orientation used in the manufacture of the nanotube;
• Particle size of catalyst used in the manufacture of the nanotube;
• Molecular weight (average and range); and
• Particle properties: shape, size (average and distribution), weight (average and distribution), count, surface area (average and distribution), surface to volume ratio, aggregation/agglomeration.

Finally, manufacturers of MWCNTs (other than Thomas Swan) will be interested in two of EPA’s general legal conclusions expressed in the consent order:

“EPA is unable to determine the potential for human health effects from exposure to the PMN substance. EPA therefore concludes, pursuant to § 5(e)(1)(A)(i) of TSCA, that the information available to the Agency is insufficient to permit a reasoned evaluation of the human health effects of the PMN substance.”

“In light of the potential risk to human health posed by the uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance, EPA has concluded, pursuant to § 5(e)(1)(A)(ii)(I) of TSCA, that uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance may present an unreasonable risk of injury to human health.”

No doubt other MWCNT manufacturers will feel the need to file PMN’s for their products similar to Thomas Swan given the language of the consent order.

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A February 2008 study published by six Stanford scientists examined the long term fate of intravenously injected carbon nanotubes in mice.   The scientists' goal was to measure the circulation of SWCNTs in the bloodstream and to determine whether they accumulate in organs and/or tissues.  At the same time, the scientists also studied the effects of functionalizing SWCNTs with polymers.  They found that functionalizing the SWCNTs with polyethyleneglycol enabled full blood circulation in 1 day, yet there was little uptake by the liver and spleen.  Additionally, near complete clearance from main organs occurred in about two months through the excretion of urine and feces.  No toxic side effects were observed.   The authors further found that the SWCNTs became more biologically inert as they increased the number of functionalized polymer branches. 

The scientists concluded that this and other studies "provide a strong indication of the lack of toxicity of well functionalized SWNTs in mice before clearance from the body. In contrast to a previous study of nonfunctionalized pristine carbon nanotubes causing fiber toxicity to mice, our well functionalized SWNTs are highly biocompatible for in vivo applications."

Z. Liu, et al., "Circulation and long-term fate of functionalized, biocompatible single-walled carbon nanotubes in mice probed by Roman spectroscopy," PNAS, Vol. 105, No. 5 at 1410-1415 (February 5, 2008).
 

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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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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.

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