Webinar: The Rise of MWNTs

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:

 

  • Sporting goods: 4 tons (2009) versus 270 tons (2020)
  • Aerospace/defense: less than 1 ton (2009) versus 67 tons (2020)
  • Wind turbines: 130 kg (2009) versus 253 tons (2020)
  • Automobile industry: 56 tons (2009) versus 2351 tons (20020)
  • Batteries: 67 tons (2009) versus 763 tons (2020)

 

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.

European Parliament Members Vote for Ban on Nanomaterials, Including Nanosilver and Carbon Nanotubes

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.

Nanoscale Carbon: In Vivo Tox Bibliography

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.

NanoSafety Consortium for Carbon

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.

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:
  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

 

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.

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

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.

Carbon Nanotubes

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.

California Formally Requests Carbon Nanotube Information From Manufacturers

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.

Interim Report: Lukewarm Response to EPA's Nanoscale Material Stewardship Program

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.

  

Beyond numbers and types of nanoscale materials, EPA also notes that "very few submissions provided either toxicity or fate studies."  This lack of information provides EPA with several challenges to meeting the NMSP's basic goal of determining whether certain nanoscale materials or categories may present risks to human health and the environment.  No doubt these challenges have contributed to EPA's recent attempt to use TSCA consent orders and SNURs to generate animal inhalation toxicity data.

An Ill-Fated Comparison

As apparent justification for the number and quality of submissions, EPA compares the information it has received under the NMSP thus far with the information available in two publicly available databases:  (i) Nanowerk's Nanomaterials Database; and (ii) Project on Emerging Nanotechnologies Inventory of Nanomaterials in Consumer Products.  EPA selected these two databases because "[a]s far as EPA is aware, there is no comprehensive database of nanoscale materials, which is a critical need for better understanding the universe of commercially available nanoscale materials."  Unfortunately, neither database was designed for this purpose (although I am a big fan of both).  Using these databases in this manner further points out the difficulties facing EPA.  Simply put, both Nanowerk and PEN appear to have far better data collections than EPA -- an unacceptable condition.

Nonetheless, EPA's search of the Nanowerk database identified 2,084 potential nanoscale materials, which the Agency then condensed to a list of 1332 potential submissions by excluding new chemical substances under TSCA (e.g./ carbon nanotubes and fullerenes), eliminating materials in which it has no interest, and grouping materials with the same molecular identity.  EPA then identified 55 commercially relevant chemicals from this truncated list.  EPA, however provides, no good reason for excluding new chemical substances from its analysis, nor does it make a convincing case that it can actually determine molecular identity from Nanowerk's database.

A similar analysis of PEN's database identifies 566 nanoscale materials, out of which EPA finds that 48 are commercially relevant chemicals. 

It is clear that despite all of this winnowing, the amount and quality of data submitted thus far under the NMSP is dwarfed by that available in both the Nanowerk and PEN databases.  Given this situation, it is hard to imagine that advocacy groups will remain muted until EPA's final NMSP report is released in 2010.  Another table from the report summarizing this comparison data follows.

 

 



 

PDF of "A Nano-Mesothelioma False Alarm"

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

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

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

 

 

Carbon Nanotubes and TSCA Registrations

Today, US EPA issued a Federal Register notice stating the Toxic Substances Control Act (TSCA) registration requirements are "potentially applicable to carbon nanotubes."  EPA confirmed its position the CNTs are "chemical substances distinct from graphite or other allotropes of carbon listed on the TSCA inventory."  The bottom line is stated succinctly by EPA: "Many CNTs may therefore be new chemicals under TSCA Section 5."

Consequently, those companies that use or import CNTs will have to ensure such materials are registered on the TSCA inventory before manufacturing commences or importation occurs.  To determine if a particular type of CNT is already on the Inventory, manufacturers and importers can submit a bona fide intent to manufacture or import letter to EPA under 40 CFR 720.25, and EPA will respond as to the particular listing.  Further, "sometime after March 1, 2009, EPA anticipates focusing its compliance monitoring efforts to determine if companies are complying with TSCA section 5 requirements for carbon nanotubes."

The message here couldn't be more clear: if you are manufacturing or using CNTs, you must comply with TSCA.  EPA admits that some of the confusion over listing/not listing may be due to prior communications, but this notice removes all confusion.  EPA indicates that it is reviewing "several" premanufacture notices for carbon nanotubes, so it is likely many of the "common" CNTs will be registered soon.  In the meantime, expect CNTs to be treated as "new" chemicals under TSCA.

Registration of Carbon Nanoscale Materials Required Under REACH

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.
 

First Commercial Insurance Exclusion for Nanotechnology

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

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

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

Background on Nanotubes

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

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

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

Notice to Policyholders

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

Nanotubes and Nanotechnology Exclusion

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

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

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

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

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

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

Nanotechnology Law Report -- June 2008

Nanotechnology Law Report -- June 2008

Functionalize Carbon Nanotubes Deemed "Highly Biocompatible"

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).
 

Media Rips Carbon Nanotubes

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.


 

The letter's authors related the results of an in vivo study in which they injected various types of carbon nanotubes into the mesothelial abdominal lining of mice. The study was driven, in part, because of prior speculation regarding a superficial resemblance between certain carbon nanotubes and asbestos fibers, as well as prior studies showing possible adverse EHS effects from exposure to certain types of carbon nanoparticles under laboratory conditions. While not actually causing mesothelioma, the scientists "observed that long MWCNTs produced inflamation FBGCs and granulomas similar to the foreign body inflammatory response caused by long asbestos fibres.“ Of course, the mice did not actually inhale carbon nanotubes (of any size) in the experiment, nor did the nanotubes end up in the chest cavity. The researchers further concluded that the "study does not address whether CNTs would be able to reach the mesothelium in sufficient numbers to cause mesothelioma following inhalation exposure.”

To those judging whether media coverage of the issue has been "fair and balanced," below are some of the more notable articles we have come across since the Poland study was published.

“Are Nanotubes the Next Asbestos?”
Chemical Week, June 2, 2008

“CANCER; Carbon Nanotubes That Look Like Asbestos, Behave Like Asbestos”
Lab Business Week, June 8, 2008
Oncology Business Week, June 8, 2008
Preventive Medicine Week, June 8, 2008
Healthcare Mergers, Acquisitions & Ventures, June 7, 2008
Law & Health Weekly, June 7, 2008
Obesity, Fitness & Wellness Week, June 7, 2008
Biotech Law Weekly, June 6, 2008
Health Business Week, June 6, 2008
Lab Law Weekly, June 6, 2008
Medicine & Law Weekly, June 6, 2008
Biotech Week, June 4, 2008
Healthcare Finance, Tax & Law Weekly, June 4, 2008
Cancer Weekly, June 3, 2008
Disease Prevention week, June 3, 2008
Health Risk Factor Week, June 3, 2008
Clinical Oncology Week, June 2, 2008
Health & Medicine Week, June 2, 2008
Space Daily, May 22, 2008
PR Newswire Europe, May 20, 2008
US Newswire, May 20, 2008

“Cancer concerns over carbon nanotubes”
MINT, May 21, 2008

“Cancer risk seen in nanotechnology; Tiny cylinders used in some products act like asbestos, a study finds”
Los Angeles Times, May 21, 2008

“Carbon nanotube has similar effects to asbestos”
Bioworld Week, May 26, 2008

“Carbon nanotubes as bad as asbestos, says study”
Indo-Asian News Service, May 21, 2008

“Carbon nanotubes behave like asbestos, study shows”
Electronic News, May 26, 2008

“Carbon Nanotubes Could Pose Health Risks Akin to Asbestos”
ChemWeek’s Business Daily, May 23, 2008

“Carbon nanotubes, key ingredient in nanotechnology work, mimic asbestos in mouse tests”
AP Worldstream, May 20, 2008

“Carbon nanotubes may be as hazardous to health as asbestos”
Guardian Unlimited, May 20, 2008

“Carbon nanotubes mimic asbestos in early study”
AP, May 20, 2008
AP Financial Wire, May 20, 2008
AP State & Local Wire, May 20, 2008

“Carbon nanotubes that look like asbestos just as cancerous”
Hindustan Times, May 21, 2008

“Comparison of Nanotubes to Asbestos Spurs Call for EPA, Hill Action”
Superfund Report, June 2, 2008
Water Policy Report, May 26, 2008
Defense Environment Alert, May 27, 2008
Risk Policy Report, May 28, 2008
Inside EPA, May 23, 2008
Environmental Policy Alert, May 21, 2008

“Danger of Nanotube”
Mirror, May 21, 2008

“Effects of Nanotubes May Lead to Cancer, Study Says”
Washington Post, May 21, 2008

“Fears over wonder nanotubes”
West Australian, May 22, 2008

“Health threat of nanotubes may be similar to asbestos, study warns”
Guardian, May 21, 2008

“Hi-Tech Fibres Scare”
Herald Sun, May 22, 2008

“How safe are nanoparticles?”
Christian Science Monitor, May 21, 2008

“In Study, Researchers Find Nanotubes May Pose Health Risks”
New York Times, May 21, 2008

“Nano-fibres lead to pre-cancer symptoms in mice”
Agence France Presse, May 20, 2008

“Nanofibres linked to cancer”
Daily Mail, May 21, 2008

“Nanotech could cause mesothelioma”
ABC Premium News, May 21, 2008

“Nanotubes could cause lung disease like asbestos”
New Scientist, May 24, 2008

“Nanotubes, Like Asbestos, Could Threaten Health”
NPR, May 21, 2008

“Nanotubes may cause cancer hazard”
Guardian Weekly, May 30, 2008

“Nanotubes may pose risk that asbestos does, study reports”
Virginian-Pilot, May 21, 2008

“New cancer alert”
Birmingham Evening Mail, May 21, 2008
Birmingham Mail, May 21, 2008

“New technology may be as bad as asbestos”
Daily Mail, May 21, 2008

“Some nanotubes as dangerous as asbestos”
UPI, May 21, 2008

“Some nanotubes could cause cancer threat – study”
E&E News PM, May 20, 20008

“Study Comparing Nanotubes, Asbestos Prompts Call for EPA Action”
Clean Air Report, May 28, 2008

“Study Finds Certain Nanotubes Could Be as Dangerous as Asbestos”
Inside OSHA, May 26, 2008

“Study links nanotubes to possible lung illness”
International Herald Tribune, May 22, 2008

“Study: ‘Nanotubes’ Pose Same Danger as Asbestos”
Post-Tribune, May 21, 2008

“Study Seen Impacting Expected Cal/EPA Nanotechnology Bill”
Inside Cal/EPA, May 23, 2008

“Study Waves Cautionary Flag About Nanotubes”
National Public Radio, May 23, 2008

“The microparticles that could pose the same risk as asbestos”
Daily Mail, May 21, 2008