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

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