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

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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