Nanotechnology Lawyer & Attorney : Bergeson & Campbell Law Firm : Nanotechnology Law Blog

The U.S. Environmental Protection Agency (EPA) published on February 3, 2010, a proposed significant new use rule (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for multi-walled carbon nanotubes. The proposed rule would require persons who intend to manufacture, import, or process the substance for an activity that is designated as a significant new use by the proposed rule to notify EPA at least 90 days before commencing that activity. EPA states that the required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. Comments are due March 5, 2010.

The proposed rule provides the following basis for action:

The PMN states that the substance will be used as an additive/filler for polymer composites and support media for industrial catalysts. Based on test data on analogous respirable, poorly soluble particulates and on other carbon nanotubes (CNTs), EPA identified concerns for lung effects, immunotoxicity, and mutagenicity from exposure to the PMN substance. For the uses described in the PMN, worker inhalation and dermal exposures are minimal due to the use of adequate personal protective equipment. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance without the use of gloves and protective clothing, where there is a potential for dermal exposure; use of the substance without a National Institute for Occupational Safety and Health (NIOSH)-approved full-face respirator with an N100 cartridge, where there is a potential for inhalation exposure; or use other than as described in the PMN, may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at 721.170(b)(3)(ii).

The proposed SNUR would apply only to the multi-walled carbon nanotubes described in premanufacture notice (PMN) P08-199. According to EPA, in the past, some stakeholders have asked whether these types of SNURs apply to all variants of carbon nanotubes. EPA states: “This is not the case.” The chemical name listed in the proposed SNUR is “multi-walled carbon nanotubes (generic),” and the CAS Number is “not available.” On November 6, 2009, EPA published a proposed SNUR for the multi-walled carbon nanotubes described in PMN P08-177.

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On January 8, 2010, the U.S. Environmental Protection Agency (EPA) extended until February 8, 2010, the comment period for its November 6, 2009, proposed significant new use rules (SNUR) for multi-walled carbon nanotubes (CNT) and single-walled CNTs.  According to the January 8, 2010, notice, EPA received a request to extend the comment period.  On December 1, 2009, the U.S. World Trade Organization (WTO) Technical Barriers to Trade (TBT) Inquiry Point at the National Institute of Standards and Technology (NIST), on behalf of the European Economic Community (EEC) WTO TBT Enquiry Point, submitted a request to extend the comment period. According to the request, “the European Communities are currently reviewing the draft regulation,” and request that the comment deadline be extended. According to Charles Auer, formerly the Director of EPA’s Office of Pollution Prevention and Toxics (OPPT) and now affiliated with Bergeson & Campbell, P.C., this is the first request he is aware of from the EEC TBT Enquiry Point to OPPT. Auer noted that the EEC is not necessarily raising a trade concern, but may simply want to know the scope of the proposed regulation.

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On November 6, 2009, the U.S. Environmental Protection Agency (EPA) proposed significant new use rules (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for two chemical substances that were the subject of premanufacture notices (PMN). EPA identified the substances generically as multi-walled carbon nanotubes and single-walled carbon nanotubes. According to the notice, these substances are subject to TSCA Section 5(e) consent orders issued by EPA. The consent orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The proposed SNURs are based on and consistent with the provisions in the underlying consent orders, and designate as a significant new use the absence of the protective measures required in the corresponding consent orders. Persons who intend to manufacture, import, or process either of these two substances for an activity that is designated as a significant new use would be required by the proposed rule to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. Comments are due December 7, 2009.

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Today’s Federal Register includes a notice from the U.S. Environmental Protection Agency (EPA) withdrawing the June 24, 2009, final significant new use rules (SNUR) for multi- and single-walled carbon nanotubes (CNT). EPA states that it published the final SNURs using direct final rulemaking procedures. Because EPA received a notice of intent to submit adverse comments on the rules, it is withdrawing the SNURs for CNTs. The Federal Register notice does not identify the commenter. The docket for the rulemaking includes a July 22, 2009, letter from WilmerHale stating that it intends to submit adverse comments on behalf of one or more clients. According to the notice, EPA “intends to publish in the Federal Register, under separate notice and comment rulemaking procedures, proposed SNURS for these two chemical substances.” The withdrawal is effective August 21, 2009.

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On July 28, 2009, the U.S. Environmental Protection Agency (EPA) clarified its June 24, 2009, final Significant New Use Rules (SNUR) for multi- and single-walled carbon nanotubes (CNT).  According to EPA, upon review of the final rule, stakeholders asked whether the SNURs applied to all types of CNTs.  EPA responded:

 

This is not the case.  These SNURs only apply to the specific carbon nanotubes that were the subject of the premanufacture notices (PMN) 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.

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According to a notice in the U.S. Environmental Protection Agency's (EPA) May 11, 2009, Regulatory Agenda, a Toxic Substances Control Act (TSCA) Section 4(a) test rule “may be needed to determine the health effects” of multiwall carbon nanotubes (CNT). EPA states that the results of the tests that could be required under the rule could assist in understanding the health effects of the substance to manage/minimize any potential risk and exposure. Results could also help with establishing a correlation between the chemical/physical properties and health effects needed to protect the health of workers handling the substance. EPA has not determined when it will publish a notice of proposed rulemaking (NPRM).

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On April 8, 2009, the National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice announcing that it “intends to evaluate the scientific data on carbon nanotubes (CNTs) and develop appropriate communication documents, such as an Alert and/or Current Intelligence Bulletin [CIB], which will convey the potential health risks and recommend measures for the safe handling of these materials.” CIBs are issued by NIOSH “to disseminate new scientific information about occupational hazards. A CIB may draw attention to a previously unrecognized hazard, report new data on a known hazard, or disseminate information on hazard control.”

According to the notice, NIOSH has developed guidelines for managing the potential health concerns associated with occupational exposures to engineered nanoparticles, which “will provide the framework for developing specific recommendations for CNTs.” Comments are due May 15, 2009.

NIOSH is requesting the following information:

1. Published and unpublished reports and findings from in vitro and in vivo toxicity studies with CNTs;
2. Information on possible health effects observed in workers exposed to CNTs;
3. Information on workplaces and products in which CNTs can be found;
4. Description of work tasks and scenarios with a potential for exposure;
5. Workplace exposure data; and
6. Information on control measures (e.g., engineering controls, work practices, personal protective equipment) that are being used in workplaces where potential exposures to CNTs occur.

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On March 6, 2009, the United Kingdom (UK) Health and Safety Executive (HSE) published an information sheet on the risk management of carbon nanotubes (CNT). According to HSE, the information sheet “is specifically about the manufacture and manipulation of carbon nanotubes and has been prepared in response to emerging evidence about the toxicology of these materials. However, the risk management principles detailed here are equally applicable to other nanodimensioned bio-persistent fibres with a similar aspect ratio.” HSE cites as “new evidence” a recent study by the University of Edinburgh, which “found that long, straight [multi-walled CNTs] with a high aspect ratio produced a marked inflammatory reaction and the formation of granulomas when injected into the abdominal cavity of mice.”

HSE states:

HSE views CNTs as being substances of very high concern. Although the recent findings only apply to some CNTs, we think a precautionary approach should be taken to the risk management of all CNTs, unless sound documented evidence is available on the hazards from breathing in CNTs. If their use cannot be avoided, HSE expects a high level of control to be used.

The information sheet includes specific recommendations for risk management. According to the information sheet, waste CNTs “should be classified and coded as hazardous waste.”

 

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In a January 22, 2009, letter, the California Department of Toxic Substances Control (CDTSC) announced that it is requiring the submission of data “regarding analytical test methods, fate and transport in the environment, and other relevant information from manufacturers of carbon nanotubes” (CNT). CDTSC states that the term “manufacturers” includes persons and businesses that produce CNTs in California or import CNTs into California for sale.  According to the letter, CDTSC is using its authority under California Health and Safety Code, Chapter 699, Sections 57018-57020. Section 57019(d)(2) requires that the data requested be provided within one year of the date of the letter.

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According to the Office of the Federal Register, tomorrow the U.S. Environmental Protection Agency (EPA) will publish a notice regarding the Toxic Substances Control Act (TSCA) requirements potentially applicable to carbon nanotubes (CNT). EPA states that it “generally considers CNTs to be chemical substances distinct from graphite or other allotropes of carbon listed on the TSCA Inventory.” As a result, many CNTs may therefore be new chemicals under TSCA Section 5. Manufacturers or importers of CNTs not on the TSCA Inventory must submit a premanufacture notice (PMN) (or applicable exemption) under TSCA Section 5 where required under 40 C.F.R. Part 720 or Part 723. To determine the TSCA Inventory status of a CNT, a manufacturer may submit to EPA a bona fide intent to manufacture or import under 40 C.F.R. Section 720.25.  According to the notice, some time after March 1, 2009, EPA anticipates focusing its compliance monitoring efforts to determine if companies are complying with TSCA Section 5 requirements for CNTs.

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The International Agency for Research on Cancer (IARC) recently solicited nominations for substances for review in future IARC Monographs, which identify environmental factors that can increase the risk of human cancer. IARC states that it will select substances for review based on: (a) evidence of human exposure; and (b) evidence or suspicion of carcinogenicity. The 51 substances nominated include carbon nanotubes, which received three nominations:

Name	David Coggon
Principal affiliation	MRC Epidemiology Resource Centre, University of Southampton, United Kingdom
Public health reason for IARC to undertake this review?	Nanotechnology is developing rapidly with many potential applications. Evidence is beginning to emerge that nanotubes could pose cancer risks similar to those from asbestos.

Name	Jennifer Sass
Principal affiliation	Natural Resources Defense Council
If the substance was previously reviewed, what new information would lead to a change in the evaluation?	Multiwalled Carbon Nanotubes (MWCNT): Substantial animal studies report that exposure to MWCNTs by tracheal installation induces progressive, irreversible lung fibrosis that would likely lead to cancer. New data strongly suggests the potential for single-walled carbon nanotubes (SWCNT) to cause lesions that may lead to mesothelioma. The potentially-widespread use of these new materials and allied potential for exposure and harm argue strongly for an evaluation of existing literature. Objective review of existing information is critical to support appropriate actions across the globe on this potential carcinogen.
Public health reason for IARC to undertake this review?	Widespread water contaminant.

Name	Paul A. Schulte, Ph.D.
Principal affiliation	National Institute for Occupational Safety and Health
Public health reason for IARC to undertake this review?	Carbon nanotubes are likely to be used increasingly in a large number of products. Therefore, increasing numbers of workers may be exposed to them. Preliminary information indicates that carbon nanotubes may have similar carcinogens potential as other durable natural or man-made fibers.

To assist IARC in selecting substances for review, it is convening an Advisory Group to review all public nominations and to recommend those it considers to be of high priority. According to IARC, the Advisory Group “may also propose additional agents at the meeting for discussion and possible inclusion on their list of recommended priorities. In making their recommendations, the Advisory Group will consider near-term public-health priorities and recent research and research in progress.” The Advisory Group will meet on June 17-20, 2008.

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On May 10, 2007, EHP-in-Press posted an article entitled “Reviewing the Environmental and Human Health Knowledge Base of Carbon Nanotubes.” The authors reviewed the currently available literature about the human health and environmental risk potential of carbon nanotubes (CNT). The authors also investigated the life cycle of the CNT, as release into different environmental compartments may occur at the production stages as well as the product’s usage and disposal stages, which may indirectly or directly cause human exposure. Because, according to the authors, the published literature revealed many open questions, they also systematically interviewed seven leading scientists worldwide and integrated their contemporary knowledge in the review. The authors interviewed scientists who were key authors or project leaders, having investigated and reported the potential impacts of CNT on human health or environment. Through this combined approach, the authors present an updated and contemporary knowledge base for scientific discussion.

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