NanoRelease Project in Phase 2

Posted on February 1, 2012 by Lynn L. Bergeson

The NanoRelease Project is intended to support the development of methods to understand the release of nanomaterials used in products. To do this, the Project will: (1) examine full life cycles of nanomaterials in products; (2) work through specific release scenarios at key exposure points of the life cycle; (3) organize existing material characteristics data and measurement methods for those release scenarios; (4) develop a “state of the science” report for release measurement; and (5) carry out inter-laboratory testing to promote improvements, standardization, and widespread use of methods. The NanoRelease Project completed Phase 1 in 2011, resulting in the selection of multi-walled carbon nanotubes (MWCNT) in polymers as the first material to be evaluated through inter-laboratory studies of methods. In Phase 2, three Task Groups of more than 40 experts are evaluating: (1) measurement methods; (2) the effect of materials selected on release rates; and (3) identifying the key exposure/release scenarios. Each Task Group will produce a white paper on their respective topic. Phase 3 is scheduled to begin in late 2012, with a “round robin” approach to inter-laboratory testing using a reference nanomaterial-matrix and positive controls for the study of MWCNT released from selected polymers. The NanoRelease Project is organized by Dr. Richard Canady of the ILSI Research Foundation, and is supported by the U.S. Environmental Protection Agency, Environment Canada, Health Canada, the American Chemistry Council, the Society of Chemical Manufacturers & Affiliates, the National Institute of Standards and Technology, the Adhesive and Sealant Council, and the American Cleaning Institute.

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EPA Issues Final SNUR for Certain Multi-Walled Carbon Nanotubes

Posted on May 9, 2011 by Lynn L. Bergeson

On May 6, 2011, the U.S. Environmental Protection Agency (EPA) promulgated a final significant new use rule (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the chemical substance identified generically as multi-walled carbon nanotubes (MWCNT), which was the subject of premanufacture notice (PMN) P-08-199. Under the final SNUR, persons intending to manufacture, import, or process MWCNT for a use that is designated as a significant new use by the final rule must notify EPA at least 90 days before commencing that activity. EPA states that it believes the final rule is necessary “because the chemical substance may be hazardous to human health,” and 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. The final rule will be effective June 6, 2011.

EPA issued a proposed SNUR on February 3, 2010, and then on July 28, 2010, it reopened the comment period for 30 days to address public comment and add information to the docket. In the May 6, 2011, Federal Register notice, EPA states that, in response to comments on the basis for the proposed SNUR, EPA developed a revised summary document entitled “Summary of EPA’s Current Assessments of Health and Environmental Effects of Carbon Nanotubes,” which specifies EPA’s current hazard concerns as supported by available information and data. According to the May 6, 2011, notice, EPA considered comments on the proposed SNUR, and the final SNUR:

  • Retains the proposed workplace protection and specific use provisions as significant new uses;
  • Adds exclusions from applicability of the SNUR uses identified as ongoing; and
  • Identifies those forms of the subject PMN substance that are exempt from the provisions of the SNUR. These exemptions apply to quantities of the PMN substance:
    • After they have 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.
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EPA Issues Final SNURs for Carbon Nanotubes

Posted on September 17, 2010 by Lynn L. Bergeson

On September 17, 2010, the U.S. Environmental Protection Agency (EPA) issued final significant new use rules (SNUR) for two chemical substances that were the subject of premanufacture notices (PMN). The two chemical substances are identified generically as multi-walled carbon nanotubes (MWCNT) (PMN P08177) and single-walled carbon nanotubes (SWCNT) (PMN P08328). Persons who intend to manufacture, import, or process either of these substances for a use that is designated as a significant new use by the final rule must notify EPA at least 90 days before commencing that activity. EPA states that it believes the SNURs are necessary because these chemical substances may be hazardous to human health and the environment. 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. The final rule is effective October 18, 2010.

EPA issued direct final SNURs on these two substances on June 24, 2009. EPA withdrew the notices on August 21, 2009, after receiving notices of intent to submit adverse comments on the SNURs. EPA issued proposed SNURs on November 6, 2009. In response to comments on the applicability of the SNURs for these chemicals, EPA has included clarifying language for those forms of the subject PMN substances that are exempt from the provisions of the SNURs.  These exemptions apply to quantities of the PMN substances: after they have 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. In response to comments on the basis for the SNURs, EPA developed revised human health effects and environmental effects summaries for carbon nanotubes (CNT).
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EP Committee Adds Nanosilver and Long Multi-Walled Carbon Nanotubes to Proposed RoHS Recast

Posted on June 8, 2010 by Lynn L. Bergeson

On June 2, 2010, the European Parliament (EP) Committee on the Environment, Public Health, and Food Safety approved the proposed recast of the Directive on the Restrictions of Hazardous Substances (RoHS) in Electrical and Electronic Equipment, with 55 votes in favor, one against, and two abstentions. The Committee adopted amendments adding nanosilver and long multi-walled carbon nanotubes (MWCNT) to Annex IV, despite the fact that nanomaterials were not included in earlier proposals. In effect, there would be no threshold, with equipment prohibited from the market if it contained either nanosilver or long MWCNTs at “detectable levels.” The Committee also adopted amendments that require equipment containing nanomaterials to be labeled, and for manufacturers to be required to provide safety data on the nanomaterials to the European Commission (EC). The Committee voted in favor of an “open scope,” meaning that the RoHS Directive would apply to all electrical equipment, unless specifically excluded. The EP plenary vote on the amended proposal is scheduled for July 2010.

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EPA Issues Consent Order for Multiwalled Carbon Nanotubes

Posted on October 16, 2008 by Lynn L. Bergeson

The Environmental Defense Fund (EDF) recently posted two blog items regarding a consent order negotiated by the U.S. Environmental Protection Agency (EPA). The October 9, 2008, item states that EPA intends to issue a sanitized version of a consent order negotiated with a producer of multiwalled carbon nanotubes (MWCNT). According to EDF, the order was prompted by EPA’s review of a premanufacturing notification (PMN).

EDF obtained a redacted copy of the consent order, and provides the following summary of the requirements:

  • Conduct a 90-day inhalation toxicity test in rats;
  • Supply EPA with a one-gram sample of its MWCNTs and its Material Safety Data Sheet;
  • Submit certain characterization data within six months after commencing full manufacture;
  • Require its workers to wear protective gloves and clothing shown to be impermeable and National Institute for Occupational Safety and Health (NIOSH)-approved respirators;
  • Use the substance only for a particular use, claimed confidential but generically identified as a “property modifier” in electronics and polymer composites; and
  • Provide the nanomaterial only to entities that agree to the same use restrictions and worker protection conditions.
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