March 1, 2010
Gibson, Dunn & Crutcher’s Environmental Litigation and Mass Tort Group is closely tracking regulatory and legislative activity relating to the regulation of nanotechnology, which is an emerging technology that involves an increasing number of products and businesses. In light of recent activity by Congress and the Environmental Protection Agency (EPA), we expect that a new federal nanotechnology regulatory environment will continue to develop this year. We will provide updates on information and legal issues that might prove useful to nanotechnology stakeholders as regulatory activity develops in this area.
Nanotechnology refers to techniques for using phenomena and structures that only occur at an extremely small scale (1 to 100 nanometers). It is considered a “general purpose technology” that, like the Internet, could significantly impact a wide range of industry sectors and products. Although many applications of nanotechnology are not yet commercially available, it has been reported that over 1,000 manufacturer-identified products or product lines on the global market are made with nanotechnology.
Carbon-based nanomaterials, such as carbon nanotubes and fullerenes, represent the second most used nanomaterial in consumer products, behind only nanoscale silver, which is an antimicrobial agent. Other nanoscale materials in use include zinc, silica, titanium, and gold. If the introduction of new products continues at the present rate, it has been estimated that the number of products will reach close to 1,600 within the next two years, and by 2012, nanoproducts will account for 15 percent of total global manufacturing.
This update focuses on EPA’s recent proposed significant new use rule for multi-walled carbon nanotubes.
EPA Reissues Significant New Use Rule for Multi-Walled Carbon Nanotubes
EPA is proposing a significant new use rule (SNUR) that will require manufacturers or importers of specific multi-walled carbon nanotubes to provide notice of any uses that deviate from the premanufacture notice submission as a significant new use. Such notices allow EPA to assess risks that may be presented by the intended uses and, if appropriate, regulate the proposed use before it occurs.
The new proposed rule, which was published in the Federal Register on February 3, applies only to the multi-walled carbon nanotubes described by the premanufacture notice number P-08-199. (See 75 Fed. Reg. 5546.) In the past, some stakeholders have questioned whether these types of SNURs apply to all variants of carbon nanotubes. The agency has indicated that is not the case.
EPA began regulating nanotechnology under the Toxic Substances Control Act (TSCA) last June. At that time, and pursuant to its authority under TSCA Section 5(a)(2), EPA issued SNURs for multi-walled and single-walled carbon nanotubes that previously were the subject of premanufacture notices. (See 74 Fed. Reg. 29,982.) The agency, however, withdrew the SNURs shortly thereafter because it had received notice that adverse comments would be submitted. (See 74 Fed. Reg. 42,177.) By re-issuing part of the direct final SNUR that was previously withdrawn, the agency continues to demonstrate its readiness to use TSCA to regulate nanomaterials.
EPA’s new proposed rule also provides some insight into the types of concerns that may be the subject of future regulation. The current proposed rule is based on the use of multi-walled carbon nanotubes as an additive and/or filler for polymer composites and support media for industrial catalysts. Test data on similar particulates identified concerns for possible lung effects, immunotoxicity, and mutagenicity from exposure to the substance.
For the uses described in the premanufacture notice, worker inhalation and skin exposures are minimal due to the use of personal protective equipment, the notice said. For that reason, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk.
On the other hand, EPA has determined that use of the substance may cause serious health effects if: (1) it is used without gloves and protective clothing (where there is a potential for skin exposure), (2) it is used without a National Institute for Occupational Safety and Health-approved full-face respirator with an N100 cartridge (where there is a potential inhalation exposure), or (3) it is used in ways other than described in the premanufacture notice.
The proposed rule also identified certain tests that would help characterize the human health effects of the multi-walled carbon nanotubes at issue. Neither the proposed rule nor TSCA Section 5 requires those submitting significant new use notices to develop any particular test data. EPA does, however, upon review of premanufacture and significant new use notices, have the authority to require testing. Such obligations may be the next step in regulating these substances.
EPA is accepting comments on the proposed rule through March 5, 2010.
Gibson, Dunn & Crutcher’s Environmental Litigation and Mass Tort Group will continue to monitor this area and provide updates as significant events occur.
Gibson, Dunn & Crutcher lawyers are available to assist in addressing any questions you may have about these developments. To learn more about the firm’s Environmental Litigation and Mass Tort Practice Group, please contact the Gibson Dunn attorney with whom you work, or any of the following Practice Group Co-Chairs:
Alan N. Bick (949-451-4211, [email protected])
© 2010 Gibson, Dunn & Crutcher LLP
Attorney Advertising: The enclosed materials have been prepared for general informational purposes only and are not intended as legal advice.