September 24, 2009
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 regulation and law develops in this area.
This update focuses on the Environmental Protection Agency’s announcement that it is withdrawing significant new use rules (SNURs) for two types of carbon nanotubes because it had received notice that adverse comments would be submitted. See 74 Fed. Reg. 42,177.
On June 24, the EPA published significant new use rules for single-walled and multi-walled carbon nanotubes—substances that were the subject of premanufacture notices (PMNs)—using direct final rulemaking procedures. In this rulemaking, EPA wrote that the premanufacture notices it received for these materials indicated that they would be used in electronic applications and in polymer composites. The agency expressed concern over possible respiratory and dermal health effects of the nanotubes, and recommended a 90-day inhalation study in rats to further characterize their possible health effects. Both single-walled and multi-walled carbon nanotubes are subject to Toxic Substances Control Act consent orders issued by EPA.
In a letter dated July 22, unnamed parties notified the agency of their intent to submit adverse or critical comments on the two significant new use rules. As a result, the agency announced on August 21st that it was withdrawing the significant new use rules and intends to resubmit the rules for the two substances to notice and comment rulemaking in a future Federal Register. This expected notice and comment period presents an opportunity for industries that may be significantly impacted by this emerging technology to address the shape of nanotechnology regulation at its inception.
Growth of Nanotechnology
Nanotechnology, which refers to techniques for using phenomena and structures that only occur at an extremely small scale (1 to 100 nanometers), 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, over 1,000 manufacturer-identified products or product lines on the global market are made with nanotechnology, according to an August 25 update of the Nanotechnology Consumer Products Inventory, which is maintained by the Project on Emerging Nanotechnologies (PEN).
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, the number of products listed in the inventory will reach close to 1,600 within the next two years, according to PEN Director David Rejeski. It is estimated that by 2012 nanoproducts will account for 15 percent of total global manufacturing.
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])
© 2009 Gibson, Dunn & Crutcher LLP
Attorney Advertising: The enclosed materials have been prepared for general informational purposes only and are not intended as legal advice.