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Fullerene PMNs Filed With EPA, Adding to PMN Submissions on Nanomaterials

Beveridge & Diamond, P.C. - Client Alert, December 23, 2008

The Environmental Protection Agency (EPA) recently announced its receipt of the first premanufacture notices (PMNs) for fullerenes known to have been submitted to EPA.  See 73 Fed. Reg. 75,711 (Dec. 12, 2008).  These PMNs are part of a growing number of PMNs filed with EPA on nanomaterials.

Fullerenes are a category of nanomaterials.  They are closed-cage carbon molecules which vary in the number of carbon atoms they have and in their shape.  Fullerenes in the shape of soccer balls are known as buckyballs (a reference to the geodesic domes of Buckminster Fuller). 

The four PMNs for fullerene compounds were submitted by Nano-C, Inc., a company specializing in the development of nanostructured carbon materials.  According to the notice, the fullerenes are based on C60, C70, and C84 (carbon cages with those numbers of carbon atoms in each molecule).  The described uses for each of the fullerenes were (1) compound for use in organic electronic devices; (2) compound used to improve the mechanical properties of rubbers, plastics, and lubricants; (3) compound for use as an additive to increase the conductivity of materials.

Section 5(a) of the Toxic Substances Control Act (TSCA) generally precludes non-exempt commercial manufacture of a new chemical substance unless the manufacturer first submits a PMN to EPA and EPA reviews it.  A chemical substance is considered “new” and therefore subject to Section 5(a) if it is not on EPA’s list of existing chemical substances known as the TSCA Inventory.  With the development of nanotechnology, debate began over whether nanomaterials should be considered new chemical substances.  Companies have taken differing approaches to the issue of whether or not nanoscale versions of existing chemicals are covered by current TSCA Inventory listings for those chemicals.

In January 2008, EPA announced that it would classify nanomaterials under TSCA according to chemical identities rather than their properties.  Substances with a chemical identity different from substances on the TSCA Inventory would be considered new chemical substances.  In October, EPA reiterated this approach by clarifying that carbon nanotubes have a different chemical identity than graphite (which is on the TSCA Inventory) and that PMNs must be submitted for carbon nanotubes which are not already listed on the TSCA Inventory.  See 73 Fed. Reg. 64,946 (Oct. 31, 2008).  

The earliest PMNs for nanomaterials identified as such date back to the 1980s, when two PMNs for dendrimers were filed.  Dendrimers are nanoscale polymers with branches in a tree-like structure.  PMNs have also been filed for other kinds of nanomaterials, including polyhedral oligomeric silsesquioxanes (POSSs), which are cage-like hybrid molecules of silica and oxygen; coated nanoparticles; carbon nanotubes; and others.  Two PMNs for coated nanoparticles have resulted in significant new use rules.  See 73 Fed. Reg. 65,743 (Nov. 5, 2008). 

It is difficult to know the precise number of PMNs submitted for nanomaterials, since the EPA notices reporting the receipt and status of PMNs may use a generic name to identify the chemical substance.1  Thus, this list of nanomaterial PMNs submitted to EPA may be incomplete.  Nevertheless, it is clear that persons manufacturing or importing nanomaterials, or planning to do so, should confirm the TSCA Inventory status of their nanomaterials and, if necessary, take appropriate actions.

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For more information, please contact Mark Duvall at (202) 789-6090 (mduvall@bdlaw.com) or Phil Moffat at (202) 789-6027 (pmoffat@bdlaw.com).

Key documents are available below:


1 Media reports indicate that EPA has received a number of nanomaterial PMNs.  See, e.g., Pat Phibbs, Manufacture of New Carbon Nanotube Approved by EPA Under an Exemption, BNA Chem. Reg. Rep. Oct. 24, 2005; Pat Phibbs-Rizzuto, EPA Reviews 15 New Nanoscale Chemicals, But Finds Only One With Unique Properties, BNA Daily Env’t Rep., Aug. 16, 2006, at A-7.