Beveridge & Diamond
 
Related Practices
Related Practices
Related Industries
Related Industries

EPA Threatens Enforcement against Manufacturers of Carbon Nanotubes and Enacts Significant New Use Rules for Two Other Nanoparticles

Beveridge & Diamond, P.C. - Client Alert, November 17, 2008

The Environmental Protection Agency (EPA) recently published two Federal Register notices concerning the regulation of nanomaterials under the Toxic Substances Control Act (TSCA), 15 U.S.C. §§ 2601-2692.  In the first notice, EPA clarified the TSCA Inventory status of carbon nanotubes (CNTs), explaining to manufacturers and importers that many CNTs may be “new” chemicals under TSCA subject to the premanufacture notice (PMN) requirements.  This first notice warns that the agency may soon begin to initiate enforcement actions against persons in violation of the PMN provisions.  In the second notice, EPA enacted significant new use rules (SNURs) for two different siloxane-modified nanoparticles, representing the agency’s first nanotechnology-specific regulations and potentially signaling more aggressive regulation of nanomaterials in the future.

Inventory Status of Carbon Nanotubes

On October 31, 2008, EPA published a Federal Register notice (73 Fed. Reg. 64946) clarifying the TSCA Inventory status of CNTs.  According to EPA, CNTs that are subject to TSCA jurisdiction may be “new” chemicals, with “molecular identities” that are distinct from graphite or other allotropes of carbon already listed on the TSCA Inventory.  EPA reports that it has made several public statements and responses to written inquiries to establish this position, which clarifies earlier guidance from the agency that may have created some confusion among industry members about the Inventory status of CNTs.  Anecdotal evidence suggests that some manufacturers or importers were relying on the Inventory listing for graphite instead of filing PMNs for their CNTs.

CNTs that are “new” chemicals would be subject to TSCA section 5(a)(1)(A) just as new non-nanoscale chemical substances would be.  Section 5(a)(1) requires a company manufacturing or importing a new chemical to file with the EPA a PMN at least 90 days prior to manufacture, including importation, of the chemical for non-exempt commercial purposes.  Alternatively, manufacturers or importers of CNTs may qualify under the provisions of 40 C.F.R. parts 720 or 723 for an exemption from the PMN requirements, but many of these exemptions require applications.  EPA reports that it has already received several PMNs for CNTs that are new chemical substances.  This latest Federal Register notice will likely increase the number of PMNs and exemption applications that it receives in the near future for CNTs.

The agency also reminds manufacturers and importers that when evaluating the TSCA Inventory status of a particular CNT, the manufacturer or importer may submit a bona fide intent to manufacture or import under 40 C.F.R. § 720.25 to determine whether a specific CNT is already on the TSCA Inventory.  In addition, the agency’s guidance document, entitled “TSCA Inventory Status of Nanoscale Substances – General Approach” (notice of availability at 73 Fed. Reg. 4861 (Jan. 28, 2008)), provides general guidelines to assist with this evaluation.  The guidance document explains some of the basic considerations when assessing whether a particular CNT, or other nanoscale chemical substance, may be a new chemical potentially subject to the PMN requirements.  Many CNT manufacturers or importers are likely to find the guidance of marginal benefit and will need to engage the agency directly.

According to EPA’s Federal Register notice, chemical manufacturers – including those entities that import CNTs for commercial purposes – should do the following:  (1) determine whether the CNTs they manufacture are outside of TSCA’s jurisdiction, which is the case for chemical substances used in pesticides, foods, drugs, and cosmetics; (2) determine whether their CNTs are presently on the TSCA Inventory; (3) determine whether any PMN exemptions apply; and (4) prepare and submit PMNs for their CNTs if they are not on the TSCA Inventory and not exempt.

EPA also issued a strong warning against continued noncompliance with the PMN requirements based on its current interpretation of the TSCA Inventory status of CNTs.  The notice states that “some time after March 1, 2009” the agency will begin to focus its efforts on determining whether CNT manufacturers or importers are complying with the TSCA PMN provisions.  Companies that may be currently importing or manufacturing CNTs in the United States, or intend do so in the future, should carefully evaluate their compliance status.  The notice may remove any defense against liability that a company may have based on a lack of sufficient notice of the agency’s interpretation.  Companies that may have potential violations of these or other TSCA requirements should carefully consider whether to voluntarily disclose their compliance status to EPA under the agency’s “Audit Policy” (Incentives for Self-Policing: Discovery, Disclosure, Correction and Prevention of Violations, 65 Fed. Reg. 19616 (Apr. 11, 2000)).  Under the Audit Policy, a company may receive up to 100% mitigation of the gravity-based component of a penalty.  However, the Audit Policy does not relieve a company from paying penalties for the “economic benefit” of its noncompliance, nor does it prevent a company from experiencing potential supply chain disruptions while it completes the PMN process.

SNURs for Siloxane-Modified Nanoparticles

On November 5, 2008, EPA published a Federal Register notice promulgating direct final Significant New Use Rules (SNURs) under TSCA section 5(a)(1)(B) for certain siloxane- modified silica and alumina nanoparticles (73 Fed. Reg. 65743).  These are the first SNURs known to have been issued on nanomaterials.

These substances were the subject of PMNs filed by an undisclosed company or companies in October 2005, P-05-673 and -687, for “additive, open, non-dispersive use”, as indicated at 70 Fed. Reg. 46513 (Aug. 10, 2005).  Following submission of notices of commencement of manufacture or import (NOCs), P-05-673 was added to the Inventory in May 2006, and -687 was added the following month.  The agency provides no explanation for why it waited over two years after receiving NOCs before promulgating the SNURs.

Industry members have filed comments with EPA in the past, analyzing the flexibility that SNURs provide the agency to regulate nanomaterials that are not subject to the PMN requirements because there are non-nanoscale versions that are currently listed on the TSCA Inventory.  With the increasing number of such materials entering the market, these first SNURs may indicate that the agency is contemplating greater use of SNURs to supplement the agency’s current voluntary program for such nanomaterials (i.e., the Nanoscale Materials Stewardship Program).  These first SNURs therefore may represent a test case before placing greater reliance on SNURs to regulate individual nanomaterials or entire categories of nanomaterials.

These first SNURs designate certain “uses” of the siloxane-modified nanoparticles to be “significant new uses” and require persons to notify EPA at least 90 days prior to manufacturing, importing or processing the nanoparticles for any of these uses.  EPA designated the following uses as significant new uses:  (1) use without impervious gloves or a NIOSH-approved respirator with an APF of at least 10; (2) the manufacture, process, or use of the nanoparticles as a powder; (3) or uses of the nanoparticles that are “different” than the uses described in the PMNs that the original manufacturers or importers submitted for them. 

If an entity wishes to use either of these nanoparticles for a significant new use, it must submit a 90-day notice, which is known as a Significant New Use Notice (SNUN) (and which is the same form as the PMN form).  EPA will evaluate available data to determine whether the new use should be subject to risk management measures (e.g., personal protective equipment, occupational exposure limits, testing).  EPA encourages, but does not require, persons submitting SNUNs for these nanoparticles to provide the results of a 90-day inhalation toxicity test (OPPTS 870.3465 test guideline) to help the agency evaluate the potential human health effects associated with them. 

The two nanoparticles are listed on the confidential TSCA Inventory, so EPA has described them generically in the notice as “siloxane modified alumina nanoparticles” and “siloxane modified silica nanoparticles.”  To determine whether a particular siloxane-modified alumina or silica nanoparticle is subject to this SNUR, or to determine whether a use is “different” than those included on the PMNs, the manufacturer, importer or processor must demonstrate a “bona fide intent to manufacture, import or process” by providing EPA with specific information about the nanoparticle and its intended use.  EPA previously reported that a particular entity filed PMNs for “siloxanes coated alumina nanoparticles” and “siloxane coated silica nanoparticles” in 2007 (72 Fed. Reg. 47026 (Aug. 22, 2007)).

As a direct final rule, the SNURs will take effect on January 5, 2009, if EPA does not receive adverse public comments on the SNURs, or a notice of intent to file such comments, by December 5, 2008. 

For a printable PDF of this article, please click here.

* * * *

For more information, please contact Cindi Lewis at (202) 789-6018 (clewis@bdlaw.com); Mark Duvall at (202) 789-6090 (mduvall@bdlaw.com); Ryan Tacorda at (415) 262-4009 (rtacorda@bdlaw.com); or Phil Moffat at (202) 789-6027 (pmoffat@bdlaw.com).

Key documents are available below.