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Update on EPA’s Regulation of Carbon Nanotubes under the Toxic Substances Control Act

Beveridge & Diamond, P.C. - Client Alert, July 10, 2009

A number of recent developments at EPA demonstrate EPA's interest in ensuring that manufacturers of carbon nanotubes meet their TSCA obligations.[1]  EPA officials have indicated that they plan to follow through on their previously announced plan to take enforcement action against companies manufacturing or importing carbon nanotubes that have not submitted premanufacture notices (PMNs) as required by the Toxic Substances Control Act (TSCA).  Along with this threat of enforcement, EPA has issued Significant New Use Rules (SNURs) for a single- and a multi-walled carbon nanotube.[2]  EPA has also indicated that it may issue a section 4(a) test rule for multi-walled carbon nanotubes.[3]   

EPA Threatens to Enforce PMN Requirements

In January 2008, EPA issued a policy document announcing that, for purposes of the TSCA Inventory, EPA would classify a nanomaterial as a new chemical substance if the nanomaterial has a molecular identity that is not identical to the molecular identity of a chemical substance already on the TSCA Inventory.[4]  As we noted in a previous client alert, on October 31, 2008, EPA clarified that carbon nanotubes regulated under TSCA may be new chemicals with molecular identities distinct from graphite or other allotropes of carbon already listed on the TSCA Inventory.[5] 

In the last several years, companies have submitted PMNs to EPA for various nanomaterials, including dendrimers, carbon nanotubes, and fullerenes.  According to a recent statement by Jim Willis, Director of EPA's Chemical Control Division, EPA has received 11 PMNs and 8 Low Release and Exposure (LoREX) exemption applications for carbon nanotubes.[6]   Jim Willis indicated that when reviewing PMNs for carbon nanotubes, EPA is focusing on the particular characteristics of each carbon nanotube, such as shape, length, and wall thickness.  EPA may consider a carbon nanotube to be a “new chemical” if, for instance, a carbon nanotube has a different spatial arrangement of atoms than the carbon nanotubes on the TSCA Inventory.  Despite the PMNs for nanomaterials that it has received, EPA remains convinced that there are nanomaterials subject to the premanufacture requirements for which PMNs have not been submitted.

In its October 2008 Federal Register notice, EPA threatened to begin enforcing the PMN requirements against manufacturers of carbon nanotubes some time after March 2009.  To date, EPA has not announced any enforcement actions.  Nonetheless, EPA officials have stated recently that they intend to begin enforcing the PMN requirements against manufacturers of carbon nanotubes.  Although EPA has highlighted carbon nanotube manufacturers as likely subjects of enforcement actions, section 5 applies to all nanomaterials that are considered new chemical substances, not just carbon nanotubes. 

Violations of the premanufacture requirements can result in civil penalties for both manufacturers and importers.  Recently, EPA increased the maximum penalties for violations of statutes it enforces, including TSCA.[7]  As a result, the maximum penalty for a violation of the premanufacture requirements is $37,500 per violation.  Moreover, section 15 makes it unlawful for anyone -- not just manufacturers or importers -- to use for commercial purposes a chemical substance that a person knows or has reason to know was manufactured, processed, or distributed in violation of the premanufacture requirements.[8]  Violating the premanufacture requirements may subject a company to liability in excess of any penalties imposed by EPA.  For example, if a company needs to halt manufacture or importation of a substance in order to go through the PMN process, the company may face supply chain problems.  Approaching EPA about potential violations may lead EPA to waive a percentage of the gravity-based component of a penalty[9] and may make EPA more willing to exercise its discretion so as to minimize potential supply chain disruptions. 

SNURs for Carbon Nanotubes

If concerns about a substance’s risks arise during the PMN review process, EPA may issue a Section 5(e) order imposing limitations on the PMN submitter’s activities and subsequently promulgate a SNUR to impose the same limitations on others.   Persons other than the PMN submitter are prohibited from manufacturing, importing, or processing the substance for a significant new use unless they submit a Significant New Use Notice (SNUN) to EPA 90 days prior to engaging in the new the use.[10]  Manufacturers, importers and processors that do not engage in the new use, but distribute the substance in commerce must submit a SNUN unless they can document that the recipient of the substance meets certain requirements.[11]  When submitting a SNUN, an entity must submit all test data related to the health or environmental effects of the substance that are in the entity's possession or control.[12]  However, test data need not be developed.  Nonetheless, EPA recommends that an entity submitting a SNUN conduct the same tests, if any, required by a section 5(e) consent order negotiated with the PMN submitter.

On June 24, 2009, EPA issued a direct final rule promulgating SNURs for the single-walled and multi-walled carbon nanotubes for which EPA had received PMNs and negotiated section 5(e) consent orders.[13]  The Federal Register notice states that EPA negotiated the consent orders out of a concern that both the single-walled and multi-walled carbon nanotubes may cause “lung health effects” and health effects from skin exposure.  EPA issued SNURs for multi-walled carbon nanotubes (generic), PMN P-08-177, and single-walled carbon nanotubes (generic), PMN P-08-328.  For both the single-walled and multi-walled carbon nanotubes, EPA designated the following uses as significant new uses: (1) use in the workplace without certain personal protective equipment, including gloves, full body chemical protective clothing, and a NIOSH-approved respirator; (2) use “other than” a use listed in the PMN submitted for the substance; and (3) manufacture or import of the substance in excess of the volume listed in the section 5(e) consent order for the substance.  The SNURs go into effect on August 24, 2009, unless EPA receives adverse comments or a notice of intent to submit adverse comments before July 24, 2009.

Jim Willis, Director of EPA's Chemical Control Division, recently stated that EPA anticipates issuing SNURs for other PMNs which it has received for carbon nanotubes.[14]  EPA expects that future SNURs will include workplace protections similar to those required in the SNURs issued on June 24, 2009 -- although EPA has emphasized that it is focusing on the particular characteristics of each carbon nanotube and will tailor SNURs to protect against the particular risks of each carbon nanotube.

Section 4(a) Test Rule for Carbon Nanotubes

In its Spring 2009 Regulatory Agenda, EPA announced that a “TSCA section 4(a) test rule may be needed to determine the health effects of multiwall carbon nanotubes.”[15]  In public remarks, EPA officials have echoed this statement.[16]  Under section 4(a), EPA may issue a rule requiring entities to develop and submit data on the health and environmental effects of a substance.[17]

If EPA issues a section 4(a) test rule for carbon nanotubes, the Agency will specify whether manufacturers (including importers) or processors or both are subject to the rule.  It remains an open question whether EPA will require the participation of small-volume manufacturers and manufacturers solely for research and development (R&D) purposes.   Typically, entities that manufacture/import less than 500 kg of a chemical substance annually (i.e., a “small volume”) must comply with a test rule only if the test rule specifically so states, or EPA publishes a notice in the Federal Register that no entity has submitted a notice of intent to conduct a required test.[18]  The same limitations usually apply to the participation of R&D manufacturers.  Since many manufacturers of carbon nanotubes manufacture less than 500 kg annually, and others manufacturer solely for R&D, EPA may specifically require that such manufacturers comply with a test rule.  Persons subject to a test rule must submit a notice of intent to conduct the required testing, or submit an application for an exemption, within 30 days of the effective date of the test rule.[19]

For more information, please contact Philip Moffat at pmoffat@bdlaw.com or Mark Duvall at mduvall@bdlaw.com.  This alert was prepared with the assistance of Matthew Gerhart.

For a printable PDF, please click here.


[1] In addition, EPA has taken enforcement action under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) against companies claiming to manufacture nanoscale antimicrobials.  For example, EPA reached a settlement with ATEN Technology, Inc. over allegations that the company's subsidiary sold computer keyboards and mice that claimed to have nanoscale antimicrobial coatings.  EPA alleged that the company had not registered these coatings as pesticides under FIFRA.  See Press Release, EPA, U.S. EPA Fines Southern California Technology Company $208,000 for “Nano Coating ” Pesticide Claims on Computer Peripherals (Mar. 5, 2008), available at http://yosemite.epa.gov/opa/admpress.nsf/2dd7f669225439b7852573590
0400c31/16a190492f2f25d585257403005c2851!OpenDocument

[2] EPA, Significant New Use Rules on Certain Chemical Substances, 74 Fed. Reg. 29,982 (June 24, 2009). 

[3] EPA, Semiannual Regulatory Agenda, Spring 2009, at p. 105, available at http://www.epa.gov/lawsregs/documents/regagendabook-spring09.pdf

[4] EPA, TSCA Inventory Status of Nanoscale Substances ­- General Approach (Jan. 23, 2008), available at http://www.epa.gov/oppt/nano/nmsp-inventorypaper2008.pdf

[5] EPA, Toxic Substances Control Act Inventory Status of Carbon Nanotubes, 73 Fed. Reg. 64,946 (Oct. 31, 2008).

[6] Pat Rizzuto, EPA Official Says Carbon Nanotubes Will Continue to Be Regulated Case-By-Case, BNA Daily Environment Report, July 9, 2009, available at http://news.bna.com/deln/DELNWB/split_display.adp?fedfid=13768683&vname=dennotallissues&fcn=14&wsn=496461000
&fn=13768683&split=0
.  The LoREX rule allows an entity to apply for an exemption from the PMN requirements if the entity manufactures a small quantity of the substance or manufactures the substance in a way that will not result in significant environmental releases and human exposures.  See 40 C.F.R. § 723.50.

[7] EPA, Civil Monetary Penalty Inflation Adjustment Rule, 73 Fed. Reg. 75,340 (Dec. 11, 2008), codified at 40 C.F.R. § 19.4.

[8] See TSCA § 15(2), 15 U.S.C. § 2614(2).

[9] EPA, Incentives for Self-Policing: Discovery, Disclosure, Correction and Prevention of Violations, 65 Fed. Reg. 19,618 (Apr. 11, 2000).

[10] TSCA § 5(a)(1), 15 U.S.C. § 2604(a)(1).

[11] An entity that distributes in commerce a substance subject to a SNUR is not required to submit a SNUN if the entity can document that: (1) the distributor notified the recipient in writing of the SNUR applicable to the substance; or (2) the recipient knows of the SNUR applicable to the substance; or (3) the recipient cannot undertake any of the significant new uses designated by the SNUR.  See 40 C.F.R. § 721.5(a)(2).

[12] See 40 C.F.R. § 721.25.

[13] 74 Fed. Reg. 29,982.  The SNUR for multi-walled carbon nanotubes (generic) will be codified at 40 C.F.R. § 721.10155.  The SNUR for single-walled carbon nanotubes (generic) will be codified at 40 C.F.R. § 721.10156.

[14] Pat Rizzuto, EPA Official Says Carbon Nanotubes Will Continue to Be Regulated Case-By-Case, BNA Daily Environment Report, July 9, 2009, available at http://news.bna.com/deln/DELNWB/split_display.adp?fedfid=13768683&vname=dennotallissues&fcn=14&wsn=496461000
&fn=13768683&split=0

[15] EPA, Semiannual Regulatory Agenda, Spring 2009, at p. 105, available at http://www.epa.gov/lawsregs/documents/regagendabook-spring09.pdf

[16] See, e.g., Pat Rizzuto, EPA to Enforce Premanufacture Reviews For Carbon Nanotubes Beginning March 1, BNA Chemical Regulation Reporter, February 23, 2009, available at http://ehscenter.bna.com/pic2/ehs.nsf/id/BNAP-7PJH3D?OpenDocument

[17] See TSCA § 4(a), 15 U.S.C. § 2603(a).  Particular test rules appear at 40 C.F.R. Part 799.

[18] See 40 C.F.R. § 790.42(a)(4).

[19] See id. § 790.45.

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