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Update on Developments in EPA Regulation of Nanotechnology

Beveridge & Diamond, P.C., April 5, 2010

Nanotechnology is a hot topic for the U.S. Environmental Protection Agency (“EPA”), having captured the attention of high-level administrative officials as well as of the enforcement branch of the agency.  At a recent chemical industry conference, GlobalChem 2010, Steve Owens, Assistant EPA Administrator for Prevention, Pesticides and Toxic Substances1, and other EPA officials spoke at length about both the great promise of nanotechnology and EPA’s view that the risks of nanotechnology are unknown and potentially serious.  In light of these concerns, EPA is taking a new path forward on regulation of manufactured nanomaterials under the Toxic Substances Control Act (“TSCA”).  Nanomaterial researchers, manufacturers, and users should be prepared for an increasingly stringent regulatory environment. 

Categorical Significant New Use Rule for Existing Nanomaterials

One key issue is the distinction between “new” and “existing” chemicals under TSCA, as applied to nanomaterials.  Pre-market notifications (“PMNs”) are required for new chemicals that are not on the TSCA Inventory that are not covered by an exemption, allowing EPA to conduct a risk assessment and possibly impose controls.  If a chemical is on the Inventory, however, no notification is required for a company to manufacture the chemical unless there is a significant new use rule (“SNUR”) applicable to the chemical. 

EPA’s January 2008 “TSCA Inventory Status of Nanoscale Substances – General Approach” indicated that EPA would deem the nanoscale version of a macroscale substance listed on the TSCA Inventory, i.e., having the same molecular identity, to be an “existing” chemical substance, and therefore not subject to new chemical notification requirements.2  In a September 2009 speech, Steve Owens announced that the new administration at EPA was reviewing that approach.3  At issue is whether EPA can effectively regulate nanomaterials which happen to have the identical molecular identity—but perhaps very different properties and hazards—other than under the PMN program.

EPA has apparently resolved that debate by planning to utilize an alternative to the PMN program for addressing “existing” nanomaterials, use of a categorical SNUR.  On February 19, 2010, EPA announced on its website that:

The Agency is developing a SNUR under section 5(a)(2) of TSCA to ensure that nanoscale materials receive appropriate regulatory review.  The SNUR would require persons who intend to manufacture, import, or process certain nanoscale materials for an activity that is designated as a significant new use to submit a Significant New Use Notice (SNUN) to EPA at least 90 days before commencing that activity.  The SNUR would identify existing uses of nanoscale materials based on information submitted under the Agency's voluntary Nanoscale Materials Stewardship Program (NMSP) and other information.

The SNUNs would provide the Agency with a basic set of information on nanoscale materials, such as chemical identification, material characterization, physical/chemical properties, commercial uses, production volume, exposure and fate data, and toxicity data.  This information would help the Agency evaluate the intended uses of these nanoscale materials and to take action to prohibit or limit activities that may present an unreasonable risk to human health or the environment.4

At the GlobalChem chemical industry conference on March 30, 2010, Steve Owens, Wendy Cleland-Hamnett (Director of the Office of Pollution Prevention and Toxics (“OPPT”) within OPPTS), and Jim Willis (Director of the Chemical Control Division of OPPT) provided further details:

  • The SNUR will be based on the category of “existing” nanomaterials (those with the same molecular identity as a macroscale substance listed on the Inventory) that are “new”.  Potentially, thousands of nanomaterials could be covered.  (Under section 26(c) of TSCA, EPA may take any action allowable for a single chemical with respect to a category, “category” meaning a group of chemicals whose members are similar in some sense or “are in some other way suitable for classification as such.”)
  • By “new”, EPA apparently plans to exclude current uses of nanomaterials.  EPA cannot regulate “ongoing” uses under its SNUR authority.
  • The SNUR would apply to any chemical for which more than 10% of its particle range is in the range of 1-100 nanometers, unless already reported as a new use. 
  • The SNUR would apply to manufacturers (a term which also applies to importers) and processors.
  • EPA will propose the SNUR by the end of 2010.

This SNUR would have the effect of requiring essentially the same information submissions for “new” and “existing” nanoscale materials, and would give EPA equal opportunities to impose controls under section 5(e) of TSCA (rather than the much more burdensome section 6).  Ultimately, according to Willis, EPA’s goal is to have a notification on every nanomaterial in commerce.

Under section 12(b) of TSCA, export notifications are required for exports of any chemical for subject to a proposed or final SNUR, which would cover nanomaterials subject to the categorical SNUR.  Willis indicated that EPA does not plan to require export notifications based on the SNUR.

Nanomaterial PMNs

At the conference, both Cleland-Hamnett and Willis mentioned that EPA has received over a hundred notices on “new” nanomaterials.  Willis commented that all notifications have been subjected to restrictions (e.g., through TSCA section 5(e) consent orders).  EPA continues to strongly recommend pre-notice consultations for companies submitting PMNs, to determine the information and tests that EPA may require through consent orders.  Manufacturers of nanomaterials may also apply for TSCA section 5(h)(4) exemptions from notification requirements, but the only exemption that EPA has been granting for any nanomaterials so far is the exemption under 40 C.F.R. § 723.50 for low release, low exposure (“LoREX”) chemicals, and not the low volume exemption (volumes less than 10,000 kg/year), also under 40 C.F.R. § 723.50. 

In November 2008, EPA clarified that carbon nanotubes (“CNTs”) would generally be considered “new” chemicals, since they belong to a different allotrope of carbon than amorphous carbon, diamond, and graphite.5  That clarification indicated that “Some time after March 1, 2009, EPA anticipates focusing its compliance monitoring efforts to determine if companies are complying with TSCA section 5 requirements for carbon nanotubes.”  At the March 30 conference, Willis reported that about 20 companies have reported CNTs. 

He added that since March 2009, OPPT has worked with the EPA Office of Enforcement and Compliance Assurance (“OECA”) to identify CNT manufacturers who have not submitted notifications.  Another speaker at the conference, Mike Bellot of the Office of Civil Enforcement within OECA, stated that since March 2009 two-thirds of TSCA inspections were for CNTs, including those ostensibly operating under the “research & development” exemption from PMN requirements.6  He emphasized that companies operating under that exemption must meet all its requirements in order for the exemption to apply.  He also mentioned that EPA is paying special attention to spray-on nanotechnology products. 

Other Data Gathering Rules and Initiatives

In the December 7, 2009 Unified Agenda, EPA announced that it was planning to issue by November 2010 a TSCA section 4 test rule for certain multi-walled CNTs and nanosized clays and alumina.7  At the March 30 conference, Willis provided additional information:

  • The test rule proposal will apply to both single-walled and multi-walled CNTs.
  • The CNTs to be tested will be those with comparatively high production and high exposure, those most commercially relevant.
  • The tests will use Organization for Economic Co-operation and Development ("OECD") procedures.
  • The tests will include a two-year bioassay, chronic exposure, and environmental fate testing. 
  • The environmental fate testing will include leaching from landfills, weathering, incineration, and photolysis, since EPA is concerned about the potential for CNTs that are agglomerated or entrained in the polymer matrix to be freed at the end-of-life and be released into the environment.

EPA is also developing a proposed rule under TSCA section 8(a) to require the submission of additional information.8  Willis indicated that it will apply to all nanomaterials already on the market.

The section 4 proposal and the section 8(a) proposal largely spring from the limited scope of the data set returned by EPA’s voluntary Nanoscale Materials Stewardship Program (“NMSP”), which concluded at the end of 2009.9  At the conference, Owens characterized the results as “disappointing.”  A final report on the NMSP is forthcoming.  Willis said that it will come out around May 1 and will note that 31 companies submitted information covering 132 unique nanomaterials.

Domestic and International Collaboration

EPA has stressed its high level of interaction with other entities working on nanotechnology health and safety issues.  It has been collaborating with other federal agencies such as the National Institute for Occupational Safety and Health and the Food and Drug Administration, with universities and research consortia, and with agencies of other countries such as the United Kingdom’s Department for Environment, Food and Rural Affairs and the U.K. Environment Agency, on nanotechnology research and regulation strategies. 

EPA has also been working with the OECD Working Party on Manufactured Nanomaterials (“WPMN”) as a co-sponsor for testing of fourteen “representative” nanomaterials for dozens of endpoints.10  EPA’s efforts as a member of the WPMN intersect with its development of a test rule under TSCA section 4: “When deciding which nanoscale materials and tests to require EPA will consider ongoing testing programs including the OECD sponsorship program.”11

For more information, please contact Mark Duvall at 202-789-6090, mduvall@bdlaw.com.  This alert was prepared with the assistance of Alexandra Wyatt. 

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


[1] On April 22, 2010 (Earth Day) the EPA Office of Prevention, Pesticides and Toxic Substances will change its name to “Office of Chemical Safety and Pollution Prevention.”  See http://www.epa.gov/oppts/pubs/basic_info.html.

[2] EPA, http://www.epa.gov/oppt/nano/nmsp-inventorypaper2008.pdf.

[3] Steve Owens, Remarks to the International Conference on Transatlantic Regulatory Co-operation: Securing the Promise of Nanotechnology (Sept. 10, 2009), http://www.epa.gov/oppts/pdfs/nanotechnology_speech.pdf.

[4] EPA OPPT, Existing Nanoscale Materials, available at http://www.epa.gov/oppt/nano/#existingmaterials.

[5] Beveridge & Diamond, P.C., Update on EPA’s Regulation of Carbon Nanotubes under the Toxic Substances Control Act (July 10, 2009), http://www.bdlaw.com/news-627.html.

[6] 40 C.F.R. § 720.36.

[7] EPA, Semiannual Regulatory Agenda - Fall 2009, at 261, available at http://www.regulations.gov/public/component/main?main=UnifiedAgenda.  

[8] EPA OPPT, Control of Nanoscale Materials under the Toxic Substances Control Act, http://www.epa.gov/oppt/nano/.

[9] EPA, Nanoscale Materials Stewardship Program, http://www.epa.gov/oppt/nano/stewardship.html.

[10] See EPA, supra note 8; OECD WPMN, Safety of Manufactured Nanomaterials, http://www.oecd.org/department/0,2688,en_2649_
37015404_1_1_1_1_1,00.html
.

[11] See OECD WPMN, Series of Safety of Manufactured Nanomaterials No. 20, Current Developments / Activities on the Safety of Manufactured Nanomaterials – Tour de Table, at 65 (Feb. 24, 2010), http://www.olis.oecd.org/olis/2010doc.nsf/LinkTo/NT00000CCE/$FILE/JT03279090.PDF.

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