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Posted: Sep 1st, 2009
The EPA sharpens its focus on nanotechnology
(Nanowerk Spotlight) For most of the last decade, the Environmental Protection Agency (EPA) has proceeded cautiously in exercising its regulatory authority over nanoscale materials. This caution was largely a reflection of EPA’s conclusion that the agency lacked sufficient information to assess whether regulations specifically directed at nanoscale materials were necessary (1). Accordingly, much of EPA’s focus over the past several years has been aimed at filling information gaps and gathering more data regarding the potential risks associated with nanomaterials, mostly through voluntary programs and agency-funded research (2).
Recently, EPA has moved to quicken the pace of its regulatory efforts, through a series of actions taken under the authority of the Toxic Substances Control Act (TSCA) (3). The agency has also fired a clear shot across the bow of the nanotechnology industry, warning producers and importers of nanoscale materials that the agency intends to pursue enforcement actions against companies that fail to heed EPA’s new focus on regulating nanomaterials under TSCA. In light of these developments, companies with an interest in nanotechnology may want to reexamine the agency’s recent regulatory initiatives, in order to gain a better understanding of how those actions might affect them.
TSCA’s Scope Key to Future Regulation
As indicated, EPA’s recent regulatory initiatives aimed at nanomaterials have been pursued primarily under the Toxic Substances Control Act. While most other environmental statutes regulate “pollution” in one form or another (e.g., air emissions, hazardous wastes, etc.), TSCA provides the EPA with unique authority to regulate chemical substances in commerce and prior to entering commerce.
Central to the TSCA regulatory program is the “Chemical Substances Inventory,” which is a list maintained by the agency of all chemical substances known to be in commerce in the United States. The TSCA provides EPA with broad authority to regulate both “new” substances (substances not listed on the Chemical Substances Inventory) as well as “existing” substances. Thus, under section 5(a)(1) of TSCA, a company may not manufacture or import a “new” chemical substance without first completing a pre manufacture notification (PMN) review by EPA (4). Based on its PMN review, EPA may permit the new substance to be placed on the Inventory – allowing it to be manufactured, processed, distributed, or imported without restriction – or the Agency may issue an administrative order under TSCA section 5(e) to impose restrictions on the manufacture, use and/or distribution of the substance, or to require the submission of more data on the substance, or to ban the chemical outright (5).
In contrast to “new” substances, which are automatically subject to PMN review when they are first manufactured or imported into the US, the process for regulating “existing” chemicals under TSCA is more cumbersome. Specifically, section 5(a)(2) of TSCA provides EPA with authority to regulate “significant new uses” of an existing chemical substance, through the promulgation of a “significant new use rule” (“SNUR”). The SNUR process allows EPA to impose restrictions on manufacture, distribution and use of a substance – similar to the restrictions that can be imposed on “new” substances under section 5(e) orders. However, in order to designate the use of a substance as being a “significant new use,” which is a necessary predicate for promulgating a SNUR, EPA must engage in a rulemaking process that includes public notice and an opportunity to comment. This is typically a more time consuming and more burdensome process for EPA, as compared to regulating a “new” substance under section 5(e).
In this context, a pivotal and controversial question for industry has been whether nanoscale versions of conventional-sized substances already listed on the TSCA Inventory should be regulated as “new” chemical substances and required to undergo PMN review prior to being manufactured or imported into the US. That question was largely resolved late last year.
EPA: Size (and Space) Matters in Determining Molecular Identity
In the summer of 2007, EPA gave its first clear indication that the agency might regulate nanoscale materials as “new substances” under TSCA, even if conventional-scale versions of those substances are already listed on the TSCA Inventory. This interpretation was outlined in a guidance document entitled “TSCA Inventory Status of Nanoscale Substances – General Approach” (the “General Approach”) (6). A casual reader of the EPA’s General Approach might have been misled by the document’s prominent statement that:
In determining whether a nanoscale substance is a new or existing chemical, the Agency intends to continue to apply its current Inventory approaches based on molecular identity, rather than focus on physical attributes such as particle size. (7)
The agency’s guidance appears to say that nanoscale versions of substances on the Inventory will not be subject to regulation as “new substances” under TSCA (since the agency purports not to distinguish between “new” and “existing” substances on the basis of particle size). However, EPA’s interpretation was actually much more nuanced. Elsewhere in the General Approach document, the agency explains that two substances will be considered to have different “molecular identities” for purposes of TSCA, and therefore will be considered different substances, if the spatial arrangements of the atoms within the molecules are different (even if the composition and chemical bonding are identical). Thus, for example, EPA explains that molecules consisting of the same atoms arranged in different crystal lattices are considered to have different molecular identities and therefore are different “substances” under TSCA, as are allotropes of the same element. (8)
Any lingering questions EPA’s General Approach may have left any regarding the agency’s intent to regulate nanomaterials as “new” substances under TSCA questions were largely answered in October 2008, when EPA published a notice in the Federal Register announcing its determination that carbon nanotubes are, in fact, “new” chemical substances for purposes of TSCA, and are therefore subject to the PMN reporting requirements. (9) Drawing upon the logic described in the General Approach, EPA explained that it considers carbon nanotubes to be distinct from graphite and other allotropes of carbon listed on the TSCA Inventory and therefore subject to PMN review. In addition, the agency alerted corporations that sometime after Spring 2009 it would begin “focusing its compliance monitoring efforts to determine if companies are complying with TSCA section 5 requirements for carbon nanotubes.” (10) This was (and is) a clear warning to companies that manufacture or import nanomaterials that they must pay close attention to their newly explained TSCA obligations or they risk facing an enforcement response. (11)
Carbon Nanotube Restrictions give Insight to Stakeholders
Following publication of the General Approach, EPA received a number of PMNs for nanoscale materials. Within the past year, at least five of those PMNs (for single-walled and multi-walled carbon nanotubes) have resulted in the issuance of section 5(e) orders. As with all section 5(e) orders, these are substance-specific (in other words, they only pertain to the specific nanotube materials that were the subject of the PMNs). In addition, the orders were predicated on EPA’s finding that: (i) information available to the agency is “insufficient to permit a reasoned evaluation of the human health effects” of the nanotube materials and (ii) uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal of those materials “may present an unreasonable risk of injury to human health.” (12)
Although the section 5(e) nanotube orders are substance-specific, they all contain a number of common elements. In particular, all of the orders impose restrictions on the types of applications in which the nanotubes may be used. In addition, each order includes the following requirements:
The manufacturer (or importer) must provide EPA with a sample of material, along with certain material characterization data;
The manufacturer (or importer) must conduct a 90-day rat inhalation toxicity study on their material;
The manufacturer (or importer) must employ specified types of personal protective equipment at facilities under its control; and
The manufacturer (or importer) may only distribute the material to persons who agree to comply with all of the restrictions of the 5(e) order. (13)
In addition, at least one of the orders prohibits any manufacture of the subject nanotube within the United States. Interestingly, all of the orders also contain language supporting the use of a consortium approach to developing inhalation toxicity data. (14)
As noted earlier, section 5(e) of TSCA provides EPA with expansive authority to prohibit or restrict the manufacture, processing, distribution and/or use of substances for which the agency has risk concerns. The multiple section 5(e) orders that the Agency has issued over the past year for carbon nanotube materials demonstrate unequivocally that the agency intends to use its expansive authority under TSCA section 5(e) to impose restrictions on nanoscale materials that, in EPA’s view, present unresolved risk concerns. Violations of section 5(e) orders are subject to civil penalties of up to $37,500 per violation as well as possible criminal penalties for “knowing” violations. (15)
New Regulations on the Horizon
Regulatory momentum at EPA regarding nanoscale materials is unlikely to abate anytime soon. One need only look at the agency’s most recent “regulatory agenda,” to draw the conclusion that we are likely to see new proposed regulations under TSCA specifically directed at nanoscale materials in the not-too-distant future. (16) In particular, one of the “long term” regulatory actions the agenda identifies is the issuance of a test rule under TSCA section 4, requiring manufacturers and importers to generate needed health and safety data on multi wall carbon nanotubes. (17) Moreover, EPA might feel compelled to proceed with this type of rulemaking if it were to conclude that its voluntary data collection efforts have failed to generate an adequate response. (For example, in a recent report on the Nanoscale Materials Stewardship Program (NMSP), the agency notes that: “a number of the environmental health and safety data gaps the Agency hoped to fill through the NMSP still exist. The EPA is considering how to best use testing and information gathering authorities under the Toxic Substances Control Act to help address those gaps.”) (18)
In addition, as manufacturers and importers of nanoscale materials heed EPA’s warnings and submit more PMNs to the agency for review, we are likely to see additional section 5(e) orders for those materials, as well as additional SNURs.
After a long period of relative inaction, EPA has recently intensified its focus on the regulation of nanoscale materials. The agency has sent a clear signal to industry that nanoscale materials are likely to require PMN review before they lawfully can be manufactured or imported into the United States. It is clear from EPA’s recent actions that the agency intends to use its expansive authority under TSCA, including section 5(e), to impose restrictions and limitations on the manufacture, processing, distribution or use of nanoscale materials in instances when the agency has unresolved risk concerns regarding those materials.
Companies that manufacture or import nanomaterials into the US would do well to heed the agency’s warnings, pay close attention to their TSCA obligations – and to watch out for new regulations that may soon be heading our way.
Thus, in a 2007 White Paper, the EPA repeatedly emphasized the need to gather more data about nanoscale materials. See “U.S. Environmental Protection Agency Nanotechnology White Paper” (February 2007). Specifically, the White Paper identified critical information gaps in the areas of: chemical identification and characterization; environmental fate, including how nanomaterials are transported through environmental media and how they transform and react with other chemicals in the environment; environmental detection methods; human exposure; human health effects; ecological effects; and risk assessment approaches. Id at 70-81. See www.epa.gov/OSA/pdfs/nanotech/epa-nanotechnology-whitepaper-0207.pdf
In addition to the EPA laboratories conducting their own research, as of 2007 the agency had also funded more than $17 million in Science to Achieve Results (STAR) grants to research the environmental fate of nanomaterials and monitoring and detection of nanomaterials. Also, in 2008 the EPA launched a voluntary “Nanoscale Materials Stewardship Program” in order to encourage companies to provide the EPA with data on material characterization, hazards, potential uses, potential exposures, and risk management practices associated with nanoscale materials. See www.epa.gov/oppt/nano/stewardship.htm
See 15 U.S.C. § 2604(a)(1). The PMN must provide certain information pertaining to the chemical identity of the substances, as well as any health and environmental effects data in the PMN submitter’s possession. See 40 C.F.R. §§ 720.45 and 720.50
In this regard it is worth noting that the EPA has already pursued enforcement actions against products that incorporate nanoscale materials, especially nano-silver, to impart anti-microbial properties. For example, last year, the EPA fined ATEN Technology, the manufacturer of IOGEAR equipment, over $200,000 for selling keyboards and other computer peripherals that purported to incorporate nano-scale silver for anti-microbial benefits, without first obtaining agency approval. See Press Release, U.S. EPA fines Southern California Technology Company $208,000 for “Nano Coating” Pesticide Claims on Computer Peripherals (March 5, 2008), available at yosemite.epa.gov/opa/admpress.nsf/0/16a190492f2f25d585257403005c2851
See, e.g., Consent Order and Determinations Supporting Consent Order, Premanufacture Notice Number: P 08 0328 (Sep. 12, 2008); see also 15 U.S.C. § 2604(e) (statutory findings required for issuance of a section 5(e) order).
Id. See also Consent Order and Determinations Supporting Consent Order, Premanufacture Notice Number: P 08 0733/0734 (Feb. 13, 2009); Consent Order and Determinations Supporting Consent Order, Premanufacture Notice Number: P 08 0177 (Aug. 11, 2008); Consent Order and Determinations Supporting Consent Order, Premanufacture Notice Number: P 08 0392 (date unavailable).
On June 24, 2009 the EPA published a notice in the Federal Register that would have established a significant new use rule for two of the nanotube materials that were the subject of section 5(e) orders: P-08-177 and P-08-328. The purpose for issuing the SNURs (which were subsequently withdrawn for additional notice and comment -- see 74 Fed. Reg. 42,177) was to extend the section 5(e) order restrictions to any person manufacturing or importing the nanotube materials. See 74 Fed. Reg. 29,982 (June 24, 2009). The agency can only accomplish this via a SNUR because the section 5(e) order itself is only effective with respect to the original PMN submitter.
EPA, Semiannual Regulatory Agenda (Spring 2009) available at http://www.the EPA.gov/regulations/search/ regagenda.html. The semiannual regulatory agenda, which previously had been published in the Federal Register, is now only available online.
EPA, Nanoscale Materials Stewardship Program Interim Report (January 2009) at 3.
By Warren U. Lehrenbaum, Pillsbury Winthrop Shaw Pittman LLP. Warren is a Washington, D.C. partner in Pillsbury’s Environment, Land Use & Natural Resources practice. He has extensive experience in chemical regulation and biotechnology issues arising under numerous state and federal laws, including the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), the Food Quality Protection Act (FQPA), the Federal Food, Drugs and Cosmetics Act (FFDCA), and the Emergency Planning and Community Right-to-Know Act (EPCRA). He assists clients in the chemical, biotechnology and other industries with obtaining regulatory approvals for their products and managing ongoing compliance with testing, pollution control and other regulations.