Over the past decade, nanotechnology has revolutionized multiple areas of the economy, including consumer products, food, sporting goods, cleaners, fertilizers, and toxic-waste cleanup. Since 2001, when President Clinton established the National Nanotechnology Initiative, the government has been actively involved in nanotechnology development. President Obama’s 2011 budget proposes to continue that support by allocating $1.8 billion to nanotechnology.

Concern has arisen because, despite the widespread integration of nanomaterials in consumer products and extensive sums spent on research and development, little is known about the possible negative effects of nanomaterials on human health and the environment. Critics point out that only $117 million of President Obama’s nanotechnology budget is devoted to studying the possible health implications of this new technology.[1]

The characteristics demonstrated by nanomaterials often differ from those of similar compounds that are larger in size. For example, titanium dioxide is an inert chemical that has been used as a joint replacement for decades. However, studies show that nano-titanium dioxide may cause illness and lead to death.[2] This difference is due to the fact that nanoparticles are able to penetrate cells and cross the blood-brain barrier, causing damage in ways that the larger version of the chemical cannot.

Regulatory agencies, both in the United States and around the world, have struggled to keep pace with this rapidly developing field. Regulators must decide whether existing regulations and regulatory regimes are sufficient to protect consumers and workers from potential toxic effects or whether a new regulatory framework is needed for nanomaterials.

The first question for regulators is how to define “nanomaterial.” While the obvious common denominator in these chemicals is their small size, size alone may not be a sufficient definition, and blanket regulation of a material on the basis of its size may cause more harm than good. For example, many nanochemicals have been used for years in applications such as microprocessors and are universally agreed to be benign. New regulation of these established nanomaterials would be unnecessary, expensive, and potentially harmful to the economy.

Some regulatory definitions of “nanomaterial” take into account attributes other than size, such as biopersistence or shape. For example, a 2009 revised cosmetics regulation approved by the Council of the European Union defined “nanomaterial” as “an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm [nanometers].”[3] And, while the Office of Pesticide Programs at the Environmental Protection Agency (“EPA”) recently indicated that its “working definition” of “nanoscale material” is “an ingredient that contains particles that have been intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers,”[4] EPA also seems to recognize that it must use more than just size to define nanotechnology. In January 2008, EPA’s Office of Pollution Prevention and Toxics stated, “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.”[5]

The definition of “nanotechnology” is critical to industry, as manufacturers attempt to determine whether they will be subject to proposed regulation. One chief technology officer recently testified to the National Academies Committee to Develop a Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials that regulatory uncertainty is causing his company to constantly question whether it should move its operations out of the United States entirely.[6] However, defining “nanotechnology” is a global issue, and regulators in Europe, Australia, and Canada are struggling with the same questions as regulators in the United States.

In November 2007, the Office of Science and Technology Policy and the Council on Environmental Quality issued a memorandum regarding “Principles for Nanotechnology Environmental, Health, and Safety Oversight.”[7] The memorandum stated that federal agencies such as EPA, the Food and Drug Administration (“FDA”), and the Occupational Safety and Health Administration (“OSHA”) “must implement sound policies to protect public health and the environment” from risks related to nanotechnology.[8]

This article addresses how EPA, the FDA, and OSHA have dealt with nanotechnology regulation to date. [9]

Regulation by the FDA

The FDA has taken the least aggressive stance of the three organizations with regard to regulation of nanotechnology. While the FDA has stringent regulations for nanotechnology used in medicine and medical technology, it has not actively regulated nanotechnology used in cosmetics, food, and dietary supplements.[10] For example, the FDA does not require manufacturers to notify it or consumers when nanotechnology is used in a product. Instead, the FDA maintains a voluntary disclosure list, meaning that the agency is not aware of all (or likely even most) consumer products containing nanomaterials.

The current FDA position is that existing regulations are sufficient to protect consumers from the potential dangers associated with nanotechnology. While the FDA maintains that “there is a most definite requirement that manufacturers ensure that the products be safe,”[11] it does not investigate until after reports indicate that a product is unsafe. Nothing unique to nanotechnology has convinced the FDA that it needs to alter this traditional, reactive style of regulation.

Regulation by OSHA

OSHA has similarly taken little action to regulate nanotechnology. The National Institute for Occupational Safety and Health (“NIOSH”), however, has published more than 170 peer-reviewed studies on the health effects of exposure to nanomaterials.[12] In addition, NIOSH has established a safe exposure limit for nano-titanium dioxide on the basis of this research.[13]

While OSHA has not turned any of these studies or recommendations into regulatory mandates, some manufacturers have used these research results to implement protective procedures for their employees. For example, a large international chemical manufacturer has voluntarily set an internal occupational limit for its carbon nanotubes at 0.05 milligram per cubic meter of air.[14] Similarly, Thomas Swan recently agreed, in a consent order with EPA, to provide its employees working with carbon nanotubes NIOSH-approved full-face respirators with N-100 cartridges, along with gloves and protective clothing.[15]

Regulation by EPA

Of the federal agencies in the United States, EPA has been the most active in developing regulations related to nanotechnology. EPA currently is developing rules and regulations for nanomaterials under both the Toxic Substances Control Act[16] (“TSCA”) and the Federal Insecticide, Fungicide, and Rodenticide Act[17] (“FIFRA”). One EPA enforcement officer stated that two-thirds of EPA’s chemical enforcement activity in 2009 focused on nanotechnology manufacturers.[18] Without adopting a specific nanomaterial rule, EPA has enforced existing requirements for chemicals and pesticides on a case-by-case basis.

The Toxic Substances Control Act. Under TSCA, EPA is charged with preventing unreasonable risks posed by chemical substances to health and the environment without creating unnecessary economic barriers to technological innovation. Walking this fine line, EPA has applied a variety of regulatory mechanisms under TSCA to nanoscale materials.

Premanufacture Review. Under TSCA § 5, chemicals are subject to premanufacture review if they are “new,” or, in other words, not on EPA’s TSCA Inventory.[19] The question of “newness” can be deceptively difficult, since many nanomaterials are just smaller versions of currently listed chemicals. But, recognizing that this smaller size may change the properties of a substance, EPA has determined that some nano-versions of existing chemicals are “new.” Currently, the TSCA Inventory includes more than 83,000 existing chemicals.[20] Since 2005, EPA has received and reviewed more than 100 new chemical notices under TSCA for nanoscale materials.[21] There has been ongoing debate among EPA, industry groups, consumer advocacy groups, and academics, however, about whether nanomaterials are “new” chemical substances as defined under TSCA § 3.

In January 2008, EPA announced its position on this question.[22] EPA classifies nanomaterials under TSCA according to their chemical identities rather than their particle size or physical properties. EPA’s rather nuanced approach considers chemical substances to have different molecular identities for purposes of TSCA when they have different molecular formulas, atom connectivities, or crystal lattices; are different allotropes of the same element; or have different isotopes of the same element. This approach results in the classification of some nanoscale materials as “new,” while others are considered existing. Rather than making a decision for all nanoscale materials, EPA employs a case-by-case determination.

In October 2008, EPA announced that carbon nanotubes are in fact “new” and thus subject to TSCA premanufacture notice (“PMN”) requirements for new chemicals.[23] A carbon nanotube is a layer of a carbon allotrope, such as graphite, wrapped into a single- or multiwalled cylinder. While only a nanometer or so in diameter, carbon nanotubes can be millions of times longer than they are wide, a configuration that makes them extremely strong. In addition, carbon nanotubes have distinctive adsorption and electrical properties. As a result, there are many potential applications for carbon nanotubes, including use in building materials, electronics, and filters. EPA clarified that because the chemical identity of carbon nanotubes differs from that of graphite or other allotropes of carbon already listed in the TSCA Inventory, carbon nanotubes are therefore “new.”[24] EPA announced it would consider enforcement against noncompliant companies in mid-2009. Violations of PMN requirements can result in significant civil penalties for manufacturers, importers, and even commercial users of the chemical if they know or have reason to know that the chemical was manufactured, processed, or distributed in violation of PMN requirements.[25]

Administrative Consent Orders. Under the authority of TSCA § 5(e), EPA may issue administrative orders to prohibit or limit the manufacture, processing, distribution, use, or disposal of new chemicals. Beginning in mid-2008, EPA entered into several administrative consent orders with nanomanufacturers under TSCA § 5(e).[26] While not prohibiting nanomaterial manufacture or sales, these consent orders generally require the manufacturer to submit to EPA samples of the nanomaterial, a copy of the Material Safety Data Sheets, and the results of a 90-day inhalation toxicity study in rats. In addition, the consent orders require the use of personal protective equipment for manufacturing employees and include some limitations on distribution of chemicals.

Significant New Use Rules. Because a § 5(e) order is binding only upon the party that submitted a PMN for a new chemical, EPA may subsequently issue Significant New Use Rules (“SNURs”), under § 5(a), to bind all other entities to the same terms and conditions for that chemical.[27] Unlike a § 5(e) order, a SNUR is subject to the procedures of notice-and-comment rulemaking. The first such SNURs were published by EPA in November 2008.[28] However, manufacturers potentially subject to these rules may be faced with uncertainty because subtle variations between nanostructures make it difficult for manufacturers not directly identified in a SNUR to determine whether their nanomaterials are regulated under a given rule. EPA has stated that if a manufacturer is uncertain as to whether its product falls under one of the SNURs, EPA will respond to a Notice of Bona Fide Intent to Manufacture requesting an EPA determination.[29]

In June 2009, EPA issued two more SNURs, as direct final rules for single- and multiwalled carbon nanotubes. In July 2009, EPA clarified that the SNURs apply not to all variants of carbon nanotubes, but only to those specific nanotubes that were the subject of the PMNs submitted. The SNURs were to go into effect in August 2009 but were withdrawn because EPA received notice that adverse comments would be submitted.[30] The SNURs would have required employees handling carbon nanotubes to use gloves impervious to nanoscale particles and to wear chemical protective clothing as well as NIOSH-approved full-face respirators with N-100 cartridges while exposed to inhalation in the work area. Manufacturers, importers, and processors would have been required to notify EPA at least 90 days before beginning any activity designated as a significant new use under the rule.

Since this time, EPA has incorporated these withdrawn rules into several newly proposed SNURs for public comment, and these rules have attracted international attention. EPA extended the comment period for the first SNUR for carbon nanotubes by a month, from January 8 until February 8, 2010, at the request of the European Economic Community’s World Trade Organization Technical Barriers to Trade Inquiry Point because of concern that the SNUR would disproportionately impact British nanotube manufacturers.[31] Another proposed SNUR was published in the Federal Register on February 3, 2010, and EPA accepted comments for 30 days.[32] The final versions of these rules are still being determined by EPA.[33]

EPA has also indicated that it plans to propose a SNUR in December 2010 that would regulate nanoscale versions of chemicals already on the TSCA Inventory as significant new uses of those chemicals.[34] This would allow EPA “to regulate nano versions of chemicals already on the TSCA Inventory the same way it would regulate a new chemical,” unless that nanomaterial is already on the market.[35]

TSCA §§ 4 and 8 Rules. Although it has not yet done so, EPA has also indicated that it plans to regulate nanomaterials under TSCA §§ 4 and 8. 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.”[36] Under § 4(a), EPA may require entities to develop and submit data on the health and environmental effects of a substance. If such a rule is issued, EPA will determine who is subject to the rule and whether small-volume manufacturers and research laboratories will be required to participate. Persons subject to a test rule must submit a notice of intent to conduct the required testing or apply for an exemption.

In August 2009, EPA also indicated that it would propose TSCA § 8(a) rules to obtain information on the production, uses, and exposures of existing nanoscale materials.[37] Section 8 allows EPA to issue rules requiring mandatory submission of data “necessary for the effective enforcement of this chapter.”[38] While not yet published, the TSCA § 8(a) rules would require nanomanufacturers to advise EPA of certain information regarding the amount of nanomaterial manufactured and the process used.

The Federal Insecticide, Fungicide, and Rodenticide Act. EPA has taken a close look at regulating nanosilver as a pesticide pursuant to FIFRA. Under FIFRA, “pesticide” means “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest.”[39] A “pest” means not only insects, rodents, fungi, and weeds, but also any virus, bacteria, or microorganism that the Administrator declares to be a pest.[40] Silver is a registered antimicrobial pesticide under FIFRA used for water-purification purposes. Nanosilver has been used in numerous consumer products, including food storage containers, clothing, toys, and electronics.

In 2007, EPA determined that a silver-ion-generating washing machine should be regulated as a pesticide. Products that release silver ions as disinfectants, such as washing machines, were targeted for EPA data collection and regulatory control. The Federal Register notice requires registration for producers of certain equipment generating silver ions for express pesticidal purposes.[41]

In February 2008, EPA Region 9 settled a FIFRA enforcement action against ATEN Technology, Inc., for selling unregistered pesticides in its nanosilver-coated computer keyboards and making unsubstantiated claims about the pesticides’ effectiveness.[42] According to EPA, the company made unsubstantiated public-health claims regarding the antimicrobial properties of the products. The company paid a fine of more than $200,000.

In addition, EPA has sought comments on a petition by nongovernment organizations that asked EPA to regulate nanoscale silver products as pesticides under FIFRA.[43] The petition asked EPA to classify nanosilver as a new pesticide and to require registration of nanosilver products. The International Center for Technology Assessment and other groups also sought regulatory action regarding products illegally sold without FIFRA approval. An appendix to the petition listed more than 200 nanosilver products, which may or may not be within the purview of FIFRA. FIFRA requirements include registration, approval, labeling, and data submission.

Like TSCA, FIFRA has been subject to questions about its effectiveness to regulate nanomaterials in its current form. According to an evaluation by the American Bar Association (“ABA”), however, FIFRA offers EPA ample statutory authority to regulate nanopesticides.[44] As the ABA noted, FIFRA allows EPA to regulate research and development, which is exempted from regulation under TSCA. According to the ABA, EPA’s most powerful tool under FIFRA is the registration requirement that provides EPA with the opportunity to prohibit, condition, or allow the manufacture and use of nanopesticides. EPA enforces violations of FIFRA with steep penalties.

As part of exercising its authority under FIFRA, EPA has announced that it will release a new interpretation of FIFRA.[45] This interpretation will reflect a new policy that nanopesticides are reportable under FIFRA § 6(a)(2) and will apply to already registered products as well as products pending registration.[46] Section 6(a)(2) requires registrants to submit information regarding “unreasonable adverse effects on the environment of the pesticide.”[47] Critics of the policy contend that it gives nanomaterials a negative connotation, implying that all use of nanomaterials in pesticides results in adverse effects. EPA maintains, however, that it is simply seeking the basic information a company has about nanomaterials used in the company’s pesticides, even if the nanomaterials are not harmful. If EPA ultimately proceeds with this policy, its regulation of nanomaterials under FIFRA may evolve from the case-by-case method to one more comprehensive in nature.

Push for Additional EPA Action. In May 2010, the Government Accountability Office (“GAO”) drafted a report regarding EPA’s regulation of nanomaterials.[48] The GAO recommended that EPA move forward in issuing regulations under TSCA and FIFRA as soon as possible, to prevent products from entering the market without EPA review of their potential risks. With regard to TSCA, the GAO recommended issuing SNURs for nanomaterials, as well as regulations requiring submission of data on nanomaterials under TSCA §§ 4 and 8. With regard to FIFRA, the GAO recommended that EPA “[m]odify FIFRA pesticide registration guidelines to require applicants to identify nanomaterial ingredients in pesticides” and clarify that nanomaterials in both registered and new pesticides must be reported to EPA.[49]

In addition, the GAO noted that EPA has the authority to regulate nanomaterials under other statutes, including the Clean Air Act, the Clean Water Act, the Resource Conservation and Recovery Act, and the Comprehensive Environmental Response, Compensation, and Liability Act. The GAO stated that “[n]anomaterials do not pose the same definitional difficulties under the air, water, and waste statutes as they do under TSCA and FIFRA because pollutants and wastes are defined by their effects on humans and the environment rather than by their composition.”[50] However, EPA is faced with the challenge of developing technology to adequately measure the amount of nanomaterials in air, water, and soil. In addition, volume thresholds in these statutes pose additional challenges for the regulation of tiny nanomaterials. Despite these challenges, the GAO recommended, as an initial step, that EPA begin using the broad information-gathering provisions of the Clean Water Act to require entities to submit data regarding their nanomaterial discharges.

Consumer Education

Beyond direct regulation, consumer advocates are pushing to get information into the hands of consumers. This effort would be aided by labeling and disclosure requirements currently under consideration by EPA. In addition, advocates have developed numerous other resources that they hope will either spur new regulation or at least inform consumers of potentially harmful effects. Arizona State University has established a searchable database attempting to collect all government documents related to nanotechnology regulation around the globe.[51] Members of the Wisconsin State Legislature have requested a study on the feasibility of a nanotechnology registry “to monitor the use, manufacture and disposal of nanomaterials in Wisconsin.”[52] In addition, the Project on Emerging Nanotechnologies (“PEN”), established by the Pew Charitable Trusts and the Woodrow Wilson International Center for Scholars, maintains a growing database of consumer products containing nanoscale materials.[53]

Conclusion and Future Outlook

Some consumer advocates believe that a new regulatory regime is necessary to adequately regulate the unique features of nanotechnology. A former EPA official has called for an entirely new, comprehensive regulatory framework that focuses on products rather than materials.[54] The primary players in this policy debate include PEN, consumer and environmental advocates, and numerous state and national regulatory agencies.

However, it is unclear whether the United States will enact comprehensive nanotechnology legislation and regulation in the future.[55] Many questions must be answered before sweeping legislation can be enacted, such as how “nanomaterial” should be defined, which types of products and operations should be regulated, and how effective existing programs are at regulating nanotechnology. Decision making on future legislation and regulation will develop pending the results of ongoing studies on the effects of nanomaterials and the effectiveness of current regulatory programs. The one thing that is clear is that nanotechnology and its regulation are dynamic, will continue to evolve, and will demand close attention.

Those interested in nanotechnology regulation can monitor news articles, agency press releases, Federal Register notices, and academic, industry, and policy-sponsored publications for new developments. In particular, chemical manufacturers should review PMNs and proposed SNURs. Interested parties should also consider submitting comments to the applicable agency when new regulations are proposed.