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Ms. Eggen is a distinguished professor of law at Widener University School of Law in Wilmington, DE. She blogs on nanotechnology and the law.
If the terms “nanotechnology,” “nanoparticles,” and “engineered nanomaterials” (ENMs) are not yet in the daily vocabulary of attorneys practicing in the area of environmental law, they soon will be. We are seeing an explosion of interest in and information about nanotechnology, its uses and its risks. But the law has yet to develop in this field. Nanotechnology impacts many fields, including the development of pesticides, consumer products, electronics, and biomedical technology. As governmental and scientific bodies have begun to consider the potential hazards of ENMs, they have sought to achieve an appropriate balance between scientific innovation and public safety.
The definition of nanotechnology developed by the National Nanotechnology Initiative (NNI)—an interagency program of the U.S. government—is “the understanding and control of matter at dimensions between approximately 1 and 100 nanometers, where unique phenomena enable novel applications.” National Science and Technology Council et al., NATIONAL NANOTECHNOLOGY INITIATIVE STRATEGIC PLAN 3 (Feb. 2011). In matters of nanotechnology, size is key, and by way of scale comparison, the NNI notes that the thickness of a sheet of paper is approximately 100,000 nanometers. At the nanoscale, particles behave differently than analogous substances of larger scale. This characteristic not only allows nanoparticles to provide new applications—such as energy efficient insulation, pollution detection devices, or drug delivery systems for cancer—but also has the potential for unique and significant health and environmental risks. Although the NNI Strategic Plan states that responsible development of nanotechnology to assure environmental health and safety is an important goal, the document emphasizes commercial goals. See id. at 29–32. And the reality is that while the government is scrambling to develop an approach to the assessment of the risks of nanotechnology, hundreds of products and applications relying on nanotechnology are in daily use without significant oversight, and a large portion of the nanoparticles find their way into the environment.
The President’s Cancer Panel has identified ENMs as a category of emerging industrial hazards requiring safety research and regulation. Nanomaterials pose potential threats to the workplace environment, ecological systems, and individual consumers, but little is known about the magnitude of those risks. According to the President’s Cancer Panel, “ENM safety research and regulation is lagging behind their creation.” President’s Cancer Panel, Reducing Environmental Cancer Risk: What We Can Do Now (2008–2009 Annual Report) 40 (2010). The panel specifically noted the ease with which nanoparticles could enter the human body and penetrate cell membranes. In a highly publicized study published in late 2009, researchers from the University of California, Los Angeles, studying the effects of titanium dioxide nanoparticles, regularly used in many consumer products, including cosmetics (especially sunblocks), food coloring, toothpaste, and paint, reported a connection between the nanoparticles and genetic harm. Benedicte Trouiller et al., Titanium Dioxide Nanoparticles Induce DNA Damage and Genetic Instability In vivo in Mice, 69 CANCER RES. 8784, 8787 (2009). Furthermore, preliminary research suggests that nanoparticles entering the environment may interfere with certain ecosystems. See, e.g., Kerstin Hund-Rinke & Markus Simon, Ecotoxic Effect of Photocatalytic Active Nanoparticles (TiO2) on Algae and Daphnids, 13 ENVTL. SCI. & POLLUTION RES. 225 (2006). Clearly, comprehensive assessments are warranted.
Going forward, the challenge for regulators is to find the appropriate balance between encouraging innovation in nanotechnology and limiting its potential health and environmental risks. This is no simple task, due to the variety of applications of nanotechnology and the number of agencies (federal, state, and international) called upon to assess and manage the risks. For example, on the federal level alone, chemical substances are regulated directly under the Toxic Substances Control Act (TSCA), Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Occupational Safety and Health Act (OSHA), Federal Food, Drug, and Cosmetic Act (FDCA), Consumer Product Safety Act (CPSA), and Federal Hazardous Substances Act (FHSA).
Furthermore, the existing applicable statutes were enacted at a time when the unique challenges of nanotechnology were not yet contemplated, and some of these statutes do not easily reach ENMs or will require time-consuming amendment to satisfactorily address the issues. Currently, efforts to determine the best ways to regulate ENMs—and the extent to which new regulation is necessary—are proceeding on all fronts, but certainty and consensus are still a distance away. At a minimum, attorneys representing manufacturers, stakeholders, environmental groups, and private citizens should be aware of the following developments currently in process.
Look for action by the U.S. Environmental Protection Agency (EPA) under TSCA Section 5 first. This section gives EPA the authority to regulate ENMs as “new chemical substances” (such as carbon nanotubes) or “significant new uses” of “existing chemical substances” (such as some metal oxide particles) through a process that begins with disclosure by the chemical manufacturer or importer. See TSCA § 5(a)(1)(B), 15 U.S.C. § 2604(a)(1)(B). The regulatory approach varies depending upon which definition the substance falls under, and there is disagreement about how to categorize some ENMs for TSCA purposes. In general, chemical importers, manufacturers, and processors must notify EPA of their use of such chemicals and must develop data and act to prevent human and environmental exposure to hazards. EPA is currently developing a process to prioritize chemicals for review under TSCA, with one factor being the characteristics of a chemical that cause it to persist or bioaccumulate in the environment, thereby creating a toxic risk to humans or the environment. EPA’s efforts to apply these provisions of TSCA to ENMs are ongoing and increasing.
At the same time, EPA is taking action under the basic FIFRA provisions governing the registration of pesticides. Section 3(a) of FIFRA requires that all pesticides must be registered to be distributed in commerce, 7 U.S.C. § 136a(a), with applicants being required to demonstrate that the proposed use of the pesticide will not “cause unreasonable adverse effects on the environment.” Id. § 136a(c)(5)(D). EPA employs a risk-benefit analysis to determine whether the environmental effects will be “unreasonable.” Id. § 136(bb). EPA’s draft policy sets forth a presumption that pesticides containing nanomaterials will be considered “new” for the purpose of registration, even if a non-nanoscale form of the same substance is contained in a previously registered product. See Pesticides; Policies Concerning Products Containing Nanoscale Materials, 76 Fed. Reg. 35, 383, 35, 387–88 (June 17, 2011); see also EPA, Regulating Pesticides that Use Nanotechnology. Thus, for example, although silver is registered as a pesticide, nanosilver would be considered “new.” EPA’s proposed risk assessment approach to nanosilver may provide a template for its treatment of other nanoscale ingredients in pesticides. Issues remain, however, as to whether specialized risk assessments should be developed for nanoscale-containing pesticides, and clearly more data are needed.
The impact of nanomaterials in the workplace environment is also a matter of concern, but no federal regulations currently exist that specifically address ENMs. Efforts are under way to determine the health and safety risks of carbon nanotubes and other substances, particularly for exposures through inhalation and absorption. In 2004, the National Institute for Occupational Safety and Health (NIOSH) established the Nanotechnology Research Center to encourage and coordinate research on ENMs with the goal of creating guidelines for the safe handling of nanomaterials in the workplace. NIOSH has published summaries of much of its field data. See NIOSH, PROGRESS TOWARD SAFE NANOTECHNOLOGY IN THE WORKPLACE: A REPORT FROM THE NIOSH NANOTECHNOLOGY RESEARCH CENTER (2010) (reporting project updates for 2007 and 2008). Without direct regulation of ENMs, the requirements of OSHA, 29 U.S.C. §§ 651–678, and the standards promulgated thereunder provide the basic workplace regulation. Even though OSHA standards may not yet exist for nanomaterials, the general duty clause in Section 5 of the Act imposes a general duty on an employer to keep the workplace free from “recognized hazards” that cause or are likely to cause death or serious physical injury to employees. Determining what is a “recognized hazard” requires some scientific data, but the degree of certainty necessary before such a hazard may be recognized is unclear.
Similarly, the Hazard Communication Standard (HCS), 29 C.F.R. § 1910.1200, provides for the evaluation of chemicals used in the workplace for hazard identification and establishes a comprehensive mechanism for the communication of hazards to employees when the “employees may be exposed under normal conditions of use or in a foreseeable emergency.” Id. § 1910.1200(b)(2). The mechanisms of communication include material safety data sheets, shipping and workplace labels, development of a written hazard communication plan, and worker training.
All of these mechanisms would apply to nanomaterials that may be identified as hazards under the regulations. Whether a chemical is a “health hazard” is determined by “statistically significant evidence based on at least one study conducted in accordance with established scientific principles that acute or chronic health effects may occur in exposed employees.” See id. § 1900.1200(c). The ongoing research by NIOSH could eventually result in determining which nanomaterials may be health hazards and whether OSHA should promulgate specific standards relevant to ENMs in the workplace.
Much is happening internationally to address nanomaterials in the environment and in consumer products. The European Union (through its REACH regulation) and Australia have taken substantial steps toward adopting a definition of “nanomaterials” for use in setting standards and developing regulations. See What’s in a Name? Defining “Nanomaterials." Among the many initiatives undertaken abroad, some countries have issued guidelines to assist industry in providing information to workers on safety data sheets about the hazards of ENMs. See, e.g., State Secretariat for Economic Affairs, Safety Data Sheet (SDS): Guidelines for Synthetic Nanomaterials (Dec. 21, 2010) (Switzerland). In another development, the International Organization for Standardization (ISO), of which the United States is a member through the American National Standards Institute, announced in 2011 the adoption of advisory standards for testing the inhalation toxicity of some nanoparticles. See ISO 10808:2010.
Beyond these few examples, other U.S. statutes (e.g., Clean Air Act, Clean Water Act, Endangered Species Act, Resource Conservation and Recovery Act), important state initiatives (e.g., California’s data call-ins), and foreign measures—all too numerous to list here—also provide authorization for actions that could result in a concerted effort to assess whether ENMs pose a threat to the environment, both outdoors and indoors. While some progress has been made, the attention to potential issues raised by nanotechnology remains highly fragmented among agencies, both domestic and international. Moreover, some agencies are intensely focused on specific substances—for example, EPA and nanosilver. The potential problems presented by nanotechnology are in need of a comprehensive regulatory policy and substantial ongoing data collection and analysis.