Reproduced from Nano Letters 2007, 7 (10). © 20 07 American Chemical Socie t y
The Challenge of Regulating NANOMATERIALS As the nanotechnology industry thunders ahead, filling consumer products with nanomaterials, experts worry about the lack of adequate oversight and regulation. RHITU CHATTERJEE
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et ready for a nanolife. Wake up in a bed with cotton sheets made bug-free with silver nanoparticles, brush your teeth with toothpaste bristling with nanogold, step into pants made dirtand moisture-resistant through nanofibers, and go out with nanosunscreen on your skin. These nanobased consumer products are already on the market around the world, and the list is growing. Nanomaterials could make life smoother. They promise to provide cleaner water and new ways to precisely target cancer cells. But despite the potential that nanotechnology holds, scientists, environmentalists, and policy experts around the world are © 2008 American Chemical Society
concerned about its unknown risks. “Every technology ever developed . . . has had some sort of adverse consequences, and sometimes they’ve been serious, sometimes not,” says J. Clarence Davies, a senior adviser to the Washington, D.C.-based, nonpartisan Woodrow Wilson International Center for Scholars’ Project on Emerging Nanotechnologies (PEN). In addition to chairing the National Academies’ Committee on Principles of Decision Making for Regulating Chemicals in the Environment, Davies served as the U.S. EPA’s assistant administrator for policy from 1989 to 1991. “It’s unprecedented and would defy common sense if there weren’t some problem somewhere” with nanotechnology, he adds. January 15, 2008 / Environmental Science & Technology ■ 339
DAVID HAW XHURST, PEN
More than 500 self-identified nanoproducts are on the market today, and the list is growing rapidly, according to the Project on Emerging Nanotechnologies. However, some warn that not all of these claims may hold up to a test of true nano-ness.
Thus far, these tiny yet powerful materials have not caused any known human-health problems or environmental disasters. However, a growing number of studies are illustrating that many of these substances can have detrimental effects on animals. A study by researchers at Southern Methodist University, Duke University, and the University of Washington Seattle showed that fullerenes (C60 nanomaterials often called buckyballs) can cause oxidative stress in the brains of largemouth bass (Environ. Health Perspect. 2004, 112 [10], 1058–1062). Another study, by a team at the Chinese Academy of Sciences and Peking University, showed that mice exposed to copper nanomaterials had serious kidney, liver, and spleen damage (Toxicol. Lett. 2006, 163 [2], 109–120). The miniature size of nanomaterials—the very property that bestows on them special powers— and the way their surfaces are modified increase the ease with which they can interact with biological systems, thus increasing the chances of causing harm. A recent study showed that when nanomaterials are coated with organic substances like lipids they become more accessible to water fleas (Environ. Sci. Technol. 2007, 41 [8], 3025–3029). The fleas ingest the materials and strip the lipid layer for food, eventually causing the naked carbon nanomaterials to block their digestive tracts and kill them. Research does not imply that all nanomaterials are inherently harmful, and experts agree that it would be unwise to stop nanomaterial production. The technology is growing rapidly. According to Lux Research, a New York-based independent intelligence and technology research and advisory firm, investments in the nanotechnology industry grew from $13 billion in 2004 to $50 billion in 2006. The firm projects that investments will reach $2.6 340 ■ Environmental Science & Technology / January 15, 2008
trillion by 2014. These predictions have many experts saying that it is imperative that the industry be carefully regulated before it’s too late. As Richard Denison, senior scientist with the advocacy organization Environmental Defense points out, given the pace of the industry’s growth, “the urgency for action has only increased.”
Regulating the new with the old In September, EPA declared that devices using silver or any other ions as a bactericide will be regulated as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This would include appliances like the Samsung washing machine that claims to use silver nanoparticles as a bactericide. However, in its notice explaining this decision, the agency maintains that it “has not yet received any information that suggests that this [Samsung washing machine] uses nanotechnology.” EPA also emphasizes that its notice “does not represent an action to regulate nanotechnology.” The agency is still discussing how best to regulate other kinds of nanomaterials in use or being developed. Regulating any new technology in its infancy is inherently problematic. A technology is pursued for its rosy promises. Yet, to develop a regulation, the government needs information about potential risks—information that is sorely missing in the beginning stages of any new technology. Nanomaterials are facing this catch-22 because scant data exist on their human-health and environmental risks. “Research into understanding the potential impacts of nanotechnology is so woefully underfunded,” says Andrew Maynard, science adviser to PEN. Until June 2005, Maynard co-chaired the Nanomateri-
Nano and TSCA A large part of the debate over legal requirements for nanomaterials has to do with whether they are considered “new chemicals” under TSCA, the law that requires companies to report to EPA any new chemicals being developed and gives the agency a chance to regulate new chemicals before they reach the market. According to Davies and many others, EPA ought to interpret TSCA to include all nanoscale substances as new chemicals, because it’s the easiest way for the agency to regulate them before they are manufactured and marketed. This interpretation would lead to the widest coverage for different types of exposure, including preventing exposures of workers. Congress passed TSCA with the goal of creating an inventory of chemicals in commerce, says Jim Willis, director of EPA’s chemical control division. When a company is planning to produce a chemical,
it’s required to register the product as a new substance with EPA and to provide all available data on the chemical. “Because of the way the program is structured, we can actually prevent new chemicals from entering into the market until our data needs are met,” says Willis. The agency reviews the company’s data, and if the product is deemed safe, the company is free to produce it. If the agency perceives a high level of risk, it requests more data or stops the chemical from being produced. Indeed, EPA has received “a number of new chemical notifications on nanoscale materials” over the past several years, Willis notes. However, EPA is still not regulating nanomaterials as new substances. In an EPA document, TSCA Inventory Status of Nanoscale Substances—General Approach, released on July 12, the agency explained why it could not group all nanomaterials as new substances solely on the basis of size. This is because the definition of a new chemical under TSCA is based on only molecular structure or identity. If a nanomaterial contains the same molecules as a chemical already in the TSCA inventory, it is an existing chemical, says Willis. And almost all nanomaterials being researched and manufactured today are chemically identical to existing chemicals in the TSCA inventory. Thus, EPA has no authority to regulate them. Carbon nanotubes and fullerenes, for example, are made of carbon, an existing chemical in the inventory. Ale x Parlini, PEN
als Environmental Health and Implications working group of the White House National Science and Technology Council. “We still don’t have a clear strategy on what research needs to be done and how that’s going to be done. We don’t have good mechanisms in place that are going to enable the research agencies to support or fund that research,” Maynard explains. While researchers and policy makers are trying to address research inadequacies, many agree that waiting for more data before regulating nanotechnology would be unwise. “There’s a large debate going on right now, both within the regulatory agencies and outside the agencies, concerning how nanotechnology fits in with the current regulatory structure,” says Maynard. But this technology poses a unique and difficult problem—a fundamental disconnect between the very basis of current regulatory structure (both in the U.S. and in other countries) and the underlying principles of nanotechnology. Many existing policies are based on the chemical properties of substances, whereas the power of nanomaterials lies mainly in their physics. “Most regulations developed over the last 50 years have really been focused on chemistry, and they’ve had a hard time dealing with physical structure,” Maynard continues. “And yet, we’re now in a case where the physical structure is becoming incredibly important. It’s something that nanotechnologists really rely on to make nanomaterials do what they want them to do. . . . We have a 21st-century technology, we’re trying to squeeze it into a 20th-century regulatory mindset, and the fit isn’t that good.” In May, PEN released the report EPA and Nanotechnology: Oversight for the 21st Century, which concluded that EPA is already empowered to regulate nanomaterials under several laws. Most of the environmental laws on the books—the Clean Water Act (CWA), the Clean Air Act (CAA), the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), the Resource Conservation and Recovery Act (RCRA), FIFRA, and the Toxic Substances Control Act (TSCA)—could be used. Each law would address “different parts of the nano life cycle,” Davies writes in the report.
Products with bona fide nanomaterials are already on the market but sometimes go unlabeled. All 19 sunscreens tested by the Consumers Union contained zinc oxide or titanium oxide nanoparticles, but only one of them—Keys Solar Rx—included nanoparticles on its label.
Representatives from companies that develop and manufacture nanomaterials say they commend EPA for clarifying its position on the matter. “We think that’s the appropriate way to look at it,” says Bill Gulledge, manager of the nanotechnology panel at the American Chemistry Council (ACC), an organization representing chemical companies. Lynn Bergeson of Bergeson and Campbell, P.C., a Washington, D.C.-based law firm specializing in industrial and chemical regulation, says that EPA’s clarification was “reassuring” to nanomaterial manufacturers. EPA’s document is neither a regulation nor guidance, she says. But it does “reaffirm that size January 15, 2008 / Environmental Science & Technology ■ 341
is not a distinguishing feature,” she adds. The EPA document also lists six characteristics that the agency considers when deciding whether a substance is new, says Bergeson. Among these characteristics are allotropes (different physical structures), isotopes (when the same element has different atomic masses because of variations in the numbers of protons), and crystal lattices of the same chemical. Carbon nanorods and fullerenes (or buckyballs) are both allotropes of carbon, as are graphite and diamond. So, the agency could potentially consider these two nanomaterials, which are variations in forms of the same chemical, as “new”. And this is where the “rubber hits the road,” says Bergeson. “I think those three [characteristics] will be subject to more comments from chemical manufacturers because EPA has not in all cases been entirely consistent with its interpretation of allotropes, isotopes, and crystal lattices,” she says. Occupational health experts from the National Institute of Occupational Safety and Health, environmentalists, and others have criticized EPA’s position on nanomaterials and TSCA, urging the agency to regard nanomaterials as new substances on the basis of their small sizes and how they interact with biological systems and the environment. According to Davies, EPA’s document makes a “pretty inexcusable policy statement,” because the agency doesn’t see a problem with the current policy. “That flies in the face of the science and the realities of the situation,” he says. “We know there are constraints in the law that keep us from regulating nano, but somehow we have to overcome those constraints.”
The voluntary approach
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PEN
Nonetheless, as Willis points out, EPA is “not convinced that it’s the time to enter into a regulatory
program.” Instead, the agency is proposing a voluntary reporting program, called the Nanoscale Materials Stewardship Program (NMSP). The NMSP proposal, released the same day as the inventory document, encourages companies to voluntarily report to EPA information on existing nanomaterials and nanobased products. The data should include chemical name; physical and chemical properties such as density, melting point, and surface area; expected uses; life cycle; and various byproducts that are likely to be produced during manufacture and use of the materials. It’s designed to have a basic and an in-depth component, Willis says. With the former, “the idea would be to have a reporting window where companies who produce these nanomaterials would voluntarily submit a report on each of the nanomaterials they manufacture,” he says. “We would hopefully get all—or at the very least, a major fraction of—the nanomaterials in production and in use in this country through that basic reporting.” The in-depth program would target select companies, those “with deeper pockets than others,” according to Willis. It would invite these industries, “either individually or by forming consortia or by other means,” to generate data on the health and environmental effects of nanomaterials. Representatives from industry groups like the NanoBusiness Alliance and ACC have praised EPA for creating the program and say they are planning to participate. Others, however, have criticized EPA for taking too long to start it. The program was initially suggested to the agency by a group of stakeholders in 2005. A similar open-ended approach was tried in the U.K., Denison says. Nine months into the British scheme, only nine companies had submitted data.
281
Product Categories Analysis: May 16, 2007
250
Number of products
Products listed as of March 8, 2006 200
150
100 61
58
50
43
42
24 0
Health and fitness
Home and garden
Electronics and computers
Food and beverage
Crosscutting
Automotive
Manufacturers of health and fitness products are leading in the race to use nanomaterials. 342 ■ Environmental Science & Technology / January 15, 2008
19 Appliances
10 Goods for children
PEN
250
247
Region of Origin Analysis: May 16, 2007 Products listed as of March 8, 2006
Number of products
200
150 123 100 76 50 27 0 USA
East Asia
(China, Taiwan, Korea, Japan)
Europe
(U.K., France, Germany, Finland, Switzerland, Italy, Sweden)
Other
(Australia, Canada, Mexico, Israel, New Zealand, Malaysia, Thailand, Singapore)
The U.S is currently ahead of all other countries in terms of the number of self-described nanobased products being manufactured.
“Not an overwhelming response.” However, EPA officials are now leaning toward setting a 3–9 month deadline for submissions for the basic program. The agency will also consider requiring mandatory reporting if participation in the NMSP is weak, says Willis.
A lot of talk, little action Lawmakers, scientists, and businesses around the globe are also discussing how best to tackle nanotechnology’s risks. The Organisation for Economic Cooperation and Development (OECD), an intergovernmental organization with representatives from 30 countries, has made nanotechnology one of its priorities. In March 2007, OECD established a working party on nanotechnology under its Committee for Scientific and Technological Policy to encourage dialogue between scientists, industries, regulators, and the public in OECD member and nonmember countries. The working group is compiling data from different countries and initiating international collaborations and discussions on the research, as well as policy approaches. Another OECD program, called the Safety of Manufactured Nanomaterials, focuses solely on the environmental and human health impacts of nanotechnology. Michael Barber of the Commonwealth Scientific and Industrial Research Organisation, Australia’s national science agency, says that OECD is providing an international forum where countries can communicate, collaborate, and share information, so that “we don’t duplicate information” and governments can “focus limited resources” on specific problems and interests. “OECD may be as good a vehicle as we
[have] for these kinds of discussions,” he adds. At the individual-country level, regulators and researchers alike are trying to address the problem of compiling and analyzing available information to get a clear picture of where the technology stands, what is known about risks, and where the industry is headed. This would also help regulators adopt more effective regulatory approaches. In the U.K, the Responsible NanoCode, an initiative founded by the Royal Society, Insight Investment (an investment company), the Nanotechnology Industries Association (NIA), and the U.K.-government-funded Nanotechnology Knowledge Transfer Network, has been working to develop a voluntary “code of conduct” for the industry. In October 2007, it released a draft for public consultation. Members of the initiative hope that the principles will be adopted worldwide to help industries identify risks from nanomaterials; share information with others, including the public; and prevent exposure of workers and consumers. The code requires a “very high level of engagement from the upper management” to develop safe nanoproducts, says Steffi Friedrichs, director of NIA. Developing regulations will take time, so in the meantime, a code can provide a good global framework for controlling the risks of nanotechnology, she says. All of this discussion illustrates just how much talk is being devoted to the environmental and human health impacts of nanomaterials, says Maynard. But, when it comes down to regulation and oversight “there is relatively little action,” he adds. Rhitu Chatterjee is an associate editor of ES&T. January 15, 2008 / Environmental Science & Technology ■ 343
