Companies are using nanotechnology (the manipulation of materials only one-billionth of a meter in size) to develop products ranging from clothing and sunscreen to high-tech computer components and sophisticated medical devices. While the nanotechnology industry is currently a darling of both public and private funding sectors, critics of the technology are urging caution, regulation or even a moratorium on the use of these tiny particles. Companies are now exploring ways to maximize the potential of the technology, while minimizing risks to workers, the environment and their bottom line. A large part of that effort should include exploring strategies to ensure that potential government regulation is firmly grounded in sound science, and is made open and accessible to the public.
Worker safety and chemical substance regulations already in existence could be applied to nanotechnology products and manufacturing processes, but it is not yet clear if or how the government might exercise this authority. Given this uncertainty, it is important for companies working with nano-sized materials to begin developing strategies for defining the potential risks associated with the technology, devising the means to mitigate these risks and, most importantly, effectively communicating this information to government agencies and the public.
Nanotechnology is a term used to describe the application of materials whose size is measured in billionths of a meter. (For perspective, consider that a human hair is about 80,000 nanometers in diameter.) At the nanoscale, materials exhibit unique properties and characteristics, enabling numerous new manufacturing possibilities in fields such as medicine, textiles, energy and electronics.
This year, the federal government will spend nearly $1 billion to fund nanotechnology research and development. The Environmental Protection Agency (EPA) has already funded dozens of projects exploring the possibilities nanotechnology holds for reducing pollution, and the Department of Defense has concluded that nanotechnology could revolutionize national security. The National Science Foundation has estimated that in just over a decade, nanotechnology will be a $1 trillion industry, employing about 2 million workers worldwide.
Potential Hazards: Real or Imagined?
Despite their manufacturing promise, some studies conclude that the small size of nano-particles can cause severe reactions in the pulmonary system, as well as other health problems. Studies that link nanoscale materials to lung and brain damage in animals have been publicized in articles appearing in the New York Times and the Washington Post. In contrast, other studies, such as testing performed by the National Institute for Occupational Safety and Health (NIOSH) at laboratories working with carbon nanotubes, indicate that very few nano-particles escape into the air where they could potentially be inhaled by workers.
In response to public health and safety concerns, some federal agencies have begun spending part of their nanotechnology budgets on risk research, and discussing how to regulate this unique industry. The EPA plans to spend $4 million funding studies on potential nanotechnology impacts, and the results of that research will guide EPA's regulatory efforts in this area. NIOSH recently launched a 5-year research program to study the health implications of nanotechnology, and plans to issue "best practices" guidelines for those working in the field.
The Regulatory Landscape
EPA and OSHA currently have regulations and standards in place that could address potential health or environmental hazards posed by the use of nanotechnology. These agencies are most likely to operate under these existing regulations rather than try to promulgate new ones specific to nanotechnology. Rulemaking is incredibly burdensome and time consuming for agencies, even for issues much less complex than this. Moreover, the formulation of a national consensus standard, assuming consensus on key issues could be reached, will certainly take years.
In lieu of new regulations, OSHA and EPA will likely develop guidance policies on how to apply their existing regulations to the nanotechnology industry. This is particularly true of OSHA, which has shown a penchant for amending compliance directives that "flesh out" existing standards.1 In light of these facts, the nanotechnology industry should position itself to educate government and the public about potential risks and the means by which industry is taking action to assess and mitigate them.
As discussed further below, other industries have been successful in assisting government agencies to develop performance-based regulatory frameworks that reflect current industry practices. For industries based on new technologies, this type of early involvement in policy-making is particularly important for consistent public acceptance.
In addition to its pollution control responsibilities for air, water and waste, EPA has the statutory authority to regulate nano-sized substances under the Toxic Substances Control Act (TSCA). TSCA authorizes EPA to regulate chemical substances that are not regulated under other statutory programs (such as food, drug or pesticide laws).This authority is quite expansive and includes market entry requirements for all new chemicals, which can result in the application of occupational safety controls and other mitigation measures before a substance ever reaches the workplace or the consumer. Adverse effect reporting and recordkeeping requirements automatically apply to all existing chemicals. EPA is also authorized to actively regulate substances that are determined to pose a known or a potential risk to human health or the environment. Whether EPA will consider nano-sized particles to be new chemicals, or whether the use of existing materials at the nano-level is considered a "new use" of an existing chemical, TSCA will apply. In appropriate instances, EPA can: require testing of chemicals for possible adverse health and environmental effects; require manufacturers to provide notice to EPA prior to marketing a new chemical substance or a new use of an existing chemical; regulate new chemicals or new uses through requirements ranging from labeling to controlled distribution to outright bans; and gather existing information about chemicals from manufacturers, processors and, in some cases, distributors.
EPA is perhaps most likely to use TSCA in the short term to obtain information on potential adverse health and environmental effects. Where such information is not voluntarily provided, EPA can require appropriate testing to be conducted and TSCA permits the costs of such testing to be shared among all manufacturers and processors of a given chemical. The small scale of nano-sized materials will make the availability of appropriate test protocols a critical factor in the development of useful data. Margins of error that could be acceptable at a larger scale may not be acceptable at the nanoscale. Industry's early development of agreed-upon test methodologies could be a significant step in determining any potential risk these materials might pose to human health and the environment, and therefore the scope of ultimate regulation of the technology.
In the longer term, EPA may consider the use of materials at the nanoscale to constitute either the use of a new chemical, or a new use of an existing chemical. In either event, EPA could require the submission of a pre-manufacture notice 90 days prior to commercialization of any nanoscale material. This 90-day period would allow EPA to review all available health, safety and environmental data regarding either the new chemical or the new use. Based on the outcome of this review, EPA would be in a position to impose appropriate controls on the substance's manufacture, processing, distribution in commerce, use or disposal.
OSHA has a variety of standards that currently apply to nanotechnology. For example, employers who manufacture nano-substances and ship them out as raw materials are required under the hazard communication standard (HCS), 29 CFR 1910.1200, to develop material safety data sheets (MSDSs) describing any known hazards of these materials, and providing other information, such as "safe handling" practices and likely "routes of exposure." Given the current uncertainty regarding the true hazards of nano-particles, the performance of hazard determinations under section 1910.1200(d) may require substantial testing. The preparation of an adequate MSDS not only presents an OSHA compliance issue, but also implicates significant tort liability issues in potential products liability lawsuits.
Assuming feasible engineering controls are not available, employers using nano-substances may also be required to provide respirators pursuant to OSHA's respiratory protection standard, 29 CFR 1910.134. Many nanotechnology applications are performed under vacuum, which would likely eliminate the need for respirators. If, however, respirators were required in some situations, novel techniques may be needed in order to determine whether they are effective and compliant with Section 1910.134 in light of nano-particle sizes.
Finally, the General Duty Clause, 29 USC 654(a)(1) could be used to address nanotechnology hazards. The general duty clause requires employers to maintain a workplace "free from recognized hazards." OSHA often relies upon voluntary consensus standards, including standards developed by the American National Standards Institute (ANSI), to prove that a hazard is "recognized." Given the current paucity of information regarding the hazards of nano-particles, it is far from clear at this point whether OSHA could prove that certain hazards are "recognized."
The ANSI Process
On June 16, the White House Office of Science and Technology Policy announced that ANSI planned to convene a group to begin developing voluntary standards for nanotechnology. As stated above, OSHA could eventually apply ANSI standards to nanotechnology to establish that a particular hazard is "recognized" under the General Duty Clause. One of the distinct benefits of the ANSI standard-setting process is its ability to facilitate international recognition of the consensus standards that result. The process is typically lengthy, however, and does not always result in the issuance of standards, particularly when controversial issues are involved.
ANSI's effort to develop an ergonomics standard is a case in point. The process began in the early 1990s and is currently at a standstill, mostly because the National Safety Council pulled out as the secretariat to the process. As such, although it offers considerable promise, the ANSI process should not be viewed as a panacea that will automatically fill any regulatory void left by OSHA or EPA.
Two Case Studies
Chemical Manufacturing: The chemical manufacturing sector has shown that educating and communicating with OSHA can result in flexible regulation that reflects industry practices. After the massive chemical accident in Bhopal, India in 1984, and subsequent U.S. incidents, OSHA decided to promulgate the process safety management (PSM) standard, 29 CFR 1910.119, to address safety at sites with certain threshold quantities of hazardous chemicals. Industry associations developed recommended practices to protect the health and safety of workers dealing with potentially hazardous chemicals, and more importantly, used their resources to educate OSHA on current industry practices. As a result, OSHA developed a fairly flexible performance standard that to some degree reflected these practices. There is no question that industry has argued through the years about OSHA's positions in applying the PSM standard, but the standard has generally allowed the chemical industry flexibility and has not hampered the development of new technologies.
Agricultural Biotechnology: Agricultural biotechnology presents a more complex picture. In the United States, industry actively supported regulation, helped educate the regulators and developed appropriate testing methodologies, all of which facilitated efforts by the federal government to build on an existing regulatory apparatus to effectively address potential health and environmental concerns. In contrast, many other countries either did not have adequate regulatory regimes in place to address products of biotechnology or were ill-prepared to respond to the concerns of a vocal minority, particularly in Europe, who oppose the technology for political, economic or ideological reasons.
Industry efforts to communicate with regulators and the public outside the United States have often been ineffectual. Although there has not been a single, validated instance of harm to humans, animals or the environment as a result of the products of agricultural biotechnology, opponents have called for bans of the technology based on unsubstantiated allegations of potential harm the technology might pose and the selective application of the so-called precautionary principle. This has resulted in a slow-down in the technology's world-wide acceptance, as well as reduced capital investment.
Some of these same critics have now set their sites on nanotechnology, and this emerging industry can learn from the lessons of agricultural biotechnology. By addressing concerns at the outset candidly and openly, adopting scientifically sound practices, and publicly engaging in a dialogue with critics, the nanotechnology industry can promote enlightened regulatory policy, encourage consumer acceptance and facilitate global freedom to operate.
The nanotechnology industry must be proactive in developing and applying scientifically sound risk assessment techniques and educating the government about how workers, consumers and the environment will be protected from any potential risks that are identified. Properly managed, these efforts will also serve to address potential liability concerns that may arise down the road.
Coordinated industry involvement in efforts to develop policies for regulatory oversight of nanotechnology will contribute to a more balanced approach that protects workers and the environment while continuing to encourage expansion of this exciting technology. Without such an industry effort, the government will regulate in a vacuum, or worse, will craft a regulatory structure based upon the potentially inflammatory and unsound allegations made by the opponents of emerging technologies.
Melissa A. Bailey and Rachel G. Lattimore are members in the Washington, D.C. office of Arent Fox PLLC. Bailey is a member of the firm's OSHA Practice Group, representing employers in safety and health compliance, litigation and legislative matters. Lattimore's practice has focused on regulatory counseling and litigation, with an emphasis on issues related to biotechnology, food safety, children's health and pesticide regulation.