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Historically, innovation is accompanied by the potential for unknown risks and uncertainties, as well as unintended consequences and benefits. With the federal promulgation of the National Nanotechnology Initiative (NNI), a multi-agency U.S. government program aimed at accelerating the discovery, development, and deployment of nanoscale science, engineering, and technology, public interest groups, here and abroad have released reports and commentaries about the alleged hazards associated with nanotechnology because of its size, at times calling for a moratorium on its advance. As research and development on nanotechnology continues, government agencies both domestic and abroad have allocated monies toward gaining a better understanding of its impact on the environment, health and safety, as well as its regulatory, legal and ethical implications. The 2006 NNI budget request for societal dimensions is $82 million, which includes $39 million for programs directed at environmental, health and safety research and development, and $43 million for educational activities and research regarding its broad ethical and legal implications for society, including the workforce and the economy. The 21st Century Nanotechnology Research and Development Act of 2003 (Public Law 108-153) calls for assurances “that the ethical, legal, environmental, and other appropriate societal concerns … are considered during the development of nanotechnology” and “requires that a one-time study be conducted to assess the need for standards, guidelines, or strategies for ensuring the responsible development of nanotechnology.” Under the coordination of the Nanotechnology Environmental and Health Implications Working Group (NEHI), an interagency subgroup of the Nanoscale Science, Engineering and Technology Subcommittee within the National Science and Technology Council, existing rules, statutes, regulations and procedures are being reviewed as they relate to nanoscale products. Together with the U.S. Food and Drug Administration, the National Institute for Occupational Safety and Health (NIOSH) co-chairs the NEHI. Nanostructured materials are not a new phenomenon. However, what is new is the ability it offers to probe, manipulate, understand and engineer matter at atomic scales. Nanoscale titanium dioxide is increasingly being used in cosmetics, sun block creams, and self-cleaning windows. Nanoscale silica is being used in dental fillings. Nano-coatings and nano-composites are being used in electronics, bicycles, automobiles, and other consumer products. Although preliminary studies indicate that exposure to nanoparticles during manufacturing may occur through inhalation, dermal contact and ingestion, there is limited and inconclusive evidence that it is associated with any health risks. Yet, NIOSH is assessing the toxicology of nanomaterials and determining if they pose an occupational health risk, proposing that nanotechnology may require almost a paradigm change in the field of occupational safety and health. While not a regulatory agency, under the Occupational Safety and Health Act of 1970 (OSH Act, Public Law 91-596), NIOSH, part of the Centers for Disease Control and Prevention in the U.S. Department of Health and Human Services, is charged with conducting “research, experiments, and demonstrations relating to occupational safety and health” and with developing “innovative methods, techniques, and approaches for dealing with those problems.” It is responsible for conducting research, making recommendations and providing guidance relevant to nanotechnology materials and products to prevent work-related injuries, illnesses, and deaths. Last year, NIOSH created a Nanotechnology Research Center to accelerate progress in nanotechnology research across the institute. Currently, a Web-based Nanoparticle Information Library is under development that will serve to share information on nanomaterials and their health and safety-associated properties. Because of the continued uncertainty surrounding the effects of nanoparticles, NIOSH has embarked on preventive strategic, multidisciplinary and international actions. It has initiated a program under the National Occupational Research Agenda to characterize the physical and chemical properties of nano-aerosols, study their effects on biological systems, and evaluate if they pose work-related health risks. This fall, as part of the program, NIOSH released for comment the first draft of its “Strategic Plan for NIOSH Nanotechnology Research: Filling the Knowledge Gaps” as a users guide to acknowledge gaps associated with possible worker exposures to nanomaterials, health risks from such exposure, and the development of control technology. STRATEGIC GOALS As part of its nanotechnology research agenda, NIOSH identified four strategic goals: understand and prevent work-related injuries and illnesses possibly resulting from nanoparticles or nanomaterials; conduct preventive research; promote healthy workplaces; and through global collaborations, enhance workplace safety and health. Ten critical topics were identified to keep pace with the rapid evolution of nanotechnology: exposure and dose; toxicity; epidemiology and surveillance; risk assessment; measurement methods; controls; safety; communication and education; recommendations; and applications. Through publications and criteria documents, NIOSH communicates its recommendations to regulatory agencies such as the Occupational Safety and Health Administration (OSHA). Communications have included a position statement on nanotechnology, FAQs concerning nanotechnology, and updates on its nanotechnology research. Under development is a “best practices” document, with a Current Intelligence Bulletin on titanium dioxide in review. To date, NIOSH has co-sponsored two International Symposia on Nanotechnology and Occupational Health, with a third scheduled for 2007. Recently it released “Approaches to Safe Nanotechnology: An Information Exchange with NIOSH” as a resource for stakeholders wishing to better understand the safety and health applications and implications of nanotechnology in the workplace. OSHA Nano-products, materials, applications, and devices are governed today within the existing framework of statutes, laws, regulations, and policies. One example is OSHA. Charged with ensuring worker safety and health in the United States by working with employers and employees to create better working environments, it applies the following current standards to nanotechnology: hazard communication; respiratory protection; personal protective equipment; and occupational exposure to hazardous chemicals in laboratories. A new initiative partnering OSHA with the U.S. Environmental Protection Agency and several Department of Justice prosecutors is intended to enhance the ability to investigate violations and increase significantly criminal prosecutions against employers causing serious workplace injury or death. OSHA compliance officers are being trained by Justice Department and EPA criminal investigators. OSHA and the EPA, pursuant to a 1991 memorandum of understanding, work together to identify environmental and workplace health and safety problems to more effectively implement enforcement of statutes. Environmental crimes pursued under federal statute may result in prison sentences. A willful violation of the Occupational Safety and Health Act or a standard promulgated under it resulting in a death carries a maximum prison sentence of six months with a maximum individual fine of $250,000 and $500,000 for an organization. Employers manufacturing or working with nanomaterials need to be aware of and in compliance with worker and workplace safety programs. Because no other federal mandates exist to ensure worker health and safety in facilities that make or use nanomaterials, companies have begun to take the initiative to protect their workforce. Recently, Luna, a Virginia-based technology company, unveiled its NanoSAFE program. To ensure worker safety, it developed a five-point safety program: employee health assurance baseline health screenings to monitor for changes; workplace safety technologies, such as protective hoods; voluntary toxicological studies and testing; environmental impact assessments; and strategies for tracking nano-based products through their lifecycle. Luna is one of several industry efforts to proactively create a nanotechnology worker safety initiative. CONCLUSION While NEHI coordinates the review of rules, statutes, regulations and procedures as they relate to nanoscale products, and given the cross-disciplinary nature of nanotechnology, the existing regulatory methods to address the uncertainties and risks associated with such technology requires close assessment and evaluation — particularly from the design and mission of the governmental institution providing the oversight. Industry needs to continue taking a proactive stance to address the many unknowns associated with nanomaterials, while the regulatory processes in place continue to assess, evaluate, and better understand the workplace health and safety uncertainties of nanotechnology within their own circles. Sonia E. Miller, an attorney in private practice in New York and Washington, D.C., is the founder and president of the Converging Technologies Bar Association.

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