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Since the National Nanotechnology Initiative was enacted into law in 2003, nanoscale technologies have captured the public spotlight. One of the hottest fields covered in the media, nanotechnology has entered the mainstream of everyday conversation as a familiar four letter word: “nano.” As a social phenomenon, it has become attached to and associated with products and devices that do not even contain nanomaterials. One nanometer, or one billionth of a meter, is a magical point on the dimensional scale. It is considered a special kind of small. At the nanoscale, phenomena occur on the length scale between 1 and 100 nanometers (nm), too small to be visible to the naked eye. This size matters to stakeholders who have substantial vested interests in the initial wave of nanoscale interdisciplinary innovation. In the last three years, a multitude of scholarly reports and scientific journals have published expected forthcoming societal benefits attributed to this so-called transformative, disruptive, emerging, converging, and enabling technology. Conferences and workshops tout the advances of building structures whose size is the same as individual molecules or collections of molecules, and creating devices with fundamentally new and unique properties and functions in government-funded or industry-based research and development laboratories. And, while this small matter has soared so much in popularity and increased in importance, how far along has nanotechnology truly advanced toward its projected expectations? What issues remain central to its continued progress? What concerns still polarize its constituents? The ETC Group helps put the regulatory status of nanotechnology in perspective. An Canada-based organization that supports responsible development of technologies and addresses international governance issues, the ETC Group recently announced an international competition to design a universal Nanotechnology Hazard Symbol to identify the presence of nanomaterials in products, laboratories and factories, or containers used in transport. Equally, this same organization calls for a moratorium on the production and release of nanoparticles until such time as a societal debate and precautionary regulations are in place to protect workers, consumers, and the environment from “the world’s most powerful (and potentially dangerous) technology.” Clearly, the ETC Group represents one extreme of the nanotechnology debate. On the other end of the controversy is the U.S. Food and Drug Administration and the Environmental Protection Agency, which convened public meetings to dialogue on the potential risks of nanotechnologies, the unpredictability of nanomaterials, and their still uncertain impact on health, workplace safety, consumer products, and the environment. Basic knowledge of the nanoscale is still a work-in-progress. A clear understanding of benefits and risks at this size scale remains elusive, as do the tools to easily and extensively manipulate it. To better identify the environmental, health, and safety research and information needed to understand and subsequently manage the potential risks of engineered nanoscale materials, the Nanotechnology Enironmental and Health Implications Working Group, comprised of 24 federal agencies and offices, recently released a report called “The Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials” (September 2006). The report defined engineered nanoscale materials, or nanomaterials, as “those that have been purposefully manufactured or synthesized to have a size with at least one dimension in the range of approximately 1-100 nm and that exhibit unique properties determined by this size.” Created by a subcommittee within the National Science and Technology Council, the working group was formally chartered in 2005 t (1) provide for exchange of information among U.S. federal agencies that support nanotechnology research and those responsible for regulation and guidelines related to nanomaterials; (2) facilitate the identification, prioritization, and implementation of research and other activities required for the responsible development, utilization, and oversight of nanotechnology, including research methods for life cycle analysis; and (3) promote communication of information related to research on environmental and health implications of nanotechnology to other government agencies and non-government parties. 1 Due to the early stage in development of nanomaterials and their applications, the working group acknowledged the risk to benefit ratio concern as a phenomenon not solely unique to nanotechnology, but to any new technology. A member and chair of the working group is the FDA, who convened its first public meeting on “Nanotechnology Materials in FDA Regulated Products” this month, fulfilling one of the mandates of its internal FDA Nanotechnology Task Force, formed just two months earlier. Charged with determining regulatory approaches that encourage the continued development of innovative, safe and effective FDA-regulated products using nanomaterials, the public meeting served to help the FDA learn about the kinds of new nanotechnology material products under development in the areas of foods, food and color additives, animal feeds, cosmetics, drugs and biologics, and medical devices that might fall under its jurisdiction. The FDA already faces several nanotechnology regulatory issues, not necessarily through any fault of its own: (1) limited authority for potentially high risk nano-products; (2) lack of a commonly accepted nomenclature, definition of a nanoparticle and an understanding of its properties; (3) limited basic public health research on nanomaterials; and (4) the possibility of new “tools” needed for new nanomaterials. 2 And, even though the FDA claims it has already approved many products with particulate materials in the nanosize range with no safety concerns raised related to particle size, it is expected to confront extensive applications for novel therapies and technologies containing these nanoscale particulates. One uncertainty will be determining when the performance of a product is a function of the size of the particular material. 3 The EPA Nanomaterials exhibit chemical, physical, and biological properties and behavior different than the same chemical substances displayed in bulk or macroscopic form, creating new classes of materials, and unique sets of properties. These not only enable new benefits, but allege to the possibility of unintended health and environmental risks. To better understand these potential risks and benefits and the types of nanoscale materials produced in the United States, the EPA called a public meeting on “Risk Management Practices for EPA Voluntary Nanoscale Materials Stewardship Program” under the Toxic Substances Control Act, 4as administered by the Office of Pollution Prevention and Toxics. 5 Held on the heels of the FDA meeting and to complement and support the EPA’s efforts on new and existing nanoscale materials, the program was designed for the purpose of encouraging the responsible commercial development of nanoscale materials while providing a firm scientific foundation for regulatory decisions. Pursuant to the announcement posted in the Federal Register, 6the EPA requested comments on the following risk management practices for nanoscale materials: (1) worker training and work practices; (2) hazard communication; (3) engineering controls; (4) personal protective equipment; (5) product labeling; (6) customer training; and (7) waste management and environmental release management. Under the Toxic Substances Control Act, many nanoscale materials are considered “chemical substances.” To date, the EPA has received and reviewed many new chemical notices under the act for nanoscale materials and expects those numbers to increase. Under its mandate, the EPA has the obligation to better understand the impact of the direct and indirect exposure to matter at nanoscale dimensions on human health and the environment. And, while the EPA proactively reaches out to glean a better understanding of potential health, environmental, and safety issues posed by the continued advance of nanotechnology, it equally acknowledges that at this stage in its research and development, it is premature to assess the impact of most engineered nanoscale materials. Early studies on its effects in the body or the environment have proven to be inconclusive. Unanswered questions did not prevent the EPA from forming a cross-Agency Nanotechnology Workgroup to develop a white paper for external review 7identifying research needs for and examining the potential environmental implications and applications of nanotechnology. Released in draft in December 2005, the Nanotechnology Environmental and Health Implications Working Group drew from this EPA paper before finalizing its inventory of research and scientific data available in the field. Aside from proposing recommendations on next steps for addressing science policy issues and research needs, the paper helped to focus the EPA on priorities for the near term. Additionally, it recognized the expected acceleration of the convergence, integration, and synergy of nanotechnology with biotechnology, information technology, and cognitive technology in the long-term resulting in the production of novel nanoscale materials. Defining convergence as “the development of novel products with enhanced capabilities that incorporate bottom-up assembly of miniature components with accompanying biological, computational and cognitive capabilities,” the EPA understands that it will need to establish a flexible, rapid and adaptable approach to expected emerging issues while formulating new policies or adapting existing policies, as needed. Nanoparticle Risk The U.S. federal nanotechnology research budget is matched or exceeded by Europe and Asia. As a result, international coordination and integrated efforts now address regulatory as well as environmental research on nanotechnology issues. The United Kingdom recently weighed in on these concerns with the release of its progress report on “Characterising the Potential Risks Posed by Engineered Nanoparticles.” 8Responding to the government’s response 9to the Royal Society and Royal Academy of Engineering report on nanotechnologies, 10the Nanotechnology Research Coordination Group was formed to coordinate research efforts related to the potential human health and environmental risks associated with nanomaterials. Organized around 19 research objectives detailed in the first research report published by theNanotechnology Research Coordination Group, 11five task forces reported: (1) metrology, characterization, standardization and reference materials; (2) exposure-sources, pathways, technologies; (3) human health hazard and risk assessment; (4) environmental hazard and risk assessment; (5) social and economic dimensions of nanotechnologies. Defining engineered nanoscale materials as “having been deliberately engineered (i.e. not natural or unintentional by-products of other processes); having two or more dimensions broadly at the nanoscale; and being ‘free’ within any environmental media at any stage in a product’s lifecycle,” the report detailed the actions plans and progress made by the United Kingdom toward meeting its 19 research objectives. Contrasting views and colliding opinions on regulating products containing nanomaterials reflect a coercive tension among stakeholders with competing interests, a common component of any innovation in any part of the world. However, until unresolved variables at the nanoscale become conclusive and data fully reliable without knowledge gaps, this four-letter small matter will continue to dominate public discourse and possibly even take on an entire new meaning. Until such time, as Sherlock Holmes admonishes in “A Scandal in Bohemia,” “It is a capital mistake to theorize before one has data.” 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. Endnotes: 1. The National Nanotechnology Initiative Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials. Nanoscale Science, Engineering, and Technology Subcommittee, Committee on Technology, National Science and Technology Council. September 2006:5. 2. http://www.fda.gov/nanotechnology . 3. Miller, Sonia E., “Regulating Nanotechnology: The FDA and the EPA Are Likely Federal Watchdogs,” NYLJ, Volume 233-Number 64 at 5. April 05, 2005. 4. http://www4.law.cornell.edu/uscode/15/ch53.html . 5. http://www.epa.gov/oppt/pubs/opptabt.htm . 6. Federal Register/Vol. 71, No. 192/Wednesday, Oct. 4, 2006/Notices. http://www2.ergweb.com/projects/conferences/nano/ . 7. http://www.epa.gov/osa/nanotech.htm . 8. http://www.defra.gov.uk/environment/nanotech/research/reports/index.htm . (October 2006). 9. http://www.dti.gov.uk/science-in-govt/st_policy_issues/nanotechnology/page20218.html . 10. www.nanotec.org.uk/finalReport.htm . 11. http://defraweb/environment/nanotech/research/reports/index.htm . (November 2005).

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